chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Immunoglobulins normal, Incontinence, Influenza virus test, Iron binding capacity total normal, Liver function test normal
Clinical narrative: SM presented to ED on 7/22/11 c/o fever (102.0), chills, and body aches. Evaluation: Temp 100F, Pulse 111, Normal pulse ox, normal BP. The pt was treated with TYLENOL, observed several hours, discharged home with 48 hrs Quarters for a diagnosis of "vaccine reaction". A VAERS report was filed. On 7/24/11 the pt was found confused, incontinent and covered with emesis. EMS transported the pt to a local civilian medical facility. SM was found to be confused, eyes open, verbally unresponsive, did not follow commands, some spastic movements, responsive to pain. Pulse 130's; Resp 30's; Pulse ox: High 90s; still afebrile and normal BP. Evaluation was basically normal (see below). On 7/25/11 the pt was transferred to another hospital. He was described as agitated, verbally non-communicative, does open eyes and moves all four extremities, responds to pain with withdrawal. Due to patient movement and agitation > MRI and LP attempts unsuccessful. On 7/26/11 the pt began to communicate - mostly fragments, short phrases; communication would continue to improve. The pt was also less agitated. EEG (7/25): generalized slowing but w/o seizure activity. On 7/27/11 the pt's speech continued to improve, but the pt still had some trouble with finding words. A Lumbar Puncture and MRI of Brain were performed using conscious sedation. On 7/28/11 the pt was engaging in self care activity. His verbal communication continued to improve with some "word finding" difficulties. The pt was discharged home on 7/29/11. The pt was seen by neurology on 8/25/11. At that time he had a normal neuro exam and complete resolution of his symptoms. The pt was found fit for full duty.
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging brain abnormal, Pain, Platelet count normal, Polymerase chain reaction
Clinical narrative: SM presented to ED on 7/22/11 c/o fever (102.0), chills, and body aches. Evaluation: Temp 100F, Pulse 111, Normal pulse ox, normal BP. The pt was treated with TYLENOL, observed several hours, discharged home with 48 hrs Quarters for a diagnosis of "vaccine reaction". A VAERS report was filed. On 7/24/11 the pt was found confused, incontinent and covered with emesis. EMS transported the pt to a local civilian medical facility. SM was found to be confused, eyes open, verbally unresponsive, did not follow commands, some spastic movements, responsive to pain. Pulse 130's; Resp 30's; Pulse ox: High 90s; still afebrile and normal BP. Evaluation was basically normal (see below). On 7/25/11 the pt was transferred to another hospital. He was described as agitated, verbally non-communicative, does open eyes and moves all four extremities, responds to pain with withdrawal. Due to patient movement and agitation > MRI and LP attempts unsuccessful. On 7/26/11 the pt began to communicate - mostly fragments, short phrases; communication would continue to improve. The pt was also less agitated. EEG (7/25): generalized slowing but w/o seizure activity. On 7/27/11 the pt's speech continued to improve, but the pt still had some trouble with finding words. A Lumbar Puncture and MRI of Brain were performed using conscious sedation. On 7/28/11 the pt was engaging in self care activity. His verbal communication continued to improve with some "word finding" difficulties. The pt was discharged home on 7/29/11. The pt was seen by neurology on 8/25/11. At that time he had a normal neuro exam and complete resolution of his symptoms. The pt was found fit for full duty.
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Prealbumin increased, Protein urine, Pyrexia, Red blood cell sedimentation rate normal, Sinus tachycardia
Clinical narrative: SM presented to ED on 7/22/11 c/o fever (102.0), chills, and body aches. Evaluation: Temp 100F, Pulse 111, Normal pulse ox, normal BP. The pt was treated with TYLENOL, observed several hours, discharged home with 48 hrs Quarters for a diagnosis of "vaccine reaction". A VAERS report was filed. On 7/24/11 the pt was found confused, incontinent and covered with emesis. EMS transported the pt to a local civilian medical facility. SM was found to be confused, eyes open, verbally unresponsive, did not follow commands, some spastic movements, responsive to pain. Pulse 130's; Resp 30's; Pulse ox: High 90s; still afebrile and normal BP. Evaluation was basically normal (see below). On 7/25/11 the pt was transferred to another hospital. He was described as agitated, verbally non-communicative, does open eyes and moves all four extremities, responds to pain with withdrawal. Due to patient movement and agitation > MRI and LP attempts unsuccessful. On 7/26/11 the pt began to communicate - mostly fragments, short phrases; communication would continue to improve. The pt was also less agitated. EEG (7/25): generalized slowing but w/o seizure activity. On 7/27/11 the pt's speech continued to improve, but the pt still had some trouble with finding words. A Lumbar Puncture and MRI of Brain were performed using conscious sedation. On 7/28/11 the pt was engaging in self care activity. His verbal communication continued to improve with some "word finding" difficulties. The pt was discharged home on 7/29/11. The pt was seen by neurology on 8/25/11. At that time he had a normal neuro exam and complete resolution of his symptoms. The pt was found fit for full duty.
