chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Eye movement disorder, Fatigue, Gait disturbance, Headache, Hyperaesthesia
Clinical narrative: Patient is a previously healthy 4 year old boy who presented with new-onset seizure in the setting of one month altered behaviors, fevers, and cough. On 12/15 patient received the MMR, VZV, and DTaP-IPV vaccines (verified in CAIR). Soon after he developed fever, cough, and rhinorrhea. These symptoms lasted for approximately 2 weeks, resolving 12/30 or so. On 1/12 symptoms returned again with fever and cough. He became fatigued and moody, refusing to get out of bed much, seeming weak and refusing to walk. Fevers were daily, both daytime and nightime and with associated chills/sweats. He saw his pediatrician about a week later and was diagnosed with viral illness. On Thursday 1/15 he again saw his pediatrician, was diagnosed with possible ear infection, and prescribed "ear drops." On Saturday 1/17 he developed rapid, fast breathing and had emesis x1. He presented to ED and discharged home with Tylenol for presumed viral illness. Around 4 PM the day of admission (1/22) pt and mom were at auntie's house. After eating some soup and water pt had emesis x 1 (NBNB) and seemed to slump down in chair. He was breathing differently, as if trouble breathing. Mom asked if he could see her and he said it was hard to see. He then seemed confused and was difficult to understand. Soon after, eyes seemed to roll up into his head and his upper and lower extremities became stiff. Parents called EMS at that point and he was brought to ED. In addition to daily fevers and cough for the last 3-4 weeks, patient has also had intermittent abdominal and back pain as well as headache. He has seemed extra sensitive, occasionally complaining that walking is painful, and seems to be walking more slowly than usual. He has had normal appetite and apart from two episodes of emesis (x1 on 1/17 and x1 on 1/22) he has had no other vomiting or diarrhea. No rashes. Parents do report weight loss, dad estimates approximately 8 pounds, despite no change in appetite.  In the past month parents have also noticed changes in patient's behavior overall. He has been more moody and fatigued than usual, intermittently confused. Specifically, in addition to the episode that occurred on 1/22 just prior to admission, mom recalls him waking up around 5 AM on 1/19 confused and asking "Where am I?". Mom was able to re-orient him at that time. Patient arrived to ED seizing and was given Ativan. Labs were sent, CXR and CT head done, and he was started on vancomycin, ceftriaxone, and acyclovir at meningitis dosing. He was then admitted to the PICU. Since arrival to the PICU he has had brain MRI which showed 3 small enhancing (necrotizing?) lesions. He was initially intubated for airway protection but has since self-extubated himself. Additional labs were sent. He has required precedex drip as well as other medications for sedation. He was continued on antibiotics sent from the ER, and started on oseltamivir as well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hyperhidrosis, Incoherent, Intensive care, Laboratory test, Mobility decreased
Clinical narrative: Patient is a previously healthy 4 year old boy who presented with new-onset seizure in the setting of one month altered behaviors, fevers, and cough. On 12/15 patient received the MMR, VZV, and DTaP-IPV vaccines (verified in CAIR). Soon after he developed fever, cough, and rhinorrhea. These symptoms lasted for approximately 2 weeks, resolving 12/30 or so. On 1/12 symptoms returned again with fever and cough. He became fatigued and moody, refusing to get out of bed much, seeming weak and refusing to walk. Fevers were daily, both daytime and nightime and with associated chills/sweats. He saw his pediatrician about a week later and was diagnosed with viral illness. On Thursday 1/15 he again saw his pediatrician, was diagnosed with possible ear infection, and prescribed "ear drops." On Saturday 1/17 he developed rapid, fast breathing and had emesis x1. He presented to ED and discharged home with Tylenol for presumed viral illness. Around 4 PM the day of admission (1/22) pt and mom were at auntie's house. After eating some soup and water pt had emesis x 1 (NBNB) and seemed to slump down in chair. He was breathing differently, as if trouble breathing. Mom asked if he could see her and he said it was hard to see. He then seemed confused and was difficult to understand. Soon after, eyes seemed to roll up into his head and his upper and lower extremities became stiff. Parents called EMS at that point and he was brought to ED. In addition to daily fevers and cough for the last 3-4 weeks, patient has also had intermittent abdominal and back pain as well as headache. He has seemed extra sensitive, occasionally complaining that walking is painful, and seems to be walking more slowly than usual. He has had normal appetite and apart from two episodes of emesis (x1 on 1/17 and x1 on 1/22) he has had no other vomiting or diarrhea. No rashes. Parents do report weight loss, dad estimates approximately 8 pounds, despite no change in appetite.  