chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after receiving multiple vaccines. Lasted one (1) minute regained consciousness. Reported to MD. No orders or treatments made. No injuries noted.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: On 5-6-10, 2" X 2" red rash at injection site, mild, swelling and warm to touch.  Low grade fever.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: On 5-6-10, 2" X 2" red rash at injection site, mild, swelling and warm to touch.  Low grade fever.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Heart rate decreased, Immediate post-injection reaction, Syncope
Clinical narrative: Fainted immediately after the shot.  HR dropped to 48/ min.  He gained consciousness after he went down.  He was later given juice (he had not had breakfast).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Returned to clinic with complaint of redness to injection site and dx with cellutlitis and vaccine reaction. Was started on cephalexin.
Age: 1.74
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Pt recieved vaccination on 26Mar10 and returned to clinic on 6April10 with c/o redness and swelling to injection site. Was dx with vaccine reaction and treated with cold compresses and home care.
Age: 4.0
Sex: F
Vaccine: PNC13
Clinical narrative: Given vaccination on 6May10 and on 8May10 mother brought child to Hospital ER for evaul.  Was admitted with cellulitis and d/c from hospital on 10May10.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Occurrence of localized raised urticaria on the right hand 15 minutes after the vaccines were given.
Age: 0.59
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Abdominal discomfort, Crying, Endocrine test, Hypopituitarism, Polydipsia
Clinical narrative: Polyuria, polydypsia, unconsolable crying, sensory integration problems, GI distress - Dx'ed with hypopituitarism.
Age: 0.59
Sex: M
Vaccine: HIBV, PNC, RV5
Symptoms: Polyuria, Sensory integrative dysfunction, Urine analysis
Clinical narrative: Polyuria, polydypsia, unconsolable crying, sensory integration problems, GI distress - Dx'ed with hypopituitarism.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Convulsion, Pallor, Paraesthesia, Posturing
Clinical narrative: Pt went pale then began to have a seizure.  No incontinence - decorticate posturing witnessed.  No change in HR but RR went to 4/min.  After approximately 5 minutes - patient awakened - a/o X4.  Pt c/o tingling in hands/feet.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Myositis
Clinical narrative: Muscle pain and weakness; Unable to bend knees, sit, or walk up stairs; MD diagnosed with Myositis on 5/11/10.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blood pressure increased, Blood test normal, Cardiac stress test normal, Chest discomfort, Chest pain
Clinical narrative: Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fatigue, Headache, Heart rate increased, Hypoaesthesia, Migraine
Clinical narrative: Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Muscle spasms, Nausea, Palpitations, Paraesthesia, Sleep apnoea syndrome
Clinical narrative: Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Throat tightness, Tremor, Urine analysis normal, Weight decreased
Clinical narrative: Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Aphasia, Dyspnoea, Fatigue, Flushing, Headache
Clinical narrative: Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Heart rate increased, Memory impairment, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Heart palpitations, chest and throat tightness, dull and sharp chest pain, Migraine headache, dizziness, feel like passing out, difficulty concentrating, hand and feet numbness and tingling, muscle cramping, extreme fatigue, naseous, difficulty breathing; feels like suffocating even though taking breaths (not getting oxygen), accelerated resting pulse and blood pressure (100+), sleep apnea, shaking (hands, legs, etc) loss of 25lbs since 02Apr10. Majority of symptoms come and go in waves; chest tightness and headache are constant.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: Initial report received on 05 May 2010 from an investigator participating in a study trial. A 22 year-old male subject received the following vaccines on 09 March 2009: ACAM2000 (lot number not reported); typhoid vaccine (manufacturer and lot number not reported); and anthrax vaccine (other manufacturer, lot number not reported). Ten days after vaccination the subject developed fatigue and severe chest pain described as "like someone was squeezing his heart". He was seen in the Emergency Room, and diagnosed with pericarditis and bronchospasm. Additional symptoms noted on the Emergency Room Report included: chills, productive cough with yellow sputum, rhinorrhea, and nasal congestion. the subject was treated