chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Pelvic pain
Clinical narrative: Information has been received from a physician concerning "a couple of young ladies" (age unknown) who, on unspecified dates, were vaccinated with doses of GARDASIL vaccine (yeast). Subsequently, on unspecified dates, the patients experienced pelvic pain. At the time of this report, the patients' outcomes were unknown. No further information is available as the physician declined to be further involved in the reporting process.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning an unspecified number of patients, who, on an unspecified dates, were vaccinated with a dose of GARDASIL vaccine (yeast). Subsequently, the patients experienced unspecified reactions. At the time of the report, the outcomes of the patients were unknown. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who was the daughter of the nurse practitioners patient. It was reported that on 02-SEP-2007 the girl was vaccinated (dose not reported) with GARDASIL vaccine (yeast) (Lot# not reported). Subsequently, the experienced that her menstrual period was delayed two weeks post vaccination. Subsequently, she recovered from the delayed menstrual period. It was also reported that the patients other daughter had the same experience (WAES#0710USA03994). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Arthralgia, Blood test
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female who was vaccinated intramuscularly with the second dose of GARDASIL vaccine (yeast) (lot# not reported). Concomitant therapy included varicella virus vaccine live (lot# not reported). Eighteen days later, the patient experienced multiple joint aches. Unspecified blood work was performed. The patient recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Influenza like illness
Clinical narrative: Information has been received from a nurse concerning her 21 year old daughter, who, on an unspecified date, was vaccinated with a second dose of GARDASIL vaccine (yeast). Subsequently, one day post vaccination the patient experienced flu like symptoms and a headache. The patient fully recovered the next day. It was reported that the patient will go on to receive the third dose. The patient did not seek medical attention. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 13 year old female was was vaccinated with GARDASIL vaccine (yeast) (route not reported). On approximately 30-OCT-2007 (also reported as "sometime this week"), the patient got her dose of GARDASIL vaccine (yeast) and had seizures immediately following the injection. The seizures lasted for a couple of seconds and the patient was fine afterwards. As of 30-OCT-2007, the patient had recovered from the seizures. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old female who on 26-OCT-2007 was vaccinated with GARDASIL vaccine (yeast) (lot# 658488/1264U), 0.5ml intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified), "into other deltoid". The patient fainted about 5 minutes after receiving GARDASIL vaccine (yeast). The patient was observed and allowed to leave when fully recovered a short time later. Medical attention was required, in the office. No laboratory studies were performed. No other symptoms noted. Additional information has been requested. Information has been receivreed from a licensed practical nurse concerning a 13 year old female who on 26-OCT-2007 was vaccinated with HPV (lot # 658488/1264U), 0.5ml, intramuscularly. The patient fainted abotu 5-10 minutes after receiving HPV vaccine. The patient was observed and allowed to leave when fully recovered a short time later. Medical attention was required, in the office. No laboratory studies were performed. No other symptoms noted. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 22 year old female, who on approximately 30-SEP-2007 was vaccinated with the second dose of Gardasil vaccine intramuscularly. There was no concomitant therapy. The patient experienced pain at the injection site after vaccination. The patient had improved but had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning 2 female patients who were vaccinated with Gardasil vaccine. Subsequently, both patients fainted. Medical attention was sought, "they were in the office office". Both patients recovered "within a few minutes". Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female who was vaccinated (date, route and site were not reported) with GARDASIL vaccine (yeast) (lot # not reported). The patient was HPV negative prior to receiving GARDASIL vaccine (yeast) and after receiving the 3rd dose the patient has tested HPV positive. The patient did not seek medical attention. Per nurse practitioner, the patient has not recovered. 