chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female patient with no drug reactions/allergies, smoker, exercise-induced asthma and a history of eczema, who in 11-OCT-2010 was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscularly (lot number 665768/1377Y). On 10-JAN-2011, the patient was administered her second dose of GARDASIL (lot number 665768/1377Y). Concomitant therapy included KARIVA. On the evening of 10-JAN-2011 the patient developed chills. The next day, on 11-JAN-2011, the patient developed difficulty breathing, wheezing, fever, body aches, lightheadedness, fatigue and back pain. The symptoms resolved within 24-36 hours. No lab diagnostics studies were performed. No treatment was given for the experience. The patient sought medical attention by a telephone call to the nurse practitioner. At the time of the report, the patient had recovered. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Wheezing
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female patient with no drug reactions/allergies, smoker, exercise-induced asthma and a history of eczema, who in 11-OCT-2010 was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscularly (lot number 665768/1377Y). On 10-JAN-2011, the patient was administered her second dose of GARDASIL (lot number 665768/1377Y). Concomitant therapy included KARIVA. On the evening of 10-JAN-2011 the patient developed chills. The next day, on 11-JAN-2011, the patient developed difficulty breathing, wheezing, fever, body aches, lightheadedness, fatigue and back pain. The symptoms resolved within 24-36 hours. No lab diagnostics studies were performed. No treatment was given for the experience. The patient sought medical attention by a telephone call to the nurse practitioner. At the time of the report, the patient had recovered. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Malaise
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 22 year old female patient with CEFTIN allergy who on 18-JAN-2011 was vaccinated with a 0.5ml first dose of GARDASIL (lot #665025/0992Y, exp date 14-OCT-2010, lot # not valid), IM. Concomitant therapy included hormonal contraceptives (unspecified) "Birth control". The nurse stated that in approximately 2011 the patient had not feeling well and had been losing hair. There were no laboratories diagnostics performed. No treatment was given for the events. At the time of the report the patient had no recovered. The patient sought medical attention by a telephone call to office. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Computerised tomogram head, Computerised tomogram normal, Epistaxis, Erythema, Face injury
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-MAR-2010 was vaccinated with the first dose of GARDASIL 0.5ml intramuscular administration (lot# 667866/1437Z) (exp. 25-FEB-2013). Concomitant vaccine included ADACEL. On 16-MAR-2011 the patient fainted after receiving her first dose of GARDASIL. She fell and injured her nose which resulted in a nosebleed. She was kept in the office for 30 minutes after she woke up and taken to an emergency room to treat her nose. Oxygen, smelling salt and ice were given as treatment for the adverse events. There was no lab diagnostics studies performed. At the time of the report, the patient's status was recovered. Additional information has been received from a physician and medical records regarding a 17 year old female with no known allergies. On 16-MAR-11, the patient was vaccinated with GARDASIL (lot# 1437Z) (expiration 25-FEB-13) injection intramuscularly in her deltoid at 4:00 pm. The patient had no known illnesses at time of vaccination. The patient had an ADACEL (lot# C3249AA) (expiration 04-NOV-11) injection intramuscularly in her deltoid at 4:00 pm. The patient had received one previous dose of ADACEL on 07-DEC-07. The patient had a FLUZONE (lot# U3774EA) (expiration 30-JUN-11) injection intramuscularly in her deltoid at 4:00 pm. It was reported that she had intranasal FLUMIST previously in 2004 and 2010. On 16-JUN-11, the patient experienced a syncope episode immediately after injections. The patient got off the exam table and fell. She injured her nose (redness, swelling) and suffered head trauma. The patient was referred to the emergency room for further work-up. An x-ray revealed that the patient had suffered a mildly displaced anterior nasal bridge fracture. The patient underwent a computed axial tomography exam of the brain for indications of fall, head trauma and loss of consciousness, which revealed no acute intracranial abnormality. The patient remained in the doctor's office after the incident for 30 minutes. The patient's vitals were checked and ice was applied to her nose. It was unknown if the patient recovered. Additional information has been requested. All available medical records will be provided upon request.