chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myopericarditis, Nuclear magnetic resonance imaging
Clinical narrative: This study case was received from the investigator on 19 August 2011. An 18-year-old male subject on 31 March 2011 received the following vaccinations: an injection of ACAM2000 (lot number not reported) and dose 2 of the anthrax vaccine (manufacturer and lot number not reported). The subject has no significant medical history. The subject received dose 1 of the anthrax vaccine on 21 March 2011. The subject had the following tests performed on 12 April 2011: an abnormal Troponin I of 10.27, an abnormal electrocardiogram (ECG), an abnormal echocardiogram and a normal magnetic resonance imaging (MRI) of the heart. On 19 April 2011, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: This study case was received from the investigator on 19 August 2011. An 18-year-old male subject on 31 March 2011 received the following vaccinations: an injection of ACAM2000 (lot number not reported) and dose 2 of the anthrax vaccine (manufacturer and lot number not reported). The subject has no significant medical history. The subject received dose 1 of the anthrax vaccine on 21 March 2011. The subject had the following tests performed on 12 April 2011: an abnormal Troponin I of 10.27, an abnormal electrocardiogram (ECG), an abnormal echocardiogram and a normal magnetic resonance imaging (MRI) of the heart. On 19 April 2011, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Nuclear magnetic resonance imaging normal, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 19 August 2011. An 18-year-old male subject on 31 March 2011 received the following vaccinations: an injection of ACAM2000 (lot number not reported) and dose 2 of the anthrax vaccine (manufacturer and lot number not reported). The subject has no significant medical history. The subject received dose 1 of the anthrax vaccine on 21 March 2011. The subject had the following tests performed on 12 April 2011: an abnormal Troponin I of 10.27, an abnormal electrocardiogram (ECG), an abnormal echocardiogram and a normal magnetic resonance imaging (MRI) of the heart. On 19 April 2011, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram PR interval, Electrocardiogram ST segment elevation
Clinical narrative: This case was received on 21 July 2011 via a third party query tool search on the VAERS database, under reference number 422721. A 42-year-old male patient received ACAM2000 (lot number VV04003A) on 29 April 2011. On 03 May 2011, 4 days post-vaccination, the patient had symptoms of malaise, fever, and chest pain. An EKG revealed diffuse ST elevations and depressed PR interval, and an echocardiogram showed global hypokinesis (coded as "hypokinesia) and depressed ejection fraction of 40-45%. Concomitant medication included doxycycline; the patient was not ill at the time of vaccination. He was hospitalized, and subsequently recovered on an unspecified date. This study case was received from the investigator on 19 August 2011. Follow-up information received from an investigator reported that on 09 May 2011, the subject had an abnormal electrocardiogram (ECG) and an abnormal echocardiogram. The subject had an abnormal troponin I of 19.47 on 10 May 2011. On 20 May 2011, the subject was diagnosed with other and unspecified acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Hypokinesia, Malaise, Pyrexia
Clinical narrative: This case was received on 21 July 2011 via a third party query tool search on the VAERS database, under reference number 422721. A 42-year-old male patient received ACAM2000 (lot number VV04003A) on 29 April 2011. On 03 May 2011, 4 days post-vaccination, the patient had symptoms of malaise, fever, and chest pain. An EKG revealed diffuse ST elevations and depressed PR interval, and an echocardiogram showed global hypokinesis (coded as "hypokinesia) and depressed ejection fraction of 40-45%. Concomitant medication included doxycycline; the patient was not ill at the time of vaccination. He was hospitalized, and subsequently recovered on an unspecified date. This study case was received from the investigator on 19 August 2011. Follow-up information received from an investigator reported that on 09 May 2011, the subject had an abnormal electrocardiogram (ECG) and an abnormal echocardiogram. The subject had an abnormal troponin I of 19.47 on 10 May 2011. On 20 May 2011, the subject was diagnosed with other and unspecified acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain
Clinical narrative: This case was received on 21 July 2011 via a third party query tool search on the VAERS database, under reference number 422721. A 42-year-old male patient received ACAM2000 (lot number VV04003A) on 29 April 2011. On 03 May 2011, 4 days post-vaccination, the patient had symptoms of malaise, fever, and chest pain. An EKG revealed diffuse ST elevations and depressed PR interval, and an echocardiogram showed global hypokinesis (coded as "hypokinesia) and depressed ejection fraction of 40-45%. Concomitant medication included doxycycline; the patient was not ill at the time of vaccination. He was hospitalized, and subsequently recovered on an unspecified date. This study case was received from the investigator on 19 August 2011. Follow-up information received from an investigator reported that on 09 May 2011, the subject had an abnormal electrocardiogram (ECG) and an abnormal echocardiogram. The subject had an abnormal troponin I of 19.47 on 10 May 2011. On 20 May 2011, the subject was diagnosed with other and unspecified acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Malaise, Myocarditis, Pyrexia, Troponin I increased
Clinical narrative: This case was received on 21 July 2011 via a third party query tool search on the VAERS database, under reference number 422721. A 42-year-old male patient received ACAM2000 (lot number VV04003A) on 29 April 2011. On 03 May 2011, 4 days post-vaccination, the patient had symptoms of malaise, fever, and chest pain. An EKG revealed diffuse ST elevations and depressed PR interval, and an echocardiogram showed global hypokinesis (coded as "hypokinesia) and depressed ejection fraction of 40-45%. Concomitant medication included doxycycline; the patient was not ill at the time of vaccination. He was hospitalized, and subsequently recovered on an unspecified date. This study case was received from the investigator on 19 August 2011. Follow-up information received from an investigator reported that on 09 May 2011, the subject had an abnormal electrocardiogram (ECG) and an abnormal echocardiogram. The subject had an abnormal troponin I of 19.47 on 10 May 2011. On 20 May 2011, the subject was diagnosed with other and unspecified acute myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood culture negative, C-reactive protein increased, Chest pain, Chills, Echocardiogram normal
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 23-year-old male subject received on 29 May 2011 the following vaccinations: an injection of ACAM2000 (lot number not reported), Anthrax vaccine (manufacturer and lot number not reported), and TYPHOID VI POLYSACCHARIDE (lot not reported). The subject had a history of asthma (include exercise induced). On 10 June 2011, the subject had an abnormal troponin I of 00.30, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 14 June 2011, the subject was diagnosed with non-specified myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Ejection fraction decreased, Electrocardiogram ST-T change, Electrocardiogram abnormal, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 23-year-old male subject received on 29 May 2011 the following vaccinations: an injection of ACAM2000 (lot number not reported), Anthrax vaccine (manufacturer and lot number not reported), and TYPHOID VI POLYSACCHARIDE (lot not reported). The subject had a history of asthma (include exercise induced). On 10 June 2011, the subject had an abnormal troponin I of 00.30, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 14 June 2011, the subject was diagnosed with non-specified myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Tremor, Troponin I increased, Urine analysis normal, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 23-year-old male subject received on 29 May 2011 the following vaccinations: an injection of ACAM2000 (lot number not reported), Anthrax vaccine (manufacturer and lot number not reported), and TYPHOID VI POLYSACCHARIDE (lot not reported). The subject had a history of asthma (include exercise induced). On 10 June 2011, the subject had an abnormal troponin I of 00.30, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 14 June 2011, the subject was diagnosed with non-specified myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 23-year-old male subject received on 29 May 2011 the following vaccinations: an injection of ACAM2000 (lot number not reported), Anthrax vaccine (manufacturer and lot number not reported), and TYPHOID VI POLYSACCHARIDE (lot not reported). The subject had a history of asthma (include exercise induced). On 10 June 2011, the subject had an abnormal troponin I of 00.30, an abnormal electrocardiogram (ECG) and a normal echocardiogram. On 14 June 2011, the subject was diagnosed with non-specified myocarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Borrelia test, VIIth nerve paralysis
Clinical narrative: Bell's Palsy - became night of vaccination 8/8/11.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Borrelia test negative, VIIth nerve paralysis
Clinical narrative: Bell's Palsy - became night of vaccination 8/8/11.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Headache, Swelling face
