chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Rash
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient experienced redness and soreness around the injection site and small shingles rash on his arm. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Antibody test negative, Blood culture negative, Full blood count, Mean platelet volume, Platelet count increased
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old female who on 02, Mar 2007 was vaccinated with the second dose of oral 2milliliters rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) Lot 654664/0726F). On 02, Mar 2007 the patient was also vaccinated with the second dose of HIB conj-hepatitis B vaccine (MSD, Lot # 653974/0198F). Other vaccinations included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal 4 6B 9V 14 18C 19F conj vaccine (CRM197) (PREVNAR). Concomitant therapy included amoxicillin, Illness at the time of vaccination included otitis media. On 03, Mar 2007, after vaccination with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine and HIB conj-hepatitis B vaccine the patient developed hives. The patient was evaluated in the emergency room and treated with topical diphenhydramine hydrochloride. The patient had a negative blood and throat culture, red blood cell count was 4.77, platelets were 568, segmented neutropils (polymorphonuclear leukocytes) were 52, and mean platelet volume was 6.3 (date not provided). The patient's hives persisted. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Red blood cell sedimentation rate increased, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old female who on 02, Mar 2007 was vaccinated with the second dose of oral 2milliliters rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) Lot 654664/0726F). On 02, Mar 2007 the patient was also vaccinated with the second dose of HIB conj-hepatitis B vaccine (MSD, Lot # 653974/0198F). Other vaccinations included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal 4 6B 9V 14 18C 19F conj vaccine (CRM197) (PREVNAR). Concomitant therapy included amoxicillin, Illness at the time of vaccination included otitis media. On 03, Mar 2007, after vaccination with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine and HIB conj-hepatitis B vaccine the patient developed hives. The patient was evaluated in the emergency room and treated with topical diphenhydramine hydrochloride. The patient had a negative blood and throat culture, red blood cell count was 4.77, platelets were 568, segmented neutropils (polymorphonuclear leukocytes) were 52, and mean platelet volume was 6.3 (date not provided). The patient's hives persisted. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Blood culture negative, Culture throat negative, Mean platelet volume decreased, Neutrophil percentage, Platelet count increased
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old female who on 02, Mar 2007 was vaccinated with the second dose of oral 2milliliters rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) Lot 654664/0726F). On 02, Mar 2007 the patient was also vaccinated with the second dose of HIB conj-hepatitis B vaccine (MSD, Lot # 653974/0198F). Other vaccinations included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal 4 6B 9V 14 18C 19F conj vaccine (CRM197) (PREVNAR). Concomitant therapy included amoxicillin, Illness at the time of vaccination included otitis media. On 03, Mar 2007, after vaccination with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine and HIB conj-hepatitis B vaccine the patient developed hives. The patient was evaluated in the emergency room and treated with topical diphenhydramine hydrochloride. The patient had a negative blood and throat culture, red blood cell count was 4.77, platelets were 568, segmented neutropils (polymorphonuclear leukocytes) were 52, and mean platelet volume was 6.3 (date not provided). The patient's hives persisted. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Red blood cell count normal, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 20 week old female who on 02, Mar 2007 was vaccinated with the second dose of oral 2milliliters rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) Lot 654664/0726F). On 02, Mar 2007 the patient was also vaccinated with the second dose of HIB conj-hepatitis B vaccine (MSD, Lot # 653974/0198F). Other vaccinations included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal 4 6B 9V 14 18C 19F conj vaccine (CRM197) (PREVNAR). Concomitant therapy included amoxicillin, Illness at the time of vaccination included otitis media. On 03, Mar 2007, after vaccination with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine and HIB conj-hepatitis B vaccine the patient developed hives. The patient was evaluated in the emergency room and treated with topical diphenhydramine hydrochloride. The patient had a negative blood and throat culture, red blood cell count was 4.77, platelets were 568, segmented neutropils (polymorphonuclear leukocytes) were 52, and mean platelet volume was 6.3 (date not provided). The patient's hives persisted. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Dizziness, Nausea
