chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 years old female patient with no drug allergy or pertinent medical history. The patient was vaccinated Subcutaneously with a dose of ZOSTAVAX (lot # reported as H011333, Exp Date 08-SEP-2013) on 06-OCT-2012. There was no concomitant medication. On an unknown date after she was vaccinated a dose of ZOSTAVAX, the patient developed redness around the injection site which included a red lump. The pharmacist reported that the patient did call and then stopped by the pharmacy. There was no lab diagnostics performed. No treatment was given. The outcome of redness around the injection site which included a red lump was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. No medical history, drug reactions or allergies were reported. On an unknown date, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On an unknown date, one day post vaccination the patient experienced swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain and tenderness. The patient sought medical attention(office visit). The patient had started treatment with unspecified antibiotics and mild analgesics. No laboratory diagnostic studies were performed. The outcome of swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain and tenderness was reported as recovering. This is one of several reports received from the same reporter regarding patient #1. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an office manager regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On an unknown date, the office manager reported that there was possibly a fourth patient who had a reaction after receiving a dose of PNEUMOVAX 23 from the lot # H013847. It was unspecified if the patient had sought medical attention. No treatment was reported. The outcome of the adverse event was unknown. This is one of several reports received from the same reporter regarding patient #4. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: C-reactive protein, Full blood count, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 66 years old female patient. The patient's medical history included hypertension, migraine, goiter and high cholesterol. The patient was vaccinated with PNEUMOVAX23 on 02-SEP-2012. No other co-suspects were reported. Concomitant medications included ALDACTAZIDE and potassium chloride. On 29-OCT-2012 the patient experienced myalgia, 58 days after onset of therapy, sweats, fever, injection site redness, tenderness at injection site and swelling. No treatment information was reported. The outcome of myalgia, sweats, fever, injection site redness, tenderness at injection site and swelling was reported as recovering/resolving. The relatedness for myalgia, sweats, fever, injection site redness, tenderness at injection site and swelling is unknown for PNEUMOVAX23. {Additional information has been requested./Additional information is not expected.}
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report as received from a physician refers to a 66 years old female patient. The patient's medical history included hypertension, migraine, goiter and high cholesterol. The patient was vaccinated with PNEUMOVAX23 on 02-SEP-2012. No other co-suspects were reported. Concomitant medications included ALDACTAZIDE and potassium chloride. On 29-OCT-2012 the patient experienced myalgia, 58 days after onset of therapy, sweats, fever, injection site redness, tenderness at injection site and swelling. No treatment information was reported. The outcome of myalgia, sweats, fever, injection site redness, tenderness at injection site and swelling was reported as recovering/resolving. The relatedness for myalgia, sweats, fever, injection site redness, tenderness at injection site and swelling is unknown for PNEUMOVAX23. {Additional information has been requested./Additional information is not expected.}
Age: 1.6
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 18 months old patient. The patient was vaccinated with VARIVAX (Merck). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles. No treatment information was reported. The outcome of shingles is unknown. The relatedness for shingles is unknown for VARIVAX (Merck). The physician reports a then 12 month old infant, gender unknown was given the VARIVAX, on and unknown date about 6 months age for vaccination. The patient's relevant medical history, concomitant medications and past drug history is unknown. On an unknown date the infant was 18 months old, they broke out in shingles. It is unknown if there is any relevant laboratory data. As of 29Oct2012 it is unknown if this infant will received another VARIVAX injection and at 18 months they broke out with the shingles, it is unknown if they have recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 72 years old female patient with prophylaxis. The patient was vaccinated with dose 1, 0.5 ml PNEUMOVAX23 (intramuscular, Lot# H013847, exp 14-MAR-2015 on 16-OCT-2012. Other suspect therapies included FLUZONE with dosage information as (UNK) on 16-OCT-2012. No concomitant medications were reported. On 16-OCT-2012 the patient reported she received an unspecified pneumococcal vaccination at an unspecified time last year. Patient stated that she was experiencing fever and the arm where vaccine administered was "distorted" but no tenderness or rash. Reporter stated FLUZONE HD was administered concomitantly with PNEUMOVAX 23 on 16-OCT-2012. Additional information is requested.
