chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a teenage female patient who was vaccinated with a dose of Gardasil. Subsequently the patient fainted in the physician's office after receiving the vaccination. Subsequently, the patient recovered while in the office and was sent home. The patient did not require additional medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who was vaccinated with a dose of Gardasil. Concomitant therapy included MMR II and another unspecified vaccine. Subsequently the patient broke into a rash on the site where the Gardasil was given. Unspecified medical attention was sought. Subsequently, the patient recovered from the rash after three days. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pulse pressure decreased, Tension, Tremor
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 01-AUG-2007 was vaccinated with the first dose of Gardasil.  On 01-AUG-2007 the patient experienced muscle tenseness in her arms, legs and torso, tremors and a weak pulse.  Subsequently, the patient recovered from muscle tenseness in her arms, legs and torso, tremors and weak pulse on the same day.  Medical attention was sought.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 15 year old female who on 01-AUG-2007 was vaccinated IM in the right deltoid with the first dose of GARDASIL vaccine (0530U). On 01-AUG-2007 the patient experienced muscle tenseness in her arms, legs and torso, tremors and a weak pulse. Subsequently the patient recovered from muscle tenseness in her arms, legs and torso, tremors and weak pulse on the same day. Medical attention was sought. Follow-up information received from a Registered Nurse reported that post vaccination the patient was walking out of the room and fainted to the floor. Her posture was almost like a seizure. The patient recovered in 3-5 minutes. The patient was monitored for 30 minutes. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 01-AUG-2007 was vaccinated with the second dose of Gardasil and fainted 2-3 minutes after receiving the vaccine. The patient recovered that same day. Medical attention was sought. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pyrexia
Clinical narrative: Information has been received from a Registered Nurse concerning a 20 year old female with an aspirin allergy who on 05-JUL-2007 was vaccinated with Gardasil (Lot#657736/0389U). There was no concomitant medication. On 05-JUL-2007 the patient experienced dizziness and low grade fever. Subsequently, the patient recovered from dizzy and low grade fever the next day. Medical attention was sought. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female patient who on 29-MAY-2007 at 11:00 AM, was vaccinated into the left arm with a first dose of Gardasil. Suspect therapy included MENACTRA and VAQTA (manufacturer unknown). After administration of the vaccine's the patient experienced a vasovagal reaction. The patient was "O.K." after 10 to 20 minutes. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Body temperature increased, Chest discomfort, Oedema peripheral, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning 8 to 9 patients who on approximately 30-JUL-2007 were vaccinated with the first or second dose of Gardasil (lot not reported).  Subsequently the patients experienced swollen arms, low grade fever and tight chestness.  The patients sought unspecified medical attention.  The outcome was not reported.  There was no product quality complaint involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Haematology test, Heat exhaustion, Syncope
Clinical narrative: Information has been received from the mother of a 20 year old female with no known medical history and no known drug reactions/allergies who "sometime in June" 2007, was vaccinated intramuscularly with a dose of Gardasil (lot # not reported). Concomitant therapy included unspecified "birth control pill". "Two to three weeks after first dose", the patient experienced three heat exhaustion episodes that included fainting since she began the Gardasil dosing schedule in June. The patient sought unspecified medical attention. The patient's three heat exhaustion episodes and fainting persisted. there was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient with an allergy to grapes who was vaccinated with a dose of Gardasil. Subsequently, the patient experienced an anaphylactic reaction. Upon further contact with the patient, the patient shared she had eaten grapes at an Italian restaurant and that "was what caused the reaction." At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Inappropriate schedule of drug administration