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 05-MAR-2007,was vaccinated with a first dose of Gardasil (yeast) with no relevant medical history or illness at the time of vaccination. Two weeks previous, on approximately 23-FEB-2007, the patient was vaccinated with a dose of MENACTRA and DTaP. the patient experienced abdominal pain three hours after vaccination with nausea and dizziness. The nausea and dizziness extended into the evening. The next day, the patient had nausea and dizziness but no more abdominal pain. The symptoms abated after 48 hours. The patient recovered on 07-Mar-2007. Subsequently, the patient experienced abdominal pain, nausea and dizziness. The nausea and dizziness extended into the evening. The next day, the patient had nausea and dizziness, but no more abdominal pain. At the time of this report, the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 28-FEB-2007 was vaccinated intramuscularly in the right deltoid with the second dose of Gardasil (Lot#656049/0187U). On 01-MAR-2007 the patient experienced injection site pain and pins and needle sensation in her right deltoid. The patient's injection site pain and pins and needle sensation in right deltoid persisted. The physician reported that the patient did not have any difficulties with the first dose of Gardasil, the date of the first vaccination was not reported. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 28-FEB-2007 was vaccinated intramuscularly in the right deltoid with the second dose of Gardasil (Lot#656049/0187U). On 01-MAR-2007 the patient experienced injection site pain and pins and needle sensation in her right deltoid. The patient's injection site pain and pins and needle sensation in right deltoid persisted. The physician reported that the patient did not have any difficulties with the first dose of Gardasil, the date of the first vaccination was not reported. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Chest discomfort, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no pertinent medical history who on 13, Mar 2007 was vaccinated, intramuscularly with a 0.5 ml first dose HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 655618/0186U) concomitantly with a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (ADACEL) into the other arm. On 13 Mar 2007, later in the evening, the patient developed "shooting pain down her arm and up into her neck." At bedtime, the patient had difficulty breathing and pain in her chest. Her mother took her to the emergency room where she had a chest x-ray. It was reported that there was no detection of wheezing, swelling or pulmonary embolism. She was treated with albuterol which " did not seem to help." As of 14, Mar 2007, the patient was improving her arm and chest were " just sore". Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no pertinent medical history who on 13, Mar 2007 was vaccinated, intramuscularly with a 0.5 ml first dose HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 655618/0186U) concomitantly with a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid (ADACEL) into the other arm. On 13 Mar 2007, later in the evening, the patient developed "shooting pain down her arm and up into her neck." At bedtime, the patient had difficulty breathing and pain in her chest. Her mother took her to the emergency room where she had a chest x-ray. It was reported that there was no detection of wheezing, swelling or pulmonary embolism. She was treated with albuterol which " did not seem to help." As of 14, Mar 2007, the patient was improving her arm and chest were " just sore". Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug hypersensitivity, Erythema, Erythema, Pruritus, Swelling
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 12-MAR-2007 was vaccinated with Gardasil (lot # not reported), 0.5 ml by injection. On 13-MAR-2007, the patient experienced redness of her neck and cheeks, face was a little puffy, and itchy almost like sunburn after receiving the second dose of Gardasil. Medical attention was sought. At the time of reporting, the outcome was unknown. No further information was available at the time of reporting. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling face, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 12-MAR-2007 was vaccinated with Gardasil (lot # not reported), 0.5 ml by injection. On 13-MAR-2007, the patient experienced redness of her neck and cheeks, face was a little puffy, and itchy almost like sunburn after receiving the second dose of Gardasil. Medical attention was sought. At the time of reporting, the outcome was unknown. No further information was available at the time of reporting. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 12-MAR-2007 was vaccinated with Gardasil (lot # not reported), 0.5 ml by injection. On 13-MAR-2007, the patient experienced redness of her neck and cheeks, face was a little puffy, and itchy almost like sunburn after receiving the second dose of Gardasil. Medical attention was sought. At the time of reporting, the outcome was unknown. No further information was available at the time of reporting. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blood test normal, Electrocardiogram normal, Hypoaesthesia, Mobility decreased
Clinical narrative: Information has been received from a physician concerning a 40 year old female patient who was vaccinated with a dose of Gardasil. The patient developed arthralgia in the opposite arm from the one in which the injection was administered and went to the Emergency Department at around 10:00 PM due to soreness, numbness in her right hand and pain/difficulty moving her right arm. She also had bilateral knee pain, especially with walking. On 20-MAR-2007 her electrocardiaogram (EKG) was normal, urine, complete blood cell count (CBC) and electrolytes were also normal. On 20-MAR-2007, she was discharged from the ER around 4:00AM with a diagnosis of arthalgia, and was given unspecified pain medication as treatment. The physician confirmaed the patient recovered on 26-MAR-2007. The physician also noted that he would not be continuing the vaccine series for the patient. No further information is expected.
