chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Deafness, Dizziness, Dysarthria, Injection site pain, Musculoskeletal pain
Clinical narrative: Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4 minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past, on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards. The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described the pt as being very dramatic. It was further reported that the pt reported seeing genital warts to the nurse practitioner, however, the nurse did not feel these were related to the vaccine. Additional information has been requested. 7/18/07-records received. HX papular condyloma. on 8/21/06-note indicated aftr 1st vaccine had a near syncope episode with no LOC. C/O slurred speech tingling in hands. Outbreak of condyloma.  1/4/10 Lack of concentration, hearing loss, blurred vision-ringing in ears. All of these we are aware of.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Pallor, Shock, Skin papilloma, Speech disorder
Clinical narrative: Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4 minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past, on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards. The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described the pt as being very dramatic. It was further reported that the pt reported seeing genital warts to the nurse practitioner, however, the nurse did not feel these were related to the vaccine. Additional information has been requested. 7/18/07-records received. HX papular condyloma. on 8/21/06-note indicated aftr 1st vaccine had a near syncope episode with no LOC. C/O slurred speech tingling in hands. Outbreak of condyloma.  1/4/10 Lack of concentration, hearing loss, blurred vision-ringing in ears. All of these we are aware of.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tinnitus, Vision blurred
Clinical narrative: Initial and follow up information has been received from a 21 year old female with breast implants and had a history of abnormal pap test and dysplasia and from a nurse practitioner. On 7/18/06 the pt was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0640F). Concomitant therapy included ethinyl estradiol + norgestimate (Ortho Lo). On 7/18/06, immediately following vaccination, the pt experienced slurred speech for approx 3 to 4 minutes and reported that she felt as if her body went into shock. She noted that her fingers curled into a fist and her fingers and hands stiffened up. She reported that the later symptoms lasted for approx 25 to 30 minutes. Also approx two weeks after receiving the vaccination, she began to have some pain and stiffness in her upper left arm and shoulder in the same arm she had received the injection. Unspecified medical attention was sought. At the time of this report, the pain and stiffness in the left arm and shoulder had not resolved. The pt also reported that although she had never had nay type of genital warts in the past, on approx 8/4/06 she noted she had small genital warts which were confirmed by her health care professional. In follow up th nurse practitioner reported conflicting information that what the pt described was not what she and another nurse witnesses. The nurse practitioner stated that following the injection the pt appeared pale and almost fainted. The pt became woozy and could speak clearly. The pt was attended to by both the nurse practitioner and another nurse. The pt was diagnosed with having a near syncopal episode. The pt was treated with a cool compress and she recovered quickly and was noted as fine afterwards. The pts blood pressure was fine noted at 130/80 mmHg. it was reported that the pt did not experience any drop in hart rate, did not loose consciousness, did not seize and did not experience wheezing. The nurse practitioner did not see what she would describe as any adverse reaction to the vaccines and described the pt as being very dramatic. It was further reported that the pt reported seeing genital warts to the nurse practitioner, however, the nurse did not feel these were related to the vaccine. Additional information has been requested. 7/18/07-records received. HX papular condyloma. on 8/21/06-note indicated aftr 1st vaccine had a near syncope episode with no LOC. C/O slurred speech tingling in hands. Outbreak of condyloma.  1/4/10 Lack of concentration, hearing loss, blurred vision-ringing in ears. All of these we are aware of.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse concerning two female pts (WAES0609USA01112) who on approx 8/8/06 were vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast (lot not provided). It was reported that after receiving the vaccinations both pts fainted. Additional information regarding the pts was not provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old who on 14-AUG-2006 was vaccinated (yeast).  Concomitant therapy included an unspecified therapy ("ESTRASTEP").  On 14-AUG-2006 the patient experienced profuse nausea, vomiting, low grade fever and myalgia.  The patient sought unspecified medical attention.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female who on 08-AUG-2006 was vaccinated with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN).  Following the vaccination, on an unspecified date in August 2006, the patient experienced diarrhea.  Unspecified medical attention was sought.  At the time of this report, the outcome of the diarrhea was unknown.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a pt who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently the pt experienced hives. No further details were provided, and at the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Tuberculin test
