chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Muscle spasms, Myalgia
Clinical narrative: Information has been received from a consumer concerning her daughter, a 14 year old female with a history of mononucleosis and no drug reaction who in March 2008, was vaccinated with the first dose of GARDASIL. Concomitant therapy included LOESTRIN FE. The patient experienced headache, muscle spasm, muscle pain and muscle aches ever since she received her first dose of GARDASIL. It was noted that the patient had received two doses of GARDASIL. At the time of report the patient was not recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise
Clinical narrative: Information has been received from an 18 year old female with no known drug allergies/reactions and no pertinent medical history reported who on an unspecified date was vaccinated with the first dose of GARDASIL.  There was no concomitant medication. The patient reported that she felt sick after taking the first dose of GARDASIL. The patient did not seek medical attention. No labs were performed. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Groin pain, Local swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 21 year old female with no medical history and drug allergies who on 11-MAR-2009 was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (660616/0570X). There was no concomitant medication. On 13-MAR-2009 the patient developed groin pain and a lump in her groin. The side of the groin that is affected was unspecified. The patient was seen in the physician's office. Sexually transmitted disease cultures were collected at the same visit that the second dose of vaccine was given. At the time of reporting (16-MAR-2009) the patient was not recovered. The patient was vaccinated intramuscularly with her first 0.5 ml dose of vaccine on 04-DEC-2008 (660616/0570X). This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a female with latex allergy who was vaccinated with a dose of GARDASIL, IM, 0.5ml. Subsequently the patient experienced "some type of allergic reaction". Symptoms of reaction were unspecified by reporter. The patient sought medical attention, office visit. At time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Fatigue, Headache, Laboratory test, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter with allergies to penicillin and other antibiotic and no pertinent medical history who in approximately 2008 ("about a year ago"), in fall 2008, and on 26-JAN-2009 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # not provided). There was no concomitant medication. On approximately 26-JAN-2009 ("right after she received the third dose") the patient experienced extreme fatigue, vomiting and headache that seemed to be getting worse everyday. Blood panel and CAT scan were performed (no results provided). At the time of reporting, the patient's extreme fatigue, vomiting and headache persisted. The patient sought medical attention via visiting primary care physician and pediatrician. Additional information has been requested.  5/13/09 medical records received DOS 1/26/09 to 3/31/09. FINAL DIAGNOSIS: Nausea and vomiting secondary to psychological issue. Post-vaccination feeling weak, tired, abdominal pain, fever, projectile vomiting, diarrhea. Bloody urine and cramps. Sore throat and swollen glands. Upper quandrant tenderness. Burning sensation in chest. Dizzeness, not eating well. Othostatic hypotension. Referred to counseling center. To schedule STD screening and pelvic exam.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 24 year old female who on 16-MAR-2009 was vaccinated with a 0.5 ml dose of GARDASIL. When she got home she had a rash on her forearm. Unspecified medical attention was sought. On 17-MAR-2009 the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a female who was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL on 17-MAR-2009. On 17-MAR-2009 the patient experienced pain at the injection site immediately after the second dose of vaccine. The patient was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL "3 months ago" At the time of reporting (17-MAR-2009) the patient was not recovered. The patient sought medical attention by visiting the physician's office. No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pain, Pregnancy test positive, Tuberculin test positive
