chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 04-JAN-2008 was vaccinated intramuscularly with the first dose of GARDASIL. On 04-JAN-2008 the patient experienced fainting "5 minutes after being vaccinated." Subsequently, the patient recovered from having fainted. No further information was provided and no lot number was given. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning multiple female patients who were vaccinated IM with a 0.5ml dose of Gardasil.  Subsequently, the patients experienced injection site pain with the prefilled syringes of Gardasil.  Unspecified medical attention was sought.  At the time of this report, the patients' outcomes were unknown.  No product quality complaint was involved.  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.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning 2 females who were vaccinated with Gardasil and fainted about 5-10 minutes after being vaccinated while the physician was out of the room.  No further information was provided.  No lot numbers were provided for either patient.  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: 14.0
Sex: F
Vaccine: HPV4, TTOX
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 14 year old female who was vaccinated with Gardasil.  Concomitant therapy included tetanus toxoid in the same arm.  The patient developed a blister at the injection site.  The patient's sister also received the first dose of Gardasil and had the same adverse event (WAES #0801USA03560).  Subsequently, the patient recovered.  No further information was provided regarding this adverse experience.  This is one of several reports from the same source.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a medical assistant concerning an approximately 13 year old female who on an unspecified date was vaccinated (route and site not reported) with the first dose of GARDASIL (Lot# not reported). Subsequently, on an unspecified date the patient's mother informed a nurse in the office that post vaccination with GARDASIL her daughter experienced irregular periods. It was reported that the patient had not been see in the office and no treatment medications have been given to the patient. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Syncope, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 21 year old female who was vaccinated intramuscularly (date and site not reported) with a dose of the GARDASIL (lot# not reported). On the same day, the patient was concomitantly intramuscularly vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Subsequently the patient fainted the next day. The patient received unspecified medical attention and recovered on an unknown date. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Lethargy, Malaise, Pallor, Pruritus
Clinical narrative: Information has been received regarding a 17 year old female who is an eyeglasses wearer and hearing aid user in the right ear, who over the past year experienced amenorrhoea, thought to be secondary to athletic participant. On unspecified dates the patient was vaccinated with the first two doses of GARDASIL (Lot #s not provided). Concomitant therapy included aspirin and unspecified calcium supplements. On 25-DEC-2007 the patient developed a rash in two areas on her sternum. The rash was reported to be less than the size of a quarter and was being treated with an unspecified steroid cream. At the time of the report the rash was reported to be resolving. On 28-DEC-2007 the patient was vaccinated with a third dose of GARDASIL (Lot # not reported). No further information is available. 02/10/2010 Follow up information was received which stated that the patient's original rash under the left axilla resolved on an unspecificed date with the use of an unspecified topical steroid cream. On an unspecified date the patient developed two new additional areas of rash plus itching on her sternum. It was also reported that the patient had "been feeling tired" which continued with the onset of the rash. On 19-FEB-2008 it was reported that the patient appeared pale. The patient was scheduled to be evaluated by a pediatrician on 05-MAR-2008. Additional follow up information was received which stated that the two new areas of rash the patient had developed were improving with the use of the unpsecified topical steriod cream which the patient was applyig ot the areas twice a day over a two week period. It was reported that the patient will follow up her pediatrician in another week and if the rash has not resolved at that time the patient will see a dermatologist. No futher information is available.  02/12/2010 Additional follow up information was received indicating that the patient's rash had resolved. It was reported that the skin is slightly discolored and that the patient also experienced fatigue, malaise and lethargy. Additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received regarding a 17 year old female who is an eyeglasses wearer and hearing aid user in the right ear, who over the past year experienced amenorrhoea, thought to be secondary to athletic participant. On unspecified dates the patient was vaccinated with the first two doses of GARDASIL (Lot #s not provided). Concomitant therapy included aspirin and unspecified calcium supplements. On 25-DEC-2007 the patient developed a rash in two areas on her sternum. The rash was reported to be less than the size of a quarter and was being treated with an unspecified steroid cream. At the time of the report the rash was reported to be resolving. On 28-DEC-2007 the patient was vaccinated with a third dose of GARDASIL (Lot # not reported). No further information is available. 