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 nurse practitioner concerning a 23 year old female with no known allergies who on 08-FEB-2007 was vaccinated SQ wiht the first dose of GARDASIL vaccine (lot #654885/1424F). On 09-APR-2007 the patient was vaccinated SQ with the second dose of GARDASIL vaccine (lot #656372/0241U). On 06-AUG-2007 the patient was vaccinated SQ with the third dose of GARDASIL vaccine (lot #658282/0929U). The nurse practitioner reported that the patient had normal PAP smears from June, 2001 through October, 2006 and was HPV negative prior to receiving GARDASIL vaccine. On an unknown date in October, 2007 the patient had a positive HPV test. On an unspecified date in November, 2007 it was reported the patient had a negative HPV DNA test. Per nurse practitioner, the event was considered non serious. the nurse practitioner reported that the patient had not recovered from the event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 19 year old female, who on an unspecified date, was vaccinated with a first dose of Gardasil vaccine. No adverse symptoms were noted. On 26-OCT-2007, the patient was vaccinated intramuscularly with a 0.5mL second dose of Gardasil vaccine (Lot# "07420"). Subsequently, sometime after 26-OCT-2007 the patient developed a painful rash. The patient called the office. The patient was going to see a dermatologist. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 or 17 year old female who was vaccinated (date, route and site not reported) with Gardasil vaccine (lot # not reported) and tetanus toxoid (manufacturer unknown). Per the nurse practitioner, post vaccination, the patient fainted while leaving the office. The patient received unspecified medical attention and the outcome of the patient is unknown. Additional information has been requested.  Follow-up received 04/16/2008 from the office manager stating that the nurse practioner is not aware of the specific patient referenced. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Myalgia, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM with a first dose of GARDASIL vaccine (yeast). On 10-JUL-2007 5 days later, the patient experienced shortness of breath, muscle ache, dizziness and nausea. It is unknown if medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007.  Information has been received from a registered nurse concerning a 23 year old female patient who on 05-JUL-2007, was vaccinated IM into the left arm with a first dose of GARDASIL (Lot# reported as "09607").  Subsequently, the patient experienced shortness of breath, muscle ache, dizziness and nausea.  It was reported on 10-JUL-2007, the patient still had dizziness and some muscle ache.  It was recommended that the patient not continue the series.  At the line of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Flushing
Clinical narrative: Information has been received from a female consumer concerning her 14 year old daughter with no known allergies and no reported medical history, who in October 2007, was vaccinated with Gardasil vaccine. There were no concomitant medications. The mother reported that on approximately 19-OCT-2007, her daughter received her first dose of vaccine. On approximately 22-OCT-2007, her daughter started experiencing heat inside her body and her face and chest would turn bright red for about 3 minutes. The mother also reported her daughter had same symptoms almost everyday until today,  30-OCT-2007. The mother could not reach the daughter's physician for consultation. No further information has been provided. Additional information not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a physician concerning a couple of patients who were vaccinated with Gardasil vaccine. The physician reported that the patients experienced burning at the injection site. No further information for any of the patients was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil vaccine. Concomitant therapy included Menactra. The patient received the first dose of Gardasil vaccine and Menactra on the same day in different arms (the office staff could not remember which vaccine was administered first or second). The patient stood up and fainted. She remained unconscious for approximately 5 minutes and as of 30-OCT-2007 had fully recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pallor
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on approximately 12-MAY-2007 "about a month ago" was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy was not reported. On approximately 12-MAY-2007 after being vaccinated, the patient became pale and she was laid back in the chair. The patient was very pale and weak but she did not faint. The patient was treated with ice that was applied to her forehead and neck. She was monitored for approximately 15 minutes. The patient felt fine and left the physician's office. The nurse considered the events as non-serious and related to therapy with GARDASIL vaccine (yeast). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Influenza, Pyrexia
