chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash papular
Clinical narrative: Information has been received from a physician and the 64 year old white female registered nurse who on 23 Feb 2007 was vaccinated SC in the right arm with a first dose of Zostavax (lot # 656412/1476F). On 23 Feb 2007, immediately after vaccination, the injection site began to get red. On 24 Feb 2007 at 18:00 (also reported as "by 25 Feb 2007"), the injection site was a 3"x3" red area with three papular red lesions, these lesions were reported to be the diameter of a nickel in size. The nurse reported that she experienced discomfort from the injection site to underneath her arm. It was reported that there was mild swelling and tenderness of her upper arm and that she could still fell a "thickness" at the injection site approximately 1.5" x 1.5" in diameter. The nurse stated that the experience seemed to be localized to the injection site area. Unspecified medical attention was sought. The nurse reported that she applied Benadryl cream and took an unspecified antihistamine. No lab or diagnostic tests were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. The patient has no adverse events following prior vaccination. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no past medical history and no allergies who on 13-FEB-2007 was vaccinated with HPV (0.5 ml) (lot # 653736/0014U), intramuscularly. Concomitant medication included Loestrin. On 13-FEB-2007, "about half hour to hour after vaccination" the patient experienced "shortness of breath" per the patient. About two hours afterwards, the patient was "fine." The nurse mentioned that the patient was anxious about needles and attributed the symptoms to anxiety. On 19-FEB-2007 the patient developed hives on her elbows and knees. On 22-FEB-2007 the hives had spread "systemically" to her face, ribs, arms and legs. The patient was ordered on Benadryl by her other physician. The symptoms had not resolved. No further information was available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. On 27-Feb-2007 the primary care physician prescribed MEDROL dose pack and within 24 hours of the start of treatment, the patient felt relief and the rash/hive disappeared. Additional informatin is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with no past medical history and no allergies who on 13-FEB-2007 was vaccinated with HPV (0.5 ml) (lot # 653736/0014U), intramuscularly. Concomitant medication included Loestrin. On 13-FEB-2007, "about half hour to hour after vaccination" the patient experienced "shortness of breath" per the patient. About two hours afterwards, the patient was "fine." The nurse mentioned that the patient was anxious about needles and attributed the symptoms to anxiety. On 19-FEB-2007 the patient developed hives on her elbows and knees. On 22-FEB-2007 the hives had spread "systemically" to her face, ribs, arms and legs. The patient was ordered on Benadryl by her other physician. The symptoms had not resolved. No further information was available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2007. On 27-Feb-2007 the primary care physician prescribed MEDROL dose pack and within 24 hours of the start of treatment, the patient felt relief and the rash/hive disappeared. Additional informatin is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fatigue, Hypotrichosis, Loss of consciousness, Malaise, Night sweats
Clinical narrative: Information has been received from a physician concerning his 22 year old female cousin with no known drug allergies, who on 29 Jan 2007 was vaccinated IM into the arm with a  first dose of Gardasil. There was no concomitant medication. On 29 2007, the patient became dizzy, nauseous and collapsed about 1 hour after vaccination. The patient recovered rapidly and went home to bed. It was noted that the patient's weakness continued for 24 hours. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 31 Jan 2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Circulatory collapse, Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning his 22 year old female cousin with no known drug allergies, who on 29 Jan 2007 was vaccinated IM into the arm with a  first dose of Gardasil. There was no concomitant medication. On 29 2007, the patient became dizzy, nauseous and collapsed about 1 hour after vaccination. The patient recovered rapidly and went home to bed. It was noted that the patient's weakness continued for 24 hours. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. On 31 Jan 2007 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Abdominal pain, Dysuria, Full blood count, Hypokinesia, Influenza
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpitation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home. Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Pain in extremity, Pyrexia, Tympanometry, Urine analysis
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpitation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home. Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Abdominal pain, Bladder obstruction, Dysuria, Full blood count, Hypokinesia
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpitation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home. Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARCEL, DTAP, IPV, VARCEL
