chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.59
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 7 month old female patient. Patient's medical history included vaccination on 25-APR-2014 with the first dose of ROTATEQ (2 ml, orally, lot # J002785, expiration date: 02-AUG-2014), first dose of DTaPHBIP (default manufacturer GlaxoSmithKline reported as "GSK) (0.5 ml, left thigh, lot # E4T92), first dose of HIB (unspecified carrier) (default manufacturer: Sanofi reported as "AVP") (0.5 ml, right thigh, lot # UH969AA) and with first dose of PCV13 (default manufacturer: Pfizer reported as "PFI") (0.5 ml, right thigh, lot # G77643), and on 25-JUN-2014 with second dose of ROTATEQ (2 ml, orally, lot # J004875, expiration date: 17-OCT-2014), second dose of DTaPHBIP (GSK) (0.5 ml, left thigh, lot # 2J534), second dose of HIB (AVP) (0.5 ml, right thigh, lot # UH969AA), and second dose of PCV13 (PFI) (0.5 ml, right thigh, lot # H17300). Patient had no history of chickenpox. On 15-SEP-2014, the patient was vaccinated with third dose of ROTATEQ (2 ml, lot # J004875, expiration date: 17-OCT-2014, orally) which was incorrectly stored. Concomitant therapies included third dose of DTaPHBIP, HIB (unspecified carrier) and PCV13. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.59
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 7 month old female patient. Patient's medical history included vaccination on 25-APR-2014 with the first dose of ROTATEQ (2 ml, orally, lot # J002785, expiration date: 02-AUG-2014), first dose of DTaPHBIP (default manufacturer GlaxoSmithKline reported as "GSK) (0.5 ml, left thigh, lot # E4T92), first dose of HIB (unspecified carrier) (default manufacturer: Sanofi reported as "AVP") (0.5 ml, right thigh, lot # UH969AA) and with first dose of PCV13 (default manufacturer: Pfizer reported as "PFI") (0.5 ml, right thigh, lot # G77643), and on 25-JUN-2014 with second dose of ROTATEQ (2 ml, orally, lot # J004875, expiration date: 17-OCT-2014), second dose of DTaPHBIP (GSK) (0.5 ml, left thigh, lot # 2J534), second dose of HIB (AVP) (0.5 ml, right thigh, lot # UH969AA), and second dose of PCV13 (PFI) (0.5 ml, right thigh, lot # H17300). Patient had no history of chickenpox. On 15-SEP-2014, the patient was vaccinated with third dose of ROTATEQ (2 ml, lot # J004875, expiration date: 17-OCT-2014, orally) which was incorrectly stored. Concomitant therapies included third dose of DTaPHBIP, HIB (unspecified carrier) and PCV13. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 2 month old male patient. Patient had no history of chickenpox. On 10-SEP-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (first dose, lot # J004875, expiration date: 17-OCT-2014, 2 ml, orally). Concomitant therapies included first doses of DTaPHBIP (default manufacturer GlaxoSmithKline reported as "GSK"), HIB (unspecified carrier) (default manufacturer: Sanofi reported as "AVP") and PCV13 (unspecified) (default manufacturer: Pfizer reported as "PFI"). On 11-NOV-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (second dose, K001194, expiration date: 06-NOV-2015 2 ml, orally). Concomitant therapies included second doses of DTaPHBIP, HIB (unspecified carrier) and PCV13 (unspecified). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incoherent, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 2 month old male patient. Patient had no history of chickenpox. On 10-SEP-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (first dose, lot # J004875, expiration date: 17-OCT-2014, 2 ml, orally). Concomitant therapies included first doses of DTaPHBIP (default manufacturer GlaxoSmithKline reported as "GSK"), HIB (unspecified carrier) (default manufacturer: Sanofi reported as "AVP") and PCV13 (unspecified) (default manufacturer: Pfizer reported as "PFI"). On 11-NOV-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (second dose, K001194, expiration date: 06-NOV-2015 2 ml, orally). Concomitant therapies included second doses of DTaPHBIP, HIB (unspecified carrier) and PCV13 (unspecified). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Nausea, Pain, Tremor
Clinical narrative: Pt had vaccines 1/9 afternoon, woke in the middle of the night/early AM 1/10 with shaking chills, severe pain, and nausea. Given VICODIN and ZOFRAN for symptoms. Still with severe pain/headache on 1/12/15.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Antinuclear antibody positive, Arthralgia, Blood immunoglobulin A normal, C-reactive protein increased
