chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Nausea, Neck pain, Pain, Painful respiration, Troponin increased
Clinical narrative: 20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Vaccinia virus infection
Clinical narrative: 20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood test, Chest discomfort, Chest pain, Headache, Myocarditis
Clinical narrative: 20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pyrexia
Clinical narrative: 20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Body temperature increased, Cardiac enzymes increased, Chest discomfort, Chest pain, Chills
Clinical narrative: 20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Nausea, Neck pain, Pain, Painful respiration, Pericardial disease
Clinical narrative: 20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pericarditis, Pleurisy, Skin lesion, Troponin I, Troponin increased
Clinical narrative: 20 y/o male calls Vaccine Call Center on 30 DEC 2010 on day #9 s/p receipt of primary SPV in LUE on 21 DEC 10. Denied other vaccines on the same day, but did receive AVA #1 and (?) Hep A/B about a month ago. Developed chills, body ache, fatigue and neck pain w/o rigidity on 29DEC10. Went to local ER at hospital on 30DEC10, as he was concerned that his smallpox lesion (vaccinia) was "spreading." "I have (2) spots that are like my vaccine site, one about 1 inch below the original shot site, left upper arm, and another on my hairline at the base of my neck." ER told me not to come back, unless my temp. was >104F. SM calls Vaccine Call Center later that evening (30DEC10) reporting temp of 101F, mild pleuritic SOB and new onset, dull, constant, midsternal, non-radiating chest pain/pressure in center of his chest, which he rated as a "2/10" initially and which increased in supine position and felt better when sitting up and leaning forward. At peak of CP ("4-5"/10) around 10PM, pt endorsed slight nausea w/o vomiting or diaphoresis. Stated that it hurt to take a deep breath. Call Center RN advised pt to have someone drive him back to the ER immediately and to ask the ER doctor to contact the Vaccine Call Center for needed clarification or clinical guidance re the Myopericarditis Algorithm. Pt admitted to hospital sometime after midnight (31DEC10) and ER doctor notified Deputy Chief Dr. that pt was responding to NSAIDS- CP & SOB resolved. Initial EKG ER was "normal," but bloodwork indicated a mild elevation of troponins. Pt kept in hospital till 02JAN11. Serial EKG's repeated & cardiac enzymes drawn with downward trend. SM d/c'd to parents' home sx free on 02JAN11, with d/c orders for "restricted activity" x 6 weeks- no fire-fighting or heavy lifting, continue Rx with ibuprofen 800 mg po tid WF x 1 week, no deployment x 6 months, cardiology f/u at 3 & 6 months. Outpatient echocardiogram on 04JAN11. F/U with PCM on 06JAN11 with echo results. Pt states the doctor told him his heart was good and that the test was normal. Pt denies any recurrent CP or SOB. States that he feels "back to normal." PMH: no chronic dz, no prior CVD, no genetic or auto-immune dz, no prior hospitalizations or surgeries. Fx rt thumb at 15 yrs age. Social Hx: single, on 06JAN11, but now cannot deploy x 6 months. No tobacco use, no ETOH or illicit drug use. FH: M-50(L) DM2, obese; F-50(L) healthy; Sister 17(L) healthy. NKDA. No known food, nut, dye, shellfish, latex, or environmental allergies. MEDS: Ibuprofen 800 mg po tid WF x 1 week.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: Arm swelling.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Convulsion, Ear infection, Electroencephalogram, Pyrexia, Screaming
Clinical narrative: Parents found pt at 5am (after he screamed) having a seizure. Pt has neurologic anomalies eval at ED -> febrile, otitis diagnosed. Child had four immunizations and SYNAGIS previous day.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Breath sounds abnormal, Computerised tomogram head, Computerised tomogram normal, Convulsion
Clinical narrative: Initial report received from consumers parent on 03 January 2011 with follow-up received from a health care professional  on 04 January 2011 and 05 January 2011. A 5-year-old female child received on 06 November 2010 a right deltoid intramuscular injection of FLUZONE, lot number unknown. The patients' parent reported that the patient had received previous flu vaccines, had no known allergies and no history of medical conditions except for "cold symptoms" at the time of vaccination. On 07 November 2010, 14 hours after FLUZONE vaccination, the patient had a seizure which was described as "wet herself", convulsive and had snoring and gurgling. The seizure lasted 2 minutes. The patient was seen in the Emergency Room (ER) and also by a pediatric neurologist. The patient had a computed