Clinical narrative: Initial report received from a health care professional on 21 August 2011. A 29-year-old female patient, who had no concurrent illnesses and no known allergies, had received an intramuscular right deltoid injection of FLUZONE SV 2011-2012 (lot number UT426AA) on 20 August 2011 at 5:00pm and 5 hours later around 10:00pm she experienced facial swelling with swollen eyes and lips, was short of breath, and had a headache. She required medical evaluation; however it was not reported whether she received any treatments. It was also not reported whether any diagnostic tests and/or laboratory data were performed. It was noted the patient had received flu vaccinations in the past with no reported adverse events. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Eye swelling, Headache, Lip swelling, Swelling face
Clinical narrative: Initial report received from a health care professional on 21 August 2011. A 29-year-old female patient, who had no concurrent illnesses and no known allergies, had received an intramuscular right deltoid injection of FLUZONE SV 2011-2012 (lot number UT426AA) on 20 August 2011 at 5:00pm and 5 hours later around 10:00pm she experienced facial swelling with swollen eyes and lips, was short of breath, and had a headache. She required medical evaluation; however it was not reported whether she received any treatments. It was also not reported whether any diagnostic tests and/or laboratory data were performed. It was noted the patient had received flu vaccinations in the past with no reported adverse events. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Barium enema, Intussusception, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician and a nurse concerning a 11 weeks old male patient with no known drug allergy, a history of "cystic fibrosis which was speculated from newborn screening" as reported by the physician and no known predisposing conditions who on 12-AUG-2011 was vaccinated with the first 2 ml dose of ROTATEQ (Lot Number: 668364/1063Z). The reason for use of this vaccine was noted as intussusception. Concomitant therapy included PREVNAR and PENTACEL. There was no other concomitant medication. The physician reported that on 15-AUG-2011 the patient experienced heavy vomiting that required surgery to repair bowel and have an appendectomy after taking one dose of ROTATEQ. The patient was sent to ER and then was admitted to hospital for 2 nights. The nurse reported that the patient had no hospital records for reference, but the chart noted that surgery followed a failed barium enema. Blood work was performed without results. The physician reported that therapy with ROTATEQ was discontinued and not reintroduced. After stopping therapy with ROTATEQ the patient was recovering. It was also reported that there were no predisposing conditions; patient's gestational age at birth was 38 weeks and 6 days; weight at birth was 6 pounds and 9 ounces. The patient's weight on 12-AUG-2011 was 14 pounds and 14 ounces. The nurse reported that the patient did not have cystic fibrosis (physician previously reported as "possible marker for cystic fibrosis"). Heavy vomiting, required surgery to repair bowel and had an appendectomy were considered to be immediately life-threatening and other important medical event by the physician. A lot check has been initiated. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Appendicectomy, Barium enema, Blood test, Intestinal operation, Laboratory test abnormal
Clinical narrative: Information has been received from a physician and a nurse concerning a 11 weeks old male patient with no known drug allergy, a history of "cystic fibrosis which was speculated from newborn screening" as reported by the physician and no known predisposing conditions who on 12-AUG-2011 was vaccinated with the first 2 ml dose of ROTATEQ (Lot Number: 668364/1063Z). The reason for use of this vaccine was noted as intussusception. Concomitant therapy included PREVNAR and PENTACEL. There was no other concomitant medication. The physician reported that on 15-AUG-2011 the patient experienced heavy vomiting that required surgery to repair bowel and have an appendectomy after taking one dose of ROTATEQ. The patient was sent to ER and then was admitted to hospital for 2 nights. The nurse reported that the patient had no hospital records for reference, but the chart noted that surgery followed a failed barium enema. Blood work was performed without results. The physician reported that therapy with ROTATEQ was discontinued and not reintroduced. After stopping therapy with ROTATEQ the patient was recovering. It was also reported that there were no predisposing conditions; patient's gestational age at birth was 38 weeks and 6 days; weight at birth was 6 pounds and 9 ounces. The patient's weight on 12-AUG-2011 was 14 pounds and 14 ounces. The nurse reported that the patient did not have cystic fibrosis (physician previously reported as "possible marker for cystic fibrosis"). Heavy vomiting, required surgery to repair bowel and had an appendectomy were considered to be immediately life-threatening and other important medical event by the physician. A lot check has been initiated. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician and a nurse concerning a 11 weeks old male patient with no known drug allergy, a history of "cystic fibrosis which was speculated from newborn screening" as reported by the physician and no known predisposing conditions who on 12-AUG-2011 was vaccinated with the first 2 ml dose of ROTATEQ (Lot Number: 668364/1063Z). The reason for use of this vaccine was noted as intussusception. Concomitant therapy included PREVNAR and PENTACEL. There was no other concomitant medication. The physician reported that on 15-AUG-2011 the patient experienced heavy vomiting that required surgery to repair bowel and have an appendectomy after taking one dose of ROTATEQ. The patient was sent to ER and then was admitted to hospital for 2 nights. The nurse reported that the patient had no hospital records for reference, but the chart noted that surgery followed a failed barium enema. Blood work was performed without results. The physician reported that therapy with ROTATEQ was discontinued and not reintroduced. After stopping therapy with ROTATEQ the patient was recovering. It was also reported that there were no predisposing conditions; patient's gestational age at birth was 38 weeks and 6 days; weight at birth was 6 pounds and 9 ounces. The patient's weight on 12-AUG-2011 was 14 pounds and 14 ounces. The nurse reported that the patient did not have cystic fibrosis (physician previously reported as "possible marker for cystic fibrosis"). Heavy vomiting, required surgery to repair bowel and had an appendectomy were considered to be immediately life-threatening and other important medical event by the physician. A lot check has been initiated. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Left leg became very swollen and hot to touch.  Taken to urgent care on 8/26/11 and diagnosed with cellulitis.   Also, on 8/29/11 developed red rash on entire body.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Left leg became very swollen and hot to touch.  Taken to urgent care on 8/26/11 and diagnosed with cellulitis.   Also, on 8/29/11 developed red rash on entire body.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 19 August 2011. A 24-year-old male subject received on 12 May 2011 the following vaccination: an injection of ACAM2000 (lot number not reported). The subject has no significant medical history. On 24 May 2011, the subject had an abnormal Troponin I of 04.80 and an abnormal electrocardiogram (ECG). On 27 May 2011, the patient had an echocardiogram which was abnormal. On 09 June 2011, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. 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. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Echocardiogram, Electrocardiogram abnormal, Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 22-year-old male subject received on 11 June 2011 received the following vaccinations: an injection of ACAM2000 (lot number not reported), and Anthrax vaccine (manufacturer and lot number not reported). The subject has no significant medical history. On 25 June 2011, the subject had an abnormal electrocardiogram (ECG) and a normal troponin I. The subject's echocardiogram was not available. On 25 June 2011, the subject was diagnosed with other and unspecified acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. 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: M
Vaccine: ANTH, SMALL, TDAP, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator on 19 August 2011. A 30-year-old male subject received on 03 June 2011 received the following vaccinations: an injection of ACAM2000 (lot number not reported), anthrax vaccine (manufacturer and lot number not reported), Tdap (manufacturer and lot number not reported) and TYPHOID Vi polysaccharide(lot not reported). Medical history was not available. On 20 June 2011, the subject had an abnormal electrocardiogram (ECG) and a normal echocardiogram. The subject's Troponin I was not available. On 20 June 2011, the subject was diagnosed acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: HEPAB, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Prinzmetal angina, Troponin I increased
Clinical narrative: This study case was received from the investigator (MILVAX) on 19 August 2011. A 29-year-old male subject who had no significant medical history had received ACAM2000 (lot number not reported) on 31 March 2011. Hep A - Hep B vaccine (other manufacturer, lot number not reported) had been administered concomitantly. On 11 April 2011, laboratory and diagnostic findings consisted of abnormal troponin I (08.50) and an abnormal ECG and abnormal Echocardiogram. On 15 April 2011, the subject was diagnosed with Prinzmetal angina. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Cardiomyopathy, Condition aggravated, Echocardiogram abnormal, Electrocardiogram abnormal, Troponin I
