chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Death, Pain
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Coma, Death
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abdominal discomfort, Antinuclear antibody negative, Autopsy, Cardiac enzymes increased, Catheterisation cardiac
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chest discomfort, Chest pain, Coxsackie virus serology test negative, Death, Dizziness
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dyspnoea, Echovirus serology test negative, Ejection fraction decreased, Hypoaesthesia, Hypoperfusion
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Influenza serology negative, Influenza serology positive, Myocarditis, Nausea, Polymerase chain reaction
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pulmonary congestion, Resuscitation, Streptococcal identification test positive, Ventricular tachycardia, Viral test negative
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Virus serology test
Clinical narrative: This is a 17-year-old patient who presents ON 8/3/08 with an approximately 4-day history of nonspecific nausea and abdominal discomfort.  This was initially thought to be dyspepsia.  The patient was treated with Pepto-Bismol.  There may have been some initial improvement; however, the patient continued to have persisting abdominal discomfort.  Upon admission, patient had increased symptoms of shortness of breath with dizziness and left upper extremity and left lower extremity numbness.  The patient also has crushing substernal left-sided chest discomfort. The patient presented to the Emergency Department, at which point cardiac enzymes ordered were significantly elevated.  Patient was given Zofran for her nausea.  Patient was also given aspirin 81 mg x3.  D-dimer was checked (2).  Patient was started on dopamine drip. Due to the patient's deteriorating status, the patient was taken emergently by Cardiologist for a right and left heart catheterization. Based on report, left heart catheterization shows no evidence of coronary disease. Ejection fraction was measured at 23%. Based on the verbal report from MD, there is no tamponade physiology on right heart catheterization.  Patient has no previous surgical or significant medical history.  She had recently received the Gardasil vaccine from her PCP.  Patient denies history of asthma, cardiac disease.  Secondary to her EF, an intraaortic balloon pump was placed and the patient was returned to CCU.  However, over the next 6-8 hours, her function continued to deteriorate, she went into V tach which led her to further decompensate.  She was resuscitated for more than 1-1/2 hours to maintain her blood pressure above 90.  Cardiothoracic surgery was consulted to place her on bypass and place her on an assistive device.  However, due to her current status, it was elected not to do so.  CPR continued until the priest was available, and care was withdrawn. Patient was pronounced dead on 8/4/08.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Recieved Flu and Pneumonia on Monday, Nov. 24th, 2 hours after developed severe pain at injection site.  It then became red and hot.  Went to PMD on Wednesday, Nove 26th and was hospitalized for 2 days, given IV antibiotics.  1/15/2009 ER record received for DOS 11/26-27/08 with DX: Left arm cellulitis. HTN. Hypothyroidism. Pt presented with redness and pain of the L arm x 3 days. PE (+) for erythema, warmth and tenderness to palpation. Tx abx.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Recieved Flu and Pneumonia on Monday, Nov. 24th, 2 hours after developed severe pain at injection site.  It then became red and hot.  Went to PMD on Wednesday, Nove 26th and was hospitalized for 2 days, given IV antibiotics.  1/15/2009 ER record received for DOS 11/26-27/08 with DX: Left arm cellulitis. HTN. Hypothyroidism. Pt presented with redness and pain of the L arm x 3 days. PE (+) for erythema, warmth and tenderness to palpation. Tx abx.
Age: 52.0
Sex: M
Vaccine: TD, DT
Symptoms: Hypotension, No reaction on previous exposure to drug, Rash, Rash pruritic, Tachycardia
Clinical narrative: Vaers ID# 333,437 NOV 11, 2008@02:36:52 by ORIGINATOR Pt received TD toxoid 0.5 ml im at hospital on 11/10/08 at 4:30 pm. He was transferred here for ETOH detox. At ER here he developed pruritic skin rash noted at 11:23 pm, initial VS were OK. He was treated with decadron 4 mg im and benadryl 50 mg im. Within one hour, he developed hypotension, tachycardia, worsening skin rash. He was given another 4 mg im of decadron, iv NSS, epipen 0.3 mg/0.3 ml im with improvement.  Comment: On 7/22/08, Pt had TD toxoid at hospital without reaction.