Sex: U
Vaccine: HIBV
Symptoms: Injection site induration
Clinical narrative: This spontaneous report as received from an other health professional (registered nurse) that refers to 4 others patients who since July 2012 that had also experienced induration at the injection site after administration of LIQUID PEDVAXHIB. Additional information has been requested. This one of several reports received from the same source.
Age: 0.21
Sex: M
Vaccine: HIBV
Symptoms: Injection site discolouration, Injection site induration
Clinical narrative: This spontaneous report as received from an other health professional (registered nurse) refers to a 3 months old male patient with sickle cell trait. The nurse was reporting the patient developed induration and discoloration at the injection site of the left anterior thigh after administration of his first dose of PEDVAXHIB (lot #0130AE, exp. date 28-JUN-2014) 0.5 ml intramuscular on 14-AUG-2012. The patient was treated for the adverse events (the treatment was not specify). On 23-OCT-2012, the patient's parent called the office to report the induration and discoloration at the injection site were still present but were slowly resolving. Additional information has been requested. This one of several reports received from the same source.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning to a female patient of unknown age. The nurse stated that the patient on 01-NOV-2012, was vaccinated subcutaneously with a dose of 0.5 ml MMR II (lot # 672573/0011AE; exp. date: 16-DEC-2013) which was later determined to have a temperature excursion that was not supported; MMR II reached 56 degrees F for 16 hours. No adverse effect were reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Discomfort, Erythema, Oedema peripheral, Skin warm
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. No medical history, drug reactions or allergies were reported. On 24-OCT-2012, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On 26-OCT-2012, two days post vaccination the patient was seen in the practice and complained of redness, discomfort, less heat and swelling of arm. The patient sought medical attention (office visit). No treatment was reported. No laboratory diagnostic studies were performed. The outcome of redness, discomfort, less heat and swelling of arm was reported as recovering. This is one of several reports received from the same reporter regarding patient #3. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Laceration, Medication error
Clinical narrative: This spontaneous report as received from a Licensed practical nurse refers to a 37 years old female (staff member) who on 01-NOV-2012 cut her finger on a piece with a prefilled syringe of VAQTA that broke during the administration of the vaccine. During a product quality complaint follow up call, the nurse confirmed that the prefilled syringe was RECOMBIVAX HB (lot # reported as H00849, exp date: 28-FEB-2015) pediatric formulation rather than VAQTA. The nurse stated that she misspoke during the initial report. The finger administer was cleaned and bandaged. No lab diagnostic test was performed. At the time of the report, the patient was recovering. This is one of the several reports of the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old female patient. The patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # was reported as H013018, expiration date was on 09-OCT-2013) subcutaneously in her ponosterior right deltoid on 29-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The following day, on 30-OCT-2012 the patient noticed a hardened area in the injection site location. Today, on 31-OCT-2012, the patient had a rash developing at the injection site. The pharmacist did not know if the patient had been treated for the adverse event, nor did he know if the patient had reported this adverse event to her physician. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention via consulting pharmacist. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a group of unspecified patients. The patients were vaccinated with VAQTA (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. On unknown dates the patients received vaccin doses that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 for 15 minutes. No adverse effect reported. No treatment information was reported. Information about GARDASIL, PNEUMOVAX23, PEDVAXHIB and RECOMBIVAX HB that were exposed to temperatures above 46 F for 45 minutes, with the highest temperature of 78 F for 15 minutes is also reported. This is information is processed in the linked cases: 1210USA007111, 1211USA001302, 1211USA001296 and 1211USA001298. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, Incorrect route of drug administration