Clinical narrative: This study case was received from the investigator in a trial on 19 August 2011. A 25-year-old male subject who had a past history of palpitations/pounding heart without exercise, chest pain, congestive heart failure, cardiomyopathy, shortness of breath, asthma, psychiatric illness and abnormal ECG (electrocardiogram), had received ACAM2000 (lot number not reported) on 29 November 2010. The subject had previously received vaccination with Influenza, live intranasal (other manufacturer, lot number not reported) on 22 November 2011. On 03 December 2010, laboratory and diagnostic findings consisted of an abnormal ECG and abnormal Echocardiogram. Troponin I results were not available. On 16 December 2010, the subject was diagnosed with "Other primary cardiomyopathies". Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Choking, Dyspnoea, Dysstasia
Clinical narrative: I had flu shot on 10-14-2010. First symptoms Nov 1, 2010, difficulty climbing stairs, then rising from seated position, weakness arms, then entire body. Could not walk then could not stand, then choking on saliva & food, then difficulty breathing.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: I had flu shot on 10-14-2010. First symptoms Nov 1, 2010, difficulty climbing stairs, then rising from seated position, weakness arms, then entire body. Could not walk then could not stand, then choking on saliva & food, then difficulty breathing.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Type 1 diabetes mellitus
Clinical narrative: Fever the same night.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Gave injection on 8/17/11. Mom called after they got home and said patient's cheeks and face was swollen. Mom stated patient was not having any trouble breathing.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Gait disturbance, Injection site movement impairment, Joint swelling, Mobility decreased, Pain
Clinical narrative: Pt received DTaP, IPV-combined & PCV 13 in left leg, MMR-arm & VZV in arm approx: 130. At 10:00 pm woke screaming in pain. Refused to move her legs - per mom both knees looked swollen but (R) looked worse than (L). When seen in office pt still had slight limp.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Screaming
Clinical narrative: Pt received DTaP, IPV-combined & PCV 13 in left leg, MMR-arm & VZV in arm approx: 130. At 10:00 pm woke screaming in pain. Refused to move her legs - per mom both knees looked swollen but (R) looked worse than (L). When seen in office pt still had slight limp.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Body temperature increased, Vomiting
Clinical narrative: Temp 103.4 2 days after administration of vaccine. Vomited x 1.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Lacrimation increased
Clinical narrative: Mom called today 8/10/11 at 3:28 PM stating that patient c/o left eye watering and (L) side of mouth cannot smile. Told mom to come to office to be evaluated. Mom called again at 4:08 PM  stating that she prefer to go hospital. She then states that (L) eye watering happens 40 hrs after the vaccines given.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Induration
Clinical narrative: 3cm x 5cm of redness with induration noted to Rt arm.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site haematoma, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swelling 6x5 cm; 2x4 bruise tender, warm.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Tension
Clinical narrative: Approximately 48 hours after injections with Tdap and varicella vaccines, area of immunization reportedly became red, inflamed, hot to touch and tense. Ibuprofen has been administered for treatment. Sxs. reducing after 3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: Extensive local reaction to DTAP, with not evidence of secondary infection.
Age: 16.0
Sex: F
Vaccine: HPV4, PPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 8/19/11 morning after injection, site was swollen slightly - about size of a nickel (per mother). As the progressed site swelled to the size of a golf ball. Area red but denies pain. Dr's eval: 3 inch diameter, fluid filled area (left deltoid), slight warmth, minimal tenderness. Tx: ice, rest, elevation, call if sx worsen.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt called & stated her (Rt) arm was red, swollen & warm to touch where she received her vaccine.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: 3 days after receiving MMR/VARIVAX pt. experienced febrile seizure lasting 1.5 min. No illness, viral or otherwise found at ER evaluation.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: 15 minutes post MMR vaccination, rash developed forearms and progressed chest wall, back & shoulders.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Soreness in the arm and red, swollen.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt received ZOSTAVAX vaccination on 8/8/11 and noticed rash approximately 1 week later, pt will speak with MD about possible treatment.
Age: 1.29
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Pyrexia, Rash papular
Clinical narrative: Fevers beginning within a few hours of vaccines, fevers to max of 103 degrees & lasting >48h. Exam in clinic 3d later showed faint pinpoint papular rash.
