chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Eczema, Erythema, Induration, Rash vesicular
Clinical narrative: This case was received on 15 December 2008 via a search of the VAERS database (reference number 325253).  It database (reference number 325253).  It was originally reported to VAERS by another manufacturer, Emergent Biosolutions.  A 25 year-old female patient received following vaccine on 26 August 2008:  a first percutaneous dose of ACAM2000 (SMALLPOX), and an intramuscular injection of TYPHIM VI, and a subcutaneous injection of ANTHRAX (BIOTHRAX).  Fifteen days later (also reported as 10 September 2008),  she developed erythema, induration, and a vesicular rash.  The patient was reported to have had an initial erythematous reaction and was treated with BENADRYL and proper site care.  The patient did well and the erythema and induration resolved.  However, approximately five days later,  the patient began having a vesicular reaction that was initially thought to be chiggers.  She presented to the clinic two days later with a chief complaint of chiggers and was diagnosed with eczema for the event was reported as "required intervention to prevent permanent impairment/damage".  The patient's recovery status was not reported.  Documents held by sender:  None
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Rash papular
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 325264.  A 26 year-old male patient received the following vaccination on 03-Sep-2008: smallpox (vaccine, manufacturer unknown, lot number not reported).  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.  Twelve days post-vaccination, the patient developed papules/vesicles scattered on the face, trunk and arms.  There was no treatment given for this event and the outcome of the event was not reported.  This presentation could be indicative of autoinoculation, and is therefore a medically significant adverse event.  List of documents held by sender: none
Age: 38.0
Sex: M
Vaccine: ANTH, HEP, HEPA, SMALL
Symptoms: Arthralgia, Chest pain, Dyspnoea, Myalgia, Visual impairment
Clinical narrative: Seriousness Criteria: Other Medically Significant. This case was considered on 11 January 2009 via a agency search on the VAERS database, under reference number 325488. A 38-year-old male patient received the following vaccinations on 26-Aug-2008: smallpox vaccine (manufacturer unknown, lot number not reported) (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: anthrax vaccine (manufacturer unknown, lot number not reported); hepatitis B vaccine (manufacturer unknown, lot number not reported) and hepatitis A vaccine (manufacturer unknown, lot number not reported). On the same day as vaccination, the patient reported muscle aches, chest pain, shortness of breath, visual disturbances and arthralgia. These events required intervention with fluids and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs). The patient was reported as recovered but required intervention to prevent permanent impairment/damage. List of documents held by sender: none
Age: 18.0
Sex: M
Vaccine: SMALL
Symptoms: Confusional state, Myalgia, Pyrexia
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 325489.  An 18 year old male patient received the following vaccination on 28 August 2008: smallpox (manufacturer unknown, lot number not reported), anthrax (manufacturer and lot number not reported), and THPHOID live oral TY21A (manufacturer and lot number not reported).  Five days after vaccination, on 2 September 2008, the following symptoms were reported: "myalgias, confusion and high fever".  The patient was treated with acetaminophen and ketavolac.  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.  List of Documents held by Sender: None
Age: 20.0
Sex: M
Vaccine: HEPA, SMALL
Symptoms: Asthenia, Cellulitis, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 325490. A 20-year-old male patient received the following vaccinations on 24-Aug-2008: smallpox vaccine, (manufacturer unknown, lot number not reported) and hepatitis A vaccine (manufacturer unknown, lot number not reported). NOTE: Although the manufacturer of the smallpox vaccine was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination. Nine days post-vaccination, the patient developed cellulitis and experienced fever, headache, weakness and a sore throat. Treatment with acetaminophen, ibuprofen and azithromycin was given.  The outcome of the event was not reported. Cellulitis could be indicative of a superinfection and is therefore a medically significant adverse event. Additionally, the adverse events required medical treatment to prevent permanent impairment or damage. List of documents held by sender: none.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema, Induration, Joint swelling, Pruritus
Clinical narrative: This case was received on 15 December 2008 via a search on the VAERS database, under reference number 325766. A 39-year-old male patient, whose medical history was not reported, received the following vaccinations on 27 August 2008: ACAM2000 (lot number not reported) and BIOTHRAX (Emergent Biosolutions, lot number not reported). On the following day, 28 August 2008, the patient had a 17cm x 16cm area of redness and swelling to the elbow which was indurated, itchy and swollen. The patient required unspecified intervention and his recovery status was not reported.