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with no pertinent medical history or drug reactions allergies who on 8/15/06 was vaccinated IM with the first dose of HPV rL1 6 11 16 18 VLP vaccine yeast (lot 653650/0702F). Concomitant therapy included Menactra. On an unspecified date the pt was given tuberculin purified protein derivative. On 8/15/06, 5 minutes after vaccination with HPV rL1 6 11 16 18 VLP vaccine yeast, the pt became faint. The pt was given water and chocolate as treatment. Subsequently, the pt recovered on 8/15/06. Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a nurse concerning a 19 year old female patient with no pertinent medical history or drug reactions/allergies who on 15-AUG-2006 at 9:00 AM was vaccinated intramuscularly with the first dose of GARDASIL (lot #653650/0702F). Concomitant therapy included "MENACTRA". On an unspecified date the patient was given tuberculin purified protein derivative. On 15-AUG-2006, within 10 minutes of receiving the vaccination, the patient became very faint and sweaty which lasted for approximately 60 seconds. The patient remained in the office for 45 minutes and was given water and chocolate as treatment. Subsequently, the patient recovered on 15-AUG-2006. No further information is expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 20 year old female with a penicillin allergy, drug hypersensitivity to cefaclor (CECLOR) and no other pertinent medical history reported.  On 15-AUG-2006, the patient was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F).  Concomitant therapy included paroxetine HCL (PAXIL), bupropion HCL (WELLBUTRIN) and famotidine.  It was reported that the patient became faint within 5 minutes of vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast).  The patient was given a soda to drink as treatment.  There were no laboratory diagnostic studies performed.  On 15-AUG-2006, the patient recovered from the event.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Initial and follow up has been received from a healthcare worker in a physician's office concerning her 19 year old daughter who was a student and an unspecified person at the physician's office.  On 11-AUG-2006, at 11:15 am, the patient was vaccinated intramuscularly in the deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F).  Other concomitant therapy included an unspecified therapy ('LO-L").  On 12-AUG-2006 (previously reported as 14-AUG-2006) the patient developed pain in her right arm and ribcage on the same side where the vaccine was administered.  On 16-AUG-2006, the patient had recovered from the events.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 14-AUG-2006 was vaccinated subcutaneously with "the standard dose" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653736/0689F).  There was no concomitant medication.  ON 15-AUG-2006 the  patient developed a rash on her face and experienced itching on her face.  It was reported that the rash was only on the patient's face and not at the injection site or any other part of her body.  The patient was instructed to take diphenhydramine hydrochloride (BENADRYL).  On 17-AUG-2006, in the morning, the patient was instructed to take diphenhydramine hydrochloride (BENADRYL).  On 17-AUG-2006, in the morning, the patient called her physician's office and reported that "it was responding to diphenhydramine hydrochloride (BENADRYL) but had not fully recovered".  The patient was scheduled to be seen by her physician on 17-AUG-2006.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 14 year old female with no pertinent medial history or drug reactions/allergies, who on 17-AUG-2006 was vaccinated intramuscularly with HPV rLI 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F).  There was no concomitant medication.  On 17-AUG-2006, 15 minutes after receiving the vaccination, the patient "passed out" in the car on her way home.  The patient was driven back to the physician's office, where she "woke up and was given soda and cold compresses".  There was no reactions at the injection site and the patient had no additional reactions.  Additional information has been requested. 01/05/2007 Initial and follow-up information has been received from a physician concerning a 14 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 at 10:00 AM was vaccinated intramuscularly in the arm with the first dose of GARDASIL (lot # 653650/0702F). There was no concomitant medication and no illnesses a time of vaccination. On 17-AUG-2006, at 10:10 AM, the patient "passed out" in the car on her way home. It was reported that following vaccination, the patient went to her car and as her mother was driving, the patient passed out. The mother drove right back to the physician's office with the patient, and the patient was carried into the office by a physician at which time she was awake. The patient lied down and was given soda and a cold compress to her forehead. It was reported that the "patient was only out a matter of 2 minutes before coming to". There was no reaction at the injection site and the patient had no additional reactions. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female who on 16-AUG-2006 was vaccinated intramuscularly in the deltoid with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml).  The patient subsequently experienced severe injection site pain.  It was reported that the patient remarked that the injection really hurt and that the pain flew down her arm.  The patient rubbed her arm for a few minutes after receiving the injection.  The patient subsequently went home and the nurse had not heard back from the patient.  The patient was to be followed by her physician's office.  The nurse also reported that she had not agitated the syringe prior to injection.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history or drug reactions/allergies, who on 10-AUG-2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F).  Concomitant therapy included ethinyl estradiol/norgestimate (TRINESSA).  On 10-AUG-2006 the patient experienced multiple episodes of vomiting.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the vomiting within 48 hours.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a physician concerning a 15 year old  female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 was vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F).  There was no concomitant medication.  On 17-aug-2006 the patient experienced nausea.  Unspecified medical attention was sought.  At the time of this report, the patient's nausea persisted.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/14/2006. Information has been received from a physician concerning a 15 year old female with no pertinent medical history or drug reactions/allergies, who on 17-AUG-2006 at 3:00 PM was vaccinated intramuscularly in the deltoid with the first dose of GARDASIL (lot # 653650/0702F). There were no illnesses at time of vaccination. There was no concomitant medication. On 17-AUG-2006 at 6:00 PM the patient experienced severe nausea. The patient subsequently recovered from the nausea on 21-AUG-2006. No further information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Syncope
Clinical narrative: Information has been received from a nurse concerning an 18 year old female with no known allergies and no other pertinent medical history reported.  On 18-AUG-2006, the patient was vaccinated intramuscularly in the deltoid with a 0.5 ml "single dose prefilled syringe" of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0702F).  There were no concomitant medication reported.  On 18-AUG-2006, the patient developed severe injection site pain with HPV rLi 6 11 16 18 VLP vaccine (yeast) injection.  The patient remarked that "it hurt and felt that the injection went to her head".  The nurse reported that the patient felt faint immediately after the vaccination.  The nurse had the patient lay down.  It was reported that the patient "got up after 1 minute and said that she was ok.". The nurse reported that the "patient left the office immediately after this and the nurse was following up with the patient later today to make sure that the patient was ok."  The nurse reported that she had not agitated the syringe prior to injection.  The patient sought unspecified medical attention.  There were no laboratory diagnostic studies performed.  On 18-AUG-2006, the patient recovered from the events.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/14/2006.  Initial and follow-up information has been received from a physician concerning a 52 year old female with a history of a "herpes outbreak" two weeks ago.  On 17-JUL-2006.  "10 days prior" to receiving GARDASIL (yeast), the patient had taken acyclovir 200 mg.  On 27-JUL-2006, the patient was vaccinated intramuscularly with the first dose of 0.5 mL of GARDASIL (yeast).  It was reported that the patient had "2 herpes lesions on her inner labia" at the time of vaccination.  On 27-JUL-2006, the patient developed a neck ache, eyelashes fell out, "a decrease memory for people" and excessive dry eye.  On 27-AUG-2006 the patient developed a migraine with vomiting (previously reported that the patient had "burning at the injection site").  The patient sought unspecified medical attention.  At the time of this report, the patient had recovered from the events (date unknown).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast).  The day after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast), the patient developed "flu-like symptoms" (date unknown).  The patient sought unspecified medical attention.  At the time of this report, the patient had recovered from the event (date unknown).  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a 22 year old female with an allergy to meperidine hydrochloride (DEMEROL) who on 21-AUG-2006 was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).  Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN).  On 21-AUG-2006, following the vaccination, the patient fainted.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, she was vaccinated with her second dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, she developed a blister at the injection site. Medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. Follow-up informatin received 4-11-08, indicated that the patient was being treated with an unspecified vaccine, and not Gardasil as previously reported. Therefore, WAES #0609USA00390 is being deleted from our files on HPV rL1 6 11 16 8 VLP vaccine (yeast). This report was previously sent to PLA V501 on 09/14/06.