Age: 7.0
Sex: M
Vaccine: TYP
Symptoms: Pruritus
Clinical narrative: Pt relative called office 7.6.11 said pt started itching 4d after vaccine administered and was still itchy 7.6.11 at time of call advised to see physician in foreign country. Advised to also call us with parents phone number or email. As well as treating physician info.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: ROTATEQ given after 14 weeks-6 days. In 15th week. No reaction - nothing but given 4 days late.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Patient had a brief, mild, seizure upon waking.  It has been two weeks since his last seizure.  It's hard to know if this was triggered by the vaccination or would have happened anyway because of his epilepsy, but perhaps epileptics are more prone to react with a seizure after the vaccine?  Patient recovered normally.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: PATIENT'S DAUGHTER REFERS THAT HER MOTHER DEVELOPED PAIN IN THE LEFT UPPER EXTREMITY APROXIMATELY 2 HRS AFTER VACCINATION.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Muscular weakness, Pruritus, Rash
Clinical narrative: rash on legs, itchy, muscle weakness, joint pain, lightheadedness
Age: 20.0
Sex: F
Vaccine: ANTH, FLU3
Symptoms: Drug exposure during pregnancy
Clinical narrative: Patient pregnant & not known at time of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in with complaints of red swollen arm. On exam patient shows symptoms of red, warm, erythematous upper arm, swollen deltoid consistent with histamine reaction (left upper arm).
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: Fever 102.4, 99.8 after MOTRIN. Headache, neck pain. Reported by his mother.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Varicella vaccine given 7-22-11 on 7-29-11 presented with lesions on left humerus area and on right side of face no fever acting fine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on inside of both arms & chest - not itchy.
Age: 36.0
Sex: U
Vaccine: HPV2, YF
Symptoms: Injection site erythema
Clinical narrative: Localized redness at injection site of yellow fever.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: 1.5-2 hrs after injection felt lightheaded & dizzy. 4-5 hrs later developed fever (101.2). Area at inj. site reddened & warm about 15 cm. Sx lessened next day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) arm redness, swelling, mildly tender at vaccine administration site, began evening of 8/19, continued through 8/22/11 - presented to pediatricians office 8/22/11.
Age: 12.0
Sex: F
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: 12 y/o female s/p IZ 2 days ago w/ increased redness & pain left upper arm w/ erythema, swelling, & tenderness. Treated for cellulitis as well as local rxn.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Arm pain PM of 7/21/11 continued and intense during evening & night. 4 weeks still arm pain & weakness.
Age: 22.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Small red bumps on both arms and upper inner thighs that itch.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Had Tdap shot 8/15, it is 8/24 area around shot red 6cm x 4cmalso had nodule 2" inside circle exists. Advised patient twice & take ADVIL & come back in 2 days. Bruised a little yellow inside red circle. No fever. Range of motion not affected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Pt here for well child ck. Offered HPV #2. Pt's mother declined said last HPV we admin on 10/4/10 caused nausea, vomiting within 24 hrs after shot lasting 7 days.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Pt here CMA from well child ck. Declines HPV #2 states had HPV #1. Within 24 hrs developed nausea, vomiting, lasting 7 days. Admin 10/7/10 during well child.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site warmth
Clinical narrative: (L) thigh reddened warm tender - bruising at injection site. Tx: TYLENOL Q 4- 6 hours, ice call if redness worsening or fever. Spoke to mom 2 days later, no symptoms bruise still exist.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: (L) deltoid with erythema & induration. 5.6cm wide x 6.5cm long.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Blister, Injection site vesicles
Clinical narrative: Vesicles on extremities, chest, back - BENADRYL, CALAMINE Lotion.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1 day after vaccine, (L) arm started hurting -> in the morning there was swelling & redness. Here in clinic (2 days after shot) circumference of (L) arm was 22 cm & (R) arm was 18 cm. Large area of redness & swelling, nontender.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Chills, fatigue, body & joint ache 102 degree fever. Brain function impaired. Pain at injection site. Swelling & very hot to the touch. Lasting symptoms for at least 48 hours. Took TYLENOL to stop fever.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site warmth, Nervous system disorder, Pain, Pyrexia
Clinical narrative: Chills, fatigue, body & joint ache 102 degree fever. Brain function impaired. Pain at injection site. Swelling & very hot to the touch. Lasting symptoms for at least 48 hours. Took TYLENOL to stop fever.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Skin warm
