chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Gait disturbance, Hemiparesis, Hyporeflexia, Intensive care, Lumbar puncture normal
Clinical narrative: Within 9 days on the morning of 1/5/07, mother found her unresponsive and rigid with her body turned to R and Left eye deviated laterally, and very shallow breathing. Admitted to hospital and transferred to another hospital. LPS nl Tx'd with Acyclovir x 21 days. CXR -. Final DX encephalitis with unknown origin or cause. Not completely recovered-Developmental delayed.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Pyrexia, Tricuspid valve incompetence
Clinical narrative: Within 9 days on the morning of 1/5/07, mother found her unresponsive and rigid with her body turned to R and Left eye deviated laterally, and very shallow breathing. Admitted to hospital and transferred to another hospital. LPS nl Tx'd with Acyclovir x 21 days. CXR -. Final DX encephalitis with unknown origin or cause. Not completely recovered-Developmental delayed.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Computerised tomogram normal, Developmental delay, Encephalitis, Eye rolling, Hypoventilation
Clinical narrative: Within 9 days on the morning of 1/5/07, mother found her unresponsive and rigid with her body turned to R and Left eye deviated laterally, and very shallow breathing. Admitted to hospital and transferred to another hospital. LPS nl Tx'd with Acyclovir x 21 days. CXR -. Final DX encephalitis with unknown origin or cause. Not completely recovered-Developmental delayed.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Inflammation, Lumbar puncture normal, Muscle rigidity, Nervous system disorder, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Within 9 days on the morning of 1/5/07, mother found her unresponsive and rigid with her body turned to R and Left eye deviated laterally, and very shallow breathing. Admitted to hospital and transferred to another hospital. LPS nl Tx'd with Acyclovir x 21 days. CXR -. Final DX encephalitis with unknown origin or cause. Not completely recovered-Developmental delayed.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Unresponsive to stimuli, X-ray abnormal
Clinical narrative: Within 9 days on the morning of 1/5/07, mother found her unresponsive and rigid with her body turned to R and Left eye deviated laterally, and very shallow breathing. Admitted to hospital and transferred to another hospital. LPS nl Tx'd with Acyclovir x 21 days. CXR -. Final DX encephalitis with unknown origin or cause. Not completely recovered-Developmental delayed.
Age: 0.99
Sex: F
Vaccine: HEPA, MMRV, HEPA, MMRV, HEPA, MMRV
Symptoms: Encephalitis
Clinical narrative: Within 9 days on the morning of 1/5/07, mother found her unresponsive and rigid with her body turned to R and Left eye deviated laterally, and very shallow breathing. Admitted to hospital and transferred to another hospital. LPS nl Tx'd with Acyclovir x 21 days. CXR -. Final DX encephalitis with unknown origin or cause. Not completely recovered-Developmental delayed.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Injection site vesicles
Clinical narrative: Information has been received from a health professional concerning a male patient with a history of localised skin reaction with pneumococcal 23v polysaccharide (WAES # 0703USA01241) who "recently" in 2007 was vaccinated in the deltoid with a dose of varicella-zoster. Subsequently one day post vaccination, the patient developed a local skin reaction; the deltoid injection site was red and blistered. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested. Follow-up information from the registered nurse indicated that the patient had a reaction to the vaccine, six days after vaccination on 31-JAN-2007. The patient had a 3 inch ring around with slight white center. There were a few small blisters at the top and bottom of the circle. No laboratory tests were performed. Subsequently the patient recovered. No further information is expected.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Skin reaction
Clinical narrative: Information has been received from a health professional concerning a male patient with a history of localised skin reaction with pneumococcal 23v polysaccharide (WAES # 0703USA01241) who "recently" in 2007 was vaccinated in the deltoid with a dose of varicella-zoster. Subsequently one day post vaccination, the patient developed a local skin reaction; the deltoid injection site was red and blistered. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested. Follow-up information from the registered nurse indicated that the patient had a reaction to the vaccine, six days after vaccination on 31-JAN-2007. The patient had a 3 inch ring around with slight white center. There were a few small blisters at the top and bottom of the circle. No laboratory tests were performed. Subsequently the patient recovered. No further information is expected.