chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I, Troponin increased, Troponin normal
Clinical narrative: A 22-year-old 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 25 March 2010 (also with a reported date of 01 April 2010) an elevated central laboratory Troponin level of 0.13 ng/ml and on 13 April 2010 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 13 April 2010. The subject had a rapid Troponin I level on 25 March 2010 that was within normal limits (negative). On 13 April 2010, the subject had a normal ECG reading. On 13 March 2010 (also with a reported date of 25 March 2010), the subject experienced AEs including intermittent fevers (recovered 15 March 2010), soreness on right smallpox site (ongoing), acid reflux (recovered 24 March 2010), and painful joints left and right legs "both legs" (ongoing). The subject's concomitant medications included ALEVE and TUMS. 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: Electrocardiogram normal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with a past medical history that included chest pain, shortness of breath, cigar smoking and chewing tobacco use had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 22 May 2010 an elevated Troponin, central laboratory level of 0.11 ng/ml (drawn date of 20 May 2010). The subject had a rapid Troponin I level on 20 May 2010 that was within normal limits (negative). On 24 May 2010, the subject has an ECG that was normal. A repeat Troponin on 24 May 2010 was <0.10 ng/mL, per investigator was normal. The subject reported that he had a sore throat, headache and congestion from 13 to 20 May 2010. Concomitant medication included OTC cold medicine. No further information was available at the time of the report. The subject's outcome was recovered on 27 May 2010. 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: Electrocardiogram abnormal, Supraventricular extrasystoles, Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A male subject (date of birth not reported) with no reported past medical history had received a ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 19 March 2010 an elevated Troponin, central laboratory level of 0.13 ng/mL (draw date 18 March 2010). The subject had a rapid Troponin I level on 18 March 2010 that was within normal limits (negative). The subject was asymptomatic according to the investigator. An ECG on 23 March 2010 was "abnormal:NCS", ectopic supraventricular rhythm. A repeat Troponin on 23 March 2010 was <0.10 ng/mL. The subject had no concomitant medications. No treatments were reported. No further information was available at the time of the report. The subject's outcome was recovered, no residual effects on 24 March 2010. 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: Electrocardiogram normal, 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 19 March 2010 an elevated Troponin, central laboratory level of 0.14 ng/ml (draw date 18 March 2010). The subject had a rapid Troponin I level on 18 March 2010 that was within normal limits (negative). An ECG on 09 April 2010 was normal. A repeat Troponin on 09 April 2010 was <0.10 ng/mL and according to the investigator was normal. The subject had no concomitant medications. No treatments were reported. No further information was available at the time of the report. The subject's outcome was recovered, no residual effects on 10 April 2010. 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.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram normal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: Initial report received on 27 August 2012 from an investigator. A 28-year-old 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 Troponin I level result of 0.12 ng/mL) on 22 February 2010 (with reported date of 25 February 2010) after receiving 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 26 February 2010. ECG was reported as normal on 26 February 2010. Treatment reported as "treatment (other than medication)". The subject had a past medical history of psychiatric illness reported on 09 February 2010 and took concomitant medication, CELEXA for depression since May 2009. Psychiatric illness was reported as "no" and concomitant medication was reported as "no" on visit on 22 February 2010. The subject had no reported surgical history, 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"). The subject denied use of alcohol (reported as "never") and denied tobacco use. The patient recovered (also reported as "no residual effects") with stop date of adverse event reported as 28 February 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.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Soreness, Redness, and Swelling from the upper left arm down to the elbow by 9/4/12. Arm feels stiff. Mild fever at 99.5 by evening on 9/3/12.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Culture wound negative, Gram stain positive, Incisional drainage, Injection site swelling, Joint swelling
Clinical narrative: Swelling of arm 12 cm above and 10 cm below the elbow.  Elbow swelling the size of a softball.  Only small amount of swelling at the injection site.  No rash, sob, n&v, myalgia, or facial swelling.  I&D of the elbow performed in the ED.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral
Clinical narrative: Swelling of arm 12 cm above and 10 cm below the elbow.  Elbow swelling the size of a softball.  Only small amount of swelling at the injection site.  No rash, sob, n&v, myalgia, or facial swelling.  I&D of the elbow performed in the ED.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Swelling, Tenderness
Clinical narrative: Patient developed a hard, raised area that was sore to touch. The area was very dry and 2 inches in diameter.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Burning sensation, Dyspnoea, Hypoaesthesia, Injection site anaesthesia, Injection site pain
Clinical narrative: 15 minutes after vaccination, there was a burning sensation starting at the vaccination site and spreading up through the neck to the jaw. Following the burning, there was a numbing/tightening sensation where the burning was. Jaw muscles tightened and tongue swelled, restricting breathing. Placed under observation until symptoms subsided 2 hours later.
