chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Neutrophil count normal, Neutrophil percentage, Nucleated red cells, Pericardial disease, Platelet count normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Red cell distribution width normal, Troponin I, White blood cell count normal
Clinical narrative: This case was received on 26 April 2011 via a third party query tool search on the VAERS database, under reference number 416956. A 27-year-old male patient received the following vaccination on 31 January 2011: ACAM2000 (lot number VV04003A). The patient had no current illnesses. The patient had a history of asthma. On 13 February 2011, with one week history of myalgia and arthralgia and with chest discomfort not associated with position was found to have myocarditis likely related to the smallpox vaccine. An echocardiogram was within normal limits. The patient's laboratory findings were as follows on 14 February 2011 at 10:38: creatine kinase (CK) 76 IU/L, creatine kinase-MB fraction (CKMB) 2.2 ng/mL, percent CKMB 2.89%, and cardiac troponin I (cTnI) 0.25 ng/mL. The patient's laboratory findings were as follows on 14 February 2011 at 05:06: CK 91 IU/L, CKMB 2.8 ng/mL, percent CKMB 3.08%, and cTnI not provided. The following laboratory findings reported a decrease in level (date and value not reported): basophil percentage, mean platelet volume decreased, and red blood cell count. The following laboratory findings reported an increase in level (date and value not reported): C-reactive protein, mean cell haemoglobin, monocyte count, monocyte percentage, and red blood cell sedimentation rate. The following laboratory findings reported a normal level (date and value not reported): basophil count, eosinophil count, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, haematocrit, haemoglobin, lymphocyte count, mean cell haemoglobin concentration, mean cell volume, neutrophil count, platelet count, red cell distribution width and white blood cell count. The following laboratory findings were performed but no date or value was reported: eosinophil percentage, lymphocyte percentage, nucleated red cells and neutrophil percentage. A pulmonary artery pressure was done but results not reported. The patient was treated as an in-hospital patient with MOTRIN and prednisone. He performed activities of daily living (ADL), tolerated oral (PO) an was hemodynamically stable at this time. The patient was placed on light limited duty pending cardiologist's recommendations. The patient will be discharged with MOTRIN and prednisone. The outcome was reported as recovered. Follow-up information was received from the investigator on 10 June 2011. It was determined that this subject had been enrolled in a study. On 13 February 2011, the subject had a abnormal troponin I level of 1.56 (no units provided) and a normal electrocardiogram (ECG). On 14 February 2011, the subject had an abnormal echocardiogram. On 17 February 2011, the subject was diagnosed with unspecified disease of the pericardium. Additional information will be requested from the investigator. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Rash on thighs - small erythematous papules not urticaria.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site rash, Rash papular
Clinical narrative: Rash on thighs - small erythematous papules not urticaria.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Convulsion
Clinical narrative: No symptoms reported by patient until 4 hrs later at restaurant. Pt had seizure & lost consciousness; hospitalized x 2 days. Now on anti-seizure meds. Events reported by patient to provider 6-14-2011.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: No symptoms reported by patient until 4 hrs later at restaurant. Pt had seizure & lost consciousness; hospitalized x 2 days. Now on anti-seizure meds. Events reported by patient to provider 6-14-2011.
Age: 11.0
Sex: M
Vaccine: YF, YF
Symptoms: Chest discomfort, Dizziness, Rash, Syncope, Vomiting
Clinical narrative: Patient received SQ Yellow Fever vaccination in his left upper arm at approximately 0915 & had a syncopal episode approximately 5 minutes later lasting 5 minutes. Patient kept supine and apparently recovered completely within 15 minutes. Mother given instructions to take patient home with no physical activity for the rest of the morning. Received a phone call at approximately 10:10 AM from the patient's mother reporting that the patient had become lightheaded again and vomited food from breakfast. She also indicated that the patient had a fine yellow, non-pruritic rash on his abdomen and had briefly c/o a tightness in his chest, although he was presently not SOB and was speaking in full sentences without difficulty. His mother was given instructions to take the child to the nearest emergency department. She agreed to do so. Approximately 1 hour later I again called the patient's mother to check on his progress. She stated he had been taken back to a treatment room, had been given BENADRYL and was now experiencing a decreasing rash with no other symptoms.