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician and health professional concerning a female who on 22-JAN-2007 in the morning was vaccinated with a dose of Zostavax. Subsequently the patient developed a rash on the left side of her chest. The physician reported that in the afternoon on 22-JAN-2007, the patient saw a dermatologist who applied topical EFUDEX on an area of the chest close to where the patient was vaccinated in the arm. It seemed like the rash appeared close to where the EFUDEX was applied. The dermatologist also applied EFUDEX to two areas on the patient's face, but no rash occurred there. The physician though that the rash occurred soon after the cream was applied but was not sure. On 01-FEB-2007 the patient was examined by her physician. The physician could not confirm whether the rash resembled shingles or not. There was no  product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician and health professional concerning a female who on 22-JAN-2007 in the morning was vaccinated with a dose of Zostavax. Subsequently the patient developed a rash on the left side of her chest. The physician reported that in the afternoon on 22-JAN-2007, the patient saw a dermatologist who applied topical EFUDEX on an area of the chest close to where the patient was vaccinated in the arm. It seemed like the rash appeared close to where the EFUDEX was applied. The dermatologist also applied EFUDEX to two areas on the patient's face, but no rash occurred there. The physician though that the rash occurred soon after the cream was applied but was not sure. On 01-FEB-2007 the patient was examined by her physician. The physician could not confirm whether the rash resembled shingles or not. There was no  product quality complaint involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Headache, Nausea
Clinical narrative: Information has been received from a certified medical assistant concerning a 23 year old female with migraine headaches who on 23-JAN-2007 was vaccinated IM with a second 0.5ml dose of Gardasil (lot #655205/1426F). The next day, the patient experienced headache and rated it 5 out of 10 on a pain scale. The patient took EXCEDRIN, EXCEDRINE MIGRAINE, TYLENOL, ALEVE, and IMITREX which did not relieve her headache. Her headache was constant. The patient also complained of nausea. On 08-FEB-2007, the patient was seen by her physician and was prescribed a Z pack and MUCINEX D for sinusitis. At the time of this report, the patient had not recovered. It was also reported that on 14-NOV-2006 the patient was vaccinated with a first dose of Gardasil. No product quality complaint was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Headache, Nausea, Sinusitis
Clinical narrative: Information has been received from a certified medical assistant concerning a 23 year old female with migraine headaches who on 23-JAN-2007 was vaccinated IM with a second 0.5ml dose of Gardasil (lot #655205/1426F). The next day, the patient experienced headache and rated it 5 out of 10 on a pain scale. The patient took EXCEDRIN, EXCEDRINE MIGRAINE, TYLENOL, ALEVE, and IMITREX which did not relieve her headache. Her headache was constant. The patient also complained of nausea. On 08-FEB-2007, the patient was seen by her physician and was prescribed a Z pack and MUCINEX D for sinusitis. At the time of this report, the patient had not recovered. It was also reported that on 14-NOV-2006 the patient was vaccinated with a first dose of Gardasil. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 15 year old female student with seasonal allergies who on 25-JAN-2007 at 3:00 Pm was vaccinated intramuscularly in the right deltoid with the first dose of Gardasil (lot #654702/0011U). There were no illnesses at time of vaccination. Concomitant therapy included hormonal contraceptives (unspecified). It was reported that on 26-JAN-2007, at 4:30AM, the patient experienced subjective fever, nausea, vomiting and headache. It was reported that the patient was unable to attend school for five days. The patient subsequently recovered from the events on 03-FEB-2007. No further information is expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Nausea, Tremor
Clinical narrative: Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on approximately 09-FEB-2007 was vaccinated with first dose of Gardasil (yeast) (lot # not reported) 0.5 ml IM. On approximately 09-FEB-2007, the patient experienced dizziness, weakness and shaky legs after receiving Gardasil (yeast). Medical attention was sought. As a result of the symptoms, the patient was home from school for 3 days. At the time of reporting, the patient was recovering. No further information was available at the time of reporting. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning an 18 year old female with a calcified hematoma at the time of vaccination and drug reactions/allergies unspecified who on 05-FEB-2007 was vaccinated with first dose of GARDASIL (lot # 654885/1424F) 0.5 ml IM in her left arm. On 06-FEB-2007, at 6:30 in the morning, the patient experienced dizziness, and shaky legs after receiving GARDASIL. On 07-Feb-2007, the patient's leg was still shaking. She also felt nauseated and faint and was in bed most of the day. Medical attention was sought. As a result of the symptoms, the patient was home for 3 days. On 10-FEB-2007, she felt better and returned to school. On 06-Mar-2007 the patient's mother stated that her daughter's face was flush real bad.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bedridden, Dizziness, Flushing, Muscular weakness, Nausea
