chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle rigidity, Nausea, Sinusitis, Syncope, Vision blurred
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter with a history of sulfonamide allergy who on 15-MAY-2007 was vaccinated with the second dose of GARDASIL (lot number not provided). Concomitant therapy included hormonal contraceptive (unspecified). On 24-MAY-2007 the patient fainted under the hair dryer at a beauty salon. The patient reported feeling hot then slumped forward unconscious. She was  sweaty, her lips were white, and her right side was jerking. The paramedics were called and they could not find a pulse but her blood pressure was low and her blood sugar was 65. She came to before being transported to the emergency clinic and had blurred vision. At the hospital her left side began jerking, her left arm was rigid, and she had a severe headache and nausea. She had many lab tests in the clinic including an electrocardiogram which was normal, a CT scan that was normal except for sinusitis. She had no fever her pulse ox was 99, pulse 80 on arrival then 64 later, her blood pressure was 78/50 on arrival then 90/60 later, and her blood sugar was 85. She was not admitted. Subsequently, the patient recovered from fainted, sinusitis, left arm rigid, left side jerking, blurred vision, right side jerking, right side jerking, loss of consciousness, severe headache and nausea. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Body mass index decreased, Drug exposure during pregnancy, Haemoglobin, Inappropriate schedule of drug administration
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 28 year old pregnant female with allergy to iodine who on 06-FEB-2007 was vaccinated intramuscularly in the right deltoid with the first 0.5 mL dose of Gardasil (lot# 654741/1208F). On 24-APR-2007, the patient was vaccinated intramuscularly in the right deltoid with the second 0.5 mL dose of Gardasil (lot# 655205/1426F). It was reported that the patient was 4 weeks into her gestation period and has a delivery date of 24-JAN-2008. The patient sought unspecified medical attention. The registered nurse reported that the patient did not have any weight gain in the last 10 week. There was no product quality complaint involved. Additional information has been requested. 07/08/2008 Follow-up information was received from the nurse on 27-MAY-2008 which indicated that the patient had delivered a healthy, normal, newborn. Both mother and baby are fine. No additional information is expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Off label use, Weight gain poor
Clinical narrative: Information has been received through the Merck pregnancy registry from a registered nurse concerning a 28 year old pregnant female with allergy to iodine who on 06-FEB-2007 was vaccinated intramuscularly in the right deltoid with the first 0.5 mL dose of Gardasil (lot# 654741/1208F). On 24-APR-2007, the patient was vaccinated intramuscularly in the right deltoid with the second 0.5 mL dose of Gardasil (lot# 655205/1426F). It was reported that the patient was 4 weeks into her gestation period and has a delivery date of 24-JAN-2008. The patient sought unspecified medical attention. The registered nurse reported that the patient did not have any weight gain in the last 10 week. There was no product quality complaint involved. Additional information has been requested. 07/08/2008 Follow-up information was received from the nurse on 27-MAY-2008 which indicated that the patient had delivered a healthy, normal, newborn. Both mother and baby are fine. No additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pericardial effusion, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning a healthy 23 year old female nurse with a history of mole removal who on 03-APR-2007 was vaccinated intramuscularly into the left deltoid with her first dose of GARDASIL (lot # 657617/0384U). On approximately 18-APR-2007, fifteen days post vaccination, while being used as a model for an ultrasound, it was detected that the patient had pericardial effusion. The patient sought medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 7/6/2007.  Initial and follow-up information has been received from a physician concerning a healthy 23 year old white female registered nurse with a history of mole removal who on 03-APR-2007 was vaccinated intramuscularly into the left deltoid with her first dose of GARDASIL (lot # 657617/0384U).  On approximately 18-APR-2007, fifteen days post vaccination, while being used as a model for an ultrasound, it was detected that the patient had pericardial effusion.  