chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Fall, Head injury, Neurological examination normal, Skin laceration
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old white female with hypersensitivity to amoxicillin and cephalosporins who on 08-AUG-2007 at 10:00, was vaccinated IM in the right arm with a 0.5 ml first dose of Gardasil (lot # 654741/1208F).  Concomitant vaccination included Tdap administered intramuscularly in the left arm. There were no illneses at the time of the vaccination and no adverse events that followed prior vaccinations. On 08-AUG-2007, approximately 6 minutes after vaccination, the patient bacame dizzy (also reported as fainted) and fell forward(previuosly reported as toppled) off of the examination table and hit her head on a cabinet in the exam room.  The patient experienced a 2 inch laceration on her forehead.  The patient received stitches and was put on pain medication (unspecified) and antibiotics (unspecified).  The patient was examined by the physician and the neuroexam was normal. The nurse reported the patient did not have anything to eat prior to the appointment. The patient was referred to a plastic surgeon. The patient recovered on an unspecified date. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old white female with hypersensitivity to amoxicillin and cephalosporins who on 08-AUG-2007 at 10:00, was vaccinated IM in the right arm with a 0.5 ml first dose of Gardasil (lot # 654741/1208F).  Concomitant vaccination included Tdap administered intramuscularly in the left arm. There were no illneses at the time of the vaccination and no adverse events that followed prior vaccinations. On 08-AUG-2007, approximately 6 minutes after vaccination, the patient bacame dizzy (also reported as fainted) and fell forward(previuosly reported as toppled) off of the examination table and hit her head on a cabinet in the exam room.  The patient experienced a 2 inch laceration on her forehead.  The patient received stitches and was put on pain medication (unspecified) and antibiotics (unspecified).  The patient was examined by the physician and the neuroexam was normal. The nurse reported the patient did not have anything to eat prior to the appointment. The patient was referred to a plastic surgeon. The patient recovered on an unspecified date. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history, who on 30-JUL-2007 was vaccinated IM in the deltoid with a dose of Gardasil (lot # 658100/0525U).  On 02-AUG-2007 the patient experienced a large red area at the injection site the size of a "50 cent piece".  Medical attention was sought and the patient was placed on antibiotics (unspecified).  On an unspecified date, the patient recovered.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with no pertinent medical history, who on 30-JUL-2007 was vaccinated IM in the deltoid with a dose of Gardasil (lot # 658100/0525U).  On 02-AUG-2007 the patient experienced a large red area at the injection site the size of a "50 cent piece".  Medical attention was sought and the patient was placed on antibiotics (unspecified).  On an unspecified date, the patient recovered.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Initial and follow-up information has been received from a physician and a health professional concerning an 11 year old female who on 30-JUL-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot # 658100/0525U).  Concomitant suspect vaccinations included varicella virus vaccine live (MSD) and Vaqta (MSD).  Other concomitant vaccination included MENACTRA and Tdap.  On 02-AUG-2007 the patient reported an injection site reaction in the right upper arm that was a 2 cm redness and tenderness with 2 cm erythema surrounding "that looked like cellulitis".  The child was put on KEFLEX.  There were no laboratory or diagnostic studies performed.  Unspecified medical attention was sought.  Subsequently the patient recovered.  Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Initial and follow-up information has been received from a physician and a health professional concerning an 11 year old female who on 30-JUL-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot # 658100/0525U).  Concomitant suspect vaccinations included varicella virus vaccine live (MSD) and Vaqta (MSD).  Other concomitant vaccination included MENACTRA and Tdap.  On 02-AUG-2007 the patient reported an injection site reaction in the right upper arm that was a 2 cm redness and tenderness with 2 cm erythema surrounding "that looked like cellulitis".  The child was put on KEFLEX.  There were no laboratory or diagnostic studies performed.  Unspecified medical attention was sought.  Subsequently the patient recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, after receiving the vaccination the patient fainted. The patient sought unspecified medical attention.  On 13-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated IM into the lower part of her arm (not sure if it was the deltoid, she felt it was in the fatty part of her arm) with a third 0.5ml dose of Gardasil.  Subsequently, the patient developed a lump in the injection area.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  Follow up information stated that the lump in the injection area has not gotten any bigger nor smaller.  No product quality complaint was involved.  Additional information has been requested.  1/5/10 follow up - injection site mass; drug administered at inappropriate site. inappropriate schedule of drug administration
