chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a mother concerning her 23 year old daughter with no pertinent medical history who on 03-OCT-2007 was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Concomitant therapy included "birth control pills" (manufacturer unknown). On 04-OCT-2007 the patient woke up in the morning with a severe headache. There were no laboratory or diagnostic test performed. The patient did not seek medical attention. At the time of the report the patient had not recovered. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist concerning a 40 year old female with a shellfish allergy who was vaccinated with a dose of Gardasil. The patient was scheduled to be administered another unspecified vaccination. Subsequently the patient developed an unspecified allergic reaction. The patient was examined at the local emergency room, At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Pruritus, Pruritus generalised, Wrong technique in drug usage process
Clinical narrative: Information has been received from a nurse concerning a 25 year old female with a penicillin and BENADRYL hypersensitivity who on 10-SEP-2007 was vaccinated intramuscularly into the right hip with a 0.5 ml first dose of Gardasil (Lot #658558/1061U). There was no concomitant medication. On 10-SEP-2007 at 11:48 the patient experienced an allergic reaction with generalized pruritus for 2 weeks. The patient went to the emergency room and she was treated with an unspecified shot to help and released that day. The patient mentioned that she had also switched her laundry detergent around the same time of vaccination, but had switched back, and the itching persisted. There were no laboratory or diagnostic tests performed. On 24-SEP-2007 the patient had recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MEN
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning her 16 year old daughter, who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted while she was walking down the hallway. The patient was in the physician's office during this event. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a registered nurse concerning her 16 year old white daughter with no medical history and no drug allergies, who, on 31-JUL-2007 at 11:15 was vaccinated intramuscularly in the right deltoid with a first dose of GARDASIL (lot# 657888/0523U). Concomitant vaccinations included a first dose of hepatitis A virus vaccine (unspecified) (Lot# "AHAVB1620B"), administered intramuscularly in the right deltoid and a first dose of meningococcal vaccine (unspecified) (Lot# "U2222AA"), administered intramuscularly in the left deltoid. There were no illnesses at the time of the vaccinations. The patient waited in the room for 15 minutes after the injection. On 31-JUL-2007 at 11:45 the patient was leaving the room and got lightheaded and passed out (previously reported as the patient fainted while she was walking down the hallway). The patient fell onto the floor and was passed out for approximately 15 seconds. The patient was in the physician's office during this event. No laboratory diagnostics were performed. The patient recovered on 31-JUL-2007 at noon. No product quality complaint was involved. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Dizziness, Lymphadenopathy, Malaise, Nausea
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a nurse concerning a 21 year old female patient who on 21-SEP-2007 was vaccinated with a dose of GARDASIL (lot # 658563/1063U). Within one hour of vaccination the patient had nausea and dizziness. The patient had hand tingling and feet tingling as well as general malaise. The patient then progressed to neck pain and had swollen glands. The patient went to ER and had a CT scan and MRI done. The patient was not admitted to the hospital The patient's outcome was unknown. No further information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a nurse concerning a 21 year old female patient who on 21-SEP-2007 was vaccinated with a dose of GARDASIL (lot # 658563/1063U). Within one hour of vaccination the patient had nausea and dizziness. The patient had hand tingling and feet tingling as well as general malaise. The patient then progressed to neck pain and had swollen glands. The patient went to ER and had a CT scan and MRI done. The patient was not admitted to the hospital The patient's outcome was unknown. No further information is expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia facial, Pain in extremity, Syncope