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot number unspecified) on 12-OCT-2012. No concomitant medications were reported. ZOSTAVAX was given via the intramuscular route and expiry date of the vaccine was 18-AUG-2012. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # and route not reported). No concomitant medications were reported. On an unknown date, the patient experienced an unspecified allergic reaction to PNEUMOVAX 23. It was unspecified if the patient had sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient. The patient was vaccinated with dose 1, .65 ZOSTAVAX on 31-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 03-NOV-2012 the patient experienced injection site reaction, 4 days after onset of therapy. No treatment information was reported. The outcome of injection site reaction was reported as not recovered/not resolved. The relatedness for injection site reaction is unknown for ZOSTAVAX. The pharmacist called to report a patient experienced an injection site reaction that was raised in the area, painful and a developing rash that radiated down her arm after receiving ZOSTAVAX on 10/31/2012. No further information is available.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 58 years old male patient with pneumococcal. The patient's medical history included labile hypertension. The patient was vaccinated with lot # (1947AA), 1 DF PNEUMOVAX 23 on 04-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 04-OCT-2010 the patient experienced pain at the injection site. On 04-OCT-2012 the patient experienced injection site swelling, 1 day after onset of therapy and injection site redness. No treatment information was reported. The outcome of injection site swelling, pain at the injection site and injection site redness was reported as recovered/resolved. The relatedness for injection site swelling is unknown for PNEUMOVAX 23. Additional information has been requested. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) and developed shingles. No concomitant medications were reported. The nurse did not have any patient specific data at the time of the call. The nurse did not know when the patient received the ZOSTAVAX or how soon after vaccination with ZOSTAVAX the patient developed shingles. The nurse believed the patient got the shingles at least a year ago. No treatment information was reported. It was unspecified if the patient had sought medical attention. On an unknown date, the patient had recovered from shingles. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Pyrexia, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a physician regarding a patient of unknown age and gender. No medical history, drug reactions or allergies were reported. On an unknown date, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # reported as H013847, expiry 15-MAR-2014). No concomitant medications were reported. On an unknown date, one day post vaccination the patient experienced swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain, tenderness and low grade fever. The patient sought medical attention (office visit). The patient had started treatment with unspecified antibiotics and mild analgesics. No laboratory diagnostic studies were performed. The outcome of swelling of the upper arm in the mid-bicep region, warmth (the area was hot to touch), pain, tenderness and low grade fever was reported as recovering. This is one of several reports received from the same reporter regarding patient #2. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Chest pain, Electrocardiogram ST segment elevation, Pericardial rub, Rash maculo-papular
Clinical narrative: Initial report was received on 27 September 2011 via a third party query tool search on the VAERS database, under the reference number 426645. A 21-year-old male patient received the following vaccinations on 24 June 2011: ACAM2000 (lot number VV04003A) and anthrax vaccine (manufacturer and lot number unknown). Seven days after vaccination, on 01 July 2011, the patient developed a maculo-papular rash, sudden onset of chest pain which was substernal, radiating to the back and lasted approximately three hours. Pain was relieved with TORADOL in the emergency department, symptoms improved when leaning forward. Laboratory and diagnostic findings noted negative troponins, EKG showed diffuse ST elevation, physical examination noted for pericardial friction rub no longer appreciated after 18 hours of NSAID therapy. The events required hospitalization. The patient had no concurrent illness and no past medical history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin normal
Clinical narrative: Initial report was received on 27 September 2011 via a third party query tool search on the VAERS database, under the reference number 426645. A 21-year-old male patient received the following vaccinations on 24 June 2011: ACAM2000 (lot number VV04003A) and anthrax vaccine (manufacturer and lot number unknown). Seven days after vaccination, on 01 July 2011, the patient developed a maculo-papular rash, sudden onset of chest pain which was substernal, radiating to the back and lasted approximately three hours. Pain was relieved with TORADOL in the emergency department, symptoms improved when leaning forward. Laboratory and diagnostic findings noted negative troponins, EKG showed diffuse ST elevation, physical examination noted for pericardial friction rub no longer appreciated after 18 hours of NSAID therapy. The events required hospitalization. The patient had no concurrent illness and no past medical history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I, Troponin normal