In the past month parents have also noticed changes in patient's behavior overall. He has been more moody and fatigued than usual, intermittently confused. Specifically, in addition to the episode that occurred on 1/22 just prior to admission, mom recalls him waking up around 5 AM on 1/19 confused and asking "Where am I?". Mom was able to re-orient him at that time. Patient arrived to ED seizing and was given Ativan. Labs were sent, CXR and CT head done, and he was started on vancomycin, ceftriaxone, and acyclovir at meningitis dosing. He was then admitted to the PICU. Since arrival to the PICU he has had brain MRI which showed 3 small enhancing (necrotizing?) lesions. He was initially intubated for airway protection but has since self-extubated himself. Additional labs were sent. He has required precedex drip as well as other medications for sedation. He was continued on antibiotics sent from the ER, and started on oseltamivir as well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Mood altered, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain abnormal, Pain, Posture abnormal
Clinical narrative: Patient is a previously healthy 4 year old boy who presented with new-onset seizure in the setting of one month altered behaviors, fevers, and cough. On 12/15 patient received the MMR, VZV, and DTaP-IPV vaccines (verified in CAIR). Soon after he developed fever, cough, and rhinorrhea. These symptoms lasted for approximately 2 weeks, resolving 12/30 or so. On 1/12 symptoms returned again with fever and cough. He became fatigued and moody, refusing to get out of bed much, seeming weak and refusing to walk. Fevers were daily, both daytime and nightime and with associated chills/sweats. He saw his pediatrician about a week later and was diagnosed with viral illness. On Thursday 1/15 he again saw his pediatrician, was diagnosed with possible ear infection, and prescribed "ear drops." On Saturday 1/17 he developed rapid, fast breathing and had emesis x1. He presented to ED and discharged home with Tylenol for presumed viral illness. Around 4 PM the day of admission (1/22) pt and mom were at auntie's house. After eating some soup and water pt had emesis x 1 (NBNB) and seemed to slump down in chair. He was breathing differently, as if trouble breathing. Mom asked if he could see her and he said it was hard to see. He then seemed confused and was difficult to understand. Soon after, eyes seemed to roll up into his head and his upper and lower extremities became stiff. Parents called EMS at that point and he was brought to ED. In addition to daily fevers and cough for the last 3-4 weeks, patient has also had intermittent abdominal and back pain as well as headache. He has seemed extra sensitive, occasionally complaining that walking is painful, and seems to be walking more slowly than usual. He has had normal appetite and apart from two episodes of emesis (x1 on 1/17 and x1 on 1/22) he has had no other vomiting or diarrhea. No rashes. Parents do report weight loss, dad estimates approximately 8 pounds, despite no change in appetite.  In the past month parents have also noticed changes in patient's behavior overall. He has been more moody and fatigued than usual, intermittently confused. Specifically, in addition to the episode that occurred on 1/22 just prior to admission, mom recalls him waking up around 5 AM on 1/19 confused and asking "Where am I?". Mom was able to re-orient him at that time. Patient arrived to ED seizing and was given Ativan. Labs were sent, CXR and CT head done, and he was started on vancomycin, ceftriaxone, and acyclovir at meningitis dosing. He was then admitted to the PICU. Since arrival to the PICU he has had brain MRI which showed 3 small enhancing (necrotizing?) lesions. He was initially intubated for airway protection but has since self-extubated himself. Additional labs were sent. He has required precedex drip as well as other medications for sedation. He was continued on antibiotics sent from the ER, and started on oseltamivir as well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia, Respiratory rate increased, Rhinorrhoea, Viral infection, Visual impairment