Age: 47.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 40 year old female patient who was vaccinated with a dose of Gardasil. The patient developed arthralgia in the opposite arm from the one in which the injection was administered and went to the Emergency Department at around 10:00 PM due to soreness, numbness in her right hand and pain/difficulty moving her right arm. She also had bilateral knee pain, especially with walking. On 20-MAR-2007 her electrocardiaogram (EKG) was normal, urine, complete blood cell count (CBC) and electrolytes were also normal. On 20-MAR-2007, she was discharged from the ER around 4:00AM with a diagnosis of arthalgia, and was given unspecified pain medication as treatment. The physician confirmaed the patient recovered on 26-MAR-2007. The physician also noted that he would not be continuing the vaccine series for the patient. No further information is expected.
Age: 47.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Arthralgia, Blood electrolytes normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 40 year old female patient who was vaccinated with a dose of Gardasil. The patient developed arthralgia in the opposite arm from the one in which the injection was administered and went to the Emergency Department at around 10:00 PM due to soreness, numbness in her right hand and pain/difficulty moving her right arm. She also had bilateral knee pain, especially with walking. On 20-MAR-2007 her electrocardiaogram (EKG) was normal, urine, complete blood cell count (CBC) and electrolytes were also normal. On 20-MAR-2007, she was discharged from the ER around 4:00AM with a diagnosis of arthalgia, and was given unspecified pain medication as treatment. The physician confirmaed the patient recovered on 26-MAR-2007. The physician also noted that he would not be continuing the vaccine series for the patient. No further information is expected.
Age: 47.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Inappropriate schedule of drug administration, Medication error, Mobility decreased, Pain
Clinical narrative: Information has been received from a physician concerning a 40 year old female patient who was vaccinated with a dose of Gardasil. The patient developed arthralgia in the opposite arm from the one in which the injection was administered and went to the Emergency Department at around 10:00 PM due to soreness, numbness in her right hand and pain/difficulty moving her right arm. She also had bilateral knee pain, especially with walking. On 20-MAR-2007 her electrocardiaogram (EKG) was normal, urine, complete blood cell count (CBC) and electrolytes were also normal. On 20-MAR-2007, she was discharged from the ER around 4:00AM with a diagnosis of arthalgia, and was given unspecified pain medication as treatment. The physician confirmaed the patient recovered on 26-MAR-2007. The physician also noted that he would not be continuing the vaccine series for the patient. No further information is expected.