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of GARDASIL. Subsequently, she was vaccinated with her second dose of GARDASIL (yeast). Subsequently, she developed a blister at the injection site.  Medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. Follow up information indicated that the patient was being treated with an unspecified vaccine, and not GARDASIL as previously reported. Therefore, WAES #0609USA00391 is being deleted from our files on GARDASIL. This report was previously sent to PLA V501 on 14-SEP-2006.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a nurse concerning two female patients who on approximately 08-AUG-2006 were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning female college students 9exact number of patients unspecified) who were vaccinated intramuscularly with HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently the patients experienced injection site (deltoid) pain.  At the time of this report, the outcome of the event was unknown.  Further attempts are being made to identify the exact number of patients and identifiers of the patients involved in this report.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injection site pain, Pain
Clinical narrative: Information has been receiving from a registered nurse concerning a 15 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).  Subsequently, on approximately 19-JUL-2006, the patient experienced burning at the injection site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry.  The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation.  Additional information has been requested.  The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema, and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (LOT#653937/0637F).
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Influenza, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 24 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, the patient experienced pain in joints and developed low grade fever.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. 01/05/2007 Follow up information has been received, the physician reported that the patient was recovered from her symptoms and stated "all it was was a one day flu". Additional follow up information has been received from the physician concerning her 24 year old daughter, a student, who on 27-JUL-2006 was vaccinated IM in left arm with her first dose of GARDASIL, lot #653735/0688F. It was reported that on 03-AUG-2006 she developed flu like symptoms. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from a 20 year old female patient who on 07-AUG-2006 was vaccinated intramuscularly with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F).  Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ).  The patient stated that "right after getting the shot" she experienced pain in the upper arm on and off throughout the day.  She also stated that the pain"feels like she has a knife in her arm".  Unspecified medical attention was sought.  The patient was treated with Ibuprofen.  As of the report date, she was recovering.  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Skin burning sensation
Clinical narrative: Information has been received from a nurse practitioner concerning a 27 year old female who on 25-AUG-2006 was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast), lot#653650/0702F.  During the administration of the vaccine, part of the fluid went into the patient's arm, the patient's arm, the patient pulled away and the remainder went on the skin (no adverse reaction noted).  The patient complained of burning during administration.  Medical attention was sought.  The patient received a repeat dose with no burning noted.  Patient's status was reported as recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no medical history who on 19-JUL-2006 was vaccinated in the right deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).  Subsequently on approximately site that lasted approximately 60 to 90 seconds and her arm became red and painful enough to cause the patient to cry.  The patient subsequently recovered from the pain in the extremity, erythema, and injection site irritation.  Additional information has been requested.  The registered nurse also reported that the patient's sister experienced pain in the extremity, erythema,and injection site irritation following vaccination with HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653937/0637F).
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient who in approximately August 2006, was vaccinated with a dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently,the patient experienced pain in joints and developed low grade fever.  Unspecified medical attention was sought.  The physician reported that the patient was recovered from her symptoms and stated "all it was was a one day flu. Additional information is expected.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Influenza, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old male patient who in approximately August 2006, was vaccinated with a  dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, the patient experienced pain in joints and developed low grade fever.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. Follow up information has been received: the physician reported that the patient was recovered from his symptoms and stated "all it was was a one day flu". Additional information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: Information has been received from an other health professional concerning a 26 year old female in sales with no pre-existing allergies, birth defects or medical conditions reported.  