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Specific gravity urine increased, Specific gravity urine normal, Speech disorder, Thyroxine free normal, Transferrin saturation
Clinical narrative: SM presented to ED on 7/22/11 c/o fever (102.0), chills, and body aches. Evaluation: Temp 100F, Pulse 111, Normal pulse ox, normal BP. The pt was treated with TYLENOL, observed several hours, discharged home with 48 hrs Quarters for a diagnosis of "vaccine reaction". A VAERS report was filed. On 7/24/11 the pt was found confused, incontinent and covered with emesis. EMS transported the pt to a local civilian medical facility. SM was found to be confused, eyes open, verbally unresponsive, did not follow commands, some spastic movements, responsive to pain. Pulse 130's; Resp 30's; Pulse ox: High 90s; still afebrile and normal BP. Evaluation was basically normal (see below). On 7/25/11 the pt was transferred to another hospital. He was described as agitated, verbally non-communicative, does open eyes and moves all four extremities, responds to pain with withdrawal. Due to patient movement and agitation > MRI and LP attempts unsuccessful. On 7/26/11 the pt began to communicate - mostly fragments, short phrases; communication would continue to improve. The pt was also less agitated. EEG (7/25): generalized slowing but w/o seizure activity. On 7/27/11 the pt's speech continued to improve, but the pt still had some trouble with finding words. A Lumbar Puncture and MRI of Brain were performed using conscious sedation. On 7/28/11 the pt was engaging in self care activity. His verbal communication continued to improve with some "word finding" difficulties. The pt was discharged home on 7/29/11. The pt was seen by neurology on 8/25/11. At that time he had a normal neuro exam and complete resolution of his symptoms. The pt was found fit for full duty.
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Transferrin saturation decreased, Treponema test, Treponema test negative, Treponema test positive, Unresponsive to stimuli
Clinical narrative: SM presented to ED on 7/22/11 c/o fever (102.0), chills, and body aches. Evaluation: Temp 100F, Pulse 111, Normal pulse ox, normal BP. The pt was treated with TYLENOL, observed several hours, discharged home with 48 hrs Quarters for a diagnosis of "vaccine reaction". A VAERS report was filed. On 7/24/11 the pt was found confused, incontinent and covered with emesis. EMS transported the pt to a local civilian medical facility. SM was found to be confused, eyes open, verbally unresponsive, did not follow commands, some spastic movements, responsive to pain. Pulse 130's; Resp 30's; Pulse ox: High 90s; still afebrile and normal BP. Evaluation was basically normal (see below). On 7/25/11 the pt was transferred to another hospital. He was described as agitated, verbally non-communicative, does open eyes and moves all four extremities, responds to pain with withdrawal. Due to patient movement and agitation > MRI and LP attempts unsuccessful. On 7/26/11 the pt began to communicate - mostly fragments, short phrases; communication would continue to improve. The pt was also less agitated. EEG (7/25): generalized slowing but w/o seizure activity. On 7/27/11 the pt's speech continued to improve, but the pt still had some trouble with finding words. A Lumbar Puncture and MRI of Brain were performed using conscious sedation. On 7/28/11 the pt was engaging in self care activity. His verbal communication continued to improve with some "word finding" difficulties. The pt was discharged home on 7/29/11. The pt was seen by neurology on 8/25/11. At that time he had a normal neuro exam and complete resolution of his symptoms. The pt was found fit for full duty.
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Urine alcohol test negative, Urine ketone body present, Vaccination complication, Varicella virus test negative, Viral test negative
Clinical narrative: SM presented to ED on 7/22/11 c/o fever (102.0), chills, and body aches. Evaluation: Temp 100F, Pulse 111, Normal pulse ox, normal BP. The pt was treated with TYLENOL, observed several hours, discharged home with 48 hrs Quarters for a diagnosis of "vaccine reaction". A VAERS report was filed. On 7/24/11 the pt was found confused, incontinent and covered with emesis. EMS transported the pt to a local civilian medical facility. SM was found to be confused, eyes open, verbally unresponsive, did not follow commands, some spastic movements, responsive to pain. Pulse 130's; Resp 30's; Pulse ox: High 90s; still afebrile and normal BP. Evaluation was basically normal (see below). On 7/25/11 the pt was transferred to another hospital. He was described as agitated, verbally non-communicative, does open eyes and moves all four extremities, responds to pain with withdrawal. Due to patient movement and agitation > MRI and LP attempts unsuccessful. On 7/26/11 the pt began to communicate - mostly fragments, short phrases; communication would continue to improve. The pt was also less agitated. EEG (7/25): generalized slowing but w/o seizure activity. On 7/27/11 the pt's speech continued to improve, but the pt still had some trouble with finding words. A Lumbar Puncture and MRI of Brain were performed using conscious sedation. On 7/28/11 the pt was engaging in self care activity. His verbal communication continued to improve with some "word finding" difficulties. The pt was discharged home on 7/29/11. The pt was seen by neurology on 8/25/11. At that time he had a normal neuro exam and complete resolution of his symptoms. The pt was found fit for full duty.
