chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Generalised oedema, Globulins increased, HIV test negative, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Headache, Hepatic steatosis, Hepatosplenomegaly, Hyperhidrosis, Injection site erythema
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Injection site swelling, International normalised ratio normal, Laboratory test normal, Leukocytosis, Lipase normal
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Lymph node pain, Lymphadenopathy, Lymphocyte percentage decreased, Malaise, Metabolic function test normal
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Mitral valve incompetence, Monocyte percentage increased, Myocardial necrosis marker, Nausea, Neck pain
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Neutrophil percentage increased, Night sweats, Nuclear magnetic resonance imaging heart, Pain, Painful respiration
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Pericardial effusion, Pericarditis, Phonophobia, Photophobia, Pleural effusion
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Protein total increased, Prothrombin time prolonged, Pyrexia, Red blood cell count decreased, Red blood cell sedimentation rate increased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Red cell distribution width increased, Serum ferritin increased, Sinus bradycardia, Thyroxine free normal, Tricuspid valve incompetence
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Troponin I normal, Troponin normal, Tuberculin test negative, Ultrasound abdomen abnormal, Urine analysis normal
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPA, SMALL, ANTH, HEPA, SMALL, ANTH, HEPA, SMALL, FLUN3, HEPA, SMALL
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 19 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium 18 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), Anthrax 1 (manufacturer, lot number, route and site of administration not reported) and Hepatitis A Adult (manufacturer, lot number, route and site of administration not reported) on 27 July 2010. Relevant laboratory data included: a normal Troponin I result, an abnormal ECG, an abnormal Echocardiogram and a normal lumbar puncture (spinal tap). Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: there is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow-up information was received on 24 August 2011 via a third party query tool search on the VAERS database, under reference number 425440. No further information was provided at the time of the report. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Cardiac enzymes, Cardiac imaging procedure, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 401761. A 22 year-old male patient had received the following vaccinations on 21 September 2010: an intradermal left arm injection of ACAM2000 (lot number VV04003A) and an intramuscular right arm injection HAVRIX (lot number AHAVB408BA) and nine days later, experienced chest pain and myocarditis with an elevated troponin. He was evaluated in the emergency room and hospitalized (dates not provided). Laboratory tests included cardiac enzymes, cardiac imaging, echocardiogram and an electrocardiogram (results not reported). No further information was available at the time of the report. The patient's outcome was not reported. A corrective version was created on 22 December 2010 to correct the route of administration from intradermal to percutaneous. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Myocarditis, Troponin increased
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 401761. A 22 year-old male patient had received the following vaccinations on 21 September 2010: an intradermal left arm injection of ACAM2000 (lot number VV04003A) and an intramuscular right arm injection HAVRIX (lot number AHAVB408BA) and nine days later, experienced chest pain and myocarditis with an elevated troponin. He was evaluated in the emergency room and hospitalized (dates not provided). Laboratory tests included cardiac enzymes, cardiac imaging, echocardiogram and an electrocardiogram (results not reported). No further information was available at the time of the report. The patient's outcome was not reported. A corrective version was created on 22 December 2010 to correct the route of administration from intradermal to percutaneous. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Nuclear magnetic resonance imaging normal, Pericardial disease
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 401761. A 22 year-old male patient had received the following vaccinations on 21 September 2010: an intradermal left arm injection of ACAM2000 (lot number VV04003A) and an intramuscular right arm injection HAVRIX (lot number AHAVB408BA) and nine days later, experienced chest pain and myocarditis with an elevated troponin. He was evaluated in the emergency room and hospitalized (dates not provided). Laboratory tests included cardiac enzymes, cardiac imaging, echocardiogram and an electrocardiogram (results not reported). No further information was available at the time of the report. The patient's outcome was not reported. A corrective version was created on 22 December 2010 to correct the route of administration from intradermal to percutaneous. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: HEPA, SMALL, FLUN3, HEPA, SMALL, VARCEL
