chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram P wave biphasic, Electrocardiogram P wave normal, Electrocardiogram normal, Extrasystoles, Full blood count normal
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncopal and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L (ref. 55-170): CKMB of 5.0 U/L within normal limits (ref. 2-16); CRP 0.1 within normal limits (ref. 1.0 mg/dl) and ESR was 6 within normal limits (0-15 mm/hr). The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptom's appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but the presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Metabolic function test normal, Nausea, Presyncope, Red blood cell sedimentation rate normal, Syncope
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncopal and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L (ref. 55-170): CKMB of 5.0 U/L within normal limits (ref. 2-16); CRP 0.1 within normal limits (ref. 1.0 mg/dl) and ESR was 6 within normal limits (0-15 mm/hr). The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptom's appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but the presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase increased, C-reactive protein normal, Chest pain, Dyspnoea
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncopal and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L (ref. 55-170): CKMB of 5.0 U/L within normal limits (ref. 2-16); CRP 0.1 within normal limits (ref. 1.0 mg/dl) and ESR was 6 within normal limits (0-15 mm/hr). The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptom's appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but the presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Electrocardiogram P wave biphasic, Electrocardiogram normal, Extrasystoles, Full blood count normal, Metabolic function test normal
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncopal and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L (ref. 55-170): CKMB of 5.0 U/L within normal limits (ref. 2-16); CRP 0.1 within normal limits (ref. 1.0 mg/dl) and ESR was 6 within normal limits (0-15 mm/hr). The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptom's appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but the presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Myopericarditis, Nausea, Presyncope, Red blood cell sedimentation rate normal, Syncope
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncopal and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L (ref. 55-170): CKMB of 5.0 U/L within normal limits (ref. 2-16); CRP 0.1 within normal limits (ref. 1.0 mg/dl) and ESR was 6 within normal limits (0-15 mm/hr). The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptom's appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but the presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Vaccinia virus infection
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 428803. A 19-year-old male patient received the following vaccinations on 06 June 2011: ACAM2000 (lot number not reported), TYPHIM VI (lot number not reported), and an unspecified Anthrax vaccine (manufacturer unknown, lot number not reported). On 21 June 2011, the patient experienced a syncopal episode and nausea. The following day, on 22 June 2011, he also had a presyncopal episode and nausea while working (on feet, bending, lifting, etc). He went to the emergency department (ED) for evaluation and was treated for "Possible Heat Exhaustion" with intravenous Normal Saline solution (2L) and ZOFRAN. No cardiac enzymes, ESR or CRP were drawn. CBC and CMP were within normal limits. An EKG obtained in the ED was interpreted as "normal: NSR, normal p axis, V-rate 50-99, consider left atrial abnormality - wide or notched P waves, PR 120 with baseline wander in Lead V4". The patient experienced a recurrent sensation of presyncopal and nausea after participating in a 4-mile run on 01 July 2011. He also reported a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes without radiation to jaw, throat, neck or left arm, accompanied by shortness of breath and sensation of heart "skipping a beat". A cardiac panel on 08 July 2011 revealed the following: positive CK of 524 U/L (ref. 55-170): CKMB of 5.0 U/L within normal limits (ref. 2-16); CRP 0.1 within normal limits (ref. 1.0 mg/dl) and ESR was 6 within normal limits (0-15 mm/hr). The patient initially denied positional worsening of chest pain / shortness of breath in supine position, but reported a recurrent episode of similar chest pain on 09 July 2011 when lying down on a bed, which lasted 5 to 10 minutes. The patient had a cardiology consultation to rule out underlying cardiac dysfunction, valvular disease, or dysrhythmias. The clinical presentation of the patient's chest pain did not seem consistent with Vaccinia Myopericarditis, but this needed to be considered in differential diagnosis as the patient's symptom's appeared within a 30-day window of primary smallpox vaccine immunization and other vaccines. Therefore, it could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the smallpox vaccine. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of smallpox vaccine, but the presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram. The outcome was recovered (date not reported). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Culture, Secondary transmission, Skin lesion