Clinical narrative: Patient is a previously healthy 4 year old boy who presented with new-onset seizure in the setting of one month altered behaviors, fevers, and cough. On 12/15 patient received the MMR, VZV, and DTaP-IPV vaccines (verified in CAIR). Soon after he developed fever, cough, and rhinorrhea. These symptoms lasted for approximately 2 weeks, resolving 12/30 or so. On 1/12 symptoms returned again with fever and cough. He became fatigued and moody, refusing to get out of bed much, seeming weak and refusing to walk. Fevers were daily, both daytime and nightime and with associated chills/sweats. He saw his pediatrician about a week later and was diagnosed with viral illness. On Thursday 1/15 he again saw his pediatrician, was diagnosed with possible ear infection, and prescribed "ear drops." On Saturday 1/17 he developed rapid, fast breathing and had emesis x1. He presented to ED and discharged home with Tylenol for presumed viral illness. Around 4 PM the day of admission (1/22) pt and mom were at auntie's house. After eating some soup and water pt had emesis x 1 (NBNB) and seemed to slump down in chair. He was breathing differently, as if trouble breathing. Mom asked if he could see her and he said it was hard to see. He then seemed confused and was difficult to understand. Soon after, eyes seemed to roll up into his head and his upper and lower extremities became stiff. Parents called EMS at that point and he was brought to ED. In addition to daily fevers and cough for the last 3-4 weeks, patient has also had intermittent abdominal and back pain as well as headache. He has seemed extra sensitive, occasionally complaining that walking is painful, and seems to be walking more slowly than usual. He has had normal appetite and apart from two episodes of emesis (x1 on 1/17 and x1 on 1/22) he has had no other vomiting or diarrhea. No rashes. Parents do report weight loss, dad estimates approximately 8 pounds, despite no change in appetite.  In the past month parents have also noticed changes in patient's behavior overall. He has been more moody and fatigued than usual, intermittently confused. Specifically, in addition to the episode that occurred on 1/22 just prior to admission, mom recalls him waking up around 5 AM on 1/19 confused and asking "Where am I?". Mom was able to re-orient him at that time. Patient arrived to ED seizing and was given Ativan. Labs were sent, CXR and CT head done, and he was started on vancomycin, ceftriaxone, and acyclovir at meningitis dosing. He was then admitted to the PICU. Since arrival to the PICU he has had brain MRI which showed 3 small enhancing (necrotizing?) lesions. He was initially intubated for airway protection but has since self-extubated himself. Additional labs were sent. He has required precedex drip as well as other medications for sedation. He was continued on antibiotics sent from the ER, and started on oseltamivir as well.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vomiting, Weight decreased
Clinical narrative: Patient is a previously healthy 4 year old boy who presented with new-onset seizure in the setting of one month altered behaviors, fevers, and cough. On 12/15 patient received the MMR, VZV, and DTaP-IPV vaccines (verified in CAIR). Soon after he developed fever, cough, and rhinorrhea. These symptoms lasted for approximately 2 weeks, resolving 12/30 or so. On 1/12 symptoms returned again with fever and cough. He became fatigued and moody, refusing to get out of bed much, seeming weak and refusing to walk. Fevers were daily, both daytime and nightime and with associated chills/sweats. He saw his pediatrician about a week later and was diagnosed with viral illness. On Thursday 1/15 he again saw his pediatrician, was diagnosed with possible ear infection, and prescribed "ear drops." On Saturday 1/17 he developed rapid, fast breathing and had emesis x1. He presented to ED and discharged home with Tylenol for presumed viral illness. Around 4 PM the day of admission (1/22) pt and mom were at auntie's house. After eating some soup and water pt had emesis x 1 (NBNB) and seemed to slump down in chair. He was breathing differently, as if trouble breathing. Mom asked if he could see her and he said it was hard to see. He then seemed confused and was difficult to understand. Soon after, eyes seemed to roll up into his head and his upper and lower extremities became stiff. Parents called EMS at that point and he was brought to ED. In addition to daily fevers and cough for the last 3-4 weeks, patient has also had intermittent abdominal and back pain as well as headache. He has seemed extra sensitive, occasionally complaining that walking is painful, and seems to be walking more slowly than usual. He has had normal appetite and apart from two episodes of emesis (x1 on 1/17 and x1 on 1/22) he has had no other vomiting or diarrhea. No rashes. Parents do report weight loss, dad estimates approximately 8 pounds, despite no change in appetite.  