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthma, Eczema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a nurse practitioner concerning a 24 year old female patient with asthma and no allergies who on 27-JUL-2007 was vaccinated IM into the left arm with a first dose of GARDASIL (Lot# 658100/0525U).  Concomitant medication included oral contraceptives.  Shortly after, the patient experienced a rash on her hip chest and thighthat was red and itchy (leg unspecified).  The patient mentioned the rash may have started prior to the vaccination but was unsure. The patient did go to urgent care and a dermatologist.  The patient was diagnosed with eczema.  The second dermatologist thougth the rash was poison oak. On an unspecified dates, the patient had recovered from the rash but was now experiencing an undiagnosed systomic itching. On 09-AUG-2007, the patient called the nurse practitioner and told her that the itching had occurred for 2 weeks. The patient was seeing an allergist because it was reported that in the last 6 weeks the symptoms have been worse. No quality complaint was involved. At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dermatitis contact, Rash erythematous, Rash pruritic
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a nurse practitioner concerning a 24 year old female patient with asthma and no allergies who on 27-JUL-2007 was vaccinated IM into the left arm with a first dose of GARDASIL (Lot# 658100/0525U).  Concomitant medication included oral contraceptives.  Shortly after, the patient experienced a rash on her hip chest and thighthat was red and itchy (leg unspecified).  The patient mentioned the rash may have started prior to the vaccination but was unsure. The patient did go to urgent care and a dermatologist.  The patient was diagnosed with eczema.  The second dermatologist thougth the rash was poison oak. On an unspecified dates, the patient had recovered from the rash but was now experiencing an undiagnosed systomic itching. On 09-AUG-2007, the patient called the nurse practitioner and told her that the itching had occurred for 2 weeks. The patient was seeing an allergist because it was reported that in the last 6 weeks the symptoms have been worse. No quality complaint was involved. At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthma, Eczema, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with asthma and no known drug allergies who on 27-JUL-2007 was vaccinated with Gardasil (lot# 658100/0525U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 27-JUL-2007 the patient experienced an itchy red rash on the right side of her hip and leg.  The patient thought it might have started before Gardasil was given.  The nurse practitioner noted that the patient was seen by a dermatologist who diagnosed questionable eczema.  In a follow-up telephone call with the patient on 13-AUG-2007, the nurse practitioner indicated that the patient was diagnosed by another physician with "probable poison oak."  The patient's symptoms were improving at the time of this report.  Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dermatitis contact, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female with asthma and no known drug allergies who on 27-JUL-2007 was vaccinated with Gardasil (lot# 658100/0525U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 27-JUL-2007 the patient experienced an itchy red rash on the right side of her hip and leg.  The patient thought it might have started before Gardasil was given.  The nurse practitioner noted that the patient was seen by a dermatologist who diagnosed questionable eczema.  In a follow-up telephone call with the patient on 13-AUG-2007, the nurse practitioner indicated that the patient was diagnosed by another physician with "probable poison oak."  The patient's symptoms were improving at the time of this report.  Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with Gardasil.  The patient fainted after receiving the vaccine.  No other details were available.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Cough, Culture throat, Dyspnoea, Pharyngeal erythema