Clinical narrative: Initial report was received on 27 September 2011 via a third party query tool search on the VAERS database, under the reference number 426645. A 21-year-old male patient received the following vaccinations on 24 June 2011: ACAM2000 (lot number VV04003A) and anthrax vaccine (manufacturer and lot number unknown). Seven days after vaccination, on 01 July 2011, the patient developed a maculo-papular rash, sudden onset of chest pain which was substernal, radiating to the back and lasted approximately three hours. Pain was relieved with TORADOL in the emergency department, symptoms improved when leaning forward. Laboratory and diagnostic findings noted negative troponins, EKG showed diffuse ST elevation, physical examination noted for pericardial friction rub no longer appreciated after 18 hours of NSAID therapy. The events required hospitalization. The patient had no concurrent illness and no past medical history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Back pain, Chest pain, Electrocardiogram ST segment elevation, Pericardial rub, Rash maculo-papular
Clinical narrative: This study case was received from the investigator on 28 October 2011. A 27 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium nine days after he had received on 24 June 2011 an injection of ACAM2000 (lot number, route and site of administration not reported) and anthrax 2 (manufacturer, lot number, route and site of administration not reported). On 25 May 2011 the subject received an injection of TYPHIM Vi (lot number, route and site of administration not reported) and anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 03 July 2011, an abnormal ECG on 03 July 2011 and a normal echocardiogram on 06 July 2011. A lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin normal
Clinical narrative: This study case was received from the investigator on 28 October 2011. A 27 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium nine days after he had received on 24 June 2011 an injection of ACAM2000 (lot number, route and site of administration not reported) and anthrax 2 (manufacturer, lot number, route and site of administration not reported). On 25 May 2011 the subject received an injection of TYPHIM Vi (lot number, route and site of administration not reported) and anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 03 July 2011, an abnormal ECG on 03 July 2011 and a normal echocardiogram on 06 July 2011. A lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I, Troponin normal
Clinical narrative: This study case was received from the investigator on 28 October 2011. A 27 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium nine days after he had received on 24 June 2011 an injection of ACAM2000 (lot number, route and site of administration not reported) and anthrax 2 (manufacturer, lot number, route and site of administration not reported). On 25 May 2011 the subject received an injection of TYPHIM Vi (lot number, route and site of administration not reported) and anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I on 03 July 2011, an abnormal ECG on 03 July 2011 and a normal echocardiogram on 06 July 2011. A lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. The subject's outcome was not reported. There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood culture negative, C-reactive protein increased, Chest pain, Chills, Culture urine negative
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 426912. A 23 year-old male patient with a history of childhood asthma with no occurrence in adulthood had received the following vaccinations on 29 May 2011: a dose one injection of ACAM2000 (lot number VV04003A, site of administration not reported), a dose one intramuscular injection of TYPHIMVI (lot number D04121, site of administration not reported) and a dose one injection of BIOTHRAX (Emergent lot number FAV256, route and site of administration not reported) and "ten days" later on 08 June 2011 (also reported as 07 June 2011), experienced chest pain "as if someone was sitting on me", fever, shaking chills, heat and swelling of smallpox vaccination site. He was transported to the ER (emergency room) and then hospitalized (dates not reported). Diagnostic tests included: Serial ECG's monitored and revealed persistent, subtle, lateral ST-T wave lability; Elevated Troponin I of 0.37 (normal 0.10); elevated sed rate of 22, elevated CRP at 66.5; normal blood and urine cultures; "Echocardiogram normal and EF 55%. The patient's Troponin trended downward and repeat echo prior to discharge remained unchanged. The event was considered to be life threatening. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Ejection fraction normal, Electrocardiogram ST-T change, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 426912. A 23 year-old male patient with a history of childhood asthma with no occurrence in adulthood had received the following vaccinations on 29 May 2011: a dose one injection of ACAM2000 (lot number VV04003A, site of administration not reported), a dose one intramuscular injection of TYPHIMVI (lot number D04121, site of administration not reported) and a dose one injection of BIOTHRAX (Emergent lot number FAV256, route and site of administration not reported) and "ten days" later on 08 June 2011 (also reported as 07 June 2011), experienced chest pain "as if someone was sitting on me", fever, shaking chills, heat and swelling of smallpox vaccination site. He was transported to the ER (emergency room) and then hospitalized (dates not reported). Diagnostic tests included: Serial ECG's monitored and revealed persistent, subtle, lateral ST-T wave lability; Elevated Troponin I of 0.37 (normal 0.10); elevated sed rate of 22, elevated CRP at 66.5; normal blood and urine cultures; "Echocardiogram normal and EF 55%. The patient's Troponin trended downward and repeat echo prior to discharge remained unchanged. The event was considered to be life threatening. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Tremor, Troponin I increased, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 426912. A 23 year-old male patient with a history of childhood asthma with no occurrence in adulthood had received the following vaccinations on 29 May 2011: a dose one injection of ACAM2000 (lot number VV04003A, site of administration not reported), a dose one intramuscular injection of TYPHIMVI (lot number D04121, site of administration not reported) and a dose one injection of BIOTHRAX (Emergent lot number FAV256, route and site of administration not reported) and "ten days" later on 08 June 2011 (also reported as 07 June 2011), experienced chest pain "as if someone was sitting on me", fever, shaking chills, heat and swelling of smallpox vaccination site. He was transported to the ER (emergency room) and then hospitalized (dates not reported). Diagnostic tests included: Serial ECG's monitored and revealed persistent, subtle, lateral ST-T wave lability; Elevated Troponin I of 0.37 (normal 0.10); elevated sed rate of 22, elevated CRP at 66.5; normal blood and urine cultures; "Echocardiogram normal and EF 55%. The patient's Troponin trended downward and repeat echo prior to discharge remained unchanged. The event was considered to be life threatening. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Abscess, Incisional drainage, Post vaccination autoinoculation, Purulent discharge, Staphylococcal infection
Clinical narrative: This case was received on 27 September 2011 via third party query tool search on the VAERS database, under reference number 427388. A 20-year-old male patient with no concurrent illnesses, no relevant medical history, and no use of other medications had received the following vaccination on 06 July 2011: ACAM2000 (lot number VV04003A, dose 0) and 5 days later, the patient was seen at the clinic for evaluation of the smallpox vaccination and was advised to return to his PMC (primary care manager) and tell them about the proximity of a secondary site that was approximately 15 cm in size with an approximate 5 cm open area that had a moderate amount of yellow pus. The patient was evaluated by his PMC who saw an abscess to the left hip that was approximately 18 inches from the original smallpox vaccination site. Incision and drainage of the site produced copious amounts of pus. The patient was diagnosed with staph infection. Per the report, the full diagnosis was unknown at the present time, but there was strong suspicion the patient was an autoinoculator. Laboratory data was reported as "none". Outcome was not reported. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: This case was received on 27 September 2011 via third party query tool search on the VAERS database, under reference number 427388. A 20-year-old male patient with no concurrent illnesses, no relevant medical history, and no use of other medications had received the following vaccination on 06 July 2011: ACAM2000 (lot number VV04003A, dose 0) and 5 days later, the patient was seen at the clinic for evaluation of the smallpox vaccination and was advised to return to his PMC (primary care manager) and tell them about the proximity of a secondary site that was approximately 15 cm in size with an approximate 5 cm open area that had a moderate amount of yellow pus. The patient was evaluated by his PMC who saw an abscess to the left hip that was approximately 18 inches from the original smallpox vaccination site. Incision and drainage of the site produced copious amounts of pus. The patient was diagnosed with staph infection. Per the report, the full diagnosis was unknown at the present time, but there was strong suspicion the patient was an autoinoculator. Laboratory data was reported as "none". Outcome was not reported. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: Abdominal pain upper, Incisional drainage, Lymphadenopathy, Rash pustular, Secretion discharge
