chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who as an infant had a milk allergy, who on 10-MAY-2007 in the morning was vaccinated in the right thigh with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot number 657034/0232U).  There was no illness at the time of vaccination.  Prior vaccinations included on 02-JUL-2003 a dose of MMR II (Enders-Edmonston, Jeryl Lynn, HPV-77) (MSD) and on 07-APR-2003 a dose of Varivax (Oka/Merck) (MSD).  It was reported that on 11-MAY-2007 (also reported as 12-MAY-2007) the patient developed a right leg that was red, swollen and warm to touch at the injection site.  The symptoms continued up to the 18-MAY-2007.  The patient's mom reported to the reporter that the redness continued up to the 25-MAY-2007.  No treatment was provided.  Unspecified medical attention was sought.  No product quality complaint was involved.  This is one of several reports from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/6/2007. In follow-up, it was reported that the patient recovered without incident. This is one of several reports from the same source. Additinal information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pruritus, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 19-JAN-2007 at 10:30 AM was vaccinated SC on right arm with second dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, (Oka/Merck upgrade process) (Lot # 655751/1121F).  Concomitant therapy on same day and time included a first IM dose on left arm of Vaqta (MSD) (Lot # 656495/1209F).  On 30-JAN-2007 the patient was seen in the office with chicken pox exposed by her father.  It was reported that rash appeared on 29-JAN-2007 on face, body with itching and no fever.  No complications were reported and the patient was given symptomatic treatment.  It was reported that patient's chicken pox was mild case.  Additional information has been received from the registered nurse who stated that the patient was seen in office on 30-JAN-2007 for rash on his face and body.  The patient was diagnosed with chickenpox.  No complications were reported.  At the time of report the patient had recovered.  No further information is expected.
Age: 1.1
Sex: M
Vaccine: MMRV
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from registered nurse (R.N.) concerning a 13-month-old male who on 30-MAY-2007 was vaccinated with a dose of PROQUAD (lot# 656551/1532F). On 05-JUN-2007 the patient broke out in a rash. On 07-Jun-2007 the patient was diagnosed with chickenpox breakthrough. The R.N. reported that the patient developed a full blown case of chickenpox. The patient was covered with about 75 lesions from his knees up. The R.N. reported that she did not think that the patient was exposed to anyone with chickenpox but she did not see the patient. Unspecified medical attention was sought. The outcome is reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a male patient who was vaccinated with a subcutaneous dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  Subsequently the patient developed swelling, tenderness, soreness and redness at the injection site.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Culture throat negative, Lymphadenopathy, Pharyngeal erythema, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a healthy, 12-month-old female with no known allergies, who on 31-MAY-2007 was vaccinated with a subcutaneous 0.5 milliliter first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655847/1386F).  There was no concomitant medication.  On 11-Jun-2007 the patient developed a measles like fine rash over her entire body, a low fever and swollen lymph nodes in her neck.  The child was treated with over the counter TYLENOL.  A throat culture on 12-Jun-2007, was negative for streptococcus.  It is reported that the patient is recovering.  No product quality complaint was involved.  Follow up information received on 30-Jul-2007 states that the patient is a female who on 04-Jun-2007, 4 days post vaccination developed swollen nodes, red throat and a fever.  On 11-Jun-2007 the patient developed a macular rash consistent with measles.  The outcome is unknown.  No more information is expected.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Streptococcal identification test negative
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a healthy, 12-month-old female with no known allergies, who on 31-MAY-2007 was vaccinated with a subcutaneous 0.5 milliliter first dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (lot# 655847/1386F).  There was no concomitant medication.  On 11-Jun-2007 the patient developed a measles like fine rash over her entire body, a low fever and swollen lymph nodes in her neck.  The child was treated with over the counter TYLENOL.  A throat culture on 12-Jun-2007, was negative for streptococcus.  It is reported that the patient is recovering.  No product quality complaint was involved.  Follow up information received on 30-Jul-2007 states that the patient is a female who on 04-Jun-2007, 4 days post vaccination developed swollen nodes, red throat and a fever.  On 11-Jun-2007 the patient developed a macular rash consistent with measles.  The outcome is unknown.  No more information is expected.