with aspirin (324 mg), nitroglycerin (0.4 mg), Toradol (30 mg), albuterol (nebulizer 2.5 mg and inhaler 0.63 mg/mL), Atrovent (500 mcg and naproxen. The subject was discharged from the Emergency Room with instructions to follow-up with his healthcare provider. The subject had previously been seen for Visit 2 Follow-up on Day 8 and was asymptomatic and had a normal rapid Troponin level. On Day 9, results of the Troponin level sent to a central laboratory for testing were received at the study site and showed an elevation in the Troponin at 0.19 ng/mL (normal range is <=0.10). The subject returned to the site on Day 11 to have the Troponin repeated. At this follow-up visit, the subject was without chest pain but reported the symptoms he had experienced on Day 10 and his evaluation and treatment in the Emergency Room. The Troponin drawn on Day 11 was 0.33 and an electrocardiogram was reported as abnormal. The resolution date and final outcome are unknown as attempts to contact the subject have been unsuccessful. The investigator assessed the event of pericarditis as probably related to the study product. List of documents held by sender: Emergency Room Record, copy of electrocardiogram.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Bronchospasm, Chest pain, Chills, Electrocardiogram abnormal, Fatigue
Clinical narrative: Initial report received on 05 May 2010 from an investigator participating in a study trial. A 22 year-old male subject received the following vaccines on 09 March 2009: ACAM2000 (lot number not reported); typhoid vaccine (manufacturer and lot number not reported); and anthrax vaccine (other manufacturer, lot number not reported). Ten days after vaccination the subject developed fatigue and severe chest pain described as "like someone was squeezing his heart". He was seen in the Emergency Room, and diagnosed with pericarditis and bronchospasm. Additional symptoms noted on the Emergency Room Report included: chills, productive cough with yellow sputum, rhinorrhea, and nasal congestion. the subject was treated with aspirin (324 mg), nitroglycerin (0.4 mg), Toradol (30 mg), albuterol (nebulizer 2.5 mg and inhaler 0.63 mg/mL), Atrovent (500 mcg and naproxen. The subject was discharged from the Emergency Room with instructions to follow-up with his healthcare provider. The subject had previously been seen for Visit 2 Follow-up on Day 8 and was asymptomatic and had a normal rapid Troponin level. On Day 9, results of the Troponin level sent to a central laboratory for testing were received at the study site and showed an elevation in the Troponin at 0.19 ng/mL (normal range is <=0.10). The subject returned to the site on Day 11 to have the Troponin repeated. At this follow-up visit, the subject was without chest pain but reported the symptoms he had experienced on Day 10 and his evaluation and treatment in the Emergency Room. The Troponin drawn on Day 11 was 0.33 and an electrocardiogram was reported as abnormal. The resolution date and final outcome are unknown as attempts to contact the subject have been unsuccessful. The investigator assessed the event of pericarditis as probably related to the study product. List of documents held by sender: Emergency Room Record, copy of electrocardiogram.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Nasal congestion, Pericarditis, Productive cough, Rhinorrhoea, Sputum discoloured
Clinical narrative: Initial report received on 05 May 2010 from an investigator participating in a study trial. A 22 year-old male subject received the following vaccines on 09 March 2009: ACAM2000 (lot number not reported); typhoid vaccine (manufacturer and lot number not reported); and anthrax vaccine (other manufacturer, lot number not reported). Ten days after vaccination the subject developed fatigue and severe chest pain described as "like someone was squeezing his heart". He was seen in the Emergency Room, and diagnosed with pericarditis and bronchospasm. Additional symptoms noted on the Emergency Room Report included: chills, productive cough with yellow sputum, rhinorrhea, and nasal congestion. the subject was treated with aspirin (324 mg), nitroglycerin (0.4 mg), Toradol (30 mg), albuterol (nebulizer 2.5 mg and inhaler 0.63 mg/mL), Atrovent (500 mcg and naproxen. The subject was discharged from the Emergency Room with instructions to follow-up with his healthcare provider. The subject had previously been seen for Visit 2 Follow-up on Day 8 and was asymptomatic and had a normal rapid Troponin level. On Day 9, results of the Troponin level sent to a central laboratory for testing were received at the study site and showed an elevation in the Troponin at 0.19 ng/mL (normal range is <=0.10). The subject returned to the site on Day 11 to have the Troponin repeated. At this follow-up visit, the subject was without chest pain but reported the symptoms he had experienced on Day 10 and his evaluation and treatment in the Emergency Room. The Troponin drawn on Day 11 was 0.33 and an electrocardiogram was reported as abnormal. The resolution date and final outcome are unknown as attempts to contact the subject have been unsuccessful. The investigator assessed the event of pericarditis as probably related to the study product. List of documents held by sender: Emergency Room Record, copy of electrocardiogram.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Troponin increased