The patient sought medical attention.  The patient had no symptoms and the pericardial effusion resolved spontaneously.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning an adolescent female, who on 08-FEB-2007 was vaccinated with her first dose of Gardasil, IM.  Subsequently, on an unknown date, she went to her physician for her second vaccination; but the physician postponed the dose because the patient had a migraine and not feeling well.  On 31-MAY-2007 the patient received her second dose, which was later than the indicated time-period.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 14 year old female patient, who on 31-MAY-2007 was vaccinated with the first dose of Gardasil (Lot #657737/0522U).  Concomitant therapy included Varivax (MSD) (Lot 657406/0516U) and MENACTRA.  The physician reported that on 31-MAY-2007, the patient passed out after receiving the vaccination, and recovered on the same day (duration of time not specified).  The patient sought unspecified medical attention.  Additional information has been requested. Initial and follow up information has been received from a physician and a healthcare professional, concerning a 14 year old, female student, with no significant medical history and no known allergies, who on 31-MAY-2007, at 3:00pm was vaccinated IM, with the first dose of GARDASIL (lot #657737/0522U). Concomitant therapy included VARICELLA virus vaccine live (lot 657406/0516U) and MENACTRA.  There was no illness at the time of vaccination. The physician reported that on 31-MAY-2007, the patient passed out, and recovered on the same day.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who in April 2007, was vaccinated with the first dose of GARDASIL. Since the injection in April 2007, the patient has had a small lump at the injection site. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007.  Initial and follow-up information has been received from a physician, concerning a 13 year old female patient, who in April 2007, was vaccinated with the first dose of GARDASIL.  Since the injection in April 2007, the patient has had a small lump at the injection site.  Follow up information from the physician confirmed there had been no further contact with the patient, however, she added that the patient had "moved or flinched and tightened her muscle during the vaccination."  The area was described as a slight induration, about 1 inch in diameter.  At the time to this report, it was unknown if the patient had recovered from the event.  The patient sougth unspecified medical attention.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 23-MAY-2007 was vaccinated with Gardasil (Lot #656051/0244U).  On approximately 24-MAY-2007 the patient experienced bruises on her body, especially her legs.  It was reported that the patient sought unspecified medical attention.  No further details were provided.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Asthenia, Dizziness, Fatigue, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a female who in April 2007, was vaccinated with Gardasil.  In April 2007, after receiving the vaccine, the patient experienced feeling very dizzy and weak.  The patient called the office the next day from school complaining that she was tired and that her arm hurt at the site of her injection.  On the third day she was fine.  The nurse felt that it was caused by anxiety.  It was reported that the patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from a licensed practical nurse (previously reported as a registered nurse) concerning a 16 year old female student, with no known allergies, who on 21-MAR-2007 at 8:39 am, was vaccinated IM in the right deltoid with a 0.5ml first dose of GARDASIL (lot #656049/0187U). On 22-MAR-2007 in the AM, the patient became very dizzy, nausea, weak, tired and arm hurt at site of injection. The patient called the office from school complaining that she was tired and that her arm hurt at the site of her injection. Patient was instructed to take TYLENOL as needed with plenty of rest and fluids. To call if symptoms persisted or worsen. On 23-MAR-2007 the patient recovered from very dizzy, nausea, weak, tired and arm hurt at site of injection. The nurse felt that it was caused by anxiety. On 25-MAR-2007 at 8:23 am, the patient was vaccinated IM in the left deltoid with a second dose of GARDASIL (lot # 656051/0244U). No further information reported on the second dose. The patients mother reported "this usually happens after vaccinations".
