chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Echocardiogram, Echocardiogram abnormal, Electrocardiogram ST segment elevation
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 27-year-old male presented with sudden, new onset, sharp, severe left chest pain radiating to his left arm that woke him from sleep. Because the pain lasted for a few hours, he was seen by an on-staff physician and given ibuprofen, which temporarily relieved the chest pain. He continued to have intermittent chest pain throughout the day and was given at a local emergency department (ED) overnight. A 12-lead electrocardiogram (ECG) revealed sinus rhythm with diffuse ST segment elevations in most of the leads with a troponin of 4.87 ng/ml and creatinine kinase of 511 units/L. He had received ACAM2000 (lot number not reported) 2 weeks prior to presentation. Two days prior, he also was diagnosed with vaccination-site cellulitis and was started on BACTRIM, which was later switched to clindamycin. Thereafter, he developed a facial rash and recurrent chest pain, prompting him to visit the local ED. After myopericarditis was considered likely, the patient was transferred to another facility for further evaluation and treatments. The patient did not have any past cardiac problems. He was a nonsmoker and did not consume alcohol or reactional drugs. His family history was negative for cardiovascular diseases. Clinical examination revealed a facial rash, 1 cm-eschar at vaccination site with 0.75 cm-area of surrounding erythema without any active discharge that developed on left upper extremity 2 days post vaccination. He had regular heart sounds with a rub and no murmur. The rest of his clinical examination was unremarkable. The patient was seen by cardiology, who advised that he continued on ibuprofen for presumed myocarditis. He was started on "cephalexin" for arm cellulitis. A transthoracic echocardiogram obtained the following day revealed normal left ventricular size and function, absence of regional wall motion abnormalities, pericardial thickening, and a tiny posterior pericardial effusion. The patient was monitored for 2 days on telemetry floor, where he remained asymptomatic and had resolution of his electrocardiographic changes. He was discharged home with ibuprofen. He continued to stay asymptomatic with no activity limitations and had a normal echocardiogram (ECHO) at a 4-week cardiology clinic follow-up visit." The reporter for this case is the same as for case number 2012-00937. Documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Myocarditis, Myopericarditis, Pericardial effusion, Rash
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 27-year-old male presented with sudden, new onset, sharp, severe left chest pain radiating to his left arm that woke him from sleep. Because the pain lasted for a few hours, he was seen by an on-staff physician and given ibuprofen, which temporarily relieved the chest pain. He continued to have intermittent chest pain throughout the day and was given at a local emergency department (ED) overnight. A 12-lead electrocardiogram (ECG) revealed sinus rhythm with diffuse ST segment elevations in most of the leads with a troponin of 4.87 ng/ml and creatinine kinase of 511 units/L. He had received ACAM2000 (lot number not reported) 2 weeks prior to presentation. Two days prior, he also was diagnosed with vaccination-site cellulitis and was started on BACTRIM, which was later switched to clindamycin. Thereafter, he developed a facial rash and recurrent chest pain, prompting him to visit the local ED. After myopericarditis was considered likely, the patient was transferred to another facility for further evaluation and treatments. The patient did not have any past cardiac problems. He was a nonsmoker and did not consume alcohol or reactional drugs. His family history was negative for cardiovascular diseases. Clinical examination revealed a facial rash, 1 cm-eschar at vaccination site with 0.75 cm-area of surrounding erythema without any active discharge that developed on left upper extremity 2 days post vaccination. He had regular heart sounds with a rub and no murmur. The rest of his clinical examination was unremarkable. The patient was seen by cardiology, who advised that he continued on ibuprofen for presumed myocarditis. He was started on "cephalexin" for arm cellulitis. A transthoracic echocardiogram obtained the following day revealed normal left ventricular size and function, absence of regional wall motion abnormalities, pericardial thickening, and a tiny posterior pericardial effusion. The patient was monitored for 2 days on telemetry floor, where he remained asymptomatic and had resolution of his electrocardiographic changes. He was discharged home with ibuprofen. He continued to stay asymptomatic with no activity limitations and had a normal echocardiogram (ECHO) at a 4-week cardiology clinic follow-up visit." The reporter for this case is the same as for case number 2012-00937. Documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Sinus rhythm, Troponin increased, Vaccination site cellulitis, Vaccination site erythema, Vaccination site eschar