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a 17 year old female patient who was vaccinated with the first, second and third doses of Gardasil vaccine (dates & lot # not reported). Following one of the doses (the nurse was not able to identify which dose), the patient developed a low grade fever and experienced flu symptoms. The nurse confirmed that the patient did not experience adverse events following the other two doses. At the time of this report, the outcome of the events was unknown. 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 (previously reported as 17 year old) female student who was vaccinated IM in the left arm on 16-MAR-2007 with the first dose (lot # 656051/0244U) with no reaction noted, and on 21-MAY-2007 with the second dose of GARDASIL (lot # invalid).  On 21-MAY-2007, following the second dose, the student developed a low grade fever of 100.7 degrees, had a continuous headache all day, and experienced flu symptom described as "itchy all over".  There were no upper respiratory symptoms.  At the time of this report, the outcome of the events was unknown.  Follow up information from the nurse indicated that on 01-OCT-2007 the student was vaccinated IM in the left arm, with the third dose of GARDASIL (lot # 658563/1063U), with no reaction reported.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Local swelling, Pelvic pain
Clinical narrative: Information has been received from a 19 year old female with no medical history, who on 29-OCT-2007, was vaccinated with a 0.5 mL dose of Gardasil vaccine. Concomitant therapy included Yaz (started on 30-OCT-2007). ON 29-OCT-2007, the patient mentioned some injection site pain after vaccination. On 30-OCT-2007, the patient developed tenderness in pelvic area and 2 quarter sized bumps above groin. The patient's tenderness in pelvic area and 2 quarter sized bumps above groin and injection site pain persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, "about a week ago", the patient was vaccinated with a second doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml IM. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date in October 2007. In October 2007, about 24 hours after being vaccinated, the patient developed a headache, dizziness, and vomiting and was hospitalized.  At the time of reporting, the patient had not recovered. The physician felt that the events were disabling. Additional information has been requested.  03/03/2008 MR received for DOS 11/8-11/2007 with DX: Headache Disorder, Intractable Migraine. Pt presented with 2 1/2 week hx of throbbing headache in the forehead, bitemporal, and occipital areas which began 1 day s/p flu and Gardasil vax.  H/A associated with nausea, dizziness, light and noise sensitivity.  Occasionally wakes from sleep with pain. Previous ER visit with normal diagnostics.  PE WNL.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Blood test, Computerised tomogram, Headache, Inappropriate schedule of drug administration, Lumbar puncture
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, "about a week ago", the patient was vaccinated with a second doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml IM. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date in October 2007. In October 2007, about 24 hours after being vaccinated, the patient developed a headache, dizziness, and vomiting and was hospitalized.  At the time of reporting, the patient had not recovered. The physician felt that the events were disabling. Additional information has been requested.  03/03/2008 MR received for DOS 11/8-11/2007 with DX: Headache Disorder, Intractable Migraine. Pt presented with 2 1/2 week hx of throbbing headache in the forehead, bitemporal, and occipital areas which began 1 day s/p flu and Gardasil vax.  H/A associated with nausea, dizziness, light and noise sensitivity.  Occasionally wakes from sleep with pain. Previous ER visit with normal diagnostics.  PE WNL.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Neck pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, "about a week ago", the patient was vaccinated with a second doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml IM. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date in October 2007. In October 2007, about 24 hours after being vaccinated, the patient developed a headache, dizziness, and vomiting and was hospitalized.  At the time of reporting, the patient had not recovered. The physician felt that the events were disabling. Additional information has been requested.  