chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Oedema peripheral, Pain
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no drug allergy, who on 30-APR-2010 was vaccinated intramuscularly with the first 0.5 ml dose GARDASIL (lot number not reported). Two days after receiving the vaccine, on 02-MAY-2010 the patient experienced swelling on hands and feet, so swollen that she couldn't walk. On an unknown date the therapy with GARDASIL was discontinued, no 2nd or 3rd doses given. After stopping therapy, the patient recovered from swelling on hands and feet. The patient called physician to seek medical attention. Follow up information has been received from the physician concerning the patient, a 24 year old female with a history of paroxysmal supraventricular tachycardia (PSVT). On 02-MAY-2010 at 6:00 PM the patient developed swelling in both feet, it was hard to walk with a lots of pain. The patient also had mild swelling in both hands. On 20-JUN-2010 the patient received the second dose of GARDASIL (lot # 0669Y) IM in the left deltoid (previously reported vaccine "discontinued, no 2nd or 3rd doses given"). No further information is available.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV2, HPV4, TDAP
Symptoms: Pyrexia
Clinical narrative: Information has been received from an office manager concerning an 11 year old female with no pertinent medical history and no drug reaction who on 20-NOV-2010 was vaccinated with the first dose of GARDASIL (lot# 666597/0768Z) (route, dose not reported) and CERVARIX. Second suspect therapy included AFLURIA (manufacturer unknown). Other concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. It was reported that the patient was being seen in the office due to a 104F fever on 22-NOV-2010. No lab diagnostics study was performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Nausea, Restless legs syndrome, Restlessness, Tremor, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female with allergy to Amoxicillin, cockroach, garlic and cottonwood pollen and no pertinent medical history who on 05-AUG-2010 was vaccinated with the first dose of GARDASIL (lot# 665607/1333Y). It was reported that the patient had no reaction to the first dose. On 21-OCT-2010, the patient received the second dose of GARDASIL (Lot# 666163/0664Z) and FLUZONE. Concomitant therapy included PREVACID. On 21-OCT-2010, within hours the patient awoke with shakes, tremors lasting 20 minutes. She walked around for awhile and experienced nausea and vomited twice. On 22-OCT-2010 morning the patient had restlessness and nausea. The patient sought unspecified medical attention. No laboratory diagnostic study was performed. At the time of the reporting, the patient was recovering. Follow up information received from the physician concerning the female student with no pre-existing allergies (this conflicts with the previously reported), birth defects, medical conditions and no illness at time of vaccination who on 21-OCT-2010 was vaccinated IM with the first dose (this conflicted with the previously reported as the second dose) of GARDASIL (Lot# 666163/0664Z) and IM with the first dose of FLUZONE (lot number U3569C). On 21-OCT-2010 the patient experienced nausea, vomiting and restless legs. The patient took promethazine, 25mg, 1 dose, for nausea. On 23-OCT-2010 the patient was recovered. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Chills, Nausea, Restless legs syndrome, Tremor, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old female with allergy to Amoxicillin, cockroach, garlic and cottonwood pollen and no pertinent medical history who on 05-AUG-2010 was vaccinated with the first dose of GARDASIL (lot# 665607/1333Y). It was reported that the patient had no reaction to the first dose. On 21-OCT-2010, the patient received the second dose of GARDASIL (Lot# 666163/0664Z) and FLUZONE. Concomitant therapy included PREVACID. On 21-OCT-2010, within hours the patient awoke with shakes, tremors lasting 20 minutes. She walked around for awhile and experienced nausea and vomited twice. On 22-OCT-2010 morning the patient had restlessness and nausea. The patient sought unspecified medical attention. No laboratory diagnostic study was performed. At the time of the reporting, the patient was recovering. Follow up information received from the physician concerning the female student with no pre-existing allergies (this conflicts with the previously reported), birth defects, medical conditions and no illness at time of vaccination who on 21-OCT-2010 was vaccinated IM with the first dose (this conflicted with the previously reported as the second dose) of GARDASIL (Lot# 666163/0664Z) and IM with the first dose of FLUZONE (lot number U3569C). On 21-OCT-2010 the patient experienced nausea, vomiting and restless legs. The patient took promethazine, 25mg, 1 dose, for nausea. On 23-OCT-2010 the patient was recovered. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Testicular pain