Clinical narrative: Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on approximately 09-FEB-2007 was vaccinated with first dose of Gardasil (yeast) (lot # not reported) 0.5 ml IM. On approximately 09-FEB-2007, the patient experienced dizziness, weakness and shaky legs after receiving Gardasil (yeast). Medical attention was sought. As a result of the symptoms, the patient was home from school for 3 days. At the time of reporting, the patient was recovering. No further information was available at the time of reporting. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning an 18 year old female with a calcified hematoma at the time of vaccination and drug reactions/allergies unspecified who on 05-FEB-2007 was vaccinated with first dose of GARDASIL (lot # 654885/1424F) 0.5 ml IM in her left arm. On 06-FEB-2007, at 6:30 in the morning, the patient experienced dizziness, and shaky legs after receiving GARDASIL. On 07-Feb-2007, the patient's leg was still shaking. She also felt nauseated and faint and was in bed most of the day. Medical attention was sought. As a result of the symptoms, the patient was home for 3 days. On 10-FEB-2007, she felt better and returned to school. On 06-Mar-2007 the patient's mother stated that her daughter's face was flush real bad.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tremor
Clinical narrative: Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on approximately 09-FEB-2007 was vaccinated with first dose of Gardasil (yeast) (lot # not reported) 0.5 ml IM. On approximately 09-FEB-2007, the patient experienced dizziness, weakness and shaky legs after receiving Gardasil (yeast). Medical attention was sought. As a result of the symptoms, the patient was home from school for 3 days. At the time of reporting, the patient was recovering. No further information was available at the time of reporting. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Information has been received from a physician concerning an 18 year old female with a calcified hematoma at the time of vaccination and drug reactions/allergies unspecified who on 05-FEB-2007 was vaccinated with first dose of GARDASIL (lot # 654885/1424F) 0.5 ml IM in her left arm. On 06-FEB-2007, at 6:30 in the morning, the patient experienced dizziness, and shaky legs after receiving GARDASIL. On 07-Feb-2007, the patient's leg was still shaking. She also felt nauseated and faint and was in bed most of the day. Medical attention was sought. As a result of the symptoms, the patient was home for 3 days. On 10-FEB-2007, she felt better and returned to school. On 06-Mar-2007 the patient's mother stated that her daughter's face was flush real bad.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arrhythmia, Blood pressure, Computerised tomogram, Dyspnoea, Dysstasia
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who on 19-DEC-2006 was vaccinated with a first dose of Gardasil. On 20-FEB-2007, the patient was vaccinated IM, into the right deltoid, with a second 0.5 ml dose of Gardasil (lot #655849/0263U). There was no concomitant medication. On 20-FEB-2007, approximately 2 to 3 minutes after the vaccination, the patient fainted for 30 to 45 seconds. It was reported that the rescue squad was called because the patient developed leg numbness spreading to the shoulders after recovering from the fainting spell. It was reported that the numbness lasted from a few minutes. The patient was transported to the emergency room of a local hospital. At the emergency room, the patient had a second episode of syncope at 12:20 p.m. At the time of the report the patient was in the emergency room and had not recovered from the second event of syncope. 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 health professional concerning a 23 year old female with no known drug allergies who on 19-DEC-2006 was vaccinated with a first dose of GARDASIL.  On 20-FEB-2007, the patient was vaccinated intramuscularly, into the right deltoid, with a second 0.5 ml dose of
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram, Fall, Feeling hot, Fluid replacement, Heart rate
