chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, DTAPHEPBIP, PPV, RV5, RV5
Symptoms: Agitation, Crying, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a consumer concerning his 28 day old daughter with no known allergies who was born prematurely after a gestation period of 33 weeks and 4 days who on 16-JUN-2008 was vaccinated orally with a "single dose" of ROTATEQ. Concomitant vaccinations on the same day included PEDVAX HIB, PNEUMOVAX 23, and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). Subsequently, on 16-JUN-2008 the patient experienced extreme agitation and crying. It was reported that the patient appeared to be in pain. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. The patient's twin sister (WAES # 0806USA03071) and twin brother (WAES # 0807USA01578) also had an adverse event after vaccination with ROTATEQ.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, DTAPHEPBIP, PPV, RV5, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 28 day triplet patient who on 16-JUN-2008 was vaccinated po with a 2.0 ml first dose of ROTATEQ. No adverse event was reported. It was reported that the patient sought medical attention at the office. A product quality complaint was not involved. This is one of several reports from the same source.  This is in follow-up to report(s) previously submitted on 7/15/2008. Follow-up information was received from a certified medical assistant who reported that the patient was in the clinic on 16-JUN-2008 for check-ups and due to computer error regarding their birthdate (listed as 19-MAR-2008 but actually 19-MAY-2008). It was presumed that the patient was 2 3/4 months and actually they were 28 days old. The patient received the 2 month vaccines by accident. No adverse reactions were reported to date. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAP, DTAPHEPBIP, PPV, RV5, RV5
Symptoms: Agitation, Crying, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 28 day triplet patient who on 16-JUN-2008 was vaccinated po with a 2.0 ml first dose of ROTATEQ. No adverse event was reported. It was reported that the patient sought medical attention at the office. A product quality complaint was not involved. This is one of several reports from the same source.  This is in follow-up to report(s) previously submitted on 7/15/2008. Follow-up information was received from a certified medical assistant who reported that the patient was in the clinic on 16-JUN-2008 for check-ups and due to computer error regarding their birthdate (listed as 19-MAR-2008 but actually 19-MAY-2008). It was presumed that the patient was 2 3/4 months and actually they were 28 days old. The patient received the 2 month vaccines by accident. No adverse reactions were reported to date. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Blood test, Fibroadenoma of breast, Surgery, Ultrasound breast
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no known allergies or pertinent medical history who on 13-APR-2007 was vaccinated with a first dose of GARDASIL. On 15-JUN-2007 was vaccinated with a second dose of GARDASIL. On 16-OCT-2007 was vaccinated with a third dose of GARDASIL. Concomitant therapy also given on 13-APR-2007 included meningococcal vaccine (unspecified) (manufacturer unknown) and hepatitis A virus vaccine (unspecified) (manufacturer unknown). Mother reported an adverse experience on her daughter. In March 2008, the patient experienced large breast tumor and had it removed on 10-APR-2008 on an outpatient basis. It was a fibroadenoma which measured 14 x 13 x 6 cm. Ultrasound was performed, no result was provided. At the time of the report the patient was not recovered. The patient sought medical attention, "yes physician". There was no product quality complaint. Additional information has been requested. Follow-up Information 02-JUL-2009: Initial tumor (breast) was removed. It is unknown if the Gardisil vaccine will result in additional breast tumors of any other tumors.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Fibroadenoma of breast, Surgery
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no known allergies or pertinent medical history who on 13-APR-2007 was vaccinated with a first dose of GARDASIL. On 15-JUN-2007 was vaccinated with a second dose of GARDASIL. On 16-OCT-2007 was vaccinated with a third dose of GARDASIL. Concomitant therapy also given on 13-APR-2007 included meningococcal vaccine (unspecified) (manufacturer unknown) and hepatitis A virus vaccine (unspecified) (manufacturer unknown). Mother reported an adverse experience on her daughter. In March 2008, the patient experienced large breast tumor and had it removed on 10-APR-2008 on an outpatient basis. It was a fibroadenoma which measured 14 x 13 x 6 cm. Ultrasound was performed, no result was provided. At the time of the report the patient was not recovered. The patient sought medical attention, "yes physician". There was no product quality complaint. Additional information has been requested. Follow-up Information 02-JUL-2009: Initial tumor (breast) was removed. It is unknown if the Gardisil vaccine will result in additional breast tumors of any other tumors.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Anxiety, Cardiac arrest, Cardioversion, Dyspnoea, Fibrin D dimer