Age: 27.0
Sex: F
Vaccine: TYP
Symptoms: Joint stiffness, Musculoskeletal stiffness, Swollen tongue
Clinical narrative: 15 minutes after vaccination, there was a burning sensation starting at the vaccination site and spreading up through the neck to the jaw. Following the burning, there was a numbing/tightening sensation where the burning was. Jaw muscles tightened and tongue swelled, restricting breathing. Placed under observation until symptoms subsided 2 hours later.
Age: 5.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Child woke up from a nap while at baby sitter's with hive-like swellings that were very itchy approximately 4 hrs. after receiving MMR #2; Varivax #2; and Hep A #1. The babysitter called her mother who then called me asking what to do. I suggested giving BENADRYL and ascertained there was no difficulty breathing, swelling of lips or tongue, and no fever. The "hives" were on the child's extremities, trunk and face. She had no other symptoms.The babysitter gave her BENADRYL and applied calamine lotion to "hives". I called mom an hour later an found that the redness had subsided and the child was running & jumping around playing and in no distress. I instructed the mother to continue to observe the child for difficulty breathing and for increased swellling. If noted, the child should be taken to the emergency room or call 911. I spoke with the mother the next morning and all hives were clear and the child is fine. She had given her BENADRYL and the applied a corisine cream to the hives the night before.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Feeling abnormal, Pyrexia, Skin lesion, Vaccination complication
Clinical narrative: Pt reports 12 vesicles to the right arm (immunization given in the right arm) on Saturday.  Now only 5 lesions.  Feeling better and no further fever.  Advised this can be a reaction from vaccine.  (? related to prednisone usage--d/c'd 2-3 weeks before vaccine given).  Will follow.  Advised to keep lesions covered until healed.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram normal, Troponin I increased, Troponin increased
Clinical narrative: This study case was received from the investigator on 27 August 2012. A 21-year-old 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 14 July 2009 an elevated central laboratory Troponin level of 2.03 ng/ml and on 23 July 2009 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 23 July 2009. The subject also had a rapid Troponin I level on 14 July 2009 that was not within normal limits (positive). On 14 July 2009, the subject had a normal ECG reading. Also, the subject had experienced chest pain on 13 July 2009, which resolved on the same day. 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 other 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. Documents held by sender: medical records.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Nausea, Pain
Clinical narrative: Flu-like symptoms, fever, nausea, chills, sweats, aches, restlessness, pain.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Restlessness
Clinical narrative: Flu-like symptoms, fever, nausea, chills, sweats, aches, restlessness, pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Injection site erythema, Injection site swelling, Nasal congestion, Ocular hyperaemia
Clinical narrative: Child began sneezing, coughing, nasal congestion, red eyes, c/o throat hurting upon ausculation: wheezing heard, one red bump on abdomen,  red, swollen left arm injection site MMR.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Oropharyngeal pain, Rash, Rash erythematous, Sneezing, Wheezing
Clinical narrative: Child began sneezing, coughing, nasal congestion, red eyes, c/o throat hurting upon ausculation: wheezing heard, one red bump on abdomen,  red, swollen left arm injection site MMR.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: Lethargy, Pruritus, Rash
Clinical narrative: 2 hours after the rash felt lethargic and complained of pruritus then 3-4 hours later developed diffuse non urticarial rash.