03/03/2008 MR received for DOS 11/8-11/2007 with DX: Headache Disorder, Intractable Migraine. Pt presented with 2 1/2 week hx of throbbing headache in the forehead, bitemporal, and occipital areas which began 1 day s/p flu and Gardasil vax.  H/A associated with nausea, dizziness, light and noise sensitivity.  Occasionally wakes from sleep with pain. Previous ER visit with normal diagnostics.  PE WNL.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female with asthma and a history of ankle sprain who on 23-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 21-OCT-2007, the patient received the second dose of GARDASIL vaccine (yeast) (lot # "1266U") in one arm and influenza virus vaccine (unspecified) in the other arm. Approximately 24 to 48 hours after the second dose of GARDASIL vaccine (yeast), the patient experienced a headache at the base of her skull and pain in the neck. The patient did not have this adverse reaction after the first dose of GARDASIL vaccine (yeast). Subsequently the patient went to the local emergency room where a neurologist performed CT scans, spinal tap, a major work-up in which all results were normal. The patient's father told the physician that his daughter is still having headaches. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Blood test, Computerised tomogram, Headache, Inappropriate schedule of drug administration, Lumbar puncture
Clinical narrative: Information has been received from a physician concerning a 15 year old female with asthma and a history of ankle sprain who on 23-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 21-OCT-2007, the patient received the second dose of GARDASIL vaccine (yeast) (lot # "1266U") in one arm and influenza virus vaccine (unspecified) in the other arm. Approximately 24 to 48 hours after the second dose of GARDASIL vaccine (yeast), the patient experienced a headache at the base of her skull and pain in the neck. The patient did not have this adverse reaction after the first dose of GARDASIL vaccine (yeast). Subsequently the patient went to the local emergency room where a neurologist performed CT scans, spinal tap, a major work-up in which all results were normal. The patient's father told the physician that his daughter is still having headaches. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV4, FLUX, HPV4
Symptoms: Neck pain
Clinical narrative: Information has been received from a physician concerning a 15 year old female with asthma and a history of ankle sprain who on 23-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 21-OCT-2007, the patient received the second dose of GARDASIL vaccine (yeast) (lot # "1266U") in one arm and influenza virus vaccine (unspecified) in the other arm. Approximately 24 to 48 hours after the second dose of GARDASIL vaccine (yeast), the patient experienced a headache at the base of her skull and pain in the neck. The patient did not have this adverse reaction after the first dose of GARDASIL vaccine (yeast). Subsequently the patient went to the local emergency room where a neurologist performed CT scans, spinal tap, a major work-up in which all results were normal. The patient's father told the physician that his daughter is still having headaches. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a female who in October 2007, was vaccinated with GARDASIL vaccine (yeast). In October 2007, the patient fainted after receiving the dose. Subsequently, the patient recovered from fainting. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated with the third dose of GARDASIL vaccine (yeast). One week later, the patient experienced diffuse bruising over entire body. Patient outcome was unknown. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure decreased, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 28-SEP-2007 was vaccinated with GARDASIL vaccine (yeast) intramuscularly (IM) (lot#657868/0523U0. Concomitant therapy included influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussia acellular 5-component vaccine (+) tetanus toxoid (ADACEL). One minute post- GARDASIL vaccination, the patient fainted and had a drop in blood pressure. Subsequently, the patient quickly recovered. She had been watched for about one hour before being allowed to leave. No other symptoms were noted. No lab testing was performed. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope, Tooth fracture
Clinical narrative: Information has been received from a registered nurse concerning a "young " female who was vaccinated with Gardasil vaccine. Subsequently, the patient experienced syncope. She passed out, hit the floor "pretty hard" and broke her two front teeth. The patient required tooth repair. Additional information has been requested. It was reported that another patient experienced syncope after vaccination with Gardasil vaccine (WAES 0711USA01539).