Age: 21.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Activated partial thromboplastin time, Blood creatine phosphokinase, Blood creatine phosphokinase MB normal, Chest discomfort, Hypoaesthesia
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326209.  A 21-year-old female patient received the following vaccinations on 02-Sep-2008:  SMALLPOX vaccine (manufacturer unknown, lot number not reported).  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; and FLU MIST (manufactured by Med immune, lot number not reported).  The patient also received a third Anthrax vaccinaton on 03-Sep-2008 (manufacture and lot unknown).     The patient reported having left arm pain and noted a swollen lymph node on the left side of her neck and left axilla with accompanying pain in these areas.  On 06 September 2008, the patient started having intermittent left arm and hand numbness.  On the night of 06 September 2008 she experienced chest pressure (graded six out of ten on a pain scale) which increased while lying down and improved upon sitting up.  The patient denied shortness of breath but did report feeling "anxious" and felt "her heart pounding".  The chest pain lasted 48 hours.  On 11 September, the patient was seen in the Emergency Room and was told that she was released to full duty.  Laboratory results reported on 11 September 2008 included the following:  Troponin I Cardiac PLASMA : 0.012 ng/mL; creatine Kinase MB PLASMA: 0.3 ng/mL; BNP Blood: 10.8 pg/mL; INR PLASMA: 0.99; Pro time PLASMA: 11.55 sec and APTT PLASMA: 28.70 sec.  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.  List of documents held by sender: none
Age: 21.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL
Symptoms: International normalised ratio decreased, Lymphadenopathy, Pain in extremity, Palpitations, Troponin I
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326209.  A 21-year-old female patient received the following vaccinations on 02-Sep-2008:  SMALLPOX vaccine (manufacturer unknown, lot number not reported).  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; and FLU MIST (manufactured by Med immune, lot number not reported).  The patient also received a third Anthrax vaccinaton on 03-Sep-2008 (manufacture and lot unknown).     The patient reported having left arm pain and noted a swollen lymph node on the left side of her neck and left axilla with accompanying pain in these areas.  On 06 September 2008, the patient started having intermittent left arm and hand numbness.  On the night of 06 September 2008 she experienced chest pressure (graded six out of ten on a pain scale) which increased while lying down and improved upon sitting up.  The patient denied shortness of breath but did report feeling "anxious" and felt "her heart pounding".  The chest pain lasted 48 hours.  On 11 September, the patient was seen in the Emergency Room and was told that she was released to full duty.  Laboratory results reported on 11 September 2008 included the following:  Troponin I Cardiac PLASMA : 0.012 ng/mL; creatine Kinase MB PLASMA: 0.3 ng/mL; BNP Blood: 10.8 pg/mL; INR PLASMA: 0.99; Pro time PLASMA: 11.55 sec and APTT PLASMA: 28.70 sec.  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.  List of documents held by sender: none
Age: 20.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Cough, Headache, Influenza like illness, Monocytosis, Myalgia
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 326315. A 20-year-old patient, whose medical history was not reported, received the following vaccinations on 16 September 2008: smallpox (trade name and manufacturer unknown, lot number not reported) and FLUMIST (Medimmune Vaccines, lot number not reported). On 23 September 2008, the patient developed "flu-like" symptoms with nasal congestion, cough, headache, and myalgias. On 25 September 2009, 9 days post vaccination, the patient developed a diffuse pruritic, erythematous, papular rash involving the face, trunk, extremities, palms and soles. A CBC was performed and was normal except for mild monocytosis of 11.7%. On 25 September, 2008, the patient received treatment with PREDNISONE, LORATADINE, HYDROXYZINE, and RANITIDINE. The patient's recovery status was not reported. 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.