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 27-year-old male presented with sudden, new onset, sharp, severe left chest pain radiating to his left arm that woke him from sleep. Because the pain lasted for a few hours, he was seen by an on-staff physician and given ibuprofen, which temporarily relieved the chest pain. He continued to have intermittent chest pain throughout the day and was given at a local emergency department (ED) overnight. A 12-lead electrocardiogram (ECG) revealed sinus rhythm with diffuse ST segment elevations in most of the leads with a troponin of 4.87 ng/ml and creatinine kinase of 511 units/L. He had received ACAM2000 (lot number not reported) 2 weeks prior to presentation. Two days prior, he also was diagnosed with vaccination-site cellulitis and was started on BACTRIM, which was later switched to clindamycin. Thereafter, he developed a facial rash and recurrent chest pain, prompting him to visit the local ED. After myopericarditis was considered likely, the patient was transferred to another facility for further evaluation and treatments. The patient did not have any past cardiac problems. He was a nonsmoker and did not consume alcohol or reactional drugs. His family history was negative for cardiovascular diseases. Clinical examination revealed a facial rash, 1 cm-eschar at vaccination site with 0.75 cm-area of surrounding erythema without any active discharge that developed on left upper extremity 2 days post vaccination. He had regular heart sounds with a rub and no murmur. The rest of his clinical examination was unremarkable. The patient was seen by cardiology, who advised that he continued on ibuprofen for presumed myocarditis. He was started on "cephalexin" for arm cellulitis. A transthoracic echocardiogram obtained the following day revealed normal left ventricular size and function, absence of regional wall motion abnormalities, pericardial thickening, and a tiny posterior pericardial effusion. The patient was monitored for 2 days on telemetry floor, where he remained asymptomatic and had resolution of his electrocardiographic changes. He was discharged home with ibuprofen. He continued to stay asymptomatic with no activity limitations and had a normal echocardiogram (ECHO) at a 4-week cardiology clinic follow-up visit." The reporter for this case is the same as for case number 2012-00937. Documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging normal, Troponin I increased
Clinical narrative: This study case was received from the investigator (MILVAX) on 23 January 2012. A 36-year-old male subject received following vaccinations: ACAM2000 (lot number not reported) on 04 November 2011; ANTHRAX VACCINE (manufacturer and lot number not reported), HEPATITIS A VACCINE (manufacturer and lot number not reported) and HEPATITIS B VACCINE (manufacturer and lot number not reported) on 25 October 2011. The subject had no significant medical history. On 16 November 2011, the subject had an abnormal troponin I of 0.07. On 22 November 2011, the subject had a normal electrocardiogram (ECG). On 02 December 2011, the subject had a normal magnetic resonance imaging (MRI) of the heart. On 29 November 2011, the subject was diagnosed with myocarditis, unspecified. The outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Erythema annulare, Injection site macule, Injection site reaction
Clinical narrative: 1-27-2012 12 cm x 9 cm erythematous annular macular lesion (R) anterolateral thigh - site of MMR and KINRIX vaccines on 1-24-2012. Began 1-25-2012 (increased in size, worsened) 1-26-2012. No pruritic. Non-tender.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, Cervicobrachial syndrome, Full blood count normal, Injection site joint movement impairment, Injection site pain
Clinical narrative: Initial report was received from a health care professional on 03 November 2011. A 57-year-old female patient had received FLUZONE intramuscular injection in left deltoid, lot number UH477AD on 28 October 2011. On the same day, two to three hour after the vaccination the patient complaint of severe pain at the injection site and surrounding area, left shoulder pain that radiates down her arm and limited range of motion. The patient was seen in an urgent care center due to pain and was referred to a neurologist. No further information was available at the time of the report. The patient outcome was reported as not resolved/not recovered. Follow-up report was received from a healthcare professional on 30 January 2012. From new information received it was determined this case now meets seriousness criteria (other medically significant) and has been upgraded from non-serious to serious. The physician reported that the patient had no history of pain or injury prior to vaccination. The neurologist diagnosed the patient with cervical radiculopathy (C7), secondary to herniated disc. The patient received a complete blood count (CBC), erythrocyte sedimentation rate (ESR) and creatine kinase (CK) all satisfactory. The patient received corrective treatment, however it was not provided. The patient outcome was not reported. Documents held by sender: none.