chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 22 year old female with hypertension and "an interstitial problem" NOS who on 09-Oct-2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Concomitant therapy included unspecified therapy.  On 16-Oct-2006 the patient developed a "quarter size knot at the injection site that was warm to touch". Medical attention was sought and the patient was treated with diphenhydramine hydrochloride (BENADRYL). It was reported that the patient will discontinue the vaccination series. At the time of this report the patient had not recovered from the event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). The physician reported that the patient "was administered the shot and then fainted/passed out". Unspecified medical attention was sought. The physician reported that the patient recovered from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently, following the vaccination, the patient fainted. Unspecified medical attention was sought. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Burning sensation, Erythema, Medical device complication, Skin warm
Clinical narrative: Information has been received from an office manager and a 42 year old female medical assistant with a Penicillin allergy who on 18-Oct-2006 went to place the needle on the HPV rL1 6 11 16 18 VLP vaccine (yeast0 (Lot#653650/0640F) pre-filled syringe and the medication squirted "out of the syringe" into the air. Concomitant therapy included bupropion HCl (WELLBUTRIN SR), Clarithromycin (BIAXIN), acetaminophen/hydrocodone bitartrate (LORTAB) and Trazodone HCl. The medication did get on her hands and she was experiencing burning and had redness on her index finger. It was warm to touch. At the time of this report, the patient was recovering from the events and the redness was decreasing. Additional information has been requested. It was reported that the patient who was scheduled to received HPV came back the next week and received a dose of HPV which was not in a prefilled syringe, without any problems. The patient had no side effects. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Initial and follow up information has been received from a physician concerning a 17 year old white female student with no pre-existing medical conditions. On 10-Oct2006, at 4 PM, the patient was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Concomitant therapy included an unspecified therapy (reported as "over-the-counter acne medication'). There were no illnesses noted at the time of vaccination.  The physician reported that when the patient left the office she was fine. That same day, the patient had been given desloratadine (CLARINEX) without positive result, by her mother and without physician consultation. On 11-Oct-2006, at 4 PM, the patient developed a rash which appeared on the ear tips, face, elbows, knee caps and around the belly button area. On 14-Oct-2006, the patient went to the emergency room (ER) but was not admitted for an overnight stay. The patient was treated with prednisone. The physician reported that she did not see the patient. The physician reported that the patient "had hives" and was given the steroids in the emergency room which she considered to be routine. At the time of this report, the patient had not recovered from the event. The physician considered the event to be non-serious. Additional information is expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: Information has been received from a 23 year old female who on 03-OCT-2006 was vaccinated with a 0.5 mL dose of GARDASIL. The patient reported that the vaccine was given in the front part of the thigh muscle. Subsequently, the muscle contracted and the patient passed out due to pain. Unspecified medical attention was sought. When the patient woke up, she reported that she "felt fine." On 03-OCT-2006, the patient recovered from the events. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Pain
Clinical narrative: Information has been received from an LPN concerning a 30 year old female patient with anxiety who on 11-Sep-2006 was vaccinated IM with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast), lot#654540/0800F. Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). After receiving the vaccination on 11-Sep-2006, the patient complained of a lot of pain under the arm pit and also on the left arm (injection arm).  The arm hurt on and off, especially during workouts and while sleeping.  the pain wakes up the patient in the middle of the night. She sought medical attention and was told to take Ibuprofen, apply ice to the area, and no upper body exercises. The nurse stated the patient was still having moderate pain 4 weeks after the injection, and that she probably would not receive further doses. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with a 0.5 ml dose of HPV vaccine. Subsequently the pt developed an upper respiratory infection. The pt sought unspecified medical attention. The nurse practitioner stated that she told the pt when the pt called the office that she did not feel the upper respiratory infection was caused by the HPV vaccine. No further information was provided at the time of this report. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Diarrhoea, Irritable bowel syndrome, Loss of consciousness, Nausea
