chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a physician via a company representative, concerning a 16 year old female who on approximately 02-Dec-2006 was vaccinated IM in the left arm with Gardasil. After receiving the injection, the patient went to school and later during the day, she got very dizzy "that she almost passed out.". She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007.  Initial and follow up information has been received from a physician, concerning a 16 year old female patient who at 3:15 pm on 29-NOV-2006 (previously reported as approximately 02-DEC-2006) was vaccinated with 0.5ml, IM in the right deltoid (previously reported as left arm), with the first dose of GARDASIL (lot # 653736/0868F).  There was no known illness at the time of vaccination.  After receiving the injection, the patient went to school and later during the day, she got very dizzy and "felt like passing out."  She also developed a red rash and bumps all over the site of the left arm where the dose was administered and had to go home.  Follow up information from the physician added that on approximately 30-NOV-2006, the patient also experienced a light edema and itching.  The patient was treated with (ZITHROMAX Z-PAK), and subsequently recovered (date not specified).  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Scleroderma
Clinical narrative: Information has been received from an office staff member concerning a 14 year old female relative who, on an unspecified date, was vaccinated with a first dose of Gardasil. A couple of days after vaccination, the patient was diagnosed with scleroderma, an autoimmune disease. The patient was referred to a specialist and was currently being treated. At the time of this report, the patient's scleroderma persisted. No product quality complaint was involved. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Gait disturbance
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning an approximately 22 year old female who was 6 weeks post partum and had completed a pelvic exam followed by the vaccination of the first dose (dose unspecified) of Gardasil. The nurse reported that 45 minutes after the appointment, the patient began to experience dizziness. The sensation of movement/dizziness" made it difficult for the patient to walk and persisted for about four hours, then abruptly resolved with no lingering effects. The patient sought unspecified medical treatment. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow up information has been received from a nurse practitioner, concerning a 21 year old female patient, with a shellfish allergy who was 6 weeks post partum who on 23-DEC-2006 had completed a pelvic exam at the visit, who was then vaccinated, IM at 3:30pm, with the first dose of GARDASIL (Lot # 653938/0954F). The nurse reported that at 4:00 pm (previously reported as 45 minutes after the appointment), the patient began to experienced dizziness. The patient was observed in the nurse's clinic and was then sent to the same day clinic for observation. The patient's vital signs were reported to be normal, and a random blood sugar was 110 (units not specified). The sensation of movement/dizziness" made it difficult for the patient to walk and persisted for about four hours, then abruptly resolved with no lingering effects. No further information was expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal swelling
Clinical narrative: Information has been received from a physician concerning a 22 year old female with a history of human papilloma virus infection who on 08-DEC-2006 was vaccinated with Gardasil. In January 2007, the patient experienced swelling of her vaginal walls. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Influenza, Insomnia, Insomnia
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a Certified Medical Assistant concerning a 24 year old female patient with neurocardiogenic syncope who on 21-NOV-2006 was vaccinated IM with her first dose of Gardasil, lot #653938/0954F. Concomitant therapy included INDERAL. On 21-NOV-2006 the patient experienced insomnia for one month following the administration of Gardasil. She later had the flu from being run down and lack of sleep. The patient desired a prescription for sleep after her next injection. Unspecified medical attention was sought. The patient was reported as recovered. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vomiting
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated with a second dose of Gardasil. Subsequently the patient became dizzy and had some vomiting. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Body temperature increased, Dizziness, Myalgia, Rash
Clinical narrative: Initial and follow up information has been received from an LPN and the mother of a 12 year old female patient with aortic insufficiency and migraine headaches who on 01-FEB-2007 was vaccinated IM with her first dose of Gardasil, lot #654741/0013U. There was no concomitant medication. Subsequently, the patient experienced dizziness and developed an elevated temperature. It was also reported that the patient felt weak and had muscle aches for several days. The side effects eventually disappeared. However on 21-FEB-2007, the patient woke up with breast rashes. As of 21-FEB-2007 breast rashes persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: Initial and follow up information has been received from an LPN and the mother of a 12 year old female patient with aortic insufficiency and migraine headaches who on 01-FEB-2007 was vaccinated IM with her first dose of Gardasil, lot #654741/0013U. There was no concomitant medication. Subsequently, the patient experienced dizziness and developed an elevated temperature. It was also reported that the patient felt weak and had muscle aches for several days. The side effects eventually disappeared. However on 21-FEB-2007, the patient woke up with breast rashes. As of 21-FEB-2007 breast rashes persisted. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Body temperature increased, Dizziness, Myalgia, Rash