Age: 48.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram abnormal, Nerve conduction studies abnormal, Troponin I, Troponin increased, Troponin normal
Clinical narrative: This study case was received from the investigator on 27 August 2012. A 48-year-old 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 15 October 2009 (also with a reported date of 19 October 2009) an elevated central laboratory Troponin level of 0.44 ng/ml and on 20 October 2009 a central laboratory Troponin level of <0.10 ng/ml. The date of recovery was reported as 20 October 2009. The subject had a rapid Troponin I level on 15 October 2009 that was within normal limits (negative). On 20 October 2009, the subject had an "abnormal:NCS" ECG reading (per medical records, the ECG reading was documented as normal). 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 other 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: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Injection site pruritus, 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 no reported past medical history had received ACAM2000 (lot number, route, site of administration not reported) "just before holiday" and an unspecified amount of time later was found to have on 04 December 2009 (also reported as study day 17) an elevated Troponin, central laboratory level of 0.17 ng/mL (also with a reported date of 11 December 2009). The subject had a rapid Troponin I level on 04 December 2009 that was within normal limits (negative). The subject was asymptomatic according to the investigator. An ECG was performed on 05 January 2010 that was reported as normal. A repeat Troponin on 05 January 2010 (also reported as study day 49) remained elevated 0.14 ng/mL. The subject had no concomitant medications. No treatments were reported. The subject had reported left arm itching at injection site with a reported start date of 22 November 2009 and an end date of 29 November 2009 (also with a reported date of 04 December 2009). 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: medical record.
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 23 September 2009 an elevated Troponin, central laboratory level of 0.17 ng/ml. The subject had a rapid Troponin I level on 23 September 2009 that was within normal limits (negative). No ECG was performed. No other reported visits, no chest x-ray, no echo and no labs. The subject had no concomitant medications. 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 elevated Troponin was considered an other important event and was 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.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cold sweat, Fall, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: Patient rec'd vaccine in clinic office. As we were leaving tx room, pt told mother she did not feel well. We sat down in pt waiting area. Mother then witnessed pt turned pale & fall over side of chair (passed out). Pt recovered (woke up) w/in 60 sec & complained she could "not think" felt like bubbles in her head & vision was "black". Mother called for assistance. Pt was pale, clammy, sweaty. Pt did not really remember where she was or what had happened corpsman then helped mother transport pt back to clinic tx area where pt was placed in recliner chair and Pulse ox & BP were monitored. Initial O2 sats mid 90's BP OK, HR increased. Continued to monitor pt for next 45 minutes. Color returned w/in 15 min of incident. Pt was released to mothers call 45 min after vaccination - all vitals were normal. Pt continued to be very "foggy" in her head all day - she was profoundly tired & complained of ringing in ears. Pt was fully recovered the following day.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness, Malaise, Pallor, Thinking abnormal
Clinical narrative: Patient rec'd vaccine in clinic office. As we were leaving tx room, pt told mother she did not feel well. We sat down in pt waiting area. Mother then witnessed pt turned pale & fall over side of chair (passed out). Pt recovered (woke up) w/in 60 sec & complained she could "not think" felt like bubbles in her head & vision was "black". Mother called for assistance. Pt was pale, clammy, sweaty. Pt did not really remember where she was or what had happened corpsman then helped mother transport pt back to clinic tx area where pt was placed in recliner chair and Pulse ox & BP were monitored. Initial O2 sats mid 90's BP OK, HR increased. Continued to monitor pt for next 45 minutes. Color returned w/in 15 min of incident. Pt was released to mothers call 45 min after vaccination - all vitals were normal. Pt continued to be very "foggy" in her head all day - she was profoundly tired & complained of ringing in ears. Pt was fully recovered the following day.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Patient rec'd vaccine in clinic office. As we were leaving tx room, pt told mother she did not feel well. We sat down in pt waiting area. Mother then witnessed pt turned pale & fall over side of chair (passed out). Pt recovered (woke up) w/in 60 sec & complained she could "not think" felt like bubbles in her head & vision was "black". Mother called for assistance. Pt was pale, clammy, sweaty. Pt did not really remember where she was or what had happened corpsman then helped mother transport pt back to clinic tx area where pt was placed in recliner chair and Pulse ox & BP were monitored. Initial O2 sats mid 90's BP OK, HR increased. Continued to monitor pt for next 45 minutes. Color returned w/in 15 min of incident. Pt was released to mothers call 45 min after vaccination - all vitals were normal. Pt continued to be very "foggy" in her head all day - she was profoundly tired & complained of ringing in ears. Pt was fully recovered the following day.
