chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion, Erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who, on an unspecified date, was vaccinated with a dose of Gardasil. On an unspecified date, the nurse practitioner stated that she "received an email from the CDC with a picture of a girl who had bruises and redness after receiving the Gardasil." At the time of this report, the outcome was unknown. No product quality complaint was involved. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Skin depigmentation
Clinical narrative: Information has been received from a registered nurse concerning a female who on 16-FEB-2007 was vaccinated with her first dose of Gardasil (lot# 654702-0011U). Concomitant therapy included ethinyl estradiol/norgestrel (LO/OVRAL). Subsequently the patient experienced depigmentation at the right deltoid injection site. Unspecified medical attention was sought. The patient's outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menorrhagia
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 19-MAR-2007 was vaccinated with her third dose of Gardasil (yeast). Since 28-MAR-2007 the patient has had very heavy period and not her usual flow. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Information has been received from a physician assistant concerning an 11 year old female who was vaccinated, intramuscularly with the first dose of Gardasil vaccine (yeast) (dose and date not provided). It was reported that the patient received the Gardasil vaccine (yeast) from the state and 2 days post vaccination experienced swelling 6.5 to 7 centimeters in diameter that was cellulitis-like swelling around the injection site. The patient sought unspecified medical attention. The physician assistant reported that the patient was seen in the office on 26-MAR-2007 and treated with BENADRYL for the symptoms. No lot number was provided. At the time of the report, it was unknown, if the patient recovered. It was also reported that the patient's 14 year old sister had the same experience after receiving the Gardasil vaccine (yeast) from the state (WAES0704USA00701). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a physician, via a company representative, concerning a female patient, who was vaccinated (date not specified) with a dose of Gardasil. Right after the shot was administered, the patient experienced "more than moderate itching" at the injection site. At the time of this report, the physician reported that the patient was recovering. The patient sought unspecified medical attention. The patient's two sisters also experienced the event as described above after vaccination with Gardasil (WAES0703USA04922,0703USA05148). Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 21 year old female patient who was vaccinated (date not specified) with a dose of Gardasil vaccine (yeast). Right after the shot was administered, the patient experienced "more than moderate itching" at the injection site. At the time of this report, the physician reported that the patient was recovering. The patient sought unspecified medical attention. The patient's two sisters also experienced the event as described above after vaccination with Gardasil vaccine (yeast) (WAES0703USA04922, 0703USA05417). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dysplasia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Gardasil vaccine (yeast) (dose and date not provided) as part of a clinical trial she was involved with. Subsequently "the physician reported that the patient had received the Gardasil vaccine (yeast) in the trial and was experiencing "dysplasia syn 2 due to one of the strains of the HPV virus, either 16 or 18." No lot number was provided. The patient sought unspecified medical attention. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning an 18 year old female patient who was vaccinated with a dose of Gardasil and fainted after receiving the injection. Unspecified medical attention was sought. On 29-MAR-2007 the patient recovered. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Electrocardiogram ambulatory, Electrocardiogram normal, Electroencephalogram
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a nurse concerning her daughter an 18 year old female who in February 2007, was vaccinated with Gardasil vaccine (yeast) (dose and date not provided). Subsequently the patient experienced heart palpitations that disappeared after 2 weeks. The patient did seek unspecified medical attention and had an electrocardiogram performed, results not available. Subsequently, the patient recovered from heart palpitations. Information has been received from a nurse concerning her 18 year old daughter with an allergy to ALEVE who in March 2007 (also reported as February 2007), was vaccinated with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Within 24 hours of vaccination, the patient experienced heart palpitations that dissappeared after 2 weeks. It was also reported in follow-up that the patient developed shortness of breath and dizziness. The patient did seek unspecified medical attention and had an electrocardiogram performed, results not available. Subsequently, the patient recovered from heart palpitations, shortness of breath and dizziness. In follow-up it was reported that on 08-MAY-2007 or 09--MAY-2007, the patient was vaccinated with a second dose of GARDASIL. Three to four hours post-vaccination (also reported as within 8 hours), at dinner time, the patient developed sweating, severe heart palpitations, dizziness and shortness of breath (also reported as "similar symptoms" as with the first dose). The patient's mother also stated that the patient's arm was very sore. The patient went to the local emergency room. An EKG was performed and the results were normal, however, the patient was given an EKG halter moniter to wear for 24 hours. An EEG was also performed (results unknown). The patient was seen by a cardiologist. The heart palpitations contnued for days and after about 1 week, the patient recovered from the heart palpitations. At the time of this report, the results of the EKG halter monitor test were not available. The patient's gynecologist thought that this was an isolated incident. The patient was not hospitalized. The patient was subsequently diagnosed with premature ventricular contractions (PVCs) without true tachycardia. The patient had no history of PVCs but her mother was currently on medications for PVCs. It was stated that the patient will not received the third dose of GARDASIL. At the time of this report, the outcome of the sweating, PVCs dizziness and shortness of breath was unknown and the patient had not recovered from the very sore arm. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Laboratory test, Pain in extremity, Palpitations, Vaccine positive rechallenge