Clinical narrative: Swelling, pain and itching at the injection site. Also heat (L) arm.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Blood glucose normal, Electrocardiogram normal, Hypotonic-hyporesponsive episode, Pallor, Resuscitation
Clinical narrative: Following vaccination with DTaP, less than 24 hours later, child had episode of pallor, diaphoresis and hypotonic, hyporesponsive state. After brief CPR by parent, returned to normal state. EMS transported to local ED, had normal glucose and EKG.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Hypoaesthesia eye, Injection site anaesthesia
Clinical narrative: On injection patient stated area around injection site numb, I received message from ER and when I returned called could not get through & left message so I called patient who said has neurology visit tomorrow & c/(L) eye & (L) face & left arm & part of (L) breast numbness, states can use arm normally.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Headache, Posture abnormal, Syncope
Clinical narrative: A couple of minutes after shot(s) were administered, client stated she "feels dizzy" and she slumped forward, client was fainted for approx. 10-15 sec. & woke up complaining of a bad headache. She drank some apple juice and went home with her father.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Tremor
Clinical narrative: After giving shots pt wanted a drink. Went to give pt cup and started towards door with pt to water fountain and noticed his face turning white. Brought pt back in room to sit in chair and that's when he passed out & then started to shake all over. Went & got Dr. laid him on floor to prop pt feet up & cool him off. Pt came to & started to feel better.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got the shot on July 19, 2011 and went to Dr with shingles Aug 14, 2011. I got 2 po. meds. and cream for shingles. (I paid $ 90.45 for the shot).
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Hypersomnia, Malaise, Pain
Clinical narrative: I got the Tdap tetanus shot Sunday evening. Monday morning I had a headache, tiredness, body aches. I had to sleep most of the afternoon on Monday and Tuesday. Today is Wednesday, and I still don't feel great.
Age: 23.0
Sex: M
Vaccine: TD
Symptoms: Impaired work ability, Injection site pain, Pain in extremity
Clinical narrative: Patient called office on above date stating he had "severe pain in left arm at Td injection site, Motrin not touching pain."  Dr. gave him a Rx for Vicodin for pain.  Patient then called back again a few days later with continued lt. arm pain, was told to take 2 Aleve twice a day.  Patient returned to office 8/24/11 complaining that he still had severe lt. arm pain that he felt was caused by Td vaccine and was unable to do his patio construction job without severe pain.  Dr. examined patient and explained to him that this was a very atypical reaction (no redness, warmth or swelling at injection site and no pain at time of injection).  She prescibed a course of Prednisone and Naprosyn and refilled Vicodin, gave referral to f/u with Dr., Ortho, if pain continued.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Acne, Biopsy skin abnormal, Blood test, Induration, Mass
Clinical narrative: Woke up with lump on left hand on wrist, front & surrounding whole wrist. Lump was hard felt like wart. Next morning spread up arm. Right hand was not as severe but looked like scars under the skin like they were old; not on forearm only on back of hand. Also on back of left hand but smaller - acne like - a couple on back of ankles & back right of legs. Called doctor within 1 week (around October 7) given ointment for allergy; doctor thought that pt was better. 2 weeks later (around October 28) seen by dermatologist but could not give diagnosis. Used ointment for a month but did not work. On January went back to dermatologist, got biopsy done, received something to help her sleep. On February returned diagnosed with purigal nagularis after biopsy. Told that no cure just use continue to use ointment. Pt thinks vaccine triggered skin problems. Currently seeing general physician and running blood tests. For itch pt taking hydroxyzine capsules and clobetasol cream. Has taken 6 different medications none of them worked.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Scar, Skin disorder, Sleep disorder, Upper extremity mass
Clinical narrative: Woke up with lump on left hand on wrist, front & surrounding whole wrist. Lump was hard felt like wart. Next morning spread up arm. Right hand was not as severe but looked like scars under the skin like they were old; not on forearm only on back of hand. Also on back of left hand but smaller - acne like - a couple on back of ankles & back right of legs. Called doctor within 1 week (around October 7) given ointment for allergy; doctor thought that pt was better. 2 weeks later (around October 28) seen by dermatologist but could not give diagnosis. Used ointment for a month but did not work. On January went back to dermatologist, got biopsy done, received something to help her sleep. On February returned diagnosed with purigal nagularis after biopsy. Told that no cure just use continue to use ointment. Pt thinks vaccine triggered skin problems. Currently seeing general physician and running blood tests. For itch pt taking hydroxyzine capsules and clobetasol cream. Has taken 6 different medications none of them worked.