Clinical narrative: Initial and follow up information has been received from a certified medical assistant (CMA), concerning a 16 year old female patient, who on 20-DEC-2006 was vaccinated IM in the arm, with the second dose, 0.5ml, of Gardasil (Lot # not provided). The CMA reported that the patient was "late" with receiving the vaccination, and added that the patient complained that "the medicine burned." At the time of this report, the patient had recovered from the event (date and duration not specified). The patient sought unspecified medical attention. The CMA reported other "young teenaged" patients also experienced the medicine burning when vaccinated with Gardasil (lot # not provided) (WAES #0708USA01332). Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician, via a company representative, concerning the physician's daughter (age not reported), who was vaccinated IM on unspecified dates with the first dose and the second dose of Gardasil (Lot # not provided).  Following both the first vaccination and the second vaccination, his daughter experienced nausea, and dizziness that lasted for "about a day afterwards."  The physician indicated he was planning to proceed with the third vaccination for his daughter.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 14 year old female who on 01-AUG-2007 at 2:00 pm, was vaccinated IM in the left arm with a first dose of Gardasil (lot # 655849/0263U).  Concomitant vaccination in her right arm included a dose of BOOSTRIX.  On 01-AUG-2007 in the evening, the patient experienced swollen lymph nodes in her neck (left side) and it was painful to the touch.  Unspecified medical attention was sought.  The patient's swollen lymph nodes in her neck and painful to the touch persisted.  Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 02-AUG-2007 was vaccinated with a first dose of Gardasil.  On 02-AUG-2007 the patient fainted.  Subsequently, the patient recovered from fainted.  It was reported that the patient did not seek medical attention.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female with no pertinent medical history who on 21-MAY-2007 was vaccinated with a first dose of Gardasil.  There was no concomitant medication. On 28-MAY-2007 the patient experienced pain at injection site.  She also had limited mobility and severe weakness in the entire arm for six weeks.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  On 27-JUL-2007, the patient was vaccinated with a second dose of Gardasil.  On approximately 27-JUL-2007 the patient experienced pain at injection site.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a physician concerning a teenage female who on an unspecified date was vaccinated IM with a first dose of Gardasil.  About a week after the vaccination the patient developed "cluster of plantar warts on her one foot".  Unspecified medical attention was sought.  At the time of the report, the patient's status was unknown.  The patient planned to continue the series.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 31-JUL-2007 was vaccinated IM with a 0.5ml dose of Gardasil.  On 02-AUG-2007 the patient was prescribed MEDROL.  The pharmacist reported, "that she did not think that the medication was prescribed to treat an allergic reaction."  The patient's specified details were not known.  Unspecified medical attention was sought.  At the time of the report, the status of the patient was unknown.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who on an unspecified date "couple of weeks ago" was vaccinated with Gardasil (lot# unknown) injection.  The patient experienced syncope "5 minutes" after receiving the Gardasil vaccination.  Medical attention was sought.  The nurse had given the patient a Popsicle.  The patient had fully recovered after a couple of minutes and walked out of the office the same day as the vaccination.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Bedridden, Nausea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old female who on 08-AUG-2007 was vaccinated with her first dose of Gardasil, intramuscularly (lot# reported at "0727U").  Concomitant therapy on that same date included Tdap and MENACTRA.  On 09-AUG-2007 the patient experienced severe nausea, vomiting and was bedridden.  The physician advised the patient to stay hydrated.  On 10-AUG-2007, the patient recovered from severe nausea, vomiting and bedridden.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on 23-AUG-2007 was vaccinated with the first dose of Gardasil.  On approximately 23-AUG-20007 the patient experienced hives on her neck and face.  The patient sought medical attention from her physician.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pharyngeal oedema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24 year old female with no drug reaction, allergies or pertinent medical history who on 30-MAY-2007 was vaccinated with her first dose of Gardasil, 0.5 mL, IM (Lot # 658222/0927U).  Concomitant therapy included LOESTRIN FE.  After her initial vaccination of Gardasil, the patient experienced redness and a feeling of swelling of the throat.  The patient denied any respiratory difficulty.  The symptoms resolved within three days without requiring treatment and on 02-JUN-2007 the patient fully recovered.  No laboratory studies were performed.  The patient sought medical attention by calling the office.  Patient Quality Complaints (PQC) was not involved.  