chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Headache, Incorrect dose administered, Incorrect route of drug administration, Joint swelling
Clinical narrative: Information has been received from an approximately 69 year old female with high blood pressure and a history of an unspecified "reaction to the smallpox vaccine", who on approximately 19-NOV-2007, was vaccinated with 0.5 ml of Zostavax (Oka/Merck).  Concomitant therapy included two unspecified high blood pressure medications, and vitamins.  On approximately 19-NOV-2007 3 to 4 hours post vaccination with Zostavax (Oka/Merck); the patient developed an elevated temperature and headache.  A couple days later, on approximately 21-NOV-2007 the patient developed a rash on her torso and legs, along with pain in her hands and feet, and swelling in her ankles.  It was also reported that the patient developed a low grade fever which lasted about four weeks.  The patient went to the emergency room (ER), but was not admitted.  Unspecified blood work was obtained, of which the results were not reported.  At the time of reporting the patient was recovering.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information has been received from a physician concerning a 71 year old female with blood pressure high and no pre-existing allergies or drug reactions who on approximately 26-NOV-2007 was vaccinated intramuscularly with a first dose of Zostavax (Oka/Merck) (Lot # 658361/1090U).  There was no illness at the time of vaccination.  Concomitant therapy included aspirin, calcium (unspecified) (+) vitamin D (unspecified), UNIRETIC and "MUR".  On 27-NOV-2007 the patient developed a rash, fever, myalgia, fatigue and arthralgia.  The patient had also reported that she had developed a headache and temperature 3 to 4 hours after vaccination, and that a low grade temperature remained for about 4 weeks.  The patient had also reported developing swelling in her ankles, of which the outcome was not reported.  The physician reported that the patient had no prior adverse events following prior vaccinations (also reported by the patient as having had an unspecified "reaction to the smallpox vaccine").  The physician reported the patient was recovered (on approximately 18 DEC 2007), and that her rash, fever, myalgia, fatigue and arthralgia lasted for three weeks.  No further information is expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rash, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from an approximately 69 year old female with high blood pressure and a history of an unspecified "reaction to the smallpox vaccine", who on approximately 19-NOV-2007, was vaccinated with 0.5 ml of Zostavax (Oka/Merck).  Concomitant therapy included two unspecified high blood pressure medications, and vitamins.  On approximately 19-NOV-2007 3 to 4 hours post vaccination with Zostavax (Oka/Merck); the patient developed an elevated temperature and headache.  A couple days later, on approximately 21-NOV-2007 the patient developed a rash on her torso and legs, along with pain in her hands and feet, and swelling in her ankles.  It was also reported that the patient developed a low grade fever which lasted about four weeks.  The patient went to the emergency room (ER), but was not admitted.  Unspecified blood work was obtained, of which the results were not reported.  At the time of reporting the patient was recovering.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information has been received from a physician concerning a 71 year old female with blood pressure high and no pre-existing allergies or drug reactions who on approximately 26-NOV-2007 was vaccinated intramuscularly with a first dose of Zostavax (Oka/Merck) (Lot # 658361/1090U).  There was no illness at the time of vaccination.  Concomitant therapy included aspirin, calcium (unspecified) (+) vitamin D (unspecified), UNIRETIC and "MUR".  On 27-NOV-2007 the patient developed a rash, fever, myalgia, fatigue and arthralgia.  The patient had also reported that she had developed a headache and temperature 3 to 4 hours after vaccination, and that a low grade temperature remained for about 4 weeks.  The patient had also reported developing swelling in her ankles, of which the outcome was not reported.  The physician reported that the patient had no prior adverse events following prior vaccinations (also reported by the patient as having had an unspecified "reaction to the smallpox vaccine").  The physician reported the patient was recovered (on approximately 18 DEC 2007), and that her rash, fever, myalgia, fatigue and arthralgia lasted for three weeks.  No further information is expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid factor negative, Syphilis test negative