Clinical narrative: Initial and follow up information has been received from a physician via a company representative, and the mother if the patient, concerning a 12 year old female who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (yeast). On approximately 02-FEB-2007 (within 24 hours), the patient developed nausea, a low grade fever, and experienced "muscle weakness that hurt." On approximately 06-FEB-2007 ("lasted for 4-5 days"), the patient recovered. Follow up information received from the mother of the patient, reported that on the morning of 21-FEB-2007, her daughter woke up with " a rash on her breasts, looks like pimples." The mother reported her daughter did not experience fever or itching with the rash, and the rash was "not on any other part of her body." The mother added that her daughter went to school, but "has not recovered from the rash." The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscular weakness, Myalgia, Nausea, Pyrexia, Rash
Clinical narrative: Initial and follow up information has been received from a physician via a company representative, and the mother if the patient, concerning a 12 year old female who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (yeast). On approximately 02-FEB-2007 (within 24 hours), the patient developed nausea, a low grade fever, and experienced "muscle weakness that hurt." On approximately 06-FEB-2007 ("lasted for 4-5 days"), the patient recovered. Follow up information received from the mother of the patient, reported that on the morning of 21-FEB-2007, her daughter woke up with " a rash on her breasts, looks like pimples." The mother reported her daughter did not experience fever or itching with the rash, and the rash was "not on any other part of her body." The mother added that her daughter went to school, but "has not recovered from the rash." The patient sought unspecified medical attention. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female student (63 inches, 112 lbs) with no illness at the time of vaccination and with a penicillin allergy. On 01-FEB-2007, at approximately 14:00 PM, the patient was vaccinated in the left arm with the first 0.5 mL dose of HPV (lot# 655619/1427F). Concomitant therapy included Yasmin. On that same day, at 4:00 PM, the patient developed a rash on her left arm from the injection site to the elbow and a rash also on her right arm (unspecified where on her right arm). The patient sought unspecified medical attention. The physician prescribed over-the-counter Benadryl and contacted the patient the next day for follow up. The patient reported that she was fine. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.  Additional infromation is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyskinesia, Eye movement disorder, Incorrect dose administered, Medical device complication
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 05-FEB-2007 was vaccinated with a dose of HPV (lot# 654540/1162F). On 05-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient's arm some of the liquid sprayed on the table and on the wall. The patient was not re-activated because of her reactions which were she "felt woozy" and her eyes were fluttering, and her whole body was shaking. It was noted that the patient did not lose consciousness. The patient will come back in two months to get re-vaccinated. 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. This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 01-FEB-2007 was vaccinated with a dose of GARDASIL (lot# 654540/1162F). On 01-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient's arm some of the liquid sprayed on the table and on the wall. The patient was not re-vaccinated because of her reactions which were that she "felt dizzy" and her eye rolled upward, and her whole body was jerking. Upon calling the patient's name, her eyes opened wide and focused on her mother and the nurse. Her body stopped jerking and she stated, "I just feel dizzy." It was noted that the patient did not lose consciousness. The patient rested a while on the exam table and walked out of the office on her own. The mother was instructed to call the office if anything appeared to be out of the ordinary. No call was received. The patient will come back in two months to get re-vaccinated. On 01-FEB-2007, the patient recovered. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 05-FEB-2007 was vaccinated with a dose of HPV (lot# 654540/1162F). On 05-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient's arm some of the liquid sprayed on the table and on the wall. The patient was not re-activated because of her reactions which were she "felt woozy" and her eyes were fluttering, and her whole body was shaking. It was noted that the patient did not lose consciousness. The patient will come back in two months to get re-vaccinated. 