In the past month parents have also noticed changes in patient's behavior overall. He has been more moody and fatigued than usual, intermittently confused. Specifically, in addition to the episode that occurred on 1/22 just prior to admission, mom recalls him waking up around 5 AM on 1/19 confused and asking "Where am I?". Mom was able to re-orient him at that time. Patient arrived to ED seizing and was given Ativan. Labs were sent, CXR and CT head done, and he was started on vancomycin, ceftriaxone, and acyclovir at meningitis dosing. He was then admitted to the PICU. Since arrival to the PICU he has had brain MRI which showed 3 small enhancing (necrotizing?) lesions. He was initially intubated for airway protection but has since self-extubated himself. Additional labs were sent. He has required precedex drip as well as other medications for sedation. He was continued on antibiotics sent from the ER, and started on oseltamivir as well.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: Patient had redness and soreness at injection site that lead to infection and patient needing to take antibiotic.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Urticarial rash x 1 week.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Discomfort, Fall, Hypoaesthesia, Lumbar puncture
Clinical narrative: Left side of body became heavy, numb and tingly. Started in just left leg and progressed to left arm and hand. I was unsteady and was off balance. I fell twice.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Left side of body became heavy, numb and tingly. Started in just left leg and progressed to left arm and hand. I was unsteady and was off balance. I fell twice.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Blood HIV RNA decreased, CD4 lymphocytes decreased, Eosinophil count normal, Lip swelling, Metabolic function test normal
Clinical narrative: This is a 37 year old male who has been on stable HIV regimen of Truvada, Prezista & Norvir since 12/16/14.  Tdap was given in clinic on the left deltoid area on 01/21/15. The patient reported pruritic papules & wheals, first over the left then the right axillary and left inner forearm areas within 24 hours of the Tdap injection.  He called the clinic and sent pictures of the rash to the clinic on 01/22/15.  He was started on prednisone 40 mg QD x 5 days + Claritin on 01/22/15.  On these medications, the rash progressed to involve the back and leg areas on 01/24/15.  He reported lip swelling with no laryngeal symptoms on the morning of 01/24/15.  His prednisone was increased to 60 mg QD and he was sent to the local ER for evaluation & observation.  No epinephrine was administered at the ER.  He was sent home with a prescription for EpiPen.  Completing a 5 day course of prednisone (01/21/15 to 01/25/15), his Claritin was switched to Atarax 25 mg TID and Zantac 300 mg QD. His HIV medications were stopped - Prezista contains sulfa moiety. No rash or anaphylaxis symptoms were noted thereafter.  He was seen in clinic today 01/30/15 and he was asymptomatic.  He is now off prednisone but is still kept on Zantac and Atarax to prevent late reactions.  Re-start of HIV medications is planned in the week of 02/02/15 with a different HIV regimen (Stribild).
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Papule, Pruritus, Rash generalised, Urticaria, White blood cell count normal
Clinical narrative: This is a 37 year old male who has been on stable HIV regimen of Truvada, Prezista & Norvir since 12/16/14.  Tdap was given in clinic on the left deltoid area on 01/21/15. The patient reported pruritic papules & wheals, first over the left then the right axillary and left inner forearm areas within 24 hours of the Tdap injection.  He called the clinic and sent pictures of the rash to the clinic on 01/22/15.  He was started on prednisone 40 mg QD x 5 days + Claritin on 01/22/15.  On these medications, the rash progressed to involve the back and leg areas on 01/24/15.  He reported lip swelling with no laryngeal symptoms on the morning of 01/24/15.  His prednisone was increased to 60 mg QD and he was sent to the local ER for evaluation & observation.  No epinephrine was administered at the ER.  He was sent home with a prescription for EpiPen.  Completing a 5 day course of prednisone (01/21/15 to 01/25/15), his Claritin was switched to Atarax 25 mg TID and Zantac 300 mg QD. His HIV medications were stopped - Prezista contains sulfa moiety. No rash or anaphylaxis symptoms were noted thereafter.  He was seen in clinic today 01/30/15 and he was asymptomatic.  He is now off prednisone but is still kept on Zantac and Atarax to prevent late reactions.  Re-start of HIV medications is planned in the week of 02/02/15 with a different HIV regimen (Stribild).