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her daughter with no pertinent medical history and no drug reactions/allergies who on 12-APR-2007 was vaccinated with 0.5 ml GARDASIL vaccine (yeast). On 14-JUN-2007, after getting her second dose of GARDASIL vaccine (yeast), the patient experienced tingling. That same day she was also vaccinated with hepatitis A vaccine (inactive) (VAQTA). She did not seek medical attention. No lab diagnostic studies were performed. As of 15-JUN-2007 the patient had improved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a mother concerning her daughter who was vaccinated with Gardasil vaccine. After receiving the second dose of Gardasil the patient's mother reported that her daughter experience injection site pain. The patient's outcome was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Musculoskeletal chest pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Information has been received from a physician concerning a 26 year old female with a poor immune system and a history of helicobacter pylori, who on 25-APR-2007 was vaccinated with the first dose of Gardasil vaccine. Within a few days, in approximately April 2007, the patient experienced shoulder and neck pain on both her right and left sides which lasted for an extended period of time. "Many" lab tests (unspecified) were conducted, results not reported. The patient had a second dose of Gardasil vaccine on 28-JUN-2007. After the second dose, in approximately June 2007, the patient experienced the same shoulder and neck pain but this time the pain also extended down to her rib cage on both her right and left sides. The patient went to the physician's office on 31-OCT-2007 and the physician decided to discontinue therapy and not give the patient the third dose of Gardasil vaccine. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 26 year old female with a poor immune system and a history of helicobacter pylori, who on 25-APR-2007 was vaccinated with the first dose of Gardasil vaccine. Within a few days, in approximately April 2007, the patient experienced shoulder and neck pain on both her right and left sides which lasted for an extended period of time. "Many" lab tests (unspecified) were conducted, results not reported. The patient had a second dose of Gardasil vaccine on 28-JUN-2007. After the second dose, in approximately June 2007, the patient experienced the same shoulder and neck pain but this time the pain also extended down to her rib cage on both her right and left sides. The patient went to the physician's office on 31-OCT-2007 and the physician decided to discontinue therapy and not give the patient the third dose of Gardasil vaccine. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site oedema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female, who on 05-OCT-2007 was vaccinated with Gardasil vaccine (lot number "1062U"). On 27-OCT-2007, the patient received her second dose of Gardasil vaccine. Concomitant therapy included Ortho Tri-Cyclen Lo. The registered nurse reported that on approximately 05-OCT-2007, the patient's arm was swollen and sore since the vaccination and there was a persistent collection of fluid at the injection site. She confirmed that the vaccine was administered in the deltoid muscle (IM) and that the patient was evaluated by several other physicians (at other offices), one healthcare professional stated that the site looked as if fluid needed to be withdrawn. Subsequently, the patient was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007; 1/17/2008. Initial and follow up information has been received from a registered nurse and the doctor's office concerning a 22 year old female who on 03-OCT-2007 (previously reported as 05-OCT-2007) was vaccinated IM into left deltoid with a first dose of GARDASIL vaccine (lot # 658560/1062U). On 27-OCT-2007, the patient received her second dose of GARDASIL vaccine. Concomitant theraphy included ORTHO TRI-CYCLEN LO. The registered nurse reported that on approximately 05-OCT-2007 the patient's arm was swollen and sore since the vaccination and there was a persisitent collection of fluid at the injection site. She confirmed that the vaccine was administered in the deltoid muscle (IM) and that the patient was evaluated by several other physicians (at other offices), one healthcare professional stated that the site looked as if fluid needed to be withdrawn. Subsequently, the patient was recovering. In follow up information from the doctor's office it was reported that the patient called on 10-OCT-2007 with complain of left deltoid injection site swollen and reported that as if fluid was collected at site. It was reported that the site was very tender. The patient recovered on an unknown day. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Heart rate decreased, Hypotension, Laceration, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old female, who on 29-OCT-2007 was vaccinated with her first dose of Gardasil vaccine, IM (lot# 658558/1061U). Concomitant therapy included influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 29-OCT-2007, the patient fainted after she stood up after receiving the vaccination. The patient developed a small cut to her lip and hit her head as she fainted. The patient's blood pressure an heart rate were low. While the patient recovered, she was observed for about an hour and a half until her blood pressure and heart rate returned to normal range. Subsequently, the patient recovered from fainting, small cut to lip, low blood pressure, low heart rate and hitting her head as she fainted. The patient sought medical attention in the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007;  1/7/2008.  Information has been received from a physician concerning a 13 year old female who on 29-OCT-2007 was vaccinated with her first dose of GARDASIL IM (Lot# 658558/1061U).  Concomitant therapy included influenza virus vaccine (unspecified) in the left deltoid (lot# 80822) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid.  On 29-OCT-2007 the patient fainted after she stood up after receiving the vaccinatinon.  This never occurred before with vaccines for this patient.  The patient developed a samll cut to her lip and hit her head as she fainted.  The patient's blood pressure and heart rate were low (BP = 90/60 and HR= 53).  The patient complained of dizziness.  She was diaphoretic, weak and cold to the touch.  While the patient recovered, she was observed for about an hour and a half until her blood pressure and heart rate returned to normal range.  Subsequently on 10-OCT-2007 the patient recovered from fainting, small cut to lip, low blood pressure, low heart rate and hitting her head as she fainted, weakness, cold to touch and being diaphoretic.  The patient sought medical attention in the office.  No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated
Clinical narrative: Information has been received from a health professional concerning a caucasian female with a history of genital warts who on 01-OCT-2007 was vaccinated with her first dose of Gardasil vaccine, IM (lot# 658563/1063U). On approximately 29-OCT-2007, the patient experienced an outbreak of genital warts. The patient has not had an outbreak of genital warts in about 4 years. The patient's genital warts persisted. On 09-NOV-2007 the patient was seen inthe office for genital warts (first noted 2 weeks prior). Patient asking if new outbreak approximately 3 weeks after GARDISIL was caused by GARDISIL. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician about a 25 year old female patient who was vaccinated with her third dose of GARDASIL vaccine (yeast). There was no concomitant medication. Subsequently the patient experienced a lump at the injection site. The patient sought unspecified medical treatment. Subsequently, the patient recovered from lump at injection site a couple of weeks after the vaccination. Physician does not want to be contacted. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Dizziness, Fatigue
Clinical narrative: Information has been received from a physician concerning a female with a history of 3 knee operations, who on 11-MAR-2007 was vaccinated with her first dose of Gardasil vaccine, IM (Lot# 654389/0961F). On approximately 14-MAY-2007, the patient was vaccinated with her second dose of Gardasil vaccine, IM (Lot# 65503/0012U). On 08-OCT-2007, the patient was vaccinated with her third dose of Gardasil vaccine, IM (Lot# 658650/1062U). Concomitant therapy included Ortho Tri-Cyclen. Shortly after 14-MAY-2007, the patient experienced headaches, extreme fatigue, light headed, shaky and weak "with a feeling of almost fainting". The patient continued to have those symptoms, but still received the third dose. The patient's headaches, extreme fatigue, light headed, shaky and weak "with a feeling of almost fainting", persisted with the patient having at least one symptom "just about everyday". The patient had blood work, CT of the head and CMP, which were all normal. The patient did not have any adverse experience after the first dose. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Metabolic function test normal, Tremor
Clinical narrative: Information has been received from a physician concerning a female with a history of 3 knee operations, who on 11-MAR-2007 was vaccinated with her first dose of Gardasil vaccine, IM (Lot# 654389/0961F). On approximately 14-MAY-2007, the patient was vaccinated with her second dose of Gardasil vaccine, IM (Lot# 65503/0012U). On 08-OCT-2007, the patient was vaccinated with her third dose of Gardasil vaccine, IM (Lot# 658650/1062U). Concomitant therapy included Ortho Tri-Cyclen. Shortly after 14-MAY-2007, the patient experienced headaches, extreme fatigue, light headed, shaky and weak "with a feeling of almost fainting". The patient continued to have those symptoms, but still received the third dose. The patient's headaches, extreme fatigue, light headed, shaky and weak "with a feeling of almost fainting", persisted with the patient having at least one symptom "just about everyday". The patient had blood work, CT of the head and CMP, which were all normal. The patient did not have any adverse experience after the first dose. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 12 year old daughter who on 25-SEP-2007 was vaccinated intramuscularly with GARDASIL vaccine (yeast). There was no concomitant medication. On 04-OCT-2007 the patient experienced recurring low fevers and nausea. The patient's fever and nausea persisted. No other symptoms were noted. A similar adverse experience was reported for the consumer's other daughter, refer to WAES#0711USA00230. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Breast pain, Breast tenderness, Chest X-ray, Chest pain, Dysmenorrhoea