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. This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a licensed practical nurse concerning a 15 year old female with no medical history or allergies, who on 01-FEB-2007 was vaccinated with a dose of GARDASIL (lot# 654540/1162F). On 01-FEB-2007 the nurse reported that the vaccine prefilled syringe malfunctioned. The nurse pushed the plunger down, the spring never activated and when she pulled the syringe out of the patient's arm some of the liquid sprayed on the table and on the wall. The patient was not re-vaccinated because of her reactions which were that she "felt dizzy" and her eye rolled upward, and her whole body was jerking. Upon calling the patient's name, her eyes opened wide and focused on her mother and the nurse. Her body stopped jerking and she stated, "I just feel dizzy." It was noted that the patient did not lose consciousness. The patient rested a while on the exam table and walked out of the office on her own. The mother was instructed to call the office if anything appeared to be out of the ordinary. No call was received. The patient will come back in two months to get re-vaccinated. On 01-FEB-2007, the patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Flushing, Hot flush, Skin warm
Clinical narrative: This is in follow-up to report (s) previously submitted on 3/14/2007. Information has been received from medical assistant via a company representative concerning the 26 year old female medical assistant who, on an unspecified date, was vaccinated with a dose of HPV. The medical assistant reported that after her vaccination with HPV, "her face turned very red and hot". The medical assistant recovered on an unspecified date. The patient (medical assistant) sought unspecified medical attention. Additional information has been requested. Information has been received from medical assistant via a company representative concerning the 26 year old female medical assistant with an allergy to LEVAQUIN who on 09-JAN-2007 at 5:00 PM, was vaccinated IM into the deltoid with a first dose of GARDASIL (Lot# 6353736/0868F). Concomitant therapy included CYMBALTA, PREVACID, LAMISIL and ZELNORM. There was no illness at the time of vaccination. The medical assistant reported that after her vaccination with GARDASIL at 5:00PM on 09-JAN-2007, "her face turned very red and hot". She also reported that she felt flushing sensation on her face, neck and chest turned beet red like a severe sunburn that lasted about 2 hours, recovered 09-JAN-2007. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Contusion
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old female who on 29-JAN-2007 was vaccinated IM in the right arm with a first 0.5mL dose of HPV. There was no concomitant medication. On approximately 31-JAN-2007 the developed bruises located on her right forearm and right upper arm. The reporter stated that "the patient noticed the bruises 2 days after the day of vaccination." At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a female who on 06-JAN-2007 was vaccinated with a first dose of Gardasil (yeast) (0.5 ml), intramuscularly. On 06-JAN-2007 the patient had a lump at injection site. It was reported that one month later the patient still had lump at injection site. Unspecified medical assistant was sought. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. The physician felt that the adverse event occurred due to "placement" versus the GARDASIL. The physician also mentioned to the nurse that the vaccine might have been administered "too far over on the leg". In follow-up, the registered nurse reported that the physician decided that the vaccine was given in an incorrect site in the thigh and confirmed that it was an administration error rather than a vaccine adverse event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Bacterial test negative, Computerised tomogram normal, Decreased activity, Diarrhoea, Headache
Clinical narrative: Information has been received from a pharmacy student concerning a 16 year old female who on December 2006, was vaccinated IM with a first 0.5 ml dose of HPV. Concomitant therapy included given the same day included a dose of influenza and a dose of Menactra. Seven days after vaccination, the patient experienced headache, nausea, vomiting and diarrhea. The patient was treated with Nexium and Phenergan tablets/suppositories. On 13-DEC-2006 the patient experienced a sinus infection and was placed on a Z-pack. All symptoms resolved except the headache. On 19-JAN-2007, the patient was seen by a neurologist and was placed on Prednisone for 10 days. He also ordered Tazepam to help her sleep since the headaches were keeping her awake and Endocet for the headache pain. The patient has missed a lot of school and is sedentary. She was also complaining of tingling in the hands and legs. The following tests have come back negative: CAT scan, MRI, Lyme and "mono" workup. At the time of this report, the patient had not recovered from tingling in the hands and legs and headache. No product quality complaint as involved. Additional information has been requested. 04/10/07-records received from neurologists for DOS 2/6/07-DX: muscular headaches with some functional overlay. Doubt side effect of Gardasil. C/O headaches, back pain, GI problems recent urinary symptoms, difficulty urinating and dysuria. C/O visual symptoms including blurry vision and spots before her eyes. PE: pain in neck, pain with deep palpation of right popliteal fossa. Walks normally. 05/01/07-records received from facility for DOS 02/09-02/12/07-DC DX: Vomiting and Abdominal Pain. HX 2month of chronic somatic complaints including nausea, epigastric discomfort, diffuse soft tissue and joint pain, vomiting, periodic shortness of breath and recent urinary symptoms. Labs, liver enzymes elevated in context of multiple Tylenol usage as an outpatient due to her pain.Hospital course included discontinuance of Tylenol and Percocet. LFTs steadily trended downward and she did not have pain or vomiting.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Mononucleosis heterophile test negative, Nausea, Nuclear magnetic resonance imaging normal, Paraesthesia, Sinusitis
