chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Syncope, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 15 year old female who approximately 18-JAN-2007 was vaccinated by injection with a 0.5 mL dose of HPV vaccine (yeast). Lot # unspecified by reporter). There was no concomitant medication. Subsequently, it was reported that five minutes after the injection the patient fainted. The patient was taken to the emergency room (ER) but no admitted to the hospital.  The physician did not think the HPV vaccine (yeast) caused the patient to faint, as much as severe anxiety from the shot.  At the time of the report, the patient had recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a physician concerning a 15 year old female who on approximately 18-JAN-2007 was vaccinated by injection with a 0.5 mL dose of GARDASIL, (Lot # unspecified by reporter). There was no concomitant medication. Subsequently, it was reported that five minutes after the injection the paitent fainted. The patient was taken to the Emergency Room (ER) but not admitted to the hospital. The physician did not think the GARDASIL caused the patient to faint, as much as severe anxiety from the shot. At the time of the report, the patient had recovered. In follow-up it was reported, that the patient had some anxiety about the vaccine injection. The actual injection went well, and the patient seemed to tolerate "ok". Five minutes later in the waiting room the patient slumped to the floor and was minimally responsive to verbal instructions, we immediately administered BENADRYL and epinephrine and called emergency. The patient's vitals remained within normal ranges during the entire episode, she was transferred to the hospital and did well with no further treatment. It was reported that the patient recovered on the same day. 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 HPV vaccine (yeast). Subsequently, the patient fainted.  Her outcome was not reported.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Burning sensation, Herpes zoster, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient who was vaccinated with her first dose of HPV vaccine (yeast) and had no adverse side effects.  Subsequently, she was vaccinated with her 2nd dose of HPV vaccine (yeast) and within 24 hours broke out in hives, which developed into shingles.  Medical attention was sought.  As of the report date, the patient was recovering. Additional information has been requested. Follow up information has been received from a Certified Medical Assistant and medical records concerning a 17 year old female stundent with current tobacco use and a history of rash with CEFZIL and CECLOR, diarrhoea with AUGMENTIN and chickenpox who on 11-DEC-2004 at 2:35 p.m. was vaccinated IM in left arm with her second dose of GARDASIL, lot #653735/068HF. Concomitant therapy included YASMIN 28 and Sulfamethoxazole and trimethoprim. The reporter indicated that the patient developed hives post injection, then on 18-DEC-2006 was seen at an urgent care clinic for shingles, which was not felt to be related to the immunization. The patient recovered on an unspecified date. According to medical notes from 18-DEC-2006. Patient states she's here for compains of a rash on her back and under her right armpit, and she describes the pain as an 8/10. States it started last Wednesday (13-DEC-2006) but it's gotten much worse. States she had the 2nd HPV immunization last Monday, and they wonder if this might be a reaction to it. "It was also reported that the patient did have a burning/pain sensation prior to 13-DEC-2006 and prior to the administration of GARDASIL and blistering. The blisters were in clumps/painful, and were aggravated by touching. The patient stated she was under a lot of stress with school and that she had some low grade fevers. Her assessment was shingles, right T5 dermatone - increase vesicles in patches along the T5 dermatone. She was treated with VALTREX. 1 tablet 3 times daily and Tylenol with Codeine #3). 1 tablet every 4 hours as needed for pain. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning an approximately 23 year old female who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she had another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm she the needle withdrawn".  The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a registered nurse concerning an approximately 23 year old female (patient 1 of 4) with no known drug allergies, who on 27-OCT-2006 was vaccinated IM into the deltoid area with a dose of GARDASIL (lot# 653938/0954F). The registered nurse reported that she and another nurse had given "numerous" GARDASIL vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The bleeding only lasted a few seconds. The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Pressure was applied and a bandaid. Bleeding resolved and the patient was sent home. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Bone pain, Joint stiffness