Age: 12.0
Sex: F
Vaccine: HPVX, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Initial report was received on 23 August 2012 from a health care professional. A 12 year-old female patient with no reported past medical history had received MENACTRA, ADACEL, HPV and Varicella vaccines (lot numbers, routes, sites and dates of administration for all vaccines were not reported) manufacturer for HPV and Varicella were not reported)) and an unspecified amount of time after vaccination, experienced syncope. No further information was provided at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2012-07890 and 2012-07891. Documents held by sender: none.
Sex: M
Vaccine: SMALL
Symptoms: Back pain, 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 04 December 2009 an elevated Troponin, central laboratory level of 0.15 ng/ml (also with a reported date of 11 December 2009). The subject had a rapid Troponin I level on 04 December 2009 that was within normal limits (negative). On study day 22, the subject had a visit for back pain. No other reported visit, no chest x-ray, no echo and no labs. 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. 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.
Age: 23.0
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 23-year-old 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 23 November 2009 (also with a reported date of 19 October 2009) an elevated central laboratory Troponin level of 0.46 ng/ml and on 03 December 2009 (also with a reported date of 04 December 2009) a central laboratory Troponin level of 0.46 ng/ml. It was reported that treatment (other than medication) was given. The subject had a rapid Troponin I level on 23 November 2009 that was within normal limits (negative). The subject had an ECG performed on 03 December 2009 with normal results. 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.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood test, Dizziness, Dyspnoea, Electrocardiogram ST segment elevation, Electrocardiogram repolarisation abnormality
Clinical narrative: This study case was received from the investigator on 25 August 2012. A male subject passed out in formation on 16 August 2012, one day 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 felt dizzy, lightheaded, short of breath (SOB), blurred vision, sweating and experienced syncope in formation. The subject denied chest pain and cough. Rapid troponin was normal, EKG on 21 August 2012 indicated ST elevation due to early repolarization but not active ischemia, unconcerning for myopericarditis. The subject did not take any medications to treat the SAE. On 21 August 2012, the subject's smallpox injection site was reported to look "horrible". One tube of blood was taken. The subject reports no new concomitant medications (con-meds) and no HURT was marked on Wong Baker scale. The subject reported that fainting was moderate and dizziness, lightheadedness, blurred vision, sweating and shortness of breath was mild. No further information was available at the time of the report. The subject's outcome was recovered on 16 August 2012. According to the investigator, passing out in formation was possibly related to the trial product. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Hyperhidrosis, Injection site reaction, Loss of consciousness, Syncope, Troponin normal
Clinical narrative: This study case was received from the investigator on 25 August 2012. A male subject passed out in formation on 16 August 2012, one day 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 felt dizzy, lightheaded, short of breath (SOB), blurred vision, sweating and experienced syncope in formation. The subject denied chest pain and cough. Rapid troponin was normal, EKG on 21 August 2012 indicated ST elevation due to early repolarization but not active ischemia, unconcerning for myopericarditis. The subject did not take any medications to treat the SAE. On 21 August 2012, the subject's smallpox injection site was reported to look "horrible". One tube of blood was taken. The subject reports no new concomitant medications (con-meds) and no HURT was marked on Wong Baker scale. The subject reported that fainting was moderate and dizziness, lightheadedness, blurred vision, sweating and shortness of breath was mild. No further information was available at the time of the report. The subject's outcome was recovered on 16 August 2012. According to the investigator, passing out in formation was possibly related to the trial product. Documents held by sender: none.