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: MINOR SWELLING OF BOTTOM LIP.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness unilateral, Cough, Full blood count, Influenza, Nuclear magnetic resonance imaging
Clinical narrative: First started with flu symptoms and then fever and persistent cough that lasted about 3 weeks. After had vision problems and total blindness of left eye. Diagnosed with optic neuritis and was given steroids.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Optic neuritis, Pyrexia, Thyroid function test, Visual impairment
Clinical narrative: First started with flu symptoms and then fever and persistent cough that lasted about 3 weeks. After had vision problems and total blindness of left eye. Diagnosed with optic neuritis and was given steroids.
Age: 28.0
Sex: F
Vaccine: VARCEL, YF
Symptoms: Dyspnoea, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Started to notice that my throat was sore. I thought it was due to a lot a talking all day. I went to get another shot after work today at around 4:30 pm (polio). I got home around 6:15 pm and I noticed my throat pain had gotten worse. I took a nap. When I woke up at 8pm, my throat was very sore and it felt a bit swollen, making it harder to breathe. I plan on calling the pharmacy to report this.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blister, Eating disorder, Herpes zoster oticus, Insomnia
Clinical narrative: Case number PHEH2015US001820, is an initial spontaneous report from a consumer (patient mother) received on 22 Jan 2015. This report refers to a 25-year-old female patient. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date in Oct 2014. On an unknown date about four days after vaccination in Oct 2014, the patient experienced painful blisters in the ear canal. The patient was sent to emergency department (ED) and the patient was hospitalized. The patient was given a diagnosis of Ramsay Hunt syndrome, a reactivation of the chickenpox virus. Subsequently, the patient developed palatal myoclonus. The patient would see a movement disorder neurologist on 26 Jan 2015. The patient was disabled, unable to sleep and eat well. The patient had lost 23 pounds in the last three months. The patient was forced to resign her job as a vocal teacher. The patient's mother reported that the patient was suicidal. The patient was treated with KLONOPIN to control the palatal myoclonus. The outcome of the event palatal myoclonus was not resolved and outcome of other events was not reported. Seriousness of the events suicidal, movement disorder, unable to sleep, lost 23 pounds was not reported. The event suicidal was upgraded based on NVS-IME list. Causality was not reported.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Myoclonus, Pain, Suicidal ideation, Weight decreased
Clinical narrative: Case number PHEH2015US001820, is an initial spontaneous report from a consumer (patient mother) received on 22 Jan 2015. This report refers to a 25-year-old female patient. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date in Oct 2014. On an unknown date about four days after vaccination in Oct 2014, the patient experienced painful blisters in the ear canal. The patient was sent to emergency department (ED) and the patient was hospitalized. The patient was given a diagnosis of Ramsay Hunt syndrome, a reactivation of the chickenpox virus. Subsequently, the patient developed palatal myoclonus. The patient would see a movement disorder neurologist on 26 Jan 2015. The patient was disabled, unable to sleep and eat well. The patient had lost 23 pounds in the last three months. The patient was forced to resign her job as a vocal teacher. The patient's mother reported that the patient was suicidal. The patient was treated with KLONOPIN to control the palatal myoclonus. The outcome of the event palatal myoclonus was not resolved and outcome of other events was not reported. Seriousness of the events suicidal, movement disorder, unable to sleep, lost 23 pounds was not reported. The event suicidal was upgraded based on NVS-IME list. Causality was not reported.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Chest X-ray, Differential white blood cell count, Febrile convulsion, Full blood count, Influenza virus test
Clinical narrative: 1/28/15 1730 fever 102 TYLENOL given. 1/29/15 0830 fever 103 degrees - TYLENOL given. 1/29/15 1220 fever 103.7 degrees took to ER. 103.5 after MOTRIN given. x2 episodes of dazed look and shaking. 1/30/15 100 degrees at 0600 TYLENOL given. 1/30/15 1300 normal temp. Dx fever, febrile seizure.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Metabolic function test, Pyrexia, Staring, Streptococcus test, Tremor
Clinical narrative: 1/28/15 1730 fever 102 TYLENOL given. 1/29/15 0830 fever 103 degrees - TYLENOL given. 1/29/15 1220 fever 103.7 degrees took to ER. 103.5 after MOTRIN given. x2 episodes of dazed look and shaking. 1/30/15 100 degrees at 0600 TYLENOL given. 1/30/15 1300 normal temp. Dx fever, febrile seizure.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13
Symptoms: Urine analysis
Clinical narrative: 1/28/15 1730 fever 102 TYLENOL given. 1/29/15 0830 fever 103 degrees - TYLENOL given. 1/29/15 1220 fever 103.7 degrees took to ER. 103.5 after MOTRIN given. x2 episodes of dazed look and shaking. 1/30/15 100 degrees at 0600 TYLENOL given. 1/30/15 1300 normal temp. Dx fever, febrile seizure.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Autopsy, Intestinal ischaemia, Intestinal malrotation, Volvulus
Clinical narrative: Midgut volvulus with bowel ischemia due to intestinal malrotation per autopsy report.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Vomiting
Clinical narrative: Patient reported that: "she threw up after she left the store", "she cannot use her left arm very well".