Age: 1.6
Sex: M
Vaccine: MMRV
Symptoms: Injection site discolouration, Injection site scar
Clinical narrative: Information has been received from physician concerning a "probably 1 1/2 -year-old" who was vaccinated on an unspecified date with a dose of PROQUAD. Subsequently, 3 or 4 weeks later, the patient developed a purplish, painless, elongated scar which was 2 inches long and 3 quarter inches wide at the injection site. From the side view there was a dent on the scar that looked like burned skin. Unspecified medical attention was sought. No laboratory or diagnostic tests were ordered. No product quality complaint was involved. The outcome is reported as not recovered. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMRV
Symptoms: Irritability, Pyrexia, Rash maculo-papular, Rash morbilliform, Streptococcal identification test negative
Clinical narrative: Information has been received from a physicians assistant concerning a 13-month-old black male with allergic rhinitis and no pertinent medical history who on 05-JUN-2007 (16:00) was vaccinated in his left thigh with his first 0.5ml dose of PROQUAD (Lot # "02266"). On 15-JUN-2007 after getting vaccinated with PROQUAD, the patient developed a measles like rash over the whole body, fever and irritability. The rash was further described as diffuse maculopapular rash which was measles like. No further information was provided. unspecified medical attention was sought during which a "strep" diagnostic lab was performed and the results were negative. No product quality complaint was involved. Follow-up information was received on 05-SEP-2007 and the previous narrative was updated to reflect exact time and date of vaccination, start date of the adverse experiences, and demographic information. The patient's status was updated to recovered for all adverse events except irritability. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning his 12 month old son who 15-MAY-2007 was vaccinated with PROQUAD. A few days later, on approximately 18-JUN-2007, the patient developed vesicles around the injection site. Subsequently, the patient recovered from vesicles around the injection site. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Neutropenia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of PROQUAD. It was reported that after receiving the vaccination the patient developed neutropenia. Unspecified medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Injection site erythema, Injection site rash, Pain, Rash
Clinical narrative: Information has been received from  a licensed visiting nurse concerning a 4 year old white female with no medical history or allergies who on 12-JUN-2007 at 9:40 AM was vaccinated SC on left leg with 0.5 ml dose of PROQUAD (Lot # 655746/1093F). Concomitant therapy on the on the say day included an IM fifth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid on right leg, a third SC dose of IPOL on left leg. Previous vaccines included a first dose of VARIVAX and a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). It was also reported  that on 19-JUN-2007 patient has possibly developed shingles. The patient developed an injection-site reaction that was a little larger than a 50 cent coin that consists of small red dots. Additionally, the patient had a triangular area consisting of 3 small red dots on her torso. There were no blisters. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from the licensed visiting nurse who stated that the child developed several red lumps around site of injection. The patient complained of stinging and also developed 4 red lumps on rib cage on left area. At the time of the report the patient recovered. No further information is expected.