Age: 11.0
Sex: M
Vaccine: YF, YF
Symptoms: Yellow skin
Clinical narrative: Patient received SQ Yellow Fever vaccination in his left upper arm at approximately 0915 & had a syncopal episode approximately 5 minutes later lasting 5 minutes. Patient kept supine and apparently recovered completely within 15 minutes. Mother given instructions to take patient home with no physical activity for the rest of the morning. Received a phone call at approximately 10:10 AM from the patient's mother reporting that the patient had become lightheaded again and vomited food from breakfast. She also indicated that the patient had a fine yellow, non-pruritic rash on his abdomen and had briefly c/o a tightness in his chest, although he was presently not SOB and was speaking in full sentences without difficulty. His mother was given instructions to take the child to the nearest emergency department. She agreed to do so. Approximately 1 hour later I again called the patient's mother to check on his progress. She stated he had been taken back to a treatment room, had been given BENADRYL and was now experiencing a decreasing rash with no other symptoms.
Age: 12.0
Sex: M
Vaccine: TYP, YF
Symptoms: Dizziness, Dyspnoea, Pyrexia
Clinical narrative: Reported shortness of breath & dizziness at 4:30 PM, fever onset 10:00 PM.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, TYP
Symptoms: Erythema, Oedema peripheral, Skin warm, Vaccination site erythema, Vaccination site pain
Clinical narrative: Developed erythema, swelling warmth and pain on the left triceps area where Pneumococcal vaccine was given earlier in the day. 48 hours after the vaccination the erythema, swelling, warmth began expanding rapidly, went below the elbow. I was hospitalized and given IV Vancomycin.
Age: 40.0
Sex: F
Vaccine: PPV, TDAP, TYP
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Developed erythema, swelling warmth and pain on the left triceps area where Pneumococcal vaccine was given earlier in the day. 48 hours after the vaccination the erythema, swelling, warmth began expanding rapidly, went below the elbow. I was hospitalized and given IV Vancomycin.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Bacterial test negative, Band neutrophil count increased, Pyrexia, Red blood cell count normal, Streptococcus test negative
Clinical narrative: Fever of 104+
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Fever of 104+
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash pruritic, Scratch, Swelling
Clinical narrative: Red, raised itchy rash that spreads when scratched.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Blister, Dermatitis, Macule, Rash erythematous, Rash vesicular
Clinical narrative: 6-12-2011 presented at hospital ER, with a diffuse red raised rash with some areas that seemed somewhat vesicular, no drainage or bleeding.  No surrounding cellulitis or erythema, or bruising.  The child had no fevers or chills, eating and drinking well and unbothered by the rash. Diagnosed with dermatitis, unknown etiology. The child had a follow up appointment on 6-13-11 and diagnosed with a varicella-like rash due to VZV vaccination.  At this visit had approximately 30-40 macules to vesicles noted on trunk, extremities.  Blanch readily.   Vesicles are on a red base.  No pattern noted.  Afebrile, well developed, well hydrated in no acute distress.  Medical provider requested a VAERS report.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Contusion, Erythema, Injection site mass, Injection site swelling, Skin warm
Clinical narrative: Redness, swelling, warm to the touch approx 2.25 in in diameter. As of 06/14/2011 site was still swollen with a noticiable lump and bruising above and bellow the site.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Swelling
Clinical narrative: Redness, swelling, warm to the touch approx 2.25 in in diameter. As of 06/14/2011 site was still swollen with a noticiable lump and bruising above and bellow the site.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Body temperature increased, Oedema peripheral
Clinical narrative: Temp of 100.3 and mild swelling of left thigh.  Parent reports that Patient had no reaction to 1st dose but had a mild reaction to 2nd dose and now.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local swelling, Pruritus, Skin irritation, Skin warm
Clinical narrative: IRRITATION, REDNESS, HOT TO THE TOUCH, SWOLLEN, ITCHY. APPROX 3IN DIAMETER AFFECTED AREA. WORSENED TO APPROX 4 IN IN DIAMETER ON 6/9/2011 BEFORE BEGINING TO SUBSIDE.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Local swelling, Pruritus
Clinical narrative: SWOLLEN, RED, WARM TO THE TOUCH AND ITCHY. AFFECTED AREA IS 3IN IN DIAMETER. WORSENED THROUGH THE 10TH THEN BEGAN TO SUBSIDED.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: In clinic reporting pain in left deltoid with swelling & redness. Pain located at injection site. Reports pain x 3 days.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Electrocardiogram normal
Clinical narrative: Received primary SPV on 5/10/2011. 24-48 hours later: <1hr Chest ache/pressure at rest described as "2 hands grabbing at lower chest" 24 hours after vaccination; and later a 2-3 hour ache to 2-4th ICS rt side of sternum 48 hours after SPV which resolved with activity. Went to ER on 5/12/11 with normal EKG and CXR. Released with dx of chest pain-resolved. SM sent to clinic by immunization clinic for VAERS and f/u evaluation of his chest pressure. He has had no recurrence of this discomfort, this SM did report 2-4 day history of light am cough prior to vaccination (?URI vs allergic rhinitis PND?).