Clinical narrative: Initial report was received on 27 September 2011 via a third party query tool search on the VAERS database, under the reference number 427424. A 29-year-old patient received the following vaccination on 04 May 2011: ACAM2000 (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. Two weeks after vaccination on 18 May 2011, the patient developed scattered pustules on his arms, legs and trunk, and one on his scalp. He also had one enlarged submandibular node. Some drained clear fluid and a few were large; 1-2 cm, and two on his knee were foul smelling. Incision and drainage was performed on these lesions and the patient was given antibiotics as corrective treatment. The patient had a history of boils occasionally. He had no other symptoms such as fever, headache, shortness of breath or chest pain. He felt well that day, but returned the next day for a dressing change and complained of LUQ (left upper quadrant) pain (5/10) x four days. His white blood cells which had been normal the day before was 12K. The patient was then transferred out for further evaluation. Outcome was unknown. Documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: SMALL
Symptoms: White blood cell count increased, Wound complication
Clinical narrative: Initial report was received on 27 September 2011 via a third party query tool search on the VAERS database, under the reference number 427424. A 29-year-old patient received the following vaccination on 04 May 2011: ACAM2000 (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. Two weeks after vaccination on 18 May 2011, the patient developed scattered pustules on his arms, legs and trunk, and one on his scalp. He also had one enlarged submandibular node. Some drained clear fluid and a few were large; 1-2 cm, and two on his knee were foul smelling. Incision and drainage was performed on these lesions and the patient was given antibiotics as corrective treatment. The patient had a history of boils occasionally. He had no other symptoms such as fever, headache, shortness of breath or chest pain. He felt well that day, but returned the next day for a dressing change and complained of LUQ (left upper quadrant) pain (5/10) x four days. His white blood cells which had been normal the day before was 12K. The patient was then transferred out for further evaluation. Outcome was unknown. Documents held by sender: None.
Age: 31.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site oedema, Injection site warmth
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 427842. A 31 year-old male patient had received on 09 July 2011 a left arm injection of ACAM2000 (lot number not reported) and an intramuscular right arm injection of Anthrax (manufacturer and lot number not reported) and 11 days later on 20 July 2011, the patient removed the bandage and noticed that part of the pustule had come off and noted redness, induration, edema and warm to touch. According to the report, it "appears to be some infection". Treatment included BACTRIM.  Other medications, current illnesses and history were reported as none.  Lab data and prior vaccinations were not reported. 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: 21.0
Sex: M
Vaccine: SMALL
Symptoms: CSF glucose decreased, CSF protein normal, CSF test normal, CSF white blood cell count negative, Culture negative
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 427964. A 21 year-old male patient had received on 11 July 2011 a dose one left arm injection of ACAM2000 (lot number VV04003A) and four days later on 15 July 2011, was diagnosed with generalized vaccinia and presented with diffuse macular-papular vesicular rash on face, torso, chest, and left shoulder. The rash worsened over the next five days. He was hospitalized (dates not provided) in isolation for supportive care upon which time he was also found to have fevers, headaches, nausea and vomiting. Laboratory tests included a negative lumbar puncture; "CSF: clear and colorless; RBC 0 WBC 1 glu 49 pro 40 gram stain negative"; culture negative; comprehensive metabolic panel normal; WBC 7.1 Hgb 15 Plt 143. A vaccinia PCR was pending on skin lesion samples as well as CSF. Current illnesses and history were none. No further information was available at the time of the report. The patient's outcome was reported in the narrative as resolving symptoms on HD #4; however the recovery status was reported as unknown. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Generalised vaccinia, Gram stain, Gram stain negative, Haemoglobin normal, Headache
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 427964. A 21 year-old male patient had received on 11 July 2011 a dose one left arm injection of ACAM2000 (lot number VV04003A) and four days later on 15 July 2011, was diagnosed with generalized vaccinia and presented with diffuse macular-papular vesicular rash on face, torso, chest, and left shoulder. The rash worsened over the next five days. He was hospitalized (dates not provided) in isolation for supportive care upon which time he was also found to have fevers, headaches, nausea and vomiting. Laboratory tests included a negative lumbar puncture; "CSF: clear and colorless; RBC 0 WBC 1 glu 49 pro 40 gram stain negative"; culture negative; comprehensive metabolic panel normal; WBC 7.1 Hgb 15 Plt 143. A vaccinia PCR was pending on skin lesion samples as well as CSF. Current illnesses and history were none. No further information was available at the time of the report. The patient's outcome was reported in the narrative as resolving symptoms on HD #4; however the recovery status was reported as unknown. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Lumbar puncture normal, Metabolic function test normal, Nausea, Platelet count decreased, Polymerase chain reaction