Symptoms: Troponin I increased
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 401761. A 22 year-old male patient had received the following vaccinations on 21 September 2010: an intradermal left arm injection of ACAM2000 (lot number VV04003A) and an intramuscular right arm injection HAVRIX (lot number AHAVB408BA) and nine days later, experienced chest pain and myocarditis with an elevated troponin. He was evaluated in the emergency room and hospitalized (dates not provided). Laboratory tests included cardiac enzymes, cardiac imaging, echocardiogram and an electrocardiogram (results not reported). No further information was available at the time of the report. The patient's outcome was not reported. A corrective version was created on 22 December 2010 to correct the route of administration from intradermal to percutaneous. Documents held by sender: none.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Dizziness, Erythema, Nausea, Syncope
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 402012. A 25-year-old male patient received the following vaccinations on 05 October 2010: ACAM2000 (lot number VV04-003-A). On the day of vaccination, the patient felt dizzy, nauseated and he noticed diffuse redness. He was seen later that night in the emergency room (ER) where he received BENADRYL as corrective treatment and was discharged home. The day after vaccination, at about 1 PM, he began to feel weak, dizzy and nauseated. At 1:30 PM he experienced a witnessed syncopal event. He was taken to a clinic and received corrective treatment with intravenous fluids and intramuscular phenergan. At 4:30 PM he felt much better and was discharged home. The patient had no past medical history and no concurrent illness. He had been taking Doxycycline concomitantly. Outcomes was reported as recovered (date not reported). There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Generalised vaccinia
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 402237. A 26-year-old male patient received the following vaccinations on 27 August 2010: ACAM2000, lot number VV04-003-A. On 03 September 2010, seven days post vaccination, the patient developed generalized vaccinia "g/l" arms. The patient had no concurrent illness and no past medical history. Other medications consisted of ALLEGRA. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Acne, Rash pruritic
Clinical narrative: This case was received on 09 December 2010 via a QScan search on the VAERS database, under reference number 402345. A 23-year-old male patient received the following vaccination on 21 September 2010: a percutaneous ACAM2000 (lot number VV04003A) and BIOTHRAX (lot number FAV248). The patient had no current illnesses and no known drug allergy (NKDA). The patient takes "meprozale". His medical history was not reported. On 21 September 2010, the patient developed acne, rash and rash pruritic. The patient had a rash break out on his chest; it was itchy and appeared to be many pimples just starting out. The patient stated that he had never had any type of acne of this magnitude. The outcome was not reported. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Erythema, Full blood count normal, Headache, Injection site erythema, Injection site induration
Clinical narrative: This case was received on 09 December 2010 via a QScan search on the VAERS database, under reference number 403327. A 29-year-old female patient received the following vaccinations on 28 September 2010: a percutaneous left arm ACAM2000, lot number VV04003A, and an intramuscular TYPHIM VI, lot number D04121. The patient had no current illnesses and no medical history. Her concomitant medications were not reported. The patient's arm started swelling and turning red approximately 4 days after vaccine administration. The patient ran a low grade fever to as high as 104 degrees. The patient was seen on 08 October 2010 by a physician and at that time her left arm had softball diameter sized hard, red, raised area surrounding scabbed immunization site. There was redness from top of shoulder to her elbow with blister-like lesions going to back. The patient's lymph nodes in neck and axilla were very enlarged. She had difficulty turning her neck due to swelling but had a negative Kernig sign. The patient's laboratory findings included a complete blood count (CBC) which showed a white count of 9.3. She was also seen on 09 October 2010 and 12 October 2010 for a severe headache and was sent to the hospital. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. The outcome was reported as unknown. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Injection site scab, Injection site swelling, Injection site vesicles, Local swelling, Lymphadenopathy