On 30-JUL-2007 the patient received her second dose of Gardasil and did not report any adverse reactions.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse, via a company representative concerning a 13 year old female patient, who in August 2007 (during the week of 13-AUG-2007), was vaccinated with the first dose of Gardasil (lot # not provided), and was also vaccinated with a dose of MENACTRA.  About 2 to 3 minutes after the vaccination was administered, the patient "passed out."  The nurse indicated she was out for approximately 20 to 30 minutes.  She was given a drink and had a cloth on her head, and was feeling better.  No medical treatment was required.  Additional information has been requested. Follow up information from the nurse stated that there were no further incidents or reactions reported. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Computerised tomogram, No reaction on previous exposure to drug, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female who on 08-AUG-2007 was vaccinated with her second IM dose of Gardasil.  On 15-AUG-2007 the patient experienced tingling sensations throughout the body.  Medical attention was sought via physician contact.  The patient was also examined by a neurologist (physician's name and outcome was not known). Lab diagnostic studies performed included "blood work" and "CAT scan" by the neurologist.  The patient's recovery status was unknown.  "It was reported that the patient did not have any problems with the first dose of Gardasil."  There was not product quality complaint.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Tongue discolouration, Tongue geographic
Clinical narrative: Information has been received from a registered nurse concerning an approximately 17 year old female who was vaccinated intramuscularly with a first dose of 0. mL Gardasil.  Concomitant therapy included MENACTRA.  Subsequently the patient experienced white patches on back of the tongue and uvula.  The patches were not painful but could be felt by the patient.  The patient sought unspecified medical attention.  As of 27-AUG-2007 the white patches in the patient's mouth were almost gone and her mother could see her uvula.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a registered nurse concerning a 17 year old white female student who was vaccinated intramuscularly with a first dose og 0.5 mL GARDASIl. Concomitant therapy included MENACTRA. Subsequently the patient experienced white patches on back of the tongue and uvula. The patches were not painful but could be felt by the patient. As of 27-AUG-2007 the white patches in the patient's mouth were almost gone and  her mother could see her uvula. In follow up it was reported that patient had "Geographic tongue" on 20-AUG-2007. The reporter mentioned it was unclear if "geographic tongue was a true reaction to any vaccine." The patient recovered. Additional information is not recovered.
Sex: F
Vaccine: HPV4
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a female 20 years of age or younger with no pertinent medical history who was vaccinated with Gardasil.  There was no concomitant medication.  Subsequently the patient experienced influenza-like symptoms (headache, some nausea, vomiting and myalgia) within 24 hours of receiving her first dose of Gardasil.  The patient possibly had a CPK level that was mildly elevated (values not provided).  The patient was possibly examined in the emergency room but was not admitted.  Subsequently, the patient's symptoms resolved within one to four days.  Unspecified medical attention was sought.  Patient Quality Complaints (PQC) was not involved.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 18-MAY-2007 was vaccinated with the first dose of Gardasil (lot # 657736/0389U) at 11:25 and experienced numbness in her arm for the rest of that day.  The patient did not seek medical attention.  There was no illness reported at the time of vaccination.  The physician did not learn of this until the patient came in for the second dose of Gardasil which was administered.  On 19-MAY-2007, the patient recovered from numbness in her arm.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/27/2007. Initial and follow-up information has been received from a physician concerning a 26 year old female with an occupation in data entry, who on 18-MAY-2007 was vaccinated intramuscularly in left deltoid with the second (previously reported as the first) dose of GARDASIL (lot # lot # 657736/0389U) at 11:25. Concomitant therapy included medroxyprogesterone acetate. Subsequently, the patient experienced numbness in her arm for the rest of that day. Also on 14-AUG-2007 the patient experienced numbness in her arm for the rest of that day. Also on 14-AUG-2007 the patient experienced left arm numbness throughout the day. The patient did not seek medical attention. There was no illness reported at the time of vaccination. The physician did not learn of this until the patient came in for the second dose of GARDASIL which was administered. On 19-MAY-2007 and 15-AUG-2007m the patient recovered from numbness in her arm. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Grip strength decreased, Lymphadenopathy, Muscular weakness, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a 12 year old female with penicillin allergy and no other pertinent medical history who, on 21-AUG-2007, was vaccinated intramuscularly (IM) in the right deltoid with Gardasil (Lot #655620/0171U).  There was no concomitant medication. Within one to two days (on approximately 22-AUG-2007), she experienced right-sided neck and right shoulder pain.  This was followed by a rash on the right side of neck and right shoulder.  She was seen in the physician's office on 27-AUG-2007 with blisters that followed a dermatome, ending at midpoint with pain continuing in the area noted, slight swollen gland on right neck, and complaining of dropping things from the right hand.  She was treated with LORTAB and FAMVIR.  As of 27-AUG-2007, the patient had not recovered from the right-sided neck and right shoulder pain, blisters, swollen gland, and "dropping things from the right hand."  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female student with penicillin allergy and no other pertinent medical history who, on 21-AUG-2007 in the afternoon, was vaccinated intramuscularly (IM) in the right deltoid with a first dose of GARDASIL (Lot #655620/0171U). There was no concomitant medication. There were no illnesses at the time of the vaccination. Within one to two days (on approximately 22-AUG-2007), she experienced right-sided neck and right shoulder pain. This was followed by a rash on the right side of neck and right shoulder. On 22-AUG-2007 the patient developed what appeared to be Herpes Zoster. She was seen in the physician's office on 27-AUG-2007 with blisters that followed a dermatome, ending at midpoint with pain continuing in the area noted, slight swollen gland on right neck, and complaining of dropping things from the right hand. No laboratory diagnostics were performed. She was treated with LORTAB and FAMVIR 500mg, 1 tablet daily for 10 days. As of 27-AUG-2007, the patient had not recovered from the right-sided neck and right shoulder pain, blisters, swollen gland, and "dropping things from the right hand". On 07-SEP-2007 the patient recovered from the rash. However, there was a scar on the patient's neck. It was reported that the rash lasted about 2 weeks from onset. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Rash
Clinical narrative: Information has been received from a physician concerning a 12 year old female with penicillin allergy and no other pertinent medical history who, on 21-AUG-2007, was vaccinated intramuscularly (IM) in the right deltoid with Gardasil (Lot #655620/0171U).  There was no concomitant medication. Within one to two days (on approximately 22-AUG-2007), she experienced right-sided neck and right shoulder pain.  This was followed by a rash on the right side of neck and right shoulder.  She was seen in the physician's office on 27-AUG-2007 with blisters that followed a dermatome, ending at midpoint with pain continuing in the area noted, slight swollen gland on right neck, and complaining of dropping things from the right hand.  She was treated with LORTAB and FAMVIR.  As of 27-AUG-2007, the patient had not recovered from the right-sided neck and right shoulder pain, blisters, swollen gland, and "dropping things from the right hand."  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female student with penicillin allergy and no other pertinent medical history who, on 21-AUG-2007 in the afternoon, was vaccinated intramuscularly (IM) in the right deltoid with a first dose of GARDASIL (Lot #655620/0171U). There was no concomitant medication. There were no illnesses at the time of the vaccination. Within one to two days (on approximately 22-AUG-2007), she experienced right-sided neck and right shoulder pain. This was followed by a rash on the right side of neck and right shoulder. On 22-AUG-2007 the patient developed what appeared to be Herpes Zoster. She was seen in the physician's office on 27-AUG-2007 with blisters that followed a dermatome, ending at midpoint with pain continuing in the area noted, slight swollen gland on right neck, and complaining of dropping things from the right hand. No laboratory diagnostics were performed. She was treated with LORTAB and FAMVIR 500mg, 1 tablet daily for 10 days. As of 27-AUG-2007, the patient had not recovered from the right-sided neck and right shoulder pain, blisters, swollen gland, and "dropping things from the right hand". On 07-SEP-2007 the patient recovered from the rash. However, there was a scar on the patient's neck. It was reported that the rash lasted about 2 weeks from onset. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who in June 2007 was vaccinated with Gardasil.  There was no concomitant medication.  There was no illness reported at the time of vaccination.  