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 429947. A 19-year-old male patient received the following vaccination on 02 August 2011: ACAM2000 (lot number VV04003A). It was reported that the patient had been wrestling with someone that had recently received the Smallpox vaccination and approximately one week later (onset date 08 August 2011), he developed lesions consistent with cowpox. He had cowpox-like lesions as follows: two on his left wrist, one on his left wrist, and one on his left temple. The patient required an emergency visit. A culture was done - results not provided. He received BACTRIM and BACTROBAN to prevent "possible secondary bacterial infection". Outcome was recovered (date not reported). Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Nausea, Papule, Pyrexia, Vaccination site papule, Vaccinia virus infection
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 430428. A 20-year-old male patient received the following vaccinations on 13 July 2011: ACAM2000 (lot number VV04003A). Two weeks after receiving the vaccine, the patient presented to the medical clinic with papules extending from the vaccination site onto his chest and beneath his eyes bilaterally. He also had nausea and fever since Friday (two days prior to the doctor's visit). SEPTRA was given as corrective treatment. The patient was sent for optometry and an emergency room evaluation and was diagnosed with vaccinia virus. The patient was quarantined in the barracks and followed in the clinic. Outcome was unknown. Documents held by sender: None.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Full blood count normal, Joint swelling, Metabolic function test normal, Oedema peripheral
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 430446. A 28-year-old male patient with no concurrent illnesses, or other medical history had received the following vaccinations on 09 August 2011: ACAM2000 (lot number VV004003A) and 10 days later presented as a transient patient complaining of a 2 days history of bilateral ankle swelling, exquisite pain in the bilateral malleolar region and edema in the achilles region. The patient was not allowed to progress further until symptoms resolved. A CBC, U/A, sed rate, and BMP were performed with a slight shift to the left but still within normal limits. There were no other lab abnormalities. Documents held by sender: None.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Red blood cell sedimentation rate normal, Shift to the left, Urine analysis normal
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 430446. A 28-year-old male patient with no concurrent illnesses, or other medical history had received the following vaccinations on 09 August 2011: ACAM2000 (lot number VV004003A) and 10 days later presented as a transient patient complaining of a 2 days history of bilateral ankle swelling, exquisite pain in the bilateral malleolar region and edema in the achilles region. The patient was not allowed to progress further until symptoms resolved. A CBC, U/A, sed rate, and BMP were performed with a slight shift to the left but still within normal limits. There were no other lab abnormalities. Documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Influenza like illness, Rash vesicular
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 431509. A 40-year-old male patient had received on 08 August 2011 a ACAM2000 (lot number VV04-003-A) and nine days post initial vaccinia immunization, experienced mild FLS (flu like symptoms) and multiple vesicular lesions over arms, neck, face and back. Blood pressure was 102/70, pulse 56 and temperature 97.8. According to the report, the patient's lesions were progression to hands and wrist on 22 August 2011. The patient had pre vaccine lab of a normal CBC, HIV (-) and varicella titer (+). The patient's last Td was 01 January 2009. Other medications, current illnesses and history were reported as none. No further information was available at the time of the report. Outcome was reported as recovered. Note: 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 had been calculated using the event date. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash pustular, Vaccinia virus infection
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 431658. A 36-year-old male patient had received the following vaccination on 10 August 2011: ACAM2000 (lot number unknown) and 10 days later on 20 August 2011, after arriving back from foreign travel, the patient developed a rash that started below the breast and spread considerably to a severe widespread vaccinia with small pustules covering the back, chest and right ankle. The patient was referred to a dermatologist for confirmation. It was noted the patient had received on 08 July 2011 a Varicella vaccine (Manufacturer Merck, lot number not reported). The patient recovered. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Fatigue, Pyrexia, Rash maculo-papular
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 431934. A 29 year-old male patient had received on 19 August 2011 a left arm injection of ACAM2000 (lot number not reported) and eight days later on 27 August 2011, experienced generalized diffuse maculopapular rash, mild fever, fatigue and chills. Lab data, other medications and prior vaccinations were not reported. Current illnesses and history were reported as none. No further information was available at the time of the report. The patient's outcome was recovered. 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.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Dry skin, Injection site pruritus, Injection site rash, Rash pruritic, Skin exfoliation