tomography (CT) scan which was reported as negative and blood work within normal limits. The patient had a second seizure on 29 December 2010 which was described as less severe shaking. She was scheduled to see the neurologist on 05 January 2011 and had a magnetic resonance (MRI) scan scheduled for the 25 January 2011. On 04 January 2011, the patient's physician's office was contact and reported that the FLUZONE lot number was UT3773AA. The form completed on day of vaccination indicated the patient had no current illnesses. The patient was seen for follow-up with the physician on 08 November 2010. The physician's office reported that paramedics were called to the home on 07 November 2010 and the patient was taken to the ER where a CT of the head without contrast was completed and confirmed negative. On 05 January 2011, the physician was contacted and reported that the patient had an electroencephalogram (EEG) that was negative. The patient's physician reported that initially the pediatric neurologist questioned if the first episode was truly a seizure as loss of urine occurred after the seizure but after the second seizure on 29 December 2010, the neurologist was thinking the first episode was probably a seizure as well. The outcome was not reported. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram normal, Snoring, Urinary incontinence
Clinical narrative: Initial report received from consumers parent on 03 January 2011 with follow-up received from a health care professional  on 04 January 2011 and 05 January 2011. A 5-year-old female child received on 06 November 2010 a right deltoid intramuscular injection of FLUZONE, lot number unknown. The patients' parent reported that the patient had received previous flu vaccines, had no known allergies and no history of medical conditions except for "cold symptoms" at the time of vaccination. On 07 November 2010, 14 hours after FLUZONE vaccination, the patient had a seizure which was described as "wet herself", convulsive and had snoring and gurgling. The seizure lasted 2 minutes. The patient was seen in the Emergency Room (ER) and also by a pediatric neurologist. The patient had a computed tomography (CT) scan which was reported as negative and blood work within normal limits. The patient had a second seizure on 29 December 2010 which was described as less severe shaking. She was scheduled to see the neurologist on 05 January 2011 and had a magnetic resonance (MRI) scan scheduled for the 25 January 2011. On 04 January 2011, the patient's physician's office was contact and reported that the FLUZONE lot number was UT3773AA. The form completed on day of vaccination indicated the patient had no current illnesses. The patient was seen for follow-up with the physician on 08 November 2010. The physician's office reported that paramedics were called to the home on 07 November 2010 and the patient was taken to the ER where a CT of the head without contrast was completed and confirmed negative. On 05 January 2011, the physician was contacted and reported that the patient had an electroencephalogram (EEG) that was negative. The patient's physician reported that initially the pediatric neurologist questioned if the first episode was truly a seizure as loss of urine occurred after the seizure but after the second seizure on 29 December 2010, the neurologist was thinking the first episode was probably a seizure as well. The outcome was not reported. Documents held by sender: None.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin normal, Pruritus
Clinical narrative: Initial report was received 03 January 2011 from a consumer, who was a friend of the patient. An 80-year-old male patient had received a left deltoid injection of FLUZONE SV, lot number U3351AA on 27 September 2009 and three days later, he developed itching which began on his hands, then spread to his arms, and now he has itching on his back. The patient was seen by a dermatologist and an allergist and he received multiple courses of steroids and topical medications as corrective treatment. A skin biopsy was negative. He had no illness at the time of vaccination and he had been taking PLAVIX concomitantly. Past medical history consisted of a formaldehyde allergy and a heart valve diagnosis. It was further noted that the patient had received prior doses of FLUZONE in the past. At the time of the report, the patient had not recovered. Documents held by sender: None.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Neurological symptom, Paraplegia