Clinical narrative: Information has been received from a pharmacy student concerning a 16 year old female who on December 2006, was vaccinated IM with a first 0.5 ml dose of HPV. Concomitant therapy included given the same day included a dose of influenza and a dose of Menactra. Seven days after vaccination, the patient experienced headache, nausea, vomiting and diarrhea. The patient was treated with Nexium and Phenergan tablets/suppositories. On 13-DEC-2006 the patient experienced a sinus infection and was placed on a Z-pack. All symptoms resolved except the headache. On 19-JAN-2007, the patient was seen by a neurologist and was placed on Prednisone for 10 days. He also ordered Tazepam to help her sleep since the headaches were keeping her awake and Endocet for the headache pain. The patient has missed a lot of school and is sedentary. She was also complaining of tingling in the hands and legs. The following tests have come back negative: CAT scan, MRI, Lyme and "mono" workup. At the time of this report, the patient had not recovered from tingling in the hands and legs and headache. No product quality complaint as involved. Additional information has been requested. 04/10/07-records received from neurologists for DOS 2/6/07-DX: muscular headaches with some functional overlay. Doubt side effect of Gardasil. C/O headaches, back pain, GI problems recent urinary symptoms, difficulty urinating and dysuria. C/O visual symptoms including blurry vision and spots before her eyes. PE: pain in neck, pain with deep palpation of right popliteal fossa. Walks normally. 05/01/07-records received from facility for DOS 02/09-02/12/07-DC DX: Vomiting and Abdominal Pain. HX 2month of chronic somatic complaints including nausea, epigastric discomfort, diffuse soft tissue and joint pain, vomiting, periodic shortness of breath and recent urinary symptoms. Labs, liver enzymes elevated in context of multiple Tylenol usage as an outpatient due to her pain.Hospital course included discontinuance of Tylenol and Percocet. LFTs steadily trended downward and she did not have pain or vomiting.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Vomiting
Clinical narrative: Information has been received from a pharmacy student concerning a 16 year old female who on December 2006, was vaccinated IM with a first 0.5 ml dose of HPV. Concomitant therapy included given the same day included a dose of influenza and a dose of Menactra. Seven days after vaccination, the patient experienced headache, nausea, vomiting and diarrhea. The patient was treated with Nexium and Phenergan tablets/suppositories. On 13-DEC-2006 the patient experienced a sinus infection and was placed on a Z-pack. All symptoms resolved except the headache. On 19-JAN-2007, the patient was seen by a neurologist and was placed on Prednisone for 10 days. He also ordered Tazepam to help her sleep since the headaches were keeping her awake and Endocet for the headache pain. The patient has missed a lot of school and is sedentary. She was also complaining of tingling in the hands and legs. The following tests have come back negative: CAT scan, MRI, Lyme and "mono" workup. At the time of this report, the patient had not recovered from tingling in the hands and legs and headache. No product quality complaint as involved. Additional information has been requested. 04/10/07-records received from neurologists for DOS 2/6/07-DX: muscular headaches with some functional overlay. Doubt side effect of Gardasil. C/O headaches, back pain, GI problems recent urinary symptoms, difficulty urinating and dysuria. C/O visual symptoms including blurry vision and spots before her eyes. PE: pain in neck, pain with deep palpation of right popliteal fossa. Walks normally. 05/01/07-records received from facility for DOS 02/09-02/12/07-DC DX: Vomiting and Abdominal Pain. HX 2month of chronic somatic complaints including nausea, epigastric discomfort, diffuse soft tissue and joint pain, vomiting, periodic shortness of breath and recent urinary symptoms. Labs, liver enzymes elevated in context of multiple Tylenol usage as an outpatient due to her pain.Hospital course included discontinuance of Tylenol and Percocet. LFTs steadily trended downward and she did not have pain or vomiting.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: Information has been received from a physician concerning a 20 year old female with allergy to unspecified medications who in approximately December 2006, around 2 months ago, was vaccinated with the first dose of HPV (lot #not reported). Concomitant medications were unspecified. In approximately December 2006, five minutes after receiving the first dose of the vaccine, the patient experienced tingling around her mouth and numbness that lasted for 20 minutes. The patient sought medical attention. The patient was then sent home and had no further problems. The patient did not continue the vaccination series because of the reaction. At the time of reporting, the patient had recovered. No further information was available at the time of reporting. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 24 year old female that works in the same office On 05-FEB-2007, the patient was vaccinated with a first dose of HPV. There were no concomitant medications. On 06-FEB-2007 the patient developed severe nausea, vomiting and chills. Unspecified medical attention was sought. At the time of the reporter, the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Presyncope