Symptoms: Influenza, Pain in extremity, Palpitations, Pyrexia, Tympanometry
Clinical narrative: 3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpitation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home. Did not want to walk. 3/6/07 diagnosed Influenza B.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Scan brain, Tremor
Clinical narrative: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Eye rolling, Fall, Head injury
Clinical narrative: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Asthenia, Computerised tomogram, Convulsion, Diplopia, Dizziness
Clinical narrative: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Injection site pain, Loss of consciousness, Musculoskeletal stiffness, Nausea, Syncope
Clinical narrative: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: Patient fainted and went into a seizure in the reception area of the clinic 10 minutes after the 1st Gardasil shot was administered. The seizure lasted approximately 2-3 minutes. Several nurses and doctor propped her in a wheelchair at which time she woke up for a few seconds and replaced her shoe that had fallen off. She immediately went into another seizure, losing conciousness, stiffened out like a board raising out of the seat of the wheelchair. The nurses and doctor hurried her back to the exam room and lifted her, still stiff and unconcious, onto the exam table. My best estimate is that this second seizure lasted a minimum of 3-4 minutes. Patient continued to feel week and slightly nauseated for several hours, also experiencing extreme pain at the sight of the injection and dizziness and double or blurred vision for 2-3 days later. When she told us about her dizziness and blurred vision the day after the 1st shot, we called doctor and he had us come to the emergency room to give her a CT scan. The 2nd Gardasil shot was administered with patient reclining on the exam table. She again complained of the painfulness at the site of the injection (this continued for several days), and approximately 5-10 minutes after receiving the shot felt faint and the room got very bright for a few seconds, then returned to normal.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Convulsion, Fall, Head injury, Orthostatic intolerance, Syncope
Clinical narrative: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a first dose of Gardasil, Lot #653735/0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she  fell after fainting. The patient was slow to wake and was Orthostatic (time line was unspecified). The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Vomiting
Clinical narrative: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a first dose of Gardasil, Lot #653735/0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she  fell after fainting. The patient was slow to wake and was Orthostatic (time line was unspecified). The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MEN
Symptoms: Convulsion, Fall, Head injury, Orthostatic hypotension, Syncope
Clinical narrative: Information has been received from a pharmacist concerning an 18 year old female patient who on 28-FEB-2007 was vaccinated with a first dose of Gardasil, Lot #653735/0688F. Concomitant therapy included Menomune. The patient fainted 10 minutes after injection Gardasil. The patient fell and hit her head when she fainted. The patient then had a seizure for 30 seconds after she  fell after fainting. The patient was slow to wake and was Orthostatic (time line was unspecified). The patient also vomited twice (no time line). The patient recovered later in the day. The reporter considered the events to be disabling. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Crying, Pain in extremity
Clinical narrative: Information has been received from a medical assistant and a nurse practitioner concerning an 11 year old female with no relevant medical history reported who on 08-FEB-2007 was vaccinated intramuscularly in the right deltoid wit a 0.5 ml dose of Gardasil (lot 654702/0011U). Concomitant therapy included METADATE. On approximately 18-FEB-2007 or 19-FEB-2007, the patient developed upper right arm pain. The patient was seen on 21-FEB-2007 and 02-MAR-2007 for the upper arm pain. The pain occurred on the whole outer portion of the upper arm. The patient has no fever. Office notes indicated that "normal flexion of the elbow without problems with bilateral strength. Normal anterior and posterior rotation of shoulder. Normal internal and external rotation of shoulder. Active abduction of only 90 degrees, stopping due to pain. Able to rotate full 180 degrees with passive range but crying due to tears. Diagnosis was arm pain without reduction of strength, secondary to HPV injection. "The patient was treated with ibuprofen 350mg every 6 hours for 4 to 5 days. The nurse practitioner reported that she assumed the patient recovered from the arm pain because the patient did not return for a follow-up visit scheduled on 08-MAR-2007. The nurse practitioner considered the patient's upper arm pain an other important medical event as the patient's pain lasted longer that the indicated time frame of 48 hours for this experience. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness, Urticaria