Clinical narrative: Information has been received from the mother of a 24 year old female with irritable bowel syndrome and food allergies to 28 different foods, including yeast and corn who on 10/16/06 was vaccinated with HPV Vaccine. Concomitant therapy included Hormonal contraceptives (unspecified) and dermotologic (unspecified). On 10/16/06 the pt experienced nausea, diarrhea, aches, and vomiting which continued for three days without changes. On 10/19/06, it was reported that the pts irritable bowel syndrome was also triggered by the above events. On 10/19/06 the pt underwent a blood test (usually very well tolerated), however following the blood test on 10/19/06, the pt passed out and vomited, Unspecified medical attention was sought. The pts mother stated that she would be contacting her daughters physician with the listed allergies. At the time of this report, the pt was recovering from the events. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Vomiting
Clinical narrative: Information has been received from the mother of a 24 year old female with irritable bowel syndrome and food allergies to 28 different foods, including yeast and corn who on 10/16/06 was vaccinated with HPV Vaccine. Concomitant therapy included Hormonal contraceptives (unspecified) and dermotologic (unspecified). On 10/16/06 the pt experienced nausea, diarrhea, aches, and vomiting which continued for three days without changes. On 10/19/06, it was reported that the pts irritable bowel syndrome was also triggered by the above events. On 10/19/06 the pt underwent a blood test (usually very well tolerated), however following the blood test on 10/19/06, the pt passed out and vomited, Unspecified medical attention was sought. The pts mother stated that she would be contacting her daughters physician with the listed allergies. At the time of this report, the pt was recovering from the events. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise
Clinical narrative: Information has been received from a nurse concerning a female pt who on an unspecified date was vaccinated IM with HPV vaccine (it was reported that it was uncertain whether this was the pts first dose). Subsequently, the day after vaccination, the pt experienced flu-like symptoms, felt horrible and felt very sick for a few days. At the time of this report, the pt had no more flu-like symptoms. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia
Clinical narrative: Information has been received from a 38 year old female pt who on 8/22/06 was vaccainted IM with a dose of HPV vaccine. The reporter stated that on 8/22/06 I had pain for two months after the injection. Medical attention was sought. The pt was recovering. A product quality complaint was not involved. Additional information has been requested. Follow up information has been received from a physician concerning the 24 year old patient (previously reported as 38). The patient was complaining of pain, right hip: was seen by the nurse and the doctor; however there was no clinical indication of any problem. The patient was recovered.
Age: 28.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site mass
Clinical narrative: Information has been received from a 38 year old female pt who on 8/22/06 was vaccainted IM with a dose of HPV vaccine. The reporter stated that on 8/22/06 I had pain for two months after the injection. Medical attention was sought. The pt was recovering. A product quality complaint was not involved. Additional information has been requested. Follow up information has been received from a physician concerning the 24 year old patient (previously reported as 38). The patient was complaining of pain, right hip: was seen by the nurse and the doctor; however there was no clinical indication of any problem. The patient was recovered.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling, Lymphadenitis, Lymphadenopathy, Lymphadenopathy, Swelling
Clinical narrative: Information has been received from a physician concerning a 21 year old female who in approximately September 2006 was vaccinated with the first dose of GARDASIL (lot # not provided). On an unspecified date in approximately September the patient developed swelling in her lymph nodes and groin. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested. 01/05/2007: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician concerning a 21 year old female with seasonal asthma and no known drug allergies who on 04-SEP-2006, was vaccinated with an intramuscular injection in the onterolateral right thigh of the first dose of GARDASIL (Lot # 0689F). On 06-SEP-2006 the patient developed swelling in her lymph nodes and groin. The patient was seen in her physicians office and a large (7.3 cm), soft, tender femoral lymph node was noted near the injection site. There was no evidence of cellulitis or drainage. THe patient was diagnosed with lymphadenitis and was given asthma precautions. THe patient was seen in the office on 09-SEP-2006 and the area was still tender and the swelling was noted to have decreased slightly. The patient was seen again in the office on 10-NOV-2006 and the lymphadenitis had not yet fully resolved. The doctor noted that the second vaccination would be delayed until the lymphadenitis had completely resolved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician concerning a 21 year old female who in approximately September 2006 was vaccinated with the first dose of GARDASIL (lot # not provided). On an unspecified date in approximately September the patient developed swelling in her lymph nodes and groin. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested. 