chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Computerised tomogram head normal, Conjunctivitis bacterial, Cough, Differential white blood cell count normal, Dysstasia
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Eosinophil count decreased, Eye discharge, Eye pain, Full blood count normal, Gait disturbance
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Grip strength decreased, Guillain-Barre syndrome, Hemiparesis, Hypoaesthesia, Hyporeflexia
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Immunoglobulin therapy, Intensive care, International normalised ratio normal, Lymphocyte count decreased, Metabolic function test normal
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Muscle spasms, Muscular weakness, Neurological examination normal, Neutrophil count increased, Nuclear magnetic resonance imaging brain normal
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pneumonia, Pneumonitis, Prothrombin time prolonged, Red blood cell sedimentation rate increased
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Rhonchi, Sensory loss, Staphylococcus test negative, Syncope, Ultrasound Doppler normal
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 17.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, MMR, MNQ, TDAP
Symptoms: Urine analysis normal, Vibrio test positive, Wheezing, White blood cell count increased
Clinical narrative: The patient arrived at work on 03/09/15. He received vaccinations on 3/13/15 at which time he was in his normal state of good health. The patient denied having any local or systemic side effects after vaccination. On 3/26/15 the patient reported to medical with complaints of a cough for 6 days and bilateral eye pain and green discharge. He was diagnosed with bacterial conjunctivitis and bronchitis. On 4/14/15, the patient complained of right sided upper and lower extremity weakness. The patient was seen in the ER where he was noted to have a cough with moderate rhonchi noted in the right posterior middle and lower lobes with scattered wheezing and a normal neuro exam. The patient was released. On 4/15/15 the patient collapsed stating that "his feet gave out from beneath" him. His VS were stable (156/68, 89, 16, 98.6); PE noted extremity weakness. The patient was seen in the ER where no focal neuro or sensory deficits were noted, motor strength was recorded as 3/5 in both hands/feet and arms, gait was normal and DTRs were recorded as 2+; moderate rhonchi were heard diffusely. The patient was treated with a nebulizer treatment and IV SOLU-MEDROL, ROCEPHIN and ZITHROMAX. He was then released back to work. On 4/16/15 the patient was seen in medical with complaints numbness of his feet, cramping right calf and difficulty trying to stand up from the lying position. He was transported to the ER where on PE the following was noted: 3/5 strength bilaterally upper and lower extremities, significant proximal motor weakness, waddling gait, trace patellar reflexes, absent Achilles reflexes bilaterally. A neurology consult revealed the following physical findings: normal shoulder shrug, no fasciculations, muscle strength 3/5 in the arms -slightly stronger in the triceps bilaterally, legs show 3 to 4/5 strength with the proximal legs stronger than distal and left leg slightly stronger than the right waddling gait, no ataxia. DTRs 2+ except absent bilaterally at the Achilles. The patient was diagnosed with Guillain-Barre syndrome and pneumonia; he was admitted to Hospital ICU and started on IVIG 1g/kg 3 day course. The patient's cough resolved on 4/18/15. He was transferred out of ICU on 4/19/15. It was noted that "strength in UE/LE was 3/5 with improvement in proximal muscle strength". The pt. was transferred to the rehab unit on 4/20/15 where he received PT/OT until his release on 5/6/15. His discharge summary indicates that "he transfers and ambulates with modified independence and that he would benefit from continued aggressive PT." On 5/11/15 the patient was evaluated by PT at clinic. Weakness of the ankles, hand grips and arms was noted (the pt. was unable to do pull-ups or pushups)-a treatment plan for 2 weeks of PT was established. The pt. continued PT and determination of level of recovery. The pt. continues to improve.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Abdominal X-ray, Culture stool, Haematochezia, Occult blood, Ultrasound abdomen
Clinical narrative: Vomiting and bloody stools.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Vomiting and bloody stools.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swollen and painful, painful to move it. Pt had 2 office visits as a result of this and was started on antibiotic on 5/11.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (lot # J014404 expiration date 22-JAN-2015). There was not concomitant therapy reported. No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Mom stated swelling and redness of right arm.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Arrhythmia, Arthralgia, Blood potassium normal, Diarrhoea, Dizziness
