chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning a 19 year old female patient who "approximately 3 years ago" (in approximately 2007) received all series GARDASIL (lot # and expire date not reported), intramuscularly. Concomitant medication included "on birth control". "Recently" (on an unspecified date), the patient had an abnormal pap smear. She was repapped. The outcome of both pap smears were for a high risk of HPV. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 20 year old female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # not reported). No other vaccines were administered with GARDASIL. The nurse practitioner stated that the patient experienced swelling of her eyes after the vaccine administration. The patient would not receive any additional doses of GARDASIL. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the nurse practitioner who stated that the 18 year old (also reported as 20 year old) with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical condition, on 09-SEP-2010 at 9:45 was vaccinated into the left deltoid with the first dose of GARDASIL (lot # 0405Z). The nurse practitioner reported that on 09-SEP-2010 in the evening, after receiving the vaccine, the patient complained of swelling around her eyes. There were no other symptoms. The symptom resolved with BENDRYL. Next day, on 10-SEP-2010, the patient had recovered. No laboratory tests were performed. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse, concerning her daughter who got a rash after receiving treatment with GARDASIL. The daughter's friend also experienced a rash. No lot number provided. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician's assistant concerning a 19 year old female patient, with allergy to abacavir and acquired immunodeficiency syndrome, who on 22-MAY-2007 was vaccinated with her first dose of GARDASIL, (lot # expire date and route not reported). About one month after her first vaccination, on approximately June 2007, the patient developed a nickel size area of alopecia. In November 2007,  the patient received her second dose of GARDASIL, (lot #, expire date and route not reported). She did not develop alopecia after her second vaccination. There were no laboratory diagnostics studies performed. The patient did not seek medical attention. On an unspecified date, the patient recovered from a nickel sized area of alopecia. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Immune system disorder, Psoriasis, Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a male senior in high school who on unspecified date in July 2010, was vaccinated with the first dose of GARDASIL (lot # not reported). Approximately two months after the vaccination (in approximately September 2010), the patient experienced a rash over his entire body. The nurse practitioner reported that the patient was treated for the rash by a dermatologist, who might have prescribed an unspecified steroid cream. At the time of reporting, the patient's rash over his entire body persisted. Follow-up information has been received from the nurse practitioner concerning the 16 year old male senior in high school with a family history of psoriasis and no illness at time of vaccination or pre-existing allergies, who on 15-JUN-2010 p.m., was vaccinated with the first dose of GARDASIL into his left arm. Approximately on 15-AUG-2010, 2 months after receiving GARDASIL, the patient got a severe red rash from head to toe. The patient went to urgent care to see 5 different doctors, it was reported that the patient "now see dermatology". The patient was diagnosed with psoriasis. The patient's mother felt the vaccine weakened the patient's immune system. No labs/diagnostics studies were performed. At the time of reporting, the patient's rash over his entire body persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue
Clinical narrative: Information has been received from a healthcare worker concerning a 15 year old female patient who was vaccinated IM with the first 0.5 ml of GARDASIL (Lot # 666929/0331Z) on 12-AUG-2010, and the second dose on 12-OCT-2010. On 13-OCT-2010 the patient started feeling dizzy which lasted all day. AE onset date was also reported as 12-OCT-2010. The patient 's feeling dizzy persisted. The patient did not seek medical attention. Follow-up information has been received from a physician concerning the 15 year old female student with no illness at time of vaccination felt dizzy and extremely tired for 24 hours. The patient felt like fainting for 24 hours. The patient's events recovered 24 hours later. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Lacrimation increased
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with acne with no pertinent medical history and no drug allergies or reaction who on 24-SEP-2010 was vaccinated intramuscularly with the first dose of GARDASIL (lot # and route not reported) and on 24-NOV-2010 with the second dose of GARDASIL (Lot # and route not reported). Concomitant therapy included doxycycline. On 09-NOV-2010 the patient experienced headache, fatigue and watering eyes and it get worse since the patient received the second dose of GARDASIL. At the time of the report, the patient had not recovered. No laboratory test were performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Dizziness, Malaise, Vomiting