Clinical narrative: Information has been received from a pharmacist concerning a 20 year old female who on 25-JAN-2007 was vaccinated with a second dose of HPV vaccine (yeast) 0.5 ml intramuscularly.  Subsequently the patient experienced joint and bone pain. The patient sought unspecified medical attention.  The patient is recovering from joint and bone pain. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a pharmacist concerning a 20 year old female with no known drug allergies who on 07-NOV-2006 was vaccinated with a first dose of GARDASIL intramuscularly in the deltoid. On 11-JAN-2007 (also reported as 24-JAN-2007), the patient was vaccinated with the second dose of GARDASIL (Lot number 654510/0962F) 0.5 ml intramuscularly in the deltoid. Concomitant therapy included APRI ORD and AUGMENTIN. On 12-JAN-2007 the patient experienced joint stiffness, bone pain and severe joint pain. On 26-JAN-2007, the patient recovered from joint stiffness, bone pain and severe joint pain. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cyst
Clinical narrative: Information has been received from a registered nurse concerning an "18 or 19" year old female who on 19-JAN-2007 was vaccinated with the first dose of HPV vaccine (yeast). On 19-JAN-2007, the patient developed a cyst at the injection site.  The patient sought unspecified medical attention. The patient was referred to a dermatologist. At the time of this report, the outcome of the event was unknown.  Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning approximately 75 female patients who were vaccinated IM with 0.5ml doses of Gardasil. Subsequently the patients experienced pain at the injection site. Unspecified medical attention was sought. Subsequently, the patients recovered. Attempts are being made to obtain additional identifying information regarding the patients mentioned in this report. Additional information will be provided when available.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pain
Clinical narrative: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine. Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the tiem of this report, the patient has recovered from the event (date unknown). the nurse reported that there were total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of Gardasil out of 130 total doses administered by the office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pain
Clinical narrative: Information has been received from a registered nurse concerning an adolescent female (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil. Subsequently, the patient passed out or was unconscious (date unknown). It was reported that the vaccination was "somewhat painful". The patient sought unspecified medical attention. At the time of this report, the patient has recovered from the event (date unknown). The nurse reported that there were total of 4 cases of adolescent females that passed out or were unconscious after receiving the first dose of Gardasil out of 130 total doses administered by the office. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated intramuscularly with the second dose of Gardasil. Subsequently, following the second vaccination, the patient experienced irregular periods. 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: Vaginal haemorrhage
Clinical narrative: Information has been received from two nurses at a physician's office concerning one of the nurses' daughter (age not reported). On an unspecified date, the patient was vaccinated with the first dose of Gardasil. Subsequently, the patient developed excessive vaginal bleeding (during her period). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Immune system disorder, Pharyngolaryngeal pain, Rash, Rash
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with no medical history and no known allergies reported on 15-Dec-2006 (previously reported as being approximately JAN-2007 and 15-Feb-2006), the patient was vaccinated with Gardasil intramusculary (Lot # 653735/0688F). Subsequently, the patient developed a weakened immune system, yeast infection, sore throat, sinusitis and had a rash on her leg that was lasting several days. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007, 4/6/2007. Initial and follow up information has been received. There were no known illnesses noted at the time of vaccination. On approximately 29-Dec-2006, two weeks after vaccination, the patient developed a rash on her legs, lasting two weeks, sinusitis (previously reported to have developed a weakend immune system), a sore throat, and condidal vaginitis. On 26-Jan-2007, the patient had recovered from the events. The patient was seen by her physician when the symptoms had resolved. No further information is availble. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician concerning a 25 year old female with no medical history and no known allergies reported. On approximately 15-JAN-2007 (conflicting information also reported as 15-FEB-2008), the patient was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 653735/0688F). There were no known illnesses noted at the time of vaccination. On unspecified dates, soon after the vaccination, the patient developed a sore throat (previously reported to have developed a weekend immune system and sinusitis). The patient then developed a rash on her legs lasting two weeks and then a yeast infection (vaginitis). On 26-JAN-2007, the patient had reported from the events. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Sinusitis, Vaginal infection, Vulvovaginal candidiasis