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Facial bones fracture, Fall, Head injury, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-MAR-2010 was vaccinated with the first dose of GARDASIL 0.5ml intramuscular administration (lot# 667866/1437Z) (exp. 25-FEB-2013). Concomitant vaccine included ADACEL. On 16-MAR-2011 the patient fainted after receiving her first dose of GARDASIL. She fell and injured her nose which resulted in a nosebleed. She was kept in the office for 30 minutes after she woke up and taken to an emergency room to treat her nose. Oxygen, smelling salt and ice were given as treatment for the adverse events. There was no lab diagnostics studies performed. At the time of the report, the patient's status was recovered. Additional information has been received from a physician and medical records regarding a 17 year old female with no known allergies. On 16-MAR-11, the patient was vaccinated with GARDASIL (lot# 1437Z) (expiration 25-FEB-13) injection intramuscularly in her deltoid at 4:00 pm. The patient had no known illnesses at time of vaccination. The patient had an ADACEL (lot# C3249AA) (expiration 04-NOV-11) injection intramuscularly in her deltoid at 4:00 pm. The patient had received one previous dose of ADACEL on 07-DEC-07. The patient had a FLUZONE (lot# U3774EA) (expiration 30-JUN-11) injection intramuscularly in her deltoid at 4:00 pm. It was reported that she had intranasal FLUMIST previously in 2004 and 2010. On 16-JUN-11, the patient experienced a syncope episode immediately after injections. The patient got off the exam table and fell. She injured her nose (redness, swelling) and suffered head trauma. The patient was referred to the emergency room for further work-up. An x-ray revealed that the patient had suffered a mildly displaced anterior nasal bridge fracture. The patient underwent a computed axial tomography exam of the brain for indications of fall, head trauma and loss of consciousness, which revealed no acute intracranial abnormality. The patient remained in the doctor's office after the incident for 30 minutes. The patient's vitals were checked and ice was applied to her nose. It was unknown if the patient recovered. Additional information has been requested. All available medical records will be provided upon request.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Swelling, Syncope, X-ray abnormal
Clinical narrative: Information has been received from a nurse concerning a 17 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-MAR-2010 was vaccinated with the first dose of GARDASIL 0.5ml intramuscular administration (lot# 667866/1437Z) (exp. 25-FEB-2013). Concomitant vaccine included ADACEL. On 16-MAR-2011 the patient fainted after receiving her first dose of GARDASIL. She fell and injured her nose which resulted in a nosebleed. She was kept in the office for 30 minutes after she woke up and taken to an emergency room to treat her nose. Oxygen, smelling salt and ice were given as treatment for the adverse events. There was no lab diagnostics studies performed. At the time of the report, the patient's status was recovered. Additional information has been received from a physician and medical records regarding a 17 year old female with no known allergies. On 16-MAR-11, the patient was vaccinated with GARDASIL (lot# 1437Z) (expiration 25-FEB-13) injection intramuscularly in her deltoid at 4:00 pm. The patient had no known illnesses at time of vaccination. The patient had an ADACEL (lot# C3249AA) (expiration 04-NOV-11) injection intramuscularly in her deltoid at 4:00 pm. The patient had received one previous dose of ADACEL on 07-DEC-07. The patient had a FLUZONE (lot# U3774EA) (expiration 30-JUN-11) injection intramuscularly in her deltoid at 4:00 pm. It was reported that she had intranasal FLUMIST previously in 2004 and 2010. On 16-JUN-11, the patient experienced a syncope episode immediately after injections. The patient got off the exam table and fell. She injured her nose (redness, swelling) and suffered head trauma. The patient was referred to the emergency room for further work-up. An x-ray revealed that the patient had suffered a mildly displaced anterior nasal bridge fracture. The patient underwent a computed axial tomography exam of the brain for indications of fall, head trauma and loss of consciousness, which revealed no acute intracranial abnormality. The patient remained in the doctor's office after the incident for 30 minutes. The patient's vitals were checked and ice was applied to her nose. It was unknown if the patient recovered. Additional information has been requested. All available medical records will be provided upon request.