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 432095. A 22-year-old male patient with a history of folliculitis and mild eczema had received on 03 August 2011 (also reported as 04 August 2011) a left arm  injection of ACAM2000 (lot number VV04003A) and one week later started to have an itchy rash around the vaccine site which continually spread from the left arm to the chest, back and right arm. The rash was described as a mostly dry, itchy, scaly rash. According to the report, the rash seems to be slowly spreading down to his forearm and abdomen. The patient reported he had no fevers, cough and had been feeling well o/w (otherwise). The patient had an emergency visit. Other medications were reported as TB. Lab data, current illnesses and prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was recovered. Note: 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. Also of note the lot number was entered as reported. Documents held by sender: none.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Dyspnoea, Lip blister, Papule, Swelling, Tongue blistering
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under the reference number 432249. A 20-year-old female patient received the following vaccination on 02 August 2011: ACAM2000 (lot number VV04003AA). Three days after receiving the vaccine, the patient presented with numerous vesicle/papules on her tongue and lips, and moderate to severe swelling with some difficulty breathing. The patient was medivac to the hospital on 06 August 2011 for definitive treatment, admitted, and placed under observation of hospital's providers. Laboratory data was not available at the time of the report. The patient had no current illness and no past medical history. In addition to hospitalization, the event seriousness was also considered to be life threatening. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Tongue eruption
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under the reference number 432249. A 20-year-old female patient received the following vaccination on 02 August 2011: ACAM2000 (lot number VV04003AA). Three days after receiving the vaccine, the patient presented with numerous vesicle/papules on her tongue and lips, and moderate to severe swelling with some difficulty breathing. The patient was medivac to the hospital on 06 August 2011 for definitive treatment, admitted, and placed under observation of hospital's providers. Laboratory data was not available at the time of the report. The patient had no current illness and no past medical history. In addition to hospitalization, the event seriousness was also considered to be life threatening. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Activities of daily living impaired, Eczema vaccinatum, Insomnia, Rash, Rash macular
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 432250. A 21-year-old male patient received the following vaccinations on 02 August 2011: ACAM2000 (lot number VV04003AA). Thirteen days after receiving the vaccine, the patient developed eczema vaccinatum; without spreading, itching rash for one week, with macular rash on chest, back, upper extremities and hands. The patient complained of profuse itching affecting sleep and work activity. The patient received ATARAX 25mg qhs, ALLEGRA 180mg daily and light duty for three days. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pruritic
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 432250. A 21-year-old male patient received the following vaccinations on 02 August 2011: ACAM2000 (lot number VV04003AA). Thirteen days after receiving the vaccine, the patient developed eczema vaccinatum; without spreading, itching rash for one week, with macular rash on chest, back, upper extremities and hands. The patient complained of profuse itching affecting sleep and work activity. The patient received ATARAX 25mg qhs, ALLEGRA 180mg daily and light duty for three days. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Generalised vaccinia
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 432252. A 32-year-old male patient received the following vaccination on 04 August 2011: ACAM2000 (lot number VV04003AA). Six days after receiving the vaccine, the patient presented with generalized vaccinia patches (approximately 4x4cm) with 2-4mm vesicles with surrounding erythema on their left arm, chest wall and back. Concurrent illness and past medical history were unknown. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Eczema vaccinatum, Papule, Rash
Clinical narrative: This case was received on 20 October 2011 via a third party query tool search on the VAERS database, under reference number 432253. A 24-year-old male patient received the following vaccinations on 04 August 2011: ACAM2000 (lot number VV04003AA). Six days after receiving the vaccine, the patient developed eczema vaccination: numerous scattered 2-4 mm vesicles/papules (approximately 20) located on the deltoid area, axilla and arm. The rash was described as spreading without pain or itching. The patient received MOTRIN 400mg prn as corrective treatment and was given light duty for five days. Concurrent illness and past medical history were unknown. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Orthopox virus infection, Orthopoxvirus test positive, Polymerase chain reaction, Secondary transmission