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who on 19-DEC-2006 was vaccinated with a first dose of Gardasil. On 20-FEB-2007, the patient was vaccinated IM, into the right deltoid, with a second 0.5 ml dose of Gardasil (lot #655849/0263U). There was no concomitant medication. On 20-FEB-2007, approximately 2 to 3 minutes after the vaccination, the patient fainted for 30 to 45 seconds. It was reported that the rescue squad was called because the patient developed leg numbness spreading to the shoulders after recovering from the fainting spell. It was reported that the numbness lasted from a few minutes. The patient was transported to the emergency room of a local hospital. At the emergency room, the patient had a second episode of syncope at 12:20 p.m. At the time of the report the patient was in the emergency room and had not recovered from the second event of syncope. 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 health professional concerning a 23 year old female with no known drug allergies who on 19-DEC-2006 was vaccinated with a first dose of GARDASIL.  On 20-FEB-2007, the patient was vaccinated intramuscularly, into the right deltoid, with a second 0.5 ml dose of
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyperhidrosis, Hyperventilation, Injury, Loss of consciousness, Nausea
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who on 19-DEC-2006 was vaccinated with a first dose of Gardasil. On 20-FEB-2007, the patient was vaccinated IM, into the right deltoid, with a second 0.5 ml dose of Gardasil (lot #655849/0263U). There was no concomitant medication. On 20-FEB-2007, approximately 2 to 3 minutes after the vaccination, the patient fainted for 30 to 45 seconds. It was reported that the rescue squad was called because the patient developed leg numbness spreading to the shoulders after recovering from the fainting spell. It was reported that the numbness lasted from a few minutes. The patient was transported to the emergency room of a local hospital. At the emergency room, the patient had a second episode of syncope at 12:20 p.m. At the time of the report the patient was in the emergency room and had not recovered from the second event of syncope. 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 health professional concerning a 23 year old female with no known drug allergies who on 19-DEC-2006 was vaccinated with a first dose of GARDASIL.  On 20-FEB-2007, the patient was vaccinated intramuscularly, into the right deltoid, with a second 0.5 ml dose of
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who on 19-DEC-2006 was vaccinated with a first dose of Gardasil. On 20-FEB-2007, the patient was vaccinated IM, into the right deltoid, with a second 0.5 ml dose of Gardasil (lot #655849/0263U). There was no concomitant medication. On 20-FEB-2007, approximately 2 to 3 minutes after the vaccination, the patient fainted for 30 to 45 seconds. It was reported that the rescue squad was called because the patient developed leg numbness spreading to the shoulders after recovering from the fainting spell. It was reported that the numbness lasted from a few minutes. The patient was transported to the emergency room of a local hospital. At the emergency room, the patient had a second episode of syncope at 12:20 p.m. At the time of the report the patient was in the emergency room and had not recovered from the second event of syncope. 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 health professional concerning a 23 year old female with no known drug allergies who on 19-DEC-2006 was vaccinated with a first dose of GARDASIL.  On 20-FEB-2007, the patient was vaccinated intramuscularly, into the right deltoid, with a second 0.5 ml dose of
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Syncope
Clinical narrative: Information has been received from a health professional concerning a 23 year old female who on 19-DEC-2006 was vaccinated with a first dose of Gardasil. On 20-FEB-2007, the patient was vaccinated IM, into the right deltoid, with a second 0.5 ml dose of Gardasil (lot #655849/0263U). There was no concomitant medication. On 20-FEB-2007, approximately 2 to 3 minutes after the vaccination, the patient fainted for 30 to 45 seconds. It was reported that the rescue squad was called because the patient developed leg numbness spreading to the shoulders after recovering from the fainting spell. It was reported that the numbness lasted from a few minutes. The patient was transported to the emergency room of a local hospital. At the emergency room, the patient had a second episode of syncope at 12:20 p.m. At the time of the report the patient was in the emergency room and had not recovered from the second event of syncope. 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 health professional concerning a 23 year old female with no known drug allergies who on 19-DEC-2006 was vaccinated with a first dose of GARDASIL.  On 20-FEB-2007, the patient was vaccinated intramuscularly, into the right deltoid, with a second 0.5 ml dose of