Clinical narrative: Information has been received from a physician concerning a male patient who on unspecified dates was vaccinated intramuscularly with 3 doses series of GARDASIL (lot # not provided). "Back in September", the patient experienced testicular pain. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a female who on an unknown date, was vaccinated with GARDASIL (dose, route, and lot# not reported). It was reported that the patient had a positive HPV reflex come back after being administered vaccination. The patient sought unsuspected medical attention. At the time of report, the outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female patient who on 28-AUG-2009 was vaccinated with a first dose of GARDASIL (Lot# 1129F) and on unspecified date was vaccinated with a second dose of GARDASIL (Lot# 663454/0672Y) and on approximately September of 2010 was vaccinated with a third dose of GARDASIL (Lot# 663454/0672Y). Concomitant therapy included MENACTRA and Tdap, "the same day of her last injection". The medical assistant stated that the patient experienced changes in her menstrual cycle after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Oligomenorrhoea
Clinical narrative: Information has been received from an approximately 23 year old female consumer with no pertinent medical history or drug reactions/allergies, who on 22-JUL-2010 was vaccinated with the first dose of GARDASIL and on 23-AUG-2010 with the second dose. There was no concomitant medication. The patient reported that her menses (period of bleeding during menstrual cycle) had not changed, but the period between menses (total menstrual cycle) had increased from her normal cycle (28 to 30 days), to 40 45 days post vaccination with GARDASIL. The patient noticed increased cycle onset began after first dose of GARDASIL was administered. The patient was currently in her third cycle of menses (post vaccination with GARDASIL), which started on 08-NOV-2010 and was continuing on the date of the report. The patient had no other complaints or problems. The patient did not seek medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from a registered nurse who indicated that on 22-JUL-2010 at 2:50 p.m. the patient was vaccinated IM with a first dose of GARDASIL (lot# 665547/1318Y) in her left deltoid. The reporter stated that the patient reported a change in menstrual cycle after receiving GARDASIL. The patient previously had her menstrual period every 28-30 days. After receiving GARDASIL, the patient's menstrual periods occurred every 45-50 days. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pruritus, Pyrexia, Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female with depression and gastrooesophageal reflux disease (reported as "GERD") and no drug reactions and allergies who on 09-NOV-2010 was vaccinated IM in her left arm with the first dose of GARDASIL. Concomitant therapy included PROZAC and omeprazole. The patient experienced itching, headache, nausea, vomiting, fever and fainting that same day. The physician prescribed REGLAN for the vomiting. No lab diagnostics were performed. At the time of reporting the outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female with depression and gastrooesophageal reflux disease (reported as "GERD") and no drug reactions and allergies who on 09-NOV-2010 was vaccinated IM in her left arm with the first dose of GARDASIL. Concomitant therapy included PROZAC and omeprazole. The patient experienced itching, headache, nausea, vomiting, fever and fainting that same day. The physician prescribed REGLAN for the vomiting. No lab diagnostics were performed. At the time of reporting the outcome was unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 9 year old female who on 08-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not provided). Concomitant therapy included influenza virus vaccine (unspecified) (Lot # not provided) given on the same day. It was reported that the patient complained of a headache within 15 minutes of administration of her first dose of GARDASIL. The patient was monitored in the office and was able to leave the office fully recovered without requiring treatment. The medical assistant added that the patient "had a thin build". She also reported that "she had seen this reaction more commonly in younger patients". Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female with allergies to VICODIN and nuts and no pertinent medical history who on 12-OCT-2010 was vaccinated intramuscularly on her left arm with the first 0.5 ml dose of GARDASIL (lot# 0450Z). Concomitant therapy included DESOGEN. On 23-OCT-2010 "11 days after administration" the patient developed a rash on her left arm. Nurse stated that the patient had sent in a picture of the rash and it looked slightly vesicular. The patient said she would be going to an unspecified dermatologist. No diagnostic laboratory tests were performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by office call. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Hot flush, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female patient who on 03-NOV-2010 was vaccinated with the first dose of GARDASIL (lot # 666596/0766Z, expire date and route not reported), 0.5 ml. "Within 4-5 days of getting vaccinated" (on approximately 07-NOV-2010), the patient developed "welts on her face and started having hot flashes". The patient was given ZYRTEC to treat her condition. There were no laboratory diagnostics studies performed. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 24 year old female with no medical history and no drug allergies who on 05-NOV-2010 ("last Friday") was intramuscularly vaccinated with the third dose of GARDASIL (lot # not reported). There was no concomitant medication. On 09-NOV-2010 ("Tuesday") the patient experienced pain, stiffness, swollen lump and warmness at injection site. At the time of reporting the patient was recovering. No lab diagnostics studies were performed. The patient didn't seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient, who on an unspecified date, received the series of GARDASIL (lot # unknown). The patient received the vaccine series prior to "her sexual debut". Shortly after engaging in sexual activity, on an unspecified date, the patient developed vaccine type HPV. It was unknown if the patient sought medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix normal
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with lactose intolerance and a history of viral hepatitis C who "while she was in high school" was vaccinated with the first and second doses of GARDASIL (dose, route and lot# not reported). Concomitant therapy included oral birth control. The nurse stated that the patient was in the office today (29-NOV-2010) requesting the third dose. The nurse also mentioned that in the patient's chart it was indicated that the patient had a history of HPV infection but was not certain if this infection occurred before or after the patient received either dose of GARDASIL. Nurse did not know if the patient received any treatment for the HPV infection. The patient had had Pap smears on 04-AUG-2009 and 02-AUG-2010 which were normal, and HPV testing was not performed, "based on the cytology". The patient recovered from the HPV infection on an unknown date. This is an amended report. Upon review of the file, another AE code "HPV infection" was added. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dysuria, Human papilloma virus test positive, Papilloma viral infection, Vulvovaginal pruritus
Clinical narrative: Information has been received from a physician assistant concerning a 17 year old female with no drug reaction/allergies and no pertinent medical history, who was vaccinated with GARDASIL (route and lot # not reported). There was no concomitant medication. On approximately 19-SEP-2010, 1 month ago, the patient experienced burning with urination, vaginal itching and went to the emergency room. The emergency room did a sexually transmitted disease (STD) screening and diagnosed with HPV. The patient was seen at the office and the physician assistant had a repeat test for HPV for the patient. At the time of this report, there was no result. The patient sought medical attention by office visit. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: Information has been received from a physician assistant concerning a 21 year old female with a history of papilloma viral infection (unspecified onset) and no drug reactions and allergies who on 10-JAN-2008 was vaccinated IM with the first dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. It was reported that the patient's HPV status was not confirmed prior to the first dose. On 14-JUL-2010, a Papanicolaou (PAP) smear was done and it came back positive for HPV. It was reported that the patient upon hearing the positive HPV test stated that she has a history of HPV, but the practitioner was unable to confirm when or how this was determined. On 28-JUL-2010, the patient received the second dose of GARDASIL. At the time of the report, the patient status was reported as HPV positive. The patient did not seek medical attention. Follow-up information has been received. It was reported that there was no adverse reaction. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Alopecia, Blood test, Headache, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a female patient who in approximately October 2010 was vaccinated with the first dose of GARDASIL (lot #, expire date and route not reported) 0.5 ml. In approximately October 2010, 72 hours after receiving GARDASIL, the patient experienced nausea, headache, abdominal pain and hair loss lasting for an unspecified period of time. On an unspecified date "blood work" was performed but results were not provided. The patient sought medical attention first at the clinic where she received the vaccine and then went to a hospital and received outpatient treatment. At the time of the report, patient had recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Syncope