Clinical narrative: Initial report received on 05 May 2010 from an investigator participating in a study trial. A 22 year-old male subject received the following vaccines on 09 March 2009: ACAM2000 (lot number not reported); typhoid vaccine (manufacturer and lot number not reported); and anthrax vaccine (other manufacturer, lot number not reported). Ten days after vaccination the subject developed fatigue and severe chest pain described as "like someone was squeezing his heart". He was seen in the Emergency Room, and diagnosed with pericarditis and bronchospasm. Additional symptoms noted on the Emergency Room Report included: chills, productive cough with yellow sputum, rhinorrhea, and nasal congestion. the subject was treated with aspirin (324 mg), nitroglycerin (0.4 mg), Toradol (30 mg), albuterol (nebulizer 2.5 mg and inhaler 0.63 mg/mL), Atrovent (500 mcg and naproxen. The subject was discharged from the Emergency Room with instructions to follow-up with his healthcare provider. The subject had previously been seen for Visit 2 Follow-up on Day 8 and was asymptomatic and had a normal rapid Troponin level. On Day 9, results of the Troponin level sent to a central laboratory for testing were received at the study site and showed an elevation in the Troponin at 0.19 ng/mL (normal range is <=0.10). The subject returned to the site on Day 11 to have the Troponin repeated. At this follow-up visit, the subject was without chest pain but reported the symptoms he had experienced on Day 10 and his evaluation and treatment in the Emergency Room. The Troponin drawn on Day 11 was 0.33 and an electrocardiogram was reported as abnormal. The resolution date and final outcome are unknown as attempts to contact the subject have been unsuccessful. The investigator assessed the event of pericarditis as probably related to the study product. List of documents held by sender: Emergency Room Record, copy of electrocardiogram.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Bronchospasm, Chest pain, Chills, Fatigue, Nasal congestion
Clinical narrative: Initial report received on 05 May 2010 from an investigator participating in a study trial. A 22 year-old male subject received the following vaccines on 09 March 2009: ACAM2000 (lot number not reported); typhoid vaccine (manufacturer and lot number not reported); and anthrax vaccine (other manufacturer, lot number not reported). Ten days after vaccination the subject developed fatigue and severe chest pain described as "like someone was squeezing his heart". He was seen in the Emergency Room, and diagnosed with pericarditis and bronchospasm. Additional symptoms noted on the Emergency Room Report included: chills, productive cough with yellow sputum, rhinorrhea, and nasal congestion. the subject was treated with aspirin (324 mg), nitroglycerin (0.4 mg), Toradol (30 mg), albuterol (nebulizer 2.5 mg and inhaler 0.63 mg/mL), Atrovent (500 mcg and naproxen. The subject was discharged from the Emergency Room with instructions to follow-up with his healthcare provider. The subject had previously been seen for Visit 2 Follow-up on Day 8 and was asymptomatic and had a normal rapid Troponin level. On Day 9, results of the Troponin level sent to a central laboratory for testing were received at the study site and showed an elevation in the Troponin at 0.19 ng/mL (normal range is <=0.10). The subject returned to the site on Day 11 to have the Troponin repeated. At this follow-up visit, the subject was without chest pain but reported the symptoms he had experienced on Day 10 and his evaluation and treatment in the Emergency Room. The Troponin drawn on Day 11 was 0.33 and an electrocardiogram was reported as abnormal. The resolution date and final outcome are unknown as attempts to contact the subject have been unsuccessful. The investigator assessed the event of pericarditis as probably related to the study product. List of documents held by sender: Emergency Room Record, copy of electrocardiogram.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Pericarditis, Productive cough, Rhinorrhoea