Clinical narrative: This case was received on 09 December 2010 via a QScan search on the VAERS database, under reference number 403327. A 29-year-old female patient received the following vaccinations on 28 September 2010: a percutaneous left arm ACAM2000, lot number VV04003A, and an intramuscular TYPHIM VI, lot number D04121. The patient had no current illnesses and no medical history. Her concomitant medications were not reported. The patient's arm started swelling and turning red approximately 4 days after vaccine administration. The patient ran a low grade fever to as high as 104 degrees. The patient was seen on 08 October 2010 by a physician and at that time her left arm had softball diameter sized hard, red, raised area surrounding scabbed immunization site. There was redness from top of shoulder to her elbow with blister-like lesions going to back. The patient's lymph nodes in neck and axilla were very enlarged. She had difficulty turning her neck due to swelling but had a negative Kernig sign. The patient's laboratory findings included a complete blood count (CBC) which showed a white count of 9.3. She was also seen on 09 October 2010 and 12 October 2010 for a severe headache and was sent to the hospital. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. The outcome was reported as unknown. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: SMALL, TYP
Symptoms: Oedema peripheral, Pyrexia, White blood cell count normal
Clinical narrative: This case was received on 09 December 2010 via a QScan search on the VAERS database, under reference number 403327. A 29-year-old female patient received the following vaccinations on 28 September 2010: a percutaneous left arm ACAM2000, lot number VV04003A, and an intramuscular TYPHIM VI, lot number D04121. The patient had no current illnesses and no medical history. Her concomitant medications were not reported. The patient's arm started swelling and turning red approximately 4 days after vaccine administration. The patient ran a low grade fever to as high as 104 degrees. The patient was seen on 08 October 2010 by a physician and at that time her left arm had softball diameter sized hard, red, raised area surrounding scabbed immunization site. There was redness from top of shoulder to her elbow with blister-like lesions going to back. The patient's lymph nodes in neck and axilla were very enlarged. She had difficulty turning her neck due to swelling but had a negative Kernig sign. The patient's laboratory findings included a complete blood count (CBC) which showed a white count of 9.3. She was also seen on 09 October 2010 and 12 October 2010 for a severe headache and was sent to the hospital. There may be a discrepancy between the event date field and the onset date information in the free text narrative field in the data reported. Latency has been calculated using the event date. The outcome was reported as unknown. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: ANTH, FLU3, SMALL
Symptoms: Orthopox virus infection, Orthopoxvirus test positive, Polymerase chain reaction, Post vaccination autoinoculation, Skin lesion
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 403751. A 39-year-old female patient, who had concurrent condition of acne of face, but no other medical history or use of other medications, had received the following vaccinations on 21 September 2010: ACAM2000 (lot number VV04-003-A), BIOTHRAX (Emergent, lot number FAV251), and AFLURIA (CSL limited, lot number M51207). Six days post-vaccination on 27 September 2010 the patient experienced accidental implantation of vaccine on the chin after smallpox vaccination requiring emergency visit. Laboratory data revealed vaccinia PCR of lesion positive from 04 October 2010, and positive orthopoxvirus test. The patient was treated with analysis, antihistamines and antibiotics. The patient was reported as recovered. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: ANTH, FLU3, SMALL
Symptoms: Vaccinia test positive
Clinical narrative: This case was received on 09 December 2010 via a third party query tool search on the VAERS database, under reference number 403751. A 39-year-old female patient, who had concurrent condition of acne of face, but no other medical history or use of other medications, had received the following vaccinations on 21 September 2010: ACAM2000 (lot number VV04-003-A), BIOTHRAX (Emergent, lot number FAV251), and AFLURIA (CSL limited, lot number M51207). Six days post-vaccination on 27 September 2010 the patient experienced accidental implantation of vaccine on the chin after smallpox vaccination requiring emergency visit. Laboratory data revealed vaccinia PCR of lesion positive from 04 October 2010, and positive orthopoxvirus test. The patient was treated with analysis, antihistamines and antibiotics. The patient was reported as recovered. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Dizziness, Nausea, Rash pruritic
Clinical narrative: This case was received on 10 January 2011 via a third party query tool search on the VAERS database, under reference number 409372. The country of occurrence is unknown/not reported; the country of the reporter is unknown/not reported; and the country where the patient was vaccinated is unknown/not reported. A 24-year-old one pack per day cigarette smoking male patient had received on 10 November 2010 a first dose percutaneous left arm ACAM2000 (lot number VV04-003-A also reported as 072618). On 17 November 2010, the patient reported experiencing chest pain, lightheadedness, nausea and a "small nickel size itchy rash progressing to three times the original size noted". Treatments were not reported. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Pain of skin, Rash erythematous