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection
Clinical narrative: Information has been received from a female patient who in approximately 2006, 4 or 5 years ago, was vaccinated with "shots" of GARDASIL (lot number not reported) and developed a severe yeast infection that she would have for the rest of her life. Unspecified treatment was given for the experience. The patient sought unspecified medical attention. At the time of the report, the patient's had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a physician concerning a 12 or 13 year old female who was vaccinated with all three doses of GARDASIL. The physician reported that the patient had not had her menses since administration of GARDASIL. Her last menses was "about 6 or 7 months ago", in approximately October 2010. It was reported that she may have received other vaccines in the last 6-7 months. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash
Clinical narrative: Information has been received from an advanced practice registered nurse (A.P.R.N) concerning a 20 year old female patient, who on 23-MAY-2011 was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot #669265/0181AA). Advance practice registered nurse, stated that the patient developed an injection site rash on her left arm after receiving GARDASIL. The nurse noted that the rash spread to the patient's upper left  arm but no fever was present. The nurse stated that the patient reported this rash on 28-MAY-2011, five days after GARDASIL was administered, but she believed that the rash developed on the same date the GARDASIL was given. ZYRTEC, BENADRYL and ZANTAC were given as a treatment for the injection site rash. No lab diagnostic studies were performed. It was unknown if patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 24-JUL-2009 was vaccinated with a second dose of GARDASIL (lot # 659054/0315Y), intramuscularly in her left deltoid. On 20-MAR-2010 the patient experienced Low Grade Squamous Intraepithelial Lesion. The patient's outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Local reaction, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female who on 15-SEP-2010 was vaccinated with the 1st dose of GARDASIL and experienced a "small local reaction". On unspecified date, the patient was vaccinated with the 2nd dose of GARDASIL. The patient experienced a "rash on her thighs which spread to her neck and back" 24 hours after the vaccine was given. At the time of the report, the outcome was unknown. Follow up information has been received from the nurse practitioner who reported that the patient called the nurse a couple of days later to report that the allergic reaction was most likely not to the GARDASIL injection, but an allergic reaction to her Christmas trees. Information has been received from the nurse practitioner concerning a 26 year old female with no medical history or allergies, and no illness at the time of report who on 30-NOV-2010 was vaccinated IM with the second dose of GARDASIL (lot # 666931/0337Z) into her left deltoid. On 01-DEC-2010, 24 hours after injection, the patient experienced rash on her thighs which spread to her neck, back and arm. The patient realized that the rash was in location where she brushed against her Christmas tree. The patient took antihistamine and slowly resolved after 2-3 weeks. The patient did not touch the Christmas again. Additional information is not expected.
Age: 20.0
Sex: M
Vaccine: FLUX, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old male patient who on 24-NOV-2010 was vaccinated with his first dose of GARDASIL (Lot # 666163/0664Z, expire date 18-SEP-2012), 0.5 ml, intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unspecified). Two days later, on 26-NOV-2010 the patient developed hives and itching on his stomach, arms and legs. The patient was treated with BENADRYL and hives resolved within two days (on 28-NOV-2010). On the same date (on 28-NOV-2010) the patient recovered from itching. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix
Clinical narrative: Information has been received from a physician concerning a female who on unknown dates was vaccinated with full series of GARDASIL (lot # not reported). Subsequently the patient was "diagnosed with HPV". At the time of reporting, the patient didn't recover. Pap smear was performed with no results provided. The patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix, Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 21 year old female who 2 years prior, in 2008 was vaccinated with 3 doses of GARDASIL (dates, site of injection and lot numbers unspecified). On 20-JUN-2010 papanicolaou smear (PAPs) was performed and revealed atypical squamous cells of undetermined significance (ASCUS), HR HPV positive and cervical intraepithelial neoplasia I (CINI). Biopsy revealed CINI within normal limits. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 21 year old female who prior to March 2009 was vaccinated with three doses of GARDASIL (lot # not reported). On 17-MAY-2010 the patient experienced + atypical squamous cells of undetermined significance (ASCUS) and + High Risk (HR) Papilloma viral infection (HPV). The patient did not seek medical attention. At the time of the report the outcome of + atypical squamous cell of undetermined significance (ASCUS) and +HR Papilloma viral infection (HPV) were unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from the physician concerning a 19 year old female patient who prior to 2008 was vaccinated with three doses of GARDASIL (Lots# not reported). On 29-JAN-2010 the patient experienced LGSIL (Low Grade Squamous Intraepitheliel Lesion) and HR (high risk) HPV PAP. At the time of this report, the patient's outcome was unknown. This is one of the reports received from same source. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 20 year old patient who in 2007, on an unspecified dates was vaccinated with the three doses of GARDASIL (Lot # and route not reported). It was reported that on 01-MAR-2009, the patient presented low grade squamous intraepithelial lesion (LGSIL) with high risk of human papilloma viral infection and low risk human papilloma viral infection and on 18-DEC-2009 these same results were found also. At the time of the report, the outcome of the patient was unknown. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Nausea, Oropharyngeal pain, Somnolence
Clinical narrative: Information has been received from the physician concerning a 23 year old female who on 29-SEP-2010 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # reported as 03372). Two hours following the administration of the first shot the patient began to feel nauseated, dizzy, and a sore throat, and had a temperature of 100 degrees. The patient had recovered at the same day as vaccination. She did not seek medical attention. The physician followed up with her after giving her the second 0.5 ml dose of GARDASIL (therapy route and lot # not provided) and no AE was reported. Follow-up information received from the physician indicated that the female patient with no pre-existing allergies and no illness at time of vaccination, was vaccinated IM on 29-SEP-2010 into left deltoid at 13:00 with a first 0.5 ml dose of GARDASIL. 2 hours after injection, at 15:00, patient felt sore throat, dizziness, sleepness and claimed she had temperature of 100 F. Patient noted this to the physician when she came for her second dose of GARDASIL injection on 30-NOV-2010. The patient did not seek medical attention. There was no diagnostic laboratory studies performed. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient with no medical history who was vaccinated IM with the first dose of GARDASIL (lot number 655618/0186U) into the left deltoid on 12-MAR-2007, the second dose (lot number 657621/0387U) into the right deltoid on 09-MAY-2007, and the third dose (lot number 658222/0927U) into the right deltoid on 21-SEP-2007. On 29-MAY-2010, the patient was found low grade squamous intraepithelial lesion (LGSIL) by cervical smear (PAP) with positive high risk HPV despite given 3 doses of GARDASIL 2 to 3 years ago. The patient's outcome was unknown. Additional information has been requested. This is one of several reports from the same source.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated with 3 doses of GARDASIL more than 3 years ago. In June 2010, the patient experienced low grade squamous intraepithelial lesion (LGSIL). On 20-JUN-2010 papanicolaou smear was performed and revealed HR HPV positive. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. On 15-MAY-2007 the patient experienced atypical squamous cells of undetermined significance (ASCUS) and HR HPV PAP. After that on unknown dates, the patient was vaccinated with three doses of GARDASIL. On 21-AUG-2009 again, the patient experienced atypical squamous cells of undetermined significance (ASCUS) and HR HPV PAP. The status of the patient was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood thyroid stimulating hormone, Culture throat, Dizziness, Full blood count, Metabolic function test
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female patient with penicillin allergy and environmental allergy who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot# and expiration not reported). Suspect therapy included that the patient was vaccinated with a dose of VARIVAX (Merck) (Lot#, dose number and expiration not reported), on the same day. Concomitant therapy included multivitamins (unspecified), ZYRTEC, montelukast sodium (MSD), evening primrose oil, MENACTRA and Tdap. The nurse reported that on 10-AUG-2010 the patient was vaccinated with GARDASIL and developed a viral infection the next day. The viral infection was described as fever, dizziness, sore throat and weakness in both arms. The fever was resolved by 13-AUG-2010 and the rest of the symptoms were resolved by 18-AUG-2010. The patient also received MENACTRA and Tdap on the same date (10-AUG-2010), unspecified sites. The laboratories CBC, CMP, TSH, throat culture with UA were performed (results were not provided). No treatment was given for this adverse event. The patient sought unspecified medical attention. At the time of reporting the patient had recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Muscular weakness, Oropharyngeal pain, Pyrexia, Urine analysis, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female patient with penicillin allergy and environmental