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction, Pain
Clinical narrative: On the day following the injection parent noted local reaction at injection site, redness, swelling thigh -> knee pt. experienced sl. pain. thigh warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Skin warm
Clinical narrative: On the day following the injection parent noted local reaction at injection site, redness, swelling thigh -> knee pt. experienced sl. pain. thigh warm to touch.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort
Clinical narrative: Stomach upset.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Headache.
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Chills
Clinical narrative: Chills.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Nausea.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Muscle ache.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Chills
Clinical narrative: Chills.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chills
Clinical narrative: Chills.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema
Clinical narrative: Redness.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Vertigo.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus
Clinical narrative: Itching.
Sex: U
Vaccine: FLUX(H1N1)
Symptoms: Exposure during pregnancy
Clinical narrative: Case number PHHY2013US010827 is an initial literature report received on 02-FEB-2013: This report refers to multiple patients whose identifiers were not reported. On an unknown date, 3327 pregnant patients were vaccinated with H1N1 (manufacturer and batch number: not reported) at on unknown dates. The author concluded the article stating that pregnant women who received H1N1 were less likely to give birth preterm, and gave birth to heavier infants.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHEH2013US021134 is an initial spontaneous report from the consumer (patient's mother) received on 08 Oct 2013. This report refers to a 09-year-old male patient. Previous vaccination history included vaccination with unspecified vaccines and were well tolerated. The patient was vaccinated with Flu vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as seasonal influenza vaccine INN) on an unknown date. On an unknown date, after vaccination his arm swelled up, became reddened and painful to touch. The events resolved after 2-3 days. No other information was available.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Lethargy
Clinical narrative: Lethargy.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Case number PHHY2013US041470, is an initial literature report received on 23 Apr 2013. This report refers to multiple patients of unspecified age and gender. Patients with heart failure were recruited in a consecutive fashion from a heart disease clinic. Patients enrolled had a diagnosis of heart failure and were stable on guideline-based heart failure therapies for at least 1 month and had previous immunization with the influenza vaccine. This study enrolled patients during the 2009/2010 influenza season. The patient's were randomized in a permuted block fashion and were stratified by age (greater than or less than 70 years old), to receive a Standard Dose (SD) of 15 mg/strain of the 2009/2010 influenza vaccine or a Double dose (DD) containing 30 mg/strain administered by intramuscular injection. Antibody responses were determined by haemagglutination inhibition assay, which measured serum influenza antibody concentrations. More participants in the SD group took beta-blockers (100% vs. 67%, P 1/4 0.013). A few other numerical differences included higher use of the combination of hydralazine and isosorbide (8% and 31%, P 1/4 0.06), use of diuretics (50% and 81%, P 1/4 0.08), and use of digoxin in the standard dose group (8% and 63%, P 1/4 0.07). Seroprotection rates at 2-4 weeks did not differ between DD and SD groups (A/H3N2 100% vs. 93%, P 1/4 0.38; A/H1N1 91% vs. 80%, P 1/4 0.45; B-type 73% vs. 67%, P 1/4 0.74). The rates of seroconversion were higher in the DD group compared with the SD group for the A/H3N2 strain (92% vs. 56% for A/H3N2, P 1/4 0.04), and numerically but not significantly higher for the A/H1N1 (75% vs. 50%, P 1/4 0.17) and the B-type strain (58% vs. 25%, P 1/4 0.35). There were no significant differences in antibody responses between participants older (n 1/4 6) or younger (n 1/4 22) than 70 years of age. Seroprotective antibody titres remained for 77% and 87.5% of participants in the SD and DD groups, respectively. The most common adverse event was injection site soreness, which occurred in three individuals per group. Two participants in the DD group experienced severe soreness. One participant in the SD group experienced muscle aches. The author concluded that patients with heart failure randomized to a DD of influenza vaccine exhibited higher initial antibody titres to A/H3N2, A/H1N1, and B-type antigens. At 4-6 months post-vaccination, absolute antibody titres were similar between DD and SD groups but well above seroprotective levels. These findings suggested that higher doses of influenza vaccine might be more protective in heart failure patients and should be further evaluated in larger randomized outcomes trials.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site erythema
Clinical narrative: Vaccination site erythema.