Clinical narrative: Information has been received from a female medical assistant who was vaccinated with her first dose of GARDASIL on an unspecified date and her second dose of GARDASIL on 16-SEP-2010. The patient stated she experienced a bit of anxiety and felt a little sick after receiving her first dose of GARDASIL. The patient's outcome was not reported. She experienced dizziness, vomiting, and felt sick after her second dose of GARDASIL on 16-SEP-2010. She had to leave work early on 16-SEP-2010 because of the symptoms. Her symptoms resolved on 18-SEP-2010 (reported as "after 2 days"). She was nervous about receiving her third dose. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Blood test, Hypoaesthesia, Paraesthesia, Skin discolouration
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with no drug reaction or allergies and no pertinent medical history who on 11-OCT-2010 around 5pm, was vaccinated with a dose of GARDASIL. Concomitant therapy included nasal flu vaccine and growth hormones. The mother stated that her daughter called her from school and told her that on 12-OCT-2010, at 12:30 pm her hands had turned a sort of light gray/bluish color. Her hands had also gone somewhat numb. They went to the doctor, where they were told to come back on 13-OCT-2010 if the symptoms hadn't subsided. It was reported the adverse events improved, but the tingliness in her hands came and went, the overall syndrome were still there. The patient was about to go back to the doctor's office. The patient had blood work every couple of months because of growth hormones (results not reported). At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Gaze palsy, Muscle spasms
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 12-OCT-2010 was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot # not reported). While the patient was checking out on 12-OCT-2010, she felt faint. The nurse then brought the patient back to a room where the patient's eyes rolled back in her head and she had involuntary muscle spasms". On 12-OCT-2010 the patient recovered before the physician allowed her to go home. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Concussion, Head injury, Skull X-ray normal, Syncope
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with penicillin allergy and a history of syncope who on 27-SEP-2010, was vaccinated IM with her first 0.5 ml dose of GARDASIL. On 27-SEP-2010, the patient had syncopal episode, hit her head on a cabinet, and had a concussion in the physician's office. Her appetite was okay though. The patient had x-ray to ensure no fracture. The result of x-ray was negative. It was reported that the adverse event improved on therapy. At the time of reporting, the patient had recovered. It was reported that the patient's mother had a history of syncopy. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Menstruation irregular, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female with no medical history and drug reaction and allergies who on 08-JUN-2010 was vaccinated with the first dose of GARDASIL (lot number 665607/1332Y) and hepatitis A virus vaccine (unspecified). On 09-SEP-2010 the patient was vaccinated IM in the right arm with the second dose of GARDASIL (reported as lot # "0785Z" was a valid lot # for VARIVAX (Merck). On 21-SEP-2010 client came in for doctor visit stating she was having irregular periods. Urine pregnancy test taken and was positive (LMP: May-2010). Client estimated due date is 08-JAN-2011 (EDD: 08-JAN-2011). Nurse states client was not experiencing any problems. Follow-up information has been received from a registered nurse concerning the 16 year old female patient with anemia and no previous pregnancy who was vaccinated with the first dose of GARDASIL (lot number 665607/1332Y) on 08-JUN-2010, and the second dose (lot number 0785Z was not valid for GARDASIL, but valid for VARIVAX (Merck)) on 09-SEP-2010. During pregnancy, the patient was treated with prenatal vitamin tablet, once a day for pregnancy on 25-OCT-2010 (duration unknown), and ferrous sulfate 325 mg tablet, BID by mouth for anemia in October 2010 (duration unknown). On 28-SEP-2010, an ultrasound was performed for normal fetal survey and revealed a 25 and 3/7 week pregnancy. As for Maternal Serum Alpha-Fetoprotein Screening (MSAFP), it was stated "too late entry to care". Follow up information has been received from a registered nurse concerning the 16 year old female teen pregnant patient with anemia and no previous pregnancy who on 08-JUN-2010 was vaccinated with the first dose of GARDASIL (lot # not charted). During pregnancy, the patient was treated with prenatal vitamins tablet, once a day for pregnancy on 21-SEP-2010 (previously reported as 25-OCT-2010) (duration unknown), and ferrous sulfate tablet, twice a day for anemia on 25-OCT-2010 (duration unknown). On 28-SEP-2010, an ultrasound was performed for dating ultrasound, and revealed the estimated delivery date as 08-JAN-2011 (EDC: 08-JAN-2011) (it was also reported that the patient's LMP was in May 2010). The patient's prenatal care was ate, and started at 29 weeks gestation. On 03-JAN-2011). The baby's weight was 6 pound 10 ounces, length 19 inches, and Apgar score 9/9. There was no congenital anomaly or other complication or abnormality.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female patient in her late teens who on approximately 24-SEP-2010 (reported as "about 3 weeks ago") was vaccinated with a 0.5 ml dose of GARDASIL (lot # not provided). On approximately 24-SEP-2010 (reported as "about 3 weeks ago") the patient experienced "broke out in hives" after received GARDASIL. At the time of reporting, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Abdominal discomfort, Abdominal pain lower, Abdominal tenderness, Diarrhoea, Dizziness