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Received primary SPV on 5/10/2011. 24-48 hours later: <1hr Chest ache/pressure at rest described as "2 hands grabbing at lower chest" 24 hours after vaccination; and later a 2-3 hour ache to 2-4th ICS rt side of sternum 48 hours after SPV which resolved with activity. Went to ER on 5/12/11 with normal EKG and CXR. Released with dx of chest pain-resolved. SM sent to clinic by immunization clinic for VAERS and f/u evaluation of his chest pressure. He has had no recurrence of this discomfort, this SM did report 2-4 day history of light am cough prior to vaccination (?URI vs allergic rhinitis PND?).
Age: 0.21
Sex: M
Vaccine: DTAPIPV, HIBV, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt was given duplicate dose of DTaP. (No adverse reaction reported). Will continue to check on pt. next 48 hours.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Laryngitis, Oropharyngeal pain, Viral pharyngitis, Viral test negative
Clinical narrative: 4/21/2011 Developed viral pharyngitis then laryngitis. 5/10/2011 Re-developed sore throat, followed 5/13/11 by loss of taste (ageusia). No recovery to date.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: This man developed a rash consistent with Shingles in the right 5th cervical distribution that extended down the right arm beginning 7 to 8 days following a ZOSTAVAX vaccine at a local pharmacy. He was prescribed VALTREX for the rash and LYRICA for moderate symptoms of post herpetic neuralgia.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Chills, Injection site pain, Urticaria
Clinical narrative: Day after injection started with chills, pain at site, temp, welts on upper arm increased pain.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Bronchitis, Bronchospasm, Condition aggravated, Cough
Clinical narrative: 12/17/10 - I was treated for Acute Upper Respiratory Infection, Acute Bronchitis, Asthma, Acute Bronchospasm. Medications prescribed: BIAXIN 500mg BID x 7 days. MEDROL Dose Pk, Albuterol inhaler as needed. 03/25/11 - I was treated for Sinusitis, Right Shoulder Pain. X-rays of Right Shoulder. Medications prescribed: CIPRO 500mg BID. FLONASE Nasal Spray, ALLEGRA, Diclofenac 75 BID. 04/18/11 - I was treated for Severe Right Shoulder Pain. Injections were given at this time: Bupivacaine, Dexamethasone Sodium Phosphate, Lidocaine HCI 1% Injection, Hydrocodone-Acetaminophen 5-500mg. 1-tablet every 6-hours as needed. 05/02/11 - Follow-up for Right Shoulder Pain, Neck Pain. 05/02/11 - MRI of Cervical Spine & Right Shoulder. 05/03/11 - Emergency Room visit - I was treated for Severe Headache. Pain in the Back Of Head, Radiating pain down Right Shoulder and arm. Medications given: TORADOL 60mg. Injection, ZOFRAN 4mg. Injection. 05/04/11 - Follow-up visit for results of MRI of Neck and Right Shoulder. Medication Prescribed: Nabumetone 500mg. 1 tablet Twice Daily. 05/10/11 - New Patient visit for Right Shoulder Pain to the Right Hand. Medications Prescribed: Tramadol 50mg. To take with 500mg TYLENOL. 05/17/11 - I was treated Asthma with Acute Exacerbation, Coughing & Wheezing. Medications Prescribed: ZPack 250mg., Prednisone 20mg, 2-tablets once a day for 3-days. Albuterol Inhaler. HYCODAN Syrup at night for cough. Albuterol Solution for Nebulizer. 05/27/11 - I was treated for Right Shoulder and Right Arm and Hand Pain with Numbness and Tingling. Medication given: Steroid Injection and Methylprednisolone Pak 4-mg. 06/02/11 - Saw doctor today for Right Shoulder Pain, Right arm and Hand Pain with Numbness and Tingling. 06/03/11 - EMG Nerve Test done today. Diagnosed with: Brachial Plexitis. 06/07/11 - Informed doctor that in the past 6-month period I have received 3-doses of Hepatitis B Vaccines. 06/13/11 - MRI done today. Results pending. 06/22/11 - Scheduled follow-up appointment for today. At this time I'm currently being treated by doctor for this condition. If you have any questions or need further information, please feel free to contact me.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Electromyogram abnormal, Headache, Hypoaesthesia, Musculoskeletal pain, Neck pain