Clinical narrative: Information has been received from a Physician Assistant (P.A.) that a consumer's mother reported concerning her 13 year old daughter who on 28-AUG-2007 was vaccinated IM with a first dose of Gardasil. The reporter indicated that on 28-AUG-2007 the patient experienced headache, fainting, legs and hands pain and numbness on half of her face after getting Gardasil. No further information was provided. The patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who on approximately 26-SEP-2007, was vaccinated with a dose of Gardasil. It was reported that in approximately 26-SEP-2007, the patient experienced injection site tenderness. The patient contacted the physician by phone but no treatment was recommended. At the time of the report, the patient's injection site tenderness persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Initial and follow-up information has been received from a registered nurse concerning a 15 year old female who on 25-SEP-2007, at 16:00, was vaccinated IM, into the left deltoid, with a second dose of GARDASIL (lot #658583/1063U). It was reported that in approximately 26-SEP-2007, the patient experienced injection site tenderness. On 03-OCT-2007, the patient's mother contacted the physician by phone to report that her arm was still sore. There was no redness, numbness, tingling, local warmth or swelling and range of motion was OK. The patient's mother was advised to have her daughter use arm and take ibuprofen regularly and use warm or cool compress. At the time of the report, the patient had not recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on approximately 06-SEP-2007 was vaccinated with a 0.5 ml second dose of Gardasil. Subsequently the patient experienced hives and unspecified burning sensation. The patient called the physician. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Chemotherapy, Platelet count decreased, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 11 year old female patient, with a history of cancer (in remission for 5 years) , who on an unknown date was vaccinated with a dose of GARDASIL. Subsequently the patient developed a drop in her blood platelet levels to below 200 (units not specified). At the time of this report, the outcome of the event was unknown. Additional information has been requested. Initial and follow up information has been received from a physician concerning an 11 year old female with a history of cancer (in remission for 5 years), who on 05-JUN-2007 was vaccinated with a dose of VLP vaccine (lot # not provided). Subsequently the patient developed a drop in her blood platelet levels to below 200 (units not specified). It was reported that bloodwork for platelets done on 19-JUL-2007 showed a slight low count of 163, 000. This was repeated on 04-AUG-2007 and was 191,000. The patient finished chemotherapy. Additionally, it was reported that this was a case of cancer reactivation after remission. At the time of this report, the patient's outcome was unknown. Upon internal review cancer reactivation was considered to be an other important medical event.  8/25/08-records received-12/10/07-referred for recent drop in platelet count. On 7/17/07 platelet count 160,000 and some URI around same time. PE on 11/15/07 no petechiae no palpable adenopathy. Platelets now 183,000. Drop in platelets could be due to a reaction to vaccination or an infection. No evidence of leukemia relapse. May receive second vaccination. At the time of this report, the outcome of the event was unknown. Follow-up information was received which reported that bloodwork for plateletes done 19-JUL-2007 showed a slight low count of 163,000. This was repeated on 04-AUG-2007 and was 191,oo (normal). The patient finished chemotherapy.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised, Rash erythematous
Clinical narrative: Information and follow up information has been received from a nurse practitioner, concerning a 19 year old female student with no pertinent medical history and no known allergies, who on 18-SEP-2007 at 1:00 p.m., was vaccinated IM in the deltoid, with the first dose of Gardasil (lot #658560/1062U). There was no concomitant medication. There was no illness at the time of vaccination. On 18-SEP-2007, following the vaccination, she developed red patches with itching all over her body. On 03-OCT-2007, the patient returned to the office, and treatment with CLARITIN was prescribed. At the time of this report, the patient had not recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported) who on an unknown date was vaccinated with a dose of GARDASIL. Following the vaccination, the patient fainted. She was evaluated by healthcare professionals. Subsequently, the patient recovered (duration not specified).