Clinical narrative: 05/17/2015 Nausea, Vomiting, Diarrhea started at approximately 5:50 pm and continued, with no resolution through 5/22/2015. 05/18/2015 Fever accompanied by muscle and joint pain with swelling to hands and lower extremities, developed ~5pm.  Temps ranging from 100 F Orally to 102.5 F Orally on 05/19/2015.  Fever and pain not responsive to Tylenol or Ibuprofen Q. 4-6 hr PRN.  Subsided 05/19/2015 after 11:00 pm. 5/20/2015 - Dizziness and malaise prompted employer to send home at 9:00 am.  Nausea and diarrhea continued. 5/21/205 04:35 am, woke to cardiac arrhythmia and shortness of breath.  Reported to Emergency Dept.  EKG with PVCs, Potassium at 3.8 mmol/L.  Dosed with 40 meq Potassium Chloride and fluids. Lomotil 2.5mg PRN.  Intermittent PVCs continued at home for another 8hrs. 5/22/2015 Malaise continued.  Diarrhea responsive to Lomotil 2.5 MG 1-2 QID PRN.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Dyspnoea, Electrocardiogram abnormal, Laboratory test, Malaise, Myalgia
Clinical narrative: 05/17/2015 Nausea, Vomiting, Diarrhea started at approximately 5:50 pm and continued, with no resolution through 5/22/2015. 05/18/2015 Fever accompanied by muscle and joint pain with swelling to hands and lower extremities, developed ~5pm.  Temps ranging from 100 F Orally to 102.5 F Orally on 05/19/2015.  Fever and pain not responsive to Tylenol or Ibuprofen Q. 4-6 hr PRN.  Subsided 05/19/2015 after 11:00 pm. 5/20/2015 - Dizziness and malaise prompted employer to send home at 9:00 am.  Nausea and diarrhea continued. 5/21/205 04:35 am, woke to cardiac arrhythmia and shortness of breath.  Reported to Emergency Dept.  EKG with PVCs, Potassium at 3.8 mmol/L.  Dosed with 40 meq Potassium Chloride and fluids. Lomotil 2.5mg PRN.  Intermittent PVCs continued at home for another 8hrs. 5/22/2015 Malaise continued.  Diarrhea responsive to Lomotil 2.5 MG 1-2 QID PRN.
Age: 42.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea, Peripheral swelling, Pyrexia, Ventricular extrasystoles, Vomiting
Clinical narrative: 05/17/2015 Nausea, Vomiting, Diarrhea started at approximately 5:50 pm and continued, with no resolution through 5/22/2015. 05/18/2015 Fever accompanied by muscle and joint pain with swelling to hands and lower extremities, developed ~5pm.  Temps ranging from 100 F Orally to 102.5 F Orally on 05/19/2015.  Fever and pain not responsive to Tylenol or Ibuprofen Q. 4-6 hr PRN.  Subsided 05/19/2015 after 11:00 pm. 5/20/2015 - Dizziness and malaise prompted employer to send home at 9:00 am.  Nausea and diarrhea continued. 5/21/205 04:35 am, woke to cardiac arrhythmia and shortness of breath.  Reported to Emergency Dept.  EKG with PVCs, Potassium at 3.8 mmol/L.  Dosed with 40 meq Potassium Chloride and fluids. Lomotil 2.5mg PRN.  Intermittent PVCs continued at home for another 8hrs. 5/22/2015 Malaise continued.  Diarrhea responsive to Lomotil 2.5 MG 1-2 QID PRN.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Redness, Induration and itchy.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Dizziness, Headache, Injection site pain, Musculoskeletal pain
Clinical narrative: Patient states about an hour after receiving the vaccine, she became lightheaded, dizzy, extreme headache, and had joint pain in her shoulders and knees. Per patient the symptoms lasted 5/29/15, 5/30/15, and 5/31/15. Patient reports headache, joint aches, dizziness resolved today 6/1/15. Patient reports she is still having injection site tenderness in the left deltoid. No redness, swelling.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 year (also reported as 16 year) old patient of unknown gender. No concurrent condition and medical hisotry was reported. On 10-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# K006117, expiry datet: 14-JAN-2017, intramuscularly in the Left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K010238 and expiry date: 14-APR-2016) that was no supported. No adverse effects were reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ route defaulted to oral (dose was not reported), lot # K001196, expiration date 22-OCT-2015. Total number of doses administer was 6. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 15 year old patient of unknown gender. No concurrent condition and medical history was reported. On 12-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# K006117, expiry date: 14-JAN-2017, intramuscularly in the left arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. There was no information about pertinent medical history or drug reaction. On an unspecified date the patient received the first dose of GARDASIL (dose, frequency, strength, route, lot# and expiration date were not provided). On 20-MAY-2015 the patient was vaccinated with GARDASIL 9 (dose, frequency, strength, route, lot# and expiration date were not provided) as a second dose. No concomitant medication was reported. No adverse effects were reported. The outcome and causality were not reported at the time of report. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the registered nurse and refers to a patient of unknown age and gender. On 04-DEC-2014, the patient was given oral, ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Crying, Lip swelling, Pyrexia
Clinical narrative: Upper lip puffy following immunizations at 2 months. Swelling started 5-6 hours after, lasted just a few hours, no respiratory distress.  Also had a low grade temp.  Had total of 3 doses of tylenol for fever, crying.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus
Clinical narrative: Patient reports pruritis to face, neck and torso approx 4 hours and 5 minutes after receiving MMR vaccine. Taken to Emergency room where she received Benadryl 25mg, Pepcid 40mg and Prednisone 50mg and given a prescription for same.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives from the torso down. Mom gave her Benadryl that night and the hives went away.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Cyanosis, Dyspnoea, Heart rate increased, Insomnia, Use of accessory respiratory muscles