Age: 20.0
Sex: M
Vaccine: FLUN3, SMALL
Symptoms: Nasal congestion, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 326315. A 20-year-old patient, whose medical history was not reported, received the following vaccinations on 16 September 2008: smallpox (trade name and manufacturer unknown, lot number not reported) and FLUMIST (Medimmune Vaccines, lot number not reported). On 23 September 2008, the patient developed "flu-like" symptoms with nasal congestion, cough, headache, and myalgias. On 25 September 2009, 9 days post vaccination, the patient developed a diffuse pruritic, erythematous, papular rash involving the face, trunk, extremities, palms and soles. A CBC was performed and was normal except for mild monocytosis of 11.7%. On 25 September, 2008, the patient received treatment with PREDNISONE, LORATADINE, HYDROXYZINE, and RANITIDINE. The patient's recovery status was not reported. 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.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Arthralgia, Blood creatine phosphokinase MB normal, Blood creatine phosphokinase increased, C-reactive protein normal, Chest pain
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database (reference number 326599). It was originally reported to VAERS by another manufacturer (manufacturer unknown). A 20 year-old male patient received the following vaccinations on 26 August 2008: smallpox (trade name and manufacturer unknown, lot number not reported) percutaneously and TYPHIM VI (lot number not reported) intramuscularly. On 05 September 2008 the patient presented with chest pain (which occurred mostly with running), knee pain, and shortness of breath on exertion. A physical assessment revealed left pectoral tenderness upon palpation. Labs revealed a normal EKG and C reactive protein, blood ESR: 1, creatine kinase MB serum: 3.20, troponin T serum: <0.010, creatine kinase MB serum: 3.380, which were all normal. The patient had an elevated creatine kinase serum: 301. The final assessment included musculoskeletal chest pain. The patient was treated with MOTRIN. During a follow up visit on 12 September 2008 the patient had improved. List of Documents held by Sender: None. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Dyspnoea, Dyspnoea exertional, Electrocardiogram normal, Musculoskeletal chest pain, Red blood cell sedimentation rate decreased
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database (reference number 326599). It was originally reported to VAERS by another manufacturer (manufacturer unknown). A 20 year-old male patient received the following vaccinations on 26 August 2008: smallpox (trade name and manufacturer unknown, lot number not reported) percutaneously and TYPHIM VI (lot number not reported) intramuscularly. On 05 September 2008 the patient presented with chest pain (which occurred mostly with running), knee pain, and shortness of breath on exertion. A physical assessment revealed left pectoral tenderness upon palpation. Labs revealed a normal EKG and C reactive protein, blood ESR: 1, creatine kinase MB serum: 3.20, troponin T serum: <0.010, creatine kinase MB serum: 3.380, which were all normal. The patient had an elevated creatine kinase serum: 301. The final assessment included musculoskeletal chest pain. The patient was treated with MOTRIN. During a follow up visit on 12 September 2008 the patient had improved. List of Documents held by Sender: None. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Tenderness, Troponin
Clinical narrative: This case was received on 11 January 2009 via a search of the VAERS database (reference number 326599). It was originally reported to VAERS by another manufacturer (manufacturer unknown). A 20 year-old male patient received the following vaccinations on 26 August 2008: smallpox (trade name and manufacturer unknown, lot number not reported) percutaneously and TYPHIM VI (lot number not reported) intramuscularly. On 05 September 2008 the patient presented with chest pain (which occurred mostly with running), knee pain, and shortness of breath on exertion. A physical assessment revealed left pectoral tenderness upon palpation. Labs revealed a normal EKG and C reactive protein, blood ESR: 1, creatine kinase MB serum: 3.20, troponin T serum: <0.010, creatine kinase MB serum: 3.380, which were all normal. The patient had an elevated creatine kinase serum: 301. The final assessment included musculoskeletal chest pain. The patient was treated with MOTRIN. During a follow up visit on 12 September 2008 the patient had improved. List of Documents held by Sender: None. A corrective version was created to amend the product to ACAM2000. Although the smallpox vaccine manufacturer was reported as unknown in this case, ACAM2000 was the only licensed smallpox vaccine at the time of the patient's vaccination.
Age: 19.0
Sex: M
Vaccine: HEPA, SMALL
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326600.  A 19-year-old male patient, whose medical history was not reported, received the following vaccinations on 09 September 2008: smallpox (trade name and manufacturer unknown, lot number not reported) and hepatitis A (trade name and manufacturer unknown, lot number not reported).  On 18 September 2008, nine days post-vaccination, the patient developed erythematous, pruritic papules on his chest that later spread to his axillary area.  The patient required unspecified intervention and his recovery status was not reported.  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.