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a 62-year-old male physician with hypertension, high cholesterol and an allergy to BACTRIM, who on 04-DEC-2006 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (Merck). Concomitant therapy included DIOVAN, CRESTOR, and EXCEDRIN (acetaminophen (+) caffeine) ). Two to three weeks after the vaccination he had 2 dermatones on his abdomen which were uncomfortable but went away. Approximately one week ago, on approximately 13-FEB-2007, the patient developed a full blown case of shingles that he described as "very painful". Medical attention was sought and the patient's internist placed him on therapy with VALTREX. At the time of this report the lesions were 7 days old and had crusted over though the patient had not recovered. No product quality compliant was involved. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a 62-year-old male physician with hypertension, high cholesterol and an allergy to BACTRIM, who on 04-DEC-2006 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (Merck). Concomitant therapy included DIOVAN, CRESTOR, and EXCEDRIN (acetaminophen (+) caffeine) ). Two to three weeks after the vaccination he had 2 dermatones on his abdomen which were uncomfortable but went away. Approximately one week ago, on approximately 13-FEB-2007, the patient developed a full blown case of shingles that he described as "very painful". Medical attention was sought and the patient's internist placed him on therapy with VALTREX. At the time of this report the lesions were 7 days old and had crusted over though the patient had not recovered. No product quality compliant was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Nausea, Syncope, Vomiting
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 15 year old female patient who at 2:00 pm on 19-FEB-2007 was vaccinated with the first dose of Gardasil. There was no illness at the time of vaccination.  On 20-FEB-2007, at 2:00 am (previously reported as "last night"), the patient experienced nausea, vomited one time, fainted for couple of seconds, and developed a fever of 100.7 degrees 12 hours after getting Gardasil. Subsequently, the patient felt okay in the a.m.   On follow up, the physician indicated that the patient did not require emergency room/doctor visit (previously reported as yes).  No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Nausea, Pyrexia, Syncope, Vomiting
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 15 year old female patient who at 2:00 pm on 19-FEB-2007 was vaccinated with the first dose of Gardasil. There was no illness at the time of vaccination.  On 20-FEB-2007, at 2:00 am (previously reported as "last night"), the patient experienced nausea, vomited one time, fainted for couple of seconds, and developed a fever of 100.7 degrees 12 hours after getting Gardasil. Subsequently, the patient felt okay in the a.m.   On follow up, the physician indicated that the patient did not require emergency room/doctor visit (previously reported as yes).  No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Herpes zoster, Pain, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 16 year old female patient with a possible allergy to AUGMENTIN who on 20-FEB-2007 was vaccinated with her second dose of Gardasil. She was seen at Urgent care on 22-FEB-2007, with a raised red tingling rash on her back, and side. The diagnosis was shingled. Patient was treated with VALTREX TID for a week. She had no adverse symptoms after the first dose of Gardasil. The patient was reported as not recovered at the time of this report. 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 Licensed Practical Nurse concerning a 16 year old female student with a possible allergy to AUGMENTIN who on 22-JAN-2007 was vaccinated with her first dose of GARDASIL.  Concomitant therapy included LO-OVRAL.  On 20-FEB-2007 she was vaccinated IM in right deltoid with her second dose of GARDASIL.  She was seen at Urgent care on 22-FEB-2007, with a raised red tingling rash on her back, and side.  The diagnosis was shingles.  It started with an itchy area that became a raised red rash, mostly on the left side of her back.  She had increased pain and tingling and went to walk-in.  The patient was treated with VALTREX TID for a week.  She had no adverse symptoms after the first dose of GARDASIL.  As of 26-FEB-2007 the patient was not recovered.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 16 year old female patient with a possible allergy to AUGMENTIN who on 20-FEB-2007 was vaccinated with her second dose of Gardasil. She was seen at Urgent care on 22-FEB-2007, with a raised red tingling rash on her back, and side. The diagnosis was shingled. Patient was treated with VALTREX TID for a week. She had no adverse symptoms after the first dose of Gardasil. The patient was reported as not recovered at the time of this report. 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 Licensed Practical Nurse concerning a 16 year old female student with a possible allergy to AUGMENTIN who on 22-JAN-2007 was vaccinated with her first dose of GARDASIL.  Concomitant therapy included LO-OVRAL.  On 20-FEB-2007 she was vaccinated IM in right deltoid with her second dose of GARDASIL.  She was seen at Urgent care on 22-FEB-2007, with a raised red tingling rash on her back, and side.  The diagnosis was shingles.  It started with an itchy area that became a raised red rash, mostly on the left side of her back.  She had increased pain and tingling and went to walk-in.  The patient was treated with VALTREX TID for a week.  She had no adverse symptoms after the first dose of GARDASIL.  As of 26-FEB-2007 the patient was not recovered.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster, No adverse effect, Paraesthesia