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old white female with no pertinent medical history or drug reactions/allergies who on 04-JUN-2007 was vaccinated with first dose of Gardasil ( lot # 656050/0245U) IM at 11AM.  Concomitant therapy included Vaqta (manufacturer unknown).  On 04-JUN-2007, the physician reported that the patient experienced passed out after receiving Gardasil.  The patient sought unspecified medical attention.  On 04-JUN-2007, the patient recovered from having passed out.  Additional information was received from a health professional. The patient had no illness at the time of vaccination. The patient experienced syncope on 04-JUN-207 at 11:10AM. Further information is not available.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician and an office worker concerning a 15 year old obese female (171 lbs.) with no history of prior vaccination adverse events who on 01-JUN-2007 was vaccinated with Gardasil (lot 65453F/0960F) intramuscularly, Menactra, Boostrix and Varivax (lot# 653360/0791F, subcutaneous injection. It was reported the patient received a previous dose of Varivax on 16-AUG-1996. On 01-JUN-2007 the patient passed out/fainted. On 01-JUN-2007 the patient recovered. The event was considered non serious. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes, Scar, Vaccine positive rechallenge
Clinical narrative: Information has been received from the mother of an 18 year old female with no history of cold sores and no known drug reactions or allergic reactions, who on 29-MAR-2007, was vaccinated with GARDASIL. Concomitant therapy included YASMIN for birth control. On approximately 22-MAR-2007, the patient received her first of 5 weekly doses of anti-malarial medication (not further specified) in preparation for a trip to another country. On approximately 31-MAR-2007 the patient developed a cold sore on her upper lip. The cold sores progressed to "a cluster of ugly cold sores" on her upper lip. The cold sores went away on approximately 07-APR-2007. Some scarring remained on her upper lip. On 24-MAY-2007, the patient received her second vaccination of GARDASIL. On approximately 31-MAY-2007 the patient broke out with cold sores in the same area of the upper lip as previously. The patient was not pregnant and not hospitalized. Additional information is expected. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from the mother of an 18 year old female with no history of cold sores and no known drug reactions or allergic reactions, who on 29-MAR-2007, was vaccinated intramuscularly with a first dose of GARDASIL (Lot # "02340"). Concomitant therapy included YASMIN for birth control and ACCUTANE. In addition, it was noted that approximately 1 week prior to her first GARDASIL vaccination, the patient began taking an anti-malarial medication (not further specified) in preparation for a trip to another country. She took the medicine once per week for five weeks. Approximately two to three days later after vaccination with GARDASIL, the patient developed a cold sore on her upper lip. The cold sore progressed to "a cluster of ugly cold sores" on her upper lip. The cold sores went away after approximately seven to ten days. Some scarring remained on her upper lip. On 24-MAY-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot #657737/0523U). Approximately one week later, the patient again broke out with cold sores in the same area of the upper lip as previously. The patient contacted the physician's office on 05-APR-2007 and 04-JUN-2007. The patient was not pregnant and was not hospitalized. At the time of this report, the patient had recovered. No product quality complaint was involved. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 21 year old female patient who on 04-JUN-2007 was vaccinated IM in the right deltoid with the second dose of GARDASIL vaccine (lot #657868/0523U). The date of the first dose of GARDASIL vaccine was not reported. It was reported that the patient flinched, jerked the arm and pulled the needle out of her arm when receiving the injection before the full dose of the vaccine was adminstered. The reported stated that "the patient received less than half of the vaccine and some ran down her arm".  No further details were provided.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested. This is in follow-up to report (s) previously received on 7/6/2007. The reported stated that "the patient received less than half of the vaccine and some ran down her arm". The reporter stated that "the patient came in the following day and received the left over vaccination". The certified medical assistant reported that the patient had recovered from the event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Iniatial and follow-up information has been received from a physician concerning a 16 year old female with no known drug allergies or illness who on 18-MAY-2007 was vaccinated with the first dose of Gardasil (Lot # 0389U/657769).  Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid.  On 18-MAY-2007 a few minutes post vaccination the patient experienced an episode of syncope.  No injury was noted.  Subsequently, the patient recovered from the episode of syncope.  Unspecified medical attention was sought.  Additional information has been requested. This is follow-up to report (s) previously submitted on 7/16/2007.