Age: 37.0
Sex: F
Vaccine: FLUN3, SMALL
Symptoms: Accidental exposure, Alanine aminotransferase increased, Aspartate aminotransferase increased, Culture wound negative, Erythema
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326719.  A 37 year-old female patient received the following vaccination on 12 September 2008:  SMALLPOX (manufacturer unknown, lot number not reported), and influenza (FLUMIST, Medimmune, lot number not reported).  The patient experienced inadvertent inoculation to multiple sites.  Eight days after vaccination, on 20 September 2008, the patient reported fever (maximum 104 degrees Fahrenheit), headache, left arm swelling, and axillary, cervical, clavicular lymphadenopathy.  The patient reported three satellite lesions around the vaccination site as well as lesions "over right thumb pad".  On 23 September 2008, lesions were noticed between right 4th and 5th toe and on 24 September 2008, on the upper lip.  The patient was seen in the Emergency Room on 22 September 2008.  No treatment was reported.  Laboratory tests performed were reported as follows:  CBC with diff unremarkable; CMP with slight elevation of AST (46) and ALT (69); and skin wound culture of the SMALLPOX vaccination site showed mixed normal skin flora.  On 26 September 2008, bilateral wrist and finger swelling and pain, and "single erythematous macule over the left 1st and right 5th MCP joints" were reported.  As of 1 October 2008, symptoms were reported as resolved.  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.  List of Documents held by Sender:  None
Age: 37.0
Sex: F
Vaccine: FLUN3, SMALL
Symptoms: Full blood count normal, Headache, Injection site reaction, Joint swelling, Lymphadenopathy
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326719.  A 37 year-old female patient received the following vaccination on 12 September 2008:  SMALLPOX (manufacturer unknown, lot number not reported), and influenza (FLUMIST, Medimmune, lot number not reported).  The patient experienced inadvertent inoculation to multiple sites.  Eight days after vaccination, on 20 September 2008, the patient reported fever (maximum 104 degrees Fahrenheit), headache, left arm swelling, and axillary, cervical, clavicular lymphadenopathy.  The patient reported three satellite lesions around the vaccination site as well as lesions "over right thumb pad".  On 23 September 2008, lesions were noticed between right 4th and 5th toe and on 24 September 2008, on the upper lip.  The patient was seen in the Emergency Room on 22 September 2008.  No treatment was reported.  Laboratory tests performed were reported as follows:  CBC with diff unremarkable; CMP with slight elevation of AST (46) and ALT (69); and skin wound culture of the SMALLPOX vaccination site showed mixed normal skin flora.  On 26 September 2008, bilateral wrist and finger swelling and pain, and "single erythematous macule over the left 1st and right 5th MCP joints" were reported.  As of 1 October 2008, symptoms were reported as resolved.  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.  List of Documents held by Sender:  None
Age: 37.0
Sex: F
Vaccine: FLUN3, SMALL
Symptoms: Metabolic function test, Oedema peripheral, Pain, Pyrexia, Rash macular
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326719.  A 37 year-old female patient received the following vaccination on 12 September 2008:  SMALLPOX (manufacturer unknown, lot number not reported), and influenza (FLUMIST, Medimmune, lot number not reported).  The patient experienced inadvertent inoculation to multiple sites.  Eight days after vaccination, on 20 September 2008, the patient reported fever (maximum 104 degrees Fahrenheit), headache, left arm swelling, and axillary, cervical, clavicular lymphadenopathy.  The patient reported three satellite lesions around the vaccination site as well as lesions "over right thumb pad".  On 23 September 2008, lesions were noticed between right 4th and 5th toe and on 24 September 2008, on the upper lip.  The patient was seen in the Emergency Room on 22 September 2008.  No treatment was reported.  Laboratory tests performed were reported as follows:  CBC with diff unremarkable; CMP with slight elevation of AST (46) and ALT (69); and skin wound culture of the SMALLPOX vaccination site showed mixed normal skin flora.  On 26 September 2008, bilateral wrist and finger swelling and pain, and "single erythematous macule over the left 1st and right 5th MCP joints" were reported.  As of 1 October 2008, symptoms were reported as resolved.  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.  List of Documents held by Sender:  None
Age: 37.0
Sex: F
Vaccine: FLUN3, SMALL
Symptoms: Skin lesion
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 326719.  A 37 year-old female patient received the following vaccination on 12 September 2008:  SMALLPOX (manufacturer unknown, lot number not reported), and influenza (FLUMIST, Medimmune, lot number not reported).  The patient experienced inadvertent inoculation to multiple sites.  Eight days after vaccination, on 20 September 2008, the patient reported fever (maximum 104 degrees Fahrenheit), headache, left arm swelling, and axillary, cervical, clavicular lymphadenopathy.  The patient reported three satellite lesions around the vaccination site as well as lesions "over right thumb pad".  On 23 September 2008, lesions were noticed between right 4th and 5th toe and on 24 September 2008, on the upper lip.  The patient was seen in the Emergency Room on 22 September 2008.  No treatment was reported.  Laboratory tests performed were reported as follows:  CBC with diff unremarkable; CMP with slight elevation of AST (46) and ALT (69); and skin wound culture of the SMALLPOX vaccination site showed mixed normal skin flora.  On 26 September 2008, bilateral wrist and finger swelling and pain, and "single erythematous macule over the left 1st and right 5th MCP joints" were reported.  As of 1 October 2008, symptoms were reported as resolved.  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.  List of Documents held by Sender:  None
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site cellulitis