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Loss of consciousness, Myocarditis, Ultrasound scan
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Body temperature increased, C-reactive protein increased, Cardiac arrest
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Chest X-ray normal, Chills, Computerised tomogram abnormal, Convulsion, Dyskinesia
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Dyspnoea, Echocardiogram abnormal, Ejection fraction, Fatigue, Feeling abnormal
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Fibrin D dimer increased, Heart rate decreased, Hyperhidrosis, Hypotonia, Influenza serology positive
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Loss of consciousness, Myocarditis, Pallor, Palpitations, Paraesthesia
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 30.0
Sex: M
Vaccine: SMALL, ANTH, HEP
Symptoms: Red blood cell sedimentation rate increased, Syncope, Troponin I increased, Ultrasound Doppler
Clinical narrative: Pt had primary SPV on 6/8/08 (of note the pt had labs done prior and fainted after the lab draw). Pt received AVA #3 and Hep B #2 on 6/7/08. On 6/17/08 pt had a temp of 102 for 12 hours. He also felt like his heart was racing and he had chills. All sx resolved after 12 hours without treatment. On 6/18/08 pt did not go to work due to fatigue. He was fatigued on 6/19/08 although less, so he returned to work. On 6/20/08 while riding in a car he felt "weird", his heart was racing and he had tingling in his arms. According to his friends the pt was pale, diaphoretic, fainted, had poss. seizure activity and then recovered. They took the pt to the ER where during an interview with the ER MD the pt who had a HR of 43, went asystolic, lost consciousness, agonal breathing, became flaccid and unconscious. CPR was started (for about 20 sec), pt had 15 sec of clinic jerking and resumed spontaneous respirations. HR was in the 40s; given atropine; within 30 sec he was alert and oriented. Pt was admitted and dx with myocarditis. Discharged on 6/22/08. Pt denied chest pain (except soreness from CPR). He c/o SOB with climbing stairs and fatigue. These ex resolved on 6/28/08. He saw the cardiologist for f/u on 7/1/08.
Age: 20.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rash generalised
Clinical narrative: Patient broke out with full-body rash nine days out from vaccine administration.  Member treated with antihistamines and methylprednisone.  As of today, member still has rash.  Diagnoses made with consults to dermatology.  Member currently deployed.
Age: 20.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Rash generalised
Clinical narrative: Patient broke out with full-body rash nine days out from vaccine administration.  Member treated with antihistamines and methylprednisone.  As of today, member still has rash.  Diagnoses made with consults to dermatology.  Member currently deployed.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Condition aggravated, Erythema, Periorbital oedema
Clinical narrative: Facial erythema, periorbital edema and flare of atopic dermatitis within one hour of vaccine admin.  Treated by Pediatrician with oral antihistamines and oral steroids.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Feeling of body temperature change, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Information has been received from a consumer concerning her granddaughter a 16 year old female patient with no allergies and a history of seizures who in approximately November 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number, route and site of administration not reported). In June 2008 the patient was vaccinated accidently with the fourth dose of GARDASIL vaccine (yeast) 0.5 ml (lot number, route and site of administration not reported) by nurse at office. Concomitant therapy included oxcarbazepine (TRILEPTAL) and therapy unspecified for birth control. On 19-JUN-2008 the patient experienced headaches, a feeling as if her muscles were heavy and hot and cold flash. The patient's headaches and a feeling as if her muscles are heavy and hot and cold flash persisted. The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her granddaughter a 16 year old female patient with no allergies and a history of seizures who in approximately November 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number, route and site of administration not reported). In June 2008 the patient was vaccinated accidently with the fourth dose of GARDASIL vaccine (yeast) 0.5 ml (lot number, route and site of administration not reported) by nurse at office. Concomitant therapy included oxcarbazepine (TRILEPTAL) and therapy unspecified for birth control. On 19-JUN-2008 the patient experienced headaches, a feeling as if her muscles were heavy and hot and cold flash. The patient's headaches and a feeling as if her muscles are heavy and hot and cold flash persisted. The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Feeling of body temperature change, Headache, Inappropriate schedule of drug administration, Sensation of heaviness