Clinical narrative: Information has been received from a consumer concerning his 11 year old grandson with no pertinent medical history who on approximately 06-OCT-2010 (reported as "about the sixth"), was vaccinated with GARDASIL (lot # not reported). Drug reactions/allergies was reported as "not sure possibly something". There was no concomitant medication. On approximately 06-OCT-2010 the patient "had dizziness, tiredness, upset stomach, loose bowels and developed acid reflux". Another reporter reported that the patient went to the doctor yesterday on 14-OCT-2010 and was prescribed an unspecified medication for acid reflux. The patient was seen by a nurse practitioner. The patient took a "blood test not sure". The patient's dizziness and tiredness and upset stomach and loose bowels and acid reflux persisted. Follow up information has been received from the nurse practitioner and medical records concerning the 11 year old male patient with no known drug allergy and the left fourth finger sprain and Gastrointestinal symptoms upset stomach 2 days before vaccination who on 28-SEP-210 was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly and a 0.5 ml dose of VARIVAX (Merck) (manufacturer unknown) subcutaneously. On 14-OCT-2010 the patient was seen in the office stating that since having GARDASIL vaccine 2 weeks ago, he experienced heartburn, diarrhea, gas, dizzy. The symptoms of Gastrointestinal symptoms upset stomach worsened 2 days after vaccination. The patient reported drinking more protein drinks and more chocolate milk in the last 2 weeks. Recently changed protein shake brands 2 weeks ago. The patient denied any previous issues with dairy. The patient had belching more frequently and nausea occurring in late afternoon. No vomiting. RLQ abdominal pain and in the LL! x 2 weeks. No radiation abdominal pain. Flatus more frequent and diarrhea. Patient reported "softer than normal but not liquid/watery." There was on change in color of stool or blood observed. The patient had body temperature 98.5 degrees Fahrenheit. Physical examination: The bowel sounds were hyperactive in all 4 quadrants and abdominal palpation revealed abnormalities. Direct tenderness mild, in the RLQ of the abdomen, negative McBurney's and in the LLQ of the abdomen but no acute tenderness in either RLQ/LLQ. Others were normal. The patient was assessed with heartburn and abdominal pain. The patient was given omeprazole 10 mg capsule delayed released, take one capsule daily might increase to twice daily if no relief in 2 weeks. Trial off protein shakes completely or switch back to previous brand as patient able to tolerate without difficulties. The patient was advised follow up for worsening or failure to improve. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Dyspepsia, Eructation, Fatigue, Flatulence, Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a consumer concerning his 11 year old grandson with no pertinent medical history who on approximately 06-OCT-2010 (reported as "about the sixth"), was vaccinated with GARDASIL (lot # not reported). Drug reactions/allergies was reported as "not sure possibly something". There was no concomitant medication. On approximately 06-OCT-2010 the patient "had dizziness, tiredness, upset stomach, loose bowels and developed acid reflux". Another reporter reported that the patient went to the doctor yesterday on 14-OCT-2010 and was prescribed an unspecified medication for acid reflux. The patient was seen by a nurse practitioner. The patient took a "blood test not sure". The patient's dizziness and tiredness and upset stomach and loose bowels and acid reflux persisted. Follow up information has been received from the nurse practitioner and medical records concerning the 11 year old male patient with no known drug allergy and the left fourth finger sprain and Gastrointestinal symptoms upset stomach 2 days before vaccination who on 28-SEP-210 was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly and a 0.5 ml dose of VARIVAX (Merck) (manufacturer unknown) subcutaneously. On 14-OCT-2010 the patient was seen in the office stating that since having GARDASIL vaccine 2 weeks ago, he experienced heartburn, diarrhea, gas, dizzy. The symptoms of Gastrointestinal symptoms upset stomach worsened 2 days after vaccination. The patient reported drinking more protein drinks and more chocolate milk in the last 2 weeks. Recently changed protein shake brands 2 weeks ago. The patient denied any previous issues with dairy. The patient had belching more frequently and nausea occurring in late afternoon. No vomiting. RLQ abdominal pain and in the LL! x 2 weeks. No radiation abdominal pain. Flatus more frequent and diarrhea. Patient reported "softer than normal but not liquid/watery." There was on change in color of stool or blood observed. The patient had body temperature 98.5 degrees Fahrenheit. Physical examination: The bowel sounds were hyperactive in all 4 quadrants and abdominal palpation revealed abnormalities. Direct tenderness mild, in the RLQ of the abdomen, negative McBurney's and in the LLQ of the abdomen but no acute tenderness in either RLQ/LLQ. Others were normal. The patient was assessed with heartburn and abdominal pain. The patient was given omeprazole 10 mg capsule delayed released, take one capsule daily might increase to twice daily if no relief in 2 weeks. Trial off protein shakes completely or switch back to previous brand as patient able to tolerate without difficulties. The patient was advised follow up for worsening or failure to improve. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Nausea