Age: 47.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Urine analysis normal
Clinical narrative: Information has been received from a physician concerning a 40 year old female patient who was vaccinated with a dose of Gardasil. The patient developed arthralgia in the opposite arm from the one in which the injection was administered and went to the Emergency Department at around 10:00 PM due to soreness, numbness in her right hand and pain/difficulty moving her right arm. She also had bilateral knee pain, especially with walking. On 20-MAR-2007 her electrocardiaogram (EKG) was normal, urine, complete blood cell count (CBC) and electrolytes were also normal. On 20-MAR-2007, she was discharged from the ER around 4:00AM with a diagnosis of arthalgia, and was given unspecified pain medication as treatment. The physician confirmaed the patient recovered on 26-MAR-2007. The physician also noted that he would not be continuing the vaccine series for the patient. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cough, Dyspnoea, Electrocardiogram normal, Heart rate increased, Middle insomnia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with Gardasil (Lot 654389/0961F). There was no concomitant medication. On 20-FEB-2007 the patient presented to the physician's office with shortness of breath and racing heart. Blood tests were performed (results unknown). The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram and Holter monitor (results unknown). Patient outcome was not reported. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot 654389/0961F), IM. There was no concomitant medication. On 20-FEB-2007, the patient presented to the physician's office with shortness of breath and racing heart since getting vaccinated. Completed blood cell count, chemistry profile and thyroid test were performed with results reported as normal. The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram, electrocardiogram and Holter monitor results reported as normal. It was reported that on 16-MAR-2007, the patient had missed five days of school and had experienced coughing, waking at night, night sweats and nausea. Patient outcome was not reported but it was reported that the patient was still tired a lot. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Night sweats, Tachycardia
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with Gardasil (Lot 654389/0961F). There was no concomitant medication. On 20-FEB-2007 the patient presented to the physician's office with shortness of breath and racing heart. Blood tests were performed (results unknown). The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram and Holter monitor (results unknown). Patient outcome was not reported. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot 654389/0961F), IM. There was no concomitant medication. On 20-FEB-2007, the patient presented to the physician's office with shortness of breath and racing heart since getting vaccinated. Completed blood cell count, chemistry profile and thyroid test were performed with results reported as normal. The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram, electrocardiogram and Holter monitor results reported as normal. It was reported that on 16-MAR-2007, the patient had missed five days of school and had experienced coughing, waking at night, night sweats and nausea. Patient outcome was not reported but it was reported that the patient was still tired a lot. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Cough, Dyspnoea, Echocardiogram normal, Electrocardiogram ambulatory abnormal
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with Gardasil (Lot 654389/0961F). There was no concomitant medication. On 20-FEB-2007 the patient presented to the physician's office with shortness of breath and racing heart. Blood tests were performed (results unknown). The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram and Holter monitor (results unknown). Patient outcome was not reported. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot 654389/0961F), IM. There was no concomitant medication. On 20-FEB-2007, the patient presented to the physician's office with shortness of breath and racing heart since getting vaccinated. Completed blood cell count, chemistry profile and thyroid test were performed with results reported as normal. The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram, electrocardiogram and Holter monitor results reported as normal. It was reported that on 16-MAR-2007, the patient had missed five days of school and had experienced coughing, waking at night, night sweats and nausea. Patient outcome was not reported but it was reported that the patient was still tired a lot. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram normal, Fatigue, Laboratory test normal, Nausea, Night sweats