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) concerning approximately 19 female patients who were vaccinated with 0.5 mL dose of Gardasil (yeast). (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. The C.M.A also reported that another patient experienced pain at the injection site lasting for about a week and reported that she almost passed out from the pain (WAES0702USA04000). 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.  This is in follow-up to report (s) previously submitted on 3/14/2007. Informationhas been received from a certified medical assistant (C.M.A.) concerning a female patient between the ages of 11 to 15 years old who on an unspecified date was vaccinated with a 0.5 mL dose of GARDASIL vaccine, (Lot # not  reported). Subsequently the patient experienced pain at the injection site lasting for about a week. This is one of several reports from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Swelling
Clinical narrative: Information has been received from an office manager who was the mother of an 18 year old female patient with an unspecified auto immune disorder who in approximately February 2007 was vaccinated with a dose of HPV. The patient developed a "huge" red circle a few inches in diameter on her arm where she was vaccinated. There was a "lot" of swelling and the patient put ice on it all week. Medical attention was sought. The patient was recovering as of the report date. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician, via a company representative concerning a 25 year old female with a history of allergies to "many products," who on 26-JAN-2007 was vaccinated with the first dose of Gardasil (yeast). On 05-FEB-2007 the patient called the physician after she developed hives. The patient believed the hives were "caused by the vaccination," though the development and timing of the onset of the hives was unclear. The patient was instructed to take BENADRYL as treatment. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a LPN concerning a 25 year old female patient with sulfonamide allergy and allergic reaction to Biaxin who on 26-JAN-2007 was vaccinated IM in right deltoid with her first dose of Gardasil, lot #654702/0011U. She developed generalized hives after the vaccination. The nurse did not know when the hives started. Benadryl was recommended as treatment. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Deafness, Dizziness, Injection site pain, Sudden hearing loss
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a female who on 05-FEB-2007 was vaccinated with a dose of Gardasil (yeast) in one arm and possibly a meningococcal vaccine (unspecified) in the other arm. Subsequently the patient felt faint, experienced a temporary loss of hearing, and also experienced pain from the injection. The nurse indicated that the patient's "fair hair (red or blonde) made them more susceptible to the adverse events." The patient was observed in the office and after a short time recovered and left. Additional information has been requested.
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Gastrooesophageal reflux disease, Headache, Injection site reaction
Clinical narrative: 19 Jul 2000 - Received Anthrax vaccination at deployed location.  For 24 hours after, experienced aching and stiffness of joint in middle finger on left hand.  Same arm that injection was given.  Symptom subsided and returned to normal. Since the completion of 5 shots, have experienced more frequent headaches, have been diagnosed with acid reflux, additionally have been considerably more tired most of the time requiring greater amounts of sleep and longer recovery times.  When discussed with the immunization clinic, was told to seek guidance from physicians.  Have been tested for sleep apnea, one night sleep study inconclusive.  Still experiencing difficulty maintaining active lifestyle and work without requiring abnormally greater amounts of rest and sleep.
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Joint stiffness
Clinical narrative: 19 Jul 2000 - Received Anthrax vaccination at deployed location.  For 24 hours after, experienced aching and stiffness of joint in middle finger on left hand.  Same arm that injection was given.  Symptom subsided and returned to normal. Since the completion of 5 shots, have experienced more frequent headaches, have been diagnosed with acid reflux, additionally have been considerably more tired most of the time requiring greater amounts of sleep and longer recovery times.  When discussed with the immunization clinic, was told to seek guidance from physicians.  Have been tested for sleep apnea, one night sleep study inconclusive.  Still experiencing difficulty maintaining active lifestyle and work without requiring abnormally greater amounts of rest and sleep.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Pain
Clinical narrative: Blister, area looks burned. Pain at blistered site.    Appears to be lower than site of injection.  Patient denies other injury.  Treated with tylenol #3 and omnicef.  Will follow up with doctor next week.