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 26 year old female with an allergy to codeine who on 27-JUL-2007 was vaccinated IM with the first dose of Gardasil (Lot #0211U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 27-JUL-2007 within hours post vaccination the patient experienced a sore throat, a fever (103F), cough and difficulty breathing.  On 30-JUL-2007 the patient sought medical attention and was seen in the physician's office.  At that time her temperature was 99F and her throat was erythematous.  A throat culture was performed, however the results were not reported.  The patient was prescribed Zithromax.  Subsequently, on an unspecified date the patient recovered from the events.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 26 year old female with an allergy to codeine who on 27-JUL-2007 was vaccinated IM with the first dose of Gardasil (Lot #0211U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 27-JUL-2007 within hours post vaccination the patient experienced a sore throat, a fever (103F), cough and difficulty breathing.  On 30-JUL-2007 the patient sought medical attention and was seen in the physician's office.  At that time her temperature was 99F and her throat was erythematous.  A throat culture was performed, however the results were not reported.  The patient was prescribed Zithromax.  Subsequently, on an unspecified date the patient recovered from the events.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Aphthous stomatitis, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with seasonal allergies who on 09-APR-2007 was vaccinated intramuscularly with a first dose of Gardasil (Lot # 657617/0384U).  Concomitant therapy included YAZ.  In April 2007 "a couple of days after vaccination the patient developed canker sores.  The patient was treated with "Magic Mouthwash".  Subsequently, the patient recovered.  On 18-JUN-2007 the patient was vaccinated with a second dose of Gardasil (Lot # 657868/0523U).  In June 2007 "a couple of days" after vaccination the patient developed canker sores.  The patient was treated with "Magic Mouthwash".  At the time of the report, the patient was recovering.  There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with asthma, juvenile rheumatoid arthritis, a hypersensitivity to drugs ending in, "sporin" and a history of a right knee operation who on 12-JUN-2007 was vaccinated intramuscularly with a first dose of Gardasil.  On 10-AUG-2007 the patient was vaccinated with a second dose of Gardasil (Lot # 654702/0011U).  It was reported the patient had not eaten any food that day.  Concomitant therapy included AMBIEN, folic acid, ORTHO TRI-CYCLEN LO and ENBREL.  On 10-AUG-2007 the patient fainted.  The patient was treated with food and liquids.  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a physician and a female nurse concerning a female patient who on 09-AUG-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  On 09-AUG-2007 the patient developed, "alot of pain and numbness in the left arm which went all the down to the fingers".  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on an unspecified date was vaccinated with Gardasil.  Eight days post vaccination, the patient experienced black marks or spots on both hands.  She sought medical attention.  She returned to the physician's for a follow-up visit.  She went to the emergency room, but no details were available.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count decreased
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on approximately 11-JUN-2007 was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). On 11-AUG-2007 the patient was seen and had purpura and platelets 80,000. Additional information has been requested. 10/16/07-received phone call from reporter-vaccination records were not completed, no lot# available. Reporter also indicated that the adverse event is not related to the vaccine and will not send additional information on the case. 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 his 18 year old student daughter who on approximately 11-JUN-2007 was vaccinated into the deltoid with a first dose of GARDASIL. There was no illness at the time of vaccination. On 11-AUG-2007 (also reported as 15-AUG-2007) the patient was seen and had a purpuric rash on both calves and a CBC revealed platelets 83,000. Follow up the next day revealed platelets 175,000. The physician mentioned that the thrombocytopenia was not life threatening, disabling. Nor did his daughter require hospitalization. The physician reported this was a questionable lab error versus effect of the GARDASIL. The patient is not receiving the second or third dose of GARDASIL. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil 0.5 ml IM.  The patient fainted after receiving the vaccination.  Unspecified medical attention was sought.  The patient recovered while in the office.  No further information was provided.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with a possible allergy to food additives who on 08-JAN-2007 was vaccinated intramuscularly in the right deltoid with a first dose of Gardasil (Lot # 654389/0961F).  On 08-JAN-2007 the patient developed right arm swelling at the site down to the wrist, redness, and pain.  There were no laboratory or diagnostic tests performed.  On approximately, 12-JAN-2007 the patient recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Laceration, Suture insertion, Syncope