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on approximately 29-MAY-2007 was vaccinated with the first dose of Gardasil (Lot # not provided). Post vaccination the patient mentioned that she "felt like someone was pulling on her bone" and stated that she felt a little dizzy. The nurse administering the vaccine had the patient lay down for 5 minutes and then stated that the patient was fine. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dehydration, Dizziness, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an "18 or 19" year old female who on approximately 31-MAY-2007 was vaccinated with a third dose of Gardasil. On 31-MAY-2007 several hours after the patient received the injection, the patient experienced fever, nausea and dizziness. On 01-JUN-2007 the patient had to be taken to the emergency department of a local hospital to be treated for dehydration. There were no adverse experiences reported after receiving the first and second doses. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a Nurse Practitioner concerning an 11 year old female who on an unspecified date in May 2007, was vaccinated intramuscularly with 0.5ml of the first dose Gardasil (Lot # not provided). Post vaccination the patient passed out. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Menstruation irregular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 21 year old female patient with no allergies or medical history, who on 28-MAR-2007 was vaccinated IM with a first 0.5ml dose of Gardasil (Lot #656051/0244U).  There was no concomitant medication.  On 18-APR-2007, the patient experienced irregular menses.  It was reported that the patient was 2 weeks late on 18-APR-2007 and has had no menses after 18-APR-2007 or in May.  It was reported that after the first dose the patient had normal menses for the first month.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female who in approximately June "last week", was vaccinated with a first dose of GARDASIL. Shortly after vaccination, the patient experienced tenderness and a pea size lump at the injection site. Subsequently, the patient recovered. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On an unspecified date the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, Rash
Clinical narrative: Information has been received from a health professional concerning a 19 year old female with no past medical history who on 23-MAY-2007 was vaccinated with a first dose of Gardasil (lot # 657005/0314U) into her hip. There was no concomitant medication. A few days after vaccination, on approximately 25-MAY-2007, the patient experienced a fine rash from waist down both legs. She was treated with BENADRYL. Subsequently, the patient recovered from fine rash from waist down both legs on 01-JUN-2007. Additional information has been requested. Initial and follow-up information has been received from a health professional concerning a 19 year old female with no past medical history or known drug allergies qho on 23-MAY-2007 in the morning who vaccinated intramuscularly into the left upper outer quadrant with a first 0.5 ml dose of GARDASIL vaccine (lot # 657005/0314U). The was no concomitant medication. On 26-MAY-2007, according to the patient, she developed a very fine rash in  the boxer short area of her legs. The patient sought unspecified medical attention. She was treated with BENADRYL and used calamine lotion to the affected areas. No laboratory diagnostic studies were performed. On 01-JUN-2007, the patient recovered. No product quality complaint was involved.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Oral mucosal exfoliation
Clinical narrative: Information has been received from an office manager concerning a 24 year old female patient who on 30-MAY-2007 was vaccinated with a dose of Gardasil.  On approximately 02-JUN-2007 the patient developed "peeling in the mouth".  Medical attention was sought.  The patient had not recovered.  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. After receiving the injection, the patient fainted. Medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Mean cell haemoglobin, Mean cell volume increased, Neutrophil count increased, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a Licensed Visiting Nurse (LVN) concerning a 22 year old female patient with a history of toe surgery who on 22-MAY-2007 was vaccinated IM in deltoid with a dose of Gardasil, lot #657736/0389U.  Concomitant therapy included escitalopram oxalate (LEXAPRO) and a multivitamin.  On 22-MAY-2007 the patient developed bilateral hands and upper arms reddish-brown discoloration, swelling and pain.  She was examined in the office on 24-MAY-2007.  Azithromycin (Z-PAK) was prescribed, "not sure if started yet".  Her outcome was unknown.  It was noted that urine and CBC were taken on 22-MAY-2007, before vaccination, and that neutrophils, MCV (mean corpuscular volume) and MCH (mean corpuscular hemoglobin) were "a little high".  Additional information has been requested. Follow up information has been received from the LVN concering the 23 year old female patient with no known drug allergies who on 22-MAY-2007 at 2:00 p.m. was vaccinated IM in right deltoid witha first dose of GARDASIL, lot #657736/0389U. At 9:00 p.m. that evening her hands and feet were red and swollen, painful and itching. One week later, her hands and feet started peeling. The patient recovered on 22-JUN-2007. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Skin discolouration, Skin exfoliation