Age: 25.0
Sex: M
Vaccine: YF, YF
Symptoms: Vitamin B12 normal, Vomiting, West Nile virus test negative, White blood cell count normal
Clinical narrative: SM presented to ED on 7/22/11 c/o fever (102.0), chills, and body aches. Evaluation: Temp 100F, Pulse 111, Normal pulse ox, normal BP. The pt was treated with TYLENOL, observed several hours, discharged home with 48 hrs Quarters for a diagnosis of "vaccine reaction". A VAERS report was filed. On 7/24/11 the pt was found confused, incontinent and covered with emesis. EMS transported the pt to a local civilian medical facility. SM was found to be confused, eyes open, verbally unresponsive, did not follow commands, some spastic movements, responsive to pain. Pulse 130's; Resp 30's; Pulse ox: High 90s; still afebrile and normal BP. Evaluation was basically normal (see below). On 7/25/11 the pt was transferred to another hospital. He was described as agitated, verbally non-communicative, does open eyes and moves all four extremities, responds to pain with withdrawal. Due to patient movement and agitation > MRI and LP attempts unsuccessful. On 7/26/11 the pt began to communicate - mostly fragments, short phrases; communication would continue to improve. The pt was also less agitated. EEG (7/25): generalized slowing but w/o seizure activity. On 7/27/11 the pt's speech continued to improve, but the pt still had some trouble with finding words. A Lumbar Puncture and MRI of Brain were performed using conscious sedation. On 7/28/11 the pt was engaging in self care activity. His verbal communication continued to improve with some "word finding" difficulties. The pt was discharged home on 7/29/11. The pt was seen by neurology on 8/25/11. At that time he had a normal neuro exam and complete resolution of his symptoms. The pt was found fit for full duty.
Age: 74.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Unevaluable event
Clinical narrative: Redness and whelps from forearm to the wrist. Arm is still red on 12-20-11. I was instantly sick to my stomach after vaccination. It lasted about 24 hrs.
Age: 74.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Erythema, Immediate post-injection reaction, Nausea, Urticaria
Clinical narrative: Redness and whelps from forearm to the wrist. Arm is still red on 12-20-11. I was instantly sick to my stomach after vaccination. It lasted about 24 hrs.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Brain oedema, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal, Vision blurred, Visual impairment
Clinical narrative: Initial report was received from a health care professional on 16 December 2011. A 24-year-old female patient had received an injection in the right deltoid of FLUZONE, lot number UT426AA (route of administration not reported) on 16 November 2011. The patient also received an injection in the left deltoid of BOOSTRIX (manufacturer GlaxoSmithKline (GSK)), lot number AC52B080DA (route of administration not reported) on 16 November 2011. On 04 December 2011, the patient began experiencing visual disturbances and cloudy vision. On 05 December 2011,  the patient "could not see one side of face". The patient had an magnetic resonance imaging (MRI) with a diagnosis of brain swelling. The patient was hospitalized for one week (dates not reported) and discharged home on steroids for the "next five to six months". It was reported that the patient's vision was improving. The patient had no reported illness at the time of vaccination, no known allergies and no other vaccinations within four weeks prior to 16 November 2011. Concomitant medications included prenatal vitamins. The patient delivered her newborn on 14 November 2011. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Blindness unilateral, Brain oedema, Nuclear magnetic resonance imaging brain abnormal, Vision blurred, Visual impairment
Clinical narrative: Initial report was received from a health care professional on 16 December 2011. A 24-year-old female patient had received an injection in the right deltoid of FLUZONE, lot number UT426AA (route of administration not reported) on 16 November 2011. The patient also received an injection in the left deltoid of BOOSTRIX (manufacturer GlaxoSmithKline (GSK)), lot number AC52B080DA (route of administration not reported) on 16 November 2011. On 04 December 2011, the patient began experiencing visual disturbances and cloudy vision. On 05 December 2011,  the patient "could not see one side of face". The patient had an magnetic resonance imaging (MRI) with a diagnosis of brain swelling. The patient was hospitalized for one week (dates not reported) and discharged home on steroids for the "next five to six months". It was reported that the patient's vision was improving. The patient had no reported illness at the time of vaccination, no known allergies and no other vaccinations within four weeks prior to 16 November 2011. Concomitant medications included prenatal vitamins. The patient delivered her newborn on 14 November 2011. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Arthralgia, Blood test normal, Bone pain, Fatigue, Feeling abnormal
Clinical narrative: Moderate to severe fatigue, headache, nausea, muscle weakness, muscle jitteriness/shaking, leg numbness, feeling of hand weakness, leg paralysis (states she can't "feel" her legs at times), glossy/glazed eyes, arms and legs feeling "heavy", bone and joint pain, "not good" feeling all over.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Feeling jittery, Headache, Hypoaesthesia, Monoplegia, Muscular weakness
Clinical narrative: Moderate to severe fatigue, headache, nausea, muscle weakness, muscle jitteriness/shaking, leg numbness, feeling of hand weakness, leg paralysis (states she can't "feel" her legs at times), glossy/glazed eyes, arms and legs feeling "heavy", bone and joint pain, "not good" feeling all over.