Clinical narrative: Information has been received from a 23 year old female with allergy to anything in the "cillin family" and a history of cesarean section and tuberculosis exposure, for the Pregnancy Registry for GARDASIL, who on 05-SEP-2008 was vaccinated with the first dose of GARDASIL. On 05-NOV-2008 the patient was vaccinated with the second dose of GARDASIL. On 16-MAR-2009 the patient was vaccinated with the third dose of GARDASIL. Home pregnancy test was done. The patient was pregnant now. Her LMP was 16-FEB-2009. On approximately 17-MAR-2009, "currently", she was experiencing sharp pains located "4 inches below her belly button and 4 inches to the left of her belly button". She stated the pain might be due to a previous cesarean section. Unspecified medical attention was sought by phone call. Follow-up information was received from the physician via a completed initial pregnancy questionnaire. It was reported that the patient had one previous pregnancy and one full term delivery. There were no birth defects or infant complications in the previous pregnancy. The patient's PPD tuberculin test was positive. The patient was taking isoniazid and vitamin B6 for the positive PPD concurrently. The lot number for the third dose of GARDASIL was provided as 661953/1130X. No other information provided at the this time. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Loop electrosurgical excision procedure, Smear cervix abnormal
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who in 2007 was vaccinated with a dose of GARDASIL. In 2009 the patient came up with an abnormal pap. In 2007 the patient had a LEEP procedure and in 2008 had a normal pap test. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Groin pain, Local swelling
Clinical narrative: Information has been received from a healthcare worker concerning a female who experienced groin pain and a lump in her groin after receiving a dose of GARDASIL (660616/0570X). The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Cough, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Information has been received from a registered nurse concerning her daughter, an 11 year old female patient with no pertinent medical history and no known drug allergies, who on 23-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# not reported) and 20 minutes later developed a stiff neck while riding home from the doctor's office. There was no concomitant medication. The stiff neck resolved after the ride. On 23-DEC-2008, the daughter had a second dose of GARDASIL (lot# not reported) and within 11 days she developed a "constant cough and an enlarged lymph node at the cervical area". There was no concomitant medication. Patient was seen at the doctor's office. No abnormal labs. The cough lasted all of January and February and impeded in her basketball activity. She was given Z-PACK and TESSALON PEARLS but it did not help. She was also given Hydrocodone and TUSSIONEX that helped some days but made her drowsy. Both the cough and enlarged lymph nodes resolved by March. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Gastrointestinal disorder, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female patient with a history of urinary tract infection who in the last couple of weeks was vaccinated with GARDASIL. Fairly recently, the patient presented with high fever and some gastrointestinal issues after receiving GARDASIL. A blood work was performed with unknown results. The patient's outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a female patient who on an unknown date was vaccinated with the first dose of GARDASIL. The patient experienced syncope after receiving the GARDASIL. It was reported that the patient had a viral illness at the time of injection. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Drug exposure during pregnancy, Malaise, Urine human chorionic gonadotropin positive, Vomiting
Clinical narrative: Information has been received from a certified medical assistant, for the GARDASIL a Pregnancy Registry, concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 02-FEB-2009 was vaccinated with the first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included HAVRIX. It was reported that the patient received her first dose of GARDASIL while pregnant. LMP was in January 2009, EDD was approximately 08-OCT-2009. The patient was seen at the physician's office for vomiting and feeling ill. Laboratory test performed on an unspecified date included urine pregnancy test. Patient's outcome for vomiting and feeling ill is unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Echocardiogram
Clinical narrative: Information has been received from an emergency medical technician concerning a 15 year old female with asthma who was vaccinated with the complete series of GARDASIL on an unspecified dates in the past. In September 2008, the patient experienced shortness of breath. The shortness of breath occurred when she was stressed or sitting still and not when exercising. She was seen in the office and Echocardiogram was performed but no result was provided. She has been prescribed antibiotics and 2 "puffers" (unknown names and manufacturers for both). At the time of reporting, the patient's shortness of breath persisted. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Lymphadenopathy, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Information has been received from a physician concerning a registered nurse who was vaccinated with her first dose of GARDASIL. 6 weeks after her first vaccination the patient experienced a fever and swollen cervical lymph nodes. The patient was treated with steroids. The nurse also experienced a fever and swollen cervical lymph nodes after her second dose of GARDASIL. She was treated again with steroids. The physician reported that the nurse approached her while working at the hospital for medical attention. The physician did not have any additional information since the nurse was not her patient. It was also reported that the patient underwent a CT scan (results not reported). No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Contraception, Dyspnoea, Restlessness