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Intervertebral disc protrusion, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Initial report was received from a health care professional on 03 November 2011. A 57-year-old female patient had received FLUZONE intramuscular injection in left deltoid, lot number UH477AD on 28 October 2011. On the same day, two to three hour after the vaccination the patient complaint of severe pain at the injection site and surrounding area, left shoulder pain that radiates down her arm and limited range of motion. The patient was seen in an urgent care center due to pain and was referred to a neurologist. No further information was available at the time of the report. The patient outcome was reported as not resolved/not recovered. Follow-up report was received from a healthcare professional on 30 January 2012. From new information received it was determined this case now meets seriousness criteria (other medically significant) and has been upgraded from non-serious to serious. The physician reported that the patient had no history of pain or injury prior to vaccination. The neurologist diagnosed the patient with cervical radiculopathy (C7), secondary to herniated disc. The patient received a complete blood count (CBC), erythrocyte sedimentation rate (ESR) and creatine kinase (CK) all satisfactory. The patient received corrective treatment, however it was not provided. The patient outcome was not reported. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: ANTH, FLUX, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease
Clinical narrative: This study case was received from the investigator (MILVAX) in a trial on 23 January 2012. A 27-year-old male subject received the following vaccinations on 03 November 2011: ACAM2000 (lot number not reported), INFLUENZA VACCINE (manufacturer and lot number not reported) and ANTHRAX VACCINE (manufacturer and lot number not reported). The subject had no significant medical history. On 18 November 2011, the subject had a normal electrocardiogram (ECG) and a normal echocardiogram. On 16 November 2011, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has redness, swelling, heat at varicella injection site. Does not have SOB, difficulty breathing/reaction is getting worse and has been present for 2-3 days. Referred to MD.
Age: 29.0
Sex: M
Vaccine: FLU3, HEPA, PPV
Symptoms: Injection site erythema, Injection site warmth, Local reaction, Pyrexia
Clinical narrative: Severe local rxn (L) deltoid (redness, warmth, fever) - Influenza & PNEUMOVAX given 1/25/12.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Oedema peripheral, Pain in extremity, Skin irritation
Clinical narrative: Left arm slightly swollen and pink. Her arm was very sore and the pink area was from the deltoid to the elbow. Arm doesn't appear infected, just irritated. Client has seen her PCP x 3 and started steroids for inflammation. Nurse called to check on client 2/3/12. Client feeling some better.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator (MILVAX) on 23 January 2012. A 20-year-old male subject received ACAM2000 (lot number not reported) on 07 November 2011. The subject had no significant medical history. On 21 November 2011, the subject had an abnormal troponin I of 1.74, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 21 November 2011, the subject was diagnosed with unspecified disease of pericardium. The outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Hives & swelling at arm at 5 days after vaccination. F/U 1/26 - still present, resolve with BENADRYL - recur later. F/U 1/31 - no hives since x 4d.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient called complaining of sore arm. (L) upper arm.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Acute myocardial infarction, Asthenia, Cardiac stress test normal, Cardiomyopathy, Catheterisation cardiac
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 41-year-old male visited a local emergency department (ED) with a 2-day history of weakness, reduced exercise tolerance, night sweats, and mid-sternal, nonradiating, nonexertional, dull chest pain. The patient had regular heart sounds without murmurs or rub and no signs of congestive heart failure. ECG revealed diffuse ST segment elevations with a Troponin of 18 ng/ml. He underwent emergent cardiac catheterization for presumed ST elevation myocardial infarction revealing minimal (nonsignificant) coronary artery disease. He had received a ACAM2000 (lot number not reported) 10 days earlier; it was suspected that his symptoms were related to smallpox vaccine-related myopericarditis. He was monitored on telemetry and started on indomethacin. An echocardiogram revealed normal left ventricular ejection fraction with thick pericardium consistent with pericarditis. A cardiac magnetic resonance imaging (MRI) scan revealed patchy diffuse mid-myocardial enhancement consistent with myocarditis. His clinical condition improved in a couple of days. However, he had improved but persistent ST-segment elevations and was discharged home on indomethacin. At a 4-week cardiology clinic visit, the patient had a normal ECG and a satisfactory stress test with improvement in pericardial thickening on echo cardiography. He subsequently returned to active duty." Documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Catheterisation cardiac abnormal, Chest pain, Coronary artery disease, Echocardiogram abnormal, Ejection fraction