Clinical narrative: Initial report received on 05 May 2010 from an investigator participating in a study trial. A 22 year-old male subject received the following vaccines on 09 March 2009: ACAM2000 (lot number not reported); typhoid vaccine (manufacturer and lot number not reported); and anthrax vaccine (other manufacturer, lot number not reported). Ten days after vaccination the subject developed fatigue and severe chest pain described as "like someone was squeezing his heart". He was seen in the Emergency Room, and diagnosed with pericarditis and bronchospasm. Additional symptoms noted on the Emergency Room Report included: chills, productive cough with yellow sputum, rhinorrhea, and nasal congestion. the subject was treated with aspirin (324 mg), nitroglycerin (0.4 mg), Toradol (30 mg), albuterol (nebulizer 2.5 mg and inhaler 0.63 mg/mL), Atrovent (500 mcg and naproxen. The subject was discharged from the Emergency Room with instructions to follow-up with his healthcare provider. The subject had previously been seen for Visit 2 Follow-up on Day 8 and was asymptomatic and had a normal rapid Troponin level. On Day 9, results of the Troponin level sent to a central laboratory for testing were received at the study site and showed an elevation in the Troponin at 0.19 ng/mL (normal range is <=0.10). The subject returned to the site on Day 11 to have the Troponin repeated. At this follow-up visit, the subject was without chest pain but reported the symptoms he had experienced on Day 10 and his evaluation and treatment in the Emergency Room. The Troponin drawn on Day 11 was 0.33 and an electrocardiogram was reported as abnormal. The resolution date and final outcome are unknown as attempts to contact the subject have been unsuccessful. The investigator assessed the event of pericarditis as probably related to the study product. List of documents held by sender: Emergency Room Record, copy of electrocardiogram.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator of a trial on 06 May 2010. A 31 year-old male subject with a medical history significant for elevated cholesterol was vaccinated with ACAM2000 on 10 September 2009. Fourteen days post-vaccination, the subject had an abnormal troponin I result (18.22) on 23 September 2009 and an abnormal electrocardiogram (results not provided) on 24 September 2009. An echocardiogram performed on 24 September 2009 was normal. The subject was diagnosed with non-specific myocarditis on 24 September 2009. No other information was provided. The outcome of the event was not reported. List of documents held by sender: None. Note: Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator of a trial on 06 May 2010. A 31 year-old male subject with a medical history significant for elevated cholesterol was vaccinated with ACAM2000 on 10 September 2009. Fourteen days post-vaccination, the subject had an abnormal troponin I result (18.22) on 23 September 2009 and an abnormal electrocardiogram (results not provided) on 24 September 2009. An echocardiogram performed on 24 September 2009 was normal. The subject was diagnosed with non-specific myocarditis on 24 September 2009. No other information was provided. The outcome of the event was not reported. List of documents held by sender: None. Note: Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Chest discomfort, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Hyperhidrosis, Laboratory test normal, Lymphadenopathy, Nausea, Troponin I
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Vaccination complication
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericardial disease, Troponin I
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Cardiac enzymes normal, Chest discomfort, Cough, Dyspnoea, Echocardiogram normal
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Electrocardiogram normal, Lymph node pain, Lymphadenopathy, Myopericarditis, Night sweats
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 26.0
Sex: F
Vaccine: SMALL, TD, SMALL, TTOX, ANTH, SMALL, TDAP, VARCEL, SMALL, TDAP, SMALL, TDAP
Symptoms: Orthopnoea
Clinical narrative: 27 y/o female with no PMH presents to Emergency Room for SOB and Orthopnea. 2 days after she had smallpox vaccination prior to deployment on the left arm. Patient notes of a painful supraclavicular lymph node enlargement on the left. Patient notes of occasional chest pressure and cough without any sputum production plus night sweat. Denies fever, chills, vomiting, iliicit drug use or recent travel.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Chills, Oedema peripheral, Pyrexia
Clinical narrative: Fever over 101 and chills, RIGHT ARM SWELLING/ SPREADING DOWN THE ARM. PT WAS DIAGNOSED WITH CELLULITIS AND PLACED ON CLINDAMYCIN (NO CULTURE S/S DATA). PT HAD RESIDUAL INFECTION POST COMPLETION OF ABX AND WAS TREATED WITH TA 2ND ROUND OF ABX. PT RECOVERY COMPLICATED BY PROLONGED DIARRHEA AND CDIFF.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Chills, Clostridium difficile colitis, Infection, Oedema peripheral