01/05/2007: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician concerning a 21 year old female with seasonal asthma and no known drug allergies who on 04-SEP-2006, was vaccinated with an intramuscular injection in the onterolateral right thigh of the first dose of GARDASIL (Lot # 0689F). On 06-SEP-2006 the patient developed swelling in her lymph nodes and groin. The patient was seen in her physicians office and a large (7.3 cm), soft, tender femoral lymph node was noted near the injection site. There was no evidence of cellulitis or drainage. THe patient was diagnosed with lymphadenitis and was given asthma precautions. THe patient was seen in the office on 09-SEP-2006 and the area was still tender and the swelling was noted to have decreased slightly. The patient was seen again in the office on 10-NOV-2006 and the lymphadenitis had not yet fully resolved. The doctor noted that the second vaccination would be delayed until the lymphadenitis had completely resolved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 27 year old female who on 10/3/06 was vaccinated with the first dose of HPV Vaccine (lot nor provided). On 10/12/06 the pt experienced a very sore arm. The physician advised the pt to take Advil and apply ice to the area. At the time of the report it was unk if the pt had recovered. Additional information has been requested. Follow up information received stated that as appriximately 03-NOV-2006 the patient recovered from the event.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccainted with the first dose of HPV vaccine (lot # not provided). Subsequently the pt experienced low grade fever. The physician reported that the pt received Tylenol and felt better. Subsequently, the pt recovered from the low grade fever. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 10/16/06 was vaccinated with an IM HVP vaccine (lot 653978/0955F). On 10/17/06 the pt was sent home from school because she developed a fever of 102F and nausea. the physician reported that after 12 hours the pt recovered and returned to school the next day symptoms free. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: DTOX, HEPAB, HPV4, TYP
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a physician concerning a female in her 20's with intermittent problems with asthma and no known drug allergies, who on 22-SEPT-2006 at 13:00  was vaccinated IM into the left deltoid with a first dose of GARDASIL (Lot #653650/0702F). Concomitant therapy given that day included a first dose of DTaP (unspecified) given IM into the left arm, a first dose of TWINRIX (lot# AHABB0583A) given IM into the right arm and a first dose of typhoid vaccine. On 27-SEP-2006, the patient experienced intense itching all oer her body. The patient self medicated with BENADRYL. The itching was mostly on theinside of her legs and her back. She was treated with ZYRTEC. No diagnostic laboratory tests were pereformed. Subsequently, the patient fully recovered. No product qualitycomplaint was involved. It was noted that the vaccines were administered at different anatomical sites. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old white female with no know drug allergies, who on 28-SEP-2006 at 14:30 was vaccinated IM into the right deltoid with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). (Lot #653978/0955F). On 29-SEP-2006 at 08:00 the patient experienced a "large red rash area near the injection site, 1x1cm red around injection site and 3x2cm spot in the superior lateral site area, and red raised spot inferior and lateral to the injection site." No diagnostic laboratory studies were performed. The patient was treated with cool compresses, ibuprofen (Advil) or ibuprofen (Motrin) and cetirizine hydorchloride (Zyrtec) every 6 to 8 hours. The patient was told to go to the emergency room if her condition worsened. Subsequently, the patient recovered as there was no more follow up phone calls to the office. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient developed severe arm pain at the injection site. At the time of this report, the outcome of the event was unknown. No further details were provided. Additional information has been requested. 01/05/07: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician and a nurse concerning a female patient who on 20-OCT-2006 was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced severe arm pain at the injection site. There was no redness and no swelling. The nurse reported that the pre-filled syringe "popped" when attempting to use it, causing the patient pain. The nurse then used another syringe which "worked fine". At the time of this report, the patient had not yet received her second vaccination. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Swelling
Clinical narrative: Information has been received from a midwife registered nurse concerning a female with genital warts who "within the last few weeks" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included imiquimod (Aldara). Subsequently "within the last few weeks" the patient experienced "swelling in genital warts". At the time of the report the patient was recovering. Unspecified medical attention was sought. Other information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female who on 24 Oct 2006 was vaccinated with Gardisil (yeast) (Lot #654540/0800F). The nurse reported that on 24 Oct 2006 the pre-filled syringe of the vaccine malfunctioned and small amount sprayed out of the syring while she was withdrawing the syringe and the patient received an incomplete dose of the vaccine. She thought most of the dose was administered. The patient also stated that "the vaccination hurt." Unspecified medical attention was sought. At the time of this report the patient's outcome was unknown. Additional information has been requested. 