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 41-year-old male visited a local emergency department (ED) with a 2-day history of weakness, reduced exercise tolerance, night sweats, and mid-sternal, nonradiating, nonexertional, dull chest pain. The patient had regular heart sounds without murmurs or rub and no signs of congestive heart failure. ECG revealed diffuse ST segment elevations with a Troponin of 18 ng/ml. He underwent emergent cardiac catheterization for presumed ST elevation myocardial infarction revealing minimal (nonsignificant) coronary artery disease. He had received a ACAM2000 (lot number not reported) 10 days earlier; it was suspected that his symptoms were related to smallpox vaccine-related myopericarditis. He was monitored on telemetry and started on indomethacin. An echocardiogram revealed normal left ventricular ejection fraction with thick pericardium consistent with pericarditis. A cardiac magnetic resonance imaging (MRI) scan revealed patchy diffuse mid-myocardial enhancement consistent with myocarditis. His clinical condition improved in a couple of days. However, he had improved but persistent ST-segment elevations and was discharged home on indomethacin. At a 4-week cardiology clinic visit, the patient had a normal ECG and a satisfactory stress test with improvement in pericardial thickening on echo cardiography. He subsequently returned to active duty." Documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Ejection fraction normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Exercise tolerance decreased, Myocarditis
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 41-year-old male visited a local emergency department (ED) with a 2-day history of weakness, reduced exercise tolerance, night sweats, and mid-sternal, nonradiating, nonexertional, dull chest pain. The patient had regular heart sounds without murmurs or rub and no signs of congestive heart failure. ECG revealed diffuse ST segment elevations with a Troponin of 18 ng/ml. He underwent emergent cardiac catheterization for presumed ST elevation myocardial infarction revealing minimal (nonsignificant) coronary artery disease. He had received a ACAM2000 (lot number not reported) 10 days earlier; it was suspected that his symptoms were related to smallpox vaccine-related myopericarditis. He was monitored on telemetry and started on indomethacin. An echocardiogram revealed normal left ventricular ejection fraction with thick pericardium consistent with pericarditis. A cardiac magnetic resonance imaging (MRI) scan revealed patchy diffuse mid-myocardial enhancement consistent with myocarditis. His clinical condition improved in a couple of days. However, he had improved but persistent ST-segment elevations and was discharged home on indomethacin. At a 4-week cardiology clinic visit, the patient had a normal ECG and a satisfactory stress test with improvement in pericardial thickening on echo cardiography. He subsequently returned to active duty." Documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Myopericarditis, Night sweats, Nuclear magnetic resonance imaging abnormal, Pericarditis, Troponin increased
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 41-year-old male visited a local emergency department (ED) with a 2-day history of weakness, reduced exercise tolerance, night sweats, and mid-sternal, nonradiating, nonexertional, dull chest pain. The patient had regular heart sounds without murmurs or rub and no signs of congestive heart failure. ECG revealed diffuse ST segment elevations with a Troponin of 18 ng/ml. He underwent emergent cardiac catheterization for presumed ST elevation myocardial infarction revealing minimal (nonsignificant) coronary artery disease. He had received a ACAM2000 (lot number not reported) 10 days earlier; it was suspected that his symptoms were related to smallpox vaccine-related myopericarditis. He was monitored on telemetry and started on indomethacin. An echocardiogram revealed normal left ventricular ejection fraction with thick pericardium consistent with pericarditis. A cardiac magnetic resonance imaging (MRI) scan revealed patchy diffuse mid-myocardial enhancement consistent with myocarditis. His clinical condition improved in a couple of days. However, he had improved but persistent ST-segment elevations and was discharged home