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with Gardasil (Lot 654389/0961F). There was no concomitant medication. On 20-FEB-2007 the patient presented to the physician's office with shortness of breath and racing heart. Blood tests were performed (results unknown). The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram and Holter monitor (results unknown). Patient outcome was not reported. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot 654389/0961F), IM. There was no concomitant medication. On 20-FEB-2007, the patient presented to the physician's office with shortness of breath and racing heart since getting vaccinated. Completed blood cell count, chemistry profile and thyroid test were performed with results reported as normal. The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram, electrocardiogram and Holter monitor results reported as normal. It was reported that on 16-MAR-2007, the patient had missed five days of school and had experienced coughing, waking at night, night sweats and nausea. Patient outcome was not reported but it was reported that the patient was still tired a lot. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Palpitations, Poor quality sleep, Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with Gardasil (Lot 654389/0961F). There was no concomitant medication. On 20-FEB-2007 the patient presented to the physician's office with shortness of breath and racing heart. Blood tests were performed (results unknown). The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram and Holter monitor (results unknown). Patient outcome was not reported. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician concerning a 16 year old female who on 15-FEB-2007 was vaccinated with the first dose of GARDASIL (Lot 654389/0961F), IM. There was no concomitant medication. On 20-FEB-2007, the patient presented to the physician's office with shortness of breath and racing heart since getting vaccinated. Completed blood cell count, chemistry profile and thyroid test were performed with results reported as normal. The patient was referred to a cardiologist. On 16-MAR-2007, the cardiologist examined the patient and administered an echocardiogram, electrocardiogram and Holter monitor results reported as normal. It was reported that on 16-MAR-2007, the patient had missed five days of school and had experienced coughing, waking at night, night sweats and nausea. Patient outcome was not reported but it was reported that the patient was still tired a lot. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Hypotrichosis, Laboratory test, Lichen planus, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old male with benign prostatic hyperplasia, arteriosclerotic cardiovascular disease, osteopenia, trigeminal neuralgia, hyperlipidaemia, dyspepsia, hypertension, and allergies to candesartan cilexetil (ANTACAND), perindopril erbumine (ACEON). ramipril (ALTACE), trandolapril (MAVIK), pravastatin sodium (PRAVACHOL), and mirtazapine (REMERON) who on 14-DEC-2006, was vaccinated with an improperly stored dose of Zostavax (lot# 654604/1406F). Concomitant therapy included dutasteride (AVODART), aspirin, atorvasatin calcium (LIPITOR), zolpidem tartrate (AMBIEN) carbamazepine (TEGRETOL), sulfamethoxazole/trimethoprim (SEPTRA DS), sildenafil citrate (VIAGRA) and clobetasol propionate. The patient developed a non-veaicular rash on his back 10 days after receiving the vaccination. The patient was referred to a dermatologist who first diagnosed pityriasis rosea and then determined the diagnosis to be lichen planus. The patient was prescribed "Soriataine." The patient also had a decrease in facial hair. At the time of the report, the patient had  not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypotrichosis, Lichen planus, Medication error, Pityriasis rosea, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old male with benign prostatic hyperplasia, arteriosclerotic cardiovascular disease, osteopenia, trigeminal neuralgia, hyperlipidaemia, dyspepsia, hypertension, and allergies to candesartan cilexetil (ANTACAND), perindopril erbumine (ACEON). ramipril (ALTACE), trandolapril (MAVIK), pravastatin sodium (PRAVACHOL), and mirtazapine (REMERON) who on 14-DEC-2006, was vaccinated with an improperly stored dose of Zostavax (lot# 654604/1406F). Concomitant therapy included dutasteride (AVODART), aspirin, atorvasatin calcium (LIPITOR), zolpidem tartrate (AMBIEN) carbamazepine (TEGRETOL), sulfamethoxazole/trimethoprim (SEPTRA DS), sildenafil citrate (VIAGRA) and clobetasol propionate. The patient developed a non-veaicular rash on his back 10 days after receiving the vaccination. The patient was referred to a dermatologist who first diagnosed pityriasis rosea and then determined the diagnosis to be lichen planus. The patient was prescribed "Soriataine." The patient also had a decrease in facial hair. At the time of the report, the patient had  not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEP, MMR, VARZOS, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 08-MAR-2007 was vaccinated SC with 0.65 ml dose of Zostavax (lot#656609/0015U) instead of Varicella. It was reported one dose of Zostavax was ordered and just put in the freezer. Another nurse thought she was pulling out the varicella vaccine from the freezer and pulled out Zostavax instead. No adverse event was reported, the patient was "fine", he was playful and no rash or fever were noted. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEP, MMR, VARZOS, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 08-MAR-2007 was vaccinated SC with 0.65 ml dose of Zostavax (lot#656609/0015U) instead of Varicella. It was reported one dose of Zostavax was ordered and just put in the freezer. Another nurse thought she was pulling out the varicella vaccine from the freezer and pulled out Zostavax instead. No adverse event was reported, the patient was "fine", he was playful and no rash or fever were noted. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes simplex, Laboratory test, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18, year old female who on 13, Mar 2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 656049/0187U). Subsequently, on an unspecified date the patient developed a fever between 102 and 103.5 F, oral fever blisters and lymphadenopathy. The patient was seen in the emergency room and treated with doxycycline. At the time of this report the patient was recovering from the events. Additional information has been requested
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Body temperature increased, Lymphadenopathy, Oral herpes, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 18, year old female who on 13, Mar 2007 was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 656049/0187U). Subsequently, on an unspecified date the patient developed a fever between 102 and 103.5 F, oral fever blisters and lymphadenopathy. The patient was seen in the emergency room and treated with doxycycline. At the time of this report the patient was recovering from the events. Additional information has been requested
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 11-JAN-2007 was vaccinated with a dose of GARDASIL vaccine (lot# 655619/1427F). There was no concomitant medication. The nurse reported that on 11-JAN-2007, "about 3 hours after receiving the dose" the patient experienced shortness of breath and chest tightness. The nurse described the symptoms as the "chest got locked." The patient went to the emergency room and prescription drug treatment was given. Subsequently, the patient recovered from shortness of breath and chest tightness. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a nurse concerning a 16 year old female with penicillin allergy who on 11-JAN-2007, at 13:00 was vaccinated, intramuscularly, into the right deltoid, with a first dose of GARDASIL vaccine (lot# 655619/1427F). There was no concomitant medication. The nurse reported that on 11-JAN-2007, "about 3 hours after receiving the dose" the patient experienced shortness of breath and chest tightness. The nurse described the symptomsas the "chest got locked." Follow-up reported that at 23:30 the patient experience chest pain. At approximately 23:30, the patient went to the emergency room. It was reported that chest x-ray, electrocardiogram and plasma D-dimer were all "normal." The patient was given ADVIL but patient 's complaint was getting better before medication was given. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 11-JAN-2007 was vaccinated with a dose of GARDASIL vaccine (lot# 655619/1427F). There was no concomitant medication. The nurse reported that on 11-JAN-2007, "about 3 hours after receiving the dose" the patient experienced shortness of breath and chest tightness. The nurse described the symptoms as the "chest got locked." The patient went to the emergency room and prescription drug treatment was given. Subsequently, the patient recovered from shortness of breath and chest tightness. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a nurse concerning a 16 year old female with penicillin allergy who on 11-JAN-2007, at 13:00 was vaccinated, intramuscularly, into the right deltoid, with a first dose of GARDASIL vaccine (lot# 655619/1427F). There was no concomitant medication. The nurse reported that on 11-JAN-2007, "about 3 hours after receiving the dose" the patient experienced shortness of breath and chest tightness. The nurse described the symptomsas the "chest got locked." Follow-up reported that at 23:30 the patient experience chest pain. At approximately 23:30, the patient went to the emergency room. It was reported that chest x-ray, electrocardiogram and plasma D-dimer were all "normal." The patient was given ADVIL but patient 's complaint was getting better before medication was given. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fibrin D dimer normal