Age: 0.29
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal pain
Clinical narrative: Significant abdominal pain
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: 4 cm area of induration to left lateral thigh beginning this am. No crusting, no discharge, no streaking and no central clearing. No ulceration. Painful and itchy per patient. Reported that redness present since vaccine received.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Local reaction, Petechiae
Clinical narrative: LARGE LOCAL RXN R LE, PETECHIA UNDER EYE
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: His arm turned hard, red and hot from shoulder to elbow. It was very itchy.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Raynaud's phenomenon, Sensory disturbance
Clinical narrative: Within 24 hours of receiving the Tdap shot, I began having sensations of hot water being poured onto my feet. I had never had this sensation before in my life. It continued for the next week and from then on out, would come and go. In March of 2011 I experienced extreme symptoms of this and went to the doctor, where I was diagnosed with primary Reynaud's.  I continue to have daily symptoms and had never experienced any of this before receiving this immunization.  Please note that the approximate date was given for the immunization. Exact date and time would need to be requested from my physician. I do not know what brand the vaccine was, except that it was Tdap.  When I visited with my physician about my Reynauds I mentioned that the initial symptoms began within 24 hours of the shot.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Complained of Rt. arm soreness.  States unable to raise arm 3 inches away from body.  MD visited on 8/25/11.  Pt. given Rx for muscle relaxers and anti-inflammatory meds.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dyspnoea, Fatigue, Malaise, Pharyngeal oedema
Clinical narrative: Sudden fatigue followed by chills for about an hour, then fever of 103 for 4 hours, swollen throat and difficulty breathing during fever. I did get up and take 2 Advil, I was home alone so I just went to bed and stayed there. Went to work next morning but didn't feel all that well so I came home. I'm 54 and this is my first ever flu shot and certainly my last!
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Sudden fatigue followed by chills for about an hour, then fever of 103 for 4 hours, swollen throat and difficulty breathing during fever. I did get up and take 2 Advil, I was home alone so I just went to bed and stayed there. Went to work next morning but didn't feel all that well so I came home. I'm 54 and this is my first ever flu shot and certainly my last!
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: Stomachache, nausea, diarrhea, vomiting
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Acute febrile neutrophilic dermatosis, Condition aggravated, Cough, Eye discharge, Eyelid oedema
Clinical narrative: Pt developed a slight progressive non productive cough 5 days ago with a rash that started 3 days ago and was characterized as papular and flesh colored lesions on the bilateral anterior and lateral legs.  The rash rapidly progressed to larger firm nodules on the legs and subsequently included the back, trunk and proximal upper extremities. There was weeping from one lesion on the foot, a clear serous d/c.  No pus, no crusting.  Pt had one episode of NBNB emesis but no diarrhea or alteration in PO intake.  There was some puffiness around the eyes which progressed to lateral canthal injection with clear discharge, and some nasal discharge.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nodule, Ocular hyperaemia, Pathology test, Rash, Rash papular
Clinical narrative: Pt developed a slight progressive non productive cough 5 days ago with a rash that started 3 days ago and was characterized as papular and flesh colored lesions on the bilateral anterior and lateral legs.  The rash rapidly progressed to larger firm nodules on the legs and subsequently included the back, trunk and proximal upper extremities. There was weeping from one lesion on the foot, a clear serous d/c.  No pus, no crusting.  Pt had one episode of NBNB emesis but no diarrhea or alteration in PO intake.  There was some puffiness around the eyes which progressed to lateral canthal injection with clear discharge, and some nasal discharge.