Clinical narrative: Information has been received from an approximately 69 year old female with high blood pressure and a history of an unspecified "reaction to the smallpox vaccine", who on approximately 19-NOV-2007, was vaccinated with 0.5 ml of Zostavax (Oka/Merck).  Concomitant therapy included two unspecified high blood pressure medications, and vitamins.  On approximately 19-NOV-2007 3 to 4 hours post vaccination with Zostavax (Oka/Merck); the patient developed an elevated temperature and headache.  A couple days later, on approximately 21-NOV-2007 the patient developed a rash on her torso and legs, along with pain in her hands and feet, and swelling in her ankles.  It was also reported that the patient developed a low grade fever which lasted about four weeks.  The patient went to the emergency room (ER), but was not admitted.  Unspecified blood work was obtained, of which the results were not reported.  At the time of reporting the patient was recovering.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information has been received from a physician concerning a 71 year old female with blood pressure high and no pre-existing allergies or drug reactions who on approximately 26-NOV-2007 was vaccinated intramuscularly with a first dose of Zostavax (Oka/Merck) (Lot # 658361/1090U).  There was no illness at the time of vaccination.  Concomitant therapy included aspirin, calcium (unspecified) (+) vitamin D (unspecified), UNIRETIC and "MUR".  On 27-NOV-2007 the patient developed a rash, fever, myalgia, fatigue and arthralgia.  The patient had also reported that she had developed a headache and temperature 3 to 4 hours after vaccination, and that a low grade temperature remained for about 4 weeks.  The patient had also reported developing swelling in her ankles, of which the outcome was not reported.  The physician reported that the patient had no prior adverse events following prior vaccinations (also reported by the patient as having had an unspecified "reaction to the smallpox vaccine").  The physician reported the patient was recovered (on approximately 18 DEC 2007), and that her rash, fever, myalgia, fatigue and arthralgia lasted for three weeks.  No further information is expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 70 year old female with no pertinent medical history, drug reaction or allergies who on 03-JAN-2008 was vaccinated with Zostavax (Oka/Merck). The reporting physician noted that the vaccine was administered at the pharmacy, and therefore he did not have access to the lot number and route of administration. There was no concomitant medication. On 05-JAN-2008 the patient developed shingles. The shingles rash followed the right thoracic dermatome. The patient was prescribed prednisone and VALTREX. At the time of reporting the patient had not yet recovered. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Laboratory test
Clinical narrative: Information has been received from a physician concerning an approximately 70 year old female with no pertinent medical history who on an unspecified date was vaccinated with ZOSTAVAX. Subsequently the patient experienced a 'weird feeling as if something was crawling on her in her legs". Unspecified medical attention was sought and "blood work" was done. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. Information has been received from a physician concerning an 67 year old female with no pertinenet medical history who on 21-NOV-2007 was vaccinated intramuscularly (IM) with ZOSTAVAX vaccine (Merck) (lot # 658084/0888U). Subsequently in November 2007, the patient expereinced a "weird feeling as if something was crawling on her in her legs". Unspecified medical attention was sought and "blood work" was done. It was noted that the patient recovered on an unspecified date. There was no product quality compliant involved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient experienced a chicken pox rash after getting the vaccine. Unspecified medical attention was sought. The outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a Registered Nurse concerning a nurse who on an unspecified date developed shingles after administering Zostavax (Oka/Merck).  At the time of the report the patinet's status was unknown. It was unspecified if medical attention was sought. There is no product quality complaint involved, no additional information was provided.  Additional information requested.  This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a female with diabetes who on 09-FEB-2008 was vaccinated with Zostavax (Oka/Merck).  On 12-FEB-2008 the patient experienced fever and injection site reaction.  There is no product quality complaint involved.  Additional information has been requested.  This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G, CSF test, Discomfort, Herpes zoster, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history or drug allergies who on 30-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658602/1080U) in the right deltoid (unspecified route).  There was no concomitant medication.  On that same day within 4 hours of vaccination, the patient developed initial symptoms of itching of the right breast and numbness followed by a rash over her right shoulder and right breast.  On 31-JAN-2008 the patient developed shingles.  The patient was seen by the physician for medical attention.  Lab diagnostic studies performed included a "VZV IgG" test.  The patient was treated with FAMVIR.  The patient was noted to be uncomfortable and was not recovered at the time of this report.  There was no product quality complaint.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of CBER and was released by the regulatory agency.