on indomethacin. At a 4-week cardiology clinic visit, the patient had a normal ECG and a satisfactory stress test with improvement in pericardial thickening on echo cardiography. He subsequently returned to active duty." Documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: This case was retrieved via a search of the scientific literature on 23 January 2012. The following is verbatim from the article. "A 41-year-old male visited a local emergency department (ED) with a 2-day history of weakness, reduced exercise tolerance, night sweats, and mid-sternal, nonradiating, nonexertional, dull chest pain. The patient had regular heart sounds without murmurs or rub and no signs of congestive heart failure. ECG revealed diffuse ST segment elevations with a Troponin of 18 ng/ml. He underwent emergent cardiac catheterization for presumed ST elevation myocardial infarction revealing minimal (nonsignificant) coronary artery disease. He had received a ACAM2000 (lot number not reported) 10 days earlier; it was suspected that his symptoms were related to smallpox vaccine-related myopericarditis. He was monitored on telemetry and started on indomethacin. An echocardiogram revealed normal left ventricular ejection fraction with thick pericardium consistent with pericarditis. A cardiac magnetic resonance imaging (MRI) scan revealed patchy diffuse mid-myocardial enhancement consistent with myocarditis. His clinical condition improved in a couple of days. However, he had improved but persistent ST-segment elevations and was discharged home on indomethacin. At a 4-week cardiology clinic visit, the patient had a normal ECG and a satisfactory stress test with improvement in pericardial thickening on echo cardiography. He subsequently returned to active duty." Documents held by sender: None.
Sex: M
Vaccine: MEN
Symptoms: Eye disorder, Fall, Tremor
Clinical narrative: Initial report was received on 26 January 2012 from an electronic lay press article. A male patient (age and date of birth not specified) had received an injection of MENINGOCOCCAL VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later slumped over, his arms started shaking and his eyes got real big. The patient quickly recovered. The patient's medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Appendicitis
Clinical narrative: Initial case was retrieved from the scientific literature on 30 January 2012. An unidentified patient (gender, age and date of birth not reported) had received a 0.5 milliliter (mL) dose intramuscularly in the deltoid of FLUZONE, sanofi pasteur Inc., lot number U239AA (date of administration not reported) and one day after vaccination experienced acute appendicitis and was hospitalized for two days (dates not reported). The patient's outcome was not reported. Documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Biopsy skin abnormal, Breast cancer female, Chills, Erythema
Clinical narrative: Information has been received from a 72 year old female consumer reporting on herself with drug reactions to many pills who 10 years ago (in January 2002), was vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported) and six months ago (on approximately 24-JUL-2011), was vaccinated with another dose of PNEUMOVAX 23 (lot number, dose and route not reported). Secondary suspect therapy included a dose of diphtheria toxoid/tetanus toxoid (manufacturer unspecified) (lot number, dose and route not reported) administered on the same date (on approximately 24-JUL-2011). Concomitant medication included many unnamed medications. The consumer reported that in 2009 she had breast cancer treated with lumpectomy and radiation. The consumer reported that she had 4 weeks of radiation treatment for breast cancer, she took ABILIFY tablets and experienced a red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low and partial kidney failure. She was admitted to the hospital overnight and received intravenous fluids. The ABILIFY was discontinued. The consumer then resumed radiation for a total of 7 weeks. She was unable to tolerate anastrozole used for breast cancer, which caused her to feel "horrible and not feeling well". The consumer reported that 6 months ago (on approximately 24-JUL-2011), after receiving PNEUMOVAX 23 and diphtheria toxoid/tetanus toxoid (manufacturer unspecified) she experienced red arm in the arm that received PNEUMOVAX 23. She also developed a fever and chills. She was seen by a dermatologist and had a biopsy of her arm. The consumer stated that the biopsy showed it was probably a drug reaction. The outcome of red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low, partial kidney failure and "horrible and not feeling well" was unknown. At the time of the report the outcome for breast cancer was unknown and the patient had recovered from red arm, fever and chills. No further information is available.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Fluid intake reduced, Heart rate increased, Hypotension, Malaise