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a nurse concerning her daughter an 18 year old female who in February 2007, was vaccinated with Gardasil vaccine (yeast) (dose and date not provided). Subsequently the patient experienced heart palpitations that disappeared after 2 weeks. The patient did seek unspecified medical attention and had an electrocardiogram performed, results not available. Subsequently, the patient recovered from heart palpitations. Information has been received from a nurse concerning her 18 year old daughter with an allergy to ALEVE who in March 2007 (also reported as February 2007), was vaccinated with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Within 24 hours of vaccination, the patient experienced heart palpitations that dissappeared after 2 weeks. It was also reported in follow-up that the patient developed shortness of breath and dizziness. The patient did seek unspecified medical attention and had an electrocardiogram performed, results not available. Subsequently, the patient recovered from heart palpitations, shortness of breath and dizziness. In follow-up it was reported that on 08-MAY-2007 or 09--MAY-2007, the patient was vaccinated with a second dose of GARDASIL. Three to four hours post-vaccination (also reported as within 8 hours), at dinner time, the patient developed sweating, severe heart palpitations, dizziness and shortness of breath (also reported as "similar symptoms" as with the first dose). The patient's mother also stated that the patient's arm was very sore. The patient went to the local emergency room. An EKG was performed and the results were normal, however, the patient was given an EKG halter moniter to wear for 24 hours. An EEG was also performed (results unknown). The patient was seen by a cardiologist. The heart palpitations contnued for days and after about 1 week, the patient recovered from the heart palpitations. At the time of this report, the results of the EKG halter monitor test were not available. The patient's gynecologist thought that this was an isolated incident. The patient was not hospitalized. The patient was subsequently diagnosed with premature ventricular contractions (PVCs) without true tachycardia. The patient had no history of PVCs but her mother was currently on medications for PVCs. It was stated that the patient will not received the third dose of GARDASIL. At the time of this report, the outcome of the sweating, PVCs dizziness and shortness of breath was unknown and the patient had not recovered from the very sore arm. No product quality complaint was involved. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ventricular extrasystoles
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a nurse concerning her daughter an 18 year old female who in February 2007, was vaccinated with Gardasil vaccine (yeast) (dose and date not provided). Subsequently the patient experienced heart palpitations that disappeared after 2 weeks. The patient did seek unspecified medical attention and had an electrocardiogram performed, results not available. Subsequently, the patient recovered from heart palpitations. Information has been received from a nurse concerning her 18 year old daughter with an allergy to ALEVE who in March 2007 (also reported as February 2007), was vaccinated with a first dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Within 24 hours of vaccination, the patient experienced heart palpitations that dissappeared after 2 weeks. It was also reported in follow-up that the patient developed shortness of breath and dizziness. The patient did seek unspecified medical attention and had an electrocardiogram performed, results not available. Subsequently, the patient recovered from heart palpitations, shortness of breath and dizziness. In follow-up it was reported that on 08-MAY-2007 or 09--MAY-2007, the patient was vaccinated with a second dose of GARDASIL. Three to four hours post-vaccination (also reported as within 8 hours), at dinner time, the patient developed sweating, severe heart palpitations, dizziness and shortness of breath (also reported as "similar symptoms" as with the first dose). The patient's mother also stated that the patient's arm was very sore. The patient went to the local emergency room. An EKG was performed and the results were normal, however, the patient was given an EKG halter moniter to wear for 24 hours. An EEG was also performed (results unknown). The patient was seen by a cardiologist. The heart palpitations contnued for days and after about 1 week, the patient recovered from the heart palpitations. At the time of this report, the results of the EKG halter monitor test were not available. The patient's gynecologist thought that this was an isolated incident. The patient was not hospitalized. The patient was subsequently diagnosed with premature ventricular contractions (PVCs) without true tachycardia. The patient had no history of PVCs but her mother was currently on medications for PVCs. It was stated that the patient will not received the third dose of GARDASIL. At the time of this report, the outcome of the sweating, PVCs dizziness and shortness of breath was unknown and the patient had not recovered from the very sore arm. No product quality complaint was involved. 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 teenager who was vaccinated in the arm with the first dose of Gardasil (dose and date not provided). It was reported that the patient experienced injection site pain after receiving the first dose. At the time of the report, it was unknown if the patient  recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Malaise, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with sulfonamide allergy and allergic reaction to antibiotics who on 14-FEB-2007 was vaccinated intramuscularly with Gardasil (yeast) (0.5 ml). On 17-FEB-2007 the patient developed facial redness, malaise and an intermittent widespread rash. The patient was evaluated at a local emergency room and prescribed a course of steroids. The patient was not hospitalized. The patient fully recovered (date unspecified). Additional information has been requested.