Clinical narrative: This case was received on 11 January 2011 via third party query tool search on the VAERS database, under reference number 409567. A 27-year-old male patient received the first left arm dose of ACAM2000 (lot number VV04003A) on 10 November 2010. His medical history included an allergy to amoxicillin. On 21 November 2010, 11 days post-vaccination, the patient developed red bumps on the chest and back, described as having "pimple-type heads" and as being painful to the touch. No additional information was reported, and outcome was unknown.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Rash
Clinical narrative: This case was received on 11 January 2011 via a third party query tool search on the VAERS database, under reference number 409569. A 27-year-old male patient received a left arm injection of ACAM2000 (lot number VV04003A) on 10 November 2010. On 21 November 2010, 11 days post-vaccination, he noticed bumps across the chest and complained of some sporadic chest pains. Recovery status was unknown.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Loss of personal independence in daily activities, Nerve block, Nervousness, Nuclear magnetic resonance imaging brain normal, Pain
Clinical narrative: I got flu shot Sept. 26, 2010 - on Sept. 29, 2010 my arm started hurting from my shoulder to the tips of my fingers - even under my fingernails. I have had MRI - nerve block shot - put on several different medicines - nothing has helped. My hand stays swollen. I can't do anything around the house because it makes it hurt worse. Needless to say my nerves are a little upset.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: I got flu shot Sept. 26, 2010 - on Sept. 29, 2010 my arm started hurting from my shoulder to the tips of my fingers - even under my fingernails. I have had MRI - nerve block shot - put on several different medicines - nothing has helped. My hand stays swollen. I can't do anything around the house because it makes it hurt worse. Needless to say my nerves are a little upset.
Age: 23.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: This case was received on 11 January 2011 via a third party query tool search on the VAERS database, under reference number 410266. A 23-year-old male patient received the following vaccines on 10 November 2010: a first left arm dose of ACAM2000 (lot number VV04003A), a first right arm dose of TYPHIM Vi (lot number D1087), a first intranasal dose of FLUMIST (lot number 501057P) and a first right arm dose of BIOTHRAX (lot number FAV261). On 19 November 2010, 9 days post-vaccination, he complained that his arm was red and warm to the touch. On 22 November 2010 he was diagnosed with cellulitis and prescribed KEFLEX. Outcome was unknown.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Myocarditis
Clinical narrative: This case was received on 10 January 2011 via a third party query tool search on the VAERS database, under reference number 410590. A 26-year-old male patient had received the following vaccinations on 23 November 2010: ACAM2000 (lot number VV04003A). The patient had previously received Anthrax vaccine on 09 November 2010 and FLUMIST on 04 November 2010. The patient had a history of syncope since 2007. On 30 November 2010, the patient developed chest pain for two hours and he was seen in the emergency department. Laboratory findings revealed elevated cardiac enzymes; suspect myocarditis. Outcome was not reported. No further information was provided. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cardiac enzymes increased, Chest pain, Laboratory test abnormal, Myocarditis
Clinical narrative: This case was received on 10 January 2011 via a third party query tool search on the VAERS database, under reference number 410590. A 26-year-old male patient had received the following vaccinations on 23 November 2010: ACAM2000 (lot number VV04003A). The patient had previously received Anthrax vaccine on 09 November 2010 and FLUMIST on 04 November 2010. The patient had a history of syncope since 2007. On 30 November 2010, the patient developed chest pain for two hours and he was seen in the emergency department. Laboratory findings revealed elevated cardiac enzymes; suspect myocarditis. Outcome was not reported. No further information was provided. Documents held by sender: None.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Antibiotic resistant Staphylococcus test positive, Injection site cellulitis, Injection site swelling, Laboratory test abnormal, Mass
Clinical narrative: This case was received on 14 February 2011 via a QScan search on the VAERS database, under reference number 412584. A 28-year-old male patient received the following vaccination on 07 November 2010: a percutaneous ACAM2000 (lot number VV04003A). The patient's medical history was not provided. On 15 November 2010, the patient began to experience swelling 6 inches by 4 inches at the site and a knot on his left shoulder. The patient required an Emergency visit. On 17 November 2010, the patient had surgery to remove the infected area. The patient's laboratory data showed cellulitis of the left deltoid, likely Methicillin-resistant Staphylococcus aureus (MRSA). The outcome was reported as recovered on 04 December 2010. Documents held by sender: None.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Staphylococcal infection, Surgery