Clinical narrative: Information has been received from a 72 year old female consumer reporting on herself with drug reactions to many pills who 10 years ago (in January 2002), was vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported) and six months ago (on approximately 24-JUL-2011), was vaccinated with another dose of PNEUMOVAX 23 (lot number, dose and route not reported). Secondary suspect therapy included a dose of diphtheria toxoid/tetanus toxoid (manufacturer unspecified) (lot number, dose and route not reported) administered on the same date (on approximately 24-JUL-2011). Concomitant medication included many unnamed medications. The consumer reported that in 2009 she had breast cancer treated with lumpectomy and radiation. The consumer reported that she had 4 weeks of radiation treatment for breast cancer, she took ABILIFY tablets and experienced a red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low and partial kidney failure. She was admitted to the hospital overnight and received intravenous fluids. The ABILIFY was discontinued. The consumer then resumed radiation for a total of 7 weeks. She was unable to tolerate anastrozole used for breast cancer, which caused her to feel "horrible and not feeling well". The consumer reported that 6 months ago (on approximately 24-JUL-2011), after receiving PNEUMOVAX 23 and diphtheria toxoid/tetanus toxoid (manufacturer unspecified) she experienced red arm in the arm that received PNEUMOVAX 23. She also developed a fever and chills. She was seen by a dermatologist and had a biopsy of her arm. The consumer stated that the biopsy showed it was probably a drug reaction. The outcome of red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low, partial kidney failure and "horrible and not feeling well" was unknown. At the time of the report the outcome for breast cancer was unknown and the patient had recovered from red arm, fever and chills. No further information is available.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Malignant breast lump removal, Pyrexia, Radiotherapy, Renal failure, Vomiting
Clinical narrative: Information has been received from a 72 year old female consumer reporting on herself with drug reactions to many pills who 10 years ago (in January 2002), was vaccinated with a dose of PNEUMOVAX 23 (lot number, dose and route not reported) and six months ago (on approximately 24-JUL-2011), was vaccinated with another dose of PNEUMOVAX 23 (lot number, dose and route not reported). Secondary suspect therapy included a dose of diphtheria toxoid/tetanus toxoid (manufacturer unspecified) (lot number, dose and route not reported) administered on the same date (on approximately 24-JUL-2011). Concomitant medication included many unnamed medications. The consumer reported that in 2009 she had breast cancer treated with lumpectomy and radiation. The consumer reported that she had 4 weeks of radiation treatment for breast cancer, she took ABILIFY tablets and experienced a red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low and partial kidney failure. She was admitted to the hospital overnight and received intravenous fluids. The ABILIFY was discontinued. The consumer then resumed radiation for a total of 7 weeks. She was unable to tolerate anastrozole used for breast cancer, which caused her to feel "horrible and not feeling well". The consumer reported that 6 months ago (on approximately 24-JUL-2011), after receiving PNEUMOVAX 23 and diphtheria toxoid/tetanus toxoid (manufacturer unspecified) she experienced red arm in the arm that received PNEUMOVAX 23. She also developed a fever and chills. She was seen by a dermatologist and had a biopsy of her arm. The consumer stated that the biopsy showed it was probably a drug reaction. The outcome of red forehead, red legs and feet, felt like stomach was punched, was unable to drink fluids, vomiting, pulse elevated, blood pressure low, partial kidney failure and "horrible and not feeling well" was unknown. At the time of the report the outcome for breast cancer was unknown and the patient had recovered from red arm, fever and chills. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TDAP, VARCEL
Symptoms: Back pain, Injection site joint pain, Neck pain
Clinical narrative: States (L) arm sore in shoulder and along neck. Also states pain radiates down to lower back. No fever. No ROM impairment.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Oedema peripheral, Rash generalised, Rash pruritic, Swelling face
Clinical narrative: Itchy rash all over body, facial swelling & swelling of feet.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Erythema, Pruritus, Urticaria
Clinical narrative: Within 5-10 minutes of receiving vaccine, patient c/o red hands, itchy skin, ears/face red, hives on arm and leg. No wheezing, no swelling of throat, cough without SOB.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Liver function test abnormal, Pain in extremity, Skin burning sensation, Ultrasound liver
Clinical narrative: Development of shingles - arm intense pain & burning skin patches.