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 11-JAN-2007 was vaccinated with a dose of GARDASIL vaccine (lot# 655619/1427F). There was no concomitant medication. The nurse reported that on 11-JAN-2007, "about 3 hours after receiving the dose" the patient experienced shortness of breath and chest tightness. The nurse described the symptoms as the "chest got locked." The patient went to the emergency room and prescription drug treatment was given. Subsequently, the patient recovered from shortness of breath and chest tightness. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a nurse concerning a 16 year old female with penicillin allergy who on 11-JAN-2007, at 13:00 was vaccinated, intramuscularly, into the right deltoid, with a first dose of GARDASIL vaccine (lot# 655619/1427F). There was no concomitant medication. The nurse reported that on 11-JAN-2007, "about 3 hours after receiving the dose" the patient experienced shortness of breath and chest tightness. The nurse described the symptomsas the "chest got locked." Follow-up reported that at 23:30 the patient experience chest pain. At approximately 23:30, the patient went to the emergency room. It was reported that chest x-ray, electrocardiogram and plasma D-dimer were all "normal." The patient was given ADVIL but patient 's complaint was getting better before medication was given. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 02, Mar 2007 was vaccinated, first dose, HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 657006/0188U). On 02, Mar 2007 the patient experienced hive-like rash all over. The patient sought medical attention on 03, Mar 2007 and was prescribed diphenhydramine hydrochloride (BENADRYL) and corticosteriode. Subsequently, the patient recovered from hive-like rash all over. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning a 25 year old female who on 02, Mar 2007 was vaccinated, first dose, HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot# 657006/0188U). On 02, Mar 2007 the patient experienced hive-like rash all over. The patient sought medical attention on 03, Mar 2007 and was prescribed diphenhydramine hydrochloride (BENADRYL) and corticosteriode. Subsequently, the patient recovered from hive-like rash all over. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Condition aggravated, Juvenile arthritis, Varicella
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician via a company representative concerning a 15 year old female with juvenile rheumatoid arthritis (JRA) (diagnosed at age 7), from deficiency anaemia and an allergy to AMOXIL, which caused hives, who on 06-MAR-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included BENADRYL, DELSYM, CLARITIN-D. On approximately 07-Mar-2007 ("over a six day period after vaccination") the patient felt weird and experienced painful, swelling in her wrist joints and she had a low grade fever. Over the weekend, her symptoms worsened. The patient's fever was much higher and had hives like bumps on most of her body. She was congested, had a bad headache and vomited a couple times. On 12-MAR-2007 the patient was seen by her physician; on examination, her skin had numerous papules scattered on her thorax, some on her extremities (some are actually vesicular); extremities: the wrist and finger joints were not swollen and had good range of motion. Subsequently, on 12-MAR-2007, the patient recovered from the painful swelling in her wrist joints and hives dissipated. The patient felt that her experiences were related to her JRA (she stated that she used to get a red rash). The patient sought unspecified medical attention. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Blister, Feeling abnormal, Headache, Joint swelling
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician via a company representative concerning a 15 year old female with juvenile rheumatoid arthritis (JRA) (diagnosed at age 7), from deficiency anaemia and an allergy to AMOXIL, which caused hives, who on 06-MAR-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included BENADRYL, DELSYM, CLARITIN-D. On approximately 07-Mar-2007 ("over a six day period after vaccination") the patient felt weird and experienced painful, swelling in her wrist joints and she had a low grade fever. Over the weekend, her symptoms worsened. The patient's fever was much higher and had hives like bumps on most of her body. She was congested, had a bad headache and vomited a couple times. On 12-MAR-2007 the patient was seen by her physician; on examination, her skin had numerous papules scattered on her thorax, some on her extremities (some are actually vesicular); extremities: the wrist and finger joints were not swollen and had good range of motion. Subsequently, on 12-MAR-2007, the patient recovered from the painful swelling in her wrist joints and hives dissipated. The patient felt that her experiences were related to her JRA (she stated that she used to get a red rash). The patient sought unspecified medical attention. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash papular, Respiratory tract congestion, Urticaria, Vomiting