Clinical narrative: Information has been received from a consumer concerning his 11 year old grandson with no pertinent medical history who on approximately 06-OCT-2010 (reported as "about the sixth"), was vaccinated with GARDASIL (lot # not reported). Drug reactions/allergies was reported as "not sure possibly something". There was no concomitant medication. On approximately 06-OCT-2010 the patient "had dizziness, tiredness, upset stomach, loose bowels and developed acid reflux". Another reporter reported that the patient went to the doctor yesterday on 14-OCT-2010 and was prescribed an unspecified medication for acid reflux. The patient was seen by a nurse practitioner. The patient took a "blood test not sure". The patient's dizziness and tiredness and upset stomach and loose bowels and acid reflux persisted. Follow up information has been received from the nurse practitioner and medical records concerning the 11 year old male patient with no known drug allergy and the left fourth finger sprain and Gastrointestinal symptoms upset stomach 2 days before vaccination who on 28-SEP-210 was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly and a 0.5 ml dose of VARIVAX (Merck) (manufacturer unknown) subcutaneously. On 14-OCT-2010 the patient was seen in the office stating that since having GARDASIL vaccine 2 weeks ago, he experienced heartburn, diarrhea, gas, dizzy. The symptoms of Gastrointestinal symptoms upset stomach worsened 2 days after vaccination. The patient reported drinking more protein drinks and more chocolate milk in the last 2 weeks. Recently changed protein shake brands 2 weeks ago. The patient denied any previous issues with dairy. The patient had belching more frequently and nausea occurring in late afternoon. No vomiting. RLQ abdominal pain and in the LL! x 2 weeks. No radiation abdominal pain. Flatus more frequent and diarrhea. Patient reported "softer than normal but not liquid/watery." There was on change in color of stool or blood observed. The patient had body temperature 98.5 degrees Fahrenheit. Physical examination: The bowel sounds were hyperactive in all 4 quadrants and abdominal palpation revealed abnormalities. Direct tenderness mild, in the RLQ of the abdomen, negative McBurney's and in the LLQ of the abdomen but no acute tenderness in either RLQ/LLQ. Others were normal. The patient was assessed with heartburn and abdominal pain. The patient was given omeprazole 10 mg capsule delayed released, take one capsule daily might increase to twice daily if no relief in 2 weeks. Trial off protein shakes completely or switch back to previous brand as patient able to tolerate without difficulties. The patient was advised follow up for worsening or failure to improve. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Lip injury, Syncope
Clinical narrative: Information has been received from a physician concerning a 22 year old female patient who on 28-OCT-2010 was vaccinated with a dose of GARDASIL (lot # and expire date not reported), intramuscularly. On 28-OCT-2010, after the patient received her GARDASIL vaccine, she had an episode of syncope and when she fell, she busted her lip. The patient did not seek medical attention. On 28-OCT-2010, the patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Anti-SS-B antibody positive, Antinuclear antibody increased, Blood test, Blood thyroid stimulating hormone increased, Condition aggravated
Clinical narrative: Information has been received from a 13 year old female with seasonal allergies and reaction to skin allergy test, pertinent medical history of asthma, allergies, swollen optic nerve and elevated Thyroid Stimulating Hormone (TSH) and Antinuclear Antibody (ANA), who in October 2008, was vaccinated IM with GARDASIL all three doses (lot # not provided) for prevention of HPV and prevention of cervical cancer. Concomitant therapy included ADVAIR, PROAIR (as needed), antimicrobial (unspecified) and PROZAC. In October 2008, after the patient got GARDASIL, she had been back and forth to many doctors concerning swollen optic nerve, elevated ANA, elevated TSH and possible Auto immune disorder. Lab diagnostics studies performed included blood work, results were not provided by reporter. No further AE information was provided. The patient's swollen optic nerve, elevated ANA and TSH and Autoimmune disorder persisted. Follow-up information received from an other health professional concerning the female student with asthma, environmental allergy, anxiety disorder and no illness at time of vaccination, who on 27-OCT-2008 was vaccinated IM with a first dose of GARDASIL (lot # 660665/0279X). Secondary suspected therapy included flu vaccine (manufacturer unknown) on the same day. On 09-MAR-2009 (previously reported as October 2008), the patient was found to have elevated optic nerve on exam. Subsequently the patient had twice confirmed antinuclear antibody (ANA) increased and elevated anti-SSB antibody associated with Sjogren's syndrome but no eye symptoms. The patient's status was unknown. On 26-MAY-2009 the patient was vaccinated IM with a third dose of GARDASIL (lot # 660616/0570X). Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Papilloedema, Sjogren's syndrome