Clinical narrative: Wheezing, shortness of breath, retractions, difficulty sleeping, fast heart rate, blue lips.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: Wheezing, shortness of breath, retractions, difficulty sleeping, fast heart rate, blue lips.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Hot, redness, swelling to left upper arm. Fever for 3 days. Red area 6cm x 10cm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Patient stated that the her arm has a rash the size of a tea cup (the redness has gotten better) and has experienced pain in the arm which has not gotten any better. Patient did state that she had the chicken pox really bad as child when administering vaccine. Advised patient to take pictures of arm and if it does not get any better within the next 24 hours to contact her doctor or go to ED. I did tell patient that a rash and pain is common but have not had anyone stress concern of large rash and severe pain. Patient said she would wait it out and see what happens. I told her to keep me posted and to call with any other questions.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure decreased, Capillary nail refill test abnormal, Pallor, Petit mal epilepsy, Slow response to stimuli
Clinical narrative: Child turned pale, stared off like petit mal sx, sow response to verbal stimuli, placed in recumbent position, b/p fell 66/33, administered epinephrine and Benadryl IM b/p improved capillary filling 1 sec., then had second staring episode, about 15-20min after medications, oxygen applied 5/l/min by nasal cannula, paramedics called and transported to ER, child never loss consciousness, no respiratory distress, no wheezing, capillary filling just before paramedics arrived 2-3 sec. no
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Staring
Clinical narrative: Child turned pale, stared off like petit mal sx, sow response to verbal stimuli, placed in recumbent position, b/p fell 66/33, administered epinephrine and Benadryl IM b/p improved capillary filling 1 sec., then had second staring episode, about 15-20min after medications, oxygen applied 5/l/min by nasal cannula, paramedics called and transported to ER, child never loss consciousness, no respiratory distress, no wheezing, capillary filling just before paramedics arrived 2-3 sec. no
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Headache, Pain, Pyrexia
Clinical narrative: Pt states she had side effects of Adacel immunization. She said she had body aches, headaches, fever, chills, lose of appetite. Pt has no primary doctor.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Pt states she had side effects of Adacel immunization. She said she had body aches, headaches, fever, chills, lose of appetite. Pt has no primary doctor.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Nausea
Clinical narrative: Nausea/chills/102 temperature for 32 hours.
Sex: F
Vaccine: HEP
Symptoms: Blood test normal, Crying, Feeding disorder neonatal, Pyrexia, Screaming
Clinical narrative: Fever, inconsolable crying/shrieking, wouldn't latch, or feed. Prior to the vaccination, she was easily comforted and was latching and feeding well. Pediatrician ordered blood tests to rule out infection - these were normal.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Painful, swelling, sent to urgent care by pharmacy, indicated allergy by attending.
Age: 1.64
Sex: M
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash on neck, behind ears, and front of neck. Increased itching treated with Benadryl.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Diarrhoea, Fatigue, Pain
Clinical narrative: Tiredness, weakness, body aches, diarrhea, pain that moves through out the body.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: SYNCOPAL EPISODE BRIEF, NORMAL BLOOD PRESSURE, AND HEART RATE POST EPISODE; NO NEUROLOGICAL CHANGES; NO SEQUELAE; NO INTERVENTION NEEDED, OBSERVED IN CLINIC 30 MINUTES POST EPISODE.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Injection site induration, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Injection site became hard, swollen and painful into right breast under right arm and across right shoulder blade. Treatment included Aleve 500mg, ice and rest.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching at the injection site.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness, Seizure like phenomena, Syncope
Clinical narrative: This spontaneous report has been received from a nurse concerning an unknown number of patients of unspecified age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patients were vaccinated with GARDASIL, (route, strength and dose were not provided). There was not concomitant medication reported. On an unknown date, the patients experienced dizziness, fainting or seizure like activity after receiving GARDASIL. The patients sought medical attention in the office, it was unspecified if they received treatment for the events and also if laboratories diagnostics were performed. At the reporting time, the outcome of seizure, syncope and dizziness was reported as recovered on an unspecified date. Upon internal review, the event of seizure like activity was considered to be medically significant. Additional information has been requested.