Clinical narrative: This case was received on 14 February 2011 via a QScan search on the VAERS database, under reference number 412584. A 28-year-old male patient received the following vaccination on 07 November 2010: a percutaneous ACAM2000 (lot number VV04003A). The patient's medical history was not provided. On 15 November 2010, the patient began to experience swelling 6 inches by 4 inches at the site and a knot on his left shoulder. The patient required an Emergency visit. On 17 November 2010, the patient had surgery to remove the infected area. The patient's laboratory data showed cellulitis of the left deltoid, likely Methicillin-resistant Staphylococcus aureus (MRSA). The outcome was reported as recovered on 04 December 2010. Documents held by sender: None.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Pain, Pain of skin, Rash pustular
Clinical narrative: This case was received on 14 February 2011 via a third party query tool search on the VAERS database, under reference number (VAERS ID 412865). A 35-year-old male patient received the following vaccination on 04 December 2010: ACAM2000 (lot number VV04003A). On 09 December 2010, five days post vaccination developed aches and chills which continued for several days. On 15 December 2010, 11 days post vaccination the patient reported he woke with several painful but not itchy pustule bumps on his neck and a large cluster under his chin. Lab data was reported as not available at the time of the report. Concomitant medications and current illnesses were reported as none. The patient was evaluated in the emergency department however treatments were not reported. The patient's outcome was reported as unknown. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: ANTH, FLU3, SMALL
Symptoms: Skin ulcer, Vaccinia virus infection
Clinical narrative: This case was received on 14 February 2011 via a third party query tool search on the VAERS database, under reference number (VAERS ID#413241). A 21-year-old male patient received the following vaccinations on 05 December 2010: ACAM2000 (lot number VV04003A), FLUZONE (lot number U3788AA), BIOTHRAX (lot number FAV265). On 17 December 2010, 12 days post vaccination complained of raised sores on his left shoulder and going down his back. Lab data, concomitant medications and current illnesses were reported as none. The patient was evaluated by a physician and diagnosed with "mild viral illness called vaccinia". On 20 December 2010, it was reported the sores had decreased in number and no problems were noted. The patient's outcome was reported as recovered. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Orthopox virus infection, Orthopoxvirus test positive, Polymerase chain reaction, Secondary transmission, Skin lesion
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 413977. A 22-year-old female patient, who had no current illness, no past medical history, and no history of smallpox vaccination, had developed an orthopox virus infection due to secondary transmission following exposure to the vaccine by contact with her boyfriend. Her boyfriend had received on 04 December 2010 a left arm injection of ACAM2000 (lot number VV04003A). The boyfriend, who stated he had a band aid on the site, had contact with the patient on 10 December 2010. The patient noticed a left calf lesion on 17 December 2010. On 28 December 2010, a sample was sent for vaccinia testing. The patient had a positive orthopox virus test and a positive polymerase chain reaction. The outcome was reported as unknown. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Exposure to vaccinated person, Orthopoxvirus test positive, Polymerase chain reaction, Secondary transmission, Skin lesion
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 413977. A 22-year-old female patient, who had no current illness, no past medical history, and no history of smallpox vaccination, had developed an orthopox virus infection due to secondary transmission following exposure to the vaccine by contact with her boyfriend. Her boyfriend had received on 04 December 2010 a left arm injection of ACAM2000 (lot number VV04003A). The boyfriend, who stated he had a band aid on the site, had contact with the patient on 10 December 2010. The patient noticed a left calf lesion on 17 December 2010. On 28 December 2010, a sample was sent for vaccinia testing. The patient had a positive orthopox virus test and a positive polymerase chain reaction. The outcome was reported as unknown. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Biopsy skin, Dermatitis bullous, Laboratory test
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 414162. A 29-year-old male patient received the following vaccinations on 06 December 2010: ACAM2000 (lot number VV04003A), TYPHIM VI (lot number d1087) and BIOTHRAX (lot number FAV264). On 21 December 2010, 15 days post-vaccination, the patient developed apparent autoimmune bullous dermatosis of the extremities. A skin biopsy was performed 28 December 2010. Laboratory testing was performed 06 January 2011. Results of skin biopsy and laboratory tests were pending. Photographs (copies not received) were taken 23 and 28 December 2010, and 06 January 2011. At the time of vaccination the patient had no concurrent illness, and no noted past history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Alanine aminotransferase increased, Biopsy skin abnormal, C-reactive protein normal, Complement factor C3 increased, Complement factor C4