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 327007. A 20 year old male patient received the following vaccination on 24 September 2008: smallpox (manufacturer unknown, lot number not reported). Nine days post vaccination smallpox vaccine associated cellulitis was reported. 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. List of Documents held by Sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Asthenia, Blood creatine phosphokinase MB, Blood lactate dehydrogenase increased, Chest X-ray normal, Chest pain
Clinical narrative: This case was received on 17 December 2008 via a search on the VAERS database, under reference number 327009. A 20-year-old male patient, with a known heart murmur and no history of hypertension, hyperlipidemia, diabetes mellitus, tobacco use or family history of cardiac disease, received the following vaccinations on 22 September 2008: ACAM2000 (lot number not reported) and a first subcutaneous injection of Anthrax (trade name and manufacturer unknown, lot number not reported). On 04 October 2008, 12 days post-vaccination, the patient complained of 2 days of retrosternal chest pain, severity 5/10, non-radiating, non-positional and non-exertional. He had no prior history of pain. He denied shortness of breath, fever, chills, nausea, vomiting, and diarrhea. EKG revealed diffuse ST elevation and PR depression. CK-MB, Troponin I, myoglobulin, and LDH were all elevated. Chest x-ray without obvious cardiomegaly. The patient was given ASA 325 mg and then Ibuprofen 800 mg Q8H. At that time the patient was stable. The diagnosis was myopericarditis. The patient was hospitalized on unspecified dates. According to the reporter, the review of medical records provided the following information: Diagnosis: acute myopericarditis, adverse effect of drug therapy-vaccine smallpox. The patient presented with chest pain, worsened by deep breathing. The patient was noted to have increased pulse rate and low grade fever. He received treatment with MOTRIN. Follow-up on 15 October 2008 with report of decreased stamina or exertional tolerance and without chest pain. EKG with diffuse ST elevation and PR depression. CK-MB, Troponin I, myoglobin, and LDH were all elevated. Chest x-ray was without obvious cardiomegaly. Echocardiogram revealed an ejection fraction of 57%. The patient's outcome was not reported.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram PR shortened, Electrocardiogram ST segment elevation, Heart rate increased, Myoglobin blood increased
Clinical narrative: This case was received on 17 December 2008 via a search on the VAERS database, under reference number 327009. A 20-year-old male patient, with a known heart murmur and no history of hypertension, hyperlipidemia, diabetes mellitus, tobacco use or family history of cardiac disease, received the following vaccinations on 22 September 2008: ACAM2000 (lot number not reported) and a first subcutaneous injection of Anthrax (trade name and manufacturer unknown, lot number not reported). On 04 October 2008, 12 days post-vaccination, the patient complained of 2 days of retrosternal chest pain, severity 5/10, non-radiating, non-positional and non-exertional. He had no prior history of pain. He denied shortness of breath, fever, chills, nausea, vomiting, and diarrhea. EKG revealed diffuse ST elevation and PR depression. CK-MB, Troponin I, myoglobulin, and LDH were all elevated. Chest x-ray without obvious cardiomegaly. The patient was given ASA 325 mg and then Ibuprofen 800 mg Q8H. At that time the patient was stable. The diagnosis was myopericarditis. The patient was hospitalized on unspecified dates. According to the reporter, the review of medical records provided the following information: Diagnosis: acute myopericarditis, adverse effect of drug therapy-vaccine smallpox. The patient presented with chest pain, worsened by deep breathing. The patient was noted to have increased pulse rate and low grade fever. He received treatment with MOTRIN. Follow-up on 15 October 2008 with report of decreased stamina or exertional tolerance and without chest pain. EKG with diffuse ST elevation and PR depression. CK-MB, Troponin I, myoglobin, and LDH were all elevated. Chest x-ray was without obvious cardiomegaly. Echocardiogram revealed an ejection fraction of 57%. The patient's outcome was not reported.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Myopericarditis, Pyrexia, Troponin I increased
Clinical narrative: This case was received on 17 December 2008 via a search on the VAERS database, under reference number 327009. A 20-year-old male patient, with a known heart murmur and no history of hypertension, hyperlipidemia, diabetes mellitus, tobacco use or family history of cardiac disease, received the following vaccinations on 22 September 2008: ACAM2000 (lot number not reported) and a first subcutaneous injection of Anthrax (trade name and manufacturer unknown, lot number not reported). On 04 October 2008, 12 days post-vaccination, the patient complained of 2 days of retrosternal chest pain, severity 5/10, non-radiating, non-positional and non-exertional. He had no prior history of pain. He denied shortness of breath, fever, chills, nausea, vomiting, and diarrhea. EKG revealed diffuse ST elevation and PR depression. CK-MB, Troponin I, myoglobulin, and LDH were all elevated. Chest x-ray without obvious cardiomegaly. The patient was given ASA 325 mg and then Ibuprofen 800 mg Q8H. At that time the patient was stable. The diagnosis was myopericarditis. The patient was hospitalized on unspecified dates. According to the reporter, the review of medical records provided the following information: Diagnosis: acute myopericarditis, adverse effect of drug therapy-vaccine smallpox. The patient presented with chest pain, worsened by deep breathing. The patient was noted to have increased pulse rate and low grade fever. He received treatment with MOTRIN. Follow-up on 15 October 2008 with report of decreased stamina or exertional tolerance and without chest pain. EKG with diffuse ST elevation and PR depression. CK-MB, Troponin I, myoglobin, and LDH were all elevated. Chest x-ray was without obvious cardiomegaly. Echocardiogram revealed an ejection fraction of 57%. The patient's outcome was not reported.