On 21-AUG-2006, in the pm, the patient was vaccinated in the left deltoid with the first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (lot#653650/0702F). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO TRI CYCLEN).  There were no illness noted at the time of vaccination.  On 21-AUG-2006, in the pm, the patient experienced an unspecified adverse event.  The patient went to the emergency room and it was reported that she "went home that day".  On 21-AUG-2006, the patient underwent a complete blood count (CBC), comprehensive metabolic panel, estimated glomerular filtration rate (GFR), urine microscopic analysis, urinalysis and an electrocardiogram (EKG).  On 21-AUG-2006, the patient's laboratory data revealed an absolute neutrophil count noted as 7.9 K/ul, urine ketones noted as >-80, a urine white blood cell count noted as 30-40/hpf and urine bacteria noted as 4+.  On 21-AUG-2006, the patient recovered from the events.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a 26 year old female licensed practical nurse with no pertinent medical history and no known allergies or adverse drug reactions reported who on 07-AUG-2006 was vaccinated intramuscularly with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast) (Lot#653650/0696F).  There were no concomitant medications reported.  The licensed practical nurse reported that she received HPV rLi 6 11 16 18 VLP vaccine (yeast) in her deltoid from a pre-filled syringe.  It was reported that when the injection was completed, the nurse administering it "let go of the plunger before taking it out of her arm" and the "spring shot the syringe out of the arm like a dart".  It was reported that "some fluid leaked out of her arm".  The licensed practical nurse reported that it "stung a little when the vaccine was administered" and then resolved in a few moments.  The area of the spill was cleansed with alcohol.  The patient sought unspecified medical attention.  There were no laboratory diagnostic studies performed.  At the time of this report, the patient had recovered from the events.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/14/2006.  Information has been received from a physician concerning a 23 year old female with no known drug allergies was vaccinated intramuscularly on 18-AUG-2006 at 15:00 in the deltoid muscle with GARDASIL (yeast).  On 24-AUG-2006 the patient developed a rash with itching and minimal swelling on the back of her neck, arms, ribs, back and behind her left knee.  Follow up information stated that the patient was treated with Benadryl, 50 mg and topical hydrocortisone cream.  It was reported that on 24-AUG-2006 the patient had recovered.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of GARDASIL.  Subsequently, she was vaccinated with her second dose of GARDASIL.  Subsequently, she developed a blister at the injection site.  Medical attention was sought.  The patient's outcome was unknown.  Follow-up information received 4-11-08 indicated that the patient was being treated with an unspecified vaccine, and not GARDASIL as previously reported. Therefore, WAES #0608USA06941 is being deleted from our files on GARDASIL. This report was previously sent to PLA V501 on 09/14/06.
Sex: U
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning an unspecified number of patient's who were vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast) and complained of burning during administration.  The patient's outcomes were not reported.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning three patients (age and gender not reported) who on an unspecified date, in the morning, were vaccinated with GARDASIL vaccine. Subsequently, the patients fainted after receiving GARDASIL vaccine (date unknown).  It was reported that the patients had not eaten anything.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning 3 patients 9age and gender not reported) who on an unspecified date were vaccinated with HPV rLi 6 11 16 18  VLP vaccine (yeast).  Subsequently the patients developed injection site pain (date unknown).  The patients sought unspecified medical attention.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 30-AUG-2006 was vaccinated intramuscularly in her right arm with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Concomitant therapy included ketorolac tromethamine (TORADOL).  On 30-aUG-2006, the patient felt "dizzy" after the injection.  The patient was then given a ketorolac tromethamine (TORADOL) injection and she "passed out" after receiving that injection (also reported as "dizziness followed by syncope").  It was reported that the patient was seeing the physician or her pain shot.  The syncope occurred after her pain injection.  The physician believed this was a vaso vagal response.  It was reported that "it was not known if the patient was that she was scheduled to receive".  The patient sought unspecified medical attention.  It was reported that "she did not her second shot yet".  On 30-AUG-2006, "a few minutes after", the patient recovered from the events.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/14/2006.  Initial and follow up information has been received from a physician concerning a 26 year old white female with no other pertinent medical history reported.  It was reported that the patient was seeing the physician for her pain shot.  On 30-AUG-2006, the patient was vaccinated intramuscularly in her right arm with a 0.5 mL dose of GARDASIL (Lot # 653650/0702F).  Subsequently, the patient felt dizzy immediately afterward.  It was reported that the patient received a concomitant injection in her right hip reported as TORADOL and she passed out after receiving that injection.  The patient developed loss of consciousness times 1 to 2 minutes, followed by diaphoresis, nausea and sedation event consistent with vaso-vagal reaction.  The patient sought unspecified medical attention.  On 30-AUG-2006, "a few minutes after", the patient had fully recovered from the events.  No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Presyncope, Syncope