Sex: U
Vaccine: FLUX, HEPA, HPV4
Symptoms: Mobility decreased
Clinical narrative: Information has been received from a registered nurse, concerning patients who were vaccinated simultaneously with a dose of Gardasil and a dose of hepatitis A vaccine (manufacturer unspecified) (dates not specified). Other possible concomitant therapy included influenza virus vaccine (unspecified). The nurse reported that she heard through a clinical coordinator who heard from another nurse, that the patients experienced "unknown  reactions" when Gardasil was given "at the same time as an unknown hepatitis A vaccine." The reporting nurse added that "when people get the flu vaccine they are sometimes not able to lift their arm afterwards." At the time of the report, it was unknown if the patients recovered from the events. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated, IM, with a dose of Gardasil (yeast) (date not specified). Subsequently the patient fainted after the vaccination was administered. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Follow up information from a nursing manager confirmed the event of fainting as reported, however, she also confirmed that further identifying details for the patient or event could not be provided. The patient sought unspecified medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated in the arm with the first dose of Gardasil. It was reported that the patient experienced injection site pain after receiving the first dose. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated in the arm with the first dose of Gardasil vaccine (yeast) (dose and date not reported). It was reported that the patient experienced injection site pain and dizziness after receiving the first dose. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Pain
Clinical narrative: Initial and follow/up information has been received from a Certified Medical Assistant (C.M.A) concerning a 16 year old female patient who on 29-MAR-2007 was vaccinated with a first dose of Gardasil lot #656050/0245U. On 29-MAR-2007 the patient developed headache, nausea and general achy feeling. Unspecified medical attention was sought. The patient was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse concerning a "late teens" female who, "about 4 months ago," in approximately December 2006, was vaccinated with her first dose of Gardasil vaccine (yeast) (dose and date not reported). Subsequently the patient fainted about six hours after receiving her first dose. Patient reported experience when in office for second dose. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dizziness
Clinical narrative: Information has been received from a consumer concerning her 15 year old daughter, with no pertinent medical history, who in January 2007, was vaccinated with a 0.5 ml dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced "some dizziness while taking" Gardasil. It was reported that the patient did not seek medical attention. On an unspecified date, the patient recovered. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician and a consumer concerning her 15 year old daughter, with no pertinent medical history, who on 20-DEC-2006 was vaccinated intramuscularly, into the left deltoid, with a 0.5 ml second dose of GARDASIL (lot #653978/0955F). There was no concomitant medication. In late March it was reported by phone that the patient felt dizzy and lightheaded. It was reported that the patient did not seek medical attention. On an unspecified date, the patient recovered. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from a health professional, via a company representative, concerning a female patient who was vaccinated with a dose, 0.5ml, of Gardasil vaccine (yeast) (date not specified). It was reported that the patient "developed auto immune disease soon after the injection." The patient sought unspecified medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder
Clinical narrative: Information has been received from a health professional, via a company representative, concerning a female patient who was vaccinated with a dose, 0.5 ml, of Gardasil (date not specified). "Soon after the injection," the patient "developed auto-immune disease." The patient sought unspecified medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Hypoaesthesia