02/10/2010 Follow up information was received which stated that the patient's original rash under the left axilla resolved on an unspecificed date with the use of an unspecified topical steroid cream. On an unspecified date the patient developed two new additional areas of rash plus itching on her sternum. It was also reported that the patient had "been feeling tired" which continued with the onset of the rash. On 19-FEB-2008 it was reported that the patient appeared pale. The patient was scheduled to be evaluated by a pediatrician on 05-MAR-2008. Additional follow up information was received which stated that the two new areas of rash the patient had developed were improving with the use of the unpsecified topical steriod cream which the patient was applyig ot the areas twice a day over a two week period. It was reported that the patient will follow up her pediatrician in another week and if the rash has not resolved at that time the patient will see a dermatologist. No futher information is available.  02/12/2010 Additional follow up information was received indicating that the patient's rash had resolved. It was reported that the skin is slightly discolored and that the patient also experienced fatigue, malaise and lethargy. Additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL. Subsequently the patient developed redness at the injection site. No additional information was provided. This is one several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 19-JUL-2007 was vaccinated with the first dose of GARDASIL. Per the reporter, the patient experienced bells palsy "one to two weeks after receiving GARDASIL." The patient sought unspecified medical attention. Subsequently, the patient recovered from bells palsy seven weeks after diagnosed, but could not move her mouth for three weeks. The patient refuses to receive the second and third dose of GARDASIL. No lot number was provided and no further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness
Clinical narrative: Information has been received from a company representative concerning a female (age not reported) who on an unspecified date was vaccinated with Gardasil 0.5 mL.  Concomitant therapy included MENACTRA at the same office visit.  On an unspecified date the patient became dizzy.  Medical attention was sought.  The representative mentioned that she did not know how long the patient was dizzy or if the dizziness has resolved.  She stated that there was no injury associated with the incident.  No additional information was available.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram normal, Syncope
Clinical narrative: Information has been received from a physician, concerning a 13 year old female with no pertinent medical history and no known allergies, who on 23-APR-2007 was vaccinated IM with the second dose, 0.5 ml, of Gardasil (lot # invalid).  Concomitant therapy included hormonal contraceptives (unspecified).  On 02-MAY-2007 the patient fainted while in the shower, and quickly recovered.  However, since that time, she has "fainted for several seconds, every few days."  The patient visited the physician's office, and an electrocardiogram (EKG) result was normal.  There were no other symptoms noted.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician concerning two female patients (ages and genders unknown), who, on unspecified dates, were vaccinated with doses of Gardasil. Concomitant vaccinations included "four unspecified vaccines" [therapy unspecified]. Subsequently, the patients experienced high fevers and flu like symptoms. It was reported that "one patient's symptoms were a little bit worse than the others." The patient were seen by the physician. The patients recovered on unspecified dates. No product quality complaint was involved. Follow-up information indicated that a health care professional reported that she could not remember who the actual patients were, just that there were two of them. She reported that their records are all electronic so she would not have any way of looking it up easily. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning approximately five female patients (ages unknown), who on unspecified dates, were vaccinated with doses of GARDASIL. Subsequently post vaccination the patients had fainted. The nurse reported that she thought some of the patients fainted. The nurse reported that the thought some of the patients fainted after the third dose. The nurse could not provide initials or patient identifiers. The patients were seen by the physician. The patients recovered on unspecified dates. No product quality complaint was involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning herself, a 26 year old female with no known allergies, who in approximately August 2007 (possibly September 2007), was vaccinated, SC, with the second dose, of Gardasil (lot # not provided).  It was noted that the first dose (date not specified) had also been administered SC.  Following the second SC dose (August or September 2007), the patient developed an injection site reaction that was red, mildly painful and warm.  She spoke with the pharmacist for medical advice (details not provided).  The symptoms lasted for "about 3 weeks," and the nurse then recovered.  On 08-JAN-2008, a third dose of Gardasil was administered, IM, with no adverse effect reported.  Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 20 year old female who was vaccinated with a dose of Gardasil.  Within seconds, the patient turned blue and passed out and was out for about one to one and a half minutes.  Unspecified 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 2/14/2008. Information has been received from a physician concerning a 23 year old female with epilepsy who on 28-DEC-2007 was vaccinated into the left deltoid with a first dose of dose of GARDASIL vaccine (lot#655327/12870U). Within seconds, the patient turned blue and passed out and was out for about one to one and a half minutes. It was also reported that the patient went to check out 15 minutes later and fell to the floor. 911 was called after the clinical staff rendered emergency care. Unspecified medical attention was sough. At the time of this report, the patient's outcome was unknown. On 28-DEC-2008, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history or allergies, on 08-JAN-2008 was vaccinated with a first 0.5 ml dose of Gardasil (lot#655327/1287U).  There was no concomitant medication.  On 08-JAN-2008 the patient experienced fainted, fell off the exam table and bumped her head.  Unspecified medical attention was sought.  No laboratory diagnostic tests were performed.  On 09-JAN-2008, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil.  On an unspecified date the patient was vaccinated with a second dose of Gardasil.  On an unspecified date, the patient experienced pain with the first dose of vaccine.  Subsequently, the patient recovered.  The mother of the patient contacted the nurse practitioner and questioned how a nurse administered the second dose of Gardasil because the second dose hurt a lot more than dose 1.  The outcome of the event was not reported.  Additional information has been requested. 02/10/2010 Additional information was received from the nurse practioner who reported that the patient did not experience erythema, no change in motion, or ability to user her arm. No additional information is expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Haemoglobin decreased, Head injury, Headache, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female who sometime during the week of 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM. As the patient was walking out of the office (approximately 31-DEC-2007), she passed out on the desk and hit her head. She went to the ER (details not provided). The outcome of the event was not reported. The physician stated that she thought it was a vasovagal reaction. Additional information has been requested. 07/08/08 Information has been received from a physician and a licensed practical nurse concerning a female student who on 27-DEC-2007 (previously reported as the week of 31-DEC-2007) was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot # 659439/1267U). On 27-DEC-2007, the patient experienced a vasovagal episode. As the patient was walking out of the office, she passed out on the desk and hit her head on the counter and the floor. The patient complained of a headache. The patient was immediately taken to the ER by a staff member. The patient had a fingerstick blood sugar performed in the office (136 mg/dL) and a blood test for hemoglobin level (11.7%). On an unspecified date, the patient recovered from the vasovagal episode; passing out and hit her head on the counter and floor and severe head pain. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a female who sometime during the week of 31-DEC-2007 was vaccinated with the first dose of Gardasil 0.5 mL IM. As the patient was walking out of the office (approximately 31-DEC-2007), she passed out on the desk and hit her head. She went to the ER (details not provided). The outcome of the event was not reported. The physician stated that she thought it was a vasovagal reaction. Additional information has been requested. 07/08/08 Information has been received from a physician and a licensed practical nurse concerning a female student who on 27-DEC-2007 (previously reported as the week of 31-DEC-2007) was vaccinated intramuscularly in the right deltoid with her first dose of GARDASIL (Lot # 659439/1267U). On 27-DEC-2007, the patient experienced a vasovagal episode. As the patient was walking out of the office, she passed out on the desk and hit her head on the counter and the floor. The patient complained of a headache. The patient was immediately taken to the ER by a staff member. The patient had a fingerstick blood sugar performed in the office (136 mg/dL) and a blood test for hemoglobin level (11.7%). On an unspecified date, the patient recovered from the vasovagal episode; passing out and hit her head on the counter and floor and severe head pain. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anorexia, Erythema, Nausea, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female with depression and allergies to iodine and IV contrast material who on 03-JAN-2008 was vaccinated with the first dose of Gardasil 0.5 mL IM (Lot #659055/1522U).  Concomitant therapy included MICROGESTIN, trazodone HCl and PROZAC.  On the way out of the office on 03-JAN-2008 the patient developed swelling and redness of her left hand.  She did not notify the office staff at that time.  The redness and swelling resolved (date not reported).  Over the next six days (approximately 04-JAN-2008) the patient experienced nausea and loss of appetite.  The nurse practitioner mentioned that the patient may have the flu.  She contacted the office by phone.  As of 09-JAN-2008, she was recovering.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Feeling hot, Influenza like illness, Injection site pain, Malaise