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with no medical history and no known allergies reported on 15-Dec-2006 (previously reported as being approximately JAN-2007 and 15-Feb-2006), the patient was vaccinated with Gardasil intramusculary (Lot # 653735/0688F). Subsequently, the patient developed a weakened immune system, yeast infection, sore throat, sinusitis and had a rash on her leg that was lasting several days. At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007, 4/6/2007. Initial and follow up information has been received. There were no known illnesses noted at the time of vaccination. On approximately 29-Dec-2006, two weeks after vaccination, the patient developed a rash on her legs, lasting two weeks, sinusitis (previously reported to have developed a weakend immune system), a sore throat, and condidal vaginitis. On 26-Jan-2007, the patient had recovered from the events. The patient was seen by her physician when the symptoms had resolved. No further information is availble. This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow up information has been received from a physician concerning a 25 year old female with no medical history and no known allergies reported. On approximately 15-JAN-2007 (conflicting information also reported as 15-FEB-2008), the patient was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 653735/0688F). There were no known illnesses noted at the time of vaccination. On unspecified dates, soon after the vaccination, the patient developed a sore throat (previously reported to have developed a weekend immune system and sinusitis). The patient then developed a rash on her legs lasting two weeks and then a yeast infection (vaginitis). On 26-JAN-2007, the patient had reported from the events. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 21 year old female on antibiotics for condition unspecified, and pertinent medical history and drug reactions/allergies unspecified who on approximately 29-JAN-2007 was vaccinated with first dose of Gardasil (lot # not reported) IM. Concomitant suspect therapy included Antimicrobial (unspecified). The physician reported that the patient sought medical attention (called the office) to report that she had hives (on approximately 25-JAN-2007). The patient had been on antibiotics for a couple of days prior to receiving Gardasil. The physician felt the hives may be related more to the antibiotics than the vaccine. The outcome of the hives was unspecified. no further information was available at the time of reporting. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with penicillin allergy who on 25-JAN-2007 was vaccinated with first dose of Gardasil (lot #654702/0011U), 0.5 ml IM in the deltoid. Concomitant therapy included Yasmin and Wellbutrin. On 28-JAN-2007, three days later, the patient woke up with a rash on her entire body. The patient sought medical attention. The patient took Benadryl, but it had not improved. The medical assistant reported that the patient stated the rash is the same over her entire body, the injection site is not any worse than the rest of her body. At the time of reporting, the patient's rash persisted. No further information was available at the time of reporting. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no known adverse drug reactions or allergies reported. On 16-JAN-2007, the patient was vaccinated with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 27-JAN--2007, the patient developed a rash on her arms and legs. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up information has been rceived from a physician concerning a 24 year old female with no pertinent medical history and no known adverse drug reactions or allergies reported. On 25-JAN-2007 (previously reported as 15-JAN-2007), at approximately 5:45 p.m. the patient was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot #6551565/1425P). There were no concomitant medications reported. On 28-JAN-2007 (previously reported as 27-JAN-2007), the patient developed a red, itchy rash on her arms and legs, reported as worse on the side the patient received her vaccination. The patient was treated with BENADRYL, as directed by the physician. On 01-FEB-2007, the physician spoke to the patient and reported that, at the time of the call, there was improvement of the patient's rash. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema nodosum
Clinical narrative: information has been received from a physician concerning a 17 year old female with amenorrhea, hirsutism and a CECLOR allergy who on 01-DEC-2006 was vaccinated IM with a first dose of Gardasil (yeast). The patient received Menactra concomitantly. Other concomitant therapy included Ovcon 50. On 16-DEC-2006 the patient developed erythema nodosum. The patient sought unspecified medical attention. The patient was treated with a course of steroids and has fully recovered. No laboratory diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning his 20 year old female daughter with no other pertinent medical history reported. On 18-JAN-2007, the patient was vaccinated IM with the first 0.5 ml dose of Gardasil (yeast). There were no concomitant medications reported. On 28-JAN-2007, the patient developed unilateral supraclavicular lympadenopathy. There were no other symptoms reported. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a dose of Gardasil (yeast). On 27-JAN-2007 the patient developed a rash on her arm, chest and back. The patient sought unspecified medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Impaired driving ability, Nausea