Clinical narrative: Fever over 101 and chills, RIGHT ARM SWELLING/ SPREADING DOWN THE ARM. PT WAS DIAGNOSED WITH CELLULITIS AND PLACED ON CLINDAMYCIN (NO CULTURE S/S DATA). PT HAD RESIDUAL INFECTION POST COMPLETION OF ABX AND WAS TREATED WITH TA 2ND ROUND OF ABX. PT RECOVERY COMPLICATED BY PROLONGED DIARRHEA AND CDIFF.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever over 101 and chills, RIGHT ARM SWELLING/ SPREADING DOWN THE ARM. PT WAS DIAGNOSED WITH CELLULITIS AND PLACED ON CLINDAMYCIN (NO CULTURE S/S DATA). PT HAD RESIDUAL INFECTION POST COMPLETION OF ABX AND WAS TREATED WITH TA 2ND ROUND OF ABX. PT RECOVERY COMPLICATED BY PROLONGED DIARRHEA AND CDIFF.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased activity, Diarrhoea, Irritability, Lethargy, Pallor
Clinical narrative: Information has been received from a physician concerning a 16 week female patient with no concurrent conditions or pertinent medical history, who on 02-MAR-2010 was vaccinated with the first dose of ROTATEQ (lot number 664882/1522Y) and on 03-MAY-2010 was vaccinated with the second dose of ROTATEQ (lot number 664946/0148Z) orally. Concomitant vaccine therapy included a dose of PENTACEL and a dose of PREVNAR 13 around 4:15 pm. Approximately 17:30 the patient became cranky and fussy. At 21:30 the patient had diarrhea, was vomiting and had lethargy. The patient was then taken to the emergency room (name, address and phone number unspecified) but the physician was not sure if they did any lab or diagnostic studies but the patient was given IV fluids (manufacturer unspecified) and steroids (manufacturer unspecified) patient was acidotic. The physician reported that the patient did leave the emergency room (name, address and phone number unspecified) and went home. Follow up information received by the medical assistant stated that per chart note, the mother said to have taken the patient on 03-MAY-2010 to the ER; there was anything else in the note about labs/diagnostics were performed or what treatment was given. As of 05-May-2010, the patient's mother reported that the baby was recovering. The medical assistant did not know if the events were disabling or life threatening. Upon internal review the treatment with steroids for the events of acidosis, lethargy, diarrhea, vomiting and irritability were considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 week female patient with no concurrent conditions or pertinent medical history, who on 02-MAR-2010 was vaccinated with the first dose of ROTATEQ (lot number 664882/1522Y) and on 03-MAY-2010 was vaccinated with the second dose of ROTATEQ (lot number 664946/0148Z) orally. Concomitant vaccine therapy included a dose of PENTACEL and a dose of PREVNAR 13 around 4:15 pm. Approximately 17:30 the patient became cranky and fussy. At 21:30 the patient had diarrhea, was vomiting and had lethargy. The patient was then taken to the emergency room (name, address and phone number unspecified) but the physician was not sure if they did any lab or diagnostic studies but the patient was given IV fluids (manufacturer unspecified) and steroids (manufacturer unspecified) patient was acidotic. The physician reported that the patient did leave the emergency room (name, address and phone number unspecified) and went home. Follow up information received by the medical assistant stated that per chart note, the mother said to have taken the patient on 03-MAY-2010 to the ER; there was anything else in the note about labs/diagnostics were performed or what treatment was given. As of 05-May-2010, the patient's mother reported that the baby was recovering. The medical assistant did not know if the events were disabling or life threatening. Upon internal review the treatment with steroids for the events of acidosis, lethargy, diarrhea, vomiting and irritability were considered to be an other important medical event. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Acidosis, Diarrhoea, Irritability, Lethargy, Vomiting
Clinical narrative: Information has been received from a physician concerning a 16 week female patient with no concurrent conditions or pertinent medical history, who on 02-MAR-2010 was vaccinated with the first dose of ROTATEQ (lot number 664882/1522Y) and on 03-MAY-2010 was vaccinated with the second dose of ROTATEQ (lot number 664946/0148Z) orally. Concomitant vaccine therapy included a dose of PENTACEL and a dose of PREVNAR 13 around 4:15 pm. Approximately 17:30 the patient became cranky and fussy. At 21:30 the patient had diarrhea, was vomiting and had lethargy. The patient was then taken to the emergency room (name, address and phone number unspecified) but the physician was not sure if they did any lab or diagnostic studies but the patient