chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea, Musculoskeletal chest pain, Painful respiration
Clinical narrative: It started out as feeling like something was stuck in my throat, then I kept coughing, it was hard to breathe because of this. By 3:15pm it had gotten much worse so I contacted my Dr. who then had me come into the office at 4pm. She stated she couldn't tell at that time if it was a reaction or if I was already getting sick and the flu shot brought it out. She told me to take Allegra when I got home and Benadryl at night. After getting in the car, the meatball feeling stuck in my throat started to move down my chest/esophagus. I got home around 5:15pm and took Allegra. I immediately undressed to take a shower and noticed I had a rash over both of my breasts. It was bright red and warm to touch. I called the office back and left a message for the doctor. The rep said not to take any medicine until I heard back from the office. While I was waiting for the office to call me back, my chest started feeling heavier and it was uncomfortable to breath (took a lot of effort) my ribs felt sore from being moved by my lungs. I didn't hear back from the office so I called the answering service around 9:30pm and explained everything to the nurse. She contacted the doctor and called me back and said to take 2 Benadryl every 4-6 hoours as needed and that should help with the hives on my chest and the meatball type feeling in my esophagus. It is the next morning now, and I still have my symptoms.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash erythematous, Sensation of foreign body, Skin warm, Urticaria
Clinical narrative: It started out as feeling like something was stuck in my throat, then I kept coughing, it was hard to breathe because of this. By 3:15pm it had gotten much worse so I contacted my Dr. who then had me come into the office at 4pm. She stated she couldn't tell at that time if it was a reaction or if I was already getting sick and the flu shot brought it out. She told me to take Allegra when I got home and Benadryl at night. After getting in the car, the meatball feeling stuck in my throat started to move down my chest/esophagus. I got home around 5:15pm and took Allegra. I immediately undressed to take a shower and noticed I had a rash over both of my breasts. It was bright red and warm to touch. I called the office back and left a message for the doctor. The rep said not to take any medicine until I heard back from the office. While I was waiting for the office to call me back, my chest started feeling heavier and it was uncomfortable to breath (took a lot of effort) my ribs felt sore from being moved by my lungs. I didn't hear back from the office so I called the answering service around 9:30pm and explained everything to the nurse. She contacted the doctor and called me back and said to take 2 Benadryl every 4-6 hoours as needed and that should help with the hives on my chest and the meatball type feeling in my esophagus. It is the next morning now, and I still have my symptoms.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Erythema, Retching, Sensation of foreign body
Clinical narrative: It started out as feeling like something was stuck in my throat, then I kept coughing, it was hard to breathe because of this. By 3:15pm it had gotten much worse so I contacted my Dr. who then had me come into the office at 4pm. She stated she couldn't tell at that time if it was a reaction or if I was already getting sick and the flu shot brought it out. She told me to take Allegra when I got home and Benadryl at night. After getting in the car, the meatball feeling stuck in my throat started to move down my chest/esophagus. I got home around 5:15pm and took Allegra. I immediately undressed to take a shower and noticed I had a rash over both of my breasts. It was bright red and warm to touch. I called the office back and left a message for the doctor. The rep said not to take any medicine until I heard back from the office. While I was waiting for the office to call me back, my chest started feeling heavier and it was uncomfortable to breath (took a lot of effort) my ribs felt sore from being moved by my lungs. I didn't hear back from the office so I called the answering service around 9:30pm and explained everything to the nurse. She contacted the doctor and called me back and said to take 2 Benadryl every 4-6 hoours as needed and that should help with the hives on my chest and the meatball type feeling in my esophagus. It is the next morning now, and I still have my symptoms.