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Vision blurred
Clinical narrative: This study case was received from the investigator on 25 August 2012. A male subject passed out in formation on 16 August 2012, one day 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 felt dizzy, lightheaded, short of breath (SOB), blurred vision, sweating and experienced syncope in formation. The subject denied chest pain and cough. Rapid troponin was normal, EKG on 21 August 2012 indicated ST elevation due to early repolarization but not active ischemia, unconcerning for myopericarditis. The subject did not take any medications to treat the SAE. On 21 August 2012, the subject's smallpox injection site was reported to look "horrible". One tube of blood was taken. The subject reports no new concomitant medications (con-meds) and no HURT was marked on Wong Baker scale. The subject reported that fainting was moderate and dizziness, lightheadedness, blurred vision, sweating and shortness of breath was mild. No further information was available at the time of the report. The subject's outcome was recovered on 16 August 2012. According to the investigator, passing out in formation was possibly related to the trial product. Documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Pt had TDaP admin 8/29. Initially develop pain & swelling at site. On 9/4 developed severe itching. No rash, hive or systemic reaction.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Local reaction, Pain in extremity, Pruritus
Clinical narrative: Sore at site the day after vaccination. X2 days had itchiness, redness, swelling 2 inches below vacc. site with warmth to touch. No blister. Sts entire arm was painful on 8-28-12. States it was a local reaction only - no fever or other generalized symptoms reported.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: Sore at site the day after vaccination. X2 days had itchiness, redness, swelling 2 inches below vacc. site with warmth to touch. No blister. Sts entire arm was painful on 8-28-12. States it was a local reaction only - no fever or other generalized symptoms reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Significant swelling and redness from shoulder to elbow.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Burning sensation, Cough, Fatigue, Feeling cold
Clinical narrative: Patient developed pain and difficulty raising arm, numbness, and heavy sensation. Started to develop burning sensation and cough, sore throat, and felt cold.  At 11:30 PM, she got up and vomited one time. The next day (8/31/12), she was very tired and spent the day laying on the couch. Patient felt OK on Saturday (9/1/12) and could return to usual daily activities.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Oropharyngeal pain, Pain in extremity, Sensation of heaviness
Clinical narrative: Patient developed pain and difficulty raising arm, numbness, and heavy sensation. Started to develop burning sensation and cough, sore throat, and felt cold.  At 11:30 PM, she got up and vomited one time. The next day (8/31/12), she was very tired and spent the day laying on the couch. Patient felt OK on Saturday (9/1/12) and could return to usual daily activities.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient developed pain and difficulty raising arm, numbness, and heavy sensation. Started to develop burning sensation and cough, sore throat, and felt cold.  At 11:30 PM, she got up and vomited one time. The next day (8/31/12), she was very tired and spent the day laying on the couch. Patient felt OK on Saturday (9/1/12) and could return to usual daily activities.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Bone pain, Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: Nausea and vomiting for 24 hours, severe bone and joint pain, sore throat, not able to keep food down for 5 days. Returned to normal on 8th day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: PATIENT CONTRACTED CELLULITIS ON ARM AT INJECTION SITE.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tenderness
Clinical narrative: RASH DEVELOPED ACROSS LEFT SIDE OF CHEST (VACCINE GIVEN IN LEFT ARM). BEGAN THE NIGHT OF ADMINISTRATION; WHEN PATIENT WOKE UP, THE RASH WAS MORE PRONOUNCED. RASH STILL PRESENT AS OF 9/5/2012, AND ARM IS STILL TENDER.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Erythema, Injection site discomfort, Injection site swelling, Musculoskeletal pain
Clinical narrative: 8/8/12  patient received vaccination subcutaneously in Right upper posterior arm. 8/21/12  patient phoned to report that she believes she may have had a reaction to the Zostavax. Relates the following events: 8/8/12 - several hours after the vaccination experienced injection site swelling and discomfort. 8/9/12  noted lumps under her Right arm. 8/13/12  noted throbbing pain in Right scapula area and down Right arm, she also noted red swollen papule type lumps approx. 5mm in diameter that were surrounded by a dark red area. These were not vesicles. 8/22/12  referred to company physician  noted she did not exhibit classic vesicles or crusting of HSV, prescribed Lyrica, Atarax, and Tylenol #3. Referred to her PCP for fup on 8/27/12. 8/27/12  saw PCP in fup.  Experienced swelling in face, legs, and feet which the Dr. related to the Lyrica, Lyrica was discontinued and a course of Prednisone was started and pt is using hydrocortisone cream under her arm for the itch. 8/31/12  fup appt with PCP, no further treatment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Pruritus, Rash papular, Swelling face