Clinical narrative: Information has been received from a Licensed Visiting Nurse (LVN) concerning a 22 year old female patient with a history of toe surgery who on 22-MAY-2007 was vaccinated IM in deltoid with a dose of Gardasil, lot #657736/0389U.  Concomitant therapy included escitalopram oxalate (LEXAPRO) and a multivitamin.  On 22-MAY-2007 the patient developed bilateral hands and upper arms reddish-brown discoloration, swelling and pain.  She was examined in the office on 24-MAY-2007.  Azithromycin (Z-PAK) was prescribed, "not sure if started yet".  Her outcome was unknown.  It was noted that urine and CBC were taken on 22-MAY-2007, before vaccination, and that neutrophils, MCV (mean corpuscular volume) and MCH (mean corpuscular hemoglobin) were "a little high".  Additional information has been requested. Follow up information has been received from the LVN concering the 23 year old female patient with no known drug allergies who on 22-MAY-2007 at 2:00 p.m. was vaccinated IM in right deltoid witha first dose of GARDASIL, lot #657736/0389U. At 9:00 p.m. that evening her hands and feet were red and swollen, painful and itching. One week later, her hands and feet started peeling. The patient recovered on 22-JUN-2007. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL. It was reported that the patient had received one dose of GARDASIL and experienced dizziness. It was not reported, if she was one of the patient's that had not eaten that day prior to her vaccination or if she was one of the patients that had received another vaccine at the same time. The patient was observed at the office for an unspecified period and then was allowed to leave. It was reported that the patient recovered. This is one of two patients. Attempts are being made to obtain additional identifying information to distinguished the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. In follow-up it was reported by the registered nurse that she did not know the patient that was described and she couldn't look up the lot number or give anymore information. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematology test normal, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Information has been received from a health professional, concerning a 26 year old female patient with allergies to latex, fruit and nuts, dysmenorrhoea, menorrhagia, depression, and history of tonsillectomy and ear operation, who on 25-MAY-2007 was vaccinated IM in the right upper arm with the first dose, 0.5ml, of GARDASIL (Lot #657736/0389U). Concomitant therapy included YASMIN. On 28-MAY-2007, three days later the injection site was hard, red and itchy, and further described as "looked like a spider bite."On 01-JUN-2007, the patient reported the event, and on 04-JUN-2007, she was seen by the physician. At that time, the physician noted there was "diffuse mild erythema" with no bruising. Bloodwork testing was ordered, with all results normal. At the time of this report, the patient was recovering from the events. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow up information has been received from a health professional (HCP), concerning a 26 year old female patient with allergies to latex, fruit and nuts, dysmenorrhoea, menorrhagia, depression, and a history of tonsillectomy and ear operation, who on 25-MAY-2007, at 10:00am, was vaccinated IM in the right upper arm with the first dose, 0.5ml, of GARDASIL (Lot #657736/0389U). Concomitant therapy included YASMIN. On 28-MAY-2007, three days later the injection site was hard, red and itchy, and further described as "looked like a spider bite". On 01-JUN-2007, the patient reported the event, and on 04-JUN-2007, she was seen by the physician. At that time, the physician noted there was "diffuse mild erythema" with no bruising. Bloodwork testing was ordered, with all results normal. At the time of this report, the patient had recovered from the events. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a health professional, concerning a 26 year old female patient with allergies to latex, fruit and nuts, dysmenorrhoea, menorrhagia, depression, and history of tonsillectomy and ear operation, who on 25-MAY-2007 was vaccinated IM in the right upper arm with the first dose, 0.5ml, of GARDASIL (Lot #657736/0389U). Concomitant therapy included YASMIN. On 28-MAY-2007, three days later the injection site was hard, red and itchy, and further described as "looked like a spider bite."On 01-JUN-2007, the patient reported the event, and on 04-JUN-2007, she was seen by the physician. At that time, the physician noted there was "diffuse mild erythema" with no bruising. Bloodwork testing was ordered, with all results normal. At the time of this report, the patient was recovering from the events. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow up information has been received from a health professional (HCP), concerning a 26 year old female patient with allergies to latex, fruit and nuts, dysmenorrhoea, menorrhagia, depression, and a history of tonsillectomy and ear operation, who on 25-MAY-2007, at 10:00am, was vaccinated IM in the right upper arm with the first dose, 0.5ml, of GARDASIL (Lot #657736/0389U). Concomitant therapy included YASMIN. On 28-MAY-2007, three days later the injection site was hard, red and itchy, and further described as "looked like a spider bite". On 01-JUN-2007, the patient reported the event, and on 04-JUN-2007, she was seen by the physician. At that time, the physician noted there was "diffuse mild erythema" with no bruising. Bloodwork testing was ordered, with all results normal. At the time of this report, the patient had recovered from the events. No further information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematology test normal, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient with multiple allergic reactions (unspecified) in past who on 22-MAY-2007 was vaccinated with a first dose of GARDASIL. On 22-MAY-2007 the patient developed hardness and warmth to the touch at the injection site. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow up information has been received from a health professional concerning a 26 year old female with latex allergy and allergic to bananas, pecans and avocados who on 25-MAY-2007 (previously reported on 22-MAY-2007) at 10:00 AM was vaccinated in to right deltoid with a first dose of GARDASIL lot # 657736/0389U. On approximately 25-MAY-2007 the patient developed hardness and warmth to the touch at the injection site. In follow up information it was indicated that on 28-MAY-2007 in the AM she had diffuse erythema at whole upper arm. Unspecified medical attention was sought by the patient. The patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient with multiple allergic reactions (unspecified) in past who on 22-MAY-2007 was vaccinated with a first dose of GARDASIL. On 22-MAY-2007 the patient developed hardness and warmth to the touch at the injection site. Unspecified medical attention was sought by the patient. The outcome was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow up information has been received from a health professional concerning a 26 year old female with latex allergy and allergic to bananas, pecans and avocados who on 25-MAY-2007 (previously reported on 22-MAY-2007) at 10:00 AM was vaccinated in to right deltoid with a first dose of GARDASIL lot # 657736/0389U. On approximately 25-MAY-2007 the patient developed hardness and warmth to the touch at the injection site. In follow up information it was indicated that on 28-MAY-2007 in the AM she had diffuse erythema at whole upper arm. Unspecified medical attention was sought by the patient. The patient recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain, Medical device complication
Clinical narrative: Information has been received from a healthcare professional, concerning an unknown number of patients who were vaccinated with a prefilled syringe filled with a dose of GARDASIL, and experienced "very painful" reactions. The reporter indicated that the prefilled syringes "eject out" quickly, and are more painful  than when the syringes supplied to the office are used. Consequently, the office discontinued the use of the prefilled syringes, and the number of very painful reactions has decreased. 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: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a female patient in "early 20s" who was vaccinated with a first dose of Gardasil. The reporter reported that "patient fainted immediately after receiving her second dose of Gardasil." The patient sought unspecified medical attention and recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4, UNK
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated with a dose of Gardasil. Concomitant therapy included other unspecified vaccines administered the same day. Subsequently, approximately five minutes after the patient was vaccinated with Gardasil, she passed out and vomited. The patient sought unspecified medical attention. The patient's outcome was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Cyanosis, Erythema, Flank pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a medical assistant (M.A.) concerning a 26 year old female patient with dysplasia and a history of chickenpox, abnormal papanicolaou smear test who on 05-JUN-2007 was vaccinated in the right arm with a second dose of Gardasil lot #657737/0522U. Concomitant therapy included AVIANE 28. On 05-JUN-2007, after she received the second injection and later that night her right hand was swollen and red. she went to the emergency room (E.R.) because her stomach and right side was hurting and the right hand was red and swollen. The patient was seen in the office on 06-JUN-2007 and the fingers were swollen, blue and the right hand was very cold. The patient had blood drawn from the right forearm the same day as receiving Gardasil. She did not have any problems from the 1st injection. The patient was doing fine and has not come back to the office since 06-JUN-2007. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Oedema peripheral, Peripheral coldness