Age: 1.31
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site swelling
Clinical narrative: Patient had physical and IZ's on 1/27/12. He developed swelling at injection site. Patient given KEFLEX & applied warm compress. Sibling has similar reaction - same DTAP lot.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest discomfort, Condition aggravated, Dizziness, Gastrooesophageal reflux disease
Clinical narrative: Pt felt lightheaded & dizzy - increased BP - chest tightness, acid reflux like symptoms/ RN assessed/ family was called - son called MD - MD advised ER.
Age: 64.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1/23/12 2:11pm client called to report redness & swelling on back of (L) arm from injection site down to 2" above elbow. Area also hot & itchy. Onset date 1/20/12. Has used natural creams with improvement. Rec cont with cream & apply heat. 1/25/12 called client arm better - no redness/itching.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging brain, Scan with contrast
Clinical narrative: Seizure at home - called on-call physician and was instructed to call 911. Child was fever free at time of seizure per hospital report. Seizure/febrile 1-5-12 and 1-22-12 history.
Age: 83.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Injection site erythema
Clinical narrative: Right upper arm had redness down to the elbow-not warm to the touch. Patient denied pain or swelling. Took Acetaminophen 500mg q4h as needed.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pruritus, Nausea
Clinical narrative: Itching, red, hard at injection site. Patient also complained of headache and nausea.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Painful respiration, Rash erythematous
Clinical narrative: School Nurse called after flu clinic mid am today and student, (who received 2nd dose of Flumist about 30 minutes ago) came into clinic with red raised bumps to right face, neck, and back. He also complained that it hurt to take a deep breath. VS were normal and lungs clear no SOB. Student is in only 6yo and speaks very little English. (He had received his first dose of Flumist on 11/30/11 with no known problem or difficulties reported.) Gave Benadryl and called parent to pick up. RN (flu laison) returned to clinic and notified me at this point.  I called and Dr. was notified - she did not think it was from vaccine but student had not had any breakfast or bites etc. and had "no known Allergies" on his Emergency card at the school. Followed protocol for allergic reaction. Parent took student straight to MD. Parent called back after MD visit and said student was doing well and for parents to bring back if has any further problems. MD further recommended for student to receive flu vaccine next year somewhere he can be monitored for 24 hours. Completed incident report in HO (health office) checking off risk management. She is also adding possible allergy to H.O. Alerts and emergency card. I am also calling risk management. RN spoke with parent later that afternoon and child was "doing fine".
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: Localized pain/swelling @ injection site; chills, body and muscles aches, fever of 103.5 orally at highest 02/03/2012 @ 1am.  Warm pack applied intially, then cold pack applies x 2 days (on 02/03 - 02/04/2012).