Clinical narrative: 8/8/12  patient received vaccination subcutaneously in Right upper posterior arm. 8/21/12  patient phoned to report that she believes she may have had a reaction to the Zostavax. Relates the following events: 8/8/12 - several hours after the vaccination experienced injection site swelling and discomfort. 8/9/12  noted lumps under her Right arm. 8/13/12  noted throbbing pain in Right scapula area and down Right arm, she also noted red swollen papule type lumps approx. 5mm in diameter that were surrounded by a dark red area. These were not vesicles. 8/22/12  referred to company physician  noted she did not exhibit classic vesicles or crusting of HSV, prescribed Lyrica, Atarax, and Tylenol #3. Referred to her PCP for fup on 8/27/12. 8/27/12  saw PCP in fup.  Experienced swelling in face, legs, and feet which the Dr. related to the Lyrica, Lyrica was discontinued and a course of Prednisone was started and pt is using hydrocortisone cream under her arm for the itch. 8/31/12  fup appt with PCP, no further treatment.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Incisional drainage, Injected limb mobility decreased
Clinical narrative: The mother reports that there was no redness or heat at the injection site at the time of vaccination. However, after a few days, the child was unable to move his right arm. The mother took the child to the doctor. A surgical drainage was performed. Mom pointed to the an area near the child's armpit as the site of the surgical drainage procedure. This was reported to us for the first time on 8/27/2012 when the child was at our clinic again for an additional set of immunizations. Mom is not aware that any VAERS report was ever filed.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Bacterial test, Body temperature increased, Borrelia test, Computerised tomogram, Convulsion
Clinical narrative: Extremities, neck & head pain, altered mental state, 100.9 temperature; 8/24/12 seizures,unconciousness, 104 temperature. Admitted to hospital and then another hospital.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electroencephalogram, Headache, Loss of consciousness, Lumbar puncture, Mental disorder
Clinical narrative: Extremities, neck & head pain, altered mental state, 100.9 temperature; 8/24/12 seizures,unconciousness, 104 temperature. Admitted to hospital and then another hospital.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Mental status changes, Microbiology test, Neck pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Extremities, neck & head pain, altered mental state, 100.9 temperature; 8/24/12 seizures,unconciousness, 104 temperature. Admitted to hospital and then another hospital.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Viral test
Clinical narrative: Extremities, neck & head pain, altered mental state, 100.9 temperature; 8/24/12 seizures,unconciousness, 104 temperature. Admitted to hospital and then another hospital.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Feeling hot, Injection site reaction, Muscle swelling, Swelling, Tenderness
Clinical narrative: Swelling of deltoid muscle from top of shoulder down to mid humerus. No swelling palpable on inferior, inner upper arm. Hot, swollen, tender. No axilla nodes palpated.
Age: 90.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Laboratory test, Malaise, Pallor, Wheezing
Clinical narrative: About 20/30 mins after vaccines were given pt. c/o SOB, slight wheezing, pale & "not feeling well" daughter states she had been previously having these spells at home but were becoming worse & more frequent. Pt. was outside in hot car. O2 placed on pt. Physician on site & 911 called.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, Swelling, warm area
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Blood parathyroid hormone increased, Borrelia test negative, CSF test normal, CSF virus no organisms observed, Diarrhoea
Clinical narrative: Vomiting x 1, diarrhea/loose stools x 2-4 then acute inappropriate lethargy and encephalopathy until 8/23. Hospitalized with presumed meningitis but CSF was negative for pleocytosis and HSV, WNV,Lyme ultimately negative. Enterovirus Ab pending.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Encephalopathy, Enterovirus test, Herpes simplex serology negative, Lethargy, Vomiting
Clinical narrative: Vomiting x 1, diarrhea/loose stools x 2-4 then acute inappropriate lethargy and encephalopathy until 8/23. Hospitalized with presumed meningitis but CSF was negative for pleocytosis and HSV, WNV,Lyme ultimately negative. Enterovirus Ab pending.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: West Nile virus test negative
Clinical narrative: Vomiting x 1, diarrhea/loose stools x 2-4 then acute inappropriate lethargy and encephalopathy until 8/23. Hospitalized with presumed meningitis but CSF was negative for pleocytosis and HSV, WNV,Lyme ultimately negative. Enterovirus Ab pending.