Clinical narrative: Initial report was received from a health care professional on 03 January 2011 via a search of the literature. A 64-year-old female patient developed neurologic complications after she had received INFLUENZA (manufacturer unknown, lot number and date of administration not reported). Eighteen days after vaccination, the patient exhibited paraplegia and was diagnosed with acute idiopathic demyelinating polyradiculopathy (Guillain-Barre Syndrome). She received intravenous gammaglobulin therapy as corrective treatment with poor response. Outcome was not reported. The reporter for this case is the same as for case number 2011-00041. Documents held by sender: None
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess rupture, Abscess sterile, Blood pressure increased, Culture negative, Headache
Clinical narrative: Initial report received from a health care professional on 06 January 2011. A 35-year-old female patient received on 26 November 2010 an intramuscular injection (site not reported) of ADACEL, lot number not reported. The patient's medical history, adverse events from prior vaccination and concomitant medications were reported as unknown. The patient was having a post partum period at the time of vaccination with ADACEL. About one month after the vaccination of ADACEL, the patient developed numbness, at the injection site, arm pain and soreness and headache. The patient's blood pressure was also elevated. An abscess formed approximately the size of a tennis ball which ruptured and leaked. The patient was seen the Emergency Room (ER) where the drainage from the abscess was cultured and showed no growth. The diagnosis was made of sterile abscess. The patient reported some improvement. The outcome was reported as not recovered. Documents held by sender: None.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site anaesthesia, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 06 January 2011. A 35-year-old female patient received on 26 November 2010 an intramuscular injection (site not reported) of ADACEL, lot number not reported. The patient's medical history, adverse events from prior vaccination and concomitant medications were reported as unknown. The patient was having a post partum period at the time of vaccination with ADACEL. About one month after the vaccination of ADACEL, the patient developed numbness, at the injection site, arm pain and soreness and headache. The patient's blood pressure was also elevated. An abscess formed approximately the size of a tennis ball which ruptured and leaked. The patient was seen the Emergency Room (ER) where the drainage from the abscess was cultured and showed no growth. The diagnosis was made of sterile abscess. The patient reported some improvement. The outcome was reported as not recovered. Documents held by sender: None.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a consumer via another manufacturer (Merck) and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of ENGERIX B (unknown) and experienced not responding to therapy. The subject's mother reported that her son was found not to have immunity to hepatitis B despite receiving the vaccine. No further information was provided.
Sex: F
Vaccine: HEP
Symptoms: Injection site nodule, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 8 December 2009 the subject received unspecified dose of ENGERIX B (.1 ml, subcutaneous, right arm). On 8 December 2009, at the time of vaccination with vaccination with ENGERIX B, the subject experienced wrong vaccine administered. Less than one month after vaccination with ENGERIX B, the subject experienced nodule injection site. This is the first of three cases in which a nurse reported the subjects inadvertently received ENGERIX B instead of PPD. ENGERIX B was administered subcutaneously on 08 December 2009. Two subjects returned on 24 December 2009 and one subject returned on 28 December 2009 reporting a reaction of "knots at the site". At the time of reporting the outcome of the injection site nodule was unspecified. Please see cases A0836975A and A0836976A for the additional two reports with ENGERIX B.
Sex: F
Vaccine: HEP
Symptoms: Injection site nodule, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 8 December 2009 the subject received unspecified dose of ENGERIX B (.1 ml, subcutaneous, right arm). On 8 December 2009, at the time of vaccination with vaccination with ENGERIX B, the subject experienced wrong vaccine administered. Less than one month after vaccination with ENGERIX B, the subject experienced nodule injection site. This is second of three cases in which a nurse reported the subjects inadvertently received ENGERIX B instead of PPD. ENGERIX B was administered subcutaneously on 08 December 2009. Two subjects returned on 24 December 2009 and one subject returned on 28 December 2009 reporting a reaction of "knots at the site". At the time of reporting the outcome of the injection site nodule was unspecified. Please see cases A0836972A and A0836976A for the additional two reports with ENGERIX B.