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Simplex virus test positive, VIIth nerve paralysis
Clinical narrative: The patient's mother called stating the patient was diagnosed with Bell's palsy on 1/26/2012 and was treated with a course of prednisone.  The patient was not complaining of any problems at the time the vaccine was administered on 12/29/2011 but did subsequently have a positive blood test for HSV 1.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ammonia increased, Angiogram, Asthenia, Blood cortisol, Blood creatine phosphokinase
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood thyroid stimulating hormone, Central venous catheterisation, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Hepatic enzyme increased, Hypotension, Injection site erythema
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Intensive care, Lethargy, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Renal failure, Serum sickness, Skin warm
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ammonia increased, Asthenia, Erythema, Hepatic function abnormal, Hypotension
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Intensive care, Lethargy, Pain, Pyrexia
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Renal failure, Serum sickness
Clinical narrative: Left arm - noted severe pain, redness, warm to touch, feverish, weak and fatique - s/s presented - pt admitted to intensive care on 1-6-12.  Pt remained in hosp until 1-18-12. Dx - Serum Sickness, renal failure, lethargy, hypotension, increase liver and ammonia level secondary to Zoster vaccine. Pt continues to present with redness at site and weakness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site vesicles, Pruritus, Scab
Clinical narrative: Chicken pox blister appeared on my forehead and lasted for a week, a week later another blister formed at the injection site and lasted for a week. Yesterday, 2 months after the vaccine was administered, another blister formed on my neck. All three itched and became very red, then scabbed over the next day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Chicken pox blister appeared on my forehead and lasted for a week, a week later another blister formed at the injection site and lasted for a week. Yesterday, 2 months after the vaccine was administered, another blister formed on my neck. All three itched and became very red, then scabbed over the next day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient described mosquito bite type bumps starting in the arm near the injection site.  Then, rash migrated up through the shoulder and started hitting all over the trunk and legs.  Did not stay on one side like actual shingles typically does. Patient has resolution of itching symptoms but rash still persists at this time.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: 2/2/12 Given Td (L) deltoid IM. Started to get red, itchy, swollen arm 30-60 minutes after injection. Had called clinic 2/6/12 10am to inform of this event. Stated she forgot to tell nurse of latex allergy. Told to alternate hot/cold compresses to site. Use BENADRYL or hydrocortisone as needed for itching.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test, Pyrexia
Clinical narrative: Redness, swelling, pain left arm inj. site. Fever of 103 degrees since 2/3/12 - pt. is still hospitalized.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Oedema, Swelling
Clinical narrative: Edema and pain in armpit - starting 5 days after receiving booster. Hard to put arm completely down to side. ADVIL & ALEVE for discomfort. Significant swelling from edge of bra around to back.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Decreased appetite, Diarrhoea, Rash, Vomiting
Clinical narrative: Began vomiting that night, has had continued loss of appetite. Diarrhea and rash also reported. Mom reported 4-inch rash 2 inches below Kinrix site.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Arthralgia, Chills, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Chills, Full blood count, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Abscess, Activities of daily living impaired, Antibody test normal, Back pain, Bacterial test negative
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Blood culture negative, Chills, Coombs test negative, Dehydration, Dizziness
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Dizziness postural, Drug hypersensitivity, Dysphagia, Dyspnoea, Full blood count normal
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative, Nausea, Oropharyngeal pain
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Pain, Pain in extremity, Pharyngeal oedema, Pyrexia, Streptococcus test negative
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Throat irritation, Tremor
Clinical narrative: Symptoms began with injection site pain and redness and progressed to joint pain, redness, and progressed to entire body joint aches, vomiting, chills, shaking, fever.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Arthralgia, Chills, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Chills, Full blood count, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.
Age: 46.0
Sex: F
Vaccine: FLU3, HEP, FLUX, HEP, FLU3, HEP
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Day 1 L arm ache, fever/chills, nausea. Day 2 Fever/chills, body aches.  Day 3 L arm lymph node swollen/tender, pain begins to radiate throughout back. Day 4 fever/chills Pain continues to radiate throughout body. Day 5 fever/ chills worsening. Extreme pain in back L arm, neck/head and starting to radiate down legs. Day 6 fever/chills continuing with pain.