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with a history of allergic reaction to antibiotics who on 07-MAR-2007 was vaccinated with first dose of Gardasil (lot # not reported) injection. On 07-MAR-2007, after being vaccinated, the patient broke out in severe hives and her airway began to close. Medical attention was sought. The physician administered an injection of Benadryl. The patient was admitted to the emergency room, it was unknown if the patient was admitted to the hospital. On 08-MAR-2007, the patient recovered. No further information was provided. Upon internal review, airway began to close was considered to be an other important medical event. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphonia, Eye swelling, Laboratory test, Nasal congestion, Swelling face
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated by injection with the first dose of Gardasil. It was reported that the patient experienced an adverse experienced 2 hours after receiving Gardasil. The patient went to the emergency room with a swollen face and eyes, no fever reported. The patient received eye drops and BENADRYL. On 06-MAR-2007 the patient returned to the clinic with tender and a "little puppy eyes". On 07-MAR-2007 the patient had an itchy throat and her eyes were still tender. On 08-MAR-2007, the patient sounded "nasal". The pat6ient sought unspecified medical attention. The physician added an antibiotic and the patient was still taking diphenhydramine hydrochloride. The patient has a "respiratory panel". The physician reported that the patient will not continue the series. At the time of the report, it was unknown if the patient recovered. The physician considered swollen face and eyes, tender eyes, itchy throat, and sounded "nasal" to be other important medical events.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Tenderness, Throat irritation
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 05-MAR-2007 was vaccinated by injection with the first dose of Gardasil. It was reported that the patient experienced an adverse experienced 2 hours after receiving Gardasil. The patient went to the emergency room with a swollen face and eyes, no fever reported. The patient received eye drops and BENADRYL. On 06-MAR-2007 the patient returned to the clinic with tender and a "little puppy eyes". On 07-MAR-2007 the patient had an itchy throat and her eyes were still tender. On 08-MAR-2007, the patient sounded "nasal". The pat6ient sought unspecified medical attention. The physician added an antibiotic and the patient was still taking diphenhydramine hydrochloride. The patient has a "respiratory panel". The physician reported that the patient will not continue the series. At the time of the report, it was unknown if the patient recovered. The physician considered swollen face and eyes, tender eyes, itchy throat, and sounded "nasal" to be other important medical events.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Crying
Clinical narrative: Information has been received from a physician concerning a 7-month-old female who on 25-SEP-2006 (Lot # 653980/0285F), 29-NOV-2006 (Lot# 654489/0941F) and 29-JAN-2007 was vaccinated PO with the first, second and third 2.0 mL doses, respectively, of Rotateq. The physician reported that on 04-MAR-2007, the child was crying and had other symptoms (unspecified). On 05-MAR-2007, the patient was seen in the physician's office where a diagnosis of intussusception was made. No laboratory/diagnostic tests were performed. On that same day, the patient was given an enema and recovered. The physician considered intussusception to be an other important medical event as the patient was given an enema. Additional information has been requested.  3/20/07 Received x-ray reports which reveal ileocolic intussusception successfully reduced by air contrast enema on 3/5/07.  Follow up abd film on 3/6/07 revealed no evidence of further IS.
Sex: U
Vaccine: RV5
Symptoms: Intussusception
Clinical narrative: Information has been requested from a physician concerning a patient who was vaccinated with a first oral 2 ml dose of Rotateq. Subsequently the patient developed intussusception. Medical attention was not sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2-month-old male who was vaccinated PO with a 2.0 mL dose of Rotateq. The physician reported that the patient subsequently developed blood in the stool. Unspecified medical attention was sought. The patient subsequently recovered. Upon internal review, blood in stool was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Heart rate increased, Pyrexia, Tachycardia
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 2-month-old female patient who experienced heart rate of 224 and temperature elevation to 104 degrees F. The patient received the first dose on 01-Nov-2006. The patient also received the first dose of Daptacel, the first dose of Rotateq, the first dose of Ipol and the first dose of Act-Hib on 01-Nov-2006. Within a few hours of receiving Prevnar on 01-Nov-2006, the patient developed a temperature elevation to 104 degrees F and a heart rate of 224. The patient was treated with Tylenol. The fever and tachycardia resolved within 24 hours. The child was taken to her cardiologist for evaluation. See related case HQWYE084208MAR07 for the report of the same events occurring to this same patient following receipt of the second dose of Prevnar. No additional information was available at the time of this report.