The patient began to feel dizzy and light headed after receiving her second dose of Gardasil (lot# 658554/0928U) on 27-AUG-2007, while still in the physician's office.  No laboratory/diagnostic tests were performed.  The patient was diaphoretic and given a wet wash cloth to place on her forehead.  There was no other symptoms or treatment.  The reaction lasted 15 minutes following the injection, also reported as the patient was recovering as of 27-AUG-2007.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a registered nurse concerning a 15 year old female with no known drug allergies, who in June 2007 was vaccinated with a first dose of GARDASIL (lot# unknown). There was no concomitant medication. There was no illness reported at the time of vaccination. The patient began to feel dizzy and lightheaded at 1:02 PM after receiving her second dose of GARDASIL (lot # 658554/0928U) IM in the left deltoid on 27-AUG-2007 at 1:00 PM, while still in the physician's office. No laboratory/diagnostic tests were performed. The patient was diaphoretic and given a wet wash cloth (also reported as a cool compress) to place on her forehead and neck. There was no other symptoms or treatment. The reaction lasted 2-3 minutes. The patient waited 15 minutes and felt fine to go home. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with Gardasil, Varivax, and MENACTRA on the same day and fainted.  The patient outcome was not provided.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Pallor, Skin discolouration
Clinical narrative: Information has been received from a nurse concerning a 16 year old female who on 24-AUG-2007 was vaccinated with first dose of Gardasil.  Within 5 minutes after receiving the injection, the patient felt light headed, pale, nauseated and looked slightly green.  The patient recovered and walked out of the office.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a nurse concerning her 22 year old daughter with allergies to DURACEF and tobramycin who in June 2007, was vaccinated with Gardasil in the left upper arm.  Concomitant therapy included APRI.  In June 2007, the patient immediately fainted after the administration of her first dose.  A few days later, she developed a firm nodule at the injection site of the left upper arm near the elbow.  The nodule continued to "crust and peel" intermittently.  She also had intermittent shooting pains from the injection site down to the mid forearm area.  The patient's firm nodule at the injection site, shooting pains from the injection site down to the mid forearm area and nodule that continued to crust and peel persisted.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a healthcare professional and a nurse, concerning the nurse's 22 year old daughter with allergies to DURACEF and tobramycin, who on 28-JUN-2007, at approximately 6:30 pm, was vaccinated IM in the left deltoid with the first dose, 0.5 ml, of GARDASIL (lot #658560/1062U). Concomitant therapy included APRI. Following the vaccination when the patient was checking out, she fainted. She was taken to the exam room and recovered quickly. A few days later, she developed a firm nodule or welt at the injection site of the left upper arm near the elbow. The nodule continued to "crust and peel" intermittently. She also had numbness and intermittent shooting pains from the injection site down to the mid forearm area. At the time of this report, the patient had recovered from nodule at the injection site, numbness radiating down arm, shooting pains from the injection site down to the mid forearm area and nodule that continued to crust and peel. Follow up information from the HCP indicated that on 28-AUG-2007, the patient returned and was vaccinated in the left outer thigh, with the second dose of GARDASIL, and there were no adverse reactions. Additional follow up from the nurse (mother of the patient), confirmed that her daughter had recovered from all of the symptoms experienced following the vaccination with the first dose in June 2007. She emphasized that the vaccination had not been in the deltoid area of the arm. No further details were provided. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Scab, Skin exfoliation, Syncope
Clinical narrative: Information has been received from a nurse concerning her 22 year old daughter with allergies to DURACEF and tobramycin who in June 2007, was vaccinated with Gardasil in the left upper arm.  Concomitant therapy included APRI.  In June 2007, the patient immediately fainted after the administration of her first dose.  A few days later, she developed a firm nodule at the injection site of the left upper arm near the elbow.  The nodule continued to "crust and peel" intermittently.  She also had intermittent shooting pains from the injection site down to the mid forearm area.  The patient's firm nodule at the injection site, shooting pains from the injection site down to the mid forearm area and nodule that continued to crust and peel persisted.