Age: 13.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Nausea, Sensation of heaviness, Staring, Tremor, Vitamin D decreased
Clinical narrative: Moderate to severe fatigue, headache, nausea, muscle weakness, muscle jitteriness/shaking, leg numbness, feeling of hand weakness, leg paralysis (states she can't "feel" her legs at times), glossy/glazed eyes, arms and legs feeling "heavy", bone and joint pain, "not good" feeling all over.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye irritation, Eye pruritus, Ocular hyperaemia
Clinical narrative: Stated 2 1/2 hours after receiving flu vaccine she developed red, itchy burning eyes. Took off her contact lenses. Symptoms persisted. Then started feeling like she had swelling in her throat, cough and sensation of feeling short of breath. Took 2 tablets of BENADRYL and symptoms began to resolve after about 45 minutes.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Stated 2 1/2 hours after receiving flu vaccine she developed red, itchy burning eyes. Took off her contact lenses. Symptoms persisted. Then started feeling like she had swelling in her throat, cough and sensation of feeling short of breath. Took 2 tablets of BENADRYL and symptoms began to resolve after about 45 minutes.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Eye pruritus, Face oedema, Injection site warmth
Clinical narrative: 9/28 1130: Influenza vaccine administered. 1430-1530: Eyes began to itch. Developed body aches/pain, warmth at injection site, hives (raised, reddened areas) on neck and torso. Had fever and chills during night. 09/29 0700: Awoke with facial edema (eyes, cheeks), body aches/ pains, hives. Took BENADRYL. 09/30 Nausea/vomiting, vertigo throughout day. Improved in evening.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Rash maculo-papular, Urticaria
Clinical narrative: 9/28 1130: Influenza vaccine administered. 1430-1530: Eyes began to itch. Developed body aches/pain, warmth at injection site, hives (raised, reddened areas) on neck and torso. Had fever and chills during night. 09/29 0700: Awoke with facial edema (eyes, cheeks), body aches/ pains, hives. Took BENADRYL. 09/30 Nausea/vomiting, vertigo throughout day. Improved in evening.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Vomiting
Clinical narrative: 9/28 1130: Influenza vaccine administered. 1430-1530: Eyes began to itch. Developed body aches/pain, warmth at injection site, hives (raised, reddened areas) on neck and torso. Had fever and chills during night. 09/29 0700: Awoke with facial edema (eyes, cheeks), body aches/ pains, hives. Took BENADRYL. 09/30 Nausea/vomiting, vertigo throughout day. Improved in evening.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Blister, Otitis media, Varicella post vaccine, Viral rash
Clinical narrative: Went to Urgent Care 12/24/11 with rash - Dx. viral and OM - rash proceeded to get blisters and worse - today (12/27/11) looks like final stages of varicella.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Convulsion, Dyskinesia, Electrocardiogram normal, Electroencephalogram abnormal
Clinical narrative: Initial report was received on 14 December 2011 from a consumer who is also the patient's parent. A 12 year-old female patient with a history of multiple allergies, amoxicillin, tree pollen "etc" had received on 14 April 2011 a first dose intramuscular left deltoid injection of MENACTRA, lot number U3713AA and an unspecified amount of time later "sometime between the 14th and 21st of April", began having problems sleeping at night including sleep terrors and somnambulism. The events became more common, more severe and were suspicious of seizure activity. It was noted during the episodes the patient would have teeth chattering, tongue biting, urinary incontinence, tremor, shaking, screaming and flailing. The patient had been taken by ambulance twice to the emergency room and then later released. The parent reports, that on one occasion the patient was sleepwalking and fell down the stairs knocking two of her teeth through her lip which "they are still working to save the teeth". The patient had an EEG on 12 August 2011 which suggested an increased predisposition to epilepsy, probably of the generalized type, but partial onset seizures with secondary generalization are also compatible with this EEG signature. The patient had a MRI and an EKG which were normal. According to the parent, the patient had a 24 hour EEG that was completed in November which showed some improvement. Treatment included anti-seizure medications. Concomitant medications reported on EEG report included Albuterol, FLOVENT, ADVAIR, ZADITOR, CLARITIN, ATIVAN, PATADAY and PATANASE. According to the parent, she did not believe the patient was on other medications at the time but "may have been on allergy meds". The patient had referred to and evaluated by multiple physicians including a neurologist and a psychologist. In addition, she had been evaluated by a sleep clinic. No further information was available at the time of the event. The patient's outcome was not recovered. Documents held by sender: EEG report.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Fall, Insomnia, Lip injury, Nuclear magnetic resonance imaging brain normal, Screaming
Clinical narrative: Initial report was received on 14 December 2011 from a consumer who is also the patient's parent. A 12 year-old female patient with a history of multiple allergies, amoxicillin, tree pollen "etc" had received on 14 April 2011 a first dose intramuscular left deltoid injection of MENACTRA, lot number U3713AA and an unspecified amount of time later "sometime between the 14th and 21st of April", began having problems sleeping at night including sleep terrors and somnambulism. The events became more common, more severe and were suspicious of seizure activity. It was noted during the episodes the patient would have teeth chattering, tongue biting, urinary incontinence, tremor, shaking, screaming and flailing. The patient had been taken by ambulance twice to the emergency room and then later released. The parent reports, that on one occasion the patient was sleepwalking and fell down the stairs knocking two of her teeth through her lip which "they are still working to save the teeth". The patient had an EEG on 12 August 2011 which suggested an increased predisposition to epilepsy, probably of the generalized type, but partial onset seizures with secondary generalization are also compatible with this EEG signature. The patient had a MRI and an EKG which were normal. According to the parent, the patient had a 24 hour EEG that was completed in November which showed some improvement. Treatment included anti-seizure medications. Concomitant medications reported on EEG report included Albuterol, FLOVENT, ADVAIR, ZADITOR, CLARITIN, ATIVAN, PATADAY and PATANASE. According to the parent, she did not believe the patient was on other medications at the time but "may have been on allergy meds". The patient had referred to and evaluated by multiple physicians including a neurologist and a psychologist. In addition, she had been evaluated by a sleep clinic. No further information was available at the time of the event. The patient's outcome was not recovered. Documents held by sender: EEG report.