Clinical narrative: Information has been received from a physician concerning a female (demographics not reported) who on an unspecified date was vaccinated intramuscularly in the deltoid with the first dose of Gardasil (Lot# not reported). Subsequently, the patient experienced numbness in lower arm and was unable to speak for 15-20 minutes post vaccination. Subsequently, the patient recovered after 15-20 minutes from the events. The physician did not consider the events to be serious, however did state that he did not plan to continue vaccinating the patient with the second and third doses of Gardasil. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on approximately 23-MAR-2007, was vaccinated intramuscularly with a first dose of Gardasil vaccine (yeast). On approximately 23-MAR-2007 the patient fainted. The patient did not seek medical attention. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/11/2007. Initial and follow-up information has been received from a physician concerning a 14 year old female who on 12-MAR-2007, at 16:30 was vaccinated intramuscular with a first dose of GARDASIL (lot #654510/0962F).  Concomitant therapy included ZYRTEC.  On 12-MAR-2007 the patient experienced syncope following vaccination.  The patient was given water and trail mix.  Te patient also experienced loss of consciousness for a few second.  She fell inito a chair in the waiting room and developed a bruise on her left stapula.  The patient was observed for 20 minutes.  On 12-MAR-2007 the patient recovered.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who in approximately March 2007 was vaccinated, intramuscularly, into the deltoid, with a first dose of Gardasil concomitantly with a dose of Menactra. In approximately March 2007 the patient fainted. Subsequently, the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 15 year old female who was vaccinated, intramuscularly, into the deltoid, with a first dose of Gardasil. Subsequently the patient fainted. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated, IM, with a dose of Gardasil vaccine (yeast) (date not specified). Subsequently the patient fainted after the vaccination was administered. The patient sought unspecified medical attention. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Follow up information from a nursing manager confirmed the event of fainting as reported, however, she also confirmed that further identifying details for the patient or event could not be provided. The patient sought unspecified medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated, IM, with a dose of Gardasil vaccine (yeast) (date not specified). Subsequently the patient fainted after the vaccination was administered. The patient sought unspecified medical attention. No further information is expected.
Sex: F
Vaccine: HPV4
Symptoms: Infertility female
Clinical narrative: Information has been received from a medical office receptionist who saw a news report in which it was reported that a female patient who was vaccinated with Gardasil was unable to get pregnant. She had no further information and reported she only saw part of the news report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: Information has been received from a Dentist concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced numbness in feet. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia, Human papilloma virus test positive, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 32 year old female who on 03-FEB-2007 was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant medication was not reported. On an unspecified date within 24 hours after the vaccination, the patient experienced sweet taste on the surface of tongue which did not last very long. Subsequently, the patient recovered from sweet taste on the surface of tongue. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning an 18 year old female who was vaccinated IM, first dose, with Gardasil vaccine (yeast). Subsequently the patient experienced itching both arms after receiving the vaccine. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Information has been received from a physician concerning an 20 year old female who was vaccinated IM, first dose, with Gardasil. Subsequently the patient experienced itching both arms after receiving the vaccine. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site cellulitis, Injection site swelling
Clinical narrative: Information has been received from a physician assistant concerning a 14 year old female who was vaccinated, intramuscularly with the first dose of Gardasil vaccine (yeast) (dose and date not provided). It was reported that the patient received the Gardasil vaccine (yeast) from the state and 2 days post vaccination experienced swelling 6.5 to 7 centimeters in diameter that was cellulitis-like swelling around the injection site. The patient sought unspecified medical attention. The physician assistant reported that the patient was seen in the office on 26-MAR-2007 and treated with BENADRYL for the symptoms. No lot number was provided. At the time of the report, it was unknown, if the patient recovered. It was also reported that the patient's 11 year old sister had the same experience after receiving the Gardasil vaccine (yeast) from the state. (WAES0703USA05406). Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a "late teens" female who, "about 4 months ago," in approximately December 2006, was vaccinated with her first dose of Gardasil (dose and date not reported). Subsequently the patient fainted about six hours after receiving her first dose. Patient reported experience when in office for second dose. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a licensed practical nurse concerning a 15 year old female with an allergy to KEFLEX who on 27-JUL-2006 and 23-OCT-2006 was vaccinated IM with her first and second 0.5 ml dose of GARDASIL (lot# 653937/0637F). It was reported that the patient came in for her third dose and she told the nurse that she had passed out a couple hours after her second vaccination (recovered same day 23-OCT-2006). She was advised per her physician's office that she could not be administered the vaccine without a parent available to drive her home. The patient came back in with her mother. The patient's mother was advised that this reaction could be worse than the second reaction and could possible require medical attention. The patient was vaccinated IM with her third 0.5 ml dose on 14-FEB-2007. The patient's mother agreed to monitor her that evening. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Gardasil vaccine (yeast). Subsequently, the patient developed hives. She was treated with BENADRYL. Her outcome was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning an 11year old female patient who was vaccinated IM in the left deltoid with a first dose of Gardasil. Subsequently the patient experienced pain while receiving the injection. The nurse indicated that it seemed as if the needle was "too big for girls with small arms and it almost feels as if the needle is hitting the bone in the child patients." The nurse said that they have to switch to a 5/8 inch needle when administering the vaccine to patients. Unspecified medical attention was sought. the patient recovered from the arm pain. No product quality complaint was involved. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Large local swelling over entire upper arm-entire deltoid triceps muscle.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL, VARCEL
Symptoms: Arthropod bite, Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with no known history or allergies who on 07-MAR-2007 was vaccinated SC with a 0.5 ml second dose of Varivax (lot # 650232/0911R). There was no concomitant medication. Subsequently twenty-four after vaccination, the patient's mother noticed 1 small "bug bite" like sore at the injection site. The area was 8 cm x 8 cm hard, red, warm and raised thirty-two hours after vaccination. The patient also complained of itching. She was seen on 09-MAR-2007, forty-eight hours after vaccination, with the same symptoms. The physician ordered Benadryl, Pediapred, ice and to monitor. On follow-up 13-MAR-2007, the redness was gone and the site was less hard. On 15-MAR-2007 redness was gone and a "25 cent" hard area was left. As of 27-MAR-2007 the "25 cent hard area" was still felt under the skin at the site and the patient continued to be monitored. It was reported that the patient was vaccinated with the first dose of Varivax on 15-JAN-2006 with no problems. The reporter considered the medicine intervention for the patient's experiences to be an other important medical events. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with no known history or allergies who on 07-MAR-2007 was vaccinated SC with a 0.5 ml second dose of Varivax (lot # 650232/0911R). There was no concomitant medication. Subsequently twenty-four after vaccination, the patient's mother noticed 1 small "bug bite" like sore at the injection site. The area was 8 cm x 8 cm hard, red, warm and raised thirty-two hours after vaccination. The patient also complained of itching. She was seen on 09-MAR-2007, forty-eight hours after vaccination, with the same symptoms. The physician ordered Benadryl, Pediapred, ice and to monitor. On follow-up 13-MAR-2007, the redness was gone and the site was less hard. On 15-MAR-2007 redness was gone and a "25 cent" hard area was left. As of 27-MAR-2007 the "25 cent hard area" was still felt under the skin at the site and the patient continued to be monitored. It was reported that the patient was vaccinated with the first dose of Varivax on 15-JAN-2006 with no problems. The reporter considered the medicine intervention for the patient's experiences to be an other important medical events. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with no known history or allergies who on 07-MAR-2007 was vaccinated SC with a 0.5 ml second dose of Varivax (lot # 650232/0911R). There was no concomitant medication. Subsequently twenty-four after vaccination, the patient's mother noticed 1 small "bug bite" like sore at the injection site. The area was 8 cm x 8 cm hard, red, warm and raised thirty-two hours after vaccination. The patient also complained of itching. She was seen on 09-MAR-2007, forty-eight hours after vaccination, with the same symptoms. The physician ordered Benadryl, Pediapred, ice and to monitor. On follow-up 13-MAR-2007, the redness was gone and the site was less hard. On 15-MAR-2007 redness was gone and a "25 cent" hard area was left. As of 27-MAR-2007 the "25 cent hard area" was still felt under the skin at the site and the patient continued to be monitored. It was reported that the patient was vaccinated with the first dose of Varivax on 15-JAN-2006 with no problems. The reporter considered the medicine intervention for the patient's experiences to be an other important medical events. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Arthralgia, Arthritis, Asthenia, Hypokinesia, Inflammation