Age: 52.0
Sex: M
Vaccine: TD, DT
Symptoms: Hypotension, Rash, Rash pruritic, Tachycardia
Clinical narrative: Vaers ID# 333,437 NOV 11, 2008@02:36:52 by ORIGINATOR Pt received TD toxoid 0.5 ml im at hospital on 11/10/08 at 4:30 pm. He was transferred here for ETOH detox. At ER here he developed pruritic skin rash noted at 11:23 pm, initial VS were OK. He was treated with decadron 4 mg im and benadryl 50 mg im. Within one hour, he developed hypotension, tachycardia, worsening skin rash. He was given another 4 mg im of decadron, iv NSS, epipen 0.3 mg/0.3 ml im with improvement.  Comment: On 7/22/08, Pt had TD toxoid at hospital without reaction.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed herpes Zoster shingleo in Nov 2008 Vaccine given 6/17/08
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Pt. went to sleep and woke up with stiff/painful right arm, which radiate to neck/jaw/and down to the rest of the arm. Pt. took CLARITIN and it helping to relieve the symptom. Lasted 2 days.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: After FLUZONE patient broke out in rash and whelps. DIPHENYLDRAMINE 25 mg by mouth DOT given. Monitored consistently by nurse and APN x 20 minutes, monitored s/s, vs and educated about action plan if worsens.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Felt faint, was diaphoretic, pale. Pt refused transport to hospital. Sat in chair after having flu shot, EMTS on scene. Generalized pallor and diaphoresis. Pt was conscious and alert and oriented.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Pain
Clinical narrative: 15-20 min - left arm discomfort from shoulder to elbow. 30 min. - aching increased; moved to forearm and hand. 40 min. - pain/dull/throbbing throughout arm from shoulder to hand. 40-1hr1/2 - continued throbbing. 1hr 1/2 took 2 ibuprofen. 1hr 45-2 hr, pain decreased.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Induration, Pain in extremity
Clinical narrative: Pt. called and stated that evening of 11/19/08 she started having hoarseness and when she woke up on 11/20/08, she was hoarse and had a knot in her armpit. She also told me that her arm had been sore and Advil helped with soreness. Advised her to call family Doctor and to please call us back with what he told her.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Blood immunoglobulin G increased, Pain in extremity, Pallor, Palmar-plantar erythrodysaesthesia syndrome, Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red sores-hands in a 68-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included bug bite. Concurrent medications included PREMARIN, PROTONIX, PEPCID, ZOCOR and WELCHOL. In 2008, the subject received a dose of Influenza vaccine (unknown). In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced red sores-hands, sores on feet, hand pain, itching and rash. The subject received influenza vaccine approximately six to eight weeks prior to this report, specific vaccine was unknown. The palms of the subjects hands and bottom of feet were red and blanched when pushed in. Her feet and hands are painful. With this facility, the only difference from normal was her IgG was elevated. Prednisolone was prescribed and was not helping according to subject. The subject also had a bug bite two to three months ago. The bug bite was treated by primary care with antibiotics. The subject previously received flu shots before with no reaction and no allergy. It started as itchy and now back and forth between itchy to painful. Rash appeared one to two days after injection. Rash became worse during the day and then improved "like in a cycle". The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Influenza vaccine.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Skin lesion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red sores-hands in a 68-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject's medical history included bug bite. Concurrent medications included PREMARIN, PROTONIX, PEPCID, ZOCOR and WELCHOL. In 2008, the subject received a dose of Influenza vaccine (unknown). In 2008, at an unspecified time after vaccination with Influenza vaccine, the subject experienced red sores-hands, sores on feet, hand pain, itching and rash. The subject received influenza vaccine approximately six to eight weeks prior to this report, specific vaccine was unknown. The palms of the subjects hands and bottom of feet were red and blanched when pushed in. Her feet and hands are painful. With this facility, the only difference from normal was her IgG was elevated. Prednisolone was prescribed and was not helping according to subject. The subject also had a bug bite two to three months ago. The bug bite was treated by primary care with antibiotics. The subject previously received flu shots before with no reaction and no allergy. It started as itchy and now back and forth between itchy to painful. Rash appeared one to two days after injection. Rash became worse during the day and then improved "like in a cycle". The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related to vaccination with Influenza vaccine.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Brain injury