Clinical narrative: Information has been received from an office registered nurse concerning a 19 year old who on 08-AUG-2007 was vaccinated with Gardasil.  On 08-AUG-2007, the patient fainted after the injection.  The patient fell from the exam table and sustained a lacerated forehead.  The patient recovered from the fainting.  Medical attention was sought and the patient was taken to a plastic surgeon's office to repair the laceration.  No other symptoms were reported.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy, Drug eruption, Rash generalised
Clinical narrative: Information has been received from a nurse concerning a 21 year old female who on 05-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection.  On an unspecified date the patient reported that she developed a "rash from head to toe" after receiving Gardasil.  Medical attention was sought.  On an unspecified date the patient had seen a dermatologist who did a biopsy and noted the rash was "drug induced".  No further information was provided.  At the time of reporting it was unknown whether the patient had recovered.  The patient was not going 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.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Feeling hot, Headache, Nervousness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 27-FEB-2007 was vaccinated with a second dose of Gardasil.  On 27-FEB-2007 the patient "felt shaky", developed a headache, a stomach ache and felt warm.  On 02-JUL-2007 at 11:15 the patient was vaccinated IM with a third dose of Gardasil (lot # 656825/0307U).  Subsequently at 5:00 pm she "felt shaky", had a headache, a stomach ache and felt warm.  She "felt better after 2 days."  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a pharmacist concerning her approximately 15 year old daughter with no known allergies and no reported medical history who was vaccinated with Gardasil.  There was no concomitant medication.  The pharmacist reported that her daughter developed muscle pain near the injection site after her last two doses of Gardasil.  The symptoms resolved several days after each dose was given.  She had not received dose number three yet.  Additional information has been requested.
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 approximately 01-AUG-2007, was vaccinated with Gardasil.  On approximately 01-AUG-2007, after she received her first dose, the patient fainted.  On 10-AUG-2007, the patient recovered.  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 licensed practical nurse concerning a 16 year old female patient with a phobia of needles, an anxiety disorder and panic attacks and a history of dysmenorrhea and fainting with injections, who on 01-AUG-2007, was vaccinated IM into the left deltoid with a first 0.5ml dose of GARDASIL (Lot# 657736/0389U). Concomitant therapy included LEXAPRO and ATIVAN, NEXIUM, SEASONIQUE and ZYRTEC. After she received the vaccine, the patient fainted in the hallway. It was reported that the "patient came to on her own after 5 seconds." She sat in the hallway for a while then laid down on the exam table for 5 minutes. The patient was reported as having more color and doing better. The nurse and the patient's mother walked her to the car to leave. It was also reported that the patient had stated prior to injection that she does not do well with needles, usually faints. At the time of this report, the patient recovered. It was reported that the patient will receive a 2nd dose in 2 months and with the next injection the patient should sit for about 15 minutes after the injection. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: Information has been received from a physician and a medical assistant concerning an 18 year old female who on 08-AUG-2007 was vaccinated intramuscularly with a first dose of Gardasil (lot 3654510/0962F) while sitting.  On 08-AUG-2007, a few minutes after vaccination, the patient stood to leave, fainted.  She hit her head on the floor.  She woke up "almost immediately" and she laid down until she felt better (approximately 5-10 minutes).  On 08-AUG-2007, the patient recovered.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 24 year old female with asthma and "problems with birth control", who on 18-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 657736/0389U).  On 18-MAY-2007 the patient experienced stinging and pain around the injection site area.  The patient experienced shortness of breath 20 minutes after the vaccination, and it lasted for about 45 minutes.  The patient consulted with the physician and was given ADVIL for the injection site reaction.  On an unspecified date, the patient recovered from the injection site pain.  