Age: 1.9
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Varicella
Clinical narrative: Patient developed atypical varicella at the age of 13.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Lymphadenopathy, Rash
Clinical narrative: Redness to anterior right shoulder and into axilla. Slight right axilla lymph node swelling. Rash right shoulder. Moist heat, alternate with ice, maximum 20 mins. Keflex 500mg X 10 dys.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Lymphadenopathy, Rash, Skin warm
Clinical narrative: Redness to anterior right shoulder and into axilla. Slight right axilla lymph node swelling. Rash right shoulder. Moist heat, alternate with ice, maximum 20 mins. Keflex 500mg X 10 dys.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site rash, Injection site swelling, Skin discolouration
Clinical narrative: Received Pneumovax vaccine on 3/8/07 and called on 3/9/07 c/o Lt arm swelling at injection site and rash at site w/ some discomfort. Took Tylenol and slept well.  Woke up on 3/9/07 and had increased swelling of entire left arm from shoulder to elbow, skin on arm was red and splotchy. Instructed patient to come to office for doctor to evaluate.  He assessed patient and instructed patient to use ice, elevate, and use tylenol and benadryl and to contact us if no improvement.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Patient broke out with what looked like hives all over his body it is now 6 days and there is still a sign of them on his body
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Headache, Injection site rash, Pain in extremity
Clinical narrative: 10-17-06. Chills, fever, severe heradache, arm sore. Seen by PCP. 10-19-06. Rash, right arm--injection site. Scattered erythema right, slightly raised. No sign of cellulitis---Senn by an NP. Ultracet for headache and arm pain.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: 10-17-06. Chills, fever, severe heradache, arm sore. Seen by PCP. 10-19-06. Rash, right arm--injection site. Scattered erythema right, slightly raised. No sign of cellulitis---Senn by an NP. Ultracet for headache and arm pain.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Headache, Injection site bruising, Injection site rash
Clinical narrative: 10-17-06. Chills, fever, severe heradache, arm sore. Seen by PCP. 10-19-06. Rash, right arm--injection site. Scattered erythema right, slightly raised. No sign of cellulitis---Senn by an NP. Ultracet for headache and arm pain.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 10-17-06. Chills, fever, severe heradache, arm sore. Seen by PCP. 10-19-06. Rash, right arm--injection site. Scattered erythema right, slightly raised. No sign of cellulitis---Senn by an NP. Ultracet for headache and arm pain.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Marked swelling, erythema, tenderness and moderate induration appearing within 24 hours of administration. Symptoms resolved within 72 of onset.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: erythema and swelling at injection site
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: erythema and swelling at injection site
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Grand mal convulsion, Metabolic function test normal, Urine analysis normal, Urine human chorionic gonadotropin
Clinical narrative: Pt. had seizure activity approximately one day following the administration of Adacel and Menactra. Paramedics took her to the ER. Diagnosed with Grand Mal seizure X 1.  No further seizure activity reported. This was a new onset. 03/30/07-records received from facility for DOS 03/08/07-DX:Gran mal seizure.  Experienced seizure in evening lasting 3-4 minutes. Did not become oriented for about 1 hour. EMS stated she was agitated and uncooperative. Denies headache, neck pain no fever has been dieting and using diet pills. PE: WNL.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injected limb mobility decreased, Nausea, Oedema, Pain in extremity
Clinical narrative: Severe left arm pain, Erythema and edema approx 7cm. Tenderness. Hurts to fully raise arm. Nausea. Ice, Darvocet N for pain.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: Severe left arm pain, Erythema and edema approx 7cm. Tenderness. Hurts to fully raise arm. Nausea. Ice, Darvocet N for pain.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe left arm pain, Erythema and edema approx 7cm. Tenderness. Hurts to fully raise arm. Nausea. Ice, Darvocet N for pain.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Oedema, Pain in extremity, Tenderness
Clinical narrative: Severe left arm pain, Erythema and edema approx 7cm. Tenderness. Hurts to fully raise arm. Nausea. Ice, Darvocet N for pain.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient Seen on 3/14/07 for complaints of pain and swelling at the site of the Gardasil vaccine given on the left upper arm. Injection administered on 3/8/07
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large area of erythema and induration around imm. site.
Age: 53.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cold compress therapy, Headache, Heat therapy, Lymphadenopathy, Pyrexia
Clinical narrative: Fever 103.6F, Axillary lymph nodes swollen, "Feels like a baseball in armpit." Headache. Alternate moist heat and cold compress. Cephalaxin.
Age: 53.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever 103.6F, Axillary lymph nodes swollen, "Feels like a baseball in armpit." Headache. Alternate moist heat and cold compress. Cephalaxin.
Age: 1.04
Sex: M
Vaccine: MMRV, PNC
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Febrile convulsion, Full blood count normal
Clinical narrative: Patient developed temp 103.8 and had simple febrile seizure approximately 9 hours after administration of vaccines.