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 30-AUG-2006 was vaccinated intramuscularly in her right arm with a 0.5 ml dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Concomitant therapy included ketorolac tromethamine (TORADOL).  On 30-aUG-2006, the patient felt "dizzy" after the injection.  The patient was then given a ketorolac tromethamine (TORADOL) injection and she "passed out" after receiving that injection (also reported as "dizziness followed by syncope").  It was reported that the patient was seeing the physician or her pain shot.  The syncope occurred after her pain injection.  The physician believed this was a vaso vagal response.  It was reported that "it was not known if the patient was that she was scheduled to receive".  The patient sought unspecified medical attention.  It was reported that "she did not her second shot yet".  On 30-AUG-2006, "a few minutes after", the patient recovered from the events.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/14/2006.  Initial and follow up information has been received from a physician concerning a 26 year old white female with no other pertinent medical history reported.  It was reported that the patient was seeing the physician for her pain shot.  On 30-AUG-2006, the patient was vaccinated intramuscularly in her right arm with a 0.5 mL dose of GARDASIL (Lot # 653650/0702F).  Subsequently, the patient felt dizzy immediately afterward.  It was reported that the patient received a concomitant injection in her right hip reported as TORADOL and she passed out after receiving that injection.  The patient developed loss of consciousness times 1 to 2 minutes, followed by diaphoresis, nausea and sedation event consistent with vaso-vagal reaction.  The patient sought unspecified medical attention.  On 30-AUG-2006, "a few minutes after", the patient had fully recovered from the events.  No further information is available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient in her early 20's who was vaccinated with her first dose of HPV rLi 6 11 16 18 VLP vaccine (yeast).  Subsequently, the patient experienced a high amount of pain and swelling at the injection site.  Medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested. 01/05/2007 Follow up information has been received from a physician concerning a 24 year old female who on 29-AUG-2006 at 9:00 a.m. was vaccinated in the left arm with her first dose of GARDASIL, lot #653736/0589F. Concomitant therapy included AMBIEN, doxycycline, ALLEGRA-D, and unspecified oral contraceptive pills. Following the vaccination, on 29-AUG-2006 at 9:00 a.m. the patient experienced pain (burning) in her left arm plus swelling and tenderness x 3 days. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Information has been received from a physician concerning a 23 year old female.  It was reported that it was "not known if the patient was pregnant, if she was taking any other medications or had a history of drug reactions or allergies."  On an unspecified date, the patient was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).  It was reported that the patient felt "light headed and dizzy" after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast).  The patient also "turned very pale", but did not faint.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse in a physician's office concerning a female patient "in her 20's" who on an unspecified date was vaccinated with HPV rLi 6 11 16 18 VLP vaccine (yeast).  It was reported that the patient "fainted" after being given HPV rLi 6 11 16 18 VLP vaccine (yeast) (date unknown).  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Arthropathy, Osteoporosis
Clinical narrative: OSTEOPOROSIS OF SPINE AND DETERIATION OF HIP BONE AT 40 YEARS OLD WITH ALL SECONDARY CAUSES RULED OUT. ANTHRAX VACCINE GIVEN BETWEEN 11/98-10/99 (5 OUT OF SERIES OF 6) CANCELLED BEFORE 6TH  COULD BE ADMINISTERED.  CONSISTANT WITH DOCUMENT DESCRIBING ADVERSE REACTIONS FOR THE ANTHRAX VACCINE.
Age: 1.96
Sex: M
Vaccine: HEP, IPV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: TEMP 102.6 REPORTED FEBRILE SEIZURE BY HOSPITAL.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Blister, Rash, Tongue oedema
Clinical narrative: PATIENT "STATES BROKE OUT IN RASH ON CHEST AND FACE; TONGUE SWELLED AND FELT WEAK; LEFT ARM (DELTOID)SORE; NOTICED BLISTERS ON TONGUE AND FEW ON CHEST; TOOK 25 MG PO BENADRYL WHICH HELPED AND TONGUE SWELLING WITHIN 30 MINUTES AND CORTISONE ON CHEST DRIED UP THE BLISTER". PT STATES SHE CALLED CDC;  ALSO STATED SHE HAD EATEN TOMATOES AND THAT SHE HAD BEEN ALLERGIC TO TOMATOES IN THE PAST. NO SIMILAR REACTION TO TOMATOES DISCUSSED.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash vesicular