01/05/2007 Information has been received from a registered nurse concerning a 18 year old female who at 12:30 on 24-OCT-2006 was vaccinated intramuscularly in the deltoid with GARDASIL (Lot#654540/0800F). The nurse reported that on 24-OCT-2006 the pre-filled syringe of the vaccine malfunctioned and a small amount sprayed out of the syringe while she was withdrawing the syringe and the patient received  an incomplete dose of the vaccine. She thought most of the dose was administered. The patient also stated that "the vaccination hurt". Unspecified medical attention was sought. At the time of this report the patient's outcome was unnknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Groin pain, Lymphadenopathy
Clinical narrative: Information has been received from a triage nurse concerning a female (age unknown) with no other pertinent medical history reported. On approximately 17 Oct 2006, the patient was vaccinated with a 0.5mL dose of Gardisal (yeast). There were no concomitant medications reported. On an unspecified date, the patient contacted the nurse complaining about pain and swelling of the lymph nodes, in the groin area on her right side. Unspecified medical attention was sought. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Influenza like illness, Malaise, Myositis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated IM with a 0.5ml first dose of Gardisal. Approximately 3 to 4 days after the vaccination, the patient experienced "myacitis", malaise and flu like symptoms and went to the emergency room. Subsequently, the patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with no medical history or allergies, who on 20 Aug 2006 and 20 Oct 2006 was vaccinated IM with a first and second 0.5mL dose of Gardisal (yeast), respectively (first dose lot # 654540/0800F and second dose lot # 653736/0868F). There was no concomitant medication. On 20 Aug 2006, the patient experienced nausea and emesis. On 20 Oct 2006, the patient again experienced immediate nausea and vomiting. On 21 Oct 2006 the patient experienced low grade fever. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered from emesis. At the time of this report, the patient's low grade fever persisted and the outcome of nausea was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a Registered Nurse concerning an adult patient who was vaccinated with a dose of Gardisal. The patient complained of pain while being injected using the prefilled syringe. The nurse reported that another patient did not complain of pain when a "normal" syringe was used. The nurse suggested the pre-filled needles may be dull causing pain during injection. The patient's out come was not reported. A product quality complaint was involved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated intramuscularly with a dose of Gardisil. The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 11 Oct 2006 was vaccinated with the first dose of 0.5mL of Gardisil (Lot # 653937/0637F). On 21 Oct 2006, the patient developed a know on the arm with no rash and no redness. On 24 Oct 2006, the patient developed throbbing pain around the arm that the injection was administered. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 28 Aug 2006 was vaccinated with a first dose of Gardisil. On 28 Aug 2006 the patient experienced vomiting within four hours of receiving the vaccination. Outcome was not reported. On 25 Oct 2006, the patient was vaccinated with a second dose of Gardisil. On 25 Oct 2006 the patient experienced vomiting within four hours of receiving the vaccination. On 25 Oct 2006, the patient recovered from vomiting. Additional information has been requested. Initial and follow-up information has been received from a physician and a licensed practical nurse concerning a 16 year old female patient who on 28-AUG-2006 was vaccinated with a first dose of GARDASIL 0.5 ml IM.  On 28-AUG-2006, the patient experienced vomiting within four hours of receivng the vaccination.  The patient recovered on 28-AUG-2006.  On 25-OCT-2006, the patient was vaccinated with a second dose of GARDASIL 0.5 ml IM.  On 25-OCT-2006 the patient experienced vomiting within four hours of receiving the vaccination.  The mother felt that the vomiting was flu related for the first dose, however the vomiting happened again after the second dose.  The patient recovered on 25-OCT-2006.  No additional information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Blister, Oral mucosal blistering, Swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on 26-OCT-2006 was vaccinated IM with a first dose of GARDASIL. On 26-OCT-2006 the patient experienced swelling as well as blisters in mouth and on the neck. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a female teenager who was vaccinated IM with a first dose of Gardisil. The patient "passed out" when she received the injection. The physician is planning to give the doses as recommended. Unspecified medical attention was sought. Shortly after vaccination, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Mononucleosis syndrome, Pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 23 Oct 2006 was vaccinated with 0.5mL of Gardisil (yeast). There were no concomitant medications reported. On 23 Oct 2006, the patient developed a high fever of 102 degrees after receiving shot of Gardisil. The temperature continued for three days and was now noted at 100 degrees. The patient also developed achy legs. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered from the events. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2006.  Initial and follow up information has been received from a physician concerning an 18 year old white female student who on 23-OCT-2006 was vaccinated intramuscularly in the arm with the first 0.5 mL dose of GARDASIL.  There were no concomitant medications reported.  On 23-OCT-2006, the patient developed a high fever of 102 degrees after receiving shot of GARDASIL.  The temperature continued for three days and on 26-OCT-2006 was noted at 100 degrees.  The patient also developed achy legs.  On 30-OCT-2006, that next week, the patient was diagnosed with mononucleosis.  At the time of this report, the outcome of the events were unknown.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Incorrect dose administered
Clinical narrative: Information has been received from a physician assistant in her "late thirties" who on an unspecified date was vaccinated intramuscularly with the first dose of Gardisil vaccine (yeast). The physician assistant reported that she did not get her period the first month after the Gardisil vaccine. It was unknown if the patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown as " the patient was not due yet for her next menstrual cycle". Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Syncope vasovagal
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of Gardisil vaccine (yeast). The nurse practitioner reported that the patient "experienced a vasovagal reaction and felt woozy and fainted within 5 minutes of the injection." At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received from a physician concerning a "15 or 16 year old" female who on approximately 25 Oct 2006 or 26 Oct 2006 was vaccinated intramuscularly in the deltoid with Gardisil. On approximately 27 Oct 2006, the patient developed a low grade fever of about 99 and dizziness. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 31-OCT-2006, the patient was vaccinated intramuscularly with GARDASIL. There were no concomitant medications reported. Subsequently, the patient experienced a cut which was less than 1/4 inch when the syringe was pulled out from the patient. It was reported that the patient had received the full dose. The patient sought unspecified medical attention. The registered nurse reported that the cut was very minor. At the time of this report, the patient was recovering from the events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Tension, Throat tightness
Clinical narrative: Information has been received from a physician concerning a female age "14 or 15 years old" who on an unspecified date was vaccinated with the first dose of 0.5 ml of GARDASIL. After vaccination, the patient felt faint. It was reported that the patient felt dizzy, had difficulty breathing (also reported as "had a short of breath feeling"), felt like her throat was closing and looked tense. Her lungs were clear, there was no wheezing, no signs or symptoms of swelling, no facial or eye swelling and her blood pressure was stable. The physician reported that she thought this looked like a "slight reaction." The patient was given diphenhydramine hydrochloride (BENADRYL) as a precaution. The physician reported that the events were resolving that same day. It was reported that the patient "experienced similar symptoms not relating to vaccines and felt the symptoms may have been more panic driven than anything else." At the time of this report, the patient had recovered from the events (date unknown). The physician reported that she did not feel that the treatment with diphenhydramine hydrochloride (BENADRYL) was needed to prevent serious criteria and did not feel that this experience was life-threatening to the patient. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEPAB, HPV4
Symptoms: Vision blurred
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 26 year old female with no other pertinent medical history and no known allergies or adverse drug reactions reported. On 24-OCT-2006 the patient was vaccinated intramuscularly in the deltoid with the first "1 vial" dose of GARDASIL (lot #653938/0954F). Concomitant therapy included azithromycin (ZITHROMAX). It was reported that on 24-OCT-2006, the patient had been vaccinated with the third dose of TWINRIX. On 25-OCT-2006, "within a day after immunization," the patient experienced blurry vision in both eyes. The patient sought unspecified medical attention. The patient was told by the physician to come to the office to be evaluated but had not. As of 02-NOV-2006, nine days after receiving GARDASIL, the physician reported that the blurred vision was "getting much better." Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 30-OCT-2006 was vaccinated with GARDASIL. Subsequently, the patient experienced redness in her face and had vomited. The patient sought unspecified medical attention. At the time of this report, the patient was recovering from the event. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 30 Oct 2006 was vaccinated with 0.5mL of Gardisil (Lot# 653736/0689F). On 30 Oct 2006, the patient developed a vasovagal reaction and passed out within one minute post vaccination. The patient was revived with an ammonia inhalant. No other symptoms were noted. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a physician concerning a 21 year old female who on 30 Oct 2006 was vaccinated with 0.5mL of Gardisil (Lot# 653736/0689F). On 30 Oct 2006, the patient developed a vasovagal reaction and passed out within one minute post vaccination. The patient was revived with an ammonia inhalant. No other symptoms were noted. Unspecified medical attention was sought. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no pre existing allergies, birth defects or medical conditions and reportedly was not ill at the time of vaccination. On 10/30/06, when the pt checked into the physicians office her blood pressure was 80/50. On 10/30/06, at 12:30pm, the pt was vaccinated IM into the left deltoid muscle with HPV vaccine (lot # 653736/0689F). Concomitant therapy included Ortho Tri Cyclen Lo), Claritin and Celexa. After the pt received the vaccination, she passed out and was unconscious, she hit her head when she fell forward out of her chair. The pt had a neurological check up per in internal medical physician. The pt was checked by two physicians and they considered the pt had a vasovagal reaction. The pt left the office ambulatory, alert, recovered and in satisfactory condition. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Loss of consciousness, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no pre existing allergies, birth defects or medical conditions and reportedly was not ill at the time of vaccination. On 10/30/06, when the pt checked into the physicians office her blood pressure was 80/50. On 10/30/06, at 12:30pm, the pt was vaccinated IM into the left deltoid muscle with HPV vaccine (lot # 653736/0689F). Concomitant therapy included Ortho Tri Cyclen Lo), Claritin and Celexa. After the pt received the vaccination, she passed out and was unconscious, she hit her head when she fell forward out of her chair. The pt had a neurological check up per in internal medical physician. The pt was checked by two physicians and they considered the pt had a vasovagal reaction. The pt left the office ambulatory, alert, recovered and in satisfactory condition. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a certified medical assistant and a physician concerning a 25 year old female with a history of hives due to orange juice who in approximately Oct 2006, a couple of weeks ago, was vaccainted with a 0.5ml first dose of HPV vaccine (lot 653736/0689F). There was no concomitant medication. Approximately 30 minutes after the vaccination, the pt experienced severe itching all over her body. It was reported that there was no rash. Unspecified medical attention was sought. Subsequently, the pt recovered after approximately 2 days. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with migraines and no known allergies or adverse drug reactions reported. On approx 8/31/06, the pt was vaccinated with the first dose of HPV vaccine. On an unspecified date, the pt was noted to be positive for an unknown number of high risk human papilloma virus types. The pt underwent a pap test (date and results not reported). The pt sought unspecified medical attention. a colposcopy was planned for the pt. At the time of this report, the pt had not recovered from the event. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 11/14/2006. Information has been received from a licensed practical nurse concerning a 16 year old female subject with migraines and no known allergies or adverse drug reactions reported. On 24-AUG-2006, the patient was vaccinated with the first dose of GARDASIL. On an unspecified date, the patient was noted to be positive for an unknown number of high risk human papilloma virus types. The patient underwent a PAP (date and results not reported). The patient sought unspecified medical attention. A colposcopy was planned for the patient. At the time of this report, the patient had not recovered from the event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Information has been received from a nurse practitioner concerning a female pt who in Oct 2006, was vaccinated IM with a dose of HPV Vaccine. Subsequently in Oct 2006, she experienced lightheadedness, weakness, pallor, and sweating, No medical attention was sought. The nurse practitioner indicated the pt was doing fine. No product quality complaint was involved. Additional information has been requested. 01/05/2007 Initial and follow up information has been received from a Nurse Practitioner concerning a 20 year old female patient who in October 2006, was vaccinated IM with a dose of GARDASIL. Subsequently, she experienced nausea, lightheadedness /lightheaded feeling/dizziness, weakness, pallor, and sweating but did not lose consciousness. No medical attention was sought. The nurse practitioner indicated the patient was "doing fine" and that she recovered after 20 minutes. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Information has been received from a nurse practitioner concerning a female pt who in Oct 2006, was vaccinated IM with a dose of HVP vaccine. Subsequently in Oct 2006 she experienced lightheadedness, weakness, pallor and sweating. No medical attention was sought. The nurse practitioner indicated the pt was doing fine. No product quality complaint was involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ocular hyperaemia, Pruritus, Rash