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female patient with no pertinent medical history and no known drug allergies/reactions who on 17-MAR-2009 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 0250X). Concomitant therapy included ORTHO-CYCLEN. On 17-MAR-2009 the patient experienced restless, shortness of breath and anxiety around the bedtime. No lab diagnostics studies were performed. At the time of reporting, the outcome was unknown. The patient sought medical attention via calling nurse practitioner. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with the first 0.5 ml dose of GARDASIL. Subsequently the patient experienced fainted. On approximately 6-NOV-2007, the patient received the second 0.5 ml dose of GARDASIL (lot # 658222/0927U). The patient experienced light headed and vomited. Therapy with GARDASIL was discontinued on 6-NOV-2007. On 6-NOV-2007, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female with no pertinent medical history or drug reactions or allergies and no pregnant who on 21-AUG-2008 was vaccinated IM with the first 0.5 ml dose of GARDASIL. On 29-OCT-2008 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL. On 11-MAR-2009 the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # 654510/0962F). There was no concomitant medication. It was reported that the third dose of GARDASIL was expired at time of administration. The third dose's expiration date was 14-FEB-2009. The nurse also reported that on 12-MAR-2009 the patient developed a sore arm after the third dose. The patient recovered on 13-MAR-2009. No lab tests were done. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician (OB/GYN) concerning a 21 year old female patient who on an unspecified date was vaccinated with her first dose of GARDASIL (lot number, site and route not reported) at her pediatrician's office and then a short time after she was diagnosed with the shingles. The physician reported that the patient's pediatrician thought she developed the shingles due to GARDASIL and so the patient did not received the rest of the series. The patient sought medical attention in the pediatrician's office. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Headache, Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient with no known drug allergies who on 19-JAN-2009 was vaccinated with her first dose of GARDASIL (lot number 661703/0651X, site and route not reported). Concomitant medication included "LOVLO" which was a birth control pill. On 19-MAR-2009, the patient went in the office for her second dose of GARDASIL (lot number, site and route not reported) and she reported that in the evening of 19-JAN-2009, when she received the first dose, she experienced nausea and vomiting which lasted for two days. The patient sought unspecified medical attention. Follow-up information was received from the physician who reported that the patient got a headache shortly after receiving vaccine on 19JAN2009 whose lot number was reported as 660616/0570X at this time. That evening she complained of nausea and vomited 3 times. She did feel bad for two days after. The patient did not notify office until 19-MAR-2009 when she came for second dose of GARDASIL. It was noted that the patient recovered. The patient and her mother decided to receive the second dose on 19-MAR-2009 with no pressure. No further information was available.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Malaise
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no relevant medical history or drug allergy who was vaccinated with a first 0.5 ml dose of GARDASIL (lot # not reported) " a week ago", on approximately 12-MAR-2009. After the vaccination the patient became light headed however did not faint. The patient sought an unspecified medical attention. It was reported that she continued to "not feel well" for 2-3 days. The patient admitted she did not eat before coming to the office. The patient recovered about 2-3 days after administration. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female with Graves' disease, latex allergy and poppy seeds allergy who on 19-SEP-2008 was vaccinated with the first dose of GARDASIL and on 25-NOV-2008 received the second dose of GARDASIL. It was reported that 4 to 5 hours after the second dose the patient experienced arm pain and swollen, red, tingling hands. The reaction lasted for 1 hour and then resolved with no complications. The nurse stated that the patient will not receive the third dose of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot # not specified). It was reported that the patient was late on getting the second dose of GARDASIL, it was given 4 months after the first dose due to an illness. The nurse indicated that the patient was from a different practice. The patient consulted a nurse. The patient's outcome is unknown. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: Information has been received from a registered nurse concerning a female student in her twenties who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not specified). The nurse stated that the patient had received one dose of GARDASIL and now her physician's office had been told her she had papilloma viral infection. The patient sought medical attentions at the physician's office. At the time of reporting, her outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthropod bite, Condition aggravated, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning an 18 year old female patient with several bug bites who on 18-MAR-2008 was vaccinated with the first dose of GARDASIL (lot # 659655/1486U) 0.5 mL, intramuscular route, and on 16-JUL-2008 was vaccinated with the second dose of GARDASIL (lot # 660555/0279X) 0.5 mL, intramuscular route. There was no concomitant medication. It was reported that on 16-JUL-2008 the patient developed hives several hours after administration of second dose of GARDASIL. The nurse indicated that at the time of the administration the patient had several bug bites and the hives caused the bug bites to intensify in appearance. On approximately 30-JUL-2008 the patient recovered completely from both the hives and bug bites. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Dyspnoea, Vaccine positive rechallenge
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot # not available). It was reported that the patient experienced shortness of breath and felt like there was a brick sitting on her chest after receiving her first and her second dose of GARDASIL. The patient was seen by her physician. At the time of reporting, the patient had recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TTOX
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter, who on 20-JAN-2009 was vaccinated with her first dose of GARDASIL. Concomitant therapy included TD and meningitis vaccine, (manufacturer unspecified), given on 20-JAN-2009. The caller stated that after the vaccination, the patient had a fever, flu like symptoms, headache and stomachache. The patient's outcome is unknown. The patient sought unspecified medical attention. Additional information has been requested.  5/15/09 Medical records received DOS 1/19/09 to 1/20/09. FINAL DIAGNOSIS: Adverse event Post vaccination: nausea, decreased appetite, arm hurts at injection site. Pt not seen information requested and provided by phone.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a 19 year old female patient with no pertinent medical history who a few months ago received the first dose of GARDASIL (lot# not reported) and approximately 4 or 5 months ago was vaccinated with the second dose GARDASIL (lot# not reported). There was no concomitant medication. On 18-MAR-2009 the patient visited the nurse practitioner and a pap smear was performed. Patient was told by the nurse practitioner that according to the pap smear results she was positive for HPV (unspecified type). At the time of the report, the patient had not yet recovered. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with the third dose of GARDASIL. There was no concomitant medication. It was reported that on 20-MAR-2009 the patient experienced "bad headache". The patient called to the office. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: Information has been received from a registered nurse concerning an 11-18 year old female who was vaccinated with her first dose of GARDASIL (lot number, route and site not reported). Subsequently the patient experienced headache. The patient did not receive anymore GARDASIL. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstrual disorder
Clinical narrative: Information has been received from a health professional concerning a female patient between 11-18 years who on an unspecified date was vaccinated with the fist dose of GARDASIL (lot number, site and route not reported). On an unspecified date, the patient's menstrual cycle was interrupted. She stopped the vaccine series because her MD recommended it. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Tension headache