Age: 0.38
Sex: F
Vaccine: PNC
Symptoms: Body temperature increased, Tachycardia, Vaccine positive rechallenge
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a health care professional regarding a 4-month-old female patient who experienced tachycardia and temperature elevation to 104 degrees F. The patient received the second dose on 19-Jan-2007. On 19-Jan-2007, the patient developed an elevated temperature of 104 degrees F and tachycardia within a few hours of receiving Prevnar. The child was treated with Tylenol. The fever and tachycardia resolved within 24 hours. No additional information was available at the time of this report.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Cognitive disorder, Convulsion, Dysstasia
Clinical narrative: Could not stand, could not understand, memory loss, ten days later had massive seizure.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blood culture, Culture urine, Full blood count, Injection site erythema, Pyrexia
Clinical narrative: Small red area on right thigh at 2 injection site. Fever since pm 3/8/07. 4/3/07 Received medical records from hospital which reveal patient experienced fever 102.7 at home w/sneezing.  Seen by PCP earlier same day & sent to ER for direct admit for overnight observation.  Progressed well & d/c to home next day.   FINAL DX: probable viral illness.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urine analysis
Clinical narrative: Small red area on right thigh at 2 injection site. Fever since pm 3/8/07. 4/3/07 Received medical records from hospital which reveal patient experienced fever 102.7 at home w/sneezing.  Seen by PCP earlier same day & sent to ER for direct admit for overnight observation.  Progressed well & d/c to home next day.   FINAL DX: probable viral illness.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Laceration, Oxygen saturation, Syncope, Tooth repair
Clinical narrative: 2-19-07 child had well check up, received vaccines of Gardasil, Hep A, Menactra, Varicella. Approx at 3:00pm had syncopal episode on the way out of the office. First aid rendered for lip laceration. B/P and vital signs checked, reverse trendelenburg position. Sent to dental office for tooth repair.
Age: 0.52
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Crying
Clinical narrative: Cried for 3 hours straight.
Age: 51.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Within 4 weeks of the Tdap vaccine, developed numbness and tingling of both soles of feet. Over the next 4 week N/T gradually moved up to waist. Then it subsided. Total time of N/T was about 8 weeks.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Computerised tomogram, Confusional state, Dyspnoea, Electrocardiogram
Clinical narrative: Syncope episode at checkout window 4 min after Gardasil vaccine given. Upon forward fall, pt sustained blow to anterior aspect of neck on our counter top. Unconscious for approx 30-60 sec, then alert but confused as to what happened for about 1 min. Labored breathing and anxiety approx 4-5 min then relaxed. Red raised mark on soft tissue of anterior neck. Remained in supine position with neck neutral at still. EMS here within 10 min. To ER pre EMS with cervical collar and neck immobilizer on.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Fall, Full blood count, Loss of consciousness, Neck injury
Clinical narrative: Syncope episode at checkout window 4 min after Gardasil vaccine given. Upon forward fall, pt sustained blow to anterior aspect of neck on our counter top. Unconscious for approx 30-60 sec, then alert but confused as to what happened for about 1 min. Labored breathing and anxiety approx 4-5 min then relaxed. Red raised mark on soft tissue of anterior neck. Remained in supine position with neck neutral at still. EMS here within 10 min. To ER pre EMS with cervical collar and neck immobilizer on.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Scan brain, Syncope
Clinical narrative: Syncope episode at checkout window 4 min after Gardasil vaccine given. Upon forward fall, pt sustained blow to anterior aspect of neck on our counter top. Unconscious for approx 30-60 sec, then alert but confused as to what happened for about 1 min. Labored breathing and anxiety approx 4-5 min then relaxed. Red raised mark on soft tissue of anterior neck. Remained in supine position with neck neutral at still. EMS here within 10 min. To ER pre EMS with cervical collar and neck immobilizer on.
Age: 1.05
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Pallor, Rash macular, Rash papular
Clinical narrative: Rash 1-3 mm pink blanchable macules and papules trunk and back, no extremities. no open sores, no pruritic. On set 11 days after MMRV vaccine and two days after completing 10 course of Omnicef.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: Pt had fever that developed the morning after administration of the vaccines and persisted for about 24 hours, and she was very fussy the following day.
Age: 0.21
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and fever x 3 hrs.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: Crying and fussy.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Decreased appetite, Irritability
Clinical narrative: Crying and fussy, decrease appetite.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Allergy to vaccine, Culture urine negative, Irritability, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever and irritability. Sent to ER, dx with allergic reaction to vaccine.