Age: 0.49
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Chest X-ray, Culture urine, Full blood count, Pyrexia, Urine analysis
Clinical narrative: Fever Tmax 103.8 degrees 4 hours following PEDIARIX and PREVNAR.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 26 yr old female with a right deltoid erythema, swelling and pain complaint. Received an ADACEL inj. 3 days ago. Initially significant red. Redness decreased but swelling increased.
Age: 1.54
Sex: F
Vaccine: HEPA
Symptoms: Seizure
Clinical narrative: She had WCC and received Hepatitis A vaccine. A couple hrs later, she has apparent seizure.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: After receiving vaccines and application of Band-Aids, infant's bilateral legs developed areas of erythema. Band-Aids removed and erythema resolved.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted, turned pale, made patient lie down, gave water. Patient fainted again, again we laid him down, water and took his blood pressure and pulse.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, MNQ
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient fainted, turned pale, made patient lie down, gave water. Patient fainted again, again we laid him down, water and took his blood pressure and pulse.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from healthcare (certified medical assistant) worker concerning an unspecified number of unspecified patients. On unknown dates the patients were vaccinated with improperly stored GARDASIL (dose and route were not reported, lot # K009482, expiry date: 06-MAR-2017). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was receive from the registered nurse and refers to a patient of unknown age and gender. On 04-DEC-2014, the patient was given oral, ROTATEQ lot# K005273, expiration date: 23-FEB-2016, that was involved in temperature excursion on 18-NOV-2014. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored PNEUMOVAX23 (lot # K004542 and expiry date: 19-AUG-2015) that was not supported. No adverse effects were reported. No product quality complaint (PQC) was reported for PNEUMOVAX23. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Erythema at injection site 3in wide by 2.5in long. Very sore (7 out of 10) at injection site with shooting pain sometimes. Decreased ranged of motion with pain when moved.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site papule, Injection site vesicles
Clinical narrative: Redness and blistering at the injection sight 5-29-15. Site applied heat with resolution: 6-1-15 residual 5 mm x 8 mm erythematous papule.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh red, warm and swollen within hours after vaccine given.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Nausea, Pruritus, Skin warm, Swelling
Clinical narrative: Red bump got larger, itchy (left arm), hot to touch, nausea, tender to touch.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Tenderness
Clinical narrative: Red bump got larger, itchy (left arm), hot to touch, nausea, tender to touch.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash
Clinical narrative: Child developed a rash.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Student developed a rash on her face, itchy.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) upper arm became very tender, swollen, with bright erythema.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Shingles vaccine received 5/29/15 AM. Pain and swelling started 12 hours later, swelling, pain and redness entire upper arm extending to elbow. Medical attention 5/31/15, antibiotics, antihistamine and cold compress.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mom stated that ER told her not to get HPV anymore since injection site had swelling, soreness and painful.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. On 17-MAR-2015, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (doses, routes, lot numbers and expiration dates were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacists and refers to an unknown number of patients of an unknown gender and age. On an unspecified dates, an unknown number of patients were inadvertently administered RECOMBIVAX HB (injection, dose, frequency, lot # and expiration date not reported) that had been improperly stored. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 05-MAY-2015, the patient was vaccinated with an incorrect storaged vaccine of GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspareunia, Human papilloma virus test positive, Menorrhagia
Clinical narrative: This spontaneous report was received from a nurse and refers to a 22 year old female patient. No information about concomitant medication, concurrent conditions and medical history was provided. On an unspecified dates, the patient had received all three doses in the series of GARDASIL injection, (dose, frequency, lot # and expiration date not reported) for HPV prevention. On unspecified dates after the administration of GARDASIL, the patient experienced heavy and continous menstrual bleeding and pain during intercourse On an unspecified date, the patient sought medical attention, she visited unspecified physician. The physician performed a pap test on the patient and the results were positive for a mild case of HPV, (unspecified strain). The outcome of all events was not reported. The relatedness between GARDASIL adn all events was not specified by reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a 11 year old patient of unknown gender. No concurrent condition and medical history was reported. On 10-MAR-2015, the patient was vaccinated with full dose of improperly stored GARDASIL Lot# J010668, expiry date: 29-APR-2016, intramuscularly in the right arm. No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.