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 15 year old female patient, with no pertinent medical history and no drug reactions or allergies, who on 13-NOV-2010 was vaccinated with the first dose of GARDASIL (lot # 666595/0992Z, expire date October 2012), 0.5 ml, intramuscularly. There was no concomitant medication. The patient fainted 30 seconds after receiving her first dose of GARDASIL (on 13-NOV-2010). The patient fainted and exhibited "jerky movements with clenched fists". The patient was monitored and left the office fully recovered within 1 hour. The licensed practical nurse also added that the patient had not eaten that day prior to the vaccination. There were no laboratory diagnostics studies performed. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: Information has been received from an 18 year old female for GARDASIL, a Pregnancy Registry product, concerning herself, who on 13-OCT-2010 was vaccinated with the first dose of GARDASIL. The patient had no relevant medical history, concomitant medications, and past drug history. After receiving the GARDASIL vaccine, she developed vaginal bleeding on 20-OCT-2010. On 21-OCT-2010, she found out that she was one month and one week pregnant. The patient's last menstrual period was approximately 14-SEP-2010, estimated delivery date was approximately 21-Jun-2011. There is no relevant laboratory data. The patient did not have a physician. As of 23-OCT-2010, it is unknown if the consumer plans to complete the GARDASIL vaccination series, and she continues to experience vaginal bleeding. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from an unspecified source concerning a female patient who on an unspecified date was vaccinated with an unspecified dose of GARDASIL (Lot# unknown). It was reported that on an unspecified date, the patient experienced hair loss. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a consumer who posted her daughter's experience on internet. On an unspecified date after her yearly visit the patient was vaccinated with a second dose of GARDASIL (Lot# unknown). The consumer reported that their doctor recommended it strongly. She stated that had taken 2 years for them to finally figure out what was wrong with her daughter. The consumer mentioned that a friend of her posted a video on a web site and that was how they learned of this. The consumer said that her daughter had been to numerous doctors including cardiologist, internal medicine, 3 neurologist, a couple of general practitioners and not one of them mentioned this could be the problem. The consumer stated "she has no life now because of the shot". The second dose was all it took. She mentioned that they want their daughter back. At the time of the report, the outcome of the patient was not reported. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix normal, Colposcopy normal, Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female patient with no pertinent medical history, who in November 2006, January 2007 and May 2007, "0, 2, 6 month schedule" was vaccinated with a three 0.5 ml doses of GARDASIL (Lot # not reported) IM, respectively. The medical assistant reported that this summer, in approximately June 2010, the patient had an abnormal PAP, she tested HPV positive, she had a colposcopy in which the biopsy was normal. She said PAP was going to be repeated in six months. At the time of the report the patient's outcome was unknown. Follow-up information was received from a medical assistant who stated that the 20 year old female consumer was not their patient. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Pruritus generalised
Clinical narrative: Information has been received from a licensed registered nurse (L.N.P.) concerning a female patient in her early 20's, who on unspecified date was vaccinated with a second 0.5 ml dose of GARDASIL (Lot # not reported) IM. The nurse said that the patient experienced systemic pruritus after being administered GARDASIL. The patient did not seek medical attention. At the time of the report the outcome of the patient was unknown. Follow-up information was received from a licensed practical nurse who stated that the 14 year old female patient with a history of pertussis per her mother and no illness at time of vaccination on 15-NOV-2010, was vaccinated IM in the right arm with the second dose of GARDASIL (lot# 666948/0886Z) at 14:40. Concomitant therapy included a dose of FLUZONE (lot# 6T3620BA) given on 02-NOV-2010, IM in the left arm at 16:15. The patient's mother reported that on 16-NOV-2010, her daughter experienced generalize body itching without rash. There was no relevant diagnostic test performed. On an unspecified date the patient recovered. The patient did not seek medical attention. No further information is available.