Clinical narrative: This case was received on 01 December 2011 via a third party query tool search on the VAERS database, under reference number 433194. A 28-year-old female patient, who's medical history and current illnesses were reported as unknown and prior vaccinations not reported, 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 03 May 2011 ACAM2000 (lot number not reported). On 21 May 2011, onset date was approximate, the girlfriend required an Emergency visit and was hospitalized with severe perineal cellulitis. The patient's viral culture grew vaccinia confirmed by state public health laboratory. The virus isolated from culture of perineal area positive by DFA for vaccinia, positive by PCR for non-variola orthopox. The outcome was reported as recovered. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the vaccination. Documents held by sender: None.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Vaccinia virus infection, Viral test positive
Clinical narrative: This case was received on 01 December 2011 via a third party query tool search on the VAERS database, under reference number 433194. A 28-year-old female patient, who's medical history and current illnesses were reported as unknown and prior vaccinations not reported, 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 03 May 2011 ACAM2000 (lot number not reported). On 21 May 2011, onset date was approximate, the girlfriend required an Emergency visit and was hospitalized with severe perineal cellulitis. The patient's viral culture grew vaccinia confirmed by state public health laboratory. The virus isolated from culture of perineal area positive by DFA for vaccinia, positive by PCR for non-variola orthopox. The outcome was reported as recovered. Although the manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the vaccination. Documents held by sender: None.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: This case was received on 01 December 2011 via a third party query tool search on the VAERS database, under reference number 433527. A 34-year-old male patient received the following vaccination on 29 June 2011: ACAM2000 (lot VV04003A). The patient had a medical history of possible immunocompromised. The patient's laboratory data was reported as unknown. On 06 July 2011, the patient had an unevaluable event which required an Emergency Visit. No further information provided. The outcome was not reported. Documents held by sender: None.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Pruritus, Rash generalised, Rash maculovesicular, Rash papular
Clinical narrative: This case was received on 01 December 2011 via a third party query tool search on the VAERS database, under reference number 434247. A 25-year-old female patient, with no current illnesses and no medical history, received the following vaccinations on 23 August 2011: a left arm ACAM2000, SP Biologics Co, lot number VV04003A). The patient developed 3 weeks after the vaccine a large macular, vesicular, blistering rash around the lesion, and other blisters throughout her body, arms, legs, upper chest, some on back, face, and on her ears bilaterally. Most were yellow-fluid filled blisters. She also had erythematous papules throughout her body with intense itching. There were no other systemic symptoms. She required an emergency visit and was treated with ZYRTEC and ATARAX three times a day (TID) for breakthrough itching. The patient was to follow-up in the AM with a dermatology consult for any super infection. The patient's laboratory testing was reported as in process and the plan was to do bacterial culture tomorrow. The outcome was reported as unknown. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Generalised vaccinia, Pain in extremity, Rash erythematous
Clinical narrative: This case was received on 01 December 2011 via a third party query tool search on the VAERS database, under reference number 435709. A 20-year-old male patient, with no current illnesses and no medical history noted, received the following vaccinations on 14 September 2011: a left arm ACAM2000, SP Biologics Co. lot number VV04003A and an intranasal FLUMIST, Medimmune lot number 501094P. The patient developed severe red bumps appearing on chest. Also, he had pain in the arm that received the vaccination. The patient was evaluated by physician on a date (reported as 09/226/2011) in September 2011 and determined to have mild generalized vaccinia. The patient required no treatment at this time. The patient's laboratory findings were not reported. The outcome was reported as recovered. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Post vaccination autoinoculation, Vaccinia virus infection