Clinical narrative: Information has been received from a 13 year old female with seasonal allergies and reaction to skin allergy test, pertinent medical history of asthma, allergies, swollen optic nerve and elevated Thyroid Stimulating Hormone (TSH) and Antinuclear Antibody (ANA), who in October 2008, was vaccinated IM with GARDASIL all three doses (lot # not provided) for prevention of HPV and prevention of cervical cancer. Concomitant therapy included ADVAIR, PROAIR (as needed), antimicrobial (unspecified) and PROZAC. In October 2008, after the patient got GARDASIL, she had been back and forth to many doctors concerning swollen optic nerve, elevated ANA, elevated TSH and possible Auto immune disorder. Lab diagnostics studies performed included blood work, results were not provided by reporter. No further AE information was provided. The patient's swollen optic nerve, elevated ANA and TSH and Autoimmune disorder persisted. Follow-up information received from an other health professional concerning the female student with asthma, environmental allergy, anxiety disorder and no illness at time of vaccination, who on 27-OCT-2008 was vaccinated IM with a first dose of GARDASIL (lot # 660665/0279X). Secondary suspected therapy included flu vaccine (manufacturer unknown) on the same day. On 09-MAR-2009 (previously reported as October 2008), the patient was found to have elevated optic nerve on exam. Subsequently the patient had twice confirmed antinuclear antibody (ANA) increased and elevated anti-SSB antibody associated with Sjogren's syndrome but no eye symptoms. The patient's status was unknown. On 26-MAY-2009 the patient was vaccinated IM with a third dose of GARDASIL (lot # 660616/0570X). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Rash
Clinical narrative: Information has been received from a nurse (also reported as a medical student) concerning a female with no medical history and no drug reactions or allergies who on 15-FEB-2010 was vaccinated IM with GARDASIL (lot # 662299/1099Y, expiration date 17-APR-2011). There was no concomitant medication. The nurse reported that the patient became nauseous and a rash appeared shortly after GARDASIL was administered (also reported as "within a week of vaccination"). No lab diagnostics studies were performed. The events went away on approximately 22-FEB-2010 ("within a week of the vaccination"). The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in September 2010, was vaccinated with her first dose of GARDASIL (Lot# not reported). The nurse stated that since the patient received GARDASIL, she had not gotten a menstrual period. At the time of the report the patient's outcome was not recovered. The patient did not seek medical attention. No further information is available.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Abdominal pain, Blood amylase, Blood calcium, Blood glucose, Blood insulin
Clinical narrative: Information has been requested from a health care student concerning a 13 year old female sulfa allergy and latex allergy and no pertinent medical history who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. There was no concomitant medication. On the morning of 27-OCT-2010 the patient returned to the office and complained of vomiting and diarrhea that had started at approximately 1:00 AM on 27-OCT-2010. It was further reported that the patient was receiving intravenous fluids and seemed to be improving. The patient was still in the office during the call. Complete blood count (CBC), serum lipase and amylase, serum calcium, thyroid levels, serum insulin and glucose levels were drawn during the office visit on 27-OCT-2010 and results were pending. Follow-up information has been received concerning the 13 year old female with sulfonamide allergy, latex allergy and gastrooesophageal reflux disease and no illness at time of vaccination, who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 665607/1332Y) intramuscularly into her left deltoid. Concomitant therapy included FLUZONE on the same day. It was reported that the patient present for evaluation of nausea and vomiting. Onset of symptoms was today on 27-OCT-2010. The patient described nausea as severe. Vomiting had occurred 9 times over the past hours. Vomitus was described as bilious, brown. Symptoms had been associated with abdominal pain of moderate severity, diarrhea, occurring 5 times over past 12 hours, inability to keep down fluids, fever to 101.5 and suspicious food/drink: fish. Patient denied hematemesis, melena, possibility of pregnancy, alcohol overuse. Course to date had been gradually worsening. Evaluation to date had been none. Treatment to date had been none. History was reviewed. The patient had no pertinent past medical history. The patient was here yesterday on 26-OCT-2010 and was not sick but got GARDASIL and FLUZONE. Vomiting, nausea and abdominal pain started at 1:00 AM on 27-OCT-2010. At the time of reporting, the patient had recovered from the events. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood thyroid stimulating hormone, Diarrhoea, Full blood count, Lipase, Nausea