was given IV fluids (manufacturer unspecified) and steroids (manufacturer unspecified) patient was acidotic. The physician reported that the patient did leave the emergency room (name, address and phone number unspecified) and went home. Follow up information received by the medical assistant stated that per chart note, the mother said to have taken the patient on 03-MAY-2010 to the ER; there was anything else in the note about labs/diagnostics were performed or what treatment was given. As of 05-May-2010, the patient's mother reported that the baby was recovering. The medical assistant did not know if the events were disabling or life threatening. Upon internal review the treatment with steroids for the events of acidosis, lethargy, diarrhea, vomiting and irritability were considered to be an other important medical event. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Skin warm, Urticaria
Clinical narrative: Erythema, increase warmth, induration 4x7 cm.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Erythema, increase warmth, induration 4x7 cm.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood culture negative, Cellulitis, Oedema peripheral, Pain in extremity, Ultrasound scan
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old male with gastrooesophageal reflux disease, hormone replacement, skin condition and codeine allergy who "sometime last week", on approximately 24-APR-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included PREVACID, CARAFATE, ANDROGEL, VIAGRA and LAC-HYDRIN. "Sometime last week", on approximately 24-APR-2010 the patient experienced injection site swelling, with redness and discomfort. As result, the physician gave the patient acetaminophen (+) hydrocodone bitartrate 325/5mg, famotidine 20mg, ibuprofen 800mg and CLARITIN. At the time of the report, the patient was recovering from the events. The patient sought unspecified medical attention. The pharmacist considered that injection site swelling, with  redness and discomfort was an other important medical event. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old male with gastrooesophageal reflux disease, hormone replacement, skin condition and codeine allergy who "sometime last week", on approximately 24-APR-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included PREVACID, CARAFATE, ANDROGEL, VIAGRA and LAC-HYDRIN. "Sometime last week", on approximately 24-APR-2010 the patient experienced injection site swelling, with redness and discomfort. As result, the physician gave the patient acetaminophen (+) hydrocodone bitartrate 325/5mg, famotidine 20mg, ibuprofen 800mg and CLARITIN. At the time of the report, the patient was recovering from the events. The patient sought unspecified medical attention. The pharmacist considered that injection site swelling, with  redness and discomfort was an other important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying, Gait disturbance, Headache, Pyrexia
Clinical narrative: Uncontrollable crying, complaining that he can't move, headache, won't walk and fever of 101.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal pain, Abdominal rigidity, Abnormal behaviour, Crying, Decreased appetite
Clinical narrative: Information has been received from a physician concerning a 9 week old male patient with no pertinent medical history and no known drug allergies who on 29-JAN-2010 was vaccinated with the first dose of ROTATEQ (lot# 663842/0068Y, expiration date: 18-NOV-2010) orally. Concomitant therapy included PENTACEL, PREVNAR and multi-vitamins (unspecified). After the first dose of ROTATEQ, on 01-FEB-2010, the patient experienced loose bowel movements, behavioral change (became fussy) and his abdominal area was hard. The patient was better after treated with TYLENOL. On 27-APR-2010, the patient was vaccinated with the second dose of ROTATEQ (lot#: 664779/1439Y, expiration date: 02-APR-2011) orally. within 24 hours of receiving his second dose, the patient also experienced behavioral change, a decrease in appetite and a decrease in sleeping. On 29-APR-2010 the patient was very fussy and would just cry. He normally would eat 5 to 6 ounces of formula or breast milk per feeding but now the mother stated it was a struggle to get him to eat 2 ounces. On 30-APR-2010, the child refused to eat and would have screaming episodes. He was brought into the office and kept for an hour for observation. His abdomen was soft and there was no blood in his stool. The physician felt he was possibly experiencing abdominal cramps. He was afebrile. No laboratory test was performed. On 03-MAY-2010, the patient ate almost 5 ounces of formula again and he slept through the night. At the time of the report, the patient was recovering. Loose bowel movements, behavioral change (became fussy), his abdominal area was hard, abdominal cramps, decrease in appetite and decrease in sleeping were considered to be disabling. Follow-up information has been received from a receptionist who provided the patient's full name. She further stated that the physician had not talked to the baby's mother since 03-MAY-2010, so the current status was left at recovering. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea, Diet refusal, Insomnia, Irritability, Screaming