Age: 26.0
Sex: F
Vaccine: ANTH, FLUN3, SMALL
Symptoms: Activities of daily living impaired, Vaccinia
Clinical narrative: This case was received on 17 December 2008 via a Qscan search on the VAERS database, under reference number 327024. A 26-year-old female patient, whose medical history was not reported, received the following vaccinations on 16 September 2008: a first dose of ACAM2000 (lot number not reported), a subcutaneous injection of BIOTHRAX (Emergent Biosolutions, lot number not reported) and an intranasal dose of FLUMIST (manufacturer unknown, lot number not reported). The patient was reported to have developed generalized vaccinia eleven days after vaccination. On 29 September 2008, 13 days post-vaccination, she was seen in urgent care and referred to a dermatology clinic. Corrective treatment was not reported, but the patient was put on convalescent leave for one week. The patient's recovery status was not reported. 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.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Biopsy skin abnormal, Culture wound negative, Eosinophilia, Pain, Perivascular dermatitis
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 327213. A 22 year-old female received the following vaccination on 29 July 2008: Smallpox (manufacturer unknown, lot number not reported), and ANTHRAX (BIOTHRAX, manufacturer and lot number not reported). Sixteen days after vaccination, on 15 August 2008, the patient was seen for evaluation of a painful, itchy rash on her face, elbows, hands, knees, feet, and palms. Steroids were prescribed. On 23 September 2008, the patient reported she had stopped taking the steroids 10 days previously (13 September 2008) and had experienced a "few outbreaks of the lesions" which were "not as bad as they were initially". Wound cultures, including viral cultures for VACCINIA, PCR, VARICELLA, and HSV were negative. Results of a punch skin biopsy showed superficial perivascular inflammation with interstitial eosinophils and epidermal spondylosis. 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. List of Documents held by Sender: None.
Age: 22.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Polymerase chain reaction, Rash pruritic, Skin lesion
Clinical narrative: This case was received on 11 January 2009 via a QScan search on the VAERS database, under reference number 327213. A 22 year-old female received the following vaccination on 29 July 2008: Smallpox (manufacturer unknown, lot number not reported), and ANTHRAX (BIOTHRAX, manufacturer and lot number not reported). Sixteen days after vaccination, on 15 August 2008, the patient was seen for evaluation of a painful, itchy rash on her face, elbows, hands, knees, feet, and palms. Steroids were prescribed. On 23 September 2008, the patient reported she had stopped taking the steroids 10 days previously (13 September 2008) and had experienced a "few outbreaks of the lesions" which were "not as bad as they were initially". Wound cultures, including viral cultures for VACCINIA, PCR, VARICELLA, and HSV were negative. Results of a punch skin biopsy showed superficial perivascular inflammation with interstitial eosinophils and epidermal spondylosis. 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. List of Documents held by Sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Eye pain, Iritis, Ocular hyperaemia, Visual impairment
Clinical narrative: This case was received on 11 January 2009 via a Qscan search on the VAERS database, under reference number 327365. A 29-year-old male patient received a vaccination on 28 August 2008 with ACAM2000, manufacturer unknown, lot number not reported. On 13 September 2008 during a clinic visit, the patient complained of eye redness, visual disturbance and eye pain that was progressively getting worse. He was sent to the Emergency Room that same day where an ophthalmologist diagnosed the patient with iritis and treated him with Sulfacet/prednisone solution. The patient was seen for a follow-up visit on 22 September 2008 and it was reported that the iritis may have been associated with smallpox/anthrax vaccinations. The patient was referred to Neurology to rule out a vascular event as a result of his immunizations. 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. List of documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site pruritus, Injection site streaking, Lymphadenopathy
Clinical narrative: This case was received on 17 December 2008 via a search on the VAERS database, under reference number 327488. A 29-year-old female patient, whose medical history was not reported, received the following vaccinations on 18 September 2008: ACAM2000 (lot number not reported) and anthrax (trade name and manufacturer unknown, lot number not reported). On 28 September 2008, 10 days post-vaccination, the patient had vigorous smallpox reaction at deltoid (local), rubor, pruritis, and lymphadenopathy (streaking). Corrective treatment and the patient's outcome were not reported.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Conjunctivitis, Eye pain, Iritis, Ocular hyperaemia, Photophobia