Clinical narrative: Information has been received from a consumer concerning her granddaughter a 16 year old female patient with no allergies and a history of seizures who in approximately November 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number, route and site of administration not reported). In June 2008 the patient was vaccinated accidently with the fourth dose of GARDASIL vaccine (yeast) 0.5 ml (lot number, route and site of administration not reported) by nurse at office. Concomitant therapy included oxcarbazepine (TRILEPTAL) and therapy unspecified for birth control. On 19-JUN-2008 the patient experienced headaches, a feeling as if her muscles were heavy and hot and cold flash. The patient's headaches and a feeling as if her muscles are heavy and hot and cold flash persisted. The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Decreased appetite, Feeling of body temperature change, Headache, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her granddaughter a 16 year old female patient with no allergies and a history of seizures who in approximately November 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot number, route and site of administration not reported). In June 2008 the patient was vaccinated accidently with the fourth dose of GARDASIL vaccine (yeast) 0.5 ml (lot number, route and site of administration not reported) by nurse at office. Concomitant therapy included oxcarbazepine (TRILEPTAL) and therapy unspecified for birth control. On 19-JUN-2008 the patient experienced headaches, a feeling as if her muscles were heavy and hot and cold flash. The patient's headaches and a feeling as if her muscles are heavy and hot and cold flash persisted. The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Feeling of body temperature change, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies reported who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 658560/1062U) 0.5 ml IM and was vaccinated with a second (lot# 658560/1062U) and a third dose (lot# 659055/1522U) of GARDASIL vaccine (yeast) 0.5 ml IM on unspecified days. On 19-JUN-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) (lot# 659964/1978U). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). The patient was experiencing headache, muscle heaviness, hot and cold flashes and a decrease in appetite. The patient sought medical attention by calling the physician. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a registered nurse, a physician and a patient's grandmother concerning a 16 year old female patient with acne, a 'mild herniation' (not further sepcified), sleep disturbance and behaviour issues no clear-cut diagnosis and temporal lobe epilepsy and with no known drug reaction/allergien who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# 658560/1062U) 0.5 ml IM. On 27-NOV-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (lot#658560/1062U) 0.5 ml IM. ON 20-FEB-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (lot# 659055/1522U) 0.5 ml IM. At 9:20 am on 19-JUN-2008 the patient was vaccinated accidentally with a fourth dose of GARDASIL vaccine (lot# 659964/1978U) in her left arm. There were no illnesses at the time of the vaccination. The patient and her grandmother realized the mistake at the time of the event when documetation of previous injections were checked. Concomitant therapy included ORTHO-CYCLEN and TRILEPTAL. The patient has gone to her job and called her grandmother reporting symptoms: the patient was experiencing a vague headache, muscle heaviness, hot and cold flashes and a decrease in appetite on the evening of the forth vaccination and her arm was still sore the next day. Two weeks before 30-JUL-2008, the patient's grandmother called the physician's office and stated that she was taking the patient to a family doctor for evaluation of on-going symptoms which she said started right after the patient received the last dose of GARDASIL vaccine. As of the end of July 2008, the patient ahd notbeen to the responsible physician's office since the date of the last vaccination on 19-JUN-2008. No testing or other treament or evaluation were done. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies reported who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 658560/1062U) 0.5 ml IM and was vaccinated with a second (lot# 658560/1062U) and a third dose (lot# 659055/1522U) of GARDASIL vaccine (yeast) 0.5 ml IM on unspecified days. On 19-JUN-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) (lot# 659964/1978U). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). The patient was experiencing headache, muscle heaviness, hot and cold flashes and a decrease in appetite. The patient sought medical attention by calling the physician. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a registered nurse, a physician and a patient's grandmother concerning a 16 year old female patient with acne, a 'mild herniation' (not further sepcified), sleep disturbance and behaviour issues no clear-cut diagnosis and temporal lobe epilepsy and with no known drug reaction/allergien who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# 658560/1062U) 0.5 ml IM. On 27-NOV-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (lot#658560/1062U) 0.5 ml IM. ON 20-FEB-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (lot# 659055/1522U) 0.5 ml IM. At 9:20 am on 19-JUN-2008 the patient was vaccinated accidentally with a fourth dose of GARDASIL vaccine (lot# 659964/1978U) in her left arm. There were no illnesses at the time of the vaccination. The patient and her grandmother realized the mistake at the time of the event when documetation of previous injections were checked. Concomitant therapy included ORTHO-CYCLEN and TRILEPTAL. The patient has gone to her job and called her grandmother reporting symptoms: the patient was experiencing a vague headache, muscle heaviness, hot and cold flashes and a decrease in appetite on the evening of the forth vaccination and her arm was still sore the next day. Two weeks before 30-JUL-2008, the patient's grandmother called the physician's office and stated that she was taking the patient to a family doctor for evaluation of on-going symptoms which she said started right after the patient received the last dose of GARDASIL vaccine. As of the end of July 2008, the patient ahd notbeen to the responsible physician's office since the date of the last vaccination on 19-JUN-2008. No testing or other treament or evaluation were done. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Feeling of body temperature change, Headache, Inappropriate schedule of drug administration, Sensation of heaviness
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies reported who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 658560/1062U) 0.5 ml IM and was vaccinated with a second (lot# 658560/1062U) and a third dose (lot# 659055/1522U) of GARDASIL vaccine (yeast) 0.5 ml IM on unspecified days. On 19-JUN-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) (lot# 659964/1978U). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). The patient was experiencing headache, muscle heaviness, hot and cold flashes and a decrease in appetite. The patient sought medical attention by calling the physician. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a registered nurse, a physician and a patient's grandmother concerning a 16 year old female patient with acne, a 'mild herniation' (not further sepcified), sleep disturbance and behaviour issues no clear-cut diagnosis and temporal lobe epilepsy and with no known drug reaction/allergien who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# 658560/1062U) 0.5 ml IM. On 27-NOV-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (lot#658560/1062U) 0.5 ml IM. ON 20-FEB-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (lot# 659055/1522U) 0.5 ml IM. At 9:20 am on 19-JUN-2008 the patient was vaccinated accidentally with a fourth dose of GARDASIL vaccine (lot# 659964/1978U) in her left arm. There were no illnesses at the time of the vaccination. The patient and her grandmother realized the mistake at the time of the event when documetation of previous injections were checked. Concomitant therapy included ORTHO-CYCLEN and TRILEPTAL. The patient has gone to her job and called her grandmother reporting symptoms: the patient was experiencing a vague headache, muscle heaviness, hot and cold flashes and a decrease in appetite on the evening of the forth vaccination and her arm was still sore the next day. Two weeks before 30-JUL-2008, the patient's grandmother called the physician's office and stated that she was taking the patient to a family doctor for evaluation of on-going symptoms which she said started right after the patient received the last dose of GARDASIL vaccine. As of the end of July 2008, the patient ahd notbeen to the responsible physician's office since the date of the last vaccination on 19-JUN-2008. No testing or other treament or evaluation were done. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Decreased appetite, Feeling of body temperature change, Headache, Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 16 year old female with no pertinent medical history or drug reactions/allergies reported who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 658560/1062U) 0.5 ml IM and was vaccinated with a second (lot# 658560/1062U) and a third dose (lot# 659055/1522U) of GARDASIL vaccine (yeast) 0.5 ml IM on unspecified days. On 19-JUN-2008 the patient was vaccinated with a fourth dose of GARDASIL vaccine (yeast) (lot# 659964/1978U). Concomitant therapy included ethinyl estradiol/norgestimate (ORTHO-CYCLEN). The patient was experiencing headache, muscle heaviness, hot and cold flashes and a decrease in appetite. The patient sought medical attention by calling the physician. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Information has been received from a registered nurse, a physician and a patient's grandmother concerning a 16 year old female patient with acne, a 'mild herniation' (not further sepcified), sleep disturbance and behaviour issues no clear-cut diagnosis and temporal lobe epilepsy and with no known drug reaction/allergien who on 21-SEP-2007 was vaccinated with a first dose of GARDASIL vaccine (lot# 658560/1062U) 0.5 ml IM. On 27-NOV-2007 the patient was vaccinated with a second dose of GARDASIL vaccine (lot#658560/1062U) 0.5 ml IM. ON 20-FEB-2008 the patient was vaccinated with a third dose of GARDASIL vaccine (lot# 659055/1522U) 0.5 ml IM. At 9:20 am on 19-JUN-2008 the patient was vaccinated accidentally with a fourth dose of GARDASIL vaccine (lot# 659964/1978U) in her left arm. There were no illnesses at the time of the vaccination. The patient and her grandmother realized the mistake at the time of the event when documetation of previous injections were checked. Concomitant therapy included ORTHO-CYCLEN and TRILEPTAL. The patient has gone to her job and called her grandmother reporting symptoms: the patient was experiencing a vague headache, muscle heaviness, hot and cold flashes and a decrease in appetite on the evening of the forth vaccination and her arm was still sore the next day. Two weeks before 30-JUL-2008, the patient's grandmother called the physician's office and stated that she was taking the patient to a family doctor for evaluation of on-going symptoms which she said started right after the patient received the last dose of GARDASIL vaccine. As of the end of July 2008, the patient ahd notbeen to the responsible physician's office since the date of the last vaccination on 19-JUN-2008. No testing or other treament or evaluation were done. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a third dose of GARDASIL IM.  One week after the third dose the patient experienced a seizure.  Subsequently, the patient recovered from the seizure.  Upon internal review, the seizure was considered to be an other important medical event.  Additional information has been requested. 12/31/08-records received for DOS 6/30/08-presented after sudden loss of consciousness with tonic and clonic movements and spontaneous resoltuion. C/O headache not present prior to event, right lateral neck pain present prior to event. Assessment:new onset seizure.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Cardiac monitoring, Confusional state, Convulsion, Electroencephalogram
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a third dose of GARDASIL IM.  One week after the third dose the patient experienced a seizure.  Subsequently, the patient recovered from the seizure.  Upon internal review, the seizure was considered to be an other important medical event.  Additional information has been requested. 12/31/08-records received for DOS 6/30/08-presented after sudden loss of consciousness with tonic and clonic movements and spontaneous resoltuion. C/O headache not present prior to event, right lateral neck pain present prior to event. Assessment:new onset seizure.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Heart rate increased, Hypertension, Inappropriate schedule of drug administration, Loss of consciousness, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a third dose of GARDASIL IM.  One week after the third dose the patient experienced a seizure.  Subsequently, the patient recovered from the seizure.  Upon internal review, the seizure was considered to be an other important medical event.  Additional information has been requested. 12/31/08-records received for DOS 6/30/08-presented after sudden loss of consciousness with tonic and clonic movements and spontaneous resoltuion. C/O headache not present prior to event, right lateral neck pain present prior to event. Assessment:new onset seizure.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test normal, Confusional state, Convulsion, Electroencephalogram normal, Heart rate increased
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a third dose of GARDASIL IM.  One week after the third dose the patient experienced a seizure.  Subsequently, the patient recovered from the seizure.  Upon internal review, the seizure was considered to be an other important medical event.  Additional information has been requested. 12/31/08-records received for DOS 6/30/08-presented after sudden loss of consciousness with tonic and clonic movements and spontaneous resoltuion. C/O headache not present prior to event, right lateral neck pain present prior to event. Assessment:new onset seizure.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Hypertension, Inappropriate schedule of drug administration, Loss of consciousness, Nuclear magnetic resonance imaging normal, Oxygen supplementation
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a third dose of GARDASIL IM.  One week after the third dose the patient experienced a seizure.  Subsequently, the patient recovered from the seizure.  Upon internal review, the seizure was considered to be an other important medical event.  Additional information has been requested. 12/31/08-records received for DOS 6/30/08-presented after sudden loss of consciousness with tonic and clonic movements and spontaneous resoltuion. C/O headache not present prior to event, right lateral neck pain present prior to event. Assessment:new onset seizure.