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a female with no pertinent medical history or drug allergies who on 30-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658602/1080U) in the right deltoid (unspecified route).  There was no concomitant medication.  On that same day within 4 hours of vaccination, the patient developed initial symptoms of itching of the right breast and numbness followed by a rash over her right shoulder and right breast.  On 31-JAN-2008 the patient developed shingles.  The patient was seen by the physician for medical attention.  Lab diagnostic studies performed included a "VZV IgG" test.  The patient was treated with FAMVIR.  The patient was noted to be uncomfortable and was not recovered at the time of this report.  There was no product quality complaint.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of CBER and was released by the regulatory agency.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 67 year old female with no known drug reactions or allergies who on 31-JAN-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included PROZAC and vitamins (unspecified). On 02-FEB-2008 the patient developed redness, pain and swelling at the injection site. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient had not yet recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an approximately 71 year old female with no pertinent medical history, drug reactions or allergies who on 31-JAN-2008 was vaccinated subcutaneously into the anterior deltoid with 0.65 ml of Zostavax (Oka/Merck) (Lot # 659403/1825U).  There was no concomitant medication.  One to two days post vaccination on approximately 01-FEB-2008 the patient experienced swelling, itching and redness at the injection site.  At the time of reporting the patient had not yet contacted her physician and had not yet recovered.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Dyspnoea, Eructation, Flatulence, Laboratory test
Clinical narrative: Information has been received from a registered pharmacist concerning an 81-year-old male with no known allergies who on 28-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included aspirin.  On 29-JAN-2008 the patient experienced bloating, gas, burping, flatulence and difficulty breathing following vaccination. The patient sought medical attention via an office visit.  On an unspecified date the patient had an "unspecified blood test" performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a 65-year-old female with an allergic reaction to the dye for an MRI and a history of shingles who on 31-JAN-2008 was vaccinated subcutaneous with 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included WELCHOL, ezetimibe (MSD), CEREFOLIN, ENABLEX, glipizide (+) metformin hydrochloride, alendronate sodium (MSD) and MICARDIS.  On 01-FEB-2008 the patient noticed a "hard lump" at the injection site which was "about the size of a fist", it had a "white circle around it", it felt "hot" and it had a "pink rash" in top.  "Now the swelling has gone down, it no longer feels hot, the white circle is gone and the rash is "spreading" on her arm.  The patient sought unspecified medical attention.  No diagnostic labs were performed.  At the time of the report the patient's status was recovering.  A product quality complaint was not involved.  No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a 65-year-old female with an allergic reaction to the dye for an MRI and a history of shingles who on 31-JAN-2008 was vaccinated subcutaneous with 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included WELCHOL, ezetimibe (MSD), CEREFOLIN, ENABLEX, glipizide (+) metformin hydrochloride, alendronate sodium (MSD) and MICARDIS.  On 01-FEB-2008 the patient noticed a "hard lump" at the injection site which was "about the size of a fist", it had a "white circle around it", it felt "hot" and it had a "pink rash" in top.  "Now the swelling has gone down, it no longer feels hot, the white circle is gone and the rash is "spreading" on her arm.  The patient sought unspecified medical attention.  No diagnostic labs were performed.  At the time of the report the patient's status was recovering.  A product quality complaint was not involved.  No further information is available.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy, Drug exposure during pregnancy, Inappropriate schedule of drug administration, Pregnancy test positive
Clinical narrative: Information has been received via the Merck pregnancy registry, from a certified medical assistant (CMA) and a healthcare professional (HCP), concerning a 36 year old caucasian female patient, who on 03-JAN-2008 was vaccinated IM with the first dose of GARDASIL (lot #659441/1446U). Concomitant therapy included ZOLOFT. The HCP indicated that on 04-FEB-2008, a colposcopy was performed, due to LSIL (Low grade squamous intraepithelial lesion) (date of onset and diagnostic test not specified). The CMA reported that on 05-FEb-2008 the patient had her LMP, and subsequently became pregnant. On 03-MAR-2008, the second dose, 0.5 ml, IM of GARDASIL (lot #659180/1758U) was administered. The patient subsequently confirmed her pregnancy with a positive home pregnancy test. The patient was seen by the physician (details not specified). The estimated date of delivery was 11-NOV-2008. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received via the Merck pregnancy registry, from a certified medical assistant (CMA) and a healthcare professional (HCP), concerning a 36 year old caucasian female patient, who on 03-JAN-2008 was vaccinated IM with the first dose of GARDASIL (lot #659441/1446U). Concomitant therapy included ZOLOFT. The HCP indicated that on 04-FEB-2008, a colposcopy was performed, due to LSIL (Low grade squamous intraepithelial lesion) (date of onset and diagnostic test not specified). The CMA reported that on 05-FEb-2008 the patient had her LMP, and subsequently became pregnant. On 03-MAR-2008, the second dose, 0.5 ml, IM of GARDASIL (lot #659180/1758U) was administered. The patient subsequently confirmed her pregnancy with a positive home pregnancy test. The patient was seen by the physician (details not specified). The estimated date of delivery was 11-NOV-2008. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blood test normal, Diarrhoea, Impaired gastric emptying, Oral intake reduced
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with a sulfonamide allergy and other unspecified allergies who in December 2007, was vaccinated IM into the deltoid muscle with a first dose of Gardasil.  Other concomitant therapy included CLARITIN.  Within two weeks, the patient experienced heart palpitations and severe abdominal cramping with diarrhea.  Due to the abdominal cramping her daughter could not eat for a period of time.  Therefore she lost 18 pounds in a 3 week period.  It was reported that her daughter has seen various specialists and gastrointestinal specialists.  Her daughter was diagnosed with gastroparesis.  It was reported that blood work and stool samples were all negative.  The consumer reported that her daughter's pediatrician felt that the events were not related to the vaccine.  The consumer stated that her daughter will not receive the additional doses of Gardasil.  At the time of this report, she was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Stool analysis normal, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her 16 year old daughter with a sulfonamide allergy and other unspecified allergies who in December 2007, was vaccinated IM into the deltoid muscle with a first dose of Gardasil.  Other concomitant therapy included CLARITIN.  Within two weeks, the patient experienced heart palpitations and severe abdominal cramping with diarrhea.  Due to the abdominal cramping her daughter could not eat for a period of time.  Therefore she lost 18 pounds in a 3 week period.  It was reported that her daughter has seen various specialists and gastrointestinal specialists.  Her daughter was diagnosed with gastroparesis.  It was reported that blood work and stool samples were all negative.  The consumer reported that her daughter's pediatrician felt that the events were not related to the vaccine.  The consumer stated that her daughter will not receive the additional doses of Gardasil.  At the time of this report, she was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Syncope
Clinical narrative: Information has been received from a pharmacist concerning a 20 year old female patient who on 20-AUG-2007 at 11:30 AM was vaccinated IM into the left arm with a first dose of Gardasil lot # 656U50/0245U.  On 20-AUG-2007 the patient received her second and third dose of Gardasil and on 03-MAR-2008 she received her third dose of Gardisil (the lot numbers were not reported for the first and second injection).  The reporter reported that the patient experienced nausea and fainted after the first injection.  The pharmacist reported that the patient also experienced nausea and dizziness after her second dose of Gardasil.  She did not experience any adverse events after her third injection.  No further information was available.  The patient recovered on an unknown date.  Additional information has been requested. 2/16/2010 In follow up information the reporter reported that on 20-AUG-2008 after the first injection patient had a difficult time getting injections. SHe drove four hours to get to the doctor's office from her school and was tired and had not eaten anything. SHe got the injection and felt weak, nauseated, and then passed out for a few seconds. This happened outside of the office. SHe was instructed to eat before taking injection and the office made her stay little longer in the office after the other two injections. SHe did not have any other reactions after the vaccination. No further information was available. The patient recovered on the same day of vaccination of first dose. Additinal informational is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Dizziness, Fatigue, Palpitations, Tremor