Age: 29.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Skin warm, Throat irritation
Clinical narrative: It started out as feeling like something was stuck in my throat, then I kept coughing, it was hard to breathe because of this. By 3:15pm it had gotten much worse so I contacted my Dr. who then had me come into the office at 4pm. She stated she couldn't tell at that time if it was a reaction or if I was already getting sick and the flu shot brought it out. She told me to take Allegra when I got home and Benadryl at night. After getting in the car, the meatball feeling stuck in my throat started to move down my chest/esophagus. I got home around 5:15pm and took Allegra. I immediately undressed to take a shower and noticed I had a rash over both of my breasts. It was bright red and warm to touch. I called the office back and left a message for the doctor. The rep said not to take any medicine until I heard back from the office. While I was waiting for the office to call me back, my chest started feeling heavier and it was uncomfortable to breath (took a lot of effort) my ribs felt sore from being moved by my lungs. I didn't hear back from the office so I called the answering service around 9:30pm and explained everything to the nurse. She contacted the doctor and called me back and said to take 2 Benadryl every 4-6 hoours as needed and that should help with the hives on my chest and the meatball type feeling in my esophagus. It is the next morning now, and I still have my symptoms.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Local reaction
Clinical narrative: Pain and redness at site, 5x7 cm.
Age: 9.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral
Clinical narrative: PER ER FROM 09/05/2012: SWELLING AND ERYTHEMA FROM SHOULDER TO ELBOW, NO FEVER.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: SWELLING AND REDNESS TO ARM 5 INCHES BY 4 INCHES.
Age: 0.87
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site rash, Rash
Clinical narrative: When mom took PJ's off infant this morning, had rash on shins of both legs and on both forearms and two red areas in front of left ear.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Egg sized Redness around injection site with heat.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Contusion, Eyelid oedema, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Mouth haemorrhage
Clinical narrative: Patient presents to office on 09/06/2012 with left eyelid bruising and swelling, oral and diffuse petechiae and bruising all over skin, platelet count of 2 on 09/06/2012. Patient sent to Pediatric Hematology clinic to see Dr.  Acute ITP confirmed in clinic, IVIG given on 09/06/2012.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: Patient presents to office on 09/06/2012 with left eyelid bruising and swelling, oral and diffuse petechiae and bruising all over skin, platelet count of 2 on 09/06/2012. Patient sent to Pediatric Hematology clinic to see Dr.  Acute ITP confirmed in clinic, IVIG given on 09/06/2012.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the entire upper arm where the DTaP was given.
Age: 39.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Asthenia, Blood culture, Body temperature increased, Dizziness, Full blood count
Clinical narrative: Temp 102.8 F, nausea, vomiting, severe headache, dizziness, weakness, myalgias, sore throat with swollen glands.
Age: 39.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Lymphadenopathy, Metabolic function test, Myalgia, Nausea
Clinical narrative: Temp 102.8 F, nausea, vomiting, severe headache, dizziness, weakness, myalgias, sore throat with swollen glands.
Age: 39.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: Temp 102.8 F, nausea, vomiting, severe headache, dizziness, weakness, myalgias, sore throat with swollen glands.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Lymphadenopathy, Pain
Clinical narrative: Swollen glands in neck (predominately on right side...same side as injection) - started around 7:30AM on 9/6/12 and lasted ~24hrs. Tiredness - started around 7:30AM on 9/6/12 and continues after ~48hrs. Body aches/chills - started about 4:00PM on 9/6/12 and continues after 20hrs - taking Ibuprofen.
Sex: M
Vaccine: SMALL
Symptoms: Atrioventricular block first degree, Electrocardiogram abnormal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: Initial report received on 27 August 2012 from an investigator. A male subject was found to have an elevated Troponin level (Rapid Troponin I level reported as within normal limits (Negative) and an elevated central laboratory (lab) Troponin I level result of 0.21 ng/ml) on 15 November 2010 (with reported date of 17 November 2010) after receiving an injection of ACAM2000, SP Biologics Co., (lot number, route and site not reported) on an unspecified date. During the event, the patient was reported as asymptomatic, according to the Investigator. The subject also had an electrocardiogram (ECG) reported as abnormal: "NCS", first degree atrioventricular (AV) Block on 18 November 2010. On same date, 18 November 2010, central lab Troponin result was reported as less than < 0.21 ng/mL. Treatment reported as "treatment (other than medication)". The subject had a past medical history of elevated cholesterol and currently of high blood pressure at screening visit on 08 November 2010 (elevated cholesterol and high blood pressure were reported as "no" on follow-up visit on 15 November 2010). The subject had a surgical history of umbilical hernia repair and one (right) rib removed reported at screening visit on 08 November 2010 (also reported as surgical history "no"), (both surgeries were reported as "no" on follow-up visit on 15 November 2010). The subject denied usage of topical steroids, and denied drug allergies. The rest of the subject's past medical history was negative (reported as "never" or "no"). Screening visit on 08 November 2010, reported concomitant medication as Amlodipine and EXFORGE taken since 04 March 2008 for hypertension (concomitant medications reported as "no" on follow-up visit 15 November 2010). The subject admitted to consuming alcohol two to four times a month and had a history of tobacco use, specifically cigarettes, amount of use not specified. The stop date of adverse event elevated Troponin was 18 November 2010. The subject recovered (also reported as "no residual effects") on date not specified. According to the investigator the event of elevated Troponin was possibly related to the trial product or the trial procedures. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: medical records.