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Presyncope
Clinical narrative: Information has been received from a registered nurse concerning a "teenaged" female with pertinent medical history and drug reactions/allergies not specified who on an unspecified date was vaccinated with the first dose of GARDASIL. Concomitant suspect therapy included VARIVAX. Other concomitant therapy included HAVRIX, MENACTRA, TDAP.  Subsequently on an unspecified date, the patient experienced dizziness and almost fainted while on GARDASIL. Laboratory/diagnostic studies were reported as none. Unspecified medical attention was sought. ON a n unspecified date, the patient was recovering from the dizziness and almost fainted. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Hot flush, Musculoskeletal pain, Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 24-SEP-2007 was vaccinated with Gardasil (lot# 1061U). On 25-SEP-2007 the patient experienced nausea, dizziness, headache, hot flashes and shoulder pain. Subsequently, the patient recovered from nausea, dizziness, headache, hot flashes and shoulder pain on 26-SEP-2007. The patient sought medical attention by calling the physicians office. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 26-SEP-2007 was vaccinated with the second dose of GARDASIL intramuscularly in the glute. On 27-SEP-2007 the patient experienced a macular papular rash on both cheecks of the face. Subsequently, the patient recovered on 27-SEP-2007 from macular papular rash on both cheeks of the face. The patient sought unspecified medical attention when her mother called the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 17 year old female who on 25-SEP-2007 was vaccinated with her second dose of GARDASIL vaccine intramuscularly in the left glute (lot# 658664/0928U). The patient had a vaginal yeast infection for 7 days at the time of the injection. She had not taken DIFLUCAN yet. On 26-SEP-2007 the patient broke out in a fine, pink, macular papular rash over both cheeks "where you would place hands if holding head." Subsequently, the patient recovered completely after 2 hours on 26-SEP-2007 from macular papular rash on both checks of face. The patient sought unspecified medical attention when her mother called the office. The patient returned to school and was not keen to be examined. The plan is to keep the patient for 1 hour in office after 3rd injection on 26-JAN-2008. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Leukoplakia oral
Clinical narrative: Information has been received from a nurse concerning a 14 year old female patient who on 09-APR-2007 was vaccinated with a first dose of GARDASIL. On 18-JUN-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 657868/0523U). Subsequently the patient experienced leukoplakia.The dentist made the diagnosis and contacted the physician.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old female with a history of recurrent urticaria who on 02-OCT-2007 was vaccinated with her first dose of Gardasil (lot# 657737/0522U). Within three hours of receiving the dose the patient experienced dizziness, headache and fever. On 03-OCT-2007 the patient experienced nausea, vomiting and abdominal pain. The patient's dizziness, headache, fever, nausea, vomiting and abdominal pain persisted. The patient sought unspecified medical attention by the physician. Concomitant therapy included CLARINEX. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007.  Initial and follow-up information has been received from a physician concerning a 14 year old female with no illness at the time of vaccination, a history of recurrent urticaria and drug hypersensitivity to "cydizir", "cyprozil", erythromycin, clavulanete, ceclor and sulfonamide who on 02-OCT-2007 was vaccinated with her first dose of GARDASIL (lot# 657737/0522U) in the lower left arm IM at 10:14 AM.  Concomitant therapy included CLARINEX daily.  On 02-OCT-2007, within three hours of receiving the dose (also reported as 03-OCT-2007).  The patient experienced dizziness, headache and fever.  On 03-OCT-2007 at 10 AM the patient experienced nausea, vomiting and abdomial pain.  The patient's dizziness, headache, fever, nausea, vomiting and abdominal pain persisted.  The patient sought unspecified medical attention by the physician.  Additional informatin is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 year old female with a history of recurrent urticaria who on 02-OCT-2007 was vaccinated with her first dose of Gardasil (lot# 657737/0522U). Within three hours of receiving the dose the patient experienced dizziness, headache and fever. On 03-OCT-2007 the patient experienced nausea, vomiting and abdominal pain. The patient's dizziness, headache, fever, nausea, vomiting and abdominal pain persisted. The patient sought unspecified medical attention by the physician. Concomitant therapy included CLARINEX. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007.  Initial and follow-up information has been received from a physician concerning a 14 year old female with no illness at the time of vaccination, a history of recurrent urticaria and drug hypersensitivity to "cydizir", "cyprozil", erythromycin, clavulanete, ceclor and sulfonamide who on 02-OCT-2007 was vaccinated with her first dose of GARDASIL (lot# 657737/0522U) in the lower left arm IM at 10:14 AM.  Concomitant therapy included CLARINEX daily.  On 02-OCT-2007, within three hours of receiving the dose (also reported as 03-OCT-2007).  The patient experienced dizziness, headache and fever.  On 03-OCT-2007 at 10 AM the patient experienced nausea, vomiting and abdomial pain.  The patient's dizziness, headache, fever, nausea, vomiting and abdominal pain persisted.  The patient sought unspecified medical attention by the physician.  Additional informatin is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 14 year old female with immunocompromised and a history of heart transplant who was vaccinated with a dose of GARDASIL. Concomitant therapy included varicella virus live, for the treatment of prophylaxis. Other concomitant therapy included HAVRIX. Ten days after the vaccination, the patient experienced cellulitis. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash macular, Rash papular, Swelling face
Clinical narrative: Information has been received form a physician concerning a 12 year old female who on 02-OCT-2007 was vaccinated with a third dose of GARDASIL. On 03-OCT-2007 the patient experienced red blotchy rash, red pauples on her forehead and cheeks with a facial swelling. On 04-OCT-2007 seen in the physician's office. Treated with BENADRYL. No adverse experiences noted from the first two doses. The patient's outcome was unknown. NO product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient (age not reported) who on an unknown date was vaccinated with a dose of GARDASIL. Following the vaccination, the patient had redness at the injection site. She was evaluated by healthcare professionals. Subsequently, the patient recovered (duration not specified). This is one of two reports received from the same source (WAES #0710USA00946).