Clinical narrative: Information has been requested from a health care student concerning a 13 year old female sulfa allergy and latex allergy and no pertinent medical history who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. There was no concomitant medication. On the morning of 27-OCT-2010 the patient returned to the office and complained of vomiting and diarrhea that had started at approximately 1:00 AM on 27-OCT-2010. It was further reported that the patient was receiving intravenous fluids and seemed to be improving. The patient was still in the office during the call. Complete blood count (CBC), serum lipase and amylase, serum calcium, thyroid levels, serum insulin and glucose levels were drawn during the office visit on 27-OCT-2010 and results were pending. Follow-up information has been received concerning the 13 year old female with sulfonamide allergy, latex allergy and gastrooesophageal reflux disease and no illness at time of vaccination, who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 665607/1332Y) intramuscularly into her left deltoid. Concomitant therapy included FLUZONE on the same day. It was reported that the patient present for evaluation of nausea and vomiting. Onset of symptoms was today on 27-OCT-2010. The patient described nausea as severe. Vomiting had occurred 9 times over the past hours. Vomitus was described as bilious, brown. Symptoms had been associated with abdominal pain of moderate severity, diarrhea, occurring 5 times over past 12 hours, inability to keep down fluids, fever to 101.5 and suspicious food/drink: fish. Patient denied hematemesis, melena, possibility of pregnancy, alcohol overuse. Course to date had been gradually worsening. Evaluation to date had been none. Treatment to date had been none. History was reviewed. The patient had no pertinent past medical history. The patient was here yesterday on 26-OCT-2010 and was not sick but got GARDASIL and FLUZONE. Vomiting, nausea and abdominal pain started at 1:00 AM on 27-OCT-2010. At the time of reporting, the patient had recovered from the events. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been requested from a health care student concerning a 13 year old female sulfa allergy and latex allergy and no pertinent medical history who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # not reported) intramuscularly. There was no concomitant medication. On the morning of 27-OCT-2010 the patient returned to the office and complained of vomiting and diarrhea that had started at approximately 1:00 AM on 27-OCT-2010. It was further reported that the patient was receiving intravenous fluids and seemed to be improving. The patient was still in the office during the call. Complete blood count (CBC), serum lipase and amylase, serum calcium, thyroid levels, serum insulin and glucose levels were drawn during the office visit on 27-OCT-2010 and results were pending. Follow-up information has been received concerning the 13 year old female with sulfonamide allergy, latex allergy and gastrooesophageal reflux disease and no illness at time of vaccination, who on the afternoon of 26-OCT-2010 was vaccinated with the first 0.5 ml dose of GARDASIL (lot # 665607/1332Y) intramuscularly into her left deltoid. Concomitant therapy included FLUZONE on the same day. It was reported that the patient present for evaluation of nausea and vomiting. Onset of symptoms was today on 27-OCT-2010. The patient described nausea as severe. Vomiting had occurred 9 times over the past hours. Vomitus was described as bilious, brown. Symptoms had been associated with abdominal pain of moderate severity, diarrhea, occurring 5 times over past 12 hours, inability to keep down fluids, fever to 101.5 and suspicious food/drink: fish. Patient denied hematemesis, melena, possibility of pregnancy, alcohol overuse. Course to date had been gradually worsening. Evaluation to date had been none. Treatment to date had been none. History was reviewed. The patient had no pertinent past medical history. The patient was here yesterday on 26-OCT-2010 and was not sick but got GARDASIL and FLUZONE. Vomiting, nausea and abdominal pain started at 1:00 AM on 27-OCT-2010. At the time of reporting, the patient had recovered from the events. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a 26 year old female consumer who on 08-NOV-2010 was vaccinated with the first dose of GARDASIL (Lot# not reported). It was reported that on 11-NOV-2010, the consumer experienced pain at the injection and she could not lift her arm. The consumer did not seek medical attention. At the time of the report, the consumer had not recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with three doses of GARDASIL, a Pregnancy Registry product, (IM, 0.5ml, lot # not reported). She was currently 4 months pregnant. The patient was told by her OB/GYN physician that she was HPV positive. The patient came to the office. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Human chorionic gonadotropin negative, Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 25 year old female patient, with no pertinent medical history and no known drug allergies, who on 26-OCT-2010 was vaccinated with a dose of GARDASIL (Lot # 666597/0768Z, expire date 17-OCT-2010), 0.5 ml, intramuscularly. Concomitant therapy included minocycline. On 26-OCT-2010 an UCG was performed with a negative result. The patient vomited the day after receiving GARDASIL (on 27-OCT-2010). She had only vomited once but she was only drinking fluids and was not eating any solid food. The patient sought medical attention via telephone. At the time of the report, the patient was recovering. Follow up information received from the registered nurse indicated the patient was a female patient with no illness at the time of vaccination. The day after the patient received the dose of GARDASIL, she developed nausea and vomiting. No laboratories studies performed. The outcome of the patient's nausea was unknown. Follow up information has been received from the physician indicating that on 14-DEC-2010 the patient received a second dose of GARDASIL (lot # not reported) and had no untoward side effects. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash, Pruritus generalised, Rash generalised, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient who on 25-OCT-2010 was vaccinated with a first dose of GARDASIL (Lot # not provided). It was reported that the patient developed hives which spread over her whole body. The rash began at the injection site on the same day she received the dose and spread all over her body, accompanied by itching. The nurse practitioner advised her to take BENADRYL, and also prescribed AMBIEN for her because the itching was keeping her awake. Her rash and itching were improving but had not completely resolved. The nurse stated that the patient did not want to receive the second and third dose of GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning two patients who, on unspecified date, were vaccinated with a dose of GARDASIL (lot # and expire date not reported) (route not specified). The patients received GARDASIL and on an unspecified date, experienced dizziness. The patients did not seek medical attention. At the time of the report, the outcome of the patients was unknown. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle atrophy
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient who on an unspecified date was vaccinated with a second dose of GARDASIL (Lot # not provided). Subsequently the patient experienced deltoid muscle atrophy. At the time of the report, the patient's deltoid muscle atrophy persisted. The patient sought unspecified medical attention. Follow up information has been received from a nurse practitioner who stated that a 13 year old female student was vaccinated IM with a second dose of GARDASIL (Lot # 665547/1318Y) in the right deltoid. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Fatigue, Full blood count normal, Human chorionic gonadotropin positive, Lipids normal, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient who on 30-Sep-2010 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# Unknown) (lot#666121/0597Z) (Exp date 19-Aug-2010), IM. The patient also received on the same date a dose of VARIVAX (Lot # 666694/1710Y) (Exp date 04-Dec-2011). Physician stated that the patient had received GARDASIL (Lot# Unknown) and was pregnant. It was reported that another physician in the practice had given GARDASIL to this patient. The patient at that time had denied pregnancy and did not know her last menstrual period because it was irregular. On 26-OCT-2010, the patient had come into the physician's office complaining of pain in the rib. The physician wanted to do an x-ray so prior to doing the x-ray and did a urine pregnancy test for the patient which had been found to be positive for pregnancy. The patient was currently complaining of being tired. Laboratory diagnostics studies revealed "HCG levels 104630. On 27-Oct-2010 did CBC that was normal, lipid panel was normal, urine test for chlamydia still pending and syphilis test still pending". At the time of the report the patient had 8 weeks of gestation (LMP approximately on 02-SEP-2010; EDD on 09-JUN-2011). The outcome for pain in the rib and tiredness was unknown. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Musculoskeletal chest pain
Clinical narrative: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 16 year old female patient who on 30-Sep-2010 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot# Unknown) (lot#666121/0597Z) (Exp date 19-Aug-2010), IM. The patient also received on the same date a dose of VARIVAX (Lot # 666694/1710Y) (Exp date 04-Dec-2011). Physician stated that the patient had received GARDASIL (Lot# Unknown) and was pregnant. It was reported that another physician in the practice had given GARDASIL to this patient. The patient at that time had denied pregnancy and did not know her last menstrual period because it was irregular. On 26-OCT-2010, the patient had come into the physician's office complaining of pain in the rib. The physician wanted to do an x-ray so prior to doing the x-ray and did a urine pregnancy test for the patient which had been found to be positive for pregnancy. The patient was currently complaining of being tired. Laboratory diagnostics studies revealed "HCG levels 104630. On 27-Oct-2010 did CBC that was normal, lipid panel was normal, urine test for chlamydia still pending and syphilis test still pending". At the time of the report the patient had 8 weeks of gestation (LMP approximately on 02-SEP-2010; EDD on 09-JUN-2011). The outcome for pain in the rib and tiredness