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 414162. A 29-year-old male patient received the following vaccinations on 06 December 2010: ACAM2000 (lot number VV04003A), TYPHIM VI (lot number d1087) and BIOTHRAX (lot number FAV264). On 21 December 2010, 15 days post-vaccination, the patient developed apparent autoimmune bullous dermatosis of the extremities. A skin biopsy was performed 28 December 2010. Laboratory testing was performed 06 January 2011. Results of skin biopsy and laboratory tests were pending. Photographs (copies not received) were taken 23 and 28 December 2010, and 06 January 2011. At the time of vaccination the patient had no concurrent illness, and no noted past history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Differential white blood cell count normal, Erythema, Full blood count normal, Immune complex assay, Immunohistochemistry
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 414162. A 29-year-old male patient received the following vaccinations on 06 December 2010: ACAM2000 (lot number VV04003A), TYPHIM VI (lot number d1087) and BIOTHRAX (lot number FAV264). On 21 December 2010, 15 days post-vaccination, the patient developed apparent autoimmune bullous dermatosis of the extremities. A skin biopsy was performed 28 December 2010. Laboratory testing was performed 06 January 2011. Results of skin biopsy and laboratory tests were pending. Photographs (copies not received) were taken 23 and 28 December 2010, and 06 January 2011. At the time of vaccination the patient had no concurrent illness, and no noted past history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Metabolic function test, Pathology test, Perivascular dermatitis, Polymerase chain reaction, Pruritus
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 414162. A 29-year-old male patient received the following vaccinations on 06 December 2010: ACAM2000 (lot number VV04003A), TYPHIM VI (lot number d1087) and BIOTHRAX (lot number FAV264). On 21 December 2010, 15 days post-vaccination, the patient developed apparent autoimmune bullous dermatosis of the extremities. A skin biopsy was performed 28 December 2010. Laboratory testing was performed 06 January 2011. Results of skin biopsy and laboratory tests were pending. Photographs (copies not received) were taken 23 and 28 December 2010, and 06 January 2011. At the time of vaccination the patient had no concurrent illness, and no noted past history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Rash papular, Rash vesicular, Red blood cell sedimentation rate normal, Skin lesion
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference number 414162. A 29-year-old male patient received the following vaccinations on 06 December 2010: ACAM2000 (lot number VV04003A), TYPHIM VI (lot number d1087) and BIOTHRAX (lot number FAV264). On 21 December 2010, 15 days post-vaccination, the patient developed apparent autoimmune bullous dermatosis of the extremities. A skin biopsy was performed 28 December 2010. Laboratory testing was performed 06 January 2011. Results of skin biopsy and laboratory tests were pending. Photographs (copies not received) were taken 23 and 28 December 2010, and 06 January 2011. At the time of vaccination the patient had no concurrent illness, and no noted past history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 31.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Angina pectoris, Cardiac enzymes normal, Electrocardiogram T wave inversion, Electrocardiogram normal, Full blood count normal
Clinical narrative: This case was received on 18 March 2011 via a third party query tool search on the VAERS database, under reference 414380. A 31-year-old female patient had received the following vaccination on 06 June 2010:  ACAM2000 (lot number not reported), and an unspecified amount of time later, experienced angina pectoris and palpitations. The patient reported to have had intermittent brief episodes of sharp "heart pains" and palpitations that lasted for three minutes at its longest duration. She reported that she could resolve them with sitting upright, leaning forward or standing upright and deep breathing. The patient denies dyspnea, nausea and vomiting (n/v), diaphoresis, history of same, family history of same, abdominal pain, fevers, chills, or recent illness. The patient was given the diagnosis of "suspect post vaccinia pericarditis" by the working group. Laboratory data included a normal cardiac enzyme, an electrocardiogram that showed a normal sinus rhythm with inverted T wave in AVR and V-1, Right axis deviation, a normal red blood cell sedimentation rate of 6, a CBC within normal limits, a general chemistry within normal limits and a negative UDS. Concomitant medications included doxycycline for malaria prevention. The patient was evaluated in the emergency room. No further information was available at the time of the report. The patient's outcome was reported as recovered on an unspecified date. Note: Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Documents held by sender: none.