There were no laboratory or diagnostic tests performed.  Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow-up information has been received from a physician and a licensed practical nurse concerning a 24 year old female with asthma and "problems with birth control" and question of antibiotics, who on 18-MAY-2007 was vaccinated IM in the left deltoid with a first dose of GARDASIL (lot # 657736/0389U). On 18-MAY-2007 15-20 minutes post vaccination, the patient experienced stinging and pain around the injection site area of the left deltoid. The patient experienced shortness of breath 20 minutes after the vaccination, and it lasted for about 45 minutes. On 19-MAY-2007 the patient consulted with the physician and was given ADVIL for the injection site reaction. On 19-MAY-2007 the patient recovered from the injection site pain. There were no laboratory or diagnostic tests performed. The next dose of GARDASIL was cancelled. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a physician concerning a "20 year" old female who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown) injection.  On an unspecified date after receiving the first dose of Gardasil the patient developed a nodule at the injection site approximately 1cm in size and was painful upon pressure.  The patient did not have any redness or fever.  Medical attention was sought.  At the time of reporting it was unknown if the patient had recovered.  Follow-up information was received from a nurse.  On an unspecified date the patient had received a second dose of Gardasil and no adverse event was reported.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 09-AUG-2007 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (lot # 658282/0929U).  Subsequently, following vaccination, the patient fainted. It was noted that the nurses are having patients lay down prior to administration of the vaccine. Unspecified medical attention was sought.  The patient subsequently recovered.  Additional information has been requested.  This is one of two reports from the same source. This is in follow-up to report (s) previously submitted on 9/17/2007.The nurse reported that the patient has had no problems since the incident. Additional information has beeb requested. This is one of two reports from the same source.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Throat tightness
Clinical narrative: Information has been received from a physician and a nurse concerning a "17 or 18" year old female who on 09-AUG-2007 was vaccinated with the first dose of Gardasil (0.5 ml).  It was reported that following vaccination, the patient felt lightheaded and dizzy.  The patient also felt her throat tightening and was rushed to the emergency room and released.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Information has been received from a female receptionist at a physician's office who on an unspecified date was vaccinated with the first dose of Gardasil.  Subsequently the patient developed a nodule that was painful upon pressure at the injection site.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  The patient stated that she did not have this experience with the second dose.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Back pain, Blood creatine phosphokinase, C-reactive protein normal, Cytomegalovirus test negative, Epstein-Barr virus test
Clinical narrative: Information has been received from a physician concerning an 18 year old female student who on 22-JUN-2007 in the pm, was vaccinated IM in the right arm  with a first dose of Gardasil (lot # 658094/0524U).  Concomitant vaccination on 22-JUN-2007 included IM in the right arm with a first dose of MENACTRA (lot # U2106AA) and IM in the left arm with a first dose of ADACEL (lot # C2644AA).  On 02-JUL-2007 in the am, the patient experienced muscle pain in the legs, then progressively involved the back and neck.  On approximately 05-JUL-2007 the patient was seen in the emergency room.  On approximately 05-JUL-2007 laboratory test was reported as negative for serum C-reactive protein test and advised to just observe.  Repeat lab work was negative.  Other laboratory tests included Epstein-Barr virus antibodies screen, Lyme disease, enzyme-linked immunosorbent assay, cytomegalovirus antigen test, and cytomegalovirus antigen test which had negative results.  The patient was then seen by a neurologist and diagnosed with severe myalgia and advised to just observe.  Repeat.  On 27-JUL-2007, the patient recovered from muscle pain in the legs, back pain and neck pain.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Full blood count, Laboratory test normal, Liver function test, Myalgia, Neck pain