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Lymphadenopathy, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 18-JUL-2007 was vaccinated with the first 0.5 mL dose of GARDASIL. On 26-SEP-2007, after the patient was vaccinated with the second dose of GARDASIL she experienced swelling and soreness in the arm. The patient also experienced fatigue and lymphadenopathy in her neck. The patient sought unspecified medical attention. The patient status was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Dry skin, Nausea, Rash, Vomiting
Clinical narrative: Information has been received from a mother regarding her 20 year old daughter with a history of feeling sick after a tetanus shot who in approximately 2007 was vaccinated with a second 0.5 ml dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently she developed a rash. It was unknown if the patient recovered. On 04-OCT-2007 she Received a third 0.5 ml dose of GARDASIL. On 04-OCT-2007 the patient developed vomiting, nausea and a rough, blistery patch near injection site (but not at the injection site). As of 05-OCT-2007 she was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received from a 27 female with no pertinent medical history who in March 2007, was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL. Concomitant therapy included "birth control pills" (manufacturer unknown). In April 2007 one month after vaccination the patient broke out into hives. There was no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 07-SEP-2007, was vaccinated with a first 0.5 ml dose of GARDASIL. Within 24 hours, the patient developed a high fever of 103F and vomiting. Unspecified medical attention was sought. The patient was instructed to take MOTRIN as needed. Subsequently, the patient's symptoms resolved and "is fine now." No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007.  Information has been received from a physician concerning an 18 year old female patient who on 07-SEP-2007 at 16:00 was vaccinated with a first 0.5ml dose of GARDASIL (Lot reported as "01984").  Within 24 hours, the patient developed a high fever of 104F and vomiting.  Unspecified medical attention was sought.  The patient was instructed to take MOTRIN as needed.  On 12-SEP-2007, the patient's symptoms received and "is fine now".  No product quality complaint was involved.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from an office nurse manager concerning a female patient "in her twenties" who was vaccinated with a third dose of GARDASIL. On 05-OCT-2007 the patient experienced vomiting. Treatment was unspecified. At the time of the report the patient's outcome was unknown. The office manager reported that the patient felt that the patient's vomiting was related to GARDASIL.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of GARDASIL. On an unspecified date, the patient was vaccinated with a second dose of GARDASIL.  Subsequently, the patient experienced hives after the second dose. The patient sought medical attention. At the time of reporting, the patient's hives persisted. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Migraine
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who on 04-OCT-2007 was vaccinated with a first dose of GARDASIL 0.5 ml IM. Concomitant therapy also given on 04-OCT-2007 included TDAP. On 04-OCT-2007, the patient experienced a migraine and dizziness. The patient sought medical attention by calling the nurse. At the time of reporting, the patient's migraine and dizziness persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Depression, Fatigue, Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old niece who on an unspecified date was vaccinated intramuscularly with a 0.5 ml second dose of GARDASIL. The nurse reported that her niece experienced nausea, vomiting, loss of appetite, fatigue and depression after the 2nd immunization. The patient did not seek medical attention for her experience. The patient's outcome was not reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Activities of daily living impaired, Blood thyroid stimulating hormone normal, Diarrhoea, Laboratory test normal, Monocyte percentage increased
Clinical narrative: Information has been received from a physician concerning a 15 year old white female with no illness at time of vaccination, who on 22-AUG-2007 was vaccinated intramuscularly in the right deltoid muscle with a 0.5 ml dose of GARDASIL and concomitantly vaccinated on the same day with a dose of MENACTRA at separate injection sites. On 24-AUG-2007, post vaccination, the patient experienced intermittent bouts/episodes (1/day to 3/week) of vomiting, nausea and diarrhea which resulted in the patient missing school. Per the reporting physician, symptoms persisted for approximately 6 weeks. The patient received unspecified medical attention. Per the doctor, at the time of this report it is unknown if the patient had recovered. Reporting physician did not associate patient's illness with vaccine. On 24-SEP-2007, laboratory evaluations revealed comprehensive panel within normal limits and serum thyroid stimulating hormone 1.72. Complete blood count revealed white blood cell count was 6.7 1000/mm3, red distribution with 12.3 (L) and monocytes 7% (H). No additional information expected