Age: 24.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Blood glucose normal, Depressed level of consciousness, Disorientation, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Patient and his wife stated that he has had a history of fainting when recieving shots and requested to lay down on the floor. He laid down on the floor prior to recieving vaccines. He recieved 3 vaccines at this time and was speaking while he recived the first 2 (Typhoid and yellow fever). During the administration of the  3rd vaccine (Hep A) pt turned pale and stopped speaking. Pt was breifly unresponsive, but was having labored breathing. Ammonia tablet used to help pt become alert. 911 was called for help. Pt became alert and oriented after being unresponsive for about 30 seconds. Pt was alert and oriented to person place and time. BP was 117/60 and pt's breathing was normal at this time. EMS arrived and monitored pt's BP for about 30 minutes. Blood glucose leverl was taken and was stable. PT was stable and was not complaining of any syncope at this time. Pt declined to be taken to the Emergency department for evaluation. Pt was driven home by his wife. A follow up call was made several hours after the incident and pt stated that he was feeling fine.
Age: 24.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Patient and his wife stated that he has had a history of fainting when recieving shots and requested to lay down on the floor. He laid down on the floor prior to recieving vaccines. He recieved 3 vaccines at this time and was speaking while he recived the first 2 (Typhoid and yellow fever). During the administration of the  3rd vaccine (Hep A) pt turned pale and stopped speaking. Pt was breifly unresponsive, but was having labored breathing. Ammonia tablet used to help pt become alert. 911 was called for help. Pt became alert and oriented after being unresponsive for about 30 seconds. Pt was alert and oriented to person place and time. BP was 117/60 and pt's breathing was normal at this time. EMS arrived and monitored pt's BP for about 30 minutes. Blood glucose leverl was taken and was stable. PT was stable and was not complaining of any syncope at this time. Pt declined to be taken to the Emergency department for evaluation. Pt was driven home by his wife. A follow up call was made several hours after the incident and pt stated that he was feeling fine.
Age: 4.0
Sex: M
Vaccine: IPV, PNC13
Symptoms: Blood test normal, Chills, Computerised tomogram normal, Gait disturbance, Hypotonia
Clinical narrative: Father reports that at 5:30 am on 8/2/12 found child to be pale and complaining of pain in the left leg. Father reports that he removed the bandaid and the leg was significantly swollen. When the child got up he was limping and remained pale. Father states that they ate breakfast and that the child went to the bathroom and minutes later he discovered the child lying on the floor very pale even to the lips and was "twitching and shivering" but was aware of surroundings and was asking "what is wrong dad, I can't move my legs or arms". Father states that he helped the child to the toilet and became limp and collapsed twice. The father reports that the child had little muscle tone at that time. He states after a while the child improved some but remained very pale and limped and continue to complain of pain in the leg. The father took the child to the emergency room and had blood work, a UA, and a CT scan performed which were all said to be negative. He was to follow up with a Dr. later in the day. After that time the child behaved as normal.
Age: 4.0
Sex: M
Vaccine: IPV, PNC13
Symptoms: Injection site pain, Injection site swelling, Muscle twitching, Pallor, Paralysis
Clinical narrative: Father reports that at 5:30 am on 8/2/12 found child to be pale and complaining of pain in the left leg. Father reports that he removed the bandaid and the leg was significantly swollen. When the child got up he was limping and remained pale. Father states that they ate breakfast and that the child went to the bathroom and minutes later he discovered the child lying on the floor very pale even to the lips and was "twitching and shivering" but was aware of surroundings and was asking "what is wrong dad, I can't move my legs or arms". Father states that he helped the child to the toilet and became limp and collapsed twice. The father reports that the child had little muscle tone at that time. He states after a while the child improved some but remained very pale and limped and continue to complain of pain in the leg. The father took the child to the emergency room and had blood work, a UA, and a CT scan performed which were all said to be negative. He was to follow up with a Dr. later in the day. After that time the child behaved as normal.