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a health professional concerning his/her nephew, an 18 year old male who on 05-AUG-2010 was vaccinated the first  0.5ml dose of with GARDASIL (Lot number not provided). On 05-AUG-2010 the patient experienced dizziness and fainting immediately after being administered GARDASIL. It was reported that the patient was planning to get his second and third doses of the regimen (also reported that the therapy was discontinued on 05-AUG-2010). The patient sought unspecified medical attention. The adverse events improved after therapy. At the time of the reporting, the patient was recovering. The patient's twin brother also experienced dizziness and fainting after being administered his first dose of GARDASIL (WAES#1010USA02874). Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a health professional concerning his/her nephew, an 18 year old male who on 05-AUG-2010 was vaccinated the first 0.5ml dose of with GARDASIL (Lot number not provided). On 05-AUG-2010 the patient experienced dizziness and fainting immediately after being administered GARDASIL. It was reported that the patient was planning to get his second and third doses of the regimen (also reported that the therapy was discontinued on 05-AUG-2010). The patient sought unspecified medical attention. The adverse events improved after therapy. At the time of the reporting, the patient was recovering. The patient's twin brother also experienced dizziness and fainting after being administered his first dose of GARDASIL (WAES#1010USA02874). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a Physician assistant concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported). The patient experienced hair loss after receiving GARDASIL. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old female patient who on 24-SEP-2010 was vaccinated with a first 0.5ml dose of GARDASIL (Lot# 662765/1353Y), IM. Concomitantly on the same day, she received a dose of influenza virus vaccine (manufacturer unknown). It was reported that the patient experienced changes in her menstrual cycle after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who on unspecified date received three doses of GARDASIL (Lot# not reported), IM. The physician stated that the patient experienced test results that determined the woman to be in high risk for Human Papillomavirus (HPV) with mild dysplasia after being administered GARDASIL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. This is one from several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blister, Injection site cellulitis, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a "10 1/2 year old" female patient, who on 19-NOV-2007 was vaccinated with a dose of VARIVAX (Merck) (route, dose and Lot # not reported) in her right arm and a dose of GARDASIL (route, dose and Lot # not reported) in her left arm. The nurse stated that she did not find out it until 18-NOV-2010 when the patient was at a doctor's appointment. The nurse stated that on 19-NOV-2007 (also reported as 21-NOV-2010), once the patient was given both the GARDASIL and VARIVAX (Merck) vaccinations, the patient had developed swelling and blisters and went to the emergency room. The patient was treated for cellulitis at the hospital and discharged on an antihistamine and BACTRIM. At the time of the report, the patient had recovered. Follow up information has been received via telephone call from a Licensed Practical Nurse concerning the female patient. He stated that the patient was not admitted to the hospital and that the event was not emergent but the Emergency Room (ER) was the easiest place for the patient to get to at that time. There were no serious criteria reported to him by the nurse practitioner. The patient or her mother had not even report the event to the doctor's office. The only way they found out was that the patient was seen at a recent well visit and they told the nurse at that time. The cellulitis was diagnosed in the left arm in which GARDASIL (Lot# not reported) was given. It was reported that the patient will receive not the second dose of GARDASIL. He stated that the nurse was asking about the patient perhaps now receiving a dose of CERVARIX. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Culture negative, Drug administered to patient of inappropriate age, Gynaecological examination, Vaginal discharge, Vaginal infection
Clinical narrative: Information has been received from a physician and an office manager concerning a 34 year old female patient who, on 19-JUN-2008, was vaccinated with her first dose of GARDASIL (Lot # 0152X, expire date 09-NOV-2009 and route not reported) in her left deltoid. On 19-AUG-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 0152X, expire date 09-NOV-2009 and route not reported) in her left deltoid and on 22-DEC-2008, the patient was vaccinated with the third dose of GARDASIL (Lot #, expire date and route not reported) in her left deltoid. The physician reported that the patient while on GARDASIL, had a "weird vaginal discharge". Also the office manager reported that the patient had had chronic vaginitis since receiving GARDASIL (on approximately 19-JUN-2008). The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from a physician who indicated that the patient received three doses of GARDASIL between June 2008 and December 2008 on her request, as she was 35 years old at that time (34 