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a healthcare professional and a nurse, concerning the nurse's 22 year old daughter with allergies to DURACEF and tobramycin, who on 28-JUN-2007, at approximately 6:30 pm, was vaccinated IM in the left deltoid with the first dose, 0.5 ml, of GARDASIL (lot #658560/1062U). Concomitant therapy included APRI. Following the vaccination when the patient was checking out, she fainted. She was taken to the exam room and recovered quickly. A few days later, she developed a firm nodule or welt at the injection site of the left upper arm near the elbow. The nodule continued to "crust and peel" intermittently. She also had numbness and intermittent shooting pains from the injection site down to the mid forearm area. At the time of this report, the patient had recovered from nodule at the injection site, numbness radiating down arm, shooting pains from the injection site down to the mid forearm area and nodule that continued to crust and peel. Follow up information from the HCP indicated that on 28-AUG-2007, the patient returned and was vaccinated in the left outer thigh, with the second dose of GARDASIL, and there were no adverse reactions. Additional follow up from the nurse (mother of the patient), confirmed that her daughter had recovered from all of the symptoms experienced following the vaccination with the first dose in June 2007. She emphasized that the vaccination had not been in the deltoid area of the arm. No further details were provided. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who on 15-AUG-2007 was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  On 25-AUG-2007 the patient called the office and reported that she had a rash at the injection site and then it got progressively worse and spread to her stomach and face.  She took BENADRYL to help the rash.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Viral rash
Clinical narrative: Information has been received from a health professional concerning her 13 year old daughter with no medical history or allergies who on 08-AUG-2007 at 14:00, was vaccinated with a first dose of Gardasil.  On 09-AUG-2007 in the evening, the patient developed a rash.  It was described by a dermatologist as viral exanthem.  It was reported to have started near both armpits and spread all over her torso and upper legs.  The rash seemed to disappear after using 1% hydrocortisone cream which was prescribed by the physician.  On 24-AUG-2007, the patient recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with a history of papilloma viral infection (HPV cervical shedding) who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown).  On an unspecified date the patient was vaccinated with a second dose of Gardasil.  Subsequently the patient developed a non-pruritic exanthem over her arms and abdomen 4 hours after her second dose of Gardasil.  At the time of reporting it was unknown if the patient had recovered.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL.  Subsequently, reported on 20-AUG-2007 that "in the past few months", the patient fainted.  Subsequently, after ten minutes of lying down, the patient recovered from fainting.  This is one of several reports received from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 13 year old female patient with a history of almost fainting about once a month, who on 27-JUN-2007, was vaccinated IM into the left arm with a dose of GARDASIL (Lot# 657737/0522U). After getting the vaccine, the patient felt light headed and dizzy. It was reported that it got worse when she sat up or stood up. The patient's blood pressure decreased to 98/58. The patient left the office after about 50 minutes when she was feeling better. Another physician was consulted before discharging the patient home. On 27-JUN-2007, the patient recovered from lightheaded and dizzy. On an unspecified date, the patient recovered from fainting. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with Gardasil (possible lot # 03884", 658222/0927U, 657737/0522U).  Subsequently, reported on 20-AUG-2007 as in the "past few months", the patient light headed.  Subsequently, after about ten minutes of lying down, the patient recovered from being light headed.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Resuscitation, Syncope, Trendelenburg position
Clinical narrative: Information has been received from a physician assistant concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient fainted.  The patient recovered before leaving the office.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information have been received from a physician's assistant and a physician concerning a 15 year old female with scoliosis and a history of chondromalacia patellae who on 30-JUL-2007 was vaccinated with the first dose of GARDASIL (lot #658282/0929U), IM. Concomitant medication was not reported. On 30-JUL-2007 within 60 seconds of receiving the vaccination, the patient experienced a vasovagal syncope episode with systolic blood pressure in the 80's. The patient was resuscitated with juice and placed in the Trendelenburg position. Subsequently on 30-JUL-2007, the patient recovered from the vasovagal syncope episode before leaving the office. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Asthenia, Chills, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter with no pertinent medical history and no prior drug reactions who on 22-AUG-2007, was vaccinated with her first dose of Gardasil.  There was no concomitant medication.  On 22-AUG-2007, a few hours after receiving the dose, the patient developed fever, loss of appetite, chills and loss of energy.  As of 28-AUG-2007, the patient's fever, loss of appetite, chills and loss of energy persisted.  The patient sought medical attention with a physician.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with no pertinent medical history who on 29-JUN-2007 was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  On 08-JUL-2007 the patient was diagnosed with an outbreak of HPV.  The patient sought medical attention when she returned to the nurse's office for the second vaccination with Gardasil.  As of 28-AUG-2007 the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Biopsy site unspecified normal, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil.  Subsequently the patient had a Pap test that resulted in an abnormal result.  The patient had a biopsy which came back negative.  The patient had not decided if she will continue with the dosing schedule.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Inappropriate schedule of drug administration, Nausea
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning a 27 year old female teacher/administrator patient who on 27-JUN-2007 at 02:50 PM (previously reported as 26-JUN-2007) was vaccinated IM into left deltoid with a first dose of Gardasil lot #658222/0927U and on 27-AUG-2007 received the second dose of Gardasil. The reporter reported that the patient felt lightheaded, nauseated and dizzy for 15 minutes after the second vaccination on 27-AUG-2007. She felt fine after lying down for 15 minutes. In follow up it was reported that the nurse went back to check on the patient after 15 minute later and "she said she was feeling fine and wanted to go to work". She did not have any problem after receiving her first dose of Gardasil. On 27-AUG-2007, the patient recovered. Additional information has been requested. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation
Clinical narrative: Information has been received from a physician concerning a 16 year old female who "2 weeks ago", on approximately 14-AUG-2007, was vaccinated with Gardasil and was, on approximately 28-AUG-2007, complaining that the skin on her palms and feet was peeling.  The patient sought unspecified medical attention.  There was no illness reported at the time of vaccination.  The patient outcome was unknown.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site rash, Swelling face
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 23-AUG-2007 was vaccinated on the left side of the arm with a dose of Gardasil (Lot # 655849/0263U).  Concomitant vaccination included MENACTRA.  On 25-AUG-2007 the right side of the patient face became swollen and a rash developed on the injection site.  On 27-AUG-2007 the patient recovered from the right side of her face being swollen and the rash that developed at the injection site.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female was vaccinated with a first dose of Gardasil.  Subsequently, the patient experienced tenderness, soreness and swelling at injection.  Unspecified medical attention was sought.  Subsequently, the patient recovered from tenderness at injection, soreness at injection and swelling at injection.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Migraine
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history who on 06-JUL-2007 was vaccinated IM with a first dose of Gardasil.  There was no concomitant medication.  On 23-AUG-2007 the patient was vaccinated with a second dose of Gardasil.  On 24-AUG-2007 the patient experienced headache and migraine the day after the second dose.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the headache and migraine on 24-AUG-2007.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history who on 06-Jul-2007 was vaccinated IM with a first dose of GARDASIL. There was no concomitant medication. On 23-Aug-2007 the patient was vaccinated with a second dose of GARDASIL. oN 24-Aug-2007 the patient experienced headache and migrane the day after the second dose. Unspecified medical attention was sought. Subsequently, the patient recovered from the headache and migrane on 24-Aug-2007. The follow up information from the physician indicated that the physician never heard from the patient about any adverse reaction.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Information has been received from a nurse concerning a 15 year old female who on approximately 14-AUG-2007 was vaccinated IM with a 0.5 ml first dose of Gardasil.  Later that evening, the patient's feet started to itch.  The itching spread through her body and the next day she developed a rash all over her body.  The patient went back to the physician's office and the physician recommended BENADRYL.  On an unspecified date, the patient recovered.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram abnormal, Contusion, Electrocardiogram normal, Haematoma, Head injury