Age: 1.1
Sex: M
Vaccine: HEPA, MMRV, PNC
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a 13 month old male who on 11-JUN-2007 was vaccinated subcutaneously with the "first dose" of PROQUAD (lot # 657555/0487U). Concomitant therapy included HAVRIX and PREVNAR. On 20-JUN-2007 the patient experienced nickel size hive by injection site. The patient sought unspecified medical attention. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on approximately 04-JUN-2007 was vaccinated with the second dose of PROQUAD. The first dose was given when the patient was 12 months old. About a week ago (on approximately 18-JUN-2007), the patient experienced "severe cellulitis on her upper thigh approximately two weeks after receiving PROQUAD. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with PROQUAD developed severe swelling at the injection site. No other information was available. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 4 year  month old male, with no previous allergies, or medical conditions who on 25-JUN-2007 was vaccinated with PROQUAD . There was no illness at the time of vaccination. Thirty hours after being immunized, on approximately 27 JUN 2007, the patient developed redness and swelling at the injection site, on the thigh. The area around the injection site measured 10 -12cm edema with 6-7 mm erythema. The patient was afebrile. The site was non tender. Unspecified medical attention was sought. No outcome was reported. There was no product quality complaint. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with two dose of ProQuad (Oka/Merck upgrade process) or two doses of Varivax (Oka/Merck). Subsequently, the patient developed a full blown case of chicken pox. The office that reported the case of chicken pox to the public health nurse was not the office that administered the vaccinations. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 19 year old female who was vaccinated IM with a first dose of Gardasil. Subsequently, the patient was diagnosed with Guillain-barre syndrome and was hospitalized. The patient's Guillain-Barre syndrome persisted. No product quality complaint was involved. Guillain-barre syndrome was considered to be disabling and immediately life-threatening. Additional information has been requested. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with a dose of GARDASIL (lot number unknown). On an unspecified date the patient developed migratory arthralgia. At the time of reporting it is unknown if the patient had recovered. The physician considered migratory arthralgia to be an other medical event (OME). Additional information is not expected. This is one of two reports.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy, Facial paresis
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no history of drug reactions/allergies who on 25-JUN-2007 was vaccinated with the first dose of GARDASIL 0.5 ml injection. On 27-AUG-2007, the patient was vaccinated with the second dose of GARDASIL 0.5 ml injection. There was no concomitant medication. On approximately 31-AUG-2007, the patient experienced Bell's palsy. On 31-AUG-2007, the patient went to the emergency room (ER) because she could not close her eye and one side of her face felt heavy. There was no swelling involved. The physician did not specify which eye or which side was involved. The ER physician gave her eye drops to keep her eye moist and a type of ointment. The ER report obtained by the physician stated the patient's condition as Bell's palsy. The reporting physician saw the patient on 05-SEP-2007 at the office and she still could not close her eye and felt heaviness on the side of her face. At the time of reporting, the patient's Bell's palsy persisted. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Abdominal pain, Hyperhidrosis
Clinical narrative: Information has been received from a physician concerning a patient who in August 2007, was vaccinated with Gardasil. After being vaccinated with Gardasil, the patient experienced sweating and abdominal cramps. The patient's outcome was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with hypersensitivity ("allergies") who on 27-JUL-2007 was vaccinated with a first dose of GARDASIL (lot# 658490/0802U). Concomitant therapy on 27-JUL-2007 included Menactra. Other concomitant therapy included Rhinocort.
Sex: F
Vaccine: HPV4
Symptoms: Prostatic acid phosphatase abnormal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first two doses of the GARDASIL series (0.5 ml, intramuscular). Subsequently the patient experienced a positive prostatic acid phosphatase (PAP) test. The patient was negative before being vaccinated with GARDASIL. The patient sought medical attention. The patient's outcome was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/8/2007.  Information has been received from a physician concerning two female patients (age not reported) who were vaccinated with the first two doses of the GARDASIL series (0.5 ml. intramuscular) (lot # not reported).  Subsequently both patients experienced a positive prostatic acid phosphatase (PAP) test.  Both patients were negative before being vaccinated with GARDASIL.  