Clinical narrative: This case was reported by a consumer and described the occurrence of brain damage in a 2-month-old male subject who was vaccinated with DTAP (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date approximately 40 years ago, the subject received unspecified dose of DTAP vaccine (unknown). At an unspecified time after vaccination with DTAP vaccine, the subject experienced brain damage. The reporter stated that her son, who is now 40 years old, suffered permanent damage after receiving the DTAP vaccine when he was only 2-months-old. No other information was provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 77.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash morbilliform, Rash pruritic
Clinical narrative: Diffuse pruritic morbilliform rash noted on about 11/24/08, fairly impressive rash, looked like drug eruption.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: 4x4 raised red and hardened, itchy and soar, hot patch at injection site. Lasted about 4 days before symptoms subside. About 1 wk before all symptoms are gone.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Headache, Heart rate increased, Hyperhidrosis, Injection site swelling, Migraine
Clinical narrative: Fever, sweating, Migraine headache, rapid heart beat paresthesia in fingers and toes, localized swelling at injection site. Pt was not examined at hospital - went to clinic and NP examined - completing this report based on phone conversation with pt. and NP. Prescription for midrin given to pt. Sent home from Dr. office.
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Fever, sweating, Migraine headache, rapid heart beat paresthesia in fingers and toes, localized swelling at injection site. Pt was not examined at hospital - went to clinic and NP examined - completing this report based on phone conversation with pt. and NP. Prescription for midrin given to pt. Sent home from Dr. office.
Age: 0.25
Sex: M
Vaccine: HIBV
Symptoms: Crying, Screaming
Clinical narrative: Crying/screaming for several hours within 2 hrs of receiving injection. (high pitched screaming)
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Bed rest, Chills, Dyspnoea, Injection site erythema, Injection site irritation
Clinical narrative: Information has been received from a female with sulfa allergy and no other medical history who on approximately 10-Nov-2008, was vaccinated with PNEUMOVAX 23 (661577/1161X). Concomitant therapy included Influenza virus vaccine (unspecified). On "the same day of vaccination", the patient developed burning pain at the injection site which was very tender to the touch. The injection site had 4 inch diameter of redness. The patient also developed chills, fever, shortness of breath and nausea. The patient was bedridden for 3 days and she was given cortisone, histamine and antibiotics. The patient saw physician for medical attention. The patient was recovering. The patient still had some tenderness on the injection site. The patient considered her events to be disabling as she was bedridden for three days. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Information has been received from a female with sulfa allergy and no other medical history who on approximately 10-Nov-2008, was vaccinated with PNEUMOVAX 23 (661577/1161X). Concomitant therapy included Influenza virus vaccine (unspecified). On "the same day of vaccination", the patient developed burning pain at the injection site which was very tender to the touch. The injection site had 4 inch diameter of redness. The patient also developed chills, fever, shortness of breath and nausea. The patient was bedridden for 3 days and she was given cortisone, histamine and antibiotics. The patient saw physician for medical attention. The patient was recovering. The patient still had some tenderness on the injection site. The patient considered her events to be disabling as she was bedridden for three days. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster, Lesion excision, Pain, Polymerase chain reaction