Age: 16.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Malaise, Nausea, Pain in extremity
Clinical narrative: Arm so sore could not lift up also, was very nauseous and sick for 2 days, brothers arm real sore but no sickness and could move it.
Age: 1.01
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site papule, Injection site vesicles, Pyrexia
Clinical narrative: Fever to 102.5 x 72 hours, small localized erythema 2 areas x 1-2 cm each, papules, blisters x 8, upper outer quadrant right thigh.
Age: 1.11
Sex: F
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Erythema, Injection site nodule, Injection site rash, Rash, Rash papular
Clinical narrative: Rash slightly raised papular, mildly red, not of a sandpaper quality, scattered but bit confluent over trunk; present but not enhanced in diaper area. Rash is fine on face and proximal extremities, rash is thick and confluent in the area surrounding right thigh. She has tender nodules at the injection sites. The rash is thickest around the site on her lower right leg and extends to upper right leg. Continue use of Benadryl and Tylenol. Avoid Pertussis vaccine in future.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Subcutaneous erythema, warm the edema in circumference4 cm diameter oval around injection site.
Age: 3.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia, Sinus disorder
Clinical narrative: High fever x 3 days. Has sinus breath.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Crying, Local reaction, Pyrexia
Clinical narrative: Fever of 103 for 3 days - crying and fussy for 3-4 days unconsoleably. Local reaction to right thigh.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Raised area of erythema, 5 cm diameter slight tender to palpitation, itchy.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Following immunization patient's left upper arm/deltoid was sore and she noted decreased ROM with abduction, flexion and internal rotation reaching behind her back. Patient was given vaccination 8/4/06 and has had no improvement or change.
Age: 49.0
Sex: U
Vaccine: ANTH
Symptoms: Deafness bilateral, Hypertension
Clinical narrative: Arterial hypertension, bilateral hearing loss.
Age: 6.5
Sex: F
Vaccine: HEPA
Symptoms: Lethargy, Musculoskeletal stiffness, Pain, Somnolence
Clinical narrative: Mom called clinic 3/7/07 reporting adverse reaction occurred 3/6/07 at 3:30 pm sleep, achy, lethargic. Slept all afternoon did not eat. Awoke 3/7/07 suddenly pointing to unknown object asking for "someone to give me that" repeatedly. Then, stiffened arms by her side whole body stiff per mom for approximately 3 min. Afterward unaware of what was happening and lethargic. No fever, no other symptoms reported. Episode occurred only once, mom instructed to take child to physician or ER.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Full blood count, Metabolic function test normal, Pyrexia
Clinical narrative: Fever and seizure, went to ER, no meds given.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Dyskinesia, Encephalopathy, Eye disorder, Eye swelling, Eyelid ptosis
Clinical narrative: Initial report received on 02 March 2007 from a physician. A 53-year-old female patient with a past medical history of allergies and asthma, had received a dose of Tetanus Adsorbed Preservative-free, lot number U1624AB, on 19 January 2007. The expiration date of the vaccine was reported as 13 December 2007. The route and site if administration were not provided. Two days post-immunization, the patient developed a rash (area not reported). Treatments received and diagnostic testing's performed were not reported. 21 days post-immunization, the patient was evaluated by her physician for mono neuropathies of the jaw. During physical examination it was noted that the patient was not able to stick her tongue out of her mouth and she "had left eye droop". The patient was treated with steroids with some improvement in her symptoms. At the time of this report, it was unknown if the patient had recovered. Additional information was received from a physician on 06 March 2006 and has been added to this initial version. The patient developed a fine whole body rash on 22 January 2007. She had malaise and a fever. On 09 February 2007, the patient developed facial muscle spasms. She reported that "the masseter and pterygoid muscles are so spasmed and constantly painful that I cannot open my mouth more than 1 cm". Additional symptoms included an "intolerable" headache and left eye swelling and drooping. She can only consume liquids. The patient is a dentist and has been unable to work for three weeks. Per the reporting physician, the patient had trismus and encephalopathy. As of 06 March 2007, the encephalopathy had cleared, but the trismus was only 30% improved. She had not recovered at the time of this report.