Clinical narrative: Information has been received from a nurse concerning an 18 year old female who on 30-OCT-2006 was vaccinated with the first dose of GARDASIL. On 30-OCT-2006 the patient developed a "rash on the palm of her hand and also red, itchy eyes." The patient sought unspecified medical attention. The nurse reported that the patient had recently purchased new eye makeup. At the time of this report, the outcome of the events were unknown. Additional information has been requested. 04/06/2007 This is in follow-up to report(s) previously submitted on 11/14/2006. Initial and follow up information has been received from a nurse concerning an 18 year old female student with no pre-existing medical conditions and no known allergies reported. On 30-OCT-2006, at approximately 9:30 AM, the patient was vaccinated with the first dose of GARDASIL (Lot# 653650/0702F). There were no illnesses noted at the time of vaccination. On 30-OCT-2006, at 11:00 AM, the patient developed swollen eyes and rash to hands and feet (previously reported as a "rash on the palm of her hand" and also red, itchy eyes). The patient sought unspecified medical attention. The patient reported that she had a new makeup product applied several days around the injection. The patient went to the school clinic after the onset of symptoms. The patient was treated with ALLEGRA and the symptoms improved in approximately 24 hours. On 31-OCT-2006, the patient had recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who on 10/30/06 was vaccainted with HPV vaccine. Subsequently, the pt experienced redness in her face and had vomited. The pt sought unspecified medical attention. At the time of this report, the pt was recovering from the event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced dizziness and nausea within a few minutes post-vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently, the patient experienced dizziness and nausea within a few minutes post-vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a female pt who on an unspecified date was vaccainted with HPV vaccine. Subsequently the pt experienced dizziness and nausea within a few minutes post vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female pt who on an unspecified date was vaccinated with HPV vaccine. Subsequently, following the vaccination, the pt fainted. At the time of this report, the outcome of the event was unk. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt received 4 shots on Weds 20th on Thurs and Friday he developed a fever and horrible cough. He died on Saturday Morning.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cough, Pharyngitis, Pyrexia, Rhinitis, Vaccine positive rechallenge
Clinical narrative: Pt received 4 shots on Weds 20th on Thurs and Friday he developed a fever and horrible cough. He died on Saturday Morning.
Sex: U
Vaccine: RV, IPV, RV5, RV5, RV5
Symptoms: Diarrhoea, Haematochezia, Intussusception
Clinical narrative: Information has been received from an office worker concerning a pt who was vaccinated PO with a dose of Rotavirus vaccine. The office worker reported that the pt subsequently developed intussusception. The office worker indicated that the pt was another offices pt. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Upon internal review, intussusception was determined to be an other important medical event (OMIC). Additional information has been requested.
Sex: U
Vaccine: RV, IPV, RV5, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from an office worker concerning a pt who was vaccinated PO with a dose of Rotavirus vaccine. The office worker reported that the pt subsequently developed intussusception. The office worker indicated that the pt was another offices pt. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Upon internal review, intussusception was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Bronchoscopy abnormal, Candidiasis, Cellulitis, Condition aggravated, Cough
Clinical narrative: Information has been received from a pharmacist concerning a 30 year old hospitalized male with cystic fibrosis and drug hypersensitivity to piperacillin sodium + tazobactam sodium (Zosyn) who on 10/30/06 was vaccinated SW with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine upon discharge from the hospital. Concomitant therapy included Zyvox. Subsequently the pt developed progressive swelling, tenderness and redness to the upper arm in a 7 by 8 cm area. ON 11/2/06, the pt was readmitted to the hospital. At the time of the report, the pt had not recovered. The pharmacist reported that the pt was vaccinated with lot 653283/0001F, 655587/0882F, 654981/0674F or 651149/0088F. The pharmacist could not narrow down which lot number the pt received and requested a lot check for each of them. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Cystic fibrosis lung, Diarrhoea, Electrolyte imbalance, Erythema, Fatigue
Clinical narrative: Information has been received from a pharmacist concerning a 30 year old hospitalized male with cystic fibrosis and drug hypersensitivity to piperacillin sodium + tazobactam sodium (Zosyn) who on 10/30/06 was vaccinated SW with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine upon discharge from the hospital. Concomitant therapy included Zyvox. Subsequently the pt developed progressive swelling, tenderness and redness to the upper arm in a 7 by 8 cm area. ON 11/2/06, the pt was readmitted to the hospital. At the time of the report, the pt had not recovered. The pharmacist reported that the pt was vaccinated with lot 653283/0001F, 655587/0882F, 654981/0674F or 651149/0088F. The pharmacist could not narrow down which lot number the pt received and requested a lot check for each of them. Additional information has been requested.