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Nausea, Red blood cell count decreased, Vomiting, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 15 year old white female with no illness at time of vaccination, who on 22-AUG-2007 was vaccinated intramuscularly in the right deltoid muscle with a 0.5 ml dose of GARDASIL and concomitantly vaccinated on the same day with a dose of MENACTRA at separate injection sites. On 24-AUG-2007, post vaccination, the patient experienced intermittent bouts/episodes (1/day to 3/week) of vomiting, nausea and diarrhea which resulted in the patient missing school. Per the reporting physician, symptoms persisted for approximately 6 weeks. The patient received unspecified medical attention. Per the doctor, at the time of this report it is unknown if the patient had recovered. Reporting physician did not associate patient's illness with vaccine. On 24-SEP-2007, laboratory evaluations revealed comprehensive panel within normal limits and serum thyroid stimulating hormone 1.72. Complete blood count revealed white blood cell count was 6.7 1000/mm3, red distribution with 12.3 (L) and monocytes 7% (H). No additional information expected
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Blood immunoglobulin M, Herpes simplex serology positive, Herpes virus infection, Rash
Clinical narrative: Information has been received from a physician concerning a 12 year old white female student who on 31-AUG-2007 at 10:20 was vaccinated intramuscularly in the left arm with a first dose of GARDASIL (lot #657006/0188U), 0.5 ml. Concomitant suspect vaccinations included a dose of VARIVAX (lot # "05950"), administered in the left arm. Concomitant vaccinations included Dtap ( lot # OC2775AA) and meningococcal (lot # U2326AA), both administered in the right arm. There were no illnesses at the time of vaccination. On 01-SEP-2007 the patient "broke out with herpes" (unspecified). It was reported that the patient had no history of sexual activity. The patient was seen at the office. A serum Herpes simplex virus immunoglobulin M antibody test was performed and was positive. The rash resolved with treatment. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Dizziness, Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a female coworker with no medical history and a latex allergy who in October 2006 was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced a sore throat with white bumps on the back of her throat and headache. After the second dose of the vaccine, the patient experienced a fever, vomiting, diarrhea, blurry vision, headache and dizziness. Subsequently, the patient recovered. It was reported that the nurse practitioner is not the coworker's healthcare professional and does not want to be contacted. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Throat lesion, Vision blurred, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a female coworker with no medical history and a latex allergy who in October 2006 was vaccinated with a first dose of GARDASIL. Subsequently, the patient experienced a sore throat with white bumps on the back of her throat and headache. After the second dose of the vaccine, the patient experienced a fever, vomiting, diarrhea, blurry vision, headache and dizziness. Subsequently, the patient recovered. It was reported that the nurse practitioner is not the coworker's healthcare professional and does not want to be contacted. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently the physician reported that the patient had a reaction to the sulfate in the vaccine. The reaction manifested as a rash on different parts of the patient's body. The patient was seen by her physician. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: Information has been received from a nurse concerning a 20 year old female who on 02-OCT-2007 was vaccinated with GARDASIL. On 02-OCT-2007 the patient experienced passed out, syncope and bump on head. Subsequently, within the first 5 minutes after receiving the vaccine she passed out and experienced syncope. She fell over and bumped her head on the wall. The nurse who was present in the room called out the patient's name and hit her on the face the patient woke up. The patient developed a bump on her head. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received form a physician concerning a female in her early 20's who was vaccinated with the first dose of GARDASIL. Shortly after the vaccine was given, the patient experienced pain and swelling at the injection site. Subsequently, the patient recovered from the events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 15 year old white female with no medical history and no drug allergies, who, on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication. There were no illnesses at the time of the vaccination. On 02-OCT-2007, the patient developed hives. The patient was seen by her physician. No laboratory diagnostics were performed. the patient recovered on 04-OCT-2007. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Pyrexia, Throat tightness