Sex: F
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: This study case was received from the investigator on 27 August 2012. A female subject who was a prior cigarette smoker had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 18 January 2011 a rapid Troponin I level that was not within normal limits (positive). The subject's central laboratory Troponin I level on 18 January 2011 was <0.10 ng/ml. No ECG was performed. The subject had no additional cardiac-related medical encounters, labs, or radiology information available. According to the investigator, repeat test was normal. Concomitant medication included SEASONIQUE. No further information was available at the time of the report. The subject's outcome was not reported. According to the investigator, the event of rapid Troponin I level positive was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: Initial report received on 27 August 2012 from an investigator. A male subject (age not reported) was found to have an elevated troponin level (Rapid Troponin I level reported as within normal limits (Negative) and an elevated central laboratory (lab) Troponin I level result of 0.14 ng/mL) on 27 May 2010 (with reported date of 01 June 2010) after receiving an injection of ACAM2000, SP Biologics Co., (lot number, route and site not reported) on an unspecified date. Central laboratory Troponin level results were reported as less than < 0.10 ng/mL, "repeat test normal", according to Investigator, on 18 June 2010. ECG was reported as normal on 18 June 2010. Treatment reported as none. The subject had a past medical history of current foot pain and shin splints and nasal congestion, stuffy nose, and coughing on 20 May 2010 screening visit (reported as "no" on follow-up visit on 27 May 2010). Surgical history, use of topical steroids, and drug allergies were reported as "no". Screening visit on 20 May 2010, reported concomitant medications ALLEGRA taken since February 2010 for nasal congestion and Naproxen taken since February 2010 for shin splints (concomitant medications reported as "no" on follow-up visit 27 May 2010). The subject admitted to consuming alcohol two drinks a month, or less, and denied tobacco use. The stop date of adverse event elevated troponin was 18 June 2010. The subject recovered (also reported as "no residual effects") on 18 June 2010. According to the investigator the event of elevated troponin was possibly related to the trial product or the trial procedures. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical Records.
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Lymphadenopathy, Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject with a medical history of penicillin allergy had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 28 July 2010 (also with a reported date of 30 July 2010) an elevated central laboratory Troponin level of 0.15 ng/ml and on 03 August 2010 a central laboratory Troponin level of 0.11 ng/ml. The subject had a rapid Troponin I level on 28 July 2010 that was within normal limits (negative). Treatment (other than medication) was given. On 26 July 2010 (also a reported date of 28 July 2010), the patient experienced swollen glands in the clavicle area on the right injection site. On 03 August 2010, the subject had a normal ECG reading. There was no other reported visit. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was ongoing. According to the Investigator, the event of elevated central lab troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. *List of docs held by sender: medical records.