Clinical narrative: Information has been received from a physician concerning a 9 week old male patient with no pertinent medical history and no known drug allergies who on 29-JAN-2010 was vaccinated with the first dose of ROTATEQ (lot# 663842/0068Y, expiration date: 18-NOV-2010) orally. Concomitant therapy included PENTACEL, PREVNAR and multi-vitamins (unspecified). After the first dose of ROTATEQ, on 01-FEB-2010, the patient experienced loose bowel movements, behavioral change (became fussy) and his abdominal area was hard. The patient was better after treated with TYLENOL. On 27-APR-2010, the patient was vaccinated with the second dose of ROTATEQ (lot#: 664779/1439Y, expiration date: 02-APR-2011) orally. within 24 hours of receiving his second dose, the patient also experienced behavioral change, a decrease in appetite and a decrease in sleeping. On 29-APR-2010 the patient was very fussy and would just cry. He normally would eat 5 to 6 ounces of formula or breast milk per feeding but now the mother stated it was a struggle to get him to eat 2 ounces. On 30-APR-2010, the child refused to eat and would have screaming episodes. He was brought into the office and kept for an hour for observation. His abdomen was soft and there was no blood in his stool. The physician felt he was possibly experiencing abdominal cramps. He was afebrile. No laboratory test was performed. On 03-MAY-2010, the patient ate almost 5 ounces of formula again and he slept through the night. At the time of the report, the patient was recovering. Loose bowel movements, behavioral change (became fussy), his abdominal area was hard, abdominal cramps, decrease in appetite and decrease in sleeping were considered to be disabling. Follow-up information has been received from a receptionist who provided the patient's full name. She further stated that the physician had not talked to the baby's mother since 03-MAY-2010, so the current status was left at recovering. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Eye swelling
Clinical narrative: Trouble breathing-swollen around eyes. Went to medical center ER. Albuterol inhaler and epi-pen. Prednisone x 3 days.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Arrested labour, Biopsy cervix normal, Caesarean section, Cephalo-pelvic disproportion, Colposcopy
Clinical narrative: Information has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a 26 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL. On 09-SEP-2008 was vaccinated with a second dose of GARDASIL. The patient is pregnant. On 22-OCT-2008, an ultrasound was performed to the patient in order to determine estimated gestational age (EGA) and the results showed, intrauterine pregnancy (IUP) of 8 weeks (LMP was on approximately 27-AUG-2008 and estimated delivery date: 03-JUN-2009). The patient has not had previous pregnancies. In August 2008, a status post colposcopy showed a negative biopsy and negative for herpes simplex 2 (HSV2). Follow up information received from a physician indicated on 21-MAY-2009 at 40 weeks from her last menstrual period the patient gave birth to a normal male, who weighted 8 pounds and 7 ounces; his Apgar score was 8/9. During the labor the patient experienced maternal fever. Follow up information received from a health worker indicated that the patient had a normal pregnancy without complications and that the patient delivered a healthy male without congenital defects. Follow up information indicated that the patient had a C-section on 21-MAY-2009; the physician who delivered the patient's baby indicated that the patient had a "term pregnancy, arrest descent, fetal tachycardia and maternal fever"; it was also confirmed that the patient had cephalopelvic disproportion. It was also reported that on 22-JUN-2009 the patient had a follow appointment with the physician for an incision check and the patient had recovered. On 29-JUN-2009 the patient had a follow up visit with the physician. The patient was diagnosed with mastitis of the left breast. The reporter did not know if the patient recovered from mastitis. The patient had cancelled her follow up appointment scheduled for July 2009. Upon internal review, cesarean section due cephalopelvic disproportion was considered an other important medical event. The baby's experience has been captured in WAES # 0810USA04882B1. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Herpes simplex serology negative, Mastitis, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Information has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a 26 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL. On 09-SEP-2008 was vaccinated with a second dose of GARDASIL. The patient is pregnant. On 22-OCT-2008, an ultrasound was performed to the patient in order to determine estimated gestational age (EGA) and the results showed, intrauterine pregnancy (IUP) of 8 weeks (LMP was on approximately 27-AUG-2008 and estimated delivery date: 03-JUN-2009). The patient has not had previous pregnancies. In August 2008, a status post colposcopy showed a negative biopsy and negative for herpes simplex 2 (HSV2). Follow up information received from a physician indicated on 21-MAY-2009 at 40 weeks from her last menstrual period the patient gave birth to a normal male, who weighted 8 pounds and 7 ounces; his Apgar score was 8/9. During the labor the patient experienced maternal fever. Follow up information received from a health worker indicated that the patient had a normal pregnancy without complications and that the patient delivered a healthy male without congenital defects. Follow up information indicated that the patient had a C-section on 21-MAY-2009; the physician who delivered the patient's baby indicated that the patient had a "term pregnancy, arrest descent, fetal tachycardia and maternal fever"; it was also confirmed that the patient had cephalopelvic disproportion. It was also reported that on 22-JUN-2009 the patient had a follow appointment with the physician for an incision check and the patient had recovered. On 29-JUN-2009 the patient had a follow up visit with the physician. The patient was diagnosed with mastitis of the left breast. The reporter did not know if the patient recovered from mastitis. The patient had cancelled her follow up appointment scheduled for July 2009. Upon internal review, cesarean section due cephalopelvic disproportion was considered an other important medical event. The baby's experience has been captured in WAES # 0810USA04882B1. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash maculo-papular, Vomiting
Clinical narrative: Fever days # 1 & 2 after vaccine, days # 14 & 15 fever, vomiting, day 16 maculopapular rash.
Age: 72.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Allergic respiratory symptom, Chest pain, Dyspnoea, Erythema, Headache
Clinical narrative: Initial consumer report received on 03 May 2010: This polymedicated patient with medical history of hypertension was vaccinated with pandemic influenza virus vaccine and seasonal influenza virus vaccine (manufacturer and batch number unknown) on 30 Apr 2010. The patient presented with high blood pressure of 22/9 and headache on 01 may 2010. The patient experienced shortness of breath, pain in the chest and allergy in the chest (described as redness) on 03 May2010. Same day, the patient was admitted to the emergency room where the physician prescribed HIXIZINE (25 mg once daily). Outcome for headache, shortness of breath, pain in the chest and allergy in the chest was reported as complete recovery. No outcome was provided for high blood pressure.
Age: 72.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Hypersensitivity, Hypertension
Clinical narrative: Initial consumer report received on 03 May 2010: This polymedicated patient with medical history of hypertension was vaccinated with pandemic influenza virus vaccine and seasonal influenza virus vaccine (manufacturer and batch number unknown) on 30 Apr 2010. The patient presented with high blood pressure of 22/9 and headache on 01 may 2010. The patient experienced shortness of breath, pain in the chest and allergy in the chest (described as redness) on 03 May2010. Same day, the patient was admitted to the emergency room where the physician prescribed HIXIZINE (25 mg once daily). Outcome for headache, shortness of breath, pain in the chest and allergy in the chest was reported as complete recovery. No outcome was provided for high blood pressure.
Age: 41.0
Sex: M
Vaccine: ANTH, HEP, SMALL, TYP, ANTH, HEP, SMALL, TYP
Symptoms: Cardiomyopathy, Condition aggravated
Clinical narrative: This report was received from the investigator of a trial on 06 May 2010. A 41 year-old male subject received the following vaccines on 29 July 2009: ACAM2000 (lot number not reported); TYPHIM VI (Lot number not reported); anthrax vaccine (other manufacturer, lot number not reported); and hepatitis B vaccine (other manufacturer, lot number not reported). One day after vaccination, the subject was diagnosed with cardiomyopathy. No additional information was provided and the outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study). List of documents held by sender: None.