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female (126 lbs., 62in.) student with no known drug allergies, who on 20-AUG-2007 was vaccinated with the first dose of Gardasil.  Concomitant therapy included MENACTRA, ADACEL and ACCUTANE.  There was no illness at the time of vaccination.  Approximately 10 minutes after vaccination, the patient fainted for approximately 1-2 minutes in the office parking lot, struck her head on the pavement and was taken by EMS to the emergency room of a hospital.  The patient experienced hematoma on the scalp of the right back side of the head and contusion due to the syncope from getting "3 shots".  The patient's ECG was "normal" and a CT scan of the head without contrast revealed soft tissue swelling in the right parietal occipital region suggestive of recent trauma and no evidence of intracranial hemorrhage or parenchymal contusion.  On the same day, 20-AUG-2007, the patient was discharged from the emergency room as "improved".  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female (126 lbs., 62in.) student with no known drug allergies, who on 20-AUG-2007 was vaccinated with the first dose of Gardasil.  Concomitant therapy included MENACTRA, ADACEL and ACCUTANE.  There was no illness at the time of vaccination.  Approximately 10 minutes after vaccination, the patient fainted for approximately 1-2 minutes in the office parking lot, struck her head on the pavement and was taken by EMS to the emergency room of a hospital.  The patient experienced hematoma on the scalp of the right back side of the head and contusion due to the syncope from getting "3 shots".  The patient's ECG was "normal" and a CT scan of the head without contrast revealed soft tissue swelling in the right parietal occipital region suggestive of recent trauma and no evidence of intracranial hemorrhage or parenchymal contusion.  On the same day, 20-AUG-2007, the patient was discharged from the emergency room as "improved".  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown).  Subsequently, the patient developed a rash after the first dose.  On an unspecified date the patient was vaccinated with a second dose of Gardasil injection and developed a rash.  Medical attention was sought.  The location of the rash and the dates were unspecified.  At the time of reporting it was unknown if the patient had recovered.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse, concerning an 18 year old female patient, who on 23-AUG-2007 was vaccinated IM, with a dose, 0.5ml, of Gardasil (Lot #658554/0928U).  Concomitant therapy on the same date included MENACTRA.  On 24-AUG-2007, about 24 hours after the vaccination, the patient developed hives on her face and neck.  Treatment included BENADRYL.  At the time of this report, it was unknown if the patient had recovered.  Additional information has been requested.
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, regarding a female patient (age not specified), who on an unknown date was vaccinated IM with a dose of Gardasil (Lot # not provided).  Concomitant therapy included DTaP (manufacturer unspecified).  Following the vaccination with Gardasil the patient fainted.  At the time of this report, the outcome of the event was unknown.  No further information is available.
Age: 1.2
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Nausea, Pyrexia, Vomiting, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a physician concerning a 14 month old female child who inadvertently was vaccinated IM in to left thigh with a dose of Gardasil lot #656371/0181U.  In follow up the physician reported that the child was experiencing nausea, vomiting, fever and decreased appetite following vaccination.  The outcome was unknown.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Limb discomfort, Malaise
Clinical narrative: Information has been received from a nurse concerning an "around 21 year" old female patient who approximately on 21-AUG-2007 was vaccinated with a first dose of Gardasil.  The reporter reported that "the patient said her arm felt weird and she did not feel well after getting the dose of Gardasil.  She called back the office after she went home because she felt tightness in her chest.  The physician suggested her to go to the Emergency Room, where she was given BENADRYL".  No additional information was provided.  The outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site extravasation
Clinical narrative: Information has been received from a healthcare professional concerning a patient who was vaccinated with a second dose of Gardasil.  After receiving the vaccine, the patient developed oozing at the injection site.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.