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Sleep disorder, Sleep terror, Somnambulism, Tongue biting, Tooth injury
Clinical narrative: Initial report was received on 14 December 2011 from a consumer who is also the patient's parent. A 12 year-old female patient with a history of multiple allergies, amoxicillin, tree pollen "etc" had received on 14 April 2011 a first dose intramuscular left deltoid injection of MENACTRA, lot number U3713AA and an unspecified amount of time later "sometime between the 14th and 21st of April", began having problems sleeping at night including sleep terrors and somnambulism. The events became more common, more severe and were suspicious of seizure activity. It was noted during the episodes the patient would have teeth chattering, tongue biting, urinary incontinence, tremor, shaking, screaming and flailing. The patient had been taken by ambulance twice to the emergency room and then later released. The parent reports, that on one occasion the patient was sleepwalking and fell down the stairs knocking two of her teeth through her lip which "they are still working to save the teeth". The patient had an EEG on 12 August 2011 which suggested an increased predisposition to epilepsy, probably of the generalized type, but partial onset seizures with secondary generalization are also compatible with this EEG signature. The patient had a MRI and an EKG which were normal. According to the parent, the patient had a 24 hour EEG that was completed in November which showed some improvement. Treatment included anti-seizure medications. Concomitant medications reported on EEG report included Albuterol, FLOVENT, ADVAIR, ZADITOR, CLARITIN, ATIVAN, PATADAY and PATANASE. According to the parent, she did not believe the patient was on other medications at the time but "may have been on allergy meds". The patient had referred to and evaluated by multiple physicians including a neurologist and a psychologist. In addition, she had been evaluated by a sleep clinic. No further information was available at the time of the event. The patient's outcome was not recovered. Documents held by sender: EEG report.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Tremor, Urinary incontinence
Clinical narrative: Initial report was received on 14 December 2011 from a consumer who is also the patient's parent. A 12 year-old female patient with a history of multiple allergies, amoxicillin, tree pollen "etc" had received on 14 April 2011 a first dose intramuscular left deltoid injection of MENACTRA, lot number U3713AA and an unspecified amount of time later "sometime between the 14th and 21st of April", began having problems sleeping at night including sleep terrors and somnambulism. The events became more common, more severe and were suspicious of seizure activity. It was noted during the episodes the patient would have teeth chattering, tongue biting, urinary incontinence, tremor, shaking, screaming and flailing. The patient had been taken by ambulance twice to the emergency room and then later released. The parent reports, that on one occasion the patient was sleepwalking and fell down the stairs knocking two of her teeth through her lip which "they are still working to save the teeth". The patient had an EEG on 12 August 2011 which suggested an increased predisposition to epilepsy, probably of the generalized type, but partial onset seizures with secondary generalization are also compatible with this EEG signature. The patient had a MRI and an EKG which were normal. According to the parent, the patient had a 24 hour EEG that was completed in November which showed some improvement. Treatment included anti-seizure medications. Concomitant medications reported on EEG report included Albuterol, FLOVENT, ADVAIR, ZADITOR, CLARITIN, ATIVAN, PATADAY and PATANASE. According to the parent, she did not believe the patient was on other medications at the time but "may have been on allergy meds". The patient had referred to and evaluated by multiple physicians including a neurologist and a psychologist. In addition, she had been evaluated by a sleep clinic. No further information was available at the time of the event. The patient's outcome was not recovered. Documents held by sender: EEG report.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Aphagia, Death, Headache, Malaise
Clinical narrative: Initial report was received on 19 December 2011 from a consumer who is also the patient's parent and additional information was received from a health care professional. A 43-year-old male patient received an injection (route and site not reported) of INFLUENZA VACCINE, Sanofi Pasteur Inc. lot not reported, on 17 November 2011 (also reported as 18 November 2011). The patient had a medical history of increased blood pressure and "Dbj". It was unknown if the patient had any illnesses at the time of vaccination, or had any vaccinations within 4 weeks of the influenza vaccine. The patient's concomitant medications were unknown. It was reported that the patient had no previous influenza vaccines. The parent stated that the patient was seen by her on 18 November 2011 and he had been sick after receiving the influenza vaccine and was having a severe headache and could not eat. The patient had called 911 on Sunday and was taken to a hospital. The patient died on 21 November 2011. The outcome was reported as fatal. Documents held by sender: None.