Both patients sought medical attention.  The patient's outcome was not reported.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site mass, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning her 24 year old daughter who was vaccinated with a 0.5 ml first dose of GARDASIL. It was reported that the patient experienced a small bump at the injection site area. Subsequently, the bump went away after the a few days. On a specified date the patient was vaccinated with a 0.5 ml second dose of GARDASIL. Subsequently the patient developed a hard bump at the injection site area which was still present. Unspecified medical attention was sought. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female with no known drug allergies or medical history who on 03-AUG-2007 was vaccinated with her first dose of Gardasil.  On 07-SEP-2007, the patient was vaccinated with her second dose of Gardasil, intramuscularly in the left arm (Lot#657868/0523U).  There was no concomitant medication.  On 07-SEP-2007 the patient experienced an itchy arm.  The itchiness was located on the same arm as the vaccination but not at the injection site.  The area that was itchy had no visible signs and was not raised or red.  The itchiness resolved before the patient left the office.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nuclear magnetic resonance imaging normal, Parosmia
Clinical narrative: Information has been received from a physician concerning a female who on June 2007, was vaccinated with a 0.5 ml first dose of GARDASIL. Subsequently the patient developed headaches, dizziness, and unusual olfactory response where she was smelling feces and other abnormal smells. The physisican referred the patient to a neurologist. Magnetic resonance imaging results were normal. The patient contacted the office by telephone. At the the time of the report the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter with an allergy to hepatitis B (manufacturer unknown) (MSD WAES 0709USA03332) who was vaccinated with a 0.5 ml first dose of Gardasil.  There was no concomitant medication.  Subsequently five days after vaccination the patient became weak, tired and dizzy.  For the first five days the patient felt fine.  The patient visited the office.  At the time of the report "it had been about 10 days since the symptoms started the the patient had not recovered".  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Hypersensitivity, No reaction on previous exposure to drug, Rash, Swelling face
Clinical narrative: Information has been received from a physician concerning a female who on approximately 05-JUL-2007 was vaccinated with a first dose of Gardasil.  The patient did not have an allergic reaction with the first dose.  On 06-SEP-2007 the patient was vaccinated with a second dose of Gardasil.  On 06-SEP-2007 within 24 hours the patient had a rash, swelling throughout the face, and redness on the left arm.  The physician prescribed ATARAX and corticosteroids (unspecified) as needed and instructed the mother to have the patient take take the corticosteroids (unspecified) if the swelling did not go down.  The patient reported that she felt she truly had an allergic reaction.  The physician reports that the patient "really did seem to have an allergic reaction" due to Gardasil.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning a 22 year old white female with no relevant medical history or illness at the time of vaccination who on 06-SEP-2007 was vaccinated in the right deltoid with a second dose of GARDASIL. There was no concomitant medication. On 06-SEP-2007 the patient experienced dizziness lasting 1/2 hour. The patient called the office and was instructed to lie down temporarily. The patient was to call if symptoms worsened or persisted The office had no further contact with the patient. On 06-SEP-2007, the patient recovered from dizziness. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 08-AUG-2007 was vaccinated with a first dose of Gardasil.  On 11-AUG-2007 the patient developed a headache.  The patient did not seek medical attention.  At the time of the report the patient was still experiencing the headaches.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  Subsequently shortly after injection the patient developed a rash.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning the nurse's daughter (age not specified), who was vaccinated (date not specified) with the first dose, 0.5 ml, of GARDASIL (lot # not provided). Following the vaccination, her daughter fainted. At the time of this report. The outcome of the event was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 15-JUN-2007 was vaccinated IM in the right upper arm with a 0.5 mL dose of Gardasil (lot #657006/0188U) and vaccinated in the left upper arm with a dose of MENACTRA.  On 16-JUN-2007, the patient developed a vesicular, itchy rash on the right arm.  The rash was described as "poison ivy-like" and spread to the other arm and then to her abdomen.  The patient contacted the physician's office and spoke to a nurse.  On approximately 20-JUN-2007, "4 or 5 days after onset of symptoms", the patient recovered.