Clinical narrative: Information has been received from a physician through the Merck Pregnancy Registry concerning a 19 year old female with anxiety, depression, chronic fatigue and drug allergy to acetaminophen who on 22-JAN-2008 was vaccinated IM with a 0.5 mL dose of Gardasil (Lot# unknown).  Concomitant therapy included clonazepam and buspirone HCl.  On 31-JAN-2008 the patient began experiencing tremors, fatigue, lightheadedness, a faint feeling, heart palpitations and blurred vision.  She reported that "complete bloodwork" was done (results not reported).  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Information has been received from a physician through the Merck Pregnancy Registry concerning a 19 year old female with anxiety, depression, chronic fatigue and drug allergy to acetaminophen who on 22-JAN-2008 was vaccinated IM with a 0.5 mL dose of Gardasil (Lot# unknown).  Concomitant therapy included clonazepam and buspirone HCl.  On 31-JAN-2008 the patient began experiencing tremors, fatigue, lightheadedness, a faint feeling, heart palpitations and blurred vision.  She reported that "complete bloodwork" was done (results not reported).  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Head injury, Laboratory test, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 15 year old white female student with no known drug allergies and no medical history, who on 06-MAR-2008 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot# 655670/1459U).  Concomitant therapy included meningococcal ACYW conj vaccine (dip toxoid)  (MENACTRA) and  diptheria toxoid (+ pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX).  On 06-MAR-2008 within five minutes of the vaccination, the patient fainted.  The patient hit her head on the tiled floor.  The patient was observed and rechecked by the physician prior to being discharged home.  The patient was recovered.  No product quality complaint was involved. Follow up information indicated that the patient fainted in office waiting room after receiving the dose of Gardisil (lot # 655670/1459U). The patient was observed by staff and reevaluated by the physician. The patient was given some juice and observed for about 15 minutes and left when felt better. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site dryness, Injection site erythema, Injection site swelling, Limb discomfort, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 23 year old female with a history of mitral valve prolapse who on 09-AUG-2007 was intramuscularly vaccinated with her first dose of Gardasil (lot # 658219/0680U).  On 09-Oct-2007 the patient was intramuscularly vaccinated with her second dose of Gardasil (lot # 657872/0515U).  On 11-Feb-2008 the patient was intramuscularly vaccinated with her third dose of Gardasil (lot # 658219/0755U).  On 11-Feb-2008 the patient experienced raised, red area the size of a dime at the injection site, dry skin at injection site which lasted about a week but then the patient started experiencing a sore arm and discomfort in her arm.  Subsequently, the patient recovered from dry skin at injection site.  the patient's raised, red area at injection and sore arm and discomfort in arm persisted.  The patient sought unspecified medical treatment.  No further information is available.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Information has been received from a consumer about her daughter, a 17 year old female who on approximately 26-FEB-2008 was vaccinated with her first dose of GARDASIL (lot number unspecified). Concomitant therapy included WELLBUTRIN. On approximately 26-FEB-2008 the patient experienced her arm hurting on that day. The patient said she experienced itchiness on her face, lips, and arms. The patient's arm hurting and itchiness on face, lips, and arms persisted. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated, Herpes zoster, Oral contraception
Clinical narrative: Information has been received from a physician concerning a 17 year old female patient who had genital warts prior to vaccination, at an unspecified date was vaccinated with the first dose of Gardasil (lot# 658558/1061U).  Concomitant therapy included ORTHO 0.5/35 and CONDYLOX.  The patient was treated for genital warts.  After the second dose of Gardasil (lot# 658488/1264U) the patient's genital warts came back and same thing happened after the third dose of Gardasil (lot# 659182/1757U).  One of the nurses mentioned that it was a "very severe case of genital warts".  The patient also developed shingles after the third vaccination.  Unknown medical attention was sought.  At the time of reporting the patient was not recovered.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Body temperature increased, Cough, Full blood count normal, Haematology test
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 04-MAR-2008 was vaccinated with her first dose of Gardasil (Lot # not reported).  There was no concomitant medication.  On 05-MAR-2008 the patient developed a fever of 101.8F, malaise and weakness.  The patient had a CBC and comprehensive blood work (not further specified).  The patient is receiving aspirin (unspecified) for her symptoms.  The patient sought unspecified medical attention in the office.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/7/2008.  Initial and follow-up information has been received from a physician concerning a 26 year old female who on 04-MAR-2008 wsa vaccinated intramuscularly with her first dose of GARDASIL (Lot # 658219/0755U).  There was no concomitant medication.  On 05-MAR-2008 the patient developed a fever of 101.8F, malaise and weakness.  It was also reported that the patient developed a fever of 101.8F on 05-MAR-2008.  