Clinical narrative: Information has been received from a nurse practitioner concerning a female with a history of tension headache who was vaccinated with the third 0.5ml dose of GARDASIL. After receiving her third dose, on approximately 16-MAR-2009, "last week", the patient experienced tension headache. The patient recovered from tension headache "last week". The patient sought unspecified medical attention. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a health department nurse concerning a patient who on 04-MAR-2009 was vaccinated with a dose of GARDASIL (lot number, site and route not reported) which was stored at 35F for 24 hours on 23-FEB-2009. No details about the patient were known. Also reported as out of range for one day on 04-MAR-2009. The reporter answered and reported that they only had one patient who received a first dose of GARDASIL (lot number 660389/1968U, site and route not reported) on 04-MAR-2009. There was no adverse event was reported. No further information was expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with no known drug allergies and no medical history who on 12-JAN-2009 was vaccinated with the first dose of GARDASIL (Lot# 661531/1311X), IM. There was no concomitant medication. The patient was subsequently determined to be pregnancy by an unspecified clinic. Her last menstrual period was 07-JAN-2009. The patient sought medical attention. There was no lab and diagnostic test performed. No problems were reported. The patient's estimated delivery date was 14-OCT-2009. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Eye pruritus, Rash
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female on 20-MAR-2009 was vaccinated with the first dose of GARDASIL (lot number, dose not reported). Concomitant therapy included YAZ as birth control pill. On 21-MAR-2009, the next day the patient experienced rash on her abdomen, arm and shoulders and the patient's eyes were itchy. On unspecified date, the patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed, Night sweats
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of human papillomavirus high risk. On 11-FEB-2009, the patient came in the office because she had an upper respiratory infection and was given ALERXPE (manufacturer unspecified) and Azithromycin manufacturer unspecified). On 19-FEB-2009, the patient came into the office and received her first dose of GARDASIL (lot # 661044/0548X) (dose not report). The mother then called the office and said after receiving GARDASIL the patient experienced night sweats and her period was eleven days late. The mother of the patient mentioned that she was unsure if the patient should receive the second dose of GARDAIL. On unspecified date, the patient sought unspecified medical attention. On an unknown date, the physician reported that the patient had recovered but there were still unsure if she could receive the second dose of GARDASIL. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Abdominal distension, Constipation, Diarrhoea, Dyspepsia
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with dysmenorrhea and no known drug allergies who was intramuscularly vaccinated with 1st, 2nd and 3rd 0.5 ml doses of GARDASIL (1st lot #0250X, 2nd lot #660620/0571X, 3rd lot #661846/1312X) on 23-SEP-2008, 24-NOV-2008 and 23-MAR-2009, respectively. Concomitant therapy included YAZ and FAMVIR. In November 2008, prior to the 2nd dose, the patient experienced sensitivity to wheat. It was reported that bread and pasta products caused severe bloating, a churning feeling in her stomach, and difficult digestion. Then she got either constipation or diarrhea. These symptoms occurred about 15 minutes after any wheat consumption. When she did not not eat those products, she felt much better. At the time of reporting, she did not recover. The patient called the office for medical attention. Additional information has been requested.  5/13/09 medical records received DOS 2/3/05 to 3/26/09 FINAL DIAGNOSIS: GI upset Post vaccination GI upset, nausea, constipation, diarrhea, feels bloated, abdominal pain. ICD-9 codes: 787.3 abdominal bloating, 789.00 abdominal pain, 626.0 amenorrhea, 625.3 dysmenorrhea, 698.9 pruritis. V13.01 HX of Nephrolithiasis, V13.8 HX of Facial Herpes
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Injection site pain, Malaise, Pain in extremity
Clinical narrative: Information has been received from a female who in September 2008, was vaccinated with her first dose of GARDASIL. On an unspecified date, she was vaccinated with the third dose of GARDASIL. She stated that she became ill "week" after the third dose was given. She was experiencing pain at the injection site, pain up and down the arm, and feeling weakness in the legs. She also stated the pain had become painfully worse. She stated that the pain in her arm was a "sharp pain" and had been getting "progressively worse" and hurt "when I move my arm in a certain way." As of 23-MAR-2009, her experience didn't improve. No laboratory diagnostic studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Headache, Wheezing
