chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Wrong technique in drug usage process
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Anxiety, Arthralgia, Blood test, Depression, Diarrhoea
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Dizziness, Fall, Frustration, Gait disturbance, Head injury
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Hypoaesthesia, Loss of consciousness, Mental disorder, Muscle spasms, Muscular weakness
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 27.0
Sex: M
Vaccine: HPV4, HPV4, HEP, HEPA, HPV4
Symptoms: Nausea, Tendonitis
Clinical narrative: Information has been received from a 27 year old male with an allergy to prednisone who about a year ago in 2007 received the complete series of GARDASIL vaccine. Lot # and dates when it was received are not available. Concomitant therapy included hepatitis A virus vaccine (unspecified) and hepatitis B virus vaccine (unspecified) when patient received his first dose of GARDASIL vaccine. Per patient, he passed out every time he received a dose of GARDASIL vaccine and he experienced three times after receiving each dose of GARDASIL. Patient also reported that he had diarrhea, bad neurological problems and arthritic type of pain about a week after receiving the third dose GARDASIL vaccine. Patient noted that he went to the emergency room numerous times last year because of the arthritic pain but he was not admitted to the hospital. It was reported the patient had an MRI done (date and results not provided). No further information provided. The patient's passed out and diarrhea and bad neurological problems and arthritis type of pain persisted. The patient sought medical attention from a neurologist. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a LPN concerning a 25 year old female with penicillin allergy and no illness at time of vaccination who on 08-JUL-2008, 2:30 pm was vaccinated with the first dose of GARDASIL (Lot# 660553/0070X) via IM.  On 08-JUL-2008, 2:50 pm the patient experienced syncope, repeat episodes over an hour and was in observation in hospital overnight for one day.  On 09-JUL-2008, the patient recovered from syncope.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Anger, Blood thyroid stimulating hormone, Crying, Death of relative
Clinical narrative: Information has been received from a physician concerning a 14 year old white female with menarche in February 2008 and irregular periods. The patient had asthma, acne and mood swings for which she was seen by a counselor prior to vaccination who on 30-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659182/1757U). Concomitant therapy included albuterol, benzoyl peroxide (TRIAZ) and RETIN-A MICRO GEL. On approximately 01-JUN-2008 (within the first week after the vaccination) the patient experienced anger outbursts, irritability, moodiness and bloating. The patient stated that she did not have a period in June 2008 but experienced bloating, moodiness and anger outburst off and on. She went on to have a menstrual period on 09-JUL-2008. The physician confirmed that the patient was not pregnant. On 16-JUL-2008, the patient was seen by the physician for the symptoms. The patient was asymptomatic at the visit. The patient was in counseling and the counselor stated that she felt mood problems were probably related to her vaccination. The patient's symptoms were noted to occur "on and off". This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Irritability, Menarche, Menstruation irregular, Mood swings, Stress
Clinical narrative: Information has been received from a physician concerning a 14 year old white female with menarche in February 2008 and irregular periods. The patient had asthma, acne and mood swings for which she was seen by a counselor prior to vaccination who on 30-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659182/1757U). Concomitant therapy included albuterol, benzoyl peroxide (TRIAZ) and RETIN-A MICRO GEL. On approximately 01-JUN-2008 (within the first week after the vaccination) the patient experienced anger outbursts, irritability, moodiness and bloating. The patient stated that she did not have a period in June 2008 but experienced bloating, moodiness and anger outburst off and on. She went on to have a menstrual period on 09-JUL-2008. The physician confirmed that the patient was not pregnant. On 16-JUL-2008, the patient was seen by the physician for the symptoms. The patient was asymptomatic at the visit. The patient was in counseling and the counselor stated that she felt mood problems were probably related to her vaccination. The patient's symptoms were noted to occur "on and off". This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thyroxine free