Sex: F
Vaccine: HPV4
Symptoms: Blindness
Clinical narrative: Information has been received from a physician assistant concerning a female, a patient's friend, who was vaccinated with GARDASIL in a different office and suffered blindness.  She recovered a little but still had the symptom.  Upon internal review the blindness was considered to be an other important medical event.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Partial seizures, Staring, Unresponsive to stimuli
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) concerning a 16 year old female patient who on 25-APR-2008 was vaccinated with a first dose of GARDASIL. The nurse reported that patient who was receiving the injection sat up staring ahead. She was not blinking in response to nurse's waving in front of her face. The nurse realized that the patient's arms were stiff. The nurse reported that patient experienced a "focal seizure". She called back and indicated that patient did have an focal seizure. Outcome was unknown. Upon internal review "focal seizure" was determined to be an other important medical event. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Optic neuropathy, Visual acuity reduced
Clinical narrative: Information has been received from a nurse practitioner concerning a 64 year old male with hypercholesterolaemia and chronic gingivitis and no allergies who on 19-JUN-2008 was vaccinated with ZOSTAVAX "1 vial" SC (lot #659760/0159X). Concomitant therapy included LIPITOR and doxycycline. On approximately 26-JUN-2008, one week after vaccination, the patient experienced optic neuropathy. The patient lost some of his vision. The patient was seeing an ophthalmologist. The patient's optic neuropathy was recovering. The patient's optic neuropathy was considered to be disabling. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Facial palsy
Clinical narrative: Initial report received on 09 July 2008 from a health care professional.  A 15-year-old male patient, who had no concurrent illnesses, pre-existing medical conditions or use of other medications, had received on 07 July 2008 in the morning a right arm dose of MENACTRA (Lot # U2562AA, route not provided), and a dose of DTAP (trade name, manufacturer name, lot #, route and site of administration not provided).  Overnight, the patient developed "facial symptoms" and was subsequently evaluated by a physician two days later and was diagnosed with facial Bell's Palsy.  It was not reported whether the patient received any treatment, or if any diagnostic tests were performed.  At the time of this report, the patient had not recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Blood test, Injection site pain, Injection site swelling
Clinical narrative: Initial information was received from a consumer (patient's mother) on 11 July 2008. A four year old female patient with no past medical history received a right deltoid injection of DAPTACEL (lot number C2953BA) and a right deltoid injection of IPOL (lot number A08362) on 03 July 2008 at 12:30 pm. The consumer reported that the patient received two other unknown vaccines on the same day in the left arm. On 05 July 2008, the patient experienced swelling and pain in the right arm. On 09 July 2008, the patient was sent to the ER by his physician. As a result, he was admitted overnight and was given antibiotics and MOTRIN. On 10 July 2008 the pain and swelling decreased and the patient was discharged. The patient recovered from the events. No other information was reported.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Death
Clinical narrative: Reported to office patient deceased. 9/22/08-autopsy report received-COD sudden unexpected infant death associated with inappropriate sleeping environment. Found dead while sleeping on an adult mattress on floor with pillows and blankets. Anatomical diagnosis:Thymic petechiae. Pulmonary edema. Cerebral edema. Medical intervention. Facial abrasions, mild and tongue contusion.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Skin warm
Clinical narrative: 11.5 x 13cm Local reaction noted: warm to touch but do not feel cellulitis noted by Dr.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Injection site swelling, Irritability
Clinical narrative: Prolonged crying - 6 hours; Extremely irritable; Local swelling at the site of 2 injections (right upper ant. thigh)
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Anxiety, Personality change, Speech disorder
Clinical narrative: Patient became very anxious after receiving shot. Change in speech pattern lasted several hours. No hives or rash. Unsure if personality change related to vaccine.