Age: 4.0
Sex: M
Vaccine: IPV, PNC13
Symptoms: Syncope, Urine analysis normal
Clinical narrative: Father reports that at 5:30 am on 8/2/12 found child to be pale and complaining of pain in the left leg. Father reports that he removed the bandaid and the leg was significantly swollen. When the child got up he was limping and remained pale. Father states that they ate breakfast and that the child went to the bathroom and minutes later he discovered the child lying on the floor very pale even to the lips and was "twitching and shivering" but was aware of surroundings and was asking "what is wrong dad, I can't move my legs or arms". Father states that he helped the child to the toilet and became limp and collapsed twice. The father reports that the child had little muscle tone at that time. He states after a while the child improved some but remained very pale and limped and continue to complain of pain in the leg. The father took the child to the emergency room and had blood work, a UA, and a CT scan performed which were all said to be negative. He was to follow up with a Dr. later in the day. After that time the child behaved as normal.
Age: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Patient was given shot and was walking out the door when four marks showed up on her skin.  They look a little like insect bites but they where not there before the shot.  We had the patient come back into the exam room and listened for wheezing.  As I sat and watched her 4 more hive broke out.  No redness around the inject site or hives, but two hives broke out on her side and then two more on her chest.  We set a timer and keep reassess her. No more hive broke out and 25 minutes after the shot her lung were clear and  no addition rash.  I gave 5mg of Claritin at about 10 minutes after the shot.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: 9PM Headache. 10PM, HA escalated, pt profusely diaphoretic (changed shirt & pants X3, nausea. Symptoms slowly subsided by 12:30. 36 hrs after injection, developed a 4 inch x 1.5 inch raised white area at injection site - with pruritis. Lasted four days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: 9PM Headache. 10PM, HA escalated, pt profusely diaphoretic (changed shirt & pants X3, nausea. Symptoms slowly subsided by 12:30. 36 hrs after injection, developed a 4 inch x 1.5 inch raised white area at injection site - with pruritis. Lasted four days.
Age: 27.0
Sex: F
Vaccine: HEP, MM, TDAP
Symptoms: Activities of daily living impaired, Hypoaesthesia, Influenza like illness, Injection site inflammation, Injection site swelling
Clinical narrative: Numbness and itchiness all over arms and legs. Lasted over 24 hours. One week after on left arm (where Tdap was inserted) a raised red inflamed area appeared and radiated heat. Area was approximately 3" in diameter. The next day, a flu-like cold appeared accompanied by numbness, tingleness and pain shooting through arms and legs. Small lumps found in legs along tibialis anterior and around ankle area. The pain makes it hard to perform normal ADL's.
Age: 27.0
Sex: F
Vaccine: HEP, MM, TDAP
Symptoms: Injection site warmth, Lower extremity mass, Nasopharyngitis, Pain in extremity, Paraesthesia
Clinical narrative: Numbness and itchiness all over arms and legs. Lasted over 24 hours. One week after on left arm (where Tdap was inserted) a raised red inflamed area appeared and radiated heat. Area was approximately 3" in diameter. The next day, a flu-like cold appeared accompanied by numbness, tingleness and pain shooting through arms and legs. Small lumps found in legs along tibialis anterior and around ankle area. The pain makes it hard to perform normal ADL's.
Age: 27.0
Sex: F
Vaccine: HEP, MM, TDAP
Symptoms: Pruritus
Clinical narrative: Numbness and itchiness all over arms and legs. Lasted over 24 hours. One week after on left arm (where Tdap was inserted) a raised red inflamed area appeared and radiated heat. Area was approximately 3" in diameter. The next day, a flu-like cold appeared accompanied by numbness, tingleness and pain shooting through arms and legs. Small lumps found in legs along tibialis anterior and around ankle area. The pain makes it hard to perform normal ADL's.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis below injection site.