Clinical narrative: This case was received on 01 December 2011 via a third party query tool search on the VAERS database, under reference number 435792. A 19-year-old male patient received the following vaccination on 07 September 2011: a right arm ACAM2000, SP Biologics Co. lot VV04003A. The patient had no current illnesses, no medical history and took no other medications. The patient's prior vaccination history was not reported. The patient received the vaccine 3 weeks prior to presentation on 20 September 2011. The patient developed two sites of vaccination with the first site being the obvious vaccine inoculation and the second nearby which was a smaller vaccinia reaction. The patient's laboratory findings were reported as none. The outcome was reported as recovered. Documents held by sender: None.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Blister
Clinical narrative: This case was received on 01 December 2011via a third party query tool search on the VAERS database, under the reference number 435947. A 20-year-old female patient, with no current illnesses and a medical history of eczema, received the following vaccination on 06 September 2011: ACAM2000, manufacturer and lot number not reported. 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. The patient developed pox formation described as vesicles on hands, arms, face and thigh. She required an Emergency visit. The patient's laboratory findings were reported as none available. The outcome was reported as recovered. Documents held by sender: None.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site haematoma
Clinical narrative: Case received from a Healthcare Professional on 29 September 2011 under the reference number 11-0450. A 73-year-old female patient, with no relevant medical history except a medical history of bleeding "prob" 3 years ago, had received an intramuscular dose of FLUZONE HD (batch number UH39AC) in the left deltoid on 26 September 2011 at 4:25pm. It was unknown if the patient had received concomitant therapies. 35 minutes post-vaccination, the patient experienced numbness in arm that lasted about 1 hour and a nickel sized bruised area at injection site. There was no redness, no swelling and no warmth at site. The patient recovered on 26 September 2011. Follow-up information was received from a healthcare professional on 06 January 2012. The reporter relayed the following information. The patient concomitant medication included eye drops after corneal transplants, PRED MILD 0.12%. The reporter can not remember saying the patient had a bleeding problem several years ago. However, she did administer the injection and did remember that there was a prolog bleeding at the injection site but nothing out of the ordinary. The patient outcome was reported as recovered/resolved on 26 September 2011, about one hour after the numbness occurred. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye pruritus, Lacrimation increased, Pain, Respiratory tract congestion
Clinical narrative: Initial report was received from a health care professional on 14 October 2011. A 56-year-old female (date of birth not reported) with a pre-existing condition of dust and mold had received an intramuscular left arm injection of FLUZONE, lot number UT472AA on 28 September 2011 at 3:00PM and later after the vaccination at 09:00pm, the patient developed congestion, scratchy throat; coughing and body aches during the night. In the A.M. the body aches increased and she had watery, itchy eyes with discharged. On 29 September 2011 at 9:00pm she treated herself with fexofenadine and ALLEGRA, ADVIL 800mg by mouth and natural tear drops at 3:00pm for comfort. Concomitant medication included FLONASE nasal spray as needed. No further informational was available at the time of the report. Outcome was reported as unknown. Follow-up information was received on 30 January 2012 from a health care professional. According to the reporter, the patient's outcome was recovered. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation
Clinical narrative: Initial report was received from a health care professional on 14 October 2011. A 56-year-old female (date of birth not reported) with a pre-existing condition of dust and mold had received an intramuscular left arm injection of FLUZONE, lot number UT472AA on 28 September 2011 at 3:00PM and later after the vaccination at 09:00pm, the patient developed congestion, scratchy throat; coughing and body aches during the night. In the A.M. the body aches increased and she had watery, itchy eyes with discharged. On 29 September 2011 at 9:00pm she treated herself with fexofenadine and ALLEGRA, ADVIL 800mg by mouth and natural tear drops at 3:00pm for comfort. Concomitant medication included FLONASE nasal spray as needed. No further informational was available at the time of the report. Outcome was reported as unknown. Follow-up information was received on 30 January 2012 from a health care professional. According to the reporter, the patient's outcome was recovered. Documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Flank pain, Full blood count normal, Metabolic function test normal