Clinical narrative: Information has been received from a medical assistant (M.A.) concerning a 26 year old female patient with dysplasia and a history of chickenpox, abnormal papanicolaou smear test who on 05-JUN-2007 was vaccinated in the right arm with a second dose of Gardasil lot #657737/0522U. Concomitant therapy included AVIANE 28. On 05-JUN-2007, after she received the second injection and later that night her right hand was swollen and red. she went to the emergency room (E.R.) because her stomach and right side was hurting and the right hand was red and swollen. The patient was seen in the office on 06-JUN-2007 and the fingers were swollen, blue and the right hand was very cold. The patient had blood drawn from the right forearm the same day as receiving Gardasil. She did not have any problems from the 1st injection. The patient was doing fine and has not come back to the office since 06-JUN-2007. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic, Urine analysis abnormal, Urticaria
Clinical narrative: Information has been received from an LPN concerning a 12 year old female with no pertinent medical history and no history of drug reactions/allergies, who on 04-JUN-2007 was vaccinated intramuscularly in the arm with Gardasil (lot # 657736/0389U). There was no concomitant medication. on 04-JUN-2007, following vaccination, the patient developed a rash over her whole body. The rash was red and itchy and was described as developing into hives from the head to toe. The rash started over the whole body a few hours after vaccination. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from an LPN and the patient's medical records concerning a 12 year old female with no pertinent medical history and no history of drug reactions/allergies, who on 04-JUN-2007 at 3:30 PM was vaccinated intramuscularly in the arm with the first dose of GARDASIL (0.5 ml) (lot # 657736/0389U). There was no illnesses at time of vaccination. Concomitant therapy included amoxicillin, loratadine and ASTELIN (condition unspecified). Previous vaccination included varicella vaccine on 15-JUN-2006 (manufacturer unknown). The patient presented to her physician's office on 06-JUN-2006 with a scattered erythematous round macular rash with some target lesions on her chest, face, arms, back and upper legs. The rash started on 04-JUN-2007, and was persistent and worsened over 48 hours with itching. The patient denied exposure to change in food, detergent, and antibiotics. The patient also denied fever. A review of eyes, ENMT, and lymph were within normal limits. A urinalysis revealed blood, however it was reported that the patient had her menses. The patient was assessed for dermatitis due to drugs and medicine and placed on a course of prednisone. On 30-JUN-2007, the patient was again seen by her physician for follow-up of rash that was temporal associated with GARDASIL. At that time the rash had resolved, however there were traces of lighter colored skin where the lesions were on her arms and neck. The patient denied fatigue and  weight change. The patient was advised to wear sunblock to prevent burning and worsening scarring and was informed that the residual rash would fade over time. The patient was assessed for GARDASIL allergy. The patient subsequently recovered from the erythematous macular rash on 30-JUN-2007. It was planned to not complete the series of GARDASIL. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Gaze palsy, Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a physician concerning a 17 year old female student who on 30-MAY-2007 at 1:35 PM was vaccinated in the right upper extremity with the first dose of Gardasil (lot # 657737/0522U). Concomitant vaccination included MENACTRA (lot # U2234AA). There were no illnesses at time of vaccination. The patient experienced a syncopal episode within a few minutes of vaccination and fell of the exam table. Her body became stiff and her eyes rolled. She had a second episode approximately 20-30 minutes later. The patient was lethargic for approximately 24 hours. The patient subsequently recovered on 31-MAY-2007. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning 3 female patients (the age of the patients ranged from 9 to 11 year old) who were vaccinated with a dose of Gardasil and fainted after being given the injection. Unspecified medical attention was sought by the patients. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning her daughter (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported). Subsequently, the patient experienced injection site pain for three days after receiving the vaccine. The pain was treated with an application of ice to the injection site. Subsequently, the patient recovered from injection site pain. No other information was provided. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Injection site extravasation, Underdose, Wrong technique in drug usage process
Clinical narrative: Information has been received from a registered nurse concerning a 47 year old female with no pertinent medical history and no known allergies, who on 30-MAY-2007 was vaccinated with the third dose Gardasil (lot # 657737/0522U). The patient reported that following the vaccination, "all the fluid leaked out along with some blood". The patient informed the nurse that she knew how to administer vaccines. The nurse stated that medical assistant at the office who administers vaccines refuted the patient's claim. The nurse confirmed the patient's age. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from an RN concerning a female patient who on approximately 06-APR-2007 was vaccinated with her first dose of Gardasil.  The day after receiving the injection the patient's arm turned red, swelled, and was itchy.  Her arm was red from the injection site to her elbow.  Unspecified medical attention was sought.  The patient treated herself with diphenhydramine hydrochloride (BENADRYL).  Her symptoms lasted seven days.  The patient's outcome was reported as recovered, date unknown.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Diarrhoea, Injection site pruritus, Nausea