On 06-MAR-2008, the patient experienced a headache and a slight cough.  The patient ahd a CBC which was normal, a WBC of 8.6 and comprehensive blood work (not further specified).  The patient was receiving ASPIRIN (unspecified) for her symptoms.  The patient sought unspecified medical attention in the office.  On 07-MAR-2008, the patient recovered from the fever of 101.8F, malaise, weakness, headache and slight cough.  No additional information is expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaise, Metabolic function test, Pyrexia, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 26 year old female who on 04-MAR-2008 was vaccinated with her first dose of Gardasil (Lot # not reported).  There was no concomitant medication.  On 05-MAR-2008 the patient developed a fever of 101.8F, malaise and weakness.  The patient had a CBC and comprehensive blood work (not further specified).  The patient is receiving aspirin (unspecified) for her symptoms.  The patient sought unspecified medical attention in the office.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/7/2008.  Initial and follow-up information has been received from a physician concerning a 26 year old female who on 04-MAR-2008 wsa vaccinated intramuscularly with her first dose of GARDASIL (Lot # 658219/0755U).  There was no concomitant medication.  On 05-MAR-2008 the patient developed a fever of 101.8F, malaise and weakness.  It was also reported that the patient developed a fever of 101.8F on 05-MAR-2008.  On 06-MAR-2008, the patient experienced a headache and a slight cough.  The patient ahd a CBC which was normal, a WBC of 8.6 and comprehensive blood work (not further specified).  The patient was receiving ASPIRIN (unspecified) for her symptoms.  The patient sought unspecified medical attention in the office.  On 07-MAR-2008, the patient recovered from the fever of 101.8F, malaise, weakness, headache and slight cough.  No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a female who on 05-MAR-2008 was vaccinated with her first dose of Gardasil (Lot # not reported).  On 07-MAR-2008 the patient broke out with an itchy rash all over her body, "from head to toes".  The physician reported that the patient had taken BACTRIM for a period of time prior to receiving Gardasil.  The patient sought unspecified medical attention.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a physician concerning a female who on 05-MAR-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (lot # 660387/1967U). On 06-Mar-2008, previously reported as 07-MAR-2008, the patient broke out with an itchy rash all over her body, "fromhead to toes". The physician reported that the patient had taken BACTRIM for a period of time prior to receiving GARDASIL. The patient sought unspecified medical attention. Follow-up information received 11-APR-2008 from a medical assistant, reported that the patient had an itchy red rash all over her body and was treated with BENADRYL for relief. The patient recovered from the itchy red rash on an unspecified date. On 27-FEB-2008, also reported as one prior to vaccination, the patient had a urinary tract infection and was treated with BACTRIM. No additional information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Arthralgia, Full blood count normal, Headache, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 22-JAN-2008 was vaccinated with her first dos eof GARDASIL (659055/1522U). Concomitant therapy included hormonal contraceptives (unspecified). On 25-JAN-2008 the patient experienced joint pain, abdominal pain, low grade fever and headache. The patient sought medical attention in the doctors office and she had unknown laboratory tests conducted which were normal. The patient's joint pain, abdominal pain, low grade fever and headache persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a physician concerning a 17 year old female who on 08-JAN-2008 was vaccinated with her first dose of GARDASIL (659055/1522U). Concomitant therapy included hormonal contraceptived (unspecified). On 25-JAN-2008 the patient experienced joint pain, abdominal pain, low  grade fever, nausea, and headache. The patient sought medical attention in the doctors office. She saw her PCP, abdominal sonogram was within normal limits, a CBC and Chem 12 were within normal limits. Patient also saw an infectious disease specialist and is waiting on records. The patient's joint pain, abdominal pain, low grade fever, nausea, and headache persisted. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Pyrexia, Ultrasound scan normal