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a healthcare provider concerning her 20 year old daughter who was a student with a penicillin allergy who on 29-JAN-2007, at 08:10, was vaccinated intramuscularly into the left deltoid with a second dose of GARDASIL (Lot # 655617/1447F). Concomitant therapy included Ortho Tri Cyclen, albuterol and Advair. On 29-JAN-2007 at 13:00 ("later in the day") the patient was driving and developed dizziness ("very dizzy") and nausea which lasted about 4 hours. She could no longer drive so the passenger took over driving. No laboratory diagnostic studies were performed. On 29-JAN-2007 the patient recovered. A first dose of GARDASIL was given IM on 22-NOV-2006. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Muscle spasms, Vaginal haemorrhage
Clinical narrative: Information has been received from a 22 year old female certified medical assistant who on 12-SEP-2006 was vaccinated IM with the first dose of Gardasil (yeast) (Lot#653735/0688F). On 13-NOV-2006 the patient received the second dose of Gardasil (yeast) (Lot#653735/0688F). Concomitant therapy included Depo-Provera. On an unspecified date in December 2006, the patient began with vaginal bleeding "on and off for several weeks. On 13-JAN-2007 the patient started with a flow that was very heavy lasting seven days, with cramping and shortness of breath. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with pertinent medical history and drug reactions/allergies unspecified who on approximately 18-JAN-2007 was vaccinated with Gardasil (yeast) (lot # not reported). On approximately 18-JAN-2007, the patient experienced a rash all over her body. The outcome of the rash was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Feeling abnormal
Clinical narrative: Information has been received from a 23 year old female emergency medical attention with a penicillin allergy who on 29-JAN-2007 was vaccinated IM with a second 0.5 ml dose of Gardasil (yeast). On 29-JAN-2007 the patient reported feeling "weird or slow in the head" and "can not concentrate or think clearly". The patient received a first IM 0.5 dose of Gardasil (yeast) on 12-DEC-2006. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 10 year old female vaccinated with a first 0.5 ml dose of Gardasil (yeast). Two days later, the patient developed a rash behind her knees and on her chest. Unspecified medical attention was sought. At the time eof this report, the patient's outcome was unknown. No product quality was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a female, pediatric patient who was vaccinated with Gardasil (yeast), (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the time of injection that the pain was in the muscle and started at the time of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dry mouth
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Gardasil (yeast). Subsequently the patient experienced dry mouth. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Dyspnoea, Groin pain, Menorrhagia
Clinical narrative: Information has been received from a health professional concerning a 12 year old white female who on 28-DEC-2006 was vaccinated intramuscularly with the first dose of HPV vaccine (yeast) (lot# 653735/0688F). Concomitant therapy included varicella virus vaccine live (MSD) received on 08-DEC-2006 and Menactra vaccine received on 27-NOV-2006.  On approximately 26-JAN-2007 the patient experienced an extremely heavy menstrual cycle with more cramps than previous cycles, one episode of pain in the groin area and shortness of breath while at basketball practice.  At the time of this report it was unknown if the patient had recovered from these events.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a female with diabetes who on 26-JAN-2007 was vaccinated with the second dose of Gardasil (yeast). On 28-JAN-2007 the patient experienced a big knot, redness and puffiness at the injection site. The patient sought medical attention. The patient is recovering from a big knot, redness and puffiness at the injection site. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Malaise, Nausea, Panic attack
Clinical narrative: Ths is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a Certified Nurse Midwife concerning a 20 year old female who is "prone to panic attacks" who on 29-JAN-2007 at 11:15 am was vaccinated IM with the first dose of Gardasil (yeast) (Lot # not provided). At 7:30 pm that same evening the patient experienced a panic attack with severe nausea, vomiting and difficulty breathing and went to the emergency room. The patient was not admitted to the hospital. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested. Information has been received from A Certified Nurse Midwife concerning a 20 year old female with an anxiety disorder who is "prone to panic attacks" who on 29-JAN-2007 at 11:15 am was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 654702/0011U). At 7:10 pm that same evening the patient experienced a panic attack with severe nausea, vomiting and difficulty breathing and went to the emergency room. The patient was not admitted to the hospital. At the time of this report it was unknown if the patient had recovered from the events. Follow up information received stated that the patient presented to the emergency room at 10:00 pm on 29-JAN-2007 with complaints of dizziness, nausea, malaise and parethesias. The patient was treated with PHENERGAN 50 mg and discharged home from the emergency room. Subsequently the patient recovered from the events. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Vomiting