Clinical narrative: This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a physician via a company representative concerning a 15 year old female with juvenile rheumatoid arthritis (JRA) (diagnosed at age 7), from deficiency anaemia and an allergy to AMOXIL, which caused hives, who on 06-MAR-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included BENADRYL, DELSYM, CLARITIN-D. On approximately 07-Mar-2007 ("over a six day period after vaccination") the patient felt weird and experienced painful, swelling in her wrist joints and she had a low grade fever. Over the weekend, her symptoms worsened. The patient's fever was much higher and had hives like bumps on most of her body. She was congested, had a bad headache and vomited a couple times. On 12-MAR-2007 the patient was seen by her physician; on examination, her skin had numerous papules scattered on her thorax, some on her extremities (some are actually vesicular); extremities: the wrist and finger joints were not swollen and had good range of motion. Subsequently, on 12-MAR-2007, the patient recovered from the painful swelling in her wrist joints and hives dissipated. The patient felt that her experiences were related to her JRA (she stated that she used to get a red rash). The patient sought unspecified medical attention. No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician and a licensed practical nurse (LPN) concerning an 17-week-old female who on 01-FEB-2007 was vaccinated PO with the second dose of Rotateq (Lot #655153/0847F). Concomitant vaccinations administered on that same day included a dose of Comvax, a dose of Dtap, a dose of Poliovirus vaccine (unspecified) and a dose of PREVNAR. It was reported that on 01-FEB-2007, the patient developed diarrhea. On 19-FEB-2007, the patient was seen in the physician's office. The physician indicated that the patient was put on a BRAT diet and their formula was changed. Stool samples were negative for all including rotavirus. On 05-MAR-2007, five weeks after onset, the patient's diarrhea resolved. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Rotavirus test negative, Stool analysis normal
Clinical narrative: Information has been received from a physician and a licensed practical nurse (LPN) concerning an 17-week-old female who on 01-FEB-2007 was vaccinated PO with the second dose of Rotateq (Lot #655153/0847F). Concomitant vaccinations administered on that same day included a dose of Comvax, a dose of Dtap, a dose of Poliovirus vaccine (unspecified) and a dose of PREVNAR. It was reported that on 01-FEB-2007, the patient developed diarrhea. On 19-FEB-2007, the patient was seen in the physician's office. The physician indicated that the patient was put on a BRAT diet and their formula was changed. Stool samples were negative for all including rotavirus. On 05-MAR-2007, five weeks after onset, the patient's diarrhea resolved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a registered nurse concerning a 23 year old female who on 09-FEB-2007 was vaccinated with Gardasil (yeast). On approximately 16-FEB-2007 the patient presented with rectal warts. The patient's rectal warts persisted as of 16-MAR-2007. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 4/13/2007, 7/6/2007.  Follow up information indicated that the patient expressed a desire to continue therapy with GARDASIL, though at the time of this report, she had not yet received the second dose.  The nurse reported the patient was "132 days late" for the second dose. No further information is expected. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a physician and nurse concerning a 23 year old female who at 10:30 am, on 09-Feb-2007 was vaccinated IM in the arm wutg the first dose of GARDASIL (Lot # 65617/1447F). The nurse reported that on 12-Mar-2007, the patient called the office to report that on approximately 16-Feb-2007 "within one week" of vaccination (also reported by the physician as onset of 01-Mar-2007), she had developed rectal warts. The physician reported the patietn was examined and was diagnosed with an outbreak of conyloma in the peri-rectal arae. At the time of this report. It was unknown if the condyloma had resolved. No further information is expected.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of lymphoma who on 07-MAR-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot# 654604/1406F). Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS) and atemolol. On 09-MAR-2007, the patient experienced a headache. On 11-MAR-2007, the patient experienced rash. On 12-MAR-2007, the patient presented with shingles and a bad headache. The shingles were on his left side of the trunk. The patient was treated with famciclovir (Famvir). As of 12-MAR-2007 the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 64 year old male with a history of lymphoma who on 07-MAR-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (lot# 654604/1406F). Concomitant therapy included amphetamine aspartate/amphetamineSO4/dex (ADDERALL TABLETS) and atemolol. On 09-MAR-2007, the patient experienced a headache. On 11-MAR-2007, the patient experienced rash. On 12-MAR-2007, the patient presented with shingles and a bad headache. The shingles were on his left side of the trunk. The patient was treated with famciclovir (Famvir). As of 12-MAR-2007 the patient had not recovered. No product quality complaint was involved. Additional information has been requested.