Clinical narrative: 8 hours post injections unable to move arms, joints aching. In bed next 2 days, felt like "tin woods man", fever 101 with nausea following day. Took ibuprophen, alka selzer. Called Health dept. to report reaction. Right arm continued aching, unable to pull up blankets at night etc. Right wrist began aching, loss of strength, then left wrist, then jaw, ankles, knees. Am now being treated for arthritis, on Relefen. Aching joints, loss of hand strength continues 5 months later.  05/17/2007 Several office notes received from PCP.  OV 12/30/06 for c/o longstanding wrist pain 2' to wrist fx in 1990's and cough with increasing chest tightness and thickened sputum. Assessment:  Chronic bronchitis with thisckened sputum.  Right wrist pain.  OV 2/26/07 for c/o pain in multiple joints. Assessment:  Likely osteoarthritis.  Wrist pain exacerbated by previous fx.   OV 4/19/07 F/U Osteoarthritis improved.  Insomnia improved.  Assessment:  Osteoarthritis, insomnia, allergic rhinitis all improved.  06/11/2007 MR received for single visit for tendinitis of the R wrist.  Hx of fx of Rwrist 20 years ago and 2 recent minor incidents. ROM is limited. Tenderness noted with palpation around the radius and ulnar side of the wrist. DX: Tendinitis of the R wrist.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Joint range of motion decreased, Laboratory test abnormal, Nausea, Pain in extremity, Pyrexia
Clinical narrative: 8 hours post injections unable to move arms, joints aching. In bed next 2 days, felt like "tin woods man", fever 101 with nausea following day. Took ibuprophen, alka selzer. Called Health dept. to report reaction. Right arm continued aching, unable to pull up blankets at night etc. Right wrist began aching, loss of strength, then left wrist, then jaw, ankles, knees. Am now being treated for arthritis, on Relefen. Aching joints, loss of hand strength continues 5 months later.  05/17/2007 Several office notes received from PCP.  OV 12/30/06 for c/o longstanding wrist pain 2' to wrist fx in 1990's and cough with increasing chest tightness and thickened sputum. Assessment:  Chronic bronchitis with thisckened sputum.  Right wrist pain.  OV 2/26/07 for c/o pain in multiple joints. Assessment:  Likely osteoarthritis.  Wrist pain exacerbated by previous fx.   OV 4/19/07 F/U Osteoarthritis improved.  Insomnia improved.  Assessment:  Osteoarthritis, insomnia, allergic rhinitis all improved.  06/11/2007 MR received for single visit for tendinitis of the R wrist.  Hx of fx of Rwrist 20 years ago and 2 recent minor incidents. ROM is limited. Tenderness noted with palpation around the radius and ulnar side of the wrist. DX: Tendinitis of the R wrist.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Antinuclear antibody, Arthralgia, Aspiration joint, Blood creatine phosphokinase, Culture
Clinical narrative: 4/5/07-DTP and conjugated meningococcal vaccines were administered in both shoulders. 4/6/07-Walked up with severe pain in both shoulders, lower extremities. Knees were very swollen as well. Mother contacted the nurse; she was told to watch and wait. 4/7/07-Patient was taken to the hospital, walking care. Dr. recommended a blood test due to inflammation. Advil was prescribed. Patient went back home. 4/8/07-Patient felt the same, no improvement. 4/9/07-Dr. diagnosed with tendonitis, recommended 5 types of exercise to make. PT unable to do it. 4/10-/07-Another Dr. diagnosed it as an adverse reaction, prescribed for pain and inflammation light steroid for 7 days. 4/12/07-Went to back to school on Thursday and had to go back home, could not walk again. 4/13/07-Primary Dr.'s assistant called the mother to take her straight to the hospital/ER because of patient's high elevated inflammation, due to a lot of fluid in her knees that had to take out. Child had to stay at the hospital. They did not know what it was. Prescribed Motrin every 6 hours. More tests were done. 4/14/08-Waiting on blood result, in the afternoon patient developed sharp pain on her right knee. 05/23/07-records received-ER DX: Knee swelling. Left knee swelling. tender but no pain over patella. Previously seen 2 weeks ago for left knee swelling then seen by PCP. Treated with Prednisone, now developed right knee pain. Had knee drained.Full ROM. Instructed to see rheumatologist.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Joint swelling, Osteochondrosis, Osteosclerosis