Sex: F
Vaccine: HEP
Symptoms: Injection site nodule, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 8 December 2009 the subject received unspecified dose of ENGERIX B (.1 ml, subcutaneous, right arm). On 8 December 2009, at the time of vaccination with vaccination with ENGERIX B, the subject experienced wrong vaccine administered. Less than one month after vaccination with ENGERIX B, the subject experienced nodule injection site. This is the third case of three in which a nurse reported the subjects inadvertently received ENGERIX B instead of PPD. ENEGERIX B was administered subcutaneously on 08 December 2009. Two subjects returned on 24 December 2009 and one subject returned on 28 December 2009 reporting a reaction of "knots at the site". At the time of reporting the outcome of the injection site nodule was unspecified. Please see cases A0836972A and A0836975A for the additional two reports with ENGERIX B.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a dentist and described the occurrence of not responding to therapy in a 47-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 28 October 2005, 6 December 2005 and 8 May 2006 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown, right arm). On 6 December 2005 and 8 May 2006 with the 2nd dose and 3rd dose of ENGERIX B, the subject experienced inappropriate schedule of vaccine administered. On 7 January 2010, 4 years after vaccination with ENGERIX B, the subject experienced not responding to therapy. The dentist reported that he immunized his employee subject with ENGERIX B, she was about to undergo a surgical procedure, had pre-surgical consult with test performed. On 07 January 2010, the pre-surgical results for Hepatitis B revealed the subject was not immune. Relevant test results included Hepatitis B revealed the subject was not immune.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of injection site pain in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 23 November 2009 at 13:30 the subject received 3rd dose of ENGERIX B (unknown route, left arm). On 23 November 2009, "shortly" after vaccination with ENGERIX B, the subject experienced injection site pain in her left upper arm. At the time of reporting the event was unresolved.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Incorrect dose administered, No adverse event, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate dose of drug administered in a 20-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. Previous vaccinations included completion of a three dose series of hepatitis B vaccine (unknown manufacturer) with the 1st dose given in infancy. Dates were not specified. It was also reported that the subject received a PPD skin test. On 19 January 2010, at 11:00, the subject received 1st dose of ENGERIX B at 10 mcg in the left arm. This was an inappropriate dose of drug administered. The subject should have received an adult dose of ENGERIX B. No adverse events were reported. Lab work performed on an unspecified date prior to receiving ENGERIX B indicated that the subject's hepatitis B titer was not detectable. She had not responded to therapy. Note: Two separate reports for this same event reported the lot number for ENGERIX B to be AHB284DA or AHAVB284DA. Linked case number A0840589A was made void as two reports for this same subject were received in GlaxoSmithKline safety and a second case was created in error. Any future correspondence will be added to case number A0840586A. Follow-up information received on 24 February 2010 indicated that the lot number of ENGERIX B administered was AHBV706AA with an expiration date of 25 June 2011. The PPD skin test was intradermal at 0.1 ml on 19 January 2010. The subject was inadvertently administered a 10 mcg intramuscular dose of ENGERIX B rather than the appropriate adult dose of 20 mcg. No adverse events were reported. The subject was advised to wait one month and then restart the hepatitis B series. It was again noted that the subject had 3 prior doses of hepatitis B vaccine given by another provider and testing reported non-detectable antibodies.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional, via Merck, and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subjects received unspecified dose of ENGERIX B (unknown). On an unspecified date, on an unspecified time after vaccination with ENGERIX B, the subjects experienced not responding to therapy. After the next vaccination with ENGERIX B the event did not recur. On 17 November 2009, it was reported that a nurse mentioned an unknown number of subjects who received TWINRIX or ENGERIX-B had negative titers. These subjects repeated the series and responded. No further information was available at the time of reporting. (Please see case ID A0817629A for details on the unknown number of subjects who received TWINRIX).