Clinical narrative: Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 13 year old female patient, who in late December 2007 ("right before Christmas") was vaccinated with the first dose of Gardasil (lot # not reported).  The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day).  Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender."  The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea.  The symptoms lasted for 1 1/2 days.  It was reported that there were flu symptoms going around the town.  No further information was provided.  It was reported that another patient experienced symptoms after receiving the Gardasil.  (WAES # 0801USA02289).  Additional information is not expected. 04/07/2008 Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 15 year old female student patient who in late December 2007 ("right before Christmas") was vaccinated with the first dose of GARDASIL (lot # not reported). The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day). Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the spot felt uncomfortable and the area was tender". The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea. The symptoms lasted for 1 1/2 days. It was reported that there were flu symptoms going around the town. No further information was provided. In follow-up it was reported that on 21-DEC-2007, the patient a 15 year old female student with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions was vaccinated intramuscularly into the "LT" with the first dose of GARDASIL, (Lot # 658563/106U). It was reported that the patient felt injection: immediate warmth throughout, became sick later in the day i.e. body aches, nausea, tired and no appetite. It was reported that another patient experienced symptoms after receiving the GARDASIL, (WAES # 0801USA02289). Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain
Clinical narrative: Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 13 year old female patient, who in late December 2007 ("right before Christmas") was vaccinated with the first dose of Gardasil (lot # not reported).  The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day).  Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender."  The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea.  The symptoms lasted for 1 1/2 days.  It was reported that there were flu symptoms going around the town.  No further information was provided.  It was reported that another patient experienced symptoms after receiving the Gardasil.  (WAES # 0801USA02289).  Additional information is not expected. 04/07/2008 Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning a 15 year old female student patient who in late December 2007 ("right before Christmas") was vaccinated with the first dose of GARDASIL (lot # not reported). The patient did not receive a concomitant vaccine (previously reported that patient received influenza virus vaccine on same day). Within 15 minutes of the vaccination, the patient experienced "a whoosh/warm feeling going through her upper leg, the spot felt uncomfortable and the area was tender". The nurse added that the patient had flu-like symptoms, including body aches and malaise, as well as nausea. The symptoms lasted for 1 1/2 days. It was reported that there were flu symptoms going around the town. No further information was provided. In follow-up it was reported that on 21-DEC-2007, the patient a 15 year old female student with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions was vaccinated intramuscularly into the "LT" with the first dose of GARDASIL, (Lot # 658563/106U). It was reported that the patient felt injection: immediate warmth throughout, became sick later in the day i.e. body aches, nausea, tired and no appetite. It was reported that another patient experienced symptoms after receiving the GARDASIL, (WAES # 0801USA02289). Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 year old female. It was reported that the patient fainted after receiving her first dose Gardasil. Lot number was not available. The patient recovered and no further information was given. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse practitioner (NP), via a company representative, concerning a 12 year old female patient, who on 28-OCT-2007 was vaccinated IM with the first dose and on 08-JAN-2008 with the second dose of Gardasil (lot # invalid dose 1; lot #658556/1060U dose 2).  On 08-JAN-2008, "within 24 hours" of receiving the second vaccination, the patient experienced nausea and a possible fever.  On 09-JAN-2008, she returned to the NP's office for evaluation, though she did not have a fever at that time.  Subsequently, the patient also recovered from nausea (duration not specified).  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse, (L.P.N.) concerning a female who was vaccinated with a 0.5 mL dose of Gardasil.  Subsequently the patient developed a rash all over her body after receiving Gardasil.  The patient sought unspecified medical attention.  At the time of the report it was unknown, if the patient had recovered.  There was no additional information.  Additional information has been requested. 