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 21 year old female patient with no known allergies, who on 20-SEP-2007 was vaccinated IM in the left deltoid with the first dose, 0.5ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #654539/0742U).  Immediately following the vaccination, she felt lightheaded, faint, dizzy, and was diaphoretic.  She was monitored at the physician's office, and then left.  Seven hours after she left the office, on approximately 20-SEP-2007, she also developed a fever, had chills and felt like her throat was closing up (this was relayed to the physician on an unrelated visit 25-SEP-2007).  Subsequently, the patient recovered from the events (date and duration not specified).  This is one of two reports received from the same source (WAES #0710USA00464).  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 21 year old female patient with no known allergies, who on 20-SEP-2007 was vaccinated IM in the left deltoid with the first dose, 0.5ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #654539/0742U).  Immediately following the vaccination, she felt lightheaded, faint, dizzy, and was diaphoretic.  She was monitored at the physician's office, and then left.  Seven hours after she left the office, on approximately 20-SEP-2007, she also developed a fever, had chills and felt like her throat was closing up (this was relayed to the physician on an unrelated visit 25-SEP-2007).  Subsequently, the patient recovered from the events (date and duration not specified).  This is one of two reports received from the same source (WAES #0710USA00464).  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Throat tightness
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 21 year old female patient with no known allergies, who on 20-SEP-2007 was vaccinated IM in the left deltoid with the first dose, 0.5ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #654539/0742U).  Immediately following the vaccination, she felt lightheaded, faint, dizzy, and was diaphoretic.  She was monitored at the physician's office, and then left.  Seven hours after she left the office, on approximately 20-SEP-2007, she also developed a fever, had chills and felt like her throat was closing up (this was relayed to the physician on an unrelated visit 25-SEP-2007).  Subsequently, the patient recovered from the events (date and duration not specified).  This is one of two reports received from the same source (WAES #0710USA00464).  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Nausea, Rash
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 26 year old female patient with an allergic reaction to antibiotics, who on 26-SEP-2007 was vaccinated IM in the left deltoid, with the third dose, 0.5 ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #654539/0742U).  On approximately 27-SEP-2007 ("within 24 hours"), the patient stated that she "felt something and developed a rash".  Treatment with diphenhydramine (BENADRYL) was prescribed.  At the time of this report, the outcome of the event was unknown.  This is one of two reports received from the same source (WAES #0710USA00457).  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 26 year old female patient with an allergic reaction to antibiotics, who on 26-SEP-2007 was vaccinated IM in the left deltoid, with the third dose, 0.5 ml, of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #654539/0742U).  On approximately 27-SEP-2007 ("within 24 hours"), the patient stated that she "felt something and developed a rash".  Treatment with diphenhydramine (BENADRYL) was prescribed.  At the time of this report, the outcome of the event was unknown.  This is one of two reports received from the same source (WAES #0710USA00457).  Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: DTAP, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, RVX, HBHEPB, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 4 month old female who on 03-AUG-2007 was vaccinated with a oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (lot#657514/0667U). Suspect therapy included HIB conj-hepatitis B vaccine received intramuscularly in the right upper thigh (lot#656269/1417F) (duration and dose not reported). on 04-AUG-207 the patient experienced a fever of 104 degrees F for 24 hours. On approximately 06-AUG-2007 the patient experienced rash about 48 hours after vaccination. Subsequently, the patient recovered from 104 degrees f fever and rash. Unspecified medical attention was sought. Additional informtion is not expected.