years old when receiving first dose). In December 2008 the patient began having chronic heavy discharge that had been resistant to all treatment. No cultures were positive. The physician suspected that the vaccine may have had triggered some type of exaggerated immune or inflammatory response. Multiple cultures and exams had been performed by specialists (results not provided). At the time of the report, the patient had not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated IM with a second dose of GARDASIL (lot # not provided) for prevention of cervical cancer. "A couple of weeks ago" the patient became faint after receiving the second GARDASIL. Subsequently the patient recovered in the office. No lab diagnostics studies performed. Patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Axillary pain, Back pain, Pain in extremity
Clinical narrative: Information has been received from nurse concerning a 21 year old female patient who on 22-NOV-2010 was vaccinated with the first dose of GARDASIL (Lot #, expire date and route not reported). An hour and 15 minutes after receiving the first dose of GARDASIL, the patient went to the emergency room with severe pain in her leg and the patient was treated with ibuprofen. Patient still had leg pain. Patient also started experiencing low back pain as well, and later, armpit pain. At the time of the report, the outcome of low back and armpit pain were unknown. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with not illness at the time of vaccination and no pre-existing allergies, birth defects or medical condition who on 13-SEP-2010 at 15:00 pm was vaccinated intramuscularly with the first dose of GARDASIL (Lot # 666929/0331Z). The registered nurse reported that on 14-SEP-2010, the morning after the patient received the dose of GARDASIL at 08:00 am, she complained of itching and rash on the back of her neck and to her back, then abdomen, thighs and legs. The patient took BENADRYL and relieved. On 15-SEP-2010 she had recovered. The physician reported that the patient would not continued with the second and third dose of GARDASIL. The patient did not seek medical attention. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alanine aminotransferase increased, Alopecia, Blood alkaline phosphatase normal, Depression, Differential white blood cell count normal
Clinical narrative: Information has been received from a consumer concerning her daughter, a 15 year old female patient who in "the end of August 2010", was vaccinated with a first dose of GARDASIL (Lot# not reported). The daughter's mother stated that on 26-NOV-2010 her daughter had experienced "hair loss and depressed" after receiving the second dose of GARDASIL (lot number not reported). At the time of the report the patient had not recovered. The patient did not seek medical attention. Follow-up information received on 25-JAN-2011 from a Nurse Practitioner (CRNP) and medical records noted that a 15 year old female (156 lbs) with no known drug allergies was vaccinated on 17-NOV-2010 with a second dose (previously reported as first dose) of GARDASIL (Lot# 663453/0249Y) IM in the right deltoid. First dose was given on 14-SEP-2010 (lot #663453/0249Y). The patient had also received HAVRIX at the same time. On approximately 24-NOV-2010 the patient developed fatigue and hair loss. Lab work on 20-NOV-2010 showed normal complete blood count with differential and normal comprehensive metabolic panel, other than alkaline phosphatase of 94 U/L and ALT of 37 U/L. The patient did not require any treatment or doctor's visit. The patient's mother reported that her symptoms were improved around 25-DEC-2010. The Nurse practitioner felt that the patient had recovered at the time of report. All available medical records will be provided upon request. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Full blood count normal, Metabolic function test normal
Clinical narrative: Information has been received from a consumer concerning her daughter, a 15 year old female patient who in "the end of August 2010", was vaccinated with a first dose of GARDASIL (Lot# not reported). The daughter's mother stated that on 26-NOV-2010 her daughter had experienced "hair loss and depressed" after receiving the second dose of GARDASIL (lot number not reported). At the time of the report the patient had not recovered. The patient did not seek medical attention. Follow-up information received on 25-JAN-2011 from a Nurse Practitioner (CRNP) and medical records noted that a 15 year old female (156 lbs) with no known drug allergies was vaccinated on 17-NOV-2010 with a second dose (previously reported as first dose) of GARDASIL (Lot# 663453/0249Y) IM in the right deltoid. First dose was given on 14-SEP-2010 (lot #663453/0249Y). The patient had also received HAVRIX at the same time. On approximately 24-NOV-2010 the patient developed fatigue and hair loss. Lab work on 20-NOV-2010 showed normal complete blood count with differential and normal comprehensive metabolic panel, other than alkaline phosphatase of 94 U/L and ALT of 37 U/L. The patient did not require any treatment or doctor's visit. The patient's mother reported that her symptoms were improved around 25-DEC-2010. The Nurse practitioner felt that the patient had recovered at the time of report. All available medical records will be provided upon request. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Allergy test negative, Blood test normal, Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 year old female patient who on in September 2010 was vaccinated with the third dose of GARDASIL (Lot # and route not reported). The certified medical assistant reported that the patient developed hives post vaccination and still had hives at the time of the report. The patient was seen by a dermatologist and her allergy tests were negative. Follow up information has been received from a physician concerning the female student patient with no known allergies who on 15-SEP-2010 was vaccinated with the third dose of GARDASIL (Lot# unknown). There was no concomitant medication. The physician reported that on 29-NOV-2010, the patient presented to office for urticarial eruption (generalized) of 3 months duration. Initial eruption occurred after the third dose of vaccine in approximately 15-SEP-2010. Blood tests were performed by allergist, all were normal. The patient was treated with ZYRTEC, 10 mg, every other night. At the time of the report, the patient had recovered. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy site unspecified abnormal, Papilloma viral infection
Clinical narrative: Information has been received from a 22 year old female with no pertinent medical history and no drug reactions and allergies who on 20-AUG-2007 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot number not provided). Concomitant therapy included ZOVIA. In July 2010, a year after she received all 3 injections of GARDASIL, biopsy was performed and the patient found out she had HPV. The patient sought unspecified medical attention. At time of the report, the patient's outcome was unknown. No further information is available.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a first dose of GARDASIL (therapy route and lot # not provided). On an unspecified date the patient experienced syncopal episode after the first dose of GARDASIL. Patient sought medical attention by speaking to physician. At the time of reporting, patient's status was not provided. Follow up information has been received from a health care professional who reported they did not know which patient experienced this adverse event. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female with no drug reactions who on 24-JUL-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (SQ) and then got shingles. Concomitant therapy "has a list" and was unspecified. The patient sought medical attention by phone. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Condition aggravated, Early satiety, Gastric disorder, Gastric hypomotility, Laboratory test abnormal
Clinical narrative: This is a verbatim narrative as reported on a website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Jan 01, 2007. Male patient, 38 years of age, was vaccinated with FLUMIST on Dec 31, 2006. "Approximately 2 months after the vaccination the patient began to experience vomiting, nausea and early satiety. The symptoms never resolved and that patient has chronic nausea and early satiety. Studies done revealed damage to the Vagal Nerve (presumed post viral) with resulting Gastric Antral Hypomotility and impaired Gastric Accommodation. After 2 years of Chronic Nausea the patient required a gastric electrical stimulator placed. This improved symptoms about 50% although the patient still suffers from chronic nausea and early satiety.". . As a child had 6 month episode of unexplained nausea...then went away. For several years prior to current illness had periodic...single day...episodes of unexplained nausea.. Patient was hospitalized Patient recovered."
Age: 38.0
Sex: M
Vaccine: FLUN3
Symptoms: Nausea, Vagus nerve disorder, Vomiting
Clinical narrative: This is a verbatim narrative as reported on a website, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Jan 01, 2007. Male patient, 38 years of age, was vaccinated with FLUMIST on Dec 31, 2006. "Approximately 2 months after the vaccination the patient began to experience vomiting, nausea and early satiety. The symptoms never resolved and that patient has chronic nausea and early satiety. Studies done revealed damage to the Vagal Nerve (presumed post viral) with resulting Gastric Antral Hypomotility and impaired Gastric Accommodation. After 2 years of Chronic Nausea the patient required a gastric electrical stimulator placed. This improved symptoms about 50% although the patient still suffers from chronic nausea and early satiety.". . As a child had 6 month episode of unexplained nausea...then went away. For several years prior to current illness had periodic...single day...episodes of unexplained nausea.. Patient was hospitalized Patient recovered."