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 16 year old female patient with a possible allergy to AUGMENTIN who on 20-FEB-2007 was vaccinated with her second dose of Gardasil. She was seen at Urgent care on 22-FEB-2007, with a raised red tingling rash on her back, and side. The diagnosis was shingled. Patient was treated with VALTREX TID for a week. She had no adverse symptoms after the first dose of Gardasil. The patient was reported as not recovered at the time of this report. 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 Licensed Practical Nurse concerning a 16 year old female student with a possible allergy to AUGMENTIN who on 22-JAN-2007 was vaccinated with her first dose of GARDASIL.  Concomitant therapy included LO-OVRAL.  On 20-FEB-2007 she was vaccinated IM in right deltoid with her second dose of GARDASIL.  She was seen at Urgent care on 22-FEB-2007, with a raised red tingling rash on her back, and side.  The diagnosis was shingles.  It started with an itchy area that became a raised red rash, mostly on the left side of her back.  She had increased pain and tingling and went to walk-in.  The patient was treated with VALTREX TID for a week.  She had no adverse symptoms after the first dose of GARDASIL.  As of 26-FEB-2007 the patient was not recovered.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Rash vesicular, Varicella virus test positive, Viral test positive
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 68 year old female who on 16-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 17-FEB-2007 the patient didn't feel well and on 18-FEB-2007 she had pain. On 20-FEB-2007 the patient was seen by the physician and present with shingles. There was a rash on the left side and under the left breast. As of 21-FEB-2007 the patient was "fine" and was not in the hospital. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Pain, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 68 year old female who on 16-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 17-FEB-2007 the patient didn't feel well and on 18-FEB-2007 she had pain. On 20-FEB-2007 the patient was seen by the physician and present with shingles. There was a rash on the left side and under the left breast. As of 21-FEB-2007 the patient was "fine" and was not in the hospital. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Culture, Herpes zoster, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old male who on 14 Feb 2007 was vaccinated SC with dose of Zostavax (lot#656606/0033U). Concomitant therapy included Lasix, Coumadin, Celebres, and Clonazepam 0.5 mg. On 17 Feb 2007, the patient developed a rash on his back which was circular and was two to three inches wide. The patient was diagnosed with shingles and prescribed Valtrex and Vicodine. Additional information was received from a physician who reported that the patient's symptoms started on 21 Feb 2007 (originally reported as 17 Feb 2007) and lesions appeared on 22 Feb 2007. The patient was seen in the office on 26 Feb 2007. Samples of the lesions were obtained in a viral culture media and were sent to a laboratory. The patient told the physician that his ear, nose, and throat specialist ordered a sinus rinse of Trimcinolone and he had been taking that for about a month. A product quality complaint was not involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Skin lesion, Virus culture
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old male who on 14 Feb 2007 was vaccinated SC with dose of Zostavax (lot#656606/0033U). Concomitant therapy included Lasix, Coumadin, Celebres, and Clonazepam 0.5 mg. On 17 Feb 2007, the patient developed a rash on his back which was circular and was two to three inches wide. The patient was diagnosed with shingles and prescribed Valtrex and Vicodine. Additional information was received from a physician who reported that the patient's symptoms started on 21 Feb 2007 (originally reported as 17 Feb 2007) and lesions appeared on 22 Feb 2007. The patient was seen in the office on 26 Feb 2007. Samples of the lesions were obtained in a viral culture media and were sent to a laboratory. The patient told the physician that his ear, nose, and throat specialist ordered a sinus rinse of Trimcinolone and he had been taking that for about a month. A product quality complaint was not involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Fatigue, Headache, Muscular weakness, Myalgia, Vaccination complication