Clinical narrative: Initial and follow-up information has been received from a pharmacist and a certified medical assistant, concerning a 70 year old male with hypertension, hypercholesterolaemia and not known drug allergy and a history of gastrooesophageal reflux disease and chickenpox in his childhood, who on 27-OCT-2008 at 9:00 a.m., was vaccinated with ZOSTAVAX, Lot number 662970/1207X, 0.65 mL, subcutaneously in back of the left arm. The certified medical assistant reported that concomitant therapy included ezetimibe (+) simvastatin (MSD), aspirin (ASA), AVAPRO and LOPRESSOR. The patient on unspecified dates, was also vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscularly into the deltoid and influenza virus vaccine (unspecified) (manufacturer unknown), 0.5 ml, intramuscularly into the deltoid. The pharmacist reported that the patient was diagnosed with zoster after receiving ZOSTAVAX. The patient was being treated with VALTREX 1 gram three times a day for 7 days. The certified medical assistant reported that the physician was interested in collecting and sending isolates for a VZVID analysis. The office scheduled a call on 05-NOV-2008. At the time of the report the patient had not recovered. The patient sought medical attention at office visit. In follow-up received on 05-Nov-2008, the physician reported he planned on asking the patient to return to the office and obtain a specimen. The physician did not further describe the status of the patient other than to report that the patient's rash which he felt was herpes zoster was on his forehead. In follow-up information, received from a questionnaire, the certified medical assistant reported that the event begun on 04-NOV-2008 and the rash did not occur at the site of injection post-vaccination. The pharmacist was not sure of a rash occurred at the site of injection post-vaccination. The patient had a dermatome C2 and the rash was located on his forehead into scalp. It was reported that the maximum patient's temperature was 98.6 degrees and the patient felt pain quantified as 4 (between 0 (least) and 10 (most)). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 10-NOV-2008. The sample was taken from a vesicular lesion on the C2 dermatome. The results were: Inadequate specimen, negative for B-globin, no strain ID. In information received from the pharmacist on 20-NOV-2008, he considered the event to be an other important medical event. No further information is available.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Viral test
Clinical narrative: Initial and follow-up information has been received from a pharmacist and a certified medical assistant, concerning a 70 year old male with hypertension, hypercholesterolaemia and not known drug allergy and a history of gastrooesophageal reflux disease and chickenpox in his childhood, who on 27-OCT-2008 at 9:00 a.m., was vaccinated with ZOSTAVAX, Lot number 662970/1207X, 0.65 mL, subcutaneously in back of the left arm. The certified medical assistant reported that concomitant therapy included ezetimibe (+) simvastatin (MSD), aspirin (ASA), AVAPRO and LOPRESSOR. The patient on unspecified dates, was also vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscularly into the deltoid and influenza virus vaccine (unspecified) (manufacturer unknown), 0.5 ml, intramuscularly into the deltoid. The pharmacist reported that the patient was diagnosed with zoster after receiving ZOSTAVAX. The patient was being treated with VALTREX 1 gram three times a day for 7 days. The certified medical assistant reported that the physician was interested in collecting and sending isolates for a VZVID analysis. The office scheduled a call on 05-NOV-2008. At the time of the report the patient had not recovered. The patient sought medical attention at office visit. In follow-up received on 05-Nov-2008, the physician reported he planned on asking the patient to return to the office and obtain a specimen. The physician did not further describe the status of the patient other than to report that the patient's rash which he felt was herpes zoster was on his forehead. In follow-up information, received from a questionnaire, the certified medical assistant reported that the event begun on 04-NOV-2008 and the rash did not occur at the site of injection post-vaccination. The pharmacist was not sure of a rash occurred at the site of injection post-vaccination. The patient had a dermatome C2 and the rash was located on his forehead into scalp. It was reported that the maximum patient's temperature was 98.6 degrees and the patient felt pain quantified as 4 (between 0 (least) and 10 (most)). The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on 10-NOV-2008. The sample was taken from a vesicular lesion on the C2 dermatome. The results were: Inadequate specimen, negative for B-globin, no strain ID. In information received from the pharmacist on 20-NOV-2008, he considered the event to be an other important medical event. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her friend's child who was vaccinated with MMR II.  After the vaccination the patient was diagnosed with autism.  The reporter would not provide further information.  Upon internal review, the patient's autism was considered to be an other important medical event.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Gait disturbance, Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who on 05-NOV-2008 was vaccinated with the second dose of GARDASIL (lot# 659655/1486U). Concomitant therapy included VARIVAX and ADACEL. On 21-NOV-2008 the patient developed rash, hives, urticaria and generalized joint pain in her knees, elbows and ankles, but she had no fever. The patient was instructed to take TYLENOL for the pain and she was referred to an urgent care physician who instructed the patient to take BENADRYL. On unspecified date lab tests were performed, but specifics are unspecified. As of 24-NOV-2008 the patient had not recovered. The physician considered the patient's experience to be disabling because "it was hard for the patient to walk". Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Appendicectomy, No reaction on previous exposure to drug, Surgery
Clinical narrative: Information has been received from a physician concerning an approximately 5 month old male patient who on 21-JUL-2008 was vaccinated with the first dose of ROTATEQ (Lot # 660600/0281X) and did not have any reactions at that time. On 22-SEP-2008 the patient was vaccinated with the second dose of ROTATEQ (Lot # 661034/0470X). The physician reported that one month after receiving his second dose on approximately 22-OCT-2008 the patient experienced intussusception. The patient received surgery because of the intussusception and also had his appendix removed at that time. It was noted that the patient did not have appendicitis at the time. The patient sought unspecific medical attention. At the time of the report the patient was currently recovering from surgery. Additional information has been requested.  12/15/2008 Reviewed hospital d/c summary of 11/21-11/22/2008. FINAL DX: ileocolic intussusception, surgically reduced; appendectomy. Records reveal patient experienced colicky abdominal pain, pallor, green diarrhea, & lethargy x 2 days.  Admitted to outlying hospital for dehydration, had bloody stool & transferred to higher level of care.  Did well postoperatively, tolerating full feeds & d/c to home w/clinic f/u.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Asthenia, Basophil count decreased, Dizziness, Dyspnoea, Eosinophil count normal
Clinical narrative: 21y male received vaccinia in right deltoid on 19 nov 08.  Awoke at 0300 on 29 nov 08 complaining of dyspnea, dizziness, blurry vision, and right sided weakness & numbness.  Arm and leg felt like they were asleep.  Seen at Hospital ED. Per their d/c note, pt stable and felt to have possible soft tissue or skin infection s/p vacccinia given right supraclavicular LAD on exam.  No fever/chills or vital sign abnormalities.  Started on Keflex & Lortab for severe pain.  Follow-up appt at flight med on 1 Dec 08.  Patient's vitals all wnl.  Dizziness and visual complaints resolved.  Still c/o right sided hypesthesia and weakness.  Slight 4/5 strength noted in right grip and shoulder shrug.  SCM's 5/5 bilat however.  Decreased sensation to light touch on right side, but other modalities intact.  Face and cranial nerves unaffected.  Close f/u scheduled for this week.  Patient to take Motrin for pain, inflammation.  Will schedule neurology consult.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Grip strength decreased, Haematocrit normal, Haemoglobin normal, Hypoaesthesia, Lymphocyte count normal
Clinical narrative: 21y male received vaccinia in right deltoid on 19 nov 08.  Awoke at 0300 on 29 nov 08 complaining of dyspnea, dizziness, blurry vision, and right sided weakness & numbness.  Arm and leg felt like they were asleep.  Seen at Hospital ED. Per their d/c note, pt stable and felt to have possible soft tissue or skin infection s/p vacccinia given right supraclavicular LAD on exam.  No fever/chills or vital sign abnormalities.  Started on Keflex & Lortab for severe pain.  Follow-up appt at flight med on 1 Dec 08.  Patient's vitals all wnl.  Dizziness and visual complaints resolved.  Still c/o right sided hypesthesia and weakness.  Slight 4/5 strength noted in right grip and shoulder shrug.  SCM's 5/5 bilat however.  Decreased sensation to light touch on right side, but other modalities intact.  Face and cranial nerves unaffected.  Close f/u scheduled for this week.  Patient to take Motrin for pain, inflammation.  Will schedule neurology consult.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume abnormal, Monocyte count normal, Neutrophil count normal