Clinical narrative: 12/17/10 - I was treated for Acute Upper Respiratory Infection, Acute Bronchitis, Asthma, Acute Bronchospasm. Medications prescribed: BIAXIN 500mg BID x 7 days. MEDROL Dose Pk, Albuterol inhaler as needed. 03/25/11 - I was treated for Sinusitis, Right Shoulder Pain. X-rays of Right Shoulder. Medications prescribed: CIPRO 500mg BID. FLONASE Nasal Spray, ALLEGRA, Diclofenac 75 BID. 04/18/11 - I was treated for Severe Right Shoulder Pain. Injections were given at this time: Bupivacaine, Dexamethasone Sodium Phosphate, Lidocaine HCI 1% Injection, Hydrocodone-Acetaminophen 5-500mg. 1-tablet every 6-hours as needed. 05/02/11 - Follow-up for Right Shoulder Pain, Neck Pain. 05/02/11 - MRI of Cervical Spine & Right Shoulder. 05/03/11 - Emergency Room visit - I was treated for Severe Headache. Pain in the Back Of Head, Radiating pain down Right Shoulder and arm. Medications given: TORADOL 60mg. Injection, ZOFRAN 4mg. Injection. 05/04/11 - Follow-up visit for results of MRI of Neck and Right Shoulder. Medication Prescribed: Nabumetone 500mg. 1 tablet Twice Daily. 05/10/11 - New Patient visit for Right Shoulder Pain to the Right Hand. Medications Prescribed: Tramadol 50mg. To take with 500mg TYLENOL. 05/17/11 - I was treated Asthma with Acute Exacerbation, Coughing & Wheezing. Medications Prescribed: ZPack 250mg., Prednisone 20mg, 2-tablets once a day for 3-days. Albuterol Inhaler. HYCODAN Syrup at night for cough. Albuterol Solution for Nebulizer. 05/27/11 - I was treated for Right Shoulder and Right Arm and Hand Pain with Numbness and Tingling. Medication given: Steroid Injection and Methylprednisolone Pak 4-mg. 06/02/11 - Saw doctor today for Right Shoulder Pain, Right arm and Hand Pain with Numbness and Tingling. 06/03/11 - EMG Nerve Test done today. Diagnosed with: Brachial Plexitis. 06/07/11 - Informed doctor that in the past 6-month period I have received 3-doses of Hepatitis B Vaccines. 06/13/11 - MRI done today. Results pending. 06/22/11 - Scheduled follow-up appointment for today. At this time I'm currently being treated by doctor for this condition. If you have any questions or need further information, please feel free to contact me.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Nerve conduction studies abnormal, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: 12/17/10 - I was treated for Acute Upper Respiratory Infection, Acute Bronchitis, Asthma, Acute Bronchospasm. Medications prescribed: BIAXIN 500mg BID x 7 days. MEDROL Dose Pk, Albuterol inhaler as needed. 03/25/11 - I was treated for Sinusitis, Right Shoulder Pain. X-rays of Right Shoulder. Medications prescribed: CIPRO 500mg BID. FLONASE Nasal Spray, ALLEGRA, Diclofenac 75 BID. 04/18/11 - I was treated for Severe Right Shoulder Pain. Injections were given at this time: Bupivacaine, Dexamethasone Sodium Phosphate, Lidocaine HCI 1% Injection, Hydrocodone-Acetaminophen 5-500mg. 1-tablet every 6-hours as needed. 05/02/11 - Follow-up for Right Shoulder Pain, Neck Pain. 05/02/11 - MRI of Cervical Spine & Right Shoulder. 