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL, 0.5 mL. The patient experienced "headaches, wheezing, dizziness and joint pains" after the vaccination. The physician did not know if this was the patient's first, second or third dose, and did not know if she got any shots of GARDASIL after this experience. Follow-up information was received from an employee at the physician's office who stated that the vaccine was not administered at the office therefore she could not provide additional information. This is one of several reports from the source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with no pertinent medical history and no known allergies who in July 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). On 06-FEB-2009 the patient was vaccinated with the second dose of GARDASIL (lot#659964/1978U) 0.5ml intramuscularly. There was no concomitant medication. One week after the second dose the patient developed nausea, vomiting, headache, fever, sore throat and runny nose. The patient has improved but continues with intermittent headaches and fever. Patient sought medical attention via a telephone call. No lab diagnostic studies were performed. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with no pertinent medical history and no known allergies who in July 2008, was vaccinated with the first dose of GARDASIL (lot# not provided). On 06-FEB-2009 the patient was vaccinated with the second dose of GARDASIL (lot#659964/1978U) 0.5ml intramuscularly. There was no concomitant medication. One week after the second dose the patient developed nausea, vomiting, headache, fever, sore throat and runny nose. The patient has improved but continues with intermittent headaches and fever. Patient sought medical attention via a telephone call. No lab diagnostic studies were performed. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a 42 year old female who on 09-FEB-2009 was vaccinated with the first 0.5 ml dose of GARDASIL. After vaccination, the patient developed rash on her left shoulder. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a physician assistant concerning a 21 year old female patient who on 08-JAN-2009 was vaccinated with the first dose of GARDASIL (lot# not provided) 0.5ml. Subsequently, on 08-JAN-2009, the patient experienced mild itching at the injection site. On 09-MAR-2009 patient received the second dose of GARDASIL (lot# not provided) and also experienced rash and itching at injection site. Patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female with no medical history or drug allergy who on 24-MAR-2009 was intramuscularly vaccinated with her first 0.5 ml dose of GARDASIL (lot #661952/1129X). She was also vaccinated with a dose of meningitis vaccine on the same day. Subsequently the patient developed an injection site reaction after receiving GARDASIL. The patient complained that the injected site was red, swollen, and painful. She did not recover at time of reporting. The patient called the office for medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: HIV test false positive, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with GARDASIL (unspecified number of doses) may have 1-2 false HIV positive. The patient was seen in the office. At the time of reporting, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Pain, Pyrexia, Viral infection
Clinical narrative: Information has been received from a physician concerning a female patient who on approximately 26-JAN-2009 ("two months ago") was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced injection site reaction. Last week the patient was vaccinated with the second dose of GARDASIL. The patient experienced viral syndrome with a fever and body aches since the second dose of vaccine was given. At the time of reporting, the patient's viral syndrome with a fever and body aches persisted. The patient sought medical attention via visiting office. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site necrosis, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 25 year old female who was received a first dose of GARDASIL (lot # not reported) in her left arm on Friday, 20-MAR-2009. It was unknown whether the injection has been administered subcutaneously instead of intramuscularly. The patient's relevant medical history, concomitant medications, and relevant past drug history were unknown. On 24-MAR-2009, the patient noted the onset of itching and swelling (the size of a quarter) at the injection site. This progressed in size (doubling) by the time she was seen on 26-MAR-2009. On 26-MAR-2009, the site was reported as tender and also started o become necrotic. At the tine of the report, the patient's outcome was unknown. The patient was being referred to her primary care physician for further evaluation. It was reported that the physician was considering this patient related issue as an emergency. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Fatigue, Pregnancy test positive
Clinical narrative: Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with pain in shoulder and reflux and a history of abnormal PAP in June 2008 who was vaccinated with the first and second dose of GARDASIL on 29-JAN-2009 and 26-MAR-2009 respectively. Concomitant therapy included NAPROXEN and ranitidine. The patient was pregnant after the second dose of GARDASIL. After the patient was given the dose, the patient was given a pregnancy test because she was reporting symptoms of "being tired and missed her monthly cycle". The patient sought medical attention- spoke to her physician. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gastrooesophageal reflux disease, Laboratory test