Age: 58.0
Sex: M
Vaccine: MMR, YF
Symptoms: Chest discomfort, Dyspnoea, Headache, Rash, Vomiting
Clinical narrative: Client received yellow fever vaccine #2 and MMR #2 on 6/16/08. Client had previously received a yellow fever vaccine approximately 10 years ago with no problems. MMR #1 was given 5/17/08 with no problems for patient. Client reported the following symptoms which started at 1600 on 6/17/08, no dizziness, HA, SOB/Chest tightness, H/V which started at 1700 to 1730, and non-prominent rash on chest only which started on 6/18/08 none in the morning. Client called to report the symptoms at 0900. Instructed client to call PMD now that he must be seen by a provider today for evaluation. Per client doctor, she believes symptoms were caused by vaccine, although this cannot be certain as client cancelled stress test appt.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation
Clinical narrative: Child's left leg became red and inflamed. Child was taken to ER.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: ADACEL given instead of DTaP.  Vaccine drawn up by one person, but given by another.  No adverse reaction reported.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Patient received shingles vaccine on 10/25/07. On approximately 04/22/08 identified recurrence of shingles rash. On 4/24/08 patient went to private physician for treatment of herpes rash - Famciclovir - herpes rash subsided 1st week of June. This is in follow-up to report (s) previously submitted on 9/24/2008. The patient recovered from shingles. The patient sought medica attention. The reporter did not express interest in the VZV analysis by PCR. No further information is available.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Cold sweat, Loss of consciousness, Muscle twitching
Clinical narrative: Pt became pale, clammy, unconscious, body twitching - head shaking, arm shaking, upper body shaking.  Pt regained consciousness but continued to remain pale, clammy, lips white, weak.  Moved to room.  Placed in supine position with leg elevated.  Juice & crackers given.  Mom refused ambulance.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pallor, Tremor
Clinical narrative: Pt became pale, clammy, unconscious, body twitching - head shaking, arm shaking, upper body shaking.  Pt regained consciousness but continued to remain pale, clammy, lips white, weak.  Moved to room.  Placed in supine position with leg elevated.  Juice & crackers given.  Mom refused ambulance.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Antiphospholipid antibodies negative, Arthralgia, Arthritis, Borrelia burgdorferi serology negative, Joint swelling
Clinical narrative: Pain in knees, swollen, painful. A week later called doctor and advised Advil and ordered blood work tested for lyme, lupus, rheumatoid arthritis and arthritis only positive for last. Early July went to new doctor prescribed doxycycline (4 weeks) for arthritis. On 7/15 doctor prescribed methotrexate but patient decided no to take it.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test abnormal, Rheumatoid factor negative
Clinical narrative: Pain in knees, swollen, painful. A week later called doctor and advised Advil and ordered blood work tested for lyme, lupus, rheumatoid arthritis and arthritis only positive for last. Early July went to new doctor prescribed doxycycline (4 weeks) for arthritis. On 7/15 doctor prescribed methotrexate but patient decided no to take it.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Hyperhidrosis, Presyncope, Syncope
Clinical narrative: Syncope + few seconds.  Diaphoresis.  Pale.  Remained presyncopal/dizzy for 2 hrs after.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Hypoaesthesia, Nausea, Vomiting
Clinical narrative: Numbness in face, hands, & abdomen, nausea, vomiting x4.
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Spots all over body - head to toe, fever.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Streptococcal identification test
Clinical narrative: Mother reports fever 103.9 within 12 hours of receiving VARICELLA and MMR vaccines.  Fever lasted 72 hours without other clear signs of infection.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness and swelling at R thigh after DTaP & varicella administered on 7/8/08.  Beginning to resolve.
Age: 1.98
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Rash, Skin swelling, Urticaria
Clinical narrative: Inj given in (R) thigh. Both arms from shoulder to wrist broke out in red puffy hive-like rash. Warm to touch. Similar reaction after Hep A #1 but was given with other vaccines at same time.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Hypervigilance, Nausea, Pallor, Presyncope
Clinical narrative: Became faint and nauseous after leaving office, returned pale and alert, improved with rest.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Child got DTaP, IPV in (R) arm on 7/9/08, then that evening became red and swollen. Improved 7/11/08 and prescribed Keflex for probable cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Pain, Rash erythematous, Skin warm, Swelling
Clinical narrative: Complained of arm pain, redness, swelling approximately 12h after vaccine, not itchy, no fevers, worsened during the day. Evaluated by MD at approximately 48 hours and very erythematous (L) Proximal arm, 16cm x 14cm erythematous region, increased warmth, improved by next day.
Age: 58.0
Sex: F
Vaccine: MMR, TD
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swelling, pain and lymph node enlargement of left axillary area the same night she received the shot.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient has golf ball sized soft swelling with erythema at site of Varicella injection.