Clinical narrative: 4/5/07-DTP and conjugated meningococcal vaccines were administered in both shoulders. 4/6/07-Walked up with severe pain in both shoulders, lower extremities. Knees were very swollen as well. Mother contacted the nurse; she was told to watch and wait. 4/7/07-Patient was taken to the hospital, walking care. Dr. recommended a blood test due to inflammation. Advil was prescribed. Patient went back home. 4/8/07-Patient felt the same, no improvement. 4/9/07-Dr. diagnosed with tendonitis, recommended 5 types of exercise to make. PT unable to do it. 4/10-/07-Another Dr. diagnosed it as an adverse reaction, prescribed for pain and inflammation light steroid for 7 days. 4/12/07-Went to back to school on Thursday and had to go back home, could not walk again. 4/13/07-Primary Dr.'s assistant called the mother to take her straight to the hospital/ER because of patient's high elevated inflammation, due to a lot of fluid in her knees that had to take out. Child had to stay at the hospital. They did not know what it was. Prescribed Motrin every 6 hours. More tests were done. 4/14/08-Waiting on blood result, in the afternoon patient developed sharp pain on her right knee. 05/23/07-records received-ER DX: Knee swelling. Left knee swelling. tender but no pain over patella. Previously seen 2 weeks ago for left knee swelling then seen by PCP. Treated with Prednisone, now developed right knee pain. Had knee drained.Full ROM. Instructed to see rheumatologist.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Arthralgia, Aspiration joint, Blood test, Gait disturbance, Inflammation
Clinical narrative: 4/5/07-DTP and conjugated meningococcal vaccines were administered in both shoulders. 4/6/07-Walked up with severe pain in both shoulders, lower extremities. Knees were very swollen as well. Mother contacted the nurse; she was told to watch and wait. 4/7/07-Patient was taken to the hospital, walking care. Dr. recommended a blood test due to inflammation. Advil was prescribed. Patient went back home. 4/8/07-Patient felt the same, no improvement. 4/9/07-Dr. diagnosed with tendonitis, recommended 5 types of exercise to make. PT unable to do it. 4/10-/07-Another Dr. diagnosed it as an adverse reaction, prescribed for pain and inflammation light steroid for 7 days. 4/12/07-Went to back to school on Thursday and had to go back home, could not walk again. 4/13/07-Primary Dr.'s assistant called the mother to take her straight to the hospital/ER because of patient's high elevated inflammation, due to a lot of fluid in her knees that had to take out. Child had to stay at the hospital. They did not know what it was. Prescribed Motrin every 6 hours. More tests were done. 4/14/08-Waiting on blood result, in the afternoon patient developed sharp pain on her right knee. 05/23/07-records received-ER DX: Knee swelling. Left knee swelling. tender but no pain over patella. Previously seen 2 weeks ago for left knee swelling then seen by PCP. Treated with Prednisone, now developed right knee pain. Had knee drained.Full ROM. Instructed to see rheumatologist.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Joint effusion, Joint swelling, Juvenile arthritis, Musculoskeletal pain, Pain in extremity
Clinical narrative: 4/5/07-DTP and conjugated meningococcal vaccines were administered in both shoulders. 4/6/07-Walked up with severe pain in both shoulders, lower extremities. Knees were very swollen as well. Mother contacted the nurse; she was told to watch and wait. 4/7/07-Patient was taken to the hospital, walking care. Dr. recommended a blood test due to inflammation. Advil was prescribed. Patient went back home. 4/8/07-Patient felt the same, no improvement. 4/9/07-Dr. diagnosed with tendonitis, recommended 5 types of exercise to make. PT unable to do it. 4/10-/07-Another Dr. diagnosed it as an adverse reaction, prescribed for pain and inflammation light steroid for 7 days. 4/12/07-Went to back to school on Thursday and had to go back home, could not walk again. 4/13/07-Primary Dr.'s assistant called the mother to take her straight to the hospital/ER because of patient's high elevated inflammation, due to a lot of fluid in her knees that had to take out. Child had to stay at the hospital. They did not know what it was. Prescribed Motrin every 6 hours. More tests were done. 4/14/08-Waiting on blood result, in the afternoon patient developed sharp pain on her right knee. 05/23/07-records received-ER DX: Knee swelling. Left knee swelling. tender but no pain over patella. Previously seen 2 weeks ago for left knee swelling then seen by PCP. Treated with Prednisone, now developed right knee pain. Had knee drained.Full ROM. Instructed to see rheumatologist.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Tendonitis