Clinical narrative: Information has been received from a physician concerning a 14 year old white female with menarche in February 2008 and irregular periods. The patient had asthma, acne and mood swings for which she was seen by a counselor prior to vaccination who on 30-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659182/1757U). Concomitant therapy included albuterol, benzoyl peroxide (TRIAZ) and RETIN-A MICRO GEL. On approximately 01-JUN-2008 (within the first week after the vaccination) the patient experienced anger outbursts, irritability, moodiness and bloating. The patient stated that she did not have a period in June 2008 but experienced bloating, moodiness and anger outburst off and on. She went on to have a menstrual period on 09-JUL-2008. The physician confirmed that the patient was not pregnant. On 16-JUL-2008, the patient was seen by the physician for the symptoms. The patient was asymptomatic at the visit. The patient was in counseling and the counselor stated that she felt mood problems were probably related to her vaccination. The patient's symptoms were noted to occur "on and off". This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal distension, Amenorrhoea, Anger, Irritability, Mood altered
Clinical narrative: Information has been received from a physician concerning a 14 year old white female with menarche in February 2008 and irregular periods. The patient had asthma, acne and mood swings for which she was seen by a counselor prior to vaccination who on 30-MAY-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659182/1757U). Concomitant therapy included albuterol, benzoyl peroxide (TRIAZ) and RETIN-A MICRO GEL. On approximately 01-JUN-2008 (within the first week after the vaccination) the patient experienced anger outbursts, irritability, moodiness and bloating. The patient stated that she did not have a period in June 2008 but experienced bloating, moodiness and anger outburst off and on. She went on to have a menstrual period on 09-JUL-2008. The physician confirmed that the patient was not pregnant. On 16-JUL-2008, the patient was seen by the physician for the symptoms. The patient was asymptomatic at the visit. The patient was in counseling and the counselor stated that she felt mood problems were probably related to her vaccination. The patient's symptoms were noted to occur "on and off". This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a health professional concerning a 15 year old white female, a contact lens wearer, weight 102.2 lb, height 60 inches, who at 09:30 AM on 24-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot#: 659962/1740U) IM in the left arm. After the vaccination the patient and her mother remained in the office. During the stay, the patient fainted. The patient complained of nausea. The physician and clinical assistant reassessed the patient's status. Staff offered sips of liquid. The patient fainted again 3-5 min later and complained of nausea. The patient remained assessed in the office. Once discharged, the patient went home and remained with complaints of nausea. On 25-JUN-2008 the patient recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Joint swelling, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on an unspecified date was vaccinated intramuscularly with 0.5 ml second dose of GARDASIL.  Subsequently the patient experienced swelling and redness in ankles.  No additional adverse event was provided.  Follow up information was received which reported that at 4:30 PM on 01-APR-2008 the patient with no pre-existing allergies, birth defects, medical conditions who was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL in her left deltoid.  No illness at the time of vaccination.  Subsequently the patient experienced swelling and redness in ankles.  No treatment was given.  On an unspecified date, the patient recovered.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Joint swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on an unspecified date was vaccinated intramuscularly with 0.5 ml second dose of GARDASIL.  Subsequently the patient experienced swelling and redness in ankles.  No additional adverse event was provided.  Follow up information was received which reported that at 4:30 PM on 01-APR-2008 the patient with no pre-existing allergies, birth defects, medical conditions who was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL in her left deltoid.  No illness at the time of vaccination.  Subsequently the patient experienced swelling and redness in ankles.  No treatment was given.  On an unspecified date, the patient recovered.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood pressure, Cold sweat, Hyperhidrosis, Malaise, Nausea
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no pertinent medical history and no known drug reactions/allergies who on 22-JUL-2008 was vaccinated intramuscularly with the 0.5 mL first dose of GARDASIL vaccine (Lot# 660393/0067X). There was no concomitant medication. Less than 5 minutes after vaccination, the patient complained that the injection site was painful and said "I don't feel good." The nurse had the patient sit down and the patient seemed to have a panic attack. The patient said that she was seeing stars. The patient laid down and she was diaphoretic and clammy. The patient stayed in the office for about a half-hour and was given water and a lollipop. The patient's blood pressure was checked three times and she was fine. Subsequently, the patient recovered from the events. This one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor, Panic reaction, Visual disturbance