Age: 7.0
Sex: U
Vaccine: PER
Symptoms: Pertussis
Clinical narrative: Initial report was received on 16 December 2011 from an electronic lay press article. It represents a cluster of two patients reported by the same reporter who each experienced pertussis following vaccination with a pertussis vaccine (manufacturer not reported). The second patient is captured in case number 2011-12374. A 7-year-old patient (gender not reported) had received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed pertussis. The patient was reported as up-to-date with immunizations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Guillain-Barre syndrome, Musculoskeletal stiffness
Clinical narrative: Initial report received on 15 December 2011 from another manufacturer (Reference number 1-4671216236), who had received the original information from a Pharmacist. A 50-year-old female patient with no pertinent medical history other than allergies to Penicillin, iron, and Erythromycin, had received a Pandemic Influenza vaccine (lot number not reported) approximately 30 years ago and at an unspecified amount of time later developed Guillain Barre syndrome that lasted for approximately 3 months. She also had a stiff neck that lasted for approximately 1 year. The patient sought medical attention; however corrective treatments received, and diagnostic tests/laboratory data performed were unspecified. It was also unspecified if the event required hospitalization or caused significant disability or incapacity. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 10.0
Sex: U
Vaccine: PER
Symptoms: Pertussis
Clinical narrative: Initial report was received on 16 December 2011 from an electronic lay press article. It represents a cluster of two patients reported by the same reporter who each experienced pertussis following vaccination with a pertussis vaccine (manufacturer not reported). The second patient is captured in case number 2011-12375. A 10-year-old patient (gender not reported) had received an injection of pertussis vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed pertussis. The patient was reported as up-to-date with immunizations. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Blood test, Haemorrhage, Open wound, Pain of skin
Clinical narrative: 4-5 days after flu vaccine patient developed red spots on arms and legs. It burned & was very painful. It evolved into blisters that opened and bled. It then evolved into deep open wounds on thighs and calves and ankle (L). Was treated at hospital with prednisone, antibiotics & pain med. Diagnosis "Vasculitis from flu vaccine".
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Skin burning sensation, Vaccination complication, Vasculitis
Clinical narrative: 4-5 days after flu vaccine patient developed red spots on arms and legs. It burned & was very painful. It evolved into blisters that opened and bled. It then evolved into deep open wounds on thighs and calves and ankle (L). Was treated at hospital with prednisone, antibiotics & pain med. Diagnosis "Vasculitis from flu vaccine".
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site joint swelling, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, rash, swelling and soreness of (Rt) upper arm and shoulder (swelling), fever for a couple of days. Onset 12/17/11. Lasted a couple of days. Pt. called to report on 12/21/11. No treatment.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Redness, rash, swelling and soreness of (Rt) upper arm and shoulder (swelling), fever for a couple of days. Onset 12/17/11. Lasted a couple of days. Pt. called to report on 12/21/11. No treatment.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pruritus, Rash macular
Clinical narrative: The same night as shot given pt developed redness, warmth to touch at injection site and blotchiness all over body. Intense itching.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Child developed redness, hardening of (L) arm hours after administration of vaccines (KINREX, varicella). Child started on antibiotics after 2 days BENADRYL given also IM after 2 days.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blister, Skin lesion, Skin warm
Clinical narrative: Onset 12-20-11 with clear blisters between buttocks. The night before (12-19-11) body was warm to touch (temp. 97.9). This AM (12-21-11) upon awakening, lesions on trunk, increasing during the day to feet, hands, and vesicles on tonsils. Rx: LORTAB ELIXIR, 500 mg 7.5 mg/15 ml - 3/4 tsp. po q 6 prn pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Feeling of body temperature change, Nausea
Clinical narrative: Described by husband. After 8h. very, very confused, nauseated, dizzy, and feeling hot and cold. Stayed in bed for 2-3 days.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Joint swelling, Lethargy, Local swelling, Mobility decreased
Clinical narrative: Fever, lethargy, swelling to arm, shoulder and neck, arm pain, shoulder joint pain and unable to move shoulder for 1 week.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Fever, lethargy, swelling to arm, shoulder and neck, arm pain, shoulder joint pain and unable to move shoulder for 1 week.