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of a seizure response to pertussis vaccine as an infant, who on 11-OCT-2006 was vaccinated with the first dose of Gardasil and on 22-JAN-2007 was vaccinated with the second dose of Gardasil. The mother reported that her daughter "had no adverse experiences" with that vaccination. Concomitant suspect therapy included influenza virus vaccine (unspecified), also administered on 22-JAN-2007. On 29-JAN-2007 the mother stated that her daughter experienced "severe systemic arthritic response," and further explained, "she woke up with severe joint pain, severe fatigue, headaches and a red, blotchy facial rash." The mother reported that her daughter had "multiple lab work" performed, however specific tests or results were not provided. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Antinuclear antibody negative, Arthralgia, Blood creatinine normal, Erythema, Fatigue
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of a seizure response to pertussis vaccine as an infant, who on 11-OCT-2006 was vaccinated with the first dose of Gardasil and on 22-JAN-2007 was vaccinated with the second dose of Gardasil. The mother reported that her daughter "had no adverse experiences" with that vaccination. Concomitant suspect therapy included influenza virus vaccine (unspecified), also administered on 22-JAN-2007. On 29-JAN-2007 the mother stated that her daughter experienced "severe systemic arthritic response," and further explained, "she woke up with severe joint pain, severe fatigue, headaches and a red, blotchy facial rash." The mother reported that her daughter had "multiple lab work" performed, however specific tests or results were not provided. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, HPV4, HPV4
Symptoms: Headache, Rash, Rash macular
Clinical narrative: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of a seizure response to pertussis vaccine as an infant, who on 11-OCT-2006 was vaccinated with the first dose of Gardasil and on 22-JAN-2007 was vaccinated with the second dose of Gardasil. The mother reported that her daughter "had no adverse experiences" with that vaccination. Concomitant suspect therapy included influenza virus vaccine (unspecified), also administered on 22-JAN-2007. On 29-JAN-2007 the mother stated that her daughter experienced "severe systemic arthritic response," and further explained, "she woke up with severe joint pain, severe fatigue, headaches and a red, blotchy facial rash." The mother reported that her daughter had "multiple lab work" performed, however specific tests or results were not provided. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a retired male physician with no known allergies and hypertension (also reported as no pertinent medical history) who on 08-JAN-2007 was vaccinated "intravascularly" in the right upper extremity with a single first dose of Zostavax (Merck) (lot # 652947/1411F). Concomitant vaccination included a first dose of ADACEL (Lot # C2531AA0) given IM in the right deltoid. Concomitant therapy included NORVASC. There was no illness at the time of vaccination. On 18-JAN-2007 (previously reported as six weeks post vaccination) the patient developed a rash over his entire bbody and when he scratched, the area scratched turned to hives. Upspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  Additional follow up information obtained from the nurse practitioner indicated that on an unspecified date the patient saw a dermatologist. The patient was prescribed MEDROL DOSEPAK and topical steroids. The patient was seen in the nurse practitioner's office on 26-FEB-2007 with a minimal macular rash, when the patient scratched he saw hives. There were no diagnostiv or lab tests performed. At the time of this visit the patient had partially recovered, some rash persisted. It was noted that after rash onset the patient was changed from therapy with NORVASC to lisinopril (manufacturer unknown) for an unspecified reason.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: TDAP, VARZOS, TDAP, VARZOS
Symptoms: Rash generalised, Rash macular, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a retired male physician with no known allergies and hypertension (also reported as no pertinent medical history) who on 08-JAN-2007 was vaccinated "intravascularly" in the right upper extremity with a single first dose of Zostavax (Merck) (lot # 652947/1411F). Concomitant vaccination included a first dose of ADACEL (Lot # C2531AA0) given IM in the right deltoid. Concomitant therapy included NORVASC. There was no illness at the time of vaccination. On 18-JAN-2007 (previously reported as six weeks post vaccination) the patient developed a rash over his entire bbody and when he scratched, the area scratched turned to hives. Upspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.  Additional follow up information obtained from the nurse practitioner indicated that on an unspecified date the patient saw a dermatologist. The patient was prescribed MEDROL DOSEPAK and topical steroids. The patient was seen in the nurse practitioner's office on 26-FEB-2007 with a minimal macular rash, when the patient scratched he saw hives. There were no diagnostiv or lab tests performed. At the time of this visit the patient had partially recovered, some rash persisted. It was noted that after rash onset the patient was changed from therapy with NORVASC to lisinopril (manufacturer unknown) for an unspecified reason.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC, VARZOS, VARZOS