Age: 0.1
Sex: F
Vaccine: DTAP, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, RVX, HBHEPB, RV5
Symptoms: Crying, Decreased appetite, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 4 month old female who on 03-AUG-2007 was vaccinated with a oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (lot#657514/0667U). Suspect therapy included HIB conj-hepatitis B vaccine received intramuscularly in the right upper thigh (lot#656269/1417F) (duration and dose not reported). on 04-AUG-207 the patient experienced a fever of 104 degrees F for 24 hours. On approximately 06-AUG-2007 the patient experienced rash about 48 hours after vaccination. Subsequently, the patient recovered from 104 degrees f fever and rash. Unspecified medical attention was sought. Additional informtion is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram, Full blood count normal, Laboratory test normal
Clinical narrative: AT 8 AM ON 10/12/07 CHILD FOUND EXTREMELY LETHARGIC AND DIAPHORETIC WHEN AWAKENED FOR SCHOOL. WAS FINE AT BEDTIME 9 PM. 10/11/07.  ON 10/12 AM WENT TO PEDIATRICIAN WHO SENT TO HOSP ER. TESTS INCLUDING CT BRAIN WERE NEG. OTHER SX NAUSEA, EMESIS 2-3 DAYS
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Nuclear magnetic resonance imaging, Postictal state, Scan brain
Clinical narrative: AT 8 AM ON 10/12/07 CHILD FOUND EXTREMELY LETHARGIC AND DIAPHORETIC WHEN AWAKENED FOR SCHOOL. WAS FINE AT BEDTIME 9 PM. 10/11/07.  ON 10/12 AM WENT TO PEDIATRICIAN WHO SENT TO HOSP ER. TESTS INCLUDING CT BRAIN WERE NEG. OTHER SX NAUSEA, EMESIS 2-3 DAYS
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Hyperhidrosis, Lethargy, Nausea
Clinical narrative: AT 8 AM ON 10/12/07 CHILD FOUND EXTREMELY LETHARGIC AND DIAPHORETIC WHEN AWAKENED FOR SCHOOL. WAS FINE AT BEDTIME 9 PM. 10/11/07.  ON 10/12 AM WENT TO PEDIATRICIAN WHO SENT TO HOSP ER. TESTS INCLUDING CT BRAIN WERE NEG. OTHER SX NAUSEA, EMESIS 2-3 DAYS
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Scan brain, Vomiting
Clinical narrative: AT 8 AM ON 10/12/07 CHILD FOUND EXTREMELY LETHARGIC AND DIAPHORETIC WHEN AWAKENED FOR SCHOOL. WAS FINE AT BEDTIME 9 PM. 10/11/07.  ON 10/12 AM WENT TO PEDIATRICIAN WHO SENT TO HOSP ER. TESTS INCLUDING CT BRAIN WERE NEG. OTHER SX NAUSEA, EMESIS 2-3 DAYS
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Rash
Clinical narrative: Information has been  received from a physician concerning a 2 month old male who on approximately 17-AUG-2007 was vaccinated PO with his first 2.0 mL RotaTeq vaccine (lot# 657520/0670U). About 1 hour later, the patient broke out in hives around the mouth area. The physician was contacted about the reaction and the patient was brought to the ER but was not hospitalized. One hour after the ER visit there was no trace of hives anymore. The "baby patient was fine after being brought to the ER." There was no product quality complaint. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Urticaria
Clinical narrative: Information has been  received from a physician concerning a 2 month old male who on approximately 17-AUG-2007 was vaccinated PO with his first 2.0 mL RotaTeq vaccine (lot# 657520/0670U). About 1 hour later, the patient broke out in hives around the mouth area. The physician was contacted about the reaction and the patient was brought to the ER but was not hospitalized. One hour after the ER visit there was no trace of hives anymore. The "baby patient was fine after being brought to the ER." There was no product quality complaint. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Pain in extremity, Syncope
Clinical narrative: Information has been received from an office manager, concerning a 15 year old female patient, who on 17-AUG-2007 was vaccinated IM with the first dose of Gardasil (lot #658222/0927U). Following the vaccination, she experienced pain and numbness from the shoulder to the elbow. The outcome of the events were unknown. On 18-OCT-2007 the patient was vaccinated IM with the second dose of Gardasil (lot # invalid), and again following the vaccination, experienced pain and numbness from the shoulder to the elbow. Five minutes after the injection, the patient fainted. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Syncope, Vaccine positive rechallenge
Clinical narrative: Information has been received from an office manager, concerning a 15 year old female patient, who on 17-AUG-2007 was vaccinated IM with the first dose of Gardasil (lot #658222/0927U). Following the vaccination, she experienced pain and numbness from the shoulder to the elbow. The outcome of the events were unknown. On 18-OCT-2007 the patient was vaccinated IM with the second dose of Gardasil (lot # invalid), and again following the vaccination, experienced pain and numbness from the shoulder to the elbow. Five minutes after the injection, the patient fainted. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia oral