Age: 58.0
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: 10-26-11 Patient came to pharmacy. Muscle aching - above elbow - drawing down to forearm on the left arm - site of vaccination - site sore immediately after vaccination on 11-15-11 talked to patient a little better applying heat per consultation with a nurse did not see MD - at elbow pain during night more painful. 12-21-11 pain around elbow and up to injection site and band pain.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dysgeusia, Immediate post-injection reaction
Clinical narrative: As soon as vaccine administered patient got a strange taste in his mouth that lasted approx 6 hrs.
Age: 1.63
Sex: F
Vaccine: HEPA
Symptoms: Injection site atrophy
Clinical narrative: Atrophy of soft tissue atrophy 4x5cm diameter over (L) medial-lateral thigh at site which would correspond with immunization administration. No underlying abnormalities noted, no inflammation, no tenderness; no functional abnormality.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Muscular weakness
Clinical narrative: Patient experienced weakness of legs and knees especially R leg.   He felt like he had to drag his leg. Some wekaness and numbness of R leg. Denies weakness of arms.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema, Oedema mouth, Urticaria
Clinical narrative: Large sporadic hives only on trunk and head and face and swelling around mouth or eyelid. Intermittent swelling lasting days at a time then recurring.  These episodes noted for approx 4 weeks.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Patient received flu vaccine at 2:15 PM. Patient was asked if he had received vaccine. He stated "I received the flu vaccine before without any problems." Patient was asked if he has any food or drug allergies and stated no. Patient was advised to stay in clinic area for 15 minutes which he did and left without any complaints. Patient stated "I feel fine." At 3:40 PM patient came back to the clinic area with complaints of muscle achiness in left arm and left leg. Took BP 230/140, retake showed 230/150 and was advised to seek emergency treatment. Patient refused treatment until he called his physician. Emergency Response was called and patient was taken to hospital in ambulance.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Feeling abnormal
Clinical narrative: Patient had never had a flu shot before. The nurse had her sit for 15 min at 2:35 PM with complaints of feeling woozy, upset stomach. BP 148/88.  After giving her a soda and sitting she felt much better.
Age: 0.56
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Urticaria
Clinical narrative: Hives. No anaphylaxis or difficulty breathing. Evaluated in clinic on 12/13/11. Benadryl given for symptoms.
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Emotional distress, Injection site warmth, Pain
Clinical narrative: Patient presented 5 hours after vaccination.  Unconsolable for 1.5 hours, no fever or redness at the injection site.  Hospitalized for observation.  Improved with Pain control following morning.  Warmth over the injection site but happy and content.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: Patient returns to the flu clinic station after recveiving a vaccine at 12:10 PM. She reports feeling "foggy headed and icky." She stated "I do this every year, I feel terrible for 2-3 days after." Patient instructed in office with nurse for monitoring.  She sat for 10 minutes. Refused to phone a physician. Alert and oriented x 3, speech clear. Smiling and laughing with other employees. Pt went home after another 10 minutes.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt rec'd flu vaccines (2011-2012) x 2. Rec'd 1st vaccine 10/13/11 & 2nd vaccine 11/30/11. Pt. did not remember getting 1st vacc & req'd another. No known injury.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Pt's mom states that he had 2 seizures in the morning following vaccination. The seizures were reportedly worse & more frequent than typical. Pt has had no problem before with vaccine. Patient on 12/18/11 called on 12/18/11 and said patient was better.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: 12/4/11 had 1st outbreak out of school all week. Then developed a few more lesions 15-20 12/9 - still dx with CP. Had both vaccines #1 2/6/07 MMRV #1548F Merck.
Age: 1.31
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Typical pox like vesicle rash - diagnosed by Dr. Less than 20 vesicles. Fever - 102.5.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased
Clinical narrative: February 28, 2011: Tetanus Shot and Neurological Symptoms in Hands. Please add to file for patient: On December 1, 2010, I received a tetanus shot as part of routine physical with Dr. Within several hours, I was unable to extend my left hand without major "zings" in the fingers and up the hand. This lasted on and off for one month with "zingers" preventing me from grabbing hard at something or extending my arm straight out. Three months later the left hand is rarely having problems, and the symptoms are not as intense anymore. However, I also have the same problem to a lesser degree in my right hand now, too, which come and goes. A couple of days after the shot, I checked on the Internet to see if any symptoms were reported with tetanus shots and neurological issues. The CDC found links to a neurological condition in the shoulder, and the Immunization Action Coalition suggest avoiding DTaP shots if neurological conditions are possible (article was aimed at children's vaccines.) Several ALS patients had blogs asking if a connection existed, but their requests were speculation-based on having the shots at various time in left compared to onset of ALS. I assumed the left-hand side-effect might have been from the shot itself until the symptoms started in the other arm. While the information below is not definitive, I would like a caution added to my records regarding a tetanus shot in the future, since our family has a chance of genetic ALS. Please place this page in my records for future reference. (My father and aunt died from it at age of early 60's and late 50's, and my uncle died from Parkinson's Disease and two of his children have had long-time myasthenia gravis.)