02/12/2010 Initial and follow up information has been received from a licensed practical nurse concerning a 12 year old female patient, a student who on 04-JUN-2007, at approximately 3:00 pm, was vaccinated IM in the left deltoid with the first dose 0.5mL of GARDASIL (lot #657736/0385U). There was no illness at the time of vaccination. Following the vaccination onthat day, the patient developed "scattered erythematous round macules with some target lesions," also described as a rash all over her body. The patient was seen by the physician, though treatment was not specified. At the time of this report the patient had recovered (date and duration not specified). Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 20-OCT-2007 was vaccinated with a first dose of Gardasil (lot# unknown).  On 17-DEC-2008 the patient was vaccinated with a second dose of Gardasil (lot# "0710U", expiration date 04-JUL-2009) IM injection.  On 18-DEC-2007, "within 24 hours" the patient experienced headaches, body aches, fever, nausea, and dizziness for eight days after receiving her second dose of the Gardasil vaccine.  Medical attention was sought.  The physician reported that the patient was seen for an office visit for her symptoms on 22-DEC-2007, and then again on 24-DEC-2007 where she was beginning to feel better.  The physician reported that the patient called the office on 26-DEC-2007 and said she was feeling better.  "The patient is fine now".  No further information was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Syncope, Tooth injury, Tooth loss
Clinical narrative: Information has been received from a registered nurse concerning a female in her 20's who was vaccinated with her first dose of 0.5 ml Gardasil via injection.  The patient fainted, fell down and knocked out her two front teeth after getting the first dose of Gardasil.  The patient was referred to a dentist.  No further information was provided.  Additional information has been requested. 07/08/08 Initial and follow-up information has been received from a registered nurse concerning a 20 year old female student, who on 27-NOV-2007 at 13:20 was vaccinated IM in the left deltoid with her first dose of 0.5 ml GARDASIL (Lot# 659435/1269U). On 27-NOV-2007 at 13:30 the patient fainted, fell down and knocked out her two front teeth after getting the first dose of GARDASIL. The patient was referred to a dentist. The patient was seen and treated by the dentist. No laboratory diagnostics were performed. The patient recovered on 27-NOV-2007. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 19 year old female who was vaccinated with 0.5 ml of Gardasil (Lot #658558/1061U) intramuscularly in the deltoid.  The nurse reported that the patient had extreme pain and numbness in her arm after she was given Gardasil.  The nurse was unsure which Gardasil dose this occurred with.  As of 10-JAN-2008 the patient had not recovered.  No other information was available from the nurse.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Spinal X-ray normal, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who on an unknown date was vaccinated IM with a first 0.5ml dose of Gardasil. After receiving the dose, the patient fainted. Laboratory diagnostic studies included a c-spine x-ray that was reported as normal. Subsequently, the patient recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Blood amylase, Blood amylase normal, Laboratory test normal, Liver function test normal
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who in December 2006 and March 2007, was vaccinated with a first a second dose of Gardasil, respectively.  On 07-DEC-2007, the patient was vaccinated IM with a third 0.5ml dose of Gardasil (Lot# 659435/1265U).  There was no concomitant medication.  On approximately 07-DEC-2007 about a month ago, the patient experienced intermittent abdominal pain in the right lower quadrant.  There was no report of radiation of pain, nausea, vomiting or diarrhea.  Unspecified medical attention was sought.  Laboratory diagnostic studies included liver function tests, complete metabolic panel, sedimentation rate and amylase.  All results were reported to be within normal ranges.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who in December 2006 and March 2007, was vaccinated with a first a second dose of Gardasil, respectively.  On 07-DEC-2007, the patient was vaccinated IM with a third 0.5ml dose of Gardasil (Lot# 659435/1265U).  There was no concomitant medication.  On approximately 07-DEC-2007 about a month ago, the patient experienced intermittent abdominal pain in the right lower quadrant.  There was no report of radiation of pain, nausea, vomiting or diarrhea.  Unspecified medical attention was sought.  Laboratory diagnostic studies included liver function tests, complete metabolic panel, sedimentation rate and amylase.  All results were reported to be within normal ranges.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female, who, on an unspecified date, was vaccinated intramuscularly with a first dose of Gardasil.  Subsequently, the patient fainted.  The patient recovered on the same day.  The patient sought unspecified medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Decreased appetite, Fatigue, Feeling hot, Influenza like illness, Injection site discomfort