Age: 42.0
Sex: M
Vaccine: FLUN3
Symptoms: Hypotension, Pneumonia, Pyrexia
Clinical narrative: This is a verbatim narrative as reported, accessed on 28 July 2011. According to these reports they were from FDA VAERS. "FLUMIST problem as reported on Jan 12, 2007. Male patient, 42 years of age, was vaccinated with FLUMIST on Jan 07, 2007. Pneumonia diagnosed and treated by medical center on 20Nov06. Had fever for 1 week before treatment. Vaccine administered on 05Nov06. Treated with moxifloxacin 400 mg. MR received for 5 day hospital admission due to pneumonia and hypotension. Pt. developed fever 3 days post FLUMIST and continue to have fever x 1 week prior to admission. Treated with abx. with good response except for residual febrile episodes. Discharged home after 5 days. DX: Pneumonia...NONE. PMH: none noted. Allergies: none noted...Patient was hospitalized patient recovered."
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Bronchitis, Clostridium difficile colitis
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Jan 16, 2007. Female patient, 42 years of age, was vaccinated with FLUMIST on Jan 08, 2007. "On 12 Oct 2006, two days after receiving FLUMIST therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving FLUMIST therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on KETEK and MEDROL DOSE PAK therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FLUMIST therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FLUMIST therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with DILAUDID, hydration therapy and clear liquids. The patient indicated that she received no antibody therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to KETEK therapy. No reporter causality as it related to FLUMIST therapy was provided.". None. Mitral valve repair - 2004. Patient recovered."
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Computerised tomogram abnormal, Cough, Diarrhoea, Diarrhoea haemorrhagic, Feeling of body temperature change
Clinical narrative: This is a verbatim narrative as reported on a web site, accessed on 28 July 2011. According to the web site these reports were from FDA VAERS. "FLUMIST problem was reported on Jan 16, 2007. Female patient, 42 years of age, was vaccinated with FLUMIST on Jan 08, 2007. "On 12 Oct 2006, two days after receiving FLUMIST therapy, a 42 year old female nurse patient experienced, feeling sick, fever like symptoms, thick mucous, congestion, diarrhea, stomach pain, joint pain and teeth pain. The sick feeling, fever like symptoms, diarrhea and stomach pain resolved on 16 Oct 2006. On 16 Oct 2006, six days after receiving FLUMIST therapy, the patient experienced coughing and bronchitis. The congestion began to manifest itself at night as well. These events persisted for two weeks. On 09 Nov 2006, the patient was seen by her primary care physician and described the events. No X rays, cultures or labs were taken. The patient was placed on KETEK and MEDROL DOSE PAK therapy. The events of joint pain, teeth pain, coughing, thick mucous, congestion at night and bronchitis resolved on 16 Nov 2006. The patient indicated that she was able to breathe freely and that her lungs were clear. On 25 Nov 2006, 46 days after receiving FLUMIST therapy, the patient experienced abdominal pain, which progressed to blood diarrhea. A computed tomography scan on 25 Nov 2006 showed an enlarged right, colon, but a mal closure could not be ruled out. On 30 Nov 2006, 51 days after receiving FLUMIST therapy, the patient was hospitalized for bloody diarrhea. The initial clinical impression was clostridium difficile. The patient was treated with DILAUDID, hydration therapy and clear liquids. The patient indicated that she received no antibody therapy while hospitalized. She was discharged on 03 Dec 2006. The events of abdominal pain, blood diarrhea and bacterial colitis were resolved at that time. The patient indicated that the events of abdominal pain, bloody diarrhea and bacterial colitis were most likely due to KETEK therapy. No reporter causality as it related to FLUMIST therapy was provided.". None. Mitral valve repair - 2004. Patient recovered."