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Nodule, Overdose, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female employee with a history of helicobacter pylori infection who on 07-SEP-2007 was vaccinated intramuscularly with a 1mL dose of GARDASIL. There was no concomitant medication. The nurse reported that the employees was vaccinated at another office and received 2 doses at once (total of 1 mL). The patient developed extra soreness and a bump on left arm. The patient received unspecified medical attention at the office where she was employed. At the time of this report, the arm was a little sore and there was no redness. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with her first dose of Gardasil, IM.  One week post vaccination, the patient experienced irregular menstrual period (two to three weeks earlier than scheduled).  Subsequently, the patient recovered from irregular menstrual period.  Medical attention was sought.  Patient Quality Complaints (PQC) was not involved.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 08-MAY-2007 was vaccinated with the first dose of Gardasil (Lot # not provided).  On 17-JUL-2007 the patient received the second dose of Gardasil (Lot # not provided).  On 18-JUL-2007 the patient experienced severe itching an a large rash.  The patient sought unspecified medical attention.  The physician reported that the patient did not have any problems after the first dose.  The physician stated that she was "not sure" that the patient will receive a third dose of the vaccine.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil.  Subsequently the patient experienced syncope.  Unspecified medical attention was sought.  At the time of the report the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Subsequently the patient experienced syncope. Unspecified medical attention was sought. At the time of the report the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise, Nausea, Rash erythematous
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 21-DEC-2006 and 23-MAR-2007 was vaccinated with and first and second dose of Gardasil, respectively.  On 24-AUG-2007 the patient was vaccinated intramuscularly in the left deltoid with a 0.5mL third dose of Gardasil (Lot# 658556/1060U).  On 25-AUG-2007 the patient experienced nausea and general malaise.  On 26-AUG-2007 the patient experienced a headache that lasted two days.  On 27-AUG-2007 the patient developed non-pruritic red bumps "rash" that appeared on chest and back.  On 28-AUG-2007 the rash spread lower on trunk, and up the neck to the face.  On 30-AUG-2007 the rash and malaise significantly improved.  On 30-Aug-2007 the patient recovered.  On 31-AUG-2007 the patient was back to normal.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: Information has been received from a registered nurse concerning 2 approximately 18 year old females with no pertinent medical history or drug/allergies who in approximately May 2007 "about a month ago" were vaccinated with the first dose of GARDASIL, IM. There was no concomitant medication. The patient's got very lightheaded after receiving the vaccine. The patient's were instructed to lay down. Medical attention was sought. The patient's recovered from the event that same day. Additional information has been requested. This is a follow-up to reports previously submitted on 10/8/2007. Information has been received from a registered nurse concerning an 18 year old female with no pertinent medical history or drug reactions/allergies who on 23-MAY-2007 "about a month ago was vaccinated with the first dose of GARDASIL (lot# 657617/0384U). IM Concomitant therapy included "birth control pills" hormonal contraceptives (unspecified). On 23-MAY-2007 after being vaccinated. The patient became pale and she was laid back in the chair. The patient was very pale and weak but she did not faint. The patient was treated with ice that was applied to her forehead and neck. She was monitored for approximately 15 minutes. The patient felt fine and left the physician's office. The nurse considered the events as non-serious and related to therapy with GARDASIL.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood pressure normal, Body temperature normal
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with minocycline hypersensitivity who on 04-SEP-2007 at 2:12 pm was vaccinated with 0.5 ml second does of GARDASIL. Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection redness or swelling. The patient was TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. The patient did not report having a similar experience after her first dose of GARDASIL.  Additional information has been requested. Initial and follow-up information has been received from a nurse practitioner concerning an 17 year old white female with a minocycline hypersensitivity who on 22-AUG-2007 at 9:45 am was vaccinated into left antecubital with a first dose of GARDASIL (Lot #658222/0927U). Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 25-AUG-2007 the patient was in the office and reported that 2 days after vaccination (24-AUG-2007) she developed knee and leg pain bilaterally and swelling in the feet as bilateral arm pain with a rash on her lower legs. She went to her family doctor and was placed on MEDROL. On an unspecified date the patient recovered. On 04-SEP-2007 at 2:12 pm she was vaccinated with 0.5 ml second dose of GARDASIL. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection site redness or swelling. The patient was given TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with minocycline hypersensitivity who on 04-SEP-2007 at 2:12 pm was vaccinated with 0.5 ml second does of GARDASIL. Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection redness or swelling. The patient was TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. The patient did not report having a similar experience after her first dose of GARDASIL.  Additional information has been requested. Initial and follow-up information has been received from a nurse practitioner concerning an 17 year old white female with a minocycline hypersensitivity who on 22-AUG-2007 at 9:45 am was vaccinated into left antecubital with a first dose of GARDASIL (Lot #658222/0927U). Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 25-AUG-2007 the patient was in the office and reported that 2 days after vaccination (24-AUG-2007) she developed knee and leg pain bilaterally and swelling in the feet as bilateral arm pain with a rash on her lower legs. She went to her family doctor and was placed on MEDROL. On an unspecified date the patient recovered. On 04-SEP-2007 at 2:12 pm she was vaccinated with 0.5 ml second dose of GARDASIL. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection site redness or swelling. The patient was given TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female with minocycline hypersensitivity who on 04-SEP-2007 at 2:12 pm was vaccinated with 0.5 ml second does of GARDASIL. Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection redness or swelling. The patient was TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. The patient did not report having a similar experience after her first dose of GARDASIL.  Additional information has been requested. Initial and follow-up information has been received from a nurse practitioner concerning an 17 year old white female with a minocycline hypersensitivity who on 22-AUG-2007 at 9:45 am was vaccinated into left antecubital with a first dose of GARDASIL (Lot #658222/0927U). Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 25-AUG-2007 the patient was in the office and reported that 2 days after vaccination (24-AUG-2007) she developed knee and leg pain bilaterally and swelling in the feet as bilateral arm pain with a rash on her lower legs. She went to her family doctor and was placed on MEDROL. On an unspecified date the patient recovered. On 04-SEP-2007 at 2:12 pm she was vaccinated with 0.5 ml second dose of GARDASIL. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection site redness or swelling. The patient was given TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abasia, Asthenia, Pallor, Tinnitus
Clinical narrative: Information has been received from a mother concerning her 27 year old daughter who on 20-JUN-2007 was vaccinated in the left arm with a dose of Gardasil (Lot #654885/1424F).  Concomitant vaccination included MENACTRA.  Other concomitant therapy included tuberculin purified protein derivative.  On 20-JUN-2007 the patient stated within five minutes after receiving the vaccines that "she started to feel weak within ringing in the ears".  Her face was pale with no color and she was unable to walk.  The nurse and the mother escorted her to the treatment room where she laid for approximately five minutes.  She used cold compresses.  On 20-JUN-2007 the patient fully recovered and went home.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a 14 year old female who on 08-AUG-2007 was vaccinated with a first dose of Gardasil. On 19-AUG-2007 "the patient developed shingles". The patient contacted the physician by phone call. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Lymphadenopathy, Pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 19-APR-2007 was vaccinated with a first dose of Gardasil.  On 31-AUG-2007, the patient was vaccinated with a 0.5 mL second dose of Gardasil (lot 658588/1061U).  On 03-SEP-2007, the patient felt achy all over, had a fever of 102-103, and tender swollen glands.  The patient sought unspecified medical attention.  At the time of this report, outcome was unknown.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female with a history of dysmenorrhoea and no known drug allergy who on 02-JUL-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 ml first dose of Gardasil (Lot #657737/0522U). Concomitant therapy included YASMIN. On 04-JUL-2007 the patient experienced fever and fatigue. It was reported by the medical assistant that the patient was instructed to call the physician's office if experiencing any injection site pain. The patient did not report injection site pain. There were no other symptoms noted. The patient did not seek medical attention. On approximately 07-JUL-2007 the patient recovered. Additional information has been requested.