allergy who on 10-AUG-2010 was vaccinated with the first dose of GARDASIL (Lot# and expiration not reported). Suspect therapy included that the patient was vaccinated with a dose of VARIVAX (Merck) (Lot#, dose number and expiration not reported), on the same day. Concomitant therapy included multivitamins (unspecified), ZYRTEC, montelukast sodium (MSD), evening primrose oil, MENACTRA and Tdap. The nurse reported that on 10-AUG-2010 the patient was vaccinated with GARDASIL and developed a viral infection the next day. The viral infection was described as fever, dizziness, sore throat and weakness in both arms. The fever was resolved by 13-AUG-2010 and the rest of the symptoms were resolved by 18-AUG-2010. The patient also received MENACTRA and Tdap on the same date (10-AUG-2010), unspecified sites. The laboratories CBC, CMP, TSH, throat culture with UA were performed (results were not provided). No treatment was given for this adverse event. The patient sought unspecified medical attention. At the time of reporting the patient had recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix, Biopsy site unspecified abnormal, Cervical dysplasia, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 19 year old female who in 2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The patient did not complete the series. On 03-OCT-2010 the patient was found high grade squamous intraepithelial lesion (HGSIC) High Risk HPV, CIN II Bx by cervical smear (PAP). The patient's outcome was unknown. Additional information has been requested. This is one of several reports from the same source.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a 19 year old female who in 2008 was vaccinated with the first dose of GARDASIL (lot # not reported). The patient did not complete the series. On 03-OCT-2010 the patient was found high grade squamous intraepithelial lesion (HGSIC) High Risk HPV, CIN II Bx by cervical smear (PAP). The patient's outcome was unknown. Additional information has been requested. This is one of several reports from the same source.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Human papilloma virus test positive
Clinical narrative: Information has been received from a physician concerning a 21 year old female patient who in 2007 (three years ago) received three doses of GARDASIL (lot not reported). It was reported that on an unspecified date, the patient was ascus (+) and HPV positive. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date in the past (recent) was vaccinated with a second dose of GARDASIL (Lot# unknown). On 24-MAR-2010, the patient developed Ascus PAP and high risk Human papilloma viral infection (HPV). The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Sinusitis
Clinical narrative: Information has been received from a physician concerning a 15 year old male patient with AUGMENTIN allergy and a history of tonsillectomy who on 05-OCT-2010, was vaccinated with the first dose of GARDASIL (lot # 0787Z, expiration date: 03-NOV-2011), intramuscularly and on 12-APR-2011, was vaccinated with the second dose of GARDASIL, (lot number and dose not reported), intramuscular. There was no concomitant medication. On 08-NOV-2010, the patient experienced sinus infection. BIAXIN 500 mg by mouth every 12 hours for 14 days, AFRIN, "salt water gargle", and TYLENOL for fever were given for the treatment of the adverse event. No lab diagnostics were performed. The patient sought medical attention office visit. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient who on unspecified dates was vaccinated with the GARDASIL series (lot numbers not provided). It was reported that and on an unspecified date, the patient testing positive for HPV. The patient sought unspecified medical attention. No treatment was given for the adverse event. It was unspecified if any lab diagnostic studies were performed. At the time of the report, the patient was not recovered. No further information is available.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Palmar erythema
Clinical narrative: Information has been received from a physician concerning a 17 year old male with BACTRIM allergy and no pertinent medical history who on 29-APR-2011 was vaccinated in the right upper arm with the first dose of GARDASIL, 0.5 mL intramuscularly (Lot number 666987/1016Z). Concomitant vaccination administered on the same day included a dose of hepatitis A vaccine (manufacturer unknown) in the left arm. The physician reported that 8 days later, on 07-MAY-2011, the entire right arm from shoulder to hand became very swollen and red. The patient was seen in the office on 13-MAY-2011 with swelling, redness with venous distension, no open areas were noted. The palm was more red than the arm. The arm was 3 cm larger than left arm. He was afebrile and denied pain. No axillary or cervical adenopathy was noted. There were no other complaints other than swelling. The erythema of arm was mild, there was no warmth. The physician did not feel that this was cellulitis or venous thrombosis, and was unsure if it was related to GARDASIL due to the date of onset. No treatment for the adverse event was given, laboratory diagnostics studies were not performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Vasodilatation