Clinical narrative: Ths is in follow-up to report (s) previously submitted on 2/14/2007. Information has been received from a Certified Nurse Midwife concerning a 20 year old female who is "prone to panic attacks" who on 29-JAN-2007 at 11:15 am was vaccinated IM with the first dose of Gardasil (yeast) (Lot # not provided). At 7:30 pm that same evening the patient experienced a panic attack with severe nausea, vomiting and difficulty breathing and went to the emergency room. The patient was not admitted to the hospital. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested. Information has been received from A Certified Nurse Midwife concerning a 20 year old female with an anxiety disorder who is "prone to panic attacks" who on 29-JAN-2007 at 11:15 am was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 654702/0011U). At 7:10 pm that same evening the patient experienced a panic attack with severe nausea, vomiting and difficulty breathing and went to the emergency room. The patient was not admitted to the hospital. At the time of this report it was unknown if the patient had recovered from the events. Follow up information received stated that the patient presented to the emergency room at 10:00 pm on 29-JAN-2007 with complaints of dizziness, nausea, malaise and parethesias. The patient was treated with PHENERGAN 50 mg and discharged home from the emergency room. Subsequently the patient recovered from the events. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a receptionist at a physician's office concerning a 23 year old female who "about a month ago" in approximately December 2006 was vaccinated with a first dose of Gardasil. Subsequently, the patient developed a sore arm. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a first dose of Gardasil (yeast). On 26-JAN-2007 the patient experienced itching and a rash around the area of the arm and the back of the knee. The rash continued to worsen and medication was ordered to treat the rash. At the time of this report, the patient's outcome was unknown. It was noted that the patient will not receive the second and third dose of the vaccine. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007. Information has been receivced from a physician concerning a female patient who on 26-JAN-2007 was vaccinated with a first dose of GARDASIL. On 26-JAN-2007 the patient experienced itching and a rash around the area of the arm and the back of the knee. The nurse stated that the rash began in the crevices of the elbows and knees and progressed to other parts of the body before the medicine was ordered to stop the itching. The rash continued to worsen and medication was ordered to treat the rash. At the time of this report, the patient's outcome was unknown. It was noted that the patient will not receive the second and third dose of the vaccine. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 2 of 4) who was vaccinated with Gardasil (yeast). The registered nurse reported that she another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved and the patient was sent home. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 3 of 4) who was vaccinated with Gardasil. The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations. Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn". The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient". Bleeding resolved ant the patient was sent home. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a registered nurse concerning an approximately 23 year old female (patient 4 of 4) who was vaccinated with HPV vaccine (yeast). The registered nurse reported that she and another nurse had given "numerous" Gardasil vaccinations.  Subsequently this patient experienced a "trickle of blood down her arm when the needle withdrawn".  The nurse further commented that there was "nothing wrong with the patient, she didn't even notice" and, "there was no blood in the syringe when the plunger was pulled back before injecting the patient".  Bleeding resolved and the patient was sent home. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Hypoaesthesia, Loss of consciousness, Paraesthesia, Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). After vaccination, the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted 02/14/2007. Information has been received from a physician and a nurse concerning a 15 year old female patient who on 07-MAR-2007, at 2:10, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left deltoid, with a 0.5 ml dose of GARDASIL (lot # 657006/0188U). The patient reportedly had one prior dose of GARDASIL (date unknown). On 11-MAR-2007, late at night/early AM, the patient got up and on the way back to bed, she felt numbness and tingling in her legs then "blacked out for a few minutes". The patient said a friend woke her up. She felt tired all day. Later that afternoon, the patient went to her room, she didn't feel right. She complained of tingling and numbness in her legs and arms, which lasted 5-10 minutes. Subsequently, the patient recoverd from her symptoms. No product quality complaint was involved. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Loss of consciousness, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female patient who in "the week of 22-JAN-2007" was vaccinated IM with a 0.5 ml dose of HPV vaccine (yeast). After vaccination, the patient fainted.