Clinical narrative: Information has been received from a nurse practitioner for the pregnancy registry of GARDASIL, concerning a 26 year old female patient with no pertinent medical history and no known drug allergies who on 4-DEC-2008 was vaccinated with the first dose of GARDASIL (lot # 0947X) 0.5ml intramuscularly. On 3-FEB-2009 patient received second dose of GARDASIL (lot # 1702X) 0.5 ml intramuscularly. Patient is now pregnant, last menstrual period: 15-JAN-2009; estimated delivery date: 22-OCT-2009; estimated conception date: 29-JAN-2009. Concomitant medications during this pregnancy include ZANTAC PRN for GERD. Patient has had two previous pregnancies, both which ended due to elective termination 6 to 7 weeks from LMP. Patient sought medical attention via an office visit. On 23-FEB-2008 patient had OB labs done. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Chills, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with first 0.5ml dose of GARDASIL (route and lot number not provided). The physician reported that the patient experienced chills and fever after vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Gastroenteritis viral, Ultrasound scan normal
Clinical narrative: Information has been received from a 24 year old female, for the Pregnancy Registry for GARDASIL who on 16-DEC-2008 was vaccinated with a first dose of GARDASIL. On approximately 2-FEB-2009 was vaccinated with a second dose of GARDASIL intramuscularly o.5 ml and had a pregnancy test and found out that she was "about 2 weeks pregnant" at the time of the vaccination (The patient was 9 weeks and 3 days pregnant at the time of reporting, so the last menstrual date was estimated as on 19-JAN-2009 and the estimated delivery date was 25-OCT-2009). An ultrasound was done and "everything looked normal". On 16-FEB-2009, (also reported "about 2 weeks ago"), the patient was really sick and couldn't eat or keep anything down. She went to emergency room but was not admitted. This was diagnosed as "stomach virus". The patient recovered from stomach virus after 4 days. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Haematology test, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 25 year old female patient with penicillin allergy who on August 2008, was vaccinated with the first dose of GARDASIL (lot # not provided). In October 2008 the patient was vaccinated with the second dose of GARDASIL (lot # not provided). On February 2009 patient was vaccinated with the third dose of GARDASIL (lot # not provided). There was no concomitant medication. After the second and first dose the patient experienced fatigue and dizziness. Patient sought unspecified medical attention and had blood work done. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Fatigue
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female patient with no pertinent medical history and no know drug allergies/reactions who on 19-JAN-2009 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 660616/0570X). There was no concomitant medication. On 20-JAN-2009 the patient experienced joint pain on her left arm where the vaccine was administered. The next day the pain spread to all joints along with fatigue. No lab diagnostics were performed. One week after the vaccination the patient recovered. The patient sought medical attention via seeing a physician. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with a third dose of GARDASIL (lot # not reported) 5 weeks ago, on approximately 19-FEB-2009. It was reported that the patient still had pain off and on at the injection site. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Claustrophobia, Dyspnoea, Fatigue, Flushing
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with a history of mononucleosis at age of 15 who on 16-MAR-2009 was vaccinated with her first dose of GARDASIL (lot # unknown). The patient experienced soreness at the injection site the day the vaccine was administered on 16-MAR-2009. The patient was experiencing difficulty breathing, hear rate of 90-100, flushed face, weakness, fatigue, "air hunger" or claustrophobic feeling and severe headache on 25-MAR-2009 9 days after her vaccination. The patient had visited the physician's office for medial attention. The only medication the patient was on was ZOVIA (manufacturer unspecified) for the completion problems and painful menstrual cycles. The patient never had any heart rate problems or headache before. At the time of reporting the patient's difficulty breathing and heart rate of 9--100 and flushed face and weakness and fatigue and "air hunger" and claustrophobic feeling and soreness at the injection site and severe headache persisted. Additional information has been requested