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient experienced rash 2 days after ZOSTAVAX vaccine given. Rash went down her left arm & appeared on right arm, abdomen & back as itchy areas. Patient was treated by her Dr with a MEDROL dose pak on 12/20/11.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: I evaluated pt on 12/14 at which time mom reported that she noted erythema to (R) thigh at injection site 2 days after immunization given. Area increased in size to approx 8cm, was warm to touch & very tender. No oozing, no fever, mom did not bring him to medical attention during acute erythema bc no fever. On my exam on 12/14 -> small nodular area palpable (R) anterior thigh (needle site per mom); no erythema, warmth or fluctuance.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Mother brought baby after 24 hrs of administration of vaccine. The right thigh appears to be swollen and warm to touch and blanching. He was afebrile at the time ice pack applied. Rechecked after 24 hrs. issue resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local reaction in area of KINRIX.
Age: 1.04
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient's mom called verbalizing a hard red spot, measuring about nickel sized at site of varicella vaccination. Varicella vaccine given on right thigh, subcutaneously. Mom verbalized no warmness et that patient has had this since two days after administration.
Age: 70.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Erythema, Oedema peripheral, Pruritus
Clinical narrative: Arthralgias, arm red & swollen, pruritus.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy skin, Dermatitis psoriasiform, Double stranded DNA antibody positive, Erythema, Injection site erythema
Clinical narrative: 11/7/11 c/o rash all over body & itched & 11/11/11 was prescribed miconazole cream > nurse. 11/15 MD assessment - large saline red circumscribed and serpentine areas to both deltoids and upper shoulder then scratched & abraded 2-3 mm lesion over most of body. Skin biopsy. Fluconazole qd for 4 days.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised, Skin oedema
Clinical narrative: 11/7/11 c/o rash all over body & itched & 11/11/11 was prescribed miconazole cream > nurse. 11/15 MD assessment - large saline red circumscribed and serpentine areas to both deltoids and upper shoulder then scratched & abraded 2-3 mm lesion over most of body. Skin biopsy. Fluconazole qd for 4 days.
Age: 20.0
Sex: F
Vaccine: FLU3, HEPA, IPV, TYP
Symptoms: Cold sweat, Hyperhidrosis, Loss of consciousness, Tremor, Vomiting
Clinical narrative: After receiving vaccines pt was sitting in chair & passed out with 3 min. arms & legs were shaking & she was clammy. Pt came to within a minute. B/P was 120/64 AP 80 & irregular. Pt was given juice & water. Pt states she had not eaten earlier in the day. Pt became sick again - shaking, emesis, diaphoretic. 911 was called. B/P 140/80. Paramedics checked pt & referred to take her to ER. Mom refused. Pt then became well enough to go home with mother.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Patient received 0.5mL Flulaval to right deltoid, IM, at 1:25 PM. At 3:30 PM, participant approached nurse with complaints of localized itching at left forearm. Light, red rash observed on inner left forearm. Patient denied SOB, HA, cough, chills, chest tightness. No facial swelling noted. Benadryl PO given at 4:45 PM.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Chest pain, Herpes zoster, Rash macular, Rash pustular, Scab
Clinical narrative: In the morning of 12/16 the left side of my thorax was mildly painful.  This pain continued, but was manageable with ibuprofen, for the next 3 days.  In the evening of 12/18, I noticed red splotches in the vicinity of the pain.  By 12/20 the splotches became raised and pustual. On 12/21 I spoke with Dr. and reported potential shingles; she indicated that it might not be shingles and if it was that it might be coincident with the vaccination. I agreed. On 12/22 the lesions became more sensitive and the pain increased.  I requested a visit to confirm the diagnosis of shingles.  On 12/23 I was seen by the office's nurse practitioner; she confirmed shingles.  She offered acyclovir, albeit late for the recurrence, and steroid cream; I declined and mentioned that I would try to manage the pain with OTC analgesics.  As of today -12/28/2011 - the pain continues; many of the lesions have scabbed; there have been a few small lesion apparent on the left side of my fore head and left leg.
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Skin lesion
Clinical narrative: In the morning of 12/16 the left side of my thorax was mildly painful.  This pain continued, but was manageable with ibuprofen, for the next 3 days.  In the evening of 12/18, I noticed red splotches in the vicinity of the pain.  By 12/20 the splotches became raised and pustual. On 12/21 I spoke with Dr. and reported potential shingles; she indicated that it might not be shingles and if it was that it might be coincident with the vaccination. I agreed. On 12/22 the lesions became more sensitive and the pain increased.  I requested a visit to confirm the diagnosis of shingles.  On 12/23 I was seen by the office's nurse practitioner; she confirmed shingles.  She offered acyclovir, albeit late for the recurrence, and steroid cream; I declined and mentioned that I would try to manage the pain with OTC analgesics.  As of today -12/28/2011 - the pain continues; many of the lesions have scabbed; there have been a few small lesion apparent on the left side of my fore head and left leg.