Clinical narrative: This case was received on 11 January 2009 via QScan search on the VAERS database, under reference 327541. A 37 year old male patient received small pox vaccine (manufacturer unknown, lot number not reported) on 12 September 2008. The patient presented to clinic 7 days after vaccination on 19 September 2008 with a complaint of right eye pain and redness for two days. The patient also reported that he experienced pain the week for two days. The patient was diagnosed with conjunctivitis and treated with POLYTRIM. On 22 September 2008, the patient was seen for follow-up. The patient's symptoms had worsened to include vision changes and photophobia. The patient reported concern that the symptoms may be related to smallpox vaccination as they started after vaccination. The patient was referred to ophthalmology and was diagnosed with iritis, possibly related to smallpox vaccination or reaction to POLYTRIM. POLYTRIM was discontinued and PREDFORTE and VIGAMOX were prescribed. The patient was seen on 23 September 2008 and 24 September 2008 for follow-up and improvement in his symptoms was noted. 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. List of Documents held by Sender: None.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Visual impairment
Clinical narrative: This case was received on 11 January 2009 via QScan search on the VAERS database, under reference 327541. A 37 year old male patient received small pox vaccine (manufacturer unknown, lot number not reported) on 12 September 2008. The patient presented to clinic 7 days after vaccination on 19 September 2008 with a complaint of right eye pain and redness for two days. The patient also reported that he experienced pain the week for two days. The patient was diagnosed with conjunctivitis and treated with POLYTRIM. On 22 September 2008, the patient was seen for follow-up. The patient's symptoms had worsened to include vision changes and photophobia. The patient reported concern that the symptoms may be related to smallpox vaccination as they started after vaccination. The patient was referred to ophthalmology and was diagnosed with iritis, possibly related to smallpox vaccination or reaction to POLYTRIM. POLYTRIM was discontinued and PREDFORTE and VIGAMOX were prescribed. The patient was seen on 23 September 2008 and 24 September 2008 for follow-up and improvement in his symptoms was noted. 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. List of Documents held by Sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Infection, Injection site pain, Injection site swelling, Purulent discharge
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 327213. A 26 year old female patient received the following vaccination on 26 August 2008: smallpox (manufacturer unknown, lot number not reported). Seventeen days after vaccination, on 12 September 2008, the patient was seen for evaluation of green drainage at the smallpox vaccination site with accompanying injection site swelling and pain. A culture was obtained which was positive for Staphylococcus aureus infection. The patient was prescribed DEMEROL and VISTRALL for pain management and an order for Cephalexin to treat the infection. The patient was seen in follow-up on 16 September 2008 and her symptoms showed improvement. Orders for LEVAQUIN and KEFLEX were given. 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. There may be 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 data. List of documents held by sender: None.
Age: 26.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Culture positive, Injection site discharge, Injection site pain, Injection site swelling, Staphylococcal infection
Clinical narrative: This case was received on 11 January 2009 via a search on the VAERS database, under reference number 327213. A 26 year old female patient received the following vaccination on 26 August 2008: smallpox (manufacturer unknown, lot number not reported). Seventeen days after vaccination, on 12 September 2008, the patient was seen for evaluation of green drainage at the smallpox vaccination site with accompanying injection site swelling and pain. A culture was obtained which was positive for Staphylococcus aureus infection. The patient was prescribed DEMEROL and VISTRALL for pain management and an order for Cephalexin to treat the infection. The patient was seen in follow-up on 16 September 2008 and her symptoms showed improvement. Orders for LEVAQUIN and KEFLEX were given. 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. There may be 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 data. List of documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: CSF culture negative, Computerised tomogram, Culture negative, Dysphagia, Genital ulceration
Clinical narrative: This case was received on 17 December 2008 via a search of the VAERS database (reference number 327661). It was originally reported to VAERS by another manufacturer, Emergent Biosolutions. A 19 year-old female patient received the following vaccinations on 19 September 2008: ACAM2000 (Acambis Inc., lot not reported), TYPHIM VI (lot not reported), ANTHRAX (BIOTHRAX, lot not reported), and nine days later on 28 September 2008, the patient broke out with vaginal burning. She was seen on 01 October 2008 for labial ulcerations and she denied sexual contact. Herpes culture was negative. The patient was admitted on 04 October 2008 for altered mental status. Tests included: negative LP (lumbar puncture), negative head CT; scrape prep, negative HSV (herpes simplex virus) changes, herpes culture negative, CSF (cerebral spinal fluid) negative, HCG (human chorionic gonadotropin) negative. She was unable to swallow valacyclovir. She was seen on 06 October 2008 and had been doing much better and had no pain. The patient was reported to have recovered from the event. No additional information was provided. Documents held by sender: None.