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Sinusitis
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of sinus infection in a 49-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included being "prone to sinus infections". Concurrent medications included LEVAQUIN. On 15 October 2009 the subject received 1st dose of ENGERIX B (20 ml, unknown). On 15 November 2009, 31 days after vaccination with ENGERIX B, the subject experienced sinus infection. At the time of reporting the event was unresolved.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 31 year old female subject who was vaccinated with Hepatitis B virus vaccine (manufacturer unspecified). On unspecified dates, the subject received two series of Hepatitis B virus vaccine (unknown) and experienced not responding to therapy. The nurse reported that a subject had previously completed the Hepatitis B series twice. The subject still had not converted to show immunity.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 35-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 31 March 2009, the subject received 1st dose of ENGERIX B (1 ml, unknown, right deltoid). On 7 May 2009, the subject received 2nd dose of ENGERIX  B (1 ml, unknown, left deltoid). On 27 August 2009 the subject received 3rd dose of ENGERIX B (1 ml, unknown, right deltoid), (drug dose administration interval too short). On an unspecified date, the subject's titer was less than 0.1 with a decreased therapeutic response. The nurse reported that the first and second dose were from the same lot number. The third dose was from another lot number. Vaccines were given in the deltoid rotating from right with the first vaccine, left with second vaccine, and right with third vaccine. The nurse reported that the titers were showing that the series of ENGERIX-B that she provided to the workers at her assisted living facility did not work. Specifically the report stated that the subject was not immune and needed to restart series. The subject's titer was less than 0.1. It was determined that the third dose in the series was administered five months from the first vaccine instead of the recommended six months. This is one of nine cases reported by the nurse; see cases A0832033A, A0832034A and A0832035A for female subjects who experienced decreased therapeutic response and drug dose interval too short; and see cases A0832032A, A0832102A, A0832103A, A0832104A, and A0832105A for female subjects who experienced drug dose interval too short.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 52-year-old female subject who was vaccinated ENGERIX B (GlaxoSmithKline). On 31 March 2009, the subject received 1st dose of ENGERIX B (1 ml, unknown, right deltoid). On 7 May 2009, the subject received 2nd dose of ENGERIX B (1 ml, unknown, left deltoid). On 27 August 2009 the subject received 3rd dose of ENGERIX B (1 ml, unknown, right deltoid), (drug dose administration interval too short). On an unspecified date, the subject's titer was less than 0.1 with a decreased therapeutic response. The nurse reported that the first and second dose were from the same lot number. The third dose was from another lot number. Vaccines were given in the deltoid rotating from right with the first vaccine, left with second vaccine, and right with third vaccine. The nurse reported that the titers were showing that the series of ENGERIX-B that she provided to the workers at her assisted living facility did not work. Specifically the report stated that the subject was not immune and needed to restart series. The subject's titer was less than 0.1. It was determined that the third dose in the series was administered five months from the first vaccine instead of the recommended six months. This is one of nine cases reported by the nurse; see cases A0832030A, A0832034A, and A0832035A for female subjects who experienced decreased therapeutic response and drug dose interval too short; and see cases A0832032A, A0832102A, A0832103A, and A0832104A for female subjects who experienced drug dose interval too short.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 27-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 31 March 2009, the subject received 1st dose of ENGERIX (1 ml, unknown, right deltoid). On 7 May 2009, the subject received 2nd dose of ENGERIX B (1 ml, unknown, left deltoid). On 27 August 2009 the subject received 3rd dose of ENGERIX B (1 ml, unknown, right deltoid) (drug dose administration interval too short). On an unspecified date, the subject's titer was 0.47, and the subject experienced not responding to therapy. The nurse reported that the first and second dose were from the same lot number. The third dose was from another lot number. Vaccines were given in the deltoid rotating from right with the first vaccine, left with second vaccine, and right with third vaccine. The nurse reported that the titers were showing that the series of ENGERIX-B that she provided to the workers at her assisted living facility did not work. Specifically the report stated that the subject was not immune and needed to restart series. Her titer was less than 0.47. It was determined that the third dose in the series was administered five months from the first vaccine instead of recommended six months. This is one of nine cases reported by the nurse; see cases A0832030A, A0832033A, and A0832035A for female subjects who experienced not responding to therapy and drug dose interval too short; and see cases A0832032A, A0832102A, A0832103A and A0832104A for female subjects who experienced drug dose interval too short.