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 427964. A 21 year-old male patient had received on 11 July 2011 a dose one left arm injection of ACAM2000 (lot number VV04003A) and four days later on 15 July 2011, was diagnosed with generalized vaccinia and presented with diffuse macular-papular vesicular rash on face, torso, chest, and left shoulder. The rash worsened over the next five days. He was hospitalized (dates not provided) in isolation for supportive care upon which time he was also found to have fevers, headaches, nausea and vomiting. Laboratory tests included a negative lumbar puncture; "CSF: clear and colorless; RBC 0 WBC 1 glu 49 pro 40 gram stain negative"; culture negative; comprehensive metabolic panel normal; WBC 7.1 Hgb 15 Plt 143. A vaccinia PCR was pending on skin lesion samples as well as CSF. Current illnesses and history were none. No further information was available at the time of the report. The patient's outcome was reported in the narrative as resolving symptoms on HD #4; however the recovery status was reported as unknown. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Rash maculo-papular, Rash vesicular, Viral test, Vomiting
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 427964. A 21 year-old male patient had received on 11 July 2011 a dose one left arm injection of ACAM2000 (lot number VV04003A) and four days later on 15 July 2011, was diagnosed with generalized vaccinia and presented with diffuse macular-papular vesicular rash on face, torso, chest, and left shoulder. The rash worsened over the next five days. He was hospitalized (dates not provided) in isolation for supportive care upon which time he was also found to have fevers, headaches, nausea and vomiting. Laboratory tests included a negative lumbar puncture; "CSF: clear and colorless; RBC 0 WBC 1 glu 49 pro 40 gram stain negative"; culture negative; comprehensive metabolic panel normal; WBC 7.1 Hgb 15 Plt 143. A vaccinia PCR was pending on skin lesion samples as well as CSF. Current illnesses and history were none. No further information was available at the time of the report. The patient's outcome was reported in the narrative as resolving symptoms on HD #4; however the recovery status was reported as unknown. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: White blood cell count normal
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 427964. A 21 year-old male patient had received on 11 July 2011 a dose one left arm injection of ACAM2000 (lot number VV04003A) and four days later on 15 July 2011, was diagnosed with generalized vaccinia and presented with diffuse macular-papular vesicular rash on face, torso, chest, and left shoulder. The rash worsened over the next five days. He was hospitalized (dates not provided) in isolation for supportive care upon which time he was also found to have fevers, headaches, nausea and vomiting. Laboratory tests included a negative lumbar puncture; "CSF: clear and colorless; RBC 0 WBC 1 glu 49 pro 40 gram stain negative"; culture negative; comprehensive metabolic panel normal; WBC 7.1 Hgb 15 Plt 143. A vaccinia PCR was pending on skin lesion samples as well as CSF. Current illnesses and history were none. No further information was available at the time of the report. The patient's outcome was reported in the narrative as resolving symptoms on HD #4; however the recovery status was reported as unknown. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Eschar, Eyelid oedema, Induration
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 428121. A 20 year-old male patient had received on 15 July 2011 a left arm injection of ACAM2000 (lot number VV04003A), and seven days later on 22 July 2011 experienced a 1 x 1 cm area of erythema and four small vesicles over the right lateral brow. Small eschar noted two cm area of induration extends beyond vesicles laterally. There was mild edema near the right upper lid but no periorbital cellulitis. Lab data, other medications, current illnesses and history were none. Prior vaccinations were not reported. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Headache, Rash papular
Clinical narrative: This case was received on 27 September 2011 via a third party query tool search on the VAERS database, under reference number 428267. A 37-year-old male patient with no medical history received the following vaccination on 22 January 2010: ACAM2000 (lot number VV04003A) and at an unspecified amount of time later experienced chills, rash (bumps) and occasional headaches (coded by VAERS as headache). The patient recovered on an unspecified date. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB increased, 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.