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 22-JAN-2008 was vaccinated with her first dos eof GARDASIL (659055/1522U). Concomitant therapy included hormonal contraceptives (unspecified). On 25-JAN-2008 the patient experienced joint pain, abdominal pain, low grade fever and headache. The patient sought medical attention in the doctors office and she had unknown laboratory tests conducted which were normal. The patient's joint pain, abdominal pain, low grade fever and headache persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a physician concerning a 17 year old female who on 08-JAN-2008 was vaccinated with her first dose of GARDASIL (659055/1522U). Concomitant therapy included hormonal contraceptived (unspecified). On 25-JAN-2008 the patient experienced joint pain, abdominal pain, low  grade fever, nausea, and headache. The patient sought medical attention in the doctors office. She saw her PCP, abdominal sonogram was within normal limits, a CBC and Chem 12 were within normal limits. Patient also saw an infectious disease specialist and is waiting on records. The patient's joint pain, abdominal pain, low grade fever, nausea, and headache persisted. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Headache, Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old female who in August 2007, was vaccinated with her first dose of Gardasil (lot# not provided).  Concomitant therapy included MENACTRA.  As the patient was walking out of the exam room she had a syncopal episode and hit her head really hard.  The patient has since been complaining about headaches.  The nurse practitioner sent the patient for an MRI which was negative for injuries and malignancies.  The patient received the second dose of Gardasil (lot# not provided) in October 2007 without a problem.  The patient's mother called the office on 07-MAR-2008 and reported her daughter still continues to have headaches.  It was not clear whether or not the patient would receive the third dose.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Blood aluminium increased, Depression, Immediate post-injection reaction, Mental disorder
Clinical narrative: Information has been received from a physician's assistant, via a company representative, concerning an 18 year old female patient, the daughter of one of her patients, who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported).  The PA stated the patient had been a normal 18 year old, who immediately after the vaccination, "started acting very strange, almost like she was on drugs, depressed."  She added the patient "started to have mental illness, drug-like symptoms."  The patient was taken to a specialist, who told her she had abnormally high levels of aluminum in her body as a result of receiving the Gardasil.  The specialist felt that the symptoms were caused by the aluminum.  At the time of this report, the outcome of the events was not specified.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Genital haemorrhage, Pregnancy test
Clinical narrative: Information has been received from a 20 year old female consumer for Merck pregnancy registry who on 23-JAN-2008 was vaccinated IM with a 0.5 ml first dose of Gardasil (lot# 657006/0188U).  There was no concomitant medication.  The patient indicated that she is now pregnant.  She had been experiencing "very light spotting" over the past two weeks which she did not experience with her previous pregnancies.  Medical attention was not sought.  The patient's very light spotting persisted.  The pregnancy outcome is unknown.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a female who in August 2007, was vaccinated with Gardasil.  The patient received the second dose of Gardasil in October 2007 and the third dose in February 2008.  Subsequently the patient experienced pruritus after the second dose of Gardasil.  The pruritus was described as severe enough to require treatment with an unspecified prescription of prednisone for an unspecified duration.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/7/2008. Follow up information received on 24-MAR-2008 stated that the patient's rash was found to be due to scabies. No further information was available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chronic fatigue syndrome, Dizziness, No adverse event, Temporomandibular joint syndrome
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female with chronic fatigue syndrome, and temporomandibular joint syndrome and a medical history of hyperrigidity of the right shoulder, who on 03-JUL-2007 was vaccinated with the first dose of Gardasil, and on 30-OCT-2007 and 27-FEB-2008 was vaccinated intramuscularly in the left arm with the second and third 0.5 mL doses of Gardasil, respectively.  Concomitant therapy included herbal supplements (unspecified).  On 27-FEB-2008 immediately after receiving the third dose, the patient felt lightheaded and experienced left arm pain.  The patient sought unspecified medical attention.  No diagnostic laboratory studies were done.  As of 03-MAR-2008 the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested. 07/08/08 This is in follow-up to report(s) previously submitted on 4/7/2008. On 15-APR-2008 the nurse reported that the left arm pain has resolved (specific date not given). No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who was vaccinated with the first dose of Gardasil. Subsequently, the patient passed out in her car on the way leaving the health department. She had not eaten before this dose. She was fine after being taken to a local restaurant. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nasopharyngitis, Pallor, Syncope