Age: 35.0
Sex: F
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I increased, Troponin increased
Clinical narrative: This study case was received from an investigator on 27 August 2012. A 35-year-old female subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 10 February 2011 elevated rapid Troponin levels [not within normal limits (positive).] Treatment (other than medication) was provided to the subject. The date of recovery was reported as 10 February 2011. On 10 February 2011, the subject also had a central laboratory Troponin I level of <0.10 ng/ml. On 10 February 2011, the subject had a normal ECG reading. There was no other reported visit. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered. According to the Investigator, the event of elevated central lab troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Sinus tachycardia, Troponin I increased
Clinical narrative: Initial report received on 27 August 2012 from an investigator. A 22-year-old male subject who had no past medical or surgical history, and who had not been taking any concomitant medications, had received ACAM2000 (route, site and date of administration not reported). On 16 February 2011, an unspecified amount of time after receiving the vaccine, he had normal Rapid Troponin I levels and elevated central laboratory Troponin I levels (2.60 ng/mL). ECG performed on 22 February 2011 had normal interpretation with findings of sinus tachycardia. Repeat tests performed on 22 February 2011 were normal. Outcome was recovered on 22 February 2011. The subject had never taken topical steroids to treat an eye problem or disease, and he was not allergic to any medications. Alcohol consumption was reported as 2-3 times per week (average three drinks per day). Consumption of five drinks or more on one occasion was reported 2-4 times a month, with consumption of 9 drinks reported in a typical week. The subject had a past history of smoking beginning at age 15. He smoked on average less than half a pack per day for one year. The subject quit smoking successfully. According to the investigator, this event was possibly related to vaccination with ACAM2000, and was considered an Other Important Medical Event. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: medical records.
Sex: M
Vaccine: SMALL
Symptoms: Chills, Cough, Influenza, Nasal congestion, Nasopharyngitis
Clinical narrative: Initial report received on 27 August 2012 from an investigator. A male subject (age not reported), who was a non-smoker with no past medical or surgical history, had received ACAM2000 (lot number, route, site and date of administration not reported). On 10 December 2010 the subject experienced a non-serious event of "cold or flu" with mild symptoms of nasal congestion, chest congestion, cough, cold chills and fever. These symptoms were reported on 13 December 2010. Laboratory and diagnostic testing performed that same day revealed negative rapid troponin I levels (within normal limits) and elevated centralized troponin I levels (6.16 ng/mL), severity unknown (reported on 16 December 2010). An ECG was not performed. Action taken for the events was reported as "none". Outcome was reported as ongoing. Alcohol consumption was reported as 2-4 times per month (average 15 drinks per day). Consumption of five drinks or more on one occasion was reported as 2-4 times per month, with a total of 20 drinks consumed the week prior which represented the number of alcoholic beverages consumed in a typical week. The subject had never taken topical steroids to treat an eye problem or disease, and he was not allergic to any medications. According to the investigator, the event of elevated centralized troponin was possibly related to vaccination with ACAM2000, and was considered to be an Other Important Medical Event. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Respiratory tract congestion, Troponin I increased
Clinical narrative: Initial report received on 27 August 2012 from an investigator. A male subject (age not reported), who was a non-smoker with no past medical or surgical history, had received ACAM2000 (lot number, route, site and date of administration not reported). On 10 December 2010 the subject experienced a non-serious event of "cold or flu" with mild symptoms of nasal congestion, chest congestion, cough, cold chills and fever. These symptoms were reported on 13 December 2010. Laboratory and diagnostic testing performed that same day revealed negative rapid troponin I levels (within normal limits) and elevated centralized troponin I levels (6.16 ng/mL), severity unknown (reported on 16 December 2010). An ECG was not performed. Action taken for the events was reported as "none". Outcome was reported as ongoing. Alcohol consumption was reported as 2-4 times per month (average 15 drinks per day). Consumption of five drinks or more on one occasion was reported as 2-4 times per month, with a total of 20 drinks consumed the week prior which represented the number of alcoholic beverages consumed in a typical week. The subject had never taken topical steroids to treat an eye problem or disease, and he was not allergic to any medications. According to the investigator, the event of elevated centralized troponin was possibly related to vaccination with ACAM2000, and was considered to be an Other Important Medical Event. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Sex: M
Vaccine: SMALL
Symptoms: Dizziness, Electrocardiogram normal, Oropharyngeal pain, Pyrexia, Somnolence