05/03/11 - Emergency Room visit - I was treated for Severe Headache. Pain in the Back Of Head, Radiating pain down Right Shoulder and arm. Medications given: TORADOL 60mg. Injection, ZOFRAN 4mg. Injection. 05/04/11 - Follow-up visit for results of MRI of Neck and Right Shoulder. Medication Prescribed: Nabumetone 500mg. 1 tablet Twice Daily. 05/10/11 - New Patient visit for Right Shoulder Pain to the Right Hand. Medications Prescribed: Tramadol 50mg. To take with 500mg TYLENOL. 05/17/11 - I was treated Asthma with Acute Exacerbation, Coughing & Wheezing. Medications Prescribed: ZPack 250mg., Prednisone 20mg, 2-tablets once a day for 3-days. Albuterol Inhaler. HYCODAN Syrup at night for cough. Albuterol Solution for Nebulizer. 05/27/11 - I was treated for Right Shoulder and Right Arm and Hand Pain with Numbness and Tingling. Medication given: Steroid Injection and Methylprednisolone Pak 4-mg. 06/02/11 - Saw doctor today for Right Shoulder Pain, Right arm and Hand Pain with Numbness and Tingling. 06/03/11 - EMG Nerve Test done today. Diagnosed with: Brachial Plexitis. 06/07/11 - Informed doctor that in the past 6-month period I have received 3-doses of Hepatitis B Vaccines. 06/13/11 - MRI done today. Results pending. 06/22/11 - Scheduled follow-up appointment for today. At this time I'm currently being treated by doctor for this condition. If you have any questions or need further information, please feel free to contact me.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Sinusitis, Upper respiratory tract infection, Wheezing, X-ray
Clinical narrative: 12/17/10 - I was treated for Acute Upper Respiratory Infection, Acute Bronchitis, Asthma, Acute Bronchospasm. Medications prescribed: BIAXIN 500mg BID x 7 days. MEDROL Dose Pk, Albuterol inhaler as needed. 03/25/11 - I was treated for Sinusitis, Right Shoulder Pain. X-rays of Right Shoulder. Medications prescribed: CIPRO 500mg BID. FLONASE Nasal Spray, ALLEGRA, Diclofenac 75 BID. 04/18/11 - I was treated for Severe Right Shoulder Pain. Injections were given at this time: Bupivacaine, Dexamethasone Sodium Phosphate, Lidocaine HCI 1% Injection, Hydrocodone-Acetaminophen 5-500mg. 1-tablet every 6-hours as needed. 05/02/11 - Follow-up for Right Shoulder Pain, Neck Pain. 05/02/11 - MRI of Cervical Spine & Right Shoulder. 05/03/11 - Emergency Room visit - I was treated for Severe Headache. Pain in the Back Of Head, Radiating pain down Right Shoulder and arm. Medications given: TORADOL 60mg. Injection, ZOFRAN 4mg. Injection. 05/04/11 - Follow-up visit for results of MRI of Neck and Right Shoulder. Medication Prescribed: Nabumetone 500mg. 1 tablet Twice Daily. 05/10/11 - New Patient visit for Right Shoulder Pain to the Right Hand. Medications Prescribed: Tramadol 50mg. To take with 500mg TYLENOL. 05/17/11 - I was treated Asthma with Acute Exacerbation, Coughing & Wheezing. Medications Prescribed: ZPack 250mg., Prednisone 20mg, 2-tablets once a day for 3-days. Albuterol Inhaler. HYCODAN Syrup at night for cough. Albuterol Solution for Nebulizer. 05/27/11 - I was treated for Right Shoulder and Right Arm and Hand Pain with Numbness and Tingling. Medication given: Steroid Injection and Methylprednisolone Pak 4-mg. 06/02/11 - Saw doctor today for Right Shoulder Pain, Right arm and Hand Pain with Numbness and Tingling. 06/03/11 - EMG Nerve Test done today. Diagnosed with: Brachial Plexitis. 06/07/11 - Informed doctor that in the past 6-month period I have received 3-doses of Hepatitis B Vaccines. 06/13/11 - MRI done today. Results pending. 06/22/11 - Scheduled follow-up appointment for today. At this time I'm currently being treated by doctor for this condition. If you have any questions or need further information, please feel free to contact me.