Clinical narrative: 21y male received vaccinia in right deltoid on 19 nov 08.  Awoke at 0300 on 29 nov 08 complaining of dyspnea, dizziness, blurry vision, and right sided weakness & numbness.  Arm and leg felt like they were asleep.  Seen at Hospital ED. Per their d/c note, pt stable and felt to have possible soft tissue or skin infection s/p vacccinia given right supraclavicular LAD on exam.  No fever/chills or vital sign abnormalities.  Started on Keflex & Lortab for severe pain.  Follow-up appt at flight med on 1 Dec 08.  Patient's vitals all wnl.  Dizziness and visual complaints resolved.  Still c/o right sided hypesthesia and weakness.  Slight 4/5 strength noted in right grip and shoulder shrug.  SCM's 5/5 bilat however.  Decreased sensation to light touch on right side, but other modalities intact.  Face and cranial nerves unaffected.  Close f/u scheduled for this week.  Patient to take Motrin for pain, inflammation.  Will schedule neurology consult.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Platelet count normal, Red blood cell count increased, Red cell distribution width normal, Sensory loss, Vision blurred
Clinical narrative: 21y male received vaccinia in right deltoid on 19 nov 08.  Awoke at 0300 on 29 nov 08 complaining of dyspnea, dizziness, blurry vision, and right sided weakness & numbness.  Arm and leg felt like they were asleep.  Seen at Hospital ED. Per their d/c note, pt stable and felt to have possible soft tissue or skin infection s/p vacccinia given right supraclavicular LAD on exam.  No fever/chills or vital sign abnormalities.  Started on Keflex & Lortab for severe pain.  Follow-up appt at flight med on 1 Dec 08.  Patient's vitals all wnl.  Dizziness and visual complaints resolved.  Still c/o right sided hypesthesia and weakness.  Slight 4/5 strength noted in right grip and shoulder shrug.  SCM's 5/5 bilat however.  Decreased sensation to light touch on right side, but other modalities intact.  Face and cranial nerves unaffected.  Close f/u scheduled for this week.  Patient to take Motrin for pain, inflammation.  Will schedule neurology consult.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: White blood cell count
Clinical narrative: 21y male received vaccinia in right deltoid on 19 nov 08.  Awoke at 0300 on 29 nov 08 complaining of dyspnea, dizziness, blurry vision, and right sided weakness & numbness.  Arm and leg felt like they were asleep.  Seen at Hospital ED. Per their d/c note, pt stable and felt to have possible soft tissue or skin infection s/p vacccinia given right supraclavicular LAD on exam.  No fever/chills or vital sign abnormalities.  Started on Keflex & Lortab for severe pain.  Follow-up appt at flight med on 1 Dec 08.  Patient's vitals all wnl.  Dizziness and visual complaints resolved.  Still c/o right sided hypesthesia and weakness.  Slight 4/5 strength noted in right grip and shoulder shrug.  SCM's 5/5 bilat however.  Decreased sensation to light touch on right side, but other modalities intact.  Face and cranial nerves unaffected.  Close f/u scheduled for this week.  Patient to take Motrin for pain, inflammation.  Will schedule neurology consult.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Urticaria
Clinical narrative: hives, lip swelling, dyspnea starting 90 minutes after influenza vaccine. 12/23/2008 MR received for DOS 11/25-26/2008 with DX: Allergic Reaction. Pt presented with itching, urticaria, SOB, throat & tongue swelling and swelling of face.  Diffues rash noted on PE. Chest tightness resolved. Tx with Benadryl, steroids with improvement. Observed o/n and d/c.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT DEVELOPED REDNESS, HEAT, INDURATION AND SWELLING AT THE INJECTION SIGHT (RT LEG) WITHIN A FEW HOURS OF THE INJECTION.  SHE WAS TREATED WITH COOL COMPRESSES, BENADRYL, AND PREDNISOLONE.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Rash
Clinical narrative: Patient developed a rash on chest after taking Oral Typhoid Vaccine.  Patient was given Oral Typhoid Vaccine On 10/28/2008 but did not take first dose until 11/16/08.  Reaction occurred about 24 hours after taking vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Gaze palsy, Loss of consciousness, Pallor, Somnolence