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Facial spasm, Headache, Jaw disorder, Malaise, Muscle spasms
Clinical narrative: Initial report received on 02 March 2007 from a physician. A 53-year-old female patient with a past medical history of allergies and asthma, had received a dose of Tetanus Adsorbed Preservative-free, lot number U1624AB, on 19 January 2007. The expiration date of the vaccine was reported as 13 December 2007. The route and site if administration were not provided. Two days post-immunization, the patient developed a rash (area not reported). Treatments received and diagnostic testing's performed were not reported. 21 days post-immunization, the patient was evaluated by her physician for mono neuropathies of the jaw. During physical examination it was noted that the patient was not able to stick her tongue out of her mouth and she "had left eye droop". The patient was treated with steroids with some improvement in her symptoms. At the time of this report, it was unknown if the patient had recovered. Additional information was received from a physician on 06 March 2006 and has been added to this initial version. The patient developed a fine whole body rash on 22 January 2007. She had malaise and a fever. On 09 February 2007, the patient developed facial muscle spasms. She reported that "the masseter and pterygoid muscles are so spasmed and constantly painful that I cannot open my mouth more than 1 cm". Additional symptoms included an "intolerable" headache and left eye swelling and drooping. She can only consume liquids. The patient is a dentist and has been unable to work for three weeks. Per the reporting physician, the patient had trismus and encephalopathy. As of 06 March 2007, the encephalopathy had cleared, but the trismus was only 30% improved. She had not recovered at the time of this report.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Pain, Pyrexia, Rash, Rash generalised, Tongue paralysis
Clinical narrative: Initial report received on 02 March 2007 from a physician. A 53-year-old female patient with a past medical history of allergies and asthma, had received a dose of Tetanus Adsorbed Preservative-free, lot number U1624AB, on 19 January 2007. The expiration date of the vaccine was reported as 13 December 2007. The route and site if administration were not provided. Two days post-immunization, the patient developed a rash (area not reported). Treatments received and diagnostic testing's performed were not reported. 21 days post-immunization, the patient was evaluated by her physician for mono neuropathies of the jaw. During physical examination it was noted that the patient was not able to stick her tongue out of her mouth and she "had left eye droop". The patient was treated with steroids with some improvement in her symptoms. At the time of this report, it was unknown if the patient had recovered. Additional information was received from a physician on 06 March 2006 and has been added to this initial version. The patient developed a fine whole body rash on 22 January 2007. She had malaise and a fever. On 09 February 2007, the patient developed facial muscle spasms. She reported that "the masseter and pterygoid muscles are so spasmed and constantly painful that I cannot open my mouth more than 1 cm". Additional symptoms included an "intolerable" headache and left eye swelling and drooping. She can only consume liquids. The patient is a dentist and has been unable to work for three weeks. Per the reporting physician, the patient had trismus and encephalopathy. As of 06 March 2007, the encephalopathy had cleared, but the trismus was only 30% improved. She had not recovered at the time of this report.