Age: 19.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Herpes simplex serology negative, Mental status changes, Pregnancy test negative, Virus culture negative, Vulvovaginal burning sensation
Clinical narrative: This case was received on 17 December 2008 via a search of the VAERS database (reference number 327661). It was originally reported to VAERS by another manufacturer, Emergent Biosolutions. A 19 year-old female patient received the following vaccinations on 19 September 2008: ACAM2000 (Acambis Inc., lot not reported), TYPHIM VI (lot not reported), ANTHRAX (BIOTHRAX, lot not reported), and nine days later on 28 September 2008, the patient broke out with vaginal burning. She was seen on 01 October 2008 for labial ulcerations and she denied sexual contact. Herpes culture was negative. The patient was admitted on 04 October 2008 for altered mental status. Tests included: negative LP (lumbar puncture), negative head CT; scrape prep, negative HSV (herpes simplex virus) changes, herpes culture negative, CSF (cerebral spinal fluid) negative, HCG (human chorionic gonadotropin) negative. She was unable to swallow valacyclovir. She was seen on 06 October 2008 and had been doing much better and had no pain. The patient was reported to have recovered from the event. No additional information was provided. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Back pain, Blood creatine phosphokinase MB increased, Blood creatinine normal, Blood electrolytes normal
Clinical narrative: This case was received on 02 February 2009 via a QScan search on the VAERS database, under reference number 332168. A 24-year-old male patient, who was previously healthy, received ACAM2000 (lot number not reported) on 24 September 2008. On 03 October 2008, nine days post vaccination, the patient developed pleuritic and substernal chest pain (6-7 out of 10), fever, but no dyspnea. On 05 October 2008, the symptoms persisted and the patient went to a health facility. On exam, the patient was afebrile with stable vital signs and O2 saturation on room air. His temperature was 98.6, pulse 86, B/P 99/63, respirations 16. Physical exam was essentially unremarkable. His primary inoculation site was healing over as anticipated. He had some costochondral tenderness. No signs and symptoms of reduced LV function by physical exam. He received INDOCIN 50 mg, which nearly alleviated his chest pain, and he was doing well since. On 08 October 2008, the patient had new onset of chest pain which was associated with occasional mild dyspnea and dizziness, cough, night sweats, fatigue, weight loss, chronic low back pain, weakness with difficulty walking, and diffuse tenderness to palpitation over most of sternum. The impression was myopericarditis, secondary to immune response to smallpox immunization. Laboratory and diagnostic test results included the following: Serum qualitative Troponin I was positive; Serum CKMB 27 (just above intermediate range upper limit of normal); essentially normal electrolytes and BUN/Cr; EKG: normal sinus rhythm and one to two millimeter ST segment elevations in II, III. The patient was reported to have been hospitalized on unspecified dates. 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.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blood urea normal, Chest pain, Cough, Dizziness, Dyspnoea
Clinical narrative: This case was received on 02 February 2009 via a QScan search on the VAERS database, under reference number 332168. A 24-year-old male patient, who was previously healthy, received ACAM2000 (lot number not reported) on 24 September 2008. On 03 October 2008, nine days post vaccination, the patient developed pleuritic and substernal chest pain (6-7 out of 10), fever, but no dyspnea. On 05 October 2008, the symptoms persisted and the patient went to a health facility. On exam, the patient was afebrile with stable vital signs and O2 saturation on room air. His temperature was 98.6, pulse 86, B/P 99/63, respirations 16. Physical exam was essentially unremarkable. His primary inoculation site was healing over as anticipated. He had some costochondral tenderness. No signs and symptoms of reduced LV function by physical exam. He received INDOCIN 50 mg, which nearly alleviated his chest pain, and he was doing well since. On 08 October 2008, the patient had new onset of chest pain which was associated with occasional mild dyspnea and dizziness, cough, night sweats, fatigue, weight loss, chronic low back pain, weakness with difficulty walking, and diffuse tenderness to palpitation over most of sternum. The impression was myopericarditis, secondary to immune response to smallpox immunization. Laboratory and diagnostic test results included the following: Serum qualitative Troponin I was positive; Serum CKMB 27 (just above intermediate range upper limit of normal); essentially normal electrolytes and BUN/Cr; EKG: normal sinus rhythm and one to two millimeter ST segment elevations in II, III. The patient was reported to have been hospitalized on unspecified dates. 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.