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 who on 31-AUG-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil (lot 657962/0515U).  There was no concomitant medication.  On 05-SEP-2007 the patient developed hives.  The patient was seen at the student health center and was treated with diphenhydramine HCl.  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 19 year old female with penicillin allergy and a history of pseudomotor cerebri who on 10-JUL-2007 at 11:00 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil.  On 04-SEP-2007, the patient was vaccinated intramuscularly with a 0.5 mL second dose of Gardasil (lot 658556/1060U).  Concomitant therapy included EFFEXOR, TOPAMAX and ALLEGRA-D.  On 04-SEP-2007, at approximately 4:15 pm, the patient called the office to report that she had hives on her face.  The patient described the hives as "coming and going".  On 04-SEP-2007, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Dizziness, Headache, Vomiting
Clinical narrative: Information has been received from a female medical assistant (age not reported) who on 04-SEP-2007 in the mid afternoon was vaccinated with the first dose of Gardasil, 0.5 mL, injection. Concomitant medication was not reported. On 05-SEP-2007 in the early hours of the day "around 2 or 3 am" following her first dose of Gardasil, the patient experienced dizziness, headache, stomach pain and vomiting. No laboratory diagnostic studies were reported. Subsequently on 05-SEP-2007 "around 10 am", the patient recovered from dizziness, headache, stomach pain and vomiting. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil (lot number not provided). Subsequently the patient experienced significant hair loss described as hair was "coming out in clumps." The patient sought medical attention and the physician recommended that the patient see a dermatologist. The product quality complaint unit was not involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first 0.5 ml dose of Gardasil.  Subsequently the patient experienced fainted.  Unspecified medical attention was sought.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy site unspecified normal, Dysphagia, Endoscopy normal, Oesophagitis, Weight decreased
Clinical narrative: Information has been received from a licensed practical nurse, concerning her 19 year old daughter with Crohn's disease, who on 26-FEB-2006 was vaccinated with the first dose of Gardasil. Concomitant therapy included PENTASA, FLAGYL, REMICADE and prednisone. Following the vaccination (duration of time not specified), her daughter experienced esophagitis, dysphagia, and weight loss. On unknown dates, her daughter was vaccinated with the second and third doses of Gardasil, and following each of these vaccinations, she experienced a return of the esophagitis, dysphagia and weight loss. Diagnostics studies included an endoscopy and a biopsy, both of which ruled out herpes esophagitis. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 17 year old female patient who was vaccinated with the first dose, 0.5 ml, of Gardasil (Lot # not provided).  Following the vaccination, she "experienced a near syncope situation and had to sit down."  Subsequently, the patient recovered (duration and date not specified).  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/8/2007. Initial and follow up information has been received from a physician concerning a 16 year old (previously reported as 17 year old) female student with no known medical conditions, who on 04-SEP-2007 at 10:00 am, was vaccinated in the right deltoid with the first dose, 0.5 ml, of GARDASIL (Lot # 658560/1062U). There was no illness at the time of vaccination. Following the vaccination, she "experienced a near syncope situation and had to sit down" symptoms include slight tremor, and she turned pale. Within a "few minutes" the patient recovered with no after effects. The patient sought unspecified medical attention. No further information is expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female with no drug reactions or allergies who on 11-JUN-2007 was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On 18-AUG-2007, the patient was vaccinated intramuscularly with the second dose of 0.5 mL dose of GARDASIL, (Lot # 0211U). It was reported that the patient called the office on 05-SEP-2007, and reported that she had not had her menses since she received her second dose of GARDASIL on 18-AUG-2007. The medical assistant was unable to provide the date of the patient's last menstrual period. The patient was scheduled for a pregnancy test in the office on 06-SEP-2007. No further information was available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Hyperventilation, Metabolic function test normal, Nausea, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 31-AUG-2007 was vaccinated with the first dose of 0.5 ml Gardasil injection.  On 31-AUG-2007, the patient experienced nausea and hyperventilation.  The patient was taken to the emergency room.  Urinalysis, serum glucose, and metabolic profile were within normal limits.  Subsequently, the patient recovered from nausea and hyperventilation on 31-AUG-2007.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Cold sweat, Diarrhoea, Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil. Ten minutes after getting the vaccination, the patient experienced syncope in the waiting room. Later that same day, she experienced abdominal cramps, cold sweats and diarrhea. The outcome was not reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Breast pain
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who was vaccinated into the left arm with a 0.5 ml second dose of Gardasil. Subsequently, the patient experienced breast pain. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a 24 year old female who on approximately 06-AUG-2007 was vaccinated IM with a 0.5 ml first dose of GARDASIL. There were no concomitant medications. The patient stated that she might be pregnant. She has not been tested, but she is "showing symptom" of pregnancy. The patient reported that if she was pregnant," it happened within the past month". Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced syncope. Unspecified medical attention was sought. At the time of the report the patient recovered. Additional information has been requested.