Clinical narrative: Information has been received from a physician concerning a 17 year old male with BACTRIM allergy and no pertinent medical history who on 29-APR-2011 was vaccinated in the right upper arm with the first dose of GARDASIL, 0.5 mL intramuscularly (Lot number 666987/1016Z). Concomitant vaccination administered on the same day included a dose of hepatitis A vaccine (manufacturer unknown) in the left arm. The physician reported that 8 days later, on 07-MAY-2011, the entire right arm from shoulder to hand became very swollen and red. The patient was seen in the office on 13-MAY-2011 with swelling, redness with venous distension, no open areas were noted. The palm was more red than the arm. The arm was 3 cm larger than left arm. He was afebrile and denied pain. No axillary or cervical adenopathy was noted. There were no other complaints other than swelling. The erythema of arm was mild, there was no warmth. The physician did not feel that this was cellulitis or venous thrombosis, and was unsure if it was related to GARDASIL due to the date of onset. No treatment for the adverse event was given, laboratory diagnostics studies were not performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her 12 year old female daughter with no drug reactions or pertinent medical history, who one year ago, in April 2010 was vaccinated with the first dose of GARDASIL (Lot# and expiration not reported) and one month ago, on approximately 06-MAR-2011 was vaccinated with the second dose of GARDASIL (Lot# and expiration not reported). No concomitant medications were reported. The consumer reported that her daughter experienced dizziness after receiving first dose and second dose of GARDASIL. The consumer's daughter recovered after sitting few minutes in the office in both incidences. The consumer sought unspecified medical attention. No labs were performed. No treatment was given for this adverse event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Allergy test, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a female patient with allergy to unknown medications who on unspecified dates was vaccinated with the first and the second doses of GARDASIL (lot # and expire date not reported), 0.5 ml, intramuscularly. The physician stated that on unspecified dates, the patient broke out in a rash after the first GARDASIL dose and worse rash after the second GARDASIL dose. On an unspecified date, allergy testing was performed (results not provided) and unspecified treatment was given to the patient. Therapy with GARDASIL was discontinued and not reintroduced. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Cold sweat, Pallor, Pulse abnormal
Clinical narrative: Information has been received from a physician concerning a 16 year old male patient, with no pertinent medical history and no known drug allergies, who on 17-MAY-2011 was vaccinated with his first dose of GARDASIL (Lot #, dose and route not reported). Secondary suspect administered on the same day included: the second dose of VARIVAX (Lot #, dose and route not reported). Concomitant therapy included the first dose of MENACTRA. Physician stated he always had the patient lying down on the table when vaccinations were administered. He waited at least 20 minutes after the vaccinations were administered and then had client sit up, stand up, and assisted walking him to the waiting room. In a few minutes doctor looked out at the waiting room and noticed client was pale, clammy and when checked his pulse was thready. Physician stated he had patient lying down and raised his legs, and monitored him until patient's pulse was normal and he had recovered. Physician stated he did not believe the event was a vasovagal episode. Physician reported that patient was in his office for approximately 50 minutes. He reported he even assisted patient into the elevator and downstairs into the car. Physician confirmed that on 17-MAY-2011 patient fully recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an either 15 or 16 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced an episode of syncope (also reported as continuous episodes of syncope throughout the whole GARDASIL series). Due to the syncope, the second and third doses were not scheduled to be given and she only received the first dose (it was also reported that all 3 doses were given, however no dates were specified). Height and weight were not given. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 23 year old female who on 17-MAY-2010 was vaccinated with the first dose of GARDASIL 0.5ml intramuscular administration (exp date unspecified), on 04-FEB-2011 was vaccinated with the second dose (lot#665607/1333Y) (exp 25-JUN-2012), and on 01-APR-2011 was vaccinated with the third dose (lot#665607/1333Y) (exp 25-JUN-2012). Following injection (number of injection unspecified) the patient experienced soreness around the injection site. There was no lab diagnostics studies performed. The patient received unspecified medical attention. At the time of the report, the patent's status was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Dyspnoea, Erythema