Age: 23.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Pericarditis, Troponin I
Clinical narrative: This study case was received from an investigator in a trial on 06 June 2011. A 23 year-old female subject with no significant medical history was found to have acute idiopathic pericarditis 13 days after she had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 11 February 2011. Relevant laboratory data included: a normal Troponin I result, a normal ECG and a normal Echocardiogram. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, ANTH, SMALL, TDAP
Symptoms: Encephalitis post immunisation
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 29 year-old male subject with no significant medical history was found to have encephalitis following immunization procedures 9 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported) and Tdap (manufacturer, lot number, route and site of administration not reported) on 08 August 2010. He also received on 11 July 2010 an injection ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 24 year-old male subject with no significant medical history was found to have other and unspecified acute pericarditis and an unspecified disease of the pericardium 15 and 14 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 03 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 20.07, an abnormal ECG and a normal Echocardiogram. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Pericarditis, Troponin I
Clinical narrative: This study case was received from the investigator on 06 June 2011. A 21 year-old male subject whose medical history was not available for dizziness/fainting spells, blood clots, shortness of breath, asthma (include exercise induced), Diabetes (Type I or Type II), eczema, headaches, numbness or paralysis, seizures, memory loss, chronic fatigue syndrome, psychiatric illness, HIV, meningitis and encephalitis (all other medical history was not significant) was found to have acute pericarditis, unspecified and an unspecified disease of the pericardium 11 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 12 November 2010. He also received on 15 October 2010 Hepatitis A (Adult) (manufacturer, lot number, route and site of administration not reported) and on 13 October 2010 he received Influenza vaccine (manufacturer, lot number, route and site of administration not reported), IPV (manufacturer, lot number, route and site of administration not reported), Meningococcal MCV4P (manufacturer, lot number, route and site of administration not reported) and Tdap (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: a normal Troponin I result, an abnormal ECG and a normal Echocardiogram. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There was no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Activated partial thromboplastin time, Contusion, Coombs test, Full blood count, Idiopathic thrombocytopenic purpura
Clinical narrative: On 5-20-11 mother noted unusual bruising and petechiae. Child seen 5-23-11, labs completed. Dx with Idiopathic thrombocytopenic purpura.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Metabolic function test, Petechiae, Platelet count, Prothrombin time, Reticulocyte count
Clinical narrative: On 5-20-11 mother noted unusual bruising and petechiae. Child seen 5-23-11, labs completed. Dx with Idiopathic thrombocytopenic purpura.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Urine analysis
Clinical narrative: On 5-20-11 mother noted unusual bruising and petechiae. Child seen 5-23-11, labs completed. Dx with Idiopathic thrombocytopenic purpura.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Hard, red and warm induration at injection site;  mom states patient very uncomfortable d/t pain
Age: 20.0
Sex: M
Vaccine: ANTH, FLUX, JEVX, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram, Myocarditis, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 20 year-old male subject with no significant medical history was found to have an unspecified disease of the pericardium and a non-specific myocarditis 27 and 19 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported), ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) and Japanese Encephalitis-IM (manufacturer, lot number, route and site of administration not reported) on 27 January 2011. Relevant laboratory data included: an abnormal Troponin I result with the highest recorded value of 01.54, a normal Echocardiogram and the ECG result was not available. Treatment were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis
Clinical narrative: This study case was received from the investigator in a trial on 06 June 2011. A 27 year-old male subject with no significant medical history was found to have a non-specific myocarditis 14 days after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 18 January 2011. Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Chills, fever, nauseated, vomiting, red, hot and swollen at injection site.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills, fever, nauseated, vomiting, red, hot and swollen at injection site.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Urticaria
Clinical narrative: Felt lethargic 1 day after vaccine.  Broke out with hives 3 days after receiving vaccine - on face, neck and upper thigh.  Self medicated with Benadryl.