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 22 February 2011 an elevated central laboratory Troponin level of 0.27 ng/ml and on 24 February 2011 a central laboratory Troponin level of <0.10 ng/ml. The subject had a rapid Troponin I level on 22 February 2011 that was within normal limits (negative). On 24 February 2011, the subject had a normal ECG reading. Also on 24 February 2011, the subject experienced non-serious events of sore throat, fever, drowsiness, and lightheadedness. The subject was given DAYQUIL and NYQUIL. There was no other reported visit. No further information was available at the time of the report. The subject's outcome was not recovered. According to the Investigator, the event of elevated central lab troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Sex: M
Vaccine: SMALL
Symptoms: Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 22 February 2011 an elevated central laboratory Troponin level of 0.27 ng/ml and on 24 February 2011 a central laboratory Troponin level of <0.10 ng/ml. The subject had a rapid Troponin I level on 22 February 2011 that was within normal limits (negative). On 24 February 2011, the subject had a normal ECG reading. Also on 24 February 2011, the subject experienced non-serious events of sore throat, fever, drowsiness, and lightheadedness. The subject was given DAYQUIL and NYQUIL. There was no other reported visit. No further information was available at the time of the report. The subject's outcome was not recovered. According to the Investigator, the event of elevated central lab troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I, Troponin normal
Clinical narrative: Initial report received on 27 August 2012 from an investigator. A male subject (age not reported) who was a non-smoker with no past medical or surgical history, and who had not been taking any concomitant medications, had received ACAM2000 (route, site and date of administration not reported). On 12 April 2011, an unspecified amount of time after receiving the vaccine, he had normal central laboratory Troponin I levels (<0.10 ng/mL), a normal ECG and positive Rapid Troponin I levels. A repeat test was normal (date not reported). An event outcome was not reported. Additional history noted alcohol consumption 2-4 times per month (two drinks per day). Consumption of five drinks or more on one occasion was reported as monthly or less, with consumption of one drink reported in a typical week. The subject had never taken topical steroids to treat an eye problem or disease, and he was not allergic to any medications. According to the investigator, this event was possibly related to vaccination with ACAM2000 and was considered an Other Important Medical Event. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A 19-year-old male subject with a medical history of frequent or severe headaches (concomitant medication FIORICET) had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 20 May 2011 (also with a reported date of 21 May 2011) an elevated central laboratory Troponin level of 0.12 ng/ml and on 26 May 2011 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 26 May 2011. The subject had a rapid Troponin I level on 20 May 2011 that was within normal limits (negative). On 26 May 2011, the subject had a normal ECG reading. There was no other reported visit. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of elevated central lab Troponin was considered an important event and possibly related. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Sex: M
Vaccine: SMALL
Symptoms: Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject with a past medical history of allergy, smokeless tobacco use and a former smoker had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 04 August an elevated Troponin, central laboratory level of 0.13 ng/ml (Draw date 02 August 2010). The subject had a rapid Troponin I level on 02 August 2010 that was within normal limits (negative). A repeat Troponin on 10 August 2010 was 0.12 ng/mL. The subject was asymptomatic according to the investigator. No ECG was performed. No additional cardiac-related medical encounters, labs or radiology information was available. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Cold sweat, Dizziness, Electrocardiogram abnormal, Nausea
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject with a medical history of Lasik and use of topical steroids to treat an eye problem/disease in November 2006, had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced chest pressure on 03 May 2010 (also with a reported date of 05 May 2010). Treatment (other than medication) was provided to the subject. On 05 May 2010, the subject had a rapid Troponin I level that was within normal limits (negative) and central laboratory Troponin I levels of <0.10 ng/ml. On 05 May 2010, the subject had ECG reading of "Abnormal: NCS." On 05 May 2010, the subject experienced non-serious events of nausea, feeling light-headed, and feeling clammy. There was no other reported visit. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of chest pressure was possibly related to vaccination with ACAM2000, and was considered to be an Other Important Medical Event. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Sex: M
Vaccine: SMALL
Symptoms: Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject with a medical history of Lasik and use of topical steroids to treat an eye problem/disease in November 2006, had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced chest pressure on 03 May 2010 (also with a reported date of 05 May 2010). Treatment (other than medication) was provided to the subject. On 05 May 2010, the subject had a rapid Troponin I level that was within normal limits (negative) and central laboratory Troponin I levels of <0.10 ng/ml. On 05 May 2010, the subject had ECG reading of "Abnormal: NCS." On 05 May 2010, the subject experienced non-serious events of nausea, feeling light-headed, and feeling clammy. There was no other reported visit. No further information was available at the time of the report. The subject's outcome was not recovered. According to the investigator, the event of chest pressure was possibly related to vaccination with ACAM2000, and was considered to be an Other Important Medical Event. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. List of docs held by sender: medical records.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram normal, Troponin I