Clinical narrative: Information has been received from a 25 year old female patient with anxiety and allergy to amoxicillin who on 04-JUN-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included unspecified anxiety medication. The patient reported that after she received the injection, she experienced itching at the injection site and nausea. On 06-JUN-2007 the patient developed diarrhea. The patient's symptoms persisted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a physician and licensed practical nurse concerning a 17 year old female student who is allergic to CECLOR who on 17-APR-2007 was vaccinated IM into the left deltoid with a first dose of GARDASIL vaccine (lot # 657621/0387U).  There was no concomitant medication.  On 21-APR-2007 (also reported as "a day after immunization") the patient developed pain in the left upper arm and shoulder.  There was no swelling or redness.  She was treated with ibuprofen.  It lasted about 4 days.  Subsequently, the patient recovered from pain left shoulder and left upper arm.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5 mL dose of Gardasil.  It was reported that the patient had fainted after vaccination.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue
Clinical narrative: Information has been received from a health professional concerning her 15 year old daughter who was vaccinated with a third dose of Gardasil. Subsequently the patient developed extreme fatigue after receiving the third dose of Gardasil. The event resolved after three days without any treatment. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated (date unspecified) with the first dose of Gardasil. Following the vaccination (duration of time not specified), the patient developed swollen lymph nodes in her neck. At the time of this report, it was unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chills, Muscular weakness, Pyrexia
Clinical narrative: Information has been received from a registered nurse, concerning a 20 year old female patient, with oligomenorrhoea, who on 05-JUN-2007, at 11:30am, was vaccinated with the third dose, 0.5ml, IM, of Gardasil (Lot #657622/0388U). There was no concomitant medication. On 05-JUN-2007, at 8:00pm, the patient developed a fever of 101F, with chills and muscular weakness. On 06-JUN-2007, the patient visited her physician, and stated the physician "thinks that it's a natural virus infection." At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Oedema peripheral, Rash
Clinical narrative: Information has been received from a registered nurse, concerning a 23 year old female patient, with no known allergies and no significant medical history, who was vaccinated (date unspecified) with the third dose, 0.5ml, IM, of Gardasil, two months after the second dose. There was no concomitant medication. Following the vaccination (duration of time not specified), she developed hand swelling, and a rash that developed on her arms. At the time of this report, the patient had recovered (date unspecified). Additional information has been requested. Initial and follow up information has been received from a registered nurse, concerning a 22 year old female patient, with no known allergies and no significant medical history, who on 22-JAN-2007, was vaccinated with the second dose of GARDASIL vaccine (lot # 653937/0637F). Following the vaccination on 01-FEB-2007, she developed hand swelling, and a rash on both hands. At the time of this report, the patient was vaccinated with the third dose, 0.5 ml, IM of GARDASIL vaccine, two months after the second dose. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician's assistant, concerning a 23 year old female patient, who on approximately 06-MAR-2007 ("three months ago"), was vaccinated with the third dose, 0.5ml, of Gardasil. Following the vaccination (duration not specified), the patient developed raised hives on all of her extremities, but not her trunk. Treatment included prednisone (manufacturer not specified). At the time of this report, the PA indicated the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder, Metrorrhagia
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female who was vaccinated on 01-JUN-2007 with a third dose of Gardasil. Subsequently on 05-JUN-2007, the patient experienced abnormal bleeding and spotting. Unspecified medical attention was sought. The patient's abnormal bleeding and spotting persisted.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 21-MAR-2007 was vaccinated with a third dose of Gardasil. Subsequently the patient experienced a skipped menstrual period in April and May (but had slight spotting in May). Unspecified medical attention was sought. A pregnancy test was not given to the patient. This is one of two reports received from the same source. Additional information has been requested.