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Encephalitis, Encephalitis post immunisation
Clinical narrative: This study case was received from the investigator in a trial on 08 June 2011. An 18 year-old male subject with no significant medical history was found to have encephalitis following immunization procedures and unspecified cause of encephalitis 11 and 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 17 December 2010. He also received on 15 December 2010 TYPHIM VI (lot number, route and site of administration not reported). Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram, Electrocardiogram abnormal, Pericardial disease, Troponin I
Clinical narrative: This study case was received from the investigator on 10 June 2011. A 23-year-old male subject, with no significant medical history, received an injection of ACAM2000, sanofi pasteur Inc. lot not reported, an injection of TYPHIM Vi, sanofi pasteur SA lot number not reported, and an injection of ANTHRAX, manufacturer and lot number not reported, on 01 February 2011. On 07 February 2011, the subject had an abnormal electrocardiogram (ECG). The results of the subject's Troponin I and echocardiogram were not available. On the 24 February 2011, the subject was diagnosed with unspecified disease of the pericardium. The outcome was not reported. Additional information will be requested from the investigator. Document held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test
Clinical narrative: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female with no relevant medical history or allergies who on approximately 17-JUN-2010 ("3 weeks ago") was vaccinated with a third 0.5 ml dose of GARDASIL (lot number, injection site and route not reported). There was no concomitant medication. The patient reported that she was pregnant at the time she was given her third dose of GARDASIL shot. Laboratory test included home pregnancy test (result not reported). No adverse event reported. Unspecified medical attention was sought. At time of this report, the patient was 3 or 4 months pregnant. Follow-up information has been received from a physician concerning the patient. The patient's pregnancy ended in spontaneous abortion from information reported by patient's mother. Date of spontaneous abortion was unknown. The physician was not able to verify if patient's fetus had a viable heart rate because she had no record of prenatal care from any physician. The physician stated that the patient was a "poor historian". No other information was known. In addition, the physician also reported that the patient had a subsequent pregnancy and voluntarily terminated this pregnancy approximately 6 months ago (captured in WAES # 1106USA01354). Upon internal review, spontaneous abortion was considered to be an other important medical event. No further information is available.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Immediate post-injection reaction, Pruritus, Scratch
Clinical narrative: Information has been received from an allergist concerning a 4 year old male patient with food allergies, who on 05-SEP-2010 was vaccinated with a dose MMR II (Lot number not reported). The allergist reported that on 05-SEP-2010 the patient had an anaphylactic reaction. The patient complained of itching, scratching and could not breath immediately following the vaccination with MMR II. It was reported that the patient visited an emergency room but was not admitted. A recent skin test was performed with sterile diluent that produced a positive skin test. BENADRYL and epinephrine were given as a treatment for the experience. The patient recovered on an unspecified date. Anaphylactic reaction was considered to be immediately life-threatening by the allergist. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Skin test positive
Clinical narrative: Information has been received from an allergist concerning a 4 year old male patient with food allergies, who on 05-SEP-2010 was vaccinated with a dose MMR II (Lot number not reported). The allergist reported that on 05-SEP-2010 the patient had an anaphylactic reaction. The patient complained of itching, scratching and could not breath immediately following the vaccination with MMR II. It was reported that the patient visited an emergency room but was not admitted. A recent skin test was performed with sterile diluent that produced a positive skin test. BENADRYL and epinephrine were given as a treatment for the experience. The patient recovered on an unspecified date. Anaphylactic reaction was considered to be immediately life-threatening by the allergist. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Dyspnoea, Pyrexia, Sensation of foreign body, Sensory disturbance
Clinical narrative: Fever (102), sinus type headache, joint aching,"knot in throat" - no difficulty with breathing, just a sensation. Next day slight shortness of breath. Seen minor emergency clinic on 5/20/11. Given ibuprofen 400 mg 1 tablet and told to rest.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Sinus headache
Clinical narrative: Fever (102), sinus type headache, joint aching,"knot in throat" - no difficulty with breathing, just a sensation. Next day slight shortness of breath. Seen minor emergency clinic on 5/20/11. Given ibuprofen 400 mg 1 tablet and told to rest.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Convulsion, Electroencephalogram normal, Encephalomalacia, Gliosis
Clinical narrative: The information for this report is extracted from the ED and inpatient medical record. 60 y.o. M with a prior hx CVA x 2 but no previous seizure history had not been feeling well and went to his PCP on 6/1 (exact time unknown), during that visit he received a B12 shot and a shot for shingles, later on at 20:15 the patient had a witnessed seizure, was taken to ED where he had 2 more witnessed seizures. In ED he was treated with Ativan, loaded with IV Keppra then put on oral Keppra 500mg po bid. He was admitted to hospital, EEG and MRI negative except for finding of old CVA, neuro consult, no further seizures and patient discharged 6/3. Per MD, the seizures are new onset and probably secondary to old CVA. Case manager noted vaccine administration earlier on same day of seizure onset and reported to pharmacy, pharmacy is making this VAERS report based on the information in the patient medical record.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging abnormal
Clinical narrative: The information for this report is extracted from the ED and inpatient medical record. 60 y.o. M with a prior hx CVA x 2 but no previous seizure history had not been feeling well and went to his PCP on 6/1 (exact time unknown), during that visit he received a B12 shot and a shot for shingles, later on at 20:15 the patient had a witnessed seizure, was taken to ED where he had 2 more witnessed seizures. In ED he was treated with Ativan, loaded with IV Keppra then put on oral Keppra 500mg po bid. He was admitted to hospital, EEG and MRI negative except for finding of old CVA, neuro consult, no further seizures and patient discharged 6/3. Per MD, the seizures are new onset and probably secondary to old CVA. Case manager noted vaccine administration earlier on same day of seizure onset and reported to pharmacy, pharmacy is making this VAERS report based on the information in the patient medical record.