Age: 1.04
Sex: M
Vaccine: MMRV, PNC
Symptoms: Laboratory test normal
Clinical narrative: Patient developed temp 103.8 and had simple febrile seizure approximately 9 hours after administration of vaccines.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site induration, Injection site oedema, Injection site reaction, Injection site warmth, Rash maculo-papular
Clinical narrative: She had moderate local reaction at vaccine site consisting of approxmimately 60x80mm indurated, edema with heat and erythema, regional and generalized whole body maculopapular rash.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin swelling, Tenderness
Clinical narrative: Marked swelling, erythema, tenderness and moderate induration appearing within 24 hours of administration. Symptoms resolved within 72 of onset.
Age: 31.0
Sex: F
Vaccine: DT
Symptoms: Arthralgia, Arthritis, Blood test, Chills, Dizziness
Clinical narrative: I was admited to the above mentioned Hospital emergency room on 03/08/2007, at 05:29 pm. for minor injury to the eye. The nurse insisted on me getting the DIPHTHERIA/TETANUS VACCINE. I was not given the vaccine information or informed of the risks prior to vaccination.  NP asssured me that vaccine is very safe. Vaccine was adminestered to me, and related printed information was given to me during the discharge on 06:23:35 pm of the same day. I went home and on the same night and woke up 4-6 hours later with sevire paine in the site of injection, in the upper right arm , which progressed in to complete numness of the same arm, followed by the severe fatigue and muscle pain of the back, arms and legs. Six hours later joint inflammation and muscle pain was so severe that it was painful for me to move at all, I started having chills and fever of 100,3 F, dizziness, fatigue and severe pains to the back of the neck in addition to al the above mentioned simptoms. My husband became very concerned, he gave me Ibprofen and took me to Emergency Room on 03/09/2007,at 09:30 pm. I was seen by doctor. I had to be wheeled in the wheel chair, because it was very painful for me to walk and I had a severe fatigue and dizziness. I explained all the above mentioned symptoms, but the doctor keep denying that my illness is vaccination related and I have a case of flu. He recomended plenty of fluids and rest and discharge me. I know he didn't fill out the adverse react. report or contact the first emergency room I was admitted to, because he denies it's vaccine related. Then we came home my husband gave me another dose of Ibprofen and I had to sleep in the recliner, in sitting position, because it was to painfull for me to lay down. I had severe muscle and joint pains for the next 3 days. The numbness in my right arm started to decrease after 3 days, I start slowly using that arm after 5 days. It is been 8 days since reaction to vaccination and I am having arthritis like pains in my joints, especially in my wrists, but NEVER develop any flu or cold. I also call to the hospital that administered the vaccine and reported the severe reaction to vaccination, asking to speak to the doctor and to file the report, the peceptionis told me that doctor can not speak to me right now, then i insisted that doctor need to call me back as soon as possible and left my phone number and message, but nobody have contacted me. I am going to my primary doctor for a pain in my joints and follow up. I want to mention that prior to vaccination I didn't have any illnesses, health conditions or take prescription medication daily. I was in excellent health.
Age: 31.0
Sex: F
Vaccine: DT
Symptoms: Fatigue, Hypoaesthesia, Injection site pain, Myalgia, Neck pain
Clinical narrative: I was admited to the above mentioned Hospital emergency room on 03/08/2007, at 05:29 pm. for minor injury to the eye. The nurse insisted on me getting the DIPHTHERIA/TETANUS VACCINE. I was not given the vaccine information or informed of the risks prior to vaccination.  NP asssured me that vaccine is very safe. Vaccine was adminestered to me, and related printed information was given to me during the discharge on 06:23:35 pm of the same day. I went home and on the same night and woke up 4-6 hours later with sevire paine in the site of injection, in the upper right arm , which progressed in to complete numness of the same arm, followed by the severe fatigue and muscle pain of the back, arms and legs. Six hours later joint inflammation and muscle pain was so severe that it was painful for me to move at all, I started having chills and fever of 100,3 F, dizziness, fatigue and severe pains to the back of the neck in addition to al the above mentioned simptoms. My husband became very concerned, he gave me Ibprofen and took me to Emergency Room on 03/09/2007,at 09:30 pm. I was seen by doctor. I had to be wheeled in the wheel chair, because it was very painful for me to walk and I had a severe fatigue and dizziness. I explained all the above mentioned symptoms, but the doctor keep denying that my illness is vaccination related and I have a case of flu. He recomended plenty of fluids and rest and discharge me. I know he didn't fill out the adverse react. report or contact the first emergency room I was admitted to, because he denies it's vaccine related. Then we came home my husband gave me another dose of Ibprofen and I had to sleep in the recliner, in sitting position, because it was to painfull for me to lay down. I had severe muscle and joint pains for the next 3 days. The numbness in my right arm started to decrease after 3 days, I start slowly using that arm after 5 days. It is been 8 days since reaction to vaccination and I am having arthritis like pains in my joints, especially in my wrists, but NEVER develop any flu or cold. I also call to the hospital that administered the vaccine and reported the severe reaction to vaccination, asking to speak to the doctor and to file the report, the peceptionis told me that doctor can not speak to me right now, then i insisted that doctor need to call me back as soon as possible and left my phone number and message, but nobody have contacted me. I am going to my primary doctor for a pain in my joints and follow up. I want to mention that prior to vaccination I didn't have any illnesses, health conditions or take prescription medication daily. I was in excellent health.