Clinical narrative: Information has been received from a physician concerning a 26 year old caucasian female who was vaccinated on 30-MAY-2007 with the first dose of GARDISIL IM (lot # 657868/0523U). Subsquently in June 2007 the patient experienced increased tenderness and pain in her breasts, chest achiness, and increased pain with her menstrual cycle. It occured after both her first and second doses. It was more pronounced the first couple days and lowered after that but she still feels some tenderness. The patient's increased tenderness in her breasts persisted. The patient sought unspecified medical attnetion. Patient does not want to continue the series. As of 11-OCT-2007 the patient still has symptoms. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 26 year old caucasian female who was vaccinated on 30-MAY-2007 with the first dose of GARDISIL IM (lot # 657868/0523U). Subsquently in June 2007 the patient experienced increased tenderness and pain in her breasts, chest achiness, and increased pain with her menstrual cycle. It occured after both her first and second doses. It was more pronounced the first couple days and lowered after that but she still feels some tenderness. The patient's increased tenderness in her breasts persisted. The patient sought unspecified medical attnetion. Patient does not want to continue the series. As of 11-OCT-2007 the patient still has symptoms. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Cellulitis
Clinical narrative: Information has been received from a health professional concerning a 10 year old female, who on 05-MAY-2007 was vaccinated with her second dose of Gardasil vaccine. On 29-OCT-2007, the patient received her third dose of Gardasil vaccine (lot number 658488/1264U). There was no concomitant medication. On 28-OCT-2007, the patient experienced cellulitis on her right forearm. The patient sought medical treatment with an office visit. Benadryl was prescribed and the patient was given a prescription for antibiotics to fill if the adverse experience worsened. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a physician concerning an over 11 year old female who was vaccinated intramuscularly with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced dizziness. The patient did not seek medical attention. Subsequently, the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter, who on 17-OCT-2007 was vaccinated with Gardasil vaccine. Concomitant therapy included Allegra and unspecified thyroid medication. On 29-OCT-2007, the patient experienced a low fever and nausea. The patients low fever and nausea persisted. No other symptoms were noted. A similar adverse experience was reported for the consumers other daughter, refer to WAES#0711USA00200. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with GARDASIL vaccine (yeast) and had a syncopal event. There was no concomitant medication. Subsequently the patient required the administration of amnonia salt to recover from the syncopal event. No other specifics were available regarding the patient, symptoms, the injection, or treatment. No other information available. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Vomiting
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with her first dose of Gardasil vaccine. There was no concomitant medication. Subsequently, the patient experienced vomiting and flu like symptoms. The patient recovered from vomiting and flu like symptoms. No further information provided. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Vaccine positive rechallenge
Clinical narrative: Information has been received from a female nurse practitioner concerning a 9 or 10 year old female, who was vaccinated with Gardasil vaccine intramuscularly in the arm. After the initial dose the patient did not have a menstrual cycle for 2 months afterward. When the patient returned for her second dose she was menstruating but when the second dose was administered the patient's cycle immediately stopped. The patient sought medical attention and no other information was given. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a physician concerning a patient's friend (age not reported) who was vaccinated with Gardasil vaccine (lot# unknown) injection. Subsequently, the patient experienced a "nervous system problem", after receiving the Gardasil vaccine. No further adverse event information was given. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Gardasil vaccine. Subsequently, the patient experience syncope. Additional information has been requested. It was reported that another patient experienced syncope after Gardasil vaccination (WAES0711USA00034).