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted 02/14/2007. Information has been received from a physician and a nurse concerning a 15 year old female patient who on 07-MAR-2007, at 2:10, (previously reported as approximately 22-JAN-2007) was vaccinated IM, left deltoid, with a 0.5 ml dose of GARDASIL (lot # 657006/0188U). The patient reportedly had one prior dose of GARDASIL (date unknown). On 11-MAR-2007, late at night/early AM, the patient got up and on the way back to bed, she felt numbness and tingling in her legs then "blacked out for a few minutes". The patient said a friend woke her up. She felt tired all day. Later that afternoon, the patient went to her room, she didn't feel right. She complained of tingling and numbness in her legs and arms, which lasted 5-10 minutes. Subsequently, the patient recoverd from her symptoms. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Nausea, Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history or allergies, who on 03-JAN-2007 and on 06-MAR-2007 was vaccinated with a first and second 0.5 ml dose of GARDASIL, respectively (second dose lot# 653735/0688F given IM). Concomitant therapy given on 03-JAN-2007 included a dose of MENACTRA. There was no illness at the time of vaccination. On approximately 03-JAN-2007, the patient experienced fatigue and subsequently recovered. After the second vaccination on 06-MAR-2007, the patient experienced nausea and extreme fatigue. After one of the vaccination the patient fainted. Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Nausea
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no medical history or allergies, who on 03-JAN-2007 and on 06-MAR-2007 was vaccinated with a first and second 0.5 ml dose of GARDASIL, respectively (second dose lot# 653735/0688F given IM). Concomitant therapy given on 03-JAN-2007 included a dose of MENACTRA. There was no illness at the time of vaccination. On approximately 03-JAN-2007, the patient experienced fatigue and subsequently recovered. After the second vaccination on 06-MAR-2007, the patient experienced nausea and extreme fatigue. After one of the vaccination the patient fainted. Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no past medical history who on 22-JAN-2007 was vaccinated IM with a second 0.5 ml dose of HPV vaccine (yeast) (lot #655617/1447F). There was no concomitant medication. On 29-JAN-2007 the patient developed erythema and mild tenderness at the site of injection. There was no fever. She sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Initial and follow up information has been received from a physician concering a 15 year old female student with no past medical history and no adverse events following prior vaccinations who on 22-JAN-2007 was vaccinated IM with a second 0.5ml dose of GARDASIL (lot # 655617/1447F).  There was no concomitant medication.  On 29-JAN-2007 the patient developed erythema, swelling and mild tenderness at the site of injection.  There was no fever.  She recovered on an unspecified date.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Lymph node pain, Malaise
Clinical narrative: Information has been received from a physician concerning an approximately 20 year old female, with no medical history, who on 11-JAN-2007 was vaccinated intramuscularly with a first dose of HPV vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 21-JAN-2006 the patient developed bilateral tender lymph nodes and malaise.  Unspecified medical attention was sought.  At the time of the report, the patient's bilateral tender lymph nodes and malaise persisted. There were no laboratory or diagnostic tests performed.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 23-JAN-2007 was vaccinated with a 0.5 ml first dose Gardasil (lot #654702/011U). On 26-JAN-2007 the patient developed a rash on her stomach.  Medical attention was sought and the patient was told to take diphenhydramine hydrochloride (BENADRYL). There were no laboratory or diagnostic tests performed.  Subsequently, the patient recovered from rash on her stomach.  Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a registered nurse from a hospital infusion center concerning a 22 year old female with sulfa allergy and no pertinent medical history who on 26-JAN-2007 was vaccinated with first dose of Gardasil (lot# 655619/1427F), 0.5 ml, IM in left deltoid.  There was no concomitant medication. On 27-JAN-2007, Saturday morning, the patient called and reported she experienced pain at the injection site and the pain had increased.  The patient sought medical attention. No diagnostic tests were performed. On 31-JAN-2007, the patient experienced pain and tingling down her left arm. At the time of reporting, the patient had no recovered. The patient was referred to her primary physician for follow-up.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site erythema, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) with pertinent medical history and drug reactions/allergies reported as unspecified who on 28-JAN-2007 was vaccinated with Gardasil (lot# not reported), 0.5 ml IM. Concomitant therapy was unspecified.  On approximately 28-JAN-2007, the patient experienced redness at the injection site with tingling in her arms. The condition progressed to tingling in her fingers with numbness in both arms and fingers. The patient sought medical attention. At time of reporting, the patient had not recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 19 year old daughter who on approximately 17-JAN-2006 was vaccinated with a dose of Gardasil. Subsequently the patient developed a "rash from head to toe." It was reported that the patient had followed up with her physician. At the tiem of the report, the patient's rash persisted. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner concerning a 21 year old female who on unspecified dates was vaccinated intramuscularly with the first and second doses of Gardasil. Subsequently, the patient experienced dizziness and injection site stinging following the first vaccination and injection site stinging following the second vaccination. It was reported that the events occurred immediately after vaccination and resolved after about 5 minutes. Unspecified medical attention was sought. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who on an unspecified date was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included a tetanus toxoid shot. Immediately with vaccination, the patient developed injection site stinging and the patient passed out for a few seconds. The patient sought unspecified medical attention. The nurse practitioner reported that the patient was fine after a few seconds and was able to drive home. Thee was no lot number provided. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Nervous system disorder, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female who was vaccinated, intramuscularly with HPV vaccine.  The nurse reported that the patient was having "neurological problems" after receiving the vaccine. The reporter stated that the patient explained she was having "pain and numbness" in her extremities.  The reporter stated the patient was going to see a neurologist. At the time eof the report, it was unknown, if the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently, following vaccination, the patient fainted.  The patient fully recovered.  No further details were provided.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following vaccination, the patient fainted.  The patient fully recovered.  No further details were provided.  Additional information has been requested. This is in follow-up to report (s) submitted on 2/14/2007.  No futher information is available.
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on unspecified dates was vaccinated with the first and second doses of HPV vaccine.  Subsequently, following each vaccination, the patient vomited. The patient fully recovered. No further details were provided.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Pain, Skin lesion
Clinical narrative: Information has been received from a physician concerning a female patient who on 12-JAN-2007 was vaccinated with a dose of HPV vaccine.  On 14-JAN-2007 the patient experienced painful raised lesions on the arm where the vaccine was administered.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Skin lesion
Clinical narrative: This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning a 25 year old female who on 12-JAN-2007 was vaccinated IM in the right deltoid, with a first 0.5 ml dose of HPV vaccine (lot#655619/1427F). There was no concomitant medication. On 14-JAN-2007 the patient developed raised erythematous papules with tenderness (previously described as skin eruptions, lesions), on the axilla of the right arm. It was reported that the patient was treated with Benadryl. The patient reported the patient's lesions continued for two weeks and were worsening.  At the time of the report, the patient had not recovered.  Additional information has been requested.  Follow up information indicated that labs (not specified) had been obtained and the results had not yet been received. The physician indicated the outcome of the erythematous and tender papules was unknown. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site rash, Rash
Clinical narrative: Information has been received from the mother of a 22 year old female, via a consumer (friend), who on approximately 24-JAN-2007 was vaccinated in the buttock with the first dose of HPV vaccine. On approximately 24-JAN-2007 the patient developed an initial rash at the injection site, which went away.  A few days later, approximately 27-JAN-2007 the patient developed a rash on her entire trunk, spreading form her crotch to her shoulders.  The patient's mother was thought to be a nurse, who administered the injection to her daughter at home after she picked up the vaccine from her daughter's physician. It was also reported that the mother of the patient had picture of her daughter's rash. At the time of the report the patient had not recovered from the rash on her trunk.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on 30-JAN-2007 was vaccinated with the second 0.5 mL dose of HPV vaccine.  Concomitant therapy included unspecified hormonal contraceptives. On 31-JAN-2007, the patient developed a rash under skin that covered entire body except her legs.  The patient sought unspecified medical attention.  At the time of this report, the patient had not recovered from the event.  The nurse did mention that the patient "did not have a reaction to the first injection of HPV vaccine. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 22 year old female healthcare worker who on 26-JAN-2007 was vaccinated with HPV vaccine.  The patient stated that the "HPV stung a lot as it was being administered." Unspecified medical attention was sought.  The patient recovered. Additional information has been requested.