Clinical narrative: Became very pale within 5 minutes of vaccine. Mom stated pts eyes rolled back and she "Passed out" in waiting room ~10 mins after vaccine. Pt initially unresponsive to voice but slowly recoevered. Mother not concerned initially as pt has hx of fainting after piercings. Pt recovered and taken home. Mother called the following day to say her daughter had been pale and moving slowly for 24 hrs after vaccine. Appeared sleepy and slightly disoriented. Full recovery at time of discussion with mother the following day.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Became very pale within 5 minutes of vaccine. Mom stated pts eyes rolled back and she "Passed out" in waiting room ~10 mins after vaccine. Pt initially unresponsive to voice but slowly recoevered. Mother not concerned initially as pt has hx of fainting after piercings. Pt recovered and taken home. Mother called the following day to say her daughter had been pale and moving slowly for 24 hrs after vaccine. Appeared sleepy and slightly disoriented. Full recovery at time of discussion with mother the following day.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: More than one month has passed, and the injection site,left arm, is still sore. Also, my left arm seems to have become siginificantly weaker.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling to thigh tx with keflex 125/5 x 10 days
Age: 72.0
Sex: U
Vaccine: FLU3, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: GIVEN ADACEL DESPITE OVER AGE LIMIT
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Mass, Meningeal neoplasm, Ostectomy, Rash maculo-papular, Skull X-ray abnormal
Clinical narrative: OCTOBER 10, 2007:  Patient completes a routine physical examination from Dr.  Patient is not experiencing any health problems and none are found during this examination.  Dr. recommends patient receive two vaccines due to her age: (1) Meningitis vaccine  (2) Cervical cancer vaccine series.  After discussion with Dr., we decide to receive only the Meningitis Vaccine at this time. One shot of Menactra was administered at this time.  NOVEMBER 18, 2007:  Patient informs me of a small raised bump on the back top of her head approximately 1" in diameter.  I told her to let me know if this bump doesn't go away. JANUARY 24, 2008: My wife is sitting on our couch rubbing patient head when she feels a large mass approximately 4" in diameter contouring to the top back of patient's skull.  Patient said it felt like part of her head when she was washing her hair.  I immediately took patient to Hospital to be examined.  An X-Ray showed a large bone distortion at the site of the mass, and we were advised to seek medical attention promptly at  Hospital in downtown.  An appointment was scheduled with neuro-surgeon on 1-25-08.  January 25, 2008:  Patient sees Dr., who examines patient, and orders a series of tests and scans.  The tests and scans indicate a lesion has developed in the meninges area of her skull, and is destroying a large portion of the skull bone in this area.  Dr. recommends surgery as soon as possible to remove the infected bone and area. FEBRUARY 5, 2008:  Patient has surgery at Hospital in downtown.  A large 4" section of her skull bone is cut out, and replaced with a temporary metal plate. FEBRUARY 25, 2008:  Patient has appointment with Dr. to evaluate her recovery.  Scan performed to size opening in patient's skull for fitting a permanent plastic covering for this area.  Surgery scheduled for May 2008, to insert plastic covering into opening. MAY 5, 2008:  Patient's pre-op work at Hospital. MAY 13, 2008: Patient has skull reconstruction surgery completed.  She will need to be seen annaully for evaluations.  1/20/09 Reviewed hospital medical records of 5/13-5/14/2008 & additional clinic records of 1/24-5/27/2008. FINAL DX: intraosseous calavarial meningioma, s/p cranioplasty Records revela patient experienced bony & scalp occipital lump.  Had been initially noted appro 3 mos earlier & thought to be secondary to trauma.  Thought to be resolved until 1/24/08.  Seen in Urgent Care.  Suspicious for osteosarcoma & referred to Heme/Onc clinic.  Seen in clinic 1/25/08 & sent for neurosurgery eval.  Craniectomy for mass excision done 2/5/08 & the resulting calavarial defect was repaired 5/13/08. Follow-up: Meninges lining shows abnormalities and has affected over laying skull bone. Surgical removed of this bone was necessary (cranioplasty) in 2008. See pictures a large plastic implant has replaced skull bone, however the meninge lining could not be removed.