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Culture negative, Eye swelling, Laboratory test, Lip swelling
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated with a first dose of GARDASIL vaccine. Subsequently, the patient developed generalized body aches, swollen lips and a temperature of 100 which lasted 1-2 days. Additional information has been requested. It was reported that her sister had an experience following vaccination with GARDASIL vaccine (WAES # 0710USA00753). 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 and a nurse practitioner, concerning a 21 year old female student, who on 30-AUG-2007, was vaccinated IM in the left deltoid, with the first dose of GARDASIL (lot #654539/0742U). There was no illness at the time of vaccination. Subsequently the student developed generalised body aches (date not specified), and on 02-SEP-2009, she devolped swollen lips, swollen eyes, and a fever of 100 degrees. The patient visited the physician or emergency room. Treatment included TYLENOL. The physician noted the symptoms lasted for 1-2 days, but the NP reported that on 04-SEP-2007 ("Tuesday"), the swelling had "decreased." The NP added that the patient's sister had developed "mono" during this time, however the patient tested negative for mono. At the time of this report, the patient had recovered from the events. Additional information is not expected. It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0710USA00753).
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated with a first dose of GARDASIL vaccine. Subsequently, the patient developed generalized body aches, swollen lips and a temperature of 100 which lasted 1-2 days. Additional information has been requested. It was reported that her sister had an experience following vaccination with GARDASIL vaccine (WAES # 0710USA00753). 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 and a nurse practitioner, concerning a 21 year old female student, who on 30-AUG-2007, was vaccinated IM in the left deltoid, with the first dose of GARDASIL (lot #654539/0742U). There was no illness at the time of vaccination. Subsequently the student developed generalised body aches (date not specified), and on 02-SEP-2009, she devolped swollen lips, swollen eyes, and a fever of 100 degrees. The patient visited the physician or emergency room. Treatment included TYLENOL. The physician noted the symptoms lasted for 1-2 days, but the NP reported that on 04-SEP-2007 ("Tuesday"), the swelling had "decreased." The NP added that the patient's sister had developed "mono" during this time, however the patient tested negative for mono. At the time of this report, the patient had recovered from the events. Additional information is not expected. It was reported that her sister had an experience following vaccination with GARDASIL (WAES # 0710USA00753).
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with Gardasil vaccine. Subsequently, the patient experienced greater than normal pain and swelling at the injection site. The vaccine was administered from a vial, not a pre-filled syringe. The patient sought unspecified medical attention. Subsequently, on therapy the patient recovered from pain and swelling at the injection site. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning an 18 year old female with a history of diabetes, who on approximately 03-SEP-2007, "about one month ago", was vaccinated with the first dose of Gardasil vaccine, IM in the deltoid. Concomitant medication was not reported. On approximately 04-SEP-2007, "the day after vaccination within 24 hours of the dose of Gardasil vaccine", the patient experienced joint pain in the hand and legs. Subsequently about a "day or so" later, the patient recovered from joint pain in the hand and legs. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a consumer concerning her daughter who on 18-SEP-2007, was vaccinated PO with her first dose of rotavirus vaccine live (human-Bovine). On approximately 18-SEP-2007, the child experienced "diarrhea for the last ten days and it seemed to start right after the dose." Medical attention was sought through an office visit. The patient's outcome was not recovered. The was no product quality complaint. No further information is available.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Faeces discoloured
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on 20-AUG-2007 was vaccinated PO with his second dose of rotavirus vaccine live (human-bovine). Subsequently, the patient experienced "black stools". The patient was scheduled for an appointment with the physician. A stool specimen lab test for the presence of decomposed blood was also scheduled. The patient's outcome status was unknown at the time of this report. There was no product quality complaint. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture, Diarrhoea
Clinical narrative: Information has been received from a physician's office worker concerning a female who on 18-SEP-2007, was vaccinated with a dose of rotavirus vaccine live (human-bovine). Concomitant vaccinations administered that day included a dose HIB conj vaccine (OMPC) (MSD), a dose of Pediarix and a dose of Prevnar. Subsequently, the patient experienced diarrhea for over two weeks. The patient was being treated in the office and the lab culture was pending at the time of this report. The patient's recovery status was unknown. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with the first 2.0 mL dose of rotavirus vaccine live (human-Bovine). No adverse event was reported. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.