Clinical narrative: Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning an 18 year old female (previously reported as "older" female) who was vaccinated in December 2007 ("right before Christmas"), with the first dose of Gardasil (lot # not reported).  Concomitantly, the patient received influenza virus vaccine (unspecified).  It was reported the patient experienced "a whoosh/warm feeling going through her leg, the shot felt uncomfortable and the area was tender."  The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including body aches and malaise, as well as nausea.  It was reported that there were flu symptoms going around the town.  The nurse reported that the symptoms lasted for 1 1/2 days.  It was reported that another patient experienced symptoms after receiving Gardasil, (WAES # 0801USA02008).  Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow up information has been received from a registered nurse concerning an 18 year old caucasian female with no pertinent medical history, who was  vaccinated IM in the left thigh, on 18-DEC-2007 at 8:55 am, with the first dose of GARDASIL (lot # 656049/0187U). Concomitantly, the patient received the first dose, IM in the left arm, of influenza virus vaccine (SP, lot #02435AA). There was no illness at the time of vaccination. It was reported the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender." The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including headache and body aches and malaise, as well as nausea. She also reported fatigue and no appetite. It was reported that there were flu symptoms going around the town. The nurse reported that the symptoms lasted for 1 1/2 days, with recovery noted on 20-DEC-2007. It was reported that another patient experienced symptoms after receiving GARDASIL. (WAES # 0801USA02008). Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Injection site pain, Malaise, Nausea, Pain
Clinical narrative: Initial and follow up information has been received from a registered nurse (previously reported as a licensed practical nurse) concerning an 18 year old female (previously reported as "older" female) who was vaccinated in December 2007 ("right before Christmas"), with the first dose of Gardasil (lot # not reported).  Concomitantly, the patient received influenza virus vaccine (unspecified).  It was reported the patient experienced "a whoosh/warm feeling going through her leg, the shot felt uncomfortable and the area was tender."  The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including body aches and malaise, as well as nausea.  It was reported that there were flu symptoms going around the town.  The nurse reported that the symptoms lasted for 1 1/2 days.  It was reported that another patient experienced symptoms after receiving Gardasil, (WAES # 0801USA02008).  Additional information is not expected. This is in follow-up to report(s) previously submitted on 2/14/2008. Initial and follow up information has been received from a registered nurse concerning an 18 year old caucasian female with no pertinent medical history, who was  vaccinated IM in the left thigh, on 18-DEC-2007 at 8:55 am, with the first dose of GARDASIL (lot # 656049/0187U). Concomitantly, the patient received the first dose, IM in the left arm, of influenza virus vaccine (SP, lot #02435AA). There was no illness at the time of vaccination. It was reported the patient experienced "a whoosh/warm feeling going through her upper leg, the shot felt uncomfortable and the area was tender." The nurse stated that within 15 minutes after the vaccination, the patient felt sick with flu-like symptoms, including headache and body aches and malaise, as well as nausea. She also reported fatigue and no appetite. It was reported that there were flu symptoms going around the town. The nurse reported that the symptoms lasted for 1 1/2 days, with recovery noted on 20-DEC-2007. It was reported that another patient experienced symptoms after receiving GARDASIL. (WAES # 0801USA02008). Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Laboratory test normal, Nausea
Clinical narrative: Information has been received from a nurse practitioner (NP), via a company representative, concerning a 10 year old female patient, who on 28-OCT-2007 was vaccinated IM with the first dose (lot # invalid), and on 07-JAN-2008 was vaccinated IM with the second dose of GARDASIL (lot #658556/1060U). On 07-JAN-2008, after receiving the second dose, the patient experienced dizziness and lightheadedness when she went to get up, and fell down on the floor. She also experienced nausea and a possible fever (onset time not clearly specified). She was observed for 45 minutes and was then released to go home. On 09-JAN-2008, she returned to the office with continued complaints of nausea and a possible fever, though she did not have a fever at the visit. Diagnostic testing was performed, but the results showed nothing abnormal. The patient recovered, and "is now doing fine" (duration not specified). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a healthcare professional, concerning a 23 year old female patient with drug hypersensitivity to MACROBID and a history of a colposcopy and abnormal Papanicolaou smears (2005 and 2006), who on 03-JAN-2008 was vaccinated with IM in the left shoulder with a dose, 0.5 ml, of Gardasil (lot #659439/1267U).  Concomitant therapy included YASMIN.  In January 2008, the patient developed hives over her whole body, and scheduled an appointment to visit for evaluation.  At the time of this report, the outcome of the event was not recovered.  Additional information has been requested. 02/10/2010 Lab testing was not performed. Treatment included Benadryl and Medrol dose pack. The patients resolved without further complaints, however the date of recovery was unknown.
Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Inappropriate schedule of drug administration, Injection site mass
Clinical narrative: Information has been received from a physician concerning an "approximately 33 year old" female, who in April 2007, was vaccinated with a first dose of Gardasil.  Subsequently, the patient developed a bump at the injection site.  It was reported that the patient was "six or seven months" pregnant and had not received any further doses of the vaccine.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil.  The physician reported that the patient got the injection and fainted.  The patient recovered "same day".  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from an office manager concerning a 13 year old female who was vaccinated with a first dose Gardasil early in the day.  On the same day, at approximately 21:00, the patient developed a "rash all over her body."  When the patient was seen by the physician, she was sent to the hospital.  No further follow-up was done by the office.  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on 06-AUG-2007 was vaccinated intramuscularly with the first dose of GARDASIL. Concomitant therapy included doxycycline. On 06-AUG-2007 the patient fainted while leaving the office. The patient was brought back into the office and monitored for 30 minutes. Subsequently, the patient recovered from fainting while leaving the office. The patient has not received the second dose of GARDASIL and no further information is available. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who was vaccinated with the third dose of GARDASIL. The mother of the patient stated that shortly after vaccination, the patient experienced swelling at the injection site and redness at the injection site. The patient sought unspecified medical attention. At the time of report, the patient was recovering from swelling at the injection site and redness at the injection site. No other information is available. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Insomnia
Clinical narrative: Information has been received from a healthcare professional concerning an 11 year old female who "in the summer of 2007" was vaccinated with the first dose of GARDASIL. Per the reporter, the patient has bot been sleeping at night since vaccination with GARDASIL. The patient sought unspecified medical attention. No lot number was provided and no further information was available. Follow-up information (11-JAN-2008): "It was originally reported that the patient received her first dose of GARDASIL a few weeks ago, but this information is incorrect. She actually received the dose in the summer of 2007." No additional information was given. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Follow-up information (20-FEB-2008). A member of the office staff has reported that the patient is not a patient of the physician. They do not have any information concerning this patient; therefore they do not want any further correspondence. Memo received from physician's office on 26-FEB-2008 stating that they have no additional information available. Additional information is not expected.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Convulsion, Electroencephalogram normal, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 20 week old female with no known allergies or pertinent medical history who on approximately 01-JAN-2008 was vaccinated with a second dose of Rotateq.  On 15-JAN-2008 the patient had a seizure.  The patient was hospitalized.  MRI of the brain was negative, EEG was negative and unspecified blood work was negative.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested. Additional information from the physician indicated that no further information is available. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Skin exfoliation, Skin wrinkling
Clinical narrative: Information has been received from a mother concerning her 22 year old daughter with allergies to unspecified therapy "SEPICOL" and therapy unspecified "SEPICHLOR" who on 06-DEC-2007 was vaccinated with Gardasil (first dose fo three).  There were no concomitant medications.  On 20-DEC-2007, "two weeks after the dose was administered", the patient experienced roughness and wrinkles on her knuckles and they felt like rubber.  A short time later, the skin on her hands, knees and elbows peeled.  The patient's roughness on her knuckles and wrinkles on her knuckles and knuckles felt like rubber and skin on hands, knees and elbows began peeling persisted.  The mother reported that she was unsure whether or not her daughter would receive the second and third doses.  Additional information is not available.
Age: 0.4
Sex: F
Vaccine: RV5, UNK
Symptoms: Diarrhoea, Pyrexia, Viral infection, Vomiting
Clinical narrative: Information has been received from a physician concerning a 4 month old female who in 2007 was vaccinated PO with her second 2.0 ml dose of ROTATEQ. Concomitant vaccinations administered on that same day included "other required vaccinations." In 28-AUG-2007 the patient experienced vomiting, diarrhea and fever. The patient went to the ER on 30-AUG-2007, and two more office visits on 05-SEP-2007 and 07-SEp2007 her condition had not improved as of this time and was diagnosed as a viral infection. Therapy with ROTATEQ was discontinued for the third dose. There was no product quality complaint. Additional informtion has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis, Rotavirus test negative
Clinical narrative: Information has been received from a physician concerning an approximately 6 month old female who on 14-SEP-2007 and 19-NOV-2007 was vaccinated PO with her first and second doses of Rotateq (no lot number provided).  Concomitant vaccinations administered on 19-NOV-2007 included a dose of PEDIARIX, a dose of Hib conj vaccine (OMPC) (MSD) and a dose of PREVNAR.  On 17-OCT-2007 the patient experienced diarrhea and was treated.  In November 2007, after the second dose of Rotateq the patient experienced "gastroenteritis."  The patient was seen for a follow-up visit in the office on 05-DEC-2007.  On 02-JAN-2008 the patient returned to the physician's office for a lab test that revealed negative results for "rotavirus."  The outcome was unknown.  The physician also reported that the patient was due for a follow-up visit on 19-JAN-2008.  There was no product quality complaint.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Supraventricular tachycardia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a 25 year old female with cardiovascular disorder and a history of AV node surgery who on 01-AUG-2007 was vaccinated with the first dose of GARDASIL. There was no illness reported at the time of vaccination. On approximately 01-AUG-2007, after getting the first dose of GARDASIL, the patient experienced a supraventricular tachycardia episode and sought unspecified medical attention. On approximately 01-OCT-2007, after getting the second dose of GARDASIL, the patient experienced a supraventricular tachycardia episode. The physician stated that patient denied for the third dose. The patient outcome was unknown. additional information has been requested.