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia, Rash erythematous, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 1 year old patient who on 23-FEB-2007 was inadvertently vaccinated with a dose of Zostavax (Merck) (lot # 656606/0033U) instead of Varivax (Merck). Unspecified medical attention was sought. At the time of the report no symptoms had been reported. It was reported that product confusion was ruled out and that this event occurred due to human error. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA, HIBV, MMR, PNC, VARZOS, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 1 year old patient who on 23-FEB-2007 was inadvertently vaccinated with a dose of Zostavax (Merck) (lot # 656606/0033U) instead of Varivax (Merck). Unspecified medical attention was sought. At the time of the report no symptoms had been reported. It was reported that product confusion was ruled out and that this event occurred due to human error. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 72 year old female with no known medical history who on 06-FEB-2007 was vaccinated with a dose of Zostavax (lot # 656608/0032U). There was no concomitant medication. Later on the day of vaccination. 06-FEB-2007, the patient developed little bumps above her left eye and a headache. The next morning she had red raised bumps from her left eyebrow into her hairline. She saw a dermatologist who diagnosed her with shingles. She also had a small red injection site reaction. She was treated with VALTREX and the patient's shingles improved. No laboratory tests were performed. As of 14-FEB-2007 the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a health professional concerning a 72 year old female with no known medical history who on 06-FEB-2007 was vaccinated with a dose of Zostavax (lot # 656608/0032U). There was no concomitant medication. Later on the day of vaccination. 06-FEB-2007, the patient developed little bumps above her left eye and a headache. The next morning she had red raised bumps from her left eyebrow into her hairline. She saw a dermatologist who diagnosed her with shingles. She also had a small red injection site reaction. She was treated with VALTREX and the patient's shingles improved. No laboratory tests were performed. As of 14-FEB-2007 the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Injection site erythema, Rash
Clinical narrative: Information has been received from a health professional concerning a 72 year old female with no known medical history who on 06-FEB-2007 was vaccinated with a dose of Zostavax (lot # 656608/0032U). There was no concomitant medication. Later on the day of vaccination. 06-FEB-2007, the patient developed little bumps above her left eye and a headache. The next morning she had red raised bumps from her left eyebrow into her hairline. She saw a dermatologist who diagnosed her with shingles. She also had a small red injection site reaction. She was treated with VALTREX and the patient's shingles improved. No laboratory tests were performed. As of 14-FEB-2007 the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 4-month-old female who on 28-FEB-2007 was vaccinated PO with the second dose of Rotateq (lot number not provided). The physician reported that on 01-MAR-2007, the patient was admitted to the hospital for intussusception requiring surgery. It was noted that surgery repaired the intussusception and the patient was discharged from the hospital. The physician also considered the intussusception to be an other important medical event as the patient required surgery. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 4-month-old female who on 28-FEB-2007 was vaccinated PO with the second dose of Rotateq (lot number not provided). The physician reported that on 01-MAR-2007, the patient was admitted to the hospital for intussusception requiring surgery. It was noted that surgery repaired the intussusception and the patient was discharged from the hospital. The physician also considered the intussusception to be an other important medical event as the patient required surgery. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site papule, Oedema peripheral, Tenderness
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: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site pain, Injection site papule
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.