Clinical narrative: Information has been received from a physician concerning an 18 year old female student who on 22-JUN-2007 in the pm, was vaccinated IM in the right arm  with a first dose of Gardasil (lot # 658094/0524U).  Concomitant vaccination on 22-JUN-2007 included IM in the right arm with a first dose of MENACTRA (lot # U2106AA) and IM in the left arm with a first dose of ADACEL (lot # C2644AA).  On 02-JUL-2007 in the am, the patient experienced muscle pain in the legs, then progressively involved the back and neck.  On approximately 05-JUL-2007 the patient was seen in the emergency room.  On approximately 05-JUL-2007 laboratory test was reported as negative for serum C-reactive protein test and advised to just observe.  Repeat lab work was negative.  Other laboratory tests included Epstein-Barr virus antibodies screen, Lyme disease, enzyme-linked immunosorbent assay, cytomegalovirus antigen test, and cytomegalovirus antigen test which had negative results.  The patient was then seen by a neurologist and diagnosed with severe myalgia and advised to just observe.  Repeat.  On 27-JUL-2007, the patient recovered from muscle pain in the legs, back pain and neck pain.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Polymerase chain reaction
Clinical narrative: Information has been received from a physician concerning an 18 year old female student who on 22-JUN-2007 in the pm, was vaccinated IM in the right arm  with a first dose of Gardasil (lot # 658094/0524U).  Concomitant vaccination on 22-JUN-2007 included IM in the right arm with a first dose of MENACTRA (lot # U2106AA) and IM in the left arm with a first dose of ADACEL (lot # C2644AA).  On 02-JUL-2007 in the am, the patient experienced muscle pain in the legs, then progressively involved the back and neck.  On approximately 05-JUL-2007 the patient was seen in the emergency room.  On approximately 05-JUL-2007 laboratory test was reported as negative for serum C-reactive protein test and advised to just observe.  Repeat lab work was negative.  Other laboratory tests included Epstein-Barr virus antibodies screen, Lyme disease, enzyme-linked immunosorbent assay, cytomegalovirus antigen test, and cytomegalovirus antigen test which had negative results.  The patient was then seen by a neurologist and diagnosed with severe myalgia and advised to just observe.  Repeat.  On 27-JUL-2007, the patient recovered from muscle pain in the legs, back pain and neck pain.  Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from the mother concerning her 21 year old daughter with no pertinent medical history who in January 2007, was vaccinated with a first dose of Gardasil.  On unspecified dates the patient was vaccinated with the second and third dose of Gardasil.  There was no concomitant medication.  On approximately 03-AUG-2007 the patient had an atypical Pap smear.  On 14-AUG-2007 the patient was scheduled to receive another Pap smear.  The patient did not seek medical attention.  At the time of the report the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who on 09-FEB-2007 was vaccinated with a first dose of Gardasil (Lot# 653978/0955F).  On 09-APR-2007 the patient was vaccinated with a second dose of Gardasil.  On 09-APR-2007, the patient developed pain in the arm.  The physician reported that the pain was not specified to the injection site.  The patient did not experience pain in the arm after the first dose of Gardasil.  Unspecified medical attention was sought.  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: Crying, Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a mother concerning her 20 year daughter with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with a first dose of Gardasil (lot # unknown).  Concomitant therapy included hormonal contraceptives (unspecified).  The patient experienced some pain after receiving the first dose of Gardasil which lasted for one week.   On an unspecified date the patient was vaccinated with a second dose of Gardasil.  The patient experienced intense pain which lasted for one week.  Medical attention was sought.  The pain from the second dose made the patient cry.  The patient recovered on an unspecified date.  No other details were given.   Additional information was been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a physician concerning a 27 year old female who on 05-FEB-2007 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) injection.  There was no adverse event associated with this vaccination.  On 09-APR-2007 the patient was vaccinated with a second dose of Gardasil (lot # 653736/0014U) injection.  On 09-APR-2007 the patient developed swelling, alot of redness and had an increase diameter of the reaction.  Medical attention was sought.  There was no further adverse event information.  At the time of reporting it was unknown if the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Information has been received from a physician concerning a female who in the end of June 2007, was vaccinated with a dose of Gardasil.  In approximately JUN-2007 the patient developed a very small bump under the skin at the injection site and pain.  On an unspecified date a Magnetic Resonance Imaging was performed, results were not reported. Unspecified medical attention was sought.  At the time of the report the patient had  not recovered from the pain.  It is unknown if the patient recovered from the bump.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Asthenia, Dizziness, Headache, Hypotension