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no pertinent medical history and no known drug reactions/allergies who on 22-JUL-2008 was vaccinated intramuscularly with the 0.5 mL first dose of GARDASIL vaccine (Lot# 660393/0067X). There was no concomitant medication. Less than 5 minutes after vaccination, the patient complained that the injection site was painful and said "I don't feel good." The nurse had the patient sit down and the patient seemed to have a panic attack. The patient said that she was seeing stars. The patient laid down and she was diaphoretic and clammy. The patient stayed in the office for about a half-hour and was given water and a lollipop. The patient's blood pressure was checked three times and she was fine. Subsequently, the patient recovered from the events. This one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cold sweat, Feeling abnormal, Hyperhidrosis, Injection site pain, Panic attack
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no pertinent medical history and no known drug reactions/allergies who on 22-JUL-2008 was vaccinated intramuscularly with the 0.5 mL first dose of GARDASIL vaccine (Lot# 660393/0067X). There was no concomitant medication. Less than 5 minutes after vaccination, the patient complained that the injection site was painful and said "I don't feel good." The nurse had the patient sit down and the patient seemed to have a panic attack. The patient said that she was seeing stars. The patient laid down and she was diaphoretic and clammy. The patient stayed in the office for about a half-hour and was given water and a lollipop. The patient's blood pressure was checked three times and she was fine. Subsequently, the patient recovered from the events. This one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Visual disturbance
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no pertinent medical history and no known drug reactions/allergies who on 22-JUL-2008 was vaccinated intramuscularly with the 0.5 mL first dose of GARDASIL vaccine (Lot# 660393/0067X). There was no concomitant medication. Less than 5 minutes after vaccination, the patient complained that the injection site was painful and said "I don't feel good." The nurse had the patient sit down and the patient seemed to have a panic attack. The patient said that she was seeing stars. The patient laid down and she was diaphoretic and clammy. The patient stayed in the office for about a half-hour and was given water and a lollipop. The patient's blood pressure was checked three times and she was fine. Subsequently, the patient recovered from the events. This one of several reports from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Arthropathy, Costochondritis
Clinical narrative: Information has been received from a physician concerning an approximately 21 year old female who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658094/0524U) intramuscular administration. On 27-AUG-2007 the patient received the second dose of GARDASIL vaccine (yeast) (lot # 658554/0928U) intramuscular administration. On 17-JAN-2008, the patient received the third dose of GARDASIL vaccine (yeast) (lot # 659439/1267U), intramuscular administration. On 08-JUL-2008, the patient's mother called the office stating that the patient had joint pain and fatigue and was limping. She was seen by a rheumatologist and tests were negative for rheumatoid arthritis. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Depression, Erythema, Fatigue, Full blood count normal, Gait disturbance
Clinical narrative: Information has been received from a physician concerning an approximately 21 year old female who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658094/0524U) intramuscular administration. On 27-AUG-2007 the patient received the second dose of GARDASIL vaccine (yeast) (lot # 658554/0928U) intramuscular administration. On 17-JAN-2008, the patient received the third dose of GARDASIL vaccine (yeast) (lot # 659439/1267U), intramuscular administration. On 08-JUL-2008, the patient's mother called the office stating that the patient had joint pain and fatigue and was limping. She was seen by a rheumatologist and tests were negative for rheumatoid arthritis. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Hypoaesthesia, Impaired work ability, Labyrinthitis, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning an approximately 21 year old female who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658094/0524U) intramuscular administration. On 27-AUG-2007 the patient received the second dose of GARDASIL vaccine (yeast) (lot # 658554/0928U) intramuscular administration. On 17-JAN-2008, the patient received the third dose of GARDASIL vaccine (yeast) (lot # 659439/1267U), intramuscular administration. On 08-JUL-2008, the patient's mother called the office stating that the patient had joint pain and fatigue and was limping. She was seen by a rheumatologist and tests were negative for rheumatoid arthritis. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal stiffness, Neck pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning an approximately 21 year old female who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658094/0524U) intramuscular administration. On 27-AUG-2007 the patient received the second dose of GARDASIL vaccine (yeast) (lot # 658554/0928U) intramuscular administration. On 17-JAN-2008, the patient received the third dose of GARDASIL vaccine (yeast) (lot # 659439/1267U), intramuscular administration. On 08-JUL-2008, the patient's mother called the office stating that the patient had joint pain and fatigue and was limping. She was seen by a rheumatologist and tests were negative for rheumatoid arthritis. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Fatigue, Gait disturbance