was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Dizziness, Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: Information has been received from a pharmacist concerning a 25 year old female patient with a history of fainting when was given shots who on 21-SEP-2010 was vaccinated IM with her first 120 microgram dose of GARDASIL (lot # 662765/0821Y, expiration unspecified). On 21-SEP-2010 the patient received her first GARDASIL shot and 15 minutes after receiving the shot the patient stood up and then felt faint and passed out. Patient hit her head and bruised her knee. Pharmacist gave patient orange juice, called her mother to pick her up, and kept her at the store for an hour before allowing her to leave to make sure she would not faint again. The mother of the patient told the pharmacist that the patient had not eaten breakfast that morning. At the time of reporting, the patient had recovered on 21-SEP-2010. The pharmacist administered the shot. Follow-up information has been received from the pharmacist indicating that he patient received the injection and then remarked that it was not bad that she usually passed out when she got shots. The pharmacist then suggested she stayed seated a while until she felt ok. After approximately 5-10 minutes she said she was ok and then proceeded to the pharmacy counter to check out. As she stood there, she then said she thought she should go back and sit down. Before the pharmacist could get out the door, she was on the floor. She was then helped to a sitting position. She was conscious but dazed. The got her to chair and she stayed there until her mother arrived. The placed a cool towel on her face and forehead and eventually she felt better, the mother came and asked if she had eaten, she stated she had not. They got her some orange juice. Eventually she felt better and walked out on her own. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from a female healthcare student who in approximately 2006 (about 4 years ago) received the complete GARDASIL (lot # not reported) series. Subsequently the patient had a positive HPV (human papilloma virus) test for a high risk HPV type. The patient had sought medical attention by office visit. At the time of report, the outcome was unknown. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Genital herpes, Smear cervix abnormal, Vulvovaginal discomfort
Clinical narrative: Information has been received from a physician concerning his daughter, a 23 year old female who in February 2007, in June 2007, in November 2007 was vaccinated with the first, second and third dose of GARDASIL (lot # not reported), respectively. There was no concomitant therapy. During the interval of the second and third dose she had sexual relations. Recently (in approximately October 2010) the patient experienced vulvar discomfort. The patient saw her gynecologist. A PAP performed within past 2 weeks (in October 2010) test showed LSIL (low-grade squamous intraepithelial lesion). The patient had herpetic vulvar lesions (not condylomata) and had responded to treatment with acyclovir. No HPV (human papilloma virus ) testing was performed. At the time of the report, the patient LSIL persisted. In follow-up, the physician indicated that he was requesting a lot check for GARDASIL (lot # 657872/0515U, expiration date 12-FEB-2010 for one of 3 doses of GARDASIL his daughter received in 2007). He was still trying to obtain the other lot numbers for the other two doses. A lot check has been initiated. Follow information has been received from the patient's physician who reported that the patient had no adverse experience following GARDASIL administration. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from physician assistant concerning a 23 year old female with no drug allergies who was vaccinated with the first dose of GARDASIL (lot # 667194/1081Z) in the left arm on 11-AUG-2010 and the second dose (lot # not reported) in the left arm on 15-OCT-2010. On an unknown date (in October 2010), the patient developed a hard nodule in her left arm which "hasn't gone away in two months." On 28-OCT-2010 the patient called the practice to report that her arm was reddened at the injection site, and her arm was swollen and difficult to move. The physician recommended cold compresses for the area and BENADRYL. On 09-NOV-2010 the patient reported to the practice again for examination. The physician assistant stated that the redness had gone away at that time except small palpable lump which the patient reported was sore when she laid on her arm. The series of GARDASIL vaccination was discontinued for the patient due to her response to this second dose. The outcome of swollen and small palpable lump and sore in her left arm and left arm difficult to move was unknown. Follow-up information has been received from a physician concerning a 23 year old female with an allergy to DURICEF and hearing impaired who on 11-AUG-2010 was vaccinated the first dose of with GARDASIL (lot # 666595/0703Z) into the right arm and the second dose of GARDASIL (lot # 667194/1081Z) into the left arm. The patient called the office on 28-OCT-2010 and complained swelling, redness/left arm sore at injection site. On 09-NOV-2010, the patient complained a deep lump in left arm where injection was given. At the time of report, the patient had not recovered. Additional information has been requested.