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with a history of mononucleosis at age of 15 who on 16-MAR-2009 was vaccinated with her first dose of GARDASIL (lot # unknown). The patient experienced soreness at the injection site the day the vaccine was administered on 16-MAR-2009. The patient was experiencing difficulty breathing, hear rate of 90-100, flushed face, weakness, fatigue, "air hunger" or claustrophobic feeling and severe headache on 25-MAR-2009 9 days after her vaccination. The patient had visited the physician's office for medial attention. The only medication the patient was on was ZOVIA (manufacturer unspecified) for the completion problems and painful menstrual cycles. The patient never had any heart rate problems or headache before. At the time of reporting the patient's difficulty breathing and heart rate of 9--100 and flushed face and weakness and fatigue and "air hunger" and claustrophobic feeling and soreness at the injection site and severe headache persisted. Additional information has been requested
Age: 13.0
Sex: F
Vaccine: HPV4, MMR
Symptoms: Syncope
Clinical narrative: Information has been received from a medical assistant concerning her 13 year old daughter with no previous medical history reported who on 17-DEC-2008 was vaccinated with a first dose of GARDASIL and concomitantly at the same time with a dose of MMR . On 17-DEC-2008, the patient fainted after receiving her first and only dose of GARDASIL. The patient did not have any breakfast prior to vaccination. On 17-DEC-2008, the patient recovered within 10 minutes. The patient sought medial attention, the physician saw the patient. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Eye pain, Eye swelling
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient with no drug allergies or medial history who on 9-MAR-2009 was vaccinated with her first and only dose of GARDASIL (lot # 661841/0653X) IM. Concomitant therapy included DIFFERIN. On 9-MAR-2009 the patient;s both eyes were swollen, bruised and sore after receiving the vaccine. The patient had called the office for medical attention. The outcome of the patient's adverse events was not reported. Additional information has been requested.  5/15/09 Medical records received DOS 3/9/09 to 5/5/9. FINAL DIAGNOSIS: Hypersensitivity to vaccine Post vaccination sore, swollen bruised eyes.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 20 year old female with egg allergy who on approximately 13-MAR-2009, two weeks ago, was vaccinated with a dose of GARDASIL. The physician was not sure if this was the first or second dose of GARDASIL, as the patient was vaccinated in another office. The patient had experienced fevers of 101F since she was given the GARDASIL vaccine. The patient was not recovered at the time of this report. It was reported that the patient came to the physician's office for evaluation if the fevers. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a nurse concerning a 25 year old female with penicillin allergy who on 30-SEP-2008 was vaccinated with her first dose of GARDASIL and her second dose of the vaccine was on 11-DEC-2008 and her third dose of GARDASIL on 24-MAR-2009 (0.5 ml IM, 661846/1312X). The same day of the 3rd vaccination, the patient called the office back because she developed redness and itching from the elbow to the shoulder in the injection arm. She also developed lightheadedness. No additional information was available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female patient who is also the receptionist in the office and on 20-MAR-2009 was vaccinated with GARDASIL (lot # was not available). Subsequently, the patient developed a red, swollen and itchy injection site. The physician added that the patient's arm became bigger and it continued to swell and now her arm hurts and the symptoms had been very persistent and progressing. The physician didn't specify if the patient received the first, second or third of GARDASIL. Physician added that the patient was given BENADRYL but the symptoms hadn't resolved yet. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Presyncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a female patient with no pertinent medical history and no known drug allergies/reactions who was vaccinated with the first 0.5 ml IM dose of GARDASIL. Subsequently the patient experienced vasovagal reaction in the waiting room. The patient recovered and was sent home. On 24-MAR-2009 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL. There was no concomitant medication. On 24-MAR-2009 after receiving the vaccine the patient experienced not responding to their questions and acting strange. The patient was not conversing for about 2 minutes, but she did not pass out, The physician clarified that the patient did not have a seizure. The patient was observed at the office. No lab diagnostic studies were performed. On 24-MAR-2009 the patient recovered and was sent home. The patient would not get the third dose of GARDASIL. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Malaise
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with the second dose of GARDASIL two weeks after the first dose and third dose another two weeks after the second dose. The reporter stated that her daughter has been feeling ill. The patient's adverse event did not improve at the time of this report. No further information is available.