Age: 31.0
Sex: F
Vaccine: DT
Symptoms: Pain in extremity, Pyrexia, Reaction to preservatives
Clinical narrative: I was admited to the above mentioned Hospital emergency room on 03/08/2007, at 05:29 pm. for minor injury to the eye. The nurse insisted on me getting the DIPHTHERIA/TETANUS VACCINE. I was not given the vaccine information or informed of the risks prior to vaccination.  NP asssured me that vaccine is very safe. Vaccine was adminestered to me, and related printed information was given to me during the discharge on 06:23:35 pm of the same day. I went home and on the same night and woke up 4-6 hours later with sevire paine in the site of injection, in the upper right arm , which progressed in to complete numness of the same arm, followed by the severe fatigue and muscle pain of the back, arms and legs. Six hours later joint inflammation and muscle pain was so severe that it was painful for me to move at all, I started having chills and fever of 100,3 F, dizziness, fatigue and severe pains to the back of the neck in addition to al the above mentioned simptoms. My husband became very concerned, he gave me Ibprofen and took me to Emergency Room on 03/09/2007,at 09:30 pm. I was seen by doctor. I had to be wheeled in the wheel chair, because it was very painful for me to walk and I had a severe fatigue and dizziness. I explained all the above mentioned symptoms, but the doctor keep denying that my illness is vaccination related and I have a case of flu. He recomended plenty of fluids and rest and discharge me. I know he didn't fill out the adverse react. report or contact the first emergency room I was admitted to, because he denies it's vaccine related. Then we came home my husband gave me another dose of Ibprofen and I had to sleep in the recliner, in sitting position, because it was to painfull for me to lay down. I had severe muscle and joint pains for the next 3 days. The numbness in my right arm started to decrease after 3 days, I start slowly using that arm after 5 days. It is been 8 days since reaction to vaccination and I am having arthritis like pains in my joints, especially in my wrists, but NEVER develop any flu or cold. I also call to the hospital that administered the vaccine and reported the severe reaction to vaccination, asking to speak to the doctor and to file the report, the peceptionis told me that doctor can not speak to me right now, then i insisted that doctor need to call me back as soon as possible and left my phone number and message, but nobody have contacted me. I am going to my primary doctor for a pain in my joints and follow up. I want to mention that prior to vaccination I didn't have any illnesses, health conditions or take prescription medication daily. I was in excellent health.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase, Arthralgia, Aspartate aminotransferase, Blood bilirubin increased, Dizziness
Clinical narrative: 3/08/07 nausea and malaise 2 hours after vaccination.  3/9/07 - 3/13/07 Nausea, hot flashes, dizziness, joint pain and jaundice.    3/14/07 To physician, lab studies performed.  3/15/07 Elevated bilirubin and liver enzymes.  Symptom improvement noted.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Hot flush, Jaundice
Clinical narrative: 3/08/07 nausea and malaise 2 hours after vaccination.  3/9/07 - 3/13/07 Nausea, hot flashes, dizziness, joint pain and jaundice.    3/14/07 To physician, lab studies performed.  3/15/07 Elevated bilirubin and liver enzymes.  Symptom improvement noted.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Nausea
Clinical narrative: 3/08/07 nausea and malaise 2 hours after vaccination.  3/9/07 - 3/13/07 Nausea, hot flashes, dizziness, joint pain and jaundice.    3/14/07 To physician, lab studies performed.  3/15/07 Elevated bilirubin and liver enzymes.  Symptom improvement noted.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt was given his first anthrax vaccine on 14 Mar 07. He stated he noticed a red rash on his back across his shoulder the next morning. Slight itching, with redness. No treatment was done. Pt was going to take OTC Benadryl and OTC cortisone cream if the itching got worse.