Age: 0.4
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2012US023572 is an initial spontaneous report received from a consumer on 28 Nov 2012: This report refers to a patient whose identifiers were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly at a dose of 0.5 ml on an unknown date in Sep 2012. After vaccination the patient experienced pain in the limb which limited the limb movement. The outcome of the event was reported as complete recovery. No further information was provided.
Age: 17.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine
Clinical narrative: Migraine headache.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Neuralgia
Clinical narrative: Nerve pain.
Sex: F
Vaccine: FLUX
Symptoms: Headache
Clinical narrative: Headache.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHEH2012US024362 is an initial spontaneous report received from a pharmacist on 06 Dec 2012. This report refers to a 38-years-old male patient. He had an allergy to thiomersal. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that he had fever for three days after receiving the flu vaccine. The outcome of the event was not reported. He was further vaccinated with FLUVIRIN (batch number: not reported) on 28 Oct 2012 (see related case: PHEH2012US024660).
Age: 48.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHEH2012US025518 is an initial spontaneous report received from a physician via Astellas on 28 Dec 2012. This case refers to a 48-year-old male patient. His medical history included of metastatic prostate cancer (castration resistant). His concomitant medications included of LUPRON, XGEVA, OXYCONTIN, VICODIN, PRILOSEC, EFFEXOR, ASA, multivitamins and FLOMAX. He was vaccinated with a flu vaccine (manufacturer and batch number: not reported) on 22 Oct 2012. On the same day, he was started treatment with XTANDI capsule 40 mg, 160 mg daily for metastatic prostate cancer. On 22 Oct 2012, after starting treatment with XTANDI and post flu vaccination he developed hives. Treatment with XTANDI was stopped within one week after starting the therapy. On an unspecified date, he had recovered from hives completely. On 02 Nov 2012, treatment with XTANDI was restarted and he did not experience hives. The reporting physician assessed the causality as not related for the event and XTANDI and felt that the hives was secondary to the flu shot. No other information was available at the time of this report.
Age: 66.0
Sex: M
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Nausea
Clinical narrative: Case number PHEH2013US020748 is an initial spontaneous report received from a consumer (patient) on 03 Oct 2013. This report refers to a 62-year-old male patient. His medical history included leukemia. He was vaccinated with flu vaccine (manufacturer and batch number: unknown) intramuscularly on an unspecified date. He experienced nausea for a couple of after receiving flu vaccine. Outcome, seriousness and causality of the event were not reported.