Clinical narrative: Initial report received on 29 August 2012 from an investigator. A male subject (age not reported) developed chest pain, shortness of breath and dizziness on 21 August 2012, six days after receiving a left arm injection of ACAM2000, SP Biologics Co., (Lot number and route not reported); TYPHOID VACCINE, manufacturer unknown, and ANTHRAX, other manufacturer, (lot numbers, routes and sites not reported on 15 August 2012. The subject had an ECG, which was reported as normal on 24 August 2012 and a chemistry Troponin I test with results reported as less than <0.10, which was reported as normal on 24 August 2012, which according to the Investigator makes cardiac etiology unlikely. No treatment was reported as prescribed. The subject was referred to Medical. The subject did not have any reported past medical history relevant to the adverse event and concomitant medications were not reported. (However, progress note noted subject had surgery for broken right tibia "tibula" as well as fibula and subtalar "subtaylor" fracture left ankle in February 2006, which causes swollen painful joints. No further medical history was reported). The subject was reported lost to follow-up. The patient's outcome was not reported. According to the investigator the event of chest pain was possibly related to the trial product or the trial procedures. Documents held by sender: Medical Records.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Troponin normal
Clinical narrative: Initial report received on 29 August 2012 from an investigator. A male subject (age not reported) developed chest pain, shortness of breath and dizziness on 21 August 2012, six days after receiving a left arm injection of ACAM2000, SP Biologics Co., (Lot number and route not reported); TYPHOID VACCINE, manufacturer unknown, and ANTHRAX, other manufacturer, (lot numbers, routes and sites not reported on 15 August 2012. The subject had an ECG, which was reported as normal on 24 August 2012 and a chemistry Troponin I test with results reported as less than <0.10, which was reported as normal on 24 August 2012, which according to the Investigator makes cardiac etiology unlikely. No treatment was reported as prescribed. The subject was referred to Medical. The subject did not have any reported past medical history relevant to the adverse event and concomitant medications were not reported. (However, progress note noted subject had surgery for broken right tibia "tibula" as well as fibula and subtalar "subtaylor" fracture left ankle in February 2006, which causes swollen painful joints. No further medical history was reported). The subject was reported lost to follow-up. The patient's outcome was not reported. According to the investigator the event of chest pain was possibly related to the trial product or the trial procedures. Documents held by sender: Medical Records.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Electrocardiogram normal, Palpitations, Tooth repair, Toothache, Troponin normal
Clinical narrative: This study case was received from the investigator on 29 August 2012. A male subject experienced heart palpitations on 23 August 2012, eight days after the subject had received on 15 August 2012 the following vaccines: ACAM2000 (lot number, route and site of administration not reported), an injection of TYPHOID VACCINE (lot number, route and site of administration not reported) and an injection of ANTHRAX VACCINE (lot number, route and site of administration not reported). The subject also went to the dentist on 22 August 2012 for a filling which caused him pain in his tooth. He took ibuprofen for that on the day only. The subject had an ECG done on 24 August 2012 which was normal. Rapid troponin on 24 August 2012 was also normal. The subject had no past medical history and took no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered on 23 August 2012. According to the investigator, palpitations were possibly related to the trial product. Documents held by sender: none.
Age: 1.45
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3153BA received on 10 August 2009, C3363AA received on 26 October 2009, C3469AA received on 18 December 2009 and C3731AA received on 19 November 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 26 May 2012, approximately 18 months after the last dose. On 30 May 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 30 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 12 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.45
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; lot number C3153BA received on 10 August 2009, C3363AA received on 26 October 2009, C3469AA received on 18 December 2009 and C3731AA received on 19 November 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 26 May 2012, approximately 18 months after the last dose. On 30 May 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 30 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 30 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 12 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea 7-8 times a day for 3 days, vomiting 1 time.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: None noted.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Lethargy, Pallor, Syncope
Clinical narrative: Child fainted shortly after receiving vaccines. We were able to revive him but he was pale and lethargic. We called an ambulance.