Age: 53.0
Sex: F
Vaccine: TTOX
Symptoms: Trismus
Clinical narrative: Initial report received on 02 March 2007 from a physician. A 53-year-old female patient with a past medical history of allergies and asthma, had received a dose of Tetanus Adsorbed Preservative-free, lot number U1624AB, on 19 January 2007. The expiration date of the vaccine was reported as 13 December 2007. The route and site if administration were not provided. Two days post-immunization, the patient developed a rash (area not reported). Treatments received and diagnostic testing's performed were not reported. 21 days post-immunization, the patient was evaluated by her physician for mono neuropathies of the jaw. During physical examination it was noted that the patient was not able to stick her tongue out of her mouth and she "had left eye droop". The patient was treated with steroids with some improvement in her symptoms. At the time of this report, it was unknown if the patient had recovered. Additional information was received from a physician on 06 March 2006 and has been added to this initial version. The patient developed a fine whole body rash on 22 January 2007. She had malaise and a fever. On 09 February 2007, the patient developed facial muscle spasms. She reported that "the masseter and pterygoid muscles are so spasmed and constantly painful that I cannot open my mouth more than 1 cm". Additional symptoms included an "intolerable" headache and left eye swelling and drooping. She can only consume liquids. The patient is a dentist and has been unable to work for three weeks. Per the reporting physician, the patient had trismus and encephalopathy. As of 06 March 2007, the encephalopathy had cleared, but the trismus was only 30% improved. She had not recovered at the time of this report.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Accidental exposure, Incorrect dose administered, Sensory disturbance, Vaccination complication
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 22 year old female student with no acute illness or chronic disease and food allergy to eggplant who on 08 Nov 2006, at 14:00, was vaccinated witha second dose of Gardasil. It was reported that the patient pulled away during adminstration due to "strange sensation" and a significant amount medication went down the patient's arm. It was estimated that only one third to one half of the dose was administered. It was reported that the patient had to repeat the second. On 08 Nov 2006, the patient recovered from the event.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Cold compress therapy, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Informatio has been received from a physician's assistant concerning a 22 year old female who on 25 Jan 2007 was vaccinated IM with a second 0.5 ml dose of Gardasil. On approximately 25 Jan 2007, the patient experienced a 1.3 inch area of swelling, redness, tenderness and itchiness at the injection site. The patient notified the physician's assistant 5 days after vaccination. It was unknown when the events started. The patient was treated with cool compresses and antihistamines with unknown results. No diagnostic laboratory studies were performed. Subsquently the patient recovered from swelling, redness, pain and tenderness at the injection site. It was also reported that on 07 Nov 2006, the patient was vaccinated with a first dose of Gardasil. No product quality complaint was involved. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a licensced practical nurse concerning a 25 year old female with no medical history or allergies, who on 26 Jan 2007 was vaccinated a first dose of with Gardasil (yeast) (lot#653736/0014U). Concomitant therapy included hormonal contraceptives (unspecified). On 31 Jan 2007 (also reported as four to five days later), the patient developed hives. The patient went to her primary care physician for treatment of the hives. She was prescribed prednisone and Benadryl. Later that day, she went to the emergency room. On 01 Feb 2007 the patient told the nurse her hives were worse. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site discolouration, Similar reaction on previous exposure to drug, Skin discolouration
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 02-NOV-2006 was vaccinated intramuscularly in the right arm with GARDASIL (Lot # not provided). Concomitant therapy included Yasmin. On 14-JAN-2007 the patient received her second vaccination of GARDASIL (Lot #653735/0688F) intramuscularly in the left arm. On approximately 09-NOV-2006 the patient experienced a lighter coloring of the skin at the injection site. It was reported that the patient did not experience any itching or swelling. On approximately 21 Jan 2007 the patient experienced lighter coloring of the skin at the injection site. Follow up information confirmed that on 01-FEB-2007 the patient experienced lighter coloring of the skin at the injection site. At the time of this report the patient's skin discoloration in both arms had not resolved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure normal, Dizziness, Fall, Heart rate normal, Loss of consciousness
Clinical narrative: Information has been received from a physician concerning a 21 year old female with no known allergies who on 01-FEB-2007 was vaccinated intramuscularly in the right deltoid with Gardasil (lot # not provided). The physician reported that after administering the injection she "turned around literally for a second" and when she turned back to the patient she found her "on the floor, with her rear in the air". The physician stated that she called for her assistant for help and the patient was already conscious, "she was only out for a second". The patient reported to the physician that she felt dizzy and felt like she instantly went to sleep. The physician reported that the patients blood pressure and pulse were normal (actual measurements not provided). The physician reported that the patient was observed in the office, had no additional episodes and considered to have recovered from the event and sent home. The physician stated that she did not feel the event was disabling and would continue the series of vaccination of Gardasil with the patient, but would have her reclined when administering future vaccinations. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 26 year old female with a history of syncope when giving blood, who on 11-Jan-2007 was vaccinated with Gardasil (lot #653978/0955F). It was reported that the patient fainted 15 minutes after vaccination. The patient subsequently recovered. No further details were provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dysgeusia
Clinical narrative: Information has been received from a physician concerning a 25 year old female with no pertinent medical history or drug reactions/allergies, who on approximately 11-Jan-2007 was vaccinated with Gardasil (0.5 ml). The physician reported that 30 seconds following vaccination, the patient experienced an intense metal taste in her mouth, however immediately recovered. No further details were provided. Additional information has been requested.