Clinical narrative: 4/5/07-DTP and conjugated meningococcal vaccines were administered in both shoulders. 4/6/07-Walked up with severe pain in both shoulders, lower extremities. Knees were very swollen as well. Mother contacted the nurse; she was told to watch and wait. 4/7/07-Patient was taken to the hospital, walking care. Dr. recommended a blood test due to inflammation. Advil was prescribed. Patient went back home. 4/8/07-Patient felt the same, no improvement. 4/9/07-Dr. diagnosed with tendonitis, recommended 5 types of exercise to make. PT unable to do it. 4/10-/07-Another Dr. diagnosed it as an adverse reaction, prescribed for pain and inflammation light steroid for 7 days. 4/12/07-Went to back to school on Thursday and had to go back home, could not walk again. 4/13/07-Primary Dr.'s assistant called the mother to take her straight to the hospital/ER because of patient's high elevated inflammation, due to a lot of fluid in her knees that had to take out. Child had to stay at the hospital. They did not know what it was. Prescribed Motrin every 6 hours. More tests were done. 4/14/08-Waiting on blood result, in the afternoon patient developed sharp pain on her right knee. 05/23/07-records received-ER DX: Knee swelling. Left knee swelling. tender but no pain over patella. Previously seen 2 weeks ago for left knee swelling then seen by PCP. Treated with Prednisone, now developed right knee pain. Had knee drained.Full ROM. Instructed to see rheumatologist.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a healthcare worker and a 71 year old male physician with benign prostatic hyperplasia, hypothyroidism, hypertension, arteriosclerosis and asthma who on 06-MAR-2007 was vaccinated subcutaneously with a 0.5 mL dose of zoster vaccine live. Concomitant therapy included levothyroxine Na (SYNTHROID), verapamil HCl (VERAPAMIL SR), montelukast sodium, morniflumate (FLOMAX), clopidogrel bisulfate, aspirin,  benazepril HCl, atorvastatin calcium (LIPITOR), valsartan (DIOVAN), omeprazole (PRILOSEC), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and cisplatin (+) cyclophosphamide (+) doxorubicin hydrochloride (+) prednisone "CAPPRA". On 07-MAR-2007 "the next day" he experienced aching in his left lateral thigh area. On 08-MAR-2007 the patient developed a red vesicular rash in the L1-L3 dermatome distribution which was reported to be shingles. The outbreak was on the lower back, left thigh and left groin. His physician prescribed famcyclovir 500 mg three times per day, oxycodone and eszopiclone (LUNESTA) and was planning continued follow-up. At the time of the report the patient had not recovered. There was no product quality complaint. No further information is available.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Gastroenteritis viral, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 week male with a history of premature birth and hospitalisation in NICU for 1 month who on 25-JAN-2007 was vaccinated with a PO dose of ROTATEQ. Concomitant therapy included SYNAGIS on 25-JAN-2007 and 22-FEB-2007. Concomitant vaccination administered that day included an IM dose of PEDVAXHIB, (manufacturer unknown), an IM dose of PREVNAR and IM dose of PEDIARIX. On 04-Mar-2007 the patient developed vomiting and diarrhea and was admitted to the hospital due to his young age. He was diagnosed with gastroenteritis and recovered in three days, which was described by the physician as typical for viral gastroenteritis. The physician also noted the patient's gastroenteritis was not related to vaccination with Rotateq. the patient's viral gastroenteritis was considered to be an other important event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 14 year old female patient who on 23-FEB-2007 was vaccinated IM with 0.5 mL of Gardasil. On 23-FEB-2007 the patient fell to floor in a seizure like state. After 30 seconds she became conscious. Patient never had a seizure like episode before this incident. Unspecified medical attention was sought by the patient. The patient recovered the same day. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Facial palsy
Clinical narrative: Information has been received from a certified nurse midwife, via a company representative, concerning a 25 year old female patient who on 01-MAR-2007 was vaccinated in the hip, with the first dose of GARDASIL (Lot #02630 - invalid). There was no concomitant medication. The nurse stated that on 27-MAR-2007, the patient developed Bell's palsy on the left side of her face, and added that the "patient's face is uncontrolled." The nurse confirmed that the patient visited the ER, but the date and details were not provided at the time of this report. Bell's palsy was considered to be disabling by the reporter. Additional information has been requested.