Clinical narrative: Case received from a Health care Professional on 11 October 2011 under the reference number 11-0777. Cluster of 4 unidentified patients (age and gender not specified), with no reported medical history and concomitant therapy, had received an intramuscular dose of FLUZONE HD (batch number UH457AA, site of administration not reported) on an unspecified date. On an unspecified date, the patients experienced chills, fever, body aches, nausea and vomiting. One of these 4 patients experienced severe chills, temperature at 102.6 and vomiting profusely. The patients' outcomes were unknown. Follow-up information received from a health care professional on 10 January 2012. All 4 patients were identified. This case is now the case of reference for the 77-year-old female patient that is mentioned below. Information regarding the other 3 patients are captured in case numbers 2012-00387-00389. A 77-year-old female patient, who had no concurrent illnesses, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number UH457A) on 28 September 2011 at 8:15 am, and later that morning had some right lower back pain (flank pain) and around 12:45 pm that day experienced shaking chills. She was re-evaluated by the physician the same day and denied having diarrhea or dysuria, but had a temperature of 101.7 degrees Fahrenheit, nausea, and vomited one time (600cc). Body aches was not mentioned. Physical examination revealed a tremulous patient in no acute distress with an oxygen saturation of 95% on room air. The rest of the exam was unremarkable. Vital signs revealed regular pulse 104 beats/minute, respirations 26 breaths/minute, and blood pressure 132/70 mmHg (sitting). Weight was 176 pounds, height was 65 inches and body mass index was 29.39 with body surface area (m2) 1.88. The patient was administered oral TYLENOL (650 mg), and oral ZOFRAN ODT (4 mg). After 20 minutes the patient's shaking chills and nausea had completely resolved, but the fever persisted at 102.6 degree Fahrenheit (taken at 15:15 pm), however the patient expressed feeling much better. A complete blood count (CBC) and complete metabolic panel were all within normal limits. The patient was unable to give a urine sample for urine analysis. The physicians assessment was most likely an acute reaction to the influenza vaccine. Relevant medical history included: non-smoker, osteopenia, grave's disease, gastroesophageal reflux disease (GERD), and "hypothyrodism." Relevant family history included: heart attack/stroke in father. Patient's relevant surgical history included: arterio-venous fistula in brain (repaired). The patients symptoms greatly improved by the time she left the clinic, and was to continue with regular adult dose of TYLENOL or ibuprofen every 4-6 hours as needed for fever or chills. She was to follow-up over the next 24-hours, but the patient recovered (date not reported). Documents held by sender: Doctor notes for 28 September 2012.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Case received from a Health care Professional on 11 October 2011 under the reference number 11-0777. Cluster of 4 unidentified patients (age and gender not specified), with no reported medical history and concomitant therapy, had received an intramuscular dose of FLUZONE HD (batch number UH457AA, site of administration not reported) on an unspecified date. On an unspecified date, the patients experienced chills, fever, body aches, nausea and vomiting. One of these 4 patients experienced severe chills, temperature at 102.6 and vomiting profusely. The patients' outcomes were unknown. Follow-up information received from a health care professional on 10 January 2012. All 4 patients were identified. This case is now the case of reference for the 77-year-old female patient that is mentioned below. Information regarding the other 3 patients are captured in case numbers 2012-00387-00389. A 77-year-old female patient, who had no concurrent illnesses, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number UH457A) on 28 September 2011 at 8:15 am, and later that morning had some right lower back pain (flank pain) and around 12:45 pm that day experienced shaking chills. She was re-evaluated by the physician the same day and denied having diarrhea or dysuria, but had a temperature of 101.7 degrees Fahrenheit, nausea, and vomited one time (600cc). Body aches was not mentioned. Physical examination revealed a tremulous patient in no acute distress with an oxygen saturation of 95% on room air. The rest of the exam was unremarkable. Vital signs revealed regular pulse 104 beats/minute, respirations 26 breaths/minute, and blood pressure 132/70 mmHg (sitting). Weight was 176 pounds, height was 65 inches and body mass index was 29.39 with body surface area (m2) 1.88. The patient was administered oral TYLENOL (650 mg), and oral ZOFRAN ODT (4 mg). After 20 minutes the patient's shaking chills and nausea had completely resolved, but the fever persisted at 102.6 degree Fahrenheit (taken at 15:15 pm), however the patient expressed feeling much better. A complete blood count (CBC) and complete metabolic panel were all within normal limits. The patient was unable to give a urine sample for urine analysis. The physicians assessment was most likely an acute reaction to the influenza vaccine. Relevant medical history included: non-smoker, osteopenia, grave's disease, gastroesophageal reflux disease (GERD), and "hypothyrodism." Relevant family history included: heart attack/stroke in father. Patient's relevant surgical history included: arterio-venous fistula in brain (repaired). The patients symptoms greatly improved by the time she left the clinic, and was to continue with regular adult dose of TYLENOL or ibuprofen every 4-6 hours as needed for fever or chills. She was to follow-up over the next 24-hours, but the patient recovered (date not reported). Documents held by sender: Doctor notes for 28 September 2012.