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2012US023573 is an initial spontaneous report received from a consumer on 28 Nov 2012: This report refers to multiple patients whose identifiers were not reported. These patients were vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly at a dose of 0.5 ml on unknown dates. After vaccination these patients experienced pain in the limb which limited the limb movement. The outcome of the event was not reported. No further information was provided.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Case number PHEH2013US021218 is an initial spontaneous report received from a physician on 08 Oct 2013: This report refers to a 29-year-old female patient. She was vaccinated with a seasonal Influenza vaccine (manufacturer and batch number: unknown) on an undetermined date and experienced aches and pains. The patient recovered on an unknown date. No further information about seriousness and causality was mentioned. The patient was further on vaccinated with seasonal Influenza vaccine for next two subsequent years and experienced aches and pains again (see related cases: PHEH2013US021425 and PHEH2013US021426).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Case number PHEH2012US022488 is an initial spontaneous report received from a consumer on 12 Nov 2012. This report refers to a 66-years-old female patient. Her medical history included rheumatoid arthritis and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 28 Oct 2012. It was reported that she began having symptoms of pain in joints (knees, shoulders and feet) on 29 Oct 2012. She went to physician and it was reported that she still had pain on 12 Nov 2012. No further information was provided.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Case number PHEH2013US021426 is an initial spontaneous report received from a physician on 08 Oct 2013: This report refers to a 29-year-old female patient. Her vaccination history included administration of two flu vaccines following which she experienced aches and pains (see related cases: PHEH2013US021218 and PHEH2013US021425). She was further on vaccinated with another seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date the following year and experienced aches and pains. The patient recovered on an unknown date. No further information about seriousness and causality was mentioned.
Age: 66.0
Sex: U
Vaccine: FLUX
Symptoms: Neck pain
Clinical narrative: Neck pain.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Case number PHEH2013US021981 is an initial spontaneous report received from a consumer (nursing student) on 18 Oct 2013. This report refers to a female patient whose age was not reported. Her medical history included anaphylactic reaction to latex in the past and egg allergy which was further explained as hurting of stomach when she ate egg. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. It was reported that she experienced fevers as high as 103 to 104 degree F after flu vaccination. The outcome of the event was not reported. The reporter stated that the fever might be possibly due to her egg allergy.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Injection site pruritus, Urticaria, Vaccination site reaction
Clinical narrative: Case number PHEH2013US023177 is an initial spontaneous report received from a consumer on 24 Oct 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on unknown date. On an unknown date, she experienced allergic reaction to the flu vaccine. The event outcome was not reported. She was further vaccinated with FLUVIRIN (batch number: 1308201) on an unspecified date and experienced welts and itching around the vaccination site (see related case: PHEH2013US022593).
Sex: M
Vaccine: FLUX
Symptoms: Injection site swelling
Clinical narrative: Case number PHEH2013US022590 is an initial spontaneous report from nurse received on 24 Oct 2013. This case refers to a male patient of an unknown age. The patient was vaccinated with Influenza virus vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Influenza vaccine- unknown INN) on an unknown date. On an unspecified date, after the vaccination, the patient "had a really big problem" and that the injection area was swollen up. The seriousness, outcome and causality of event were not reported.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Case number PHEH2013US021425 is an initial spontaneous report received from a physician on 08 Oct 2013: This report refers to a 29-year-old female patient. Her vaccination history included administration of a flu vaccine following which she experienced aches and pains (see related case: PHEH2013US021218) in the previous year. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number) on an undetermined date and experienced aches and pains. The patient recovered on an unknown date. No further information about seriousness and causality was mentioned. The patient was subsequently vaccinated with another seasonal influenza vaccine the next year and experienced same reaction (see related case: PHEH2013US021426).
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-DEC-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # K011004 and expiry date: 13-NOV-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous report was received from a nurse refers to a female patient of unknown age. No medical history was reported. On an unknown date, the patient was vaccinated with M-M-R II (dose and frequency not provided). No concomitant therapy was reported. On an unknown date the patient had a really bad reaction to M-M-R II when she was in college, that was almost anaphylactic. The outcome of the event was unknown. The causality assessment was not provided by the reporter. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-JUL-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H0108796 and expiry date:24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from other company Pfizer (2015025790) on 29-JAN-2015. This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information concerning the patient's relevant medical history was reported. On an unknown date, the patient experienced an allergic reaction to PNEUMOVAX 23. The outcome of the event was unknown. The allergy reaction was considered to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 19-SEP-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient pertinent medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # and expiry date were unknown) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-FEB-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reported excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree D and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 16-JUL-2013, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # H0108796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-SEP-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # K009471 and expiry date: 03-JAN-3026) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date0 affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.