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 30-JUL-2007 was vaccinated with a first dose of Gardasil (lot# unknown) injection.  Concomitant therapy also given on 30-JUL-2007 included Varivax (MSD) and MENACTRA.  On 30-JUL-2007 the patient became dizzy, had a headache and felt weak after receiving the first dose of Gardasil.  The patient also had low blood pressure.  Medical attention was sought.  The physician gave BENADRYL 15mg.  The patient was taken to the emergency room.  On an unspecified date the patient recovered from the events.  No additional information was provided.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with an allergic reaction to bee stings, penicillin, DARVACET, SEPTRA and lactose who on an unknown date, was vaccinated with a dose of Gardasil.  Concomitant therapy included ALEVE.  Subsequently, the patient developed a rectangular 5 by 2.5 inches raised, red, hot area at the injection site.  Unspecified medical attention was sought.  On an unknown date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient experienced "bone pain" around the injection site.  Unspecified medical attention was sought.  The patient's "bone pain" around the injection site persisted.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal dreams, Dyskinesia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female with allergies (unspecified) and a penicillin allergy who on 09-JUL-2007 was vaccinated with a 0.5 ml first dose of Gardasil (657868/0523U).  Concomitant therapy included montelukast sodium MSD, LORATIDINE D and vitamins (unspecified).  On 09-JUL-2007 the patient passed out within 10 seconds of receiving Gardasil and there was jerking of the body noted.  The patient awoke and mentioned that she had a "weird dream" when she passed out.  Again the patient passed out and jerking was noted for 5-10 seconds.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  On 09-JUL-2007 the patient recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated with a first dose of Gardasil.  Subsequently the patient developed a migraine shortly after receiving the first dose.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  On an unspecified date, the patient was vaccinated with a second dose of Gardasil.  The migraine did not reappear after the second dose.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain
Clinical narrative: Information has been received from a nurse concerning a female who in January 2007, was vaccinated IM with a first dose of Gardasil.  Subsequently, in January 2007 the patient experienced pain and nausea.  It was reported that the patient did not seek medical attention.  On an unspecified date, the patient recovered from pain and nausea.  On an unspecified date, the patient was vaccinated with a second dose of Gardasil and planned to finish the series.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 16 year old female who was vaccinated with a first dose of Gardasil.  Concomitant therapy included MENACTRA.  Patient fainted 15 minutes after receiving her first dose of Gardasil.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Injection site pain, Musculoskeletal stiffness, Myositis, Tendonitis
Clinical narrative: Information has been received from a physician concerning a female patient in her 20's who was vaccinated with a first and second dose of Gardasil. The physician reported that the patient had unusual soreness at the injection site after the first and second injection. He also reported that the patient had unusual stiffness and weakness with local mechanical trouble after she was given the third dose of Gardasil. The patient had not recovered as of this report day. The physician reported that this is one of the three patient who experienced similar experiences. 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 physician concerning a 20 year old female student who was vaccinated with a first and second dose of GARDASIL vaccine. In follow up it was reported that on 27-JUL-2007, the patient had shoulder tendinitis and myositis. On 01-SEP-2007 patient recovered. The reporter indicated that the patient's adverse event left shoulder tendinitis and myositis was disabling. The physician reported that this is one of the three patient who expereinced similar experiences. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary mass, Breast pain, Nodule