Clinical narrative: Information has been received from a physician concerning an approximately 21 year old female who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658094/0524U) intramuscular administration. On 27-AUG-2007 the patient received the second dose of GARDASIL vaccine (yeast) (lot # 658554/0928U) intramuscular administration. On 17-JAN-2008, the patient received the third dose of GARDASIL vaccine (yeast) (lot # 659439/1267U), intramuscular administration. On 08-JUL-2008, the patient's mother called the office stating that the patient had joint pain and fatigue and was limping. She was seen by a rheumatologist and tests were negative for rheumatoid arthritis. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Pharyngitis, Pharyngolaryngeal pain, Pyrexia, Streptococcal identification test negative
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no known allergies or pertinent medical history who on 30-JAN-2008 was vaccinated IM with the first dose of GARDASIL vaccine (yeast) 0.5ml, on 28-MAR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast), on 30-JUL-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). Concomitant therapy included ACCUTANE. On 30-JUL-2008 the patient developed a high fever, joint pain and eye pain after receiving her third dose of GARDASIL vaccine (yeast). The patient's high fever and joint pain and eye pain persisted. No lab diagnostics were performed. The patient sought medical attention, "phone call and the patient will be seen in the office". There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Eye pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old female with no known allergies or pertinent medical history who on 30-JAN-2008 was vaccinated IM with the first dose of GARDASIL vaccine (yeast) 0.5ml, on 28-MAR-2008 was vaccinated with the second dose of GARDASIL vaccine (yeast), on 30-JUL-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast). Concomitant therapy included ACCUTANE. On 30-JUL-2008 the patient developed a high fever, joint pain and eye pain after receiving her third dose of GARDASIL vaccine (yeast). The patient's high fever and joint pain and eye pain persisted. No lab diagnostics were performed. The patient sought medical attention, "phone call and the patient will be seen in the office". There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Coagulation factor V level
Clinical narrative: Information has been from a registered nurse concerning a female who was vaccinated with the third dose of GARDASIL. Subsequently the patient experienced blood clots three months after receiving the third dose of GARDASIL. The dates of administration and lot number were not known. No additional was provided. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Thrombosis
Clinical narrative: Information has been from a registered nurse concerning a female who was vaccinated with the third dose of GARDASIL. Subsequently the patient experienced blood clots three months after receiving the third dose of GARDASIL. The dates of administration and lot number were not known. No additional was provided. The patient sought medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Muscular weakness
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician assistant concerning a 19 year old with no pertinent medical history or drug reactions or allergies who on 28-JUL-2008 at 3:49 PM was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast) (lot no. 659184/0843X). Concomitant therapy included ORTHO-NOVUM 1/3 (patient had been on for years). On the same day, at the evening, a few hours after leaving the office the patient had a significant headache described as severe. On 29-JUL-2008, "the following day" the patient experienced extreme fatigue, muscle weakness, weakness, headache, blurred vision, dizziness, dirriness and shortness of breath during a workout. The patient had always regularly worked out before the vaccination. On 30-JUL-2008, "today", the patient was feeling better but not fully recovered. The patient called the office to seek unspecified medical attention. On 30-JUL-2008, the patient recovered spontaneously by the time she contacted the office. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician assistant concerning a 19 year old with no pertinent medical history or drug reactions or allergies who on 28-JUL-2008 at 3:49 PM was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast) (lot no. 659184/0843X). Concomitant therapy included ORTHO-NOVUM 1/3 (patient had been on for years). On the same day, at the evening, a few hours after leaving the office the patient had a significant headache described as severe. On 29-JUL-2008, "the following day" the patient experienced extreme fatigue, muscle weakness, weakness, headache, blurred vision, dizziness, dirriness and shortness of breath during a workout. The patient had always regularly worked out before the vaccination. On 30-JUL-2008, "today", the patient was feeling better but not fully recovered. The patient called the office to seek unspecified medical attention. On 30-JUL-2008, the patient recovered spontaneously by the time she contacted the office. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician assistant concerning a 19 year old with no pertinent medical history or drug reactions or allergies who on 28-JUL-2008 at 3:49 PM was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast) (lot no. 659184/0843X). Concomitant therapy included ORTHO-NOVUM 1/3 (patient had been on for years). On the same day, at the evening, a few hours after leaving the office the patient had a significant headache described as severe. On 29-JUL-2008, "the following day" the patient experienced extreme fatigue, muscle weakness, weakness, headache, blurred vision, dizziness, dirriness and shortness of breath during a workout. The patient had always regularly worked out before the vaccination. On 30-JUL-2008, "today", the patient was feeling better but not fully recovered. The patient called the office to seek unspecified medical attention. On 30-JUL-2008, the patient recovered spontaneously by the time she contacted the office. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Vision blurred
Clinical narrative: This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician assistant concerning a 19 year old with no pertinent medical history or drug reactions or allergies who on 28-JUL-2008 at 3:49 PM was vaccinated intramuscularly with the first dose of GARDASIL vaccine (yeast) (lot no. 659184/0843X). Concomitant therapy included ORTHO-NOVUM 1/3 (patient had been on for years). On the same day, at the evening, a few hours after leaving the office the patient had a significant headache described as severe. On 29-JUL-2008, "the following day" the patient experienced extreme fatigue, muscle weakness, weakness, headache, blurred vision, dizziness, dirriness and shortness of breath during a workout. The patient had always regularly worked out before the vaccination. On 30-JUL-2008, "today", the patient was feeling better but not fully recovered. The patient called the office to seek unspecified medical attention. On 30-JUL-2008, the patient recovered spontaneously by the time she contacted the office. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Had fainting spell - short generalized seizure - tonic clonic tremors, lasted approximately 1 minute.  Felt well after seizure.  Has declined 2nd GARDASIL.  2nd idiopathic seizure today (8-1-08) while on the beach generalized lasted less than 1 minute.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Grand mal convulsion, Laboratory test, Scan, Syncope
Clinical narrative: Had fainting spell - short generalized seizure - tonic clonic tremors, lasted approximately 1 minute.  Felt well after seizure.  Has declined 2nd GARDASIL.  2nd idiopathic seizure today (8-1-08) while on the beach generalized lasted less than 1 minute.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne
Clinical narrative: 2-3 days after vaccine pimples & follicles on arms, legs, one in face.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Skin warm
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 68 year old male with hypercholesterolaemia, depression, oesophageal acid reflux, and no drug allergies, who on 17-OCT-2007 was vaccinated intramuscularly in the right arm with a 0.5mL dose of PNEUMOVAX (Lot# 657526/0555U).  Concomitant therapy included ZOLOFT, NEXIUM and niacin.  On 18-OCT-2007 the patient developed erythema, warmth, and swelling at the injection site of the right arm.  On 18-OCT-2007 the physician examined the patient and noted that the erythema and swelling extended into the right axillary area.  The patient was treated with a warm compress and TYLENOL.  No laboratory diagnostics were performed.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  This report is one of two reports from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 68 year old male with hypercholesterolaemia, depression, oesophageal acid reflux, and no drug allergies, who on 17-OCT-2007 was vaccinated intramuscularly in the right arm with a 0.5mL dose of PNEUMOVAX (Lot# 657526/0555U).  Concomitant therapy included ZOLOFT, NEXIUM and niacin.  On 18-OCT-2007 the patient developed erythema, warmth, and swelling at the injection site of the right arm.  On 18-OCT-2007 the physician examined the patient and noted that the erythema and swelling extended into the right axillary area.  The patient was treated with a warm compress and TYLENOL.  No laboratory diagnostics were performed.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  This report is one of two reports from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Oedema peripheral, Rash