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea haemorrhagic, Headache, Influenza like illness, Pyrexia, Rash
Clinical narrative: Flu-like, headache, vertigo, fever, rash, bloody diarrhea.  Patient reported this went on from 8/3/2012 until 8/27/2012. She also received other vaccines from another provider. (Tdap, ipv, Hep A & B)
Age: 29.0
Sex: F
Vaccine: YF
Symptoms: Vertigo
Clinical narrative: Flu-like, headache, vertigo, fever, rash, bloody diarrhea.  Patient reported this went on from 8/3/2012 until 8/27/2012. She also received other vaccines from another provider. (Tdap, ipv, Hep A & B)
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule
Clinical narrative: Immediate development of 2 cm raised red nodule lateral to injection site (likely in muscle body) on R thigh.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Joint stiffness, Nausea, Paraesthesia oral
Clinical narrative: Developed stiff jaw, tingling lips, nausea.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Headache, Injection site swelling, Pain, Pyrexia
Clinical narrative: Low grade fever, bad head ache, achy, large swollen arm at injection site (about silver dollar size, hard raised about 1/4-1/2 of an inch, very tired.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Meningitis viral, Varicella post vaccine
Clinical narrative: Patient's daughter reports that the patient developed "chicken pox" within 3 days of receiving the vaccine. She also stated that the patient later developed viral meningitis as a directed result of the vaccine.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Headache, Malaise, Tremor
Clinical narrative: 08/15/2012 dizziness. 08/16/2012 headache, hands shaking. 08/17/2012 headache, hands shaking, dizziness. School nurse mother pick him up from school due to visible illness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Urticaria. Benadryl PO, Methylprednisone IM.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, PNC13
Symptoms: Urticaria
Clinical narrative: Urticaria like rash, and hives.
Age: 4.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Local reaction, Rash erythematous, Swelling
Clinical narrative: Swelling and redness with raised white edge. Pt. was comfortable, no fever, emesis, pain, decreased ROM in limb, eating, playing and sleeping fine. Area was marked with pen to identify if it was getting larger. Spoke with mother 3 hrs after seeing child in clinic and she was taking child to hospital. E/R doc stated locallized reaction, but gave Bactrim anti-biotics and sent home. Spoke with pt. mother the next morning @ 8:40 am. Redness is lessened, but is still outisde the borders that were marked with pen. Not as hot and the raised white edge is gone completely. Mother has chosen to continue with antibiotics as suggested by E/R MD.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Feeling hot, Mass, Pruritus
Clinical narrative: A lump, bruising, warmth, itching, swelling, redness. Treatment includes Diphenhydramine HCL (25mg) and 1% hydrocortisone ointment.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: A lump, bruising, warmth, itching, swelling, redness. Treatment includes Diphenhydramine HCL (25mg) and 1% hydrocortisone ointment.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper, Back pain, Decreased appetite, Diarrhoea, Flatulence
Clinical narrative: (Currently occurring) nausea, inability to sleep, loss of appetite, diarrhea, watery stool, stomach cramps, headache, gas, back pain/ache.
Age: 21.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Insomnia, Nausea
Clinical narrative: (Currently occurring) nausea, inability to sleep, loss of appetite, diarrhea, watery stool, stomach cramps, headache, gas, back pain/ache.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pain at injection site.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 10-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3930AA received on 20 September 2011, lot number C4081AA received on 30 November 2011 and lot number C4163AA received on 15 February 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 18 June 2012, approximately 4 months after the last dose. On 24 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 24 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in an 10-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3930AA received on 20 September 2011, lot number C4081AA received on 30 November 2011 and lot number C4163AA received on 15 February 2012 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 18 June 2012, approximately 4 months after the last dose. On 24 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 24 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 25 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 30 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.63
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray abnormal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3840AA received on 02 May 2011, C3893AA received on 05 July 2011 and C3930AA received on 19 September 2011 (routes and sites of administration not reported). The subject developed paroxysmal cough (without whoop) and cold-like symptoms on 05 July 2012, approximately 9 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 15 July 2012. Chest x-ray was positive, indicating pneumonia, but the subject was not hospitalized. Corrective treatment consisted of azithromycin starting on 15 July 2012 for 5 days. At the time of final contact on 22 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.