Clinical narrative: Information has been received from a physician concerning a 23 year old female, who on 02-AUG-2007 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (Lot# 655618/0186U). There was no concomitant medication. On 07-AUG-2007 the patient developed a lump in the axilla of her left side which was causing pain that radiates to her left breast. The patient was given a breast examination that showed to be normal. A pea size nodule was found in the patient's left axilla. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. There were no illnesses at the time of the vaccination. No laboratory diagnostics were performed. At the time of the report the patient's outcome was unknown (previously reported as had not recovered). No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Muscle rigidity, Nausea, Tremor
Clinical narrative: Information has been received from a office manager concerning a female who did not eat the day of the vaccination and a history of passing out who was vaccinated with a first dose of Gardasil. Within 5 minutes of the vaccination the patient's arm went rigid, she "shook a little", and passed out. After she came to she was nauseated. Unspecified medical attention was sought. On the day of the vaccination, the patient recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Feeling hot, Nausea, Pallor, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female with no drug allergies and no medical history, who on 09-AUG-2007 was vaccinated with a 0.5mL second dose of Gardasil (Lot# 658222/0927U). Concomitant therapy included loratadine and ORTHO TRI-CYCLEN. On 09-AUG-2007 the patient felt odd, felt tingling on whole arm of the injection site and the patient felt the medication traveling down her arm. The medical assistant reported that the patient felt hot, nauseated, and she became pale immediately after receiving the vaccination. No laboratory diagnostics were performed. The patient did not seek medical attention. On 09-AUG-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Nausea, Pain in extremity, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a 19 female who, on an unspecified date was vaccinated in the right arm with a first dose of Gardasil and experienced redness that went away fairly quickly but the arm hurt for 2 weeks after. On 07-AUG-2007 the patient was vaccinated intramuscularly in the left arm with a 0.5mL second dose of Gardasil (Lot# 658222/0927U). Subsequently, the patient developed redness and pain in the left arm from the elbow to shoulder, was nauseous and pale. No shortness of breath. The patient was treated with BENADRYL and was observed. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Dizziness, Feeling abnormal, Nausea, Pallor
Clinical narrative: Information has been received from a certified medical assistant concerning a 18 year old female with no allergies and no medical history, who on 08-AUG-2007 was vaccinated with a 0.5mL first dose of Gardasil (Lot# 658222/0927U). Concomitant therapy included meningococcal vaccine (unspecified). On 08-AUG-2007 the patient experienced lightheadness, her blood pressure dropped, she felt odd, she became pale, and she felt nauseated and had a feeling that she was going to vomit but did not. Three blood pressure measurements were taken the first reading was 94 over 52, the second was 80 over 52, and the third was 90 over 54. The patient sought unspecified medical attention. On 08-AUG-2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning a 20 year old female with no drug allergies and no medical history, who on 27-JUN-2007 was vaccinated with a 0.5mL third dose of Gardasil. There was no concomitant medication. On 18-JUL-2007 the patient had a PAP test that was positive for HPV. In November 2006 and January 2007 the patient was vaccinated with a first and second dose of Gardasil, respectively. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Immediate post-injection reaction, Nausea, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female, who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, she developed a little bit of redness and swelling.  On 07-AUG-2007 the patient was vaccinated with a second dose of Gardasil.  Immediately following the vaccination the patient began to swell from the elbow to the shoulder.  The patient felt nauseated and faint.  The patient was treated with BENADRYL.  The patient sought unspecified medical attention.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested. Initial and follow-up information has been received from a registered nurse concerning a 17 year old female, who, on an unspecified date, was vaccinated with a first dose of GARDASIL. Subsequently, she developed a little bit of a reddness and swelling. On 07-Aug-2007 the patient was vaccinated with a second dose of GARDASIL. Immediately following the vaccination the patient began to swell from the elbow to the shoulder. The patient felt nauseated and faint. The patient was treated with BENADRYL. The patient sought unspecified medical attention. At the time of the report, the patient was "doing wwell." No product quality complaint was involved. Additional information is not expected.