Clinical narrative: Information has been received from a mother of a 14 year old female who n 04-MAR-2008 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # not reported). There was no concomitant medication. On 04-MAR-2008 the patient experienced coldness in her head, syncope, dizziness and pallor after receiving vaccination. Subsequently, the patient recovered from coldness in her head, syncope, dizziness and pallor after 15 minutes. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/7/2008.  Follow up information was received.  A licensed practical nurse reported taht the patient, a white female with no known medical history who on 04-MAR-2008 was vaccinated IM in the right deltoid with the first dose of GARDASIL (lot # 655670/14590).  On 04-MAR-2008 the patient felt "cold" inside her head.  The symptom lasted about 10 minutes (previously reported as 15 minutes).  The patient recovered the same day.  No further information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse (RN), concerning a 25 year old female patient, who on 22-FEB-2008 was vaccinated IM, with the second dose, 0.5 ml, of Gardasil (lot #659657/1487U).  There was no concomitant medication.  On 02-MAR-2008 the patient developed "hives all over the body after receiving her second dose of Gardasil."  The patient went to an emergency room (ER), and was treated with prednisone and BENADRYL.  At the time of this report, the patient was recovering.  The RN considered the event to be serious as on other important medical event.  Additional information has been requested. This is in follow- up to report (s) previously submitted on 4/7/2008. Follow up from the RN, indicated that after the patient went to urgent care for treatment, there was no further follow up information provided to the office. No further information is available.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Fungal infection, Laboratory test
Clinical narrative: Information has been received from the mother of a female (age not reported) in November 2007, was vaccinated with the second dose of Gardasil (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). The mother reported that her daughter developed three yeast infections after receiving the second dose of Gardasil (lot # not reported) in November 2007. The patient status's was reported as not recovered. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Condition aggravated, Eye disorder
Clinical narrative: Information has been received from a 26 year old female who in 2006 was diagnosed with an "auto immune disease with her eyes."  The consumer reported that she received the first dose of Gardasil (lot not reported) in June 2007.  The patient received the second dose of Gardasil (lot not reported) on an unspecified date.  In August 2007, the patient reported she started unspecified immunosuppressive therapy for her auto immune disease with her eyes.  The patient's status was not reported.  No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with a 0.5 mL first dose of Gardasil (lot # not reported). The consumer reported that her daughter fainted after receiving Gardasil. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Back pain
Clinical narrative: Information has been received from a physician concerning a female who received her Gardasil doses on the following schedule: first dose 17-DEC-2007 (no lot # provided), second dose 16-JAN-2008 (no lot # provided), third dose 01-MAR-2008 (lot # 659655/1486U). On 04-MAR-2008, "approximately three days post vaccination" with her third dose of Gardasil (lot # 659655/1486U), the patient experienced severe back pain. The patient sought unspecified medical attention. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Culture throat, Tonsillar hypertrophy
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who on 14-AUG-2007 was vaccinated in the left arm with Gardasil (lot number reported as "0802U"). Concomitant therapy included MENACTRA (lot #42235AA) and BOOSTRIX (lot # C2734AA). On 19-SEP-2007 the patient experienced enlarged tonsils, throat culture have been performed. She has been seen five times for the same reason and has been referred to an ENT. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, MNQ, VARCEL
Symptoms: Drug exposure during pregnancy, Menorrhagia, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Information has been received through the pregnancy registry from a nurse practitioner concerning a 14 year old female with a history of anaemia and no allergies, who on 07-NOV-2007 and 09-JAN-2008 was vaccinated intramuscularly with the first and second 0.5 mL dose of Gardasil (Lot # 658490/0802U same Lot# for both doses), respectively. Concomitant therapies included HAVRIX, influenza virus vaccine (unspecified), MENACTRA, hormonal contraceptives (unspecified) and Varivax (MSD) (Lot# 658574/1269U). On 05-MAR-2008 the nurse practitioner reported that the patient is pregnant. It was reported that the patient had consistent bleeding so she didn't think she was pregnant. "It was believed that the patient was 26 weeks pregnant on 09-JAN-2008." The patient sought unspecified medical attention. Diagnostic studies performed included ultrasound ("everything is normal"), blood work-results unknown and urine pregnancy testing in February 2008. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 02/17/2010 It was reported that the patient moved out of state in her third trimester and the nurse practioner has had no further contact with the patient. This patient is lost to follow up. No further information is available.