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female with a history of pneumonia and no drug allergies, who on 16-OCT-2007 was vaccinated in the left deltoid with a 0.5mL third dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot #658488/1264U).  There was no concomitant medication.  On 16-OCT-2007, the patient developed numbness of the tongue 10 minutes post vaccination, and then the symptom subsided.  After leaving the office the mother called stating that her daughter's tongue was numb.  When the nurse practitioner spoke to the mother the patient's tongue was no longer numb.  On 18-OCT-2007 the mother called the office again stating that her daughter's tongue was numb again.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Antiphospholipid antibodies positive, Colour vision tests normal, Eye pain, Eye pain, Heterophoria
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with environmental allergies, allergy to ciprofloxacin and a history of pyelonephritis and inflammation conditions who on 04-JUN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot #657736/0389U) 0.5mL IM.  Concomitant therapy included cetirizine hydrochloride  (ZYRTEC).  On 08-AUG-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #658488/0930U) in the right arm.  On 11-AUG-2007 the patient experienced optic neuritis and left eye pain.  The patient was seen by a neuro ophthalmologist.  The outcome for the events of optic neuritis and left eye pain was not reported.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hypermetropia, Laboratory test normal, Neurological examination, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with environmental allergies, allergy to ciprofloxacin and a history of pyelonephritis and inflammation conditions who on 04-JUN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot #657736/0389U) 0.5mL IM.  Concomitant therapy included cetirizine hydrochloride  (ZYRTEC).  On 08-AUG-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #658488/0930U) in the right arm.  On 11-AUG-2007 the patient experienced optic neuritis and left eye pain.  The patient was seen by a neuro ophthalmologist.  The outcome for the events of optic neuritis and left eye pain was not reported.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Ophthalmological examination abnormal, Optic neuritis, Visual acuity reduced, Visual acuity tests abnormal, Visual evoked potentials normal
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with environmental allergies, allergy to ciprofloxacin and a history of pyelonephritis and inflammation conditions who on 04-JUN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot #657736/0389U) 0.5mL IM.  Concomitant therapy included cetirizine hydrochloride  (ZYRTEC).  On 08-AUG-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #658488/0930U) in the right arm.  On 11-AUG-2007 the patient experienced optic neuritis and left eye pain.  The patient was seen by a neuro ophthalmologist.  The outcome for the events of optic neuritis and left eye pain was not reported.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Eye pain, Visual acuity reduced
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with environmental allergies, allergy to ciprofloxacin and a history of pyelonephritis and inflammation conditions who on 04-JUN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot #657736/0389U) 0.5mL IM.  Concomitant therapy included cetirizine hydrochloride  (ZYRTEC).  On 08-AUG-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #658488/0930U) in the right arm.  On 11-AUG-2007 the patient experienced optic neuritis and left eye pain.  The patient was seen by a neuro ophthalmologist.  The outcome for the events of optic neuritis and left eye pain was not reported.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Eye pain, Optic neuritis
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient with environmental allergies, allergy to ciprofloxacin and a history of pyelonephritis and inflammation conditions who on 04-JUN-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), (lot #657736/0389U) 0.5mL IM.  Concomitant therapy included cetirizine hydrochloride  (ZYRTEC).  On 08-AUG-2007 the patient received her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot #658488/0930U) in the right arm.  On 11-AUG-2007 the patient experienced optic neuritis and left eye pain.  The patient was seen by a neuro ophthalmologist.  The outcome for the events of optic neuritis and left eye pain was not reported.  Additional information has been requested.