Clinical narrative: Patient received MMRV injection on 8/29/06 in right deltoid.  On 9/06/06, patient had a vesicular-like rash as reported by her mother.  Rash was on patient's stomach and right thigh.  Patient's mother has been treating the rash with antibiotic ointment. As of this date, the mother says the area on the stomach has improved and is almost completely healed, but the rash on the thigh is still open and requires a light dressing before getting dressed.  No fever noted.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: VOMITING, FEVER, HEADACHE. FEVER ON THE DAY OF THE VACCINE & HEADACHES THE DAY AFTER THE VACCINE.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Lethargy, Pallor, Pharyngolaryngeal pain, Thirst
Clinical narrative: Child was given DTaP, IPV, and MMR vaccines at  10:10 AM.  She did well at time of vaccines- barely cried, got up from exam table and went to check out with mom and siblings.  Before leaving office child c/o being thirsty and said her throat was hurting.  Mom told staff that she had not been c/o throat hurting before shots but that child was a "drama queen" and child went to water fountain to get water. Mom and child left office at approximately 10:18 AM.  Mom carried child back into office at approximately 10:22 AM.  Child was extremely pale and lethargic.  Dr. was immediately notified and went in to see child.  BP was 66/40 and child was c/o stomachache.  Oxygen was started at 2L per min and 0.2 ml of Epinephrine (1:1000) was given at 10:25 AM.  Oxygen level was 96-98% at this time.  Child's color improved while she was crying after Epi was given.  Child's color turned very pale again as soon as child calmed down.  Solumedrol 35 mg was given IM at 10:30 AM.  Dr. and staff monitored child's condition for several minutes after Solumedrol was given. Oxygen level remained 96-98% even though child was removing oxygen mask periodically.  911 was called at Dr's request because child's skin color had only improved slightly after all of the treatments we had administered.  Child was transported to hospital via EMS.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash, Skin ulcer
Clinical narrative: Within 15 minutes of recieving vaccines, the child developed a rash on the soles of both feet. A few lesions were noted on the back and abdomen (2). Lesions disappeared within 45 minutes. A few recurred 15 minutes later. Baby remained without any other symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Listless, Pyrexia
Clinical narrative: Mother called the clinic approx 2 hours after vaccination reporting a fever of 102.  I recommended Children's Tylenol or Children's Ibuprofen.  Begin cooling measures ie: warm water bath, liquids and to call PMD and notify.  At about 3pm Mom called again and reported a Temp of 104.and child is "listless" (she had not done the cooling measures).  Call PMD and begin cooling measures...she did.  In AM of 9-19-06 mother reports child continued with fever as high as 104 but is at 101 at the time (9am)of the call.  She plans on calling PMD again.  I told here to continue cooling measures as needed and to contine Tylenol or Motrin.
Age: 65.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Joint stiffness, Joint swelling
Clinical narrative: The day after immunization expected local pain but then gradually progresses to diffuse joint pain/stiffness and swelling.  Has been slowly improving.
Age: 26.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Chills, Dizziness
Clinical narrative: About 2 1/2 hours after receiving hepatitis a & b shots c/o slight dizziness, while smoking a cigarette, which lasted about 30 minutes and then began having slight chills. Denied any other complaints, breathing unaffected.V/S normal.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Laboratory test abnormal, Retinal haemorrhage, Subdural haematoma
Clinical narrative: Nursing staff was notified today that the patient was in the pediatric intensive care unit with a hx of seizure of 15 minute duration Sept 17, 2006, found to have subdural hematoma with retinal hemorrhage.  Pt did receive immunizations 09-12-2006. 10/10/2006-records received for DOS 8/18-9/27/06. DC DX: subdural hemorrhage, retinal hemorrhage. Pt admitted after seizure activity at home. Child while being held by father was crying and the baby "stiffened" and was unresponsive. Paramedics arrived in less than 5 minutes, and baby regaining consciousness upon their arrival.  HX: Baby is very easy in temperament, barely cries around time of fee. Does cry when mother turns baby over to dad in evenings. On 9/17/06 returned from visiting extended family and later that evening is when the baby was stiff with one or both arms extended and was unconscious, he could not move and no noise was coming from him. Family denies abuse. At about 3 weeks of age the baby rolled off a mattress onto the floor at which time he seemed fine and was alert thereafter. Mother relates that baby seemed to be more irritable past several days, crying more than usual but not more lethargic but rather more awake yet as interactive and normal acting as usual. The head circumference increased between 1-2 months of age which was noted by the PCP but felt to be unimportant and 5 days prior to admission a wheeze was noted at PCP office. Otherwise review of systems appears unremarkable. Hospital course: vomiting, Dobbhoff feeding tube placed. Per 60 day follow up: Recovery status unknown unable to locate at home #.