Clinical narrative: Information has been received from a physician regarding a case in litigation concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23.  Subsequently the patient experienced an allergy to the vaccine which caused a rash and swelling in her arm.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Information has been received from a 67 year old female pharmacy technician who is also the consumer with sulfonamide allergy and no other pertinent medical history who on 02-APR-2008, was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous.  Concomitant therapy included PREMARIN.  On 01-AUG-2008 the patient developed 101.9 F degrees fever and stinging, shooting pain over her entire body, after receiving a dose of ZOSTAVAX.  The pain is now (11-AUG-2008) "across her shoulder blades" and under her left arm, the patient also reported that she experienced lethargy.  The patient was being treated with gabapentin.  Unspecified blood tests were performed (no results provided).  The patient considered the symptoms to be disabling.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from an 18 year old female patient, with no pertinent medical history and no drug reactions/allergies, who on 07-MAY-2008, was vaccinated with GARDASIL. Concomitant therapy included RECOMBIVAX HB the same day of the GARDASIL. The patient conceived on 03-MAY-2008. The mother reported that her daughter received GARDASIL and had a miscarriage two weeks ago. The mother reported that her daughter went to the hospital to have dilatation and curettage; however she did not stay in the hospital overnight. The patient sought unspecified medical attention. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: No reaction on previous exposure to drug, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female with no pertinent medical history and no allergies who on 19-JAN-2008 was vaccinated with the first dose of GARDASIL IM 0.5 ml (lot # 659439/1267U) well tolerated.  On 29-MAR-2008 the patient was vaccinated with the second dose of GARDASIL IM 0.5 ml (lot # 655604/0052X) well tolerated.  On 04-AUG-2008 the patient was vaccinated with the third dose of GARDASIL IM 0.5 ml (lot # 659184/0843X).  There was no concomitant medication.  On 04-AUG-2008 the patient experienced body chills and tingling in both legs several hours after receiving her third dose.  The patient was examined in the local emergency room.  The patient was rehydrated with an unspecified intravenous fluid and released to home.  The patient's mother contacted the office by phone, on 05-AUG-2008, to relay the adverse event.  The current status of the patient was unknown.  The reporter considered the body chills and tingling in both legs to be other important events (IV hydration).  This is one of several reports from the same source.  Additional information has been requested.  9/23/08 Reviewed ER medical records of 8/4/08. FINAL DX: none provided Records reveal patient experienced numbness & pain in both legs, achy joints, pins & needles feeling in legs, temporal HA, felt feverish & chills.  Tx w/IVF & pain meds.  Improved & d/c to home.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abasia, Adrenal disorder, Angiogram, Angiogram cerebral, Aphasia
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Autism, Blindness transient, Computerised tomogram, Condition aggravated, Confusional state
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Congenital hearing disorder, Convulsion, Detoxification, Echocardiogram, Electroencephalogram
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Extremity contracture, Foaming at mouth, Gaze palsy, Hand deformity, Headache
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hepatic enzyme abnormal, Hormone level abnormal, Hypoaesthesia, Hypoglycaemia, Hypothyroidism
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Lumbar puncture, Malaise, Migraine, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Palpitations, Paraesthesia, Quality of life decreased, Regressive behaviour, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ultrasound scan, Vitamin D deficiency, Weight increased
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female with anxiety, depression and gastrointestinal issues, who on 07-NOV-2007 was vaccinated with a second 0.5 ml dose of GARDASIL intramuscularly (lot number and injection site not reported).  On 07-NOV-2007 after the vaccination the patient began having seizure type episodes and was hospitalized for a week (dates unspecified).  Therapy with human papillomavirus vaccine was discontinued.  The outcome of the patient was unspecified.  Additional information has been requested.  7/30/09 Consultant records received DOS 6/1/09. Assessment: Uncertain of Diagnosis. Patient presented with weight gain, migraine, palpitations, seizures, and deafness. Nosebleed. Pain upon palpation of all joints. Tenderness upon palpation of lower extremities.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Breech presentation, Caesarean section, Contraception, Drug exposure during pregnancy, Live birth
Clinical narrative: Information has been received from a 25 year old female with no known drug reactions/allergies who on an unknown date was vaccinated with the first dose of GARDASIL.  This is part of a pregnancy registry.  On 17-MAY-2007, the patient was vaccinated with a second dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  3 months later, on approximately 17-AUG-2008, the patient returned for the third dose and a urine test was positive for pregnancy.  On an unspecified date, the patient was hospitalized and delivered a female infant one month early on 19-APR-2008 via Cesarean section due to breech presentation.  The infant is healthy.  Additional information has been requested.