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 45-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 31 March 2009, the subject received 1st dose of ENGERIX B (1 ml, unknown, unknown). On 19 May 2009, the subject received 2nd dose of ENGERIX B (1 ml, unknown, unknown). On 27 August 2009 the subject received 3rd dose of ENGERIX B (1 ml, unknown, unknown) and experienced decreased therapeutic response and drug dose administration interval too short. On an unspecified date, the subject's titer was less than 0.1 with a decreased therapeutic response. The nurse reported that the first and second dose were from the same lot number. The third dose was from another lot number. The nurse reported that the titers were showing that the series of ENGERIX-B that she provided to the workers at her assisted living facility did not work. Specifically the report stated that the subject was not immune and needed to restart series. The subject's titer was less than 0.1. It was determined that the third dose in the series was administered five months from the first vaccine instead of the recommended six months. This is one of nine cases reported by the nurse; see cases A0832030A, A0832033A, and A0832034A for female subjects who experienced decreased therapeutic response and drug dose interval too short; and see cases A0832032A, A0832102A, A0832103A, and A0832104A for female subjects who experienced drug dose interval too short.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a consumer and described the occurrence of not responding to therapy in a 69-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Relevant medical history was reported as "borderline". Concurrent medications included Vitamin, Calcium and PLAVIX. On 3 December 2009, 5 June 2009 and 6 May 2009 the subject received 3rd dose , 2nd dose and 1st dose of ENGERIX B (20 mcg, unknown, left arm). On 3 December 2009, less than one day after vaccination with dose 3 of ENGERIX B, 6 months after vaccination with dose 2 of ENGERIX B, 7 months after vaccination with dose 1 ENGERIX B, the subject experienced not responding to therapy. The subject stated that she received her 3rd ENGERIX B vaccine on 03 December 2009 after she was exposed to a dirty needle that same day. Because of the dirty needle exposure (from a normal blood draw from another person - subject was a phlebotomist), her blood was drawn to get a baseline of her level of immunity to the Hepatitis B virus. Subject was found to be not immune to Hepatitis B despite her having received those previous two ENGERIX B vaccines.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site erythema, Injection site induration, Injection site warmth, Skin hyperpigmentation
Clinical narrative: Large area of erythema and induration at injection site. Flu-like sx for 4 days after vaccination. At 6 wk after injection, continues to have hyperpigmentation, increased, warmth and 2x2 cm induration at site.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count normal
Clinical narrative: Large area of erythema and induration at injection site. Flu-like sx for 4 days after vaccination. At 6 wk after injection, continues to have hyperpigmentation, increased, warmth and 2x2 cm induration at site.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: None. Patient received extra HIB vaccine.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Therapeutic response decreased
Clinical narrative: This case was reported by a consumer who is also a healthcare professional and described the occurrence of decreased therapeutic response in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. Concurrent medical conditions included accidental needle stick. Concurrent medications included Birth control. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown) and in 1997 the subject received a series of Hepatitis B vaccine (unknown). On 13 January 2010, approximately one and half years after vaccination with ENGERIX B and approximately 13 years after Hepatitis B vaccine series (unknown manufacturer), the subject experienced decreased therapeutic response. The subject reported she experienced a needle stick in the hospital, as protocol for needle sticks at her hospital; titers were drawn for hepatitis B. Her titers for hepatitis B were less than 0.1. The subject received one series of hepatitis B (unknown manufacturer) in 1997 and received another series that was ENGERIX B approximately a year and half ago. Relevant test results included Hepatitis B titer on 13 January 2010: less than 0.1.
Sex: U
Vaccine: HEP
Symptoms: Head banging
Clinical narrative: This case was reported by a consumer and described the occurrence of head banging in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced head banging. The subject experienced head banging after the last dose in the series. At time of the report, no additional information was available. The reporter did not want to be contacted. At the time of reporting the outcome of the head banging was unspecified.