Clinical narrative: Information has been received from a healthcare worker concerning a 13 year old male patient with no allergies or drug reactions and no pertinent medical history who on 18-MAY-2011, was vaccinated with a dose of GARDASIL intramuscularly in the left deltoid (lot number 668554/0306AA, Exp: 10-MAY-2013). There was no concomitant medication. On 18-MAY-2011, within an hour of receiving the vaccine of GARDASIL the patient started experienced shortness of breath, redness of face, achy joints and dizziness "could not get up due to dizziness". On 19-MAY-2011, the mother of the patient called and reported to the healthcare worker's office that the patient was still very dizzy but the shortness of breath was much better. The patient received as treatment for the event ALLEGRA. No laboratories were performed. There was no mention of the status of the achy joints or redness of the face. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvovaginal pain
Clinical narrative: Information has been received from a physician concerning a 19 year old female patient with a history of papilloma virus infection (HPV) and no drug reaction or allergies who on 07-APR-2011 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot # 666987/1016Z, exp date 22-NOV-2011). There was no concomitant medication. The patient had no HPV lesions present at the time of vaccination and the following day, on 08-APR-2011, the patient felt sore in the vaginal area. The lesions found were consistent with HPV. The patient was treated with ALDARA 5% cream. No laboratory diagnostics studies performed. At the time of reporting, the patient was recovering. The patient sought medical attention by phone call and office visit. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal, Urinary tract infection
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with asthma as a child and environmental allergies who sometime in 2009 was vaccinated with two doses of GARDASIL (lot number, dose and site of administration not reported). The consumer had never received a third dose of GARDASIL. Concomitant therapy included oral contraceptive. Also, the consumer reported that her daughter had recently had an unspecified abnormal cervical screening (Pap screening) positive for Human papillomavirus (HPV). The consumer also mentioned that her daughter had a urinary tract infection at the time of her cervical screening. No treatment was given for the adverse event. The patient sought medical attention by an office visit. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Burning sensation, Pruritus, Skin lesion, Swelling face
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient with ovarian cyst removed in the past who in "October or November 2010" and in December 2010 were vaccinated with the first and second doses of GARDASIL. Patient did not have any reaction after dose one. Several hours after vaccination with dose two, patient developed facial itching and swelling. Patient also developed lesions on her face and neck. The patient described the lesions as looking like "pimples" which burned and itched. The patient did not seek medical attention and treated herself wit BENADRYL. Patient recovered 5 to 7 days later. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning her 27 year old daughter who in 2007 was vaccinated with the first dose of GARDASIL (route and lot number not provided) and did not return to complete the regimen. The physician reported that in 2010 the patient was diagnosed as positive for Human Papilloma Virus (HPV) and returned for her second dose of GARDASIL (route and lot number not provided), in 2011. It was unspecified if the patient sought medical attention or received any treatment for the adverse event. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a pediatrician concerning a 19 year old female patient who "within the last year" was vaccinated with a dose of GARDASIL (route and lot number not reported). On an unspecified date, the patient developed warts on her head. This was reported to the pediatrician by the mother of the patient, who stated that her daughter went to see a dermatologist who stated that it was "probably a venereal wart caused by GARDASIL". the patient received unspecified treatment for the event. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse concerning one of two sisters (another sister's adverse event captured in WAES1105USA04010) who was vaccinated with GARDASIL. The nurse reported two sisters who wanted to be vaccinated simulatneuosly. She recollected that she and another nurse at both of the sisters on the same table, administered each sister a shot of GARDASIL at the same time, and she reported that both sisters lost consciousness at the same time. She reported she and another nurse held both of the sisters up to keep them from falling off the table, since they could not lay them down on the same table. She stated that this occurrence was over a year ago which was in approximately 2010, and that both sisters were "fine with no residual effects." Neither of the girls was injured in any way, but she stated that she would never do that again. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with penicillin allergy and venereal warts (condyloma and Chlamydia) who on 31-MAR-2011 was vaccinated intramuscularly in the right arm with the first dose of GARDASIL (Lot number 667930/1561Z) and on 27-MAY-2011 received the second dose of GARDASIL (Lot number 667930/1561Z) intramuscularly in the left arm. There was no concomitant medication. The registered nurse reported that over the weekend the patient developed a blister at the injection site in the arm, she returned to the office and the site was a "1 cm blister that had popped on 31-MAY-2011". It was reported that no redness, swelling, itching or pain were noted at the site. No respiratory distress or difficulty breathing were noted. The description of the fluid within the blister when it popped was not known. No exposure or injuries were noted. The registered nurse stated that the patient did not have any difficulties following the first dose. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female patient with no pertinent medical history and no drug reactions or allergies who between the age of 14 and 15 received 3 GARDASIL vaccinations (lot number, dose and site of administration not reported) from another physician. There was no concomitant medication. Physician reported that he performed a PAP test (on unspecified date) and the result of the test indicated that "one high risk HPV was detected but test did not indicate what the HPV type was detected". It was unknown if the patient sought medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient who on 06-JUN-2008 and 16-SEP-2008 were vaccinated with the first and second doses of GARDASIL respectively. On 27-APR-2011 the patient was in office "today" for an unrelated, unspecified reason but would like to receive the third dose of GARDASIL. In March 2011 the patient had a PAP smear that was positive for "high risk HPV, Group 1 and Group 2". At the time of report the patient's status was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female with no medical history or known drug allergies who on 21-JAN-2011 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot number: 666948/0886Z). On 29-MAR-2011 the patient was vaccinated IM with her second 0.5 ml dose of GARDASIL (Lot number: 667866/1437Z; Expiration date: 25-SEP-2013). Concomitant therapy included RETIN-A and BENZACLIN. On 29-MAR-2011 the patient developed a headache after administration of her second dose of GARDASIL. Her headache improved while taking ibuprofen but returned when not taking ibuprofen. The patient sought unspecified medical attention. A complete blood count was order but results were not available yet. Upon the time of the report, the patient was not recovered. Follow up information has been received from a nurse practitioner concerning a 14 year old female "healthy" student with no known drug allergies, and no significant past medical or surgical history who at 4:08 PM on 29-MAR-2011 was vaccinated with the second dose of GARDASIL (Lot number: 667866/1437Z). On 29-MAR-2011, the patient experienced pain in neck and shoulder immediately following injection. Headache started later that evening and persisted for 1 week following injection. The patient followed up in office because ADVIL helped but headache returned when ibuprofen was wore off. The patient also took TORADOL for treatment. Complete blood count was performed on 04-APR-2011 without result provided. On 06-APR-2011, the patient recovered. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Swollen tongue
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 year old female patient with no pertinent medical history and no drug reactions or allergies who on 17-JAN-2011 was vaccinated with the first dose of GARDASIL (Lot # and expired date not reported), prefilled syringe, intramuscularly. On 29-MAR-2011, the patient was vaccinated with the second dose of GARDASIL (Lot # 666596/0097Z and expiration date 15-OCT-2012), prefilled syringe, intramuscularly. There was no concomitant medication. The certified medical assistant stated that on an unspecified date, the patient developed a rash. The patient went to an emergency room. The certified medical assistant mentioned that the patient was treated with SOLU-MEDROL and BENADRYL. On an unspecified date, the patient recovered. Follow up information has been received from certified medical assistant concerning a 25 year old female registered nurse with no illness at the time of vaccination who on 29-MAR-2011 was vaccinated intramuscularly in the left deltoid with the second dose of GARDASIL (Lot # 666596/0097Z). It was reported that on 29-MAR-2011 the patient experienced tongue swelled. The patient sought medical attention. The patient was treated with SOLU-MEDROL and BENADRYL. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a nurse concerning her teenager daughter, who on an unknown date, was vaccinated with the third injection of GARDASIL (Lot number not provided). The nurse informed that while on GARDASIL, at least a year ago, in approximately 2010 her daughter had an unspecified test performed on her cervix, that showed she had an abnormal cervical test results. The patient sought unspecified medical attention and has received follow up medical visits every 6 months. At the time of the report, patient had not recovered. Additional information has been requested.