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Urticaria, Wheezing
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant male subject who was vaccinated with Dtap vaccine (manufacturer unspecified), Hepatitis A vaccine, MMR vaccine (non-GSK) and IPV (non-GSK). The subject's medical history included premature birth at 30 weeks gestation. Concurrent medical conditions included cataract, lens replacement, latex allergy and Ig E positive for gelatin. On an unspecified date the subject received unspecified dose of Dtap vaccine (unknown route, unknown lot number), unspecified dose of Hepatitis A vaccine (unknown route, unknown lot number), unspecified dose of MMR vaccine (Non-GSK) (unknown route, unknown lot number), unspecified dose of IPV (Non-GSK) (unknown route, unknown lot number). 2 hours after vaccination with Dtap vaccine, Hepatitis A vaccine, MMR vaccine (Non-GSK) and IPV (Non-GSK), the subject experienced anaphylaxis, cough, sore throat, welt, shortness of breath, wheezing and urticaria. This case was assessed as medically serious by GSK. The subject was treated with Oral steroids and diphenhydramine. At the time of reporting the events were resolved. The Program was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the Program charged the Institute with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute's review, the author undertook a systematic analysis of the Program's anaphylaxis case experiences. The Program administrative database was queried for all cases submitted to the Program alleging anaphylaxis or anaphylactic shock for the 10-year period from January 1, 2000 through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the agency case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the agency case definitions for anaphylaxis. All of our anaphylaxis cases met the agency diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 1 of certainty. The subject had previous testing demonstrating elevated IgE levels to gelatin, a known risk factor for vaccine-associated anaphylaxis. This review represented the first systematic approach in analyzing the Program experience with anaphylaxis and will be useful when the VIT is updated. This is one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain, Anaphylactic reaction, Depressed level of consciousness, Hypotension, Urticaria
Clinical narrative: This case was reported in a literature article and described the occurrence of anaphylaxis in an infant female subject who was vaccinated with DTAP vaccine (manufacturer unspecified0, poliomyelitis vaccine inactivated (non-GSK) and MMR vaccine (non-GSK). The subject had no relevant medical history. On an unspecified date the subject received unspecified dose of DTAP vaccine (unknown route, unknown lot number), unspecified dose of Poliomyelitis vaccine inactivated (Non-GSK) (unknown route, unknown lot number), unspecified dose of MMR vaccine (Non-GSK) (unknown route, unknown lot number). Within minutes of vaccination with DTAP vaccine, MMR vaccine (Non-GSK) and Poliomyelitis vaccine inactivated (Non-GSK), the subject experienced anaphylaxis, decreased consciousness, hive, abdominal pain and hypotension. This case was assessed as medically serious by GSK. The subject was treated with EPINEPHRINE and diphenhydramine. At the time of reporting the events were resolved. Initial case was retrieved from the scientific literature on 08 June 2011. The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP''s anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 2 of certainty. This review represented the first systematic approach in analyzing the VICP experience with anaphylaxis and will be useful when the VIT is updated. This was one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.