Clinical narrative: On 12-14-14, pt developed arthralgia both knees (Lt) > (Rt) and purpuric rash on legs. Was hospitalized with a diagnosis of Henoch Schonlein Purpura. CBC WNL, ESR 21, CRP 17, U/A 3 RBC. Pt had abd. pain. Abdominal sonogram was WNL. Pt was discharged on 12-16-14 as she was feeling better. As pt developed extensive purpuric lesions on legs, arms, feet, body she was readmitted on 12-18-14. Had Rheumatology consult. Was placed on naproxen PRN. IgA WNL. Coag profile WNL. Pt continued to get new purpuric rash until 12-30-14.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Coagulation test normal, Full blood count normal, Henoch-Schonlein purpura, Purpura, Rash
Clinical narrative: On 12-14-14, pt developed arthralgia both knees (Lt) > (Rt) and purpuric rash on legs. Was hospitalized with a diagnosis of Henoch Schonlein Purpura. CBC WNL, ESR 21, CRP 17, U/A 3 RBC. Pt had abd. pain. Abdominal sonogram was WNL. Pt was discharged on 12-16-14 as she was feeling better. As pt developed extensive purpuric lesions on legs, arms, feet, body she was readmitted on 12-18-14. Had Rheumatology consult. Was placed on naproxen PRN. IgA WNL. Coag profile WNL. Pt continued to get new purpuric rash until 12-30-14.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Red blood cells urine positive, Urine analysis normal
Clinical narrative: On 12-14-14, pt developed arthralgia both knees (Lt) > (Rt) and purpuric rash on legs. Was hospitalized with a diagnosis of Henoch Schonlein Purpura. CBC WNL, ESR 21, CRP 17, U/A 3 RBC. Pt had abd. pain. Abdominal sonogram was WNL. Pt was discharged on 12-16-14 as she was feeling better. As pt developed extensive purpuric lesions on legs, arms, feet, body she was readmitted on 12-18-14. Had Rheumatology consult. Was placed on naproxen PRN. IgA WNL. Coag profile WNL. Pt continued to get new purpuric rash until 12-30-14.
Sex: M
Vaccine: DTAP
Symptoms: Haematochezia
Clinical narrative: This initial, unsolicited case was received on 02 January 2015 from a registered nurse. A male pediatric patient, age not reported, received a DTaP vaccine (manufacturer and lot number not reported) on an unspecified date and subsequently experienced bloody stools "again". The patient had a history of extreme dairy allergy, and per the reporter the bloody stools were an indication of dairy intolerance/allergy. Outcome was not reported. Documents held by sender: None.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Angina pectoris, Arrhythmia, Cardiac monitoring, Cardiac stress test abnormal, Dizziness
Clinical narrative: On March 14, 2014 I received ZOSTAVAX, the shingles vaccine. About 4-6 days later I was achy, had a headache and was running a fever of about 101-102. I kept the fever for a two or more days and my glands were swollen in my neck as well as my tonsils. About a week from the onset of the fever on 3/24/14, I went to my Doctor because I couldn't seem to get my glands clear. I did not have any sinus issues, runny nose, earache and my lungs were clear. Just swollen glands in my neck and swollen and painful tonsils. My doctor gave me a prescription for antibiotics, but suggested I could beat this and would not need to fill it. I waited a few more days, but when my tonsils were so bad that it was very difficult to swallow, I filled the prescription. My Doctor did agree that I must have had a reaction to the vaccine. Within a few days to a week I was fine. On June 15th I started having irregular heartbeats and went to see my doctor on the 16th. He verified the irregular heartbeats and scheduled a visit with a cardiologist. I was not able to see the cardiologist until Sept 5th. (I went to immediate care in July due to dizziness, heart ache, shortness of breath and heart arrhythmia. A thyroid test was done and it was fine. He prescribed a beta blocker, but I was reluctant to take it since my blood pressure and pulse are normally low. I continued to limit caffeine, alcohol, and I did not take any other medicines.) On Sept 5th I met with the cardiologist and he prescribed a 2 week heart monitor. I took the monitor home with me on the 5th. On Sept 8th I went to our local hospital emergency room. I had shortness of breath, pain in my left shoulder and arm, heart ache, racing heart. The hospital ER treated me like I was in cardiac distress and admitted me for more tests. I had an electrocardiogram and a stress test. My arrhythmia doctor noted the rapid pulse rate increase from the stress test and said that it appears that I have inappropriate sinus node tachycardia. But, that I would have to of had a virus that would have caused this. I told him about having the shingles vaccine I received in March and he is now treating me for this condition. I have been taking a beta blocker since September 9, 2014 until now. I am much better and trying to reduce the amount of medication that I am taking. All the tests perform indicate that heart is structurally normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Dyspnoea, Electrocardiogram, Headache, Heart rate increased
Clinical narrative: On March 14, 2014 I received ZOSTAVAX, the shingles vaccine. About 4-6 days later I was achy, had a headache and was running a fever of about 101-102. I kept the fever for a two or more days and my glands were swollen in my neck as well as my tonsils. About a week from the onset of the fever on 3/24/14, I went to my Doctor because I couldn't seem to get my glands clear. I did not have any sinus issues, runny nose, earache and my lungs were clear. Just swollen glands in my neck and swollen and painful tonsils. My doctor gave me a prescription for antibiotics, but suggested I could beat this and would not need to fill it. I waited a few more days, but when my tonsils were so bad that it was very difficult to swallow, I filled the prescription. My Doctor did agree that I must have had a reaction to the vaccine. Within a few days to a week I was fine. On June 15th I started having irregular heartbeats and went to see my doctor on the 16th. He verified the irregular heartbeats and scheduled a visit with a cardiologist. I was not able to see the cardiologist until Sept 5th. (I went to immediate care in July due to dizziness, heart ache, shortness of breath and heart arrhythmia. A thyroid test was done and it was fine. He prescribed a beta blocker, but I was reluctant to take it since my blood pressure and pulse are normally low. I continued to limit caffeine, alcohol, and I did not take any other medicines.) On Sept 5th I met with the cardiologist and he prescribed a 2 week heart monitor. I took the monitor home with me on the 5th. On Sept 8th I went to our local hospital emergency room. I had shortness of breath, pain in my left shoulder and arm, heart ache, racing heart. The hospital ER treated me like I was in cardiac distress and admitted me for more tests. I had an electrocardiogram and a stress test. My arrhythmia doctor noted the rapid pulse rate increase from the stress test and said that it appears that I have inappropriate sinus node tachycardia. But, that I would have to of had a virus that would have caused this. I told him about having the shingles vaccine I received in March and he is now treating me for this condition. I have been taking a beta blocker since September 9, 2014 until now. I am much better and trying to reduce the amount of medication that I am taking. All the tests perform indicate that heart is structurally normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate irregular, Lymphadenopathy, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: On March 14, 2014 I received ZOSTAVAX, the shingles vaccine. About 4-6 days later I was achy, had a headache and was running a fever of about 101-102. I kept the fever for a two or more days and my glands were swollen in my neck as well as my tonsils. About a week from the onset of the fever on 3/24/14, I went to my Doctor because I couldn't seem to get my glands clear. I did not have any sinus issues, runny nose, earache and my lungs were clear. Just swollen glands in my neck and swollen and painful tonsils. My doctor gave me a prescription for antibiotics, but suggested I could beat this and would not need to fill it. I waited a few more days, but when my tonsils were so bad that it was very difficult to swallow, I filled the prescription. My Doctor did agree that I must have had a reaction to the vaccine. Within a few days to a week I was fine. On June 15th I started having irregular heartbeats and went to see my doctor on the 16th. He verified the irregular heartbeats and scheduled a visit with a cardiologist. I was not able to see the cardiologist until Sept 5th. (I went to immediate care in July due to dizziness, heart ache, shortness of breath and heart arrhythmia. A thyroid test was done and it was fine. He prescribed a beta blocker, but I was reluctant to take it since my blood pressure and pulse are normally low. I continued to limit caffeine, alcohol, and I did not take any other medicines.) On Sept 5th I met with the cardiologist and he prescribed a 2 week heart monitor. I took the monitor home with me on the 5th. On Sept 8th I went to our local hospital emergency room. I had shortness of breath, pain in my left shoulder and arm, heart ache, racing heart. The hospital ER treated me like I was in cardiac distress and admitted me for more tests. I had an electrocardiogram and a stress test. My arrhythmia doctor noted the rapid pulse rate increase from the stress test and said that it appears that I have inappropriate sinus node tachycardia. But, that I would have to of had a virus that would have caused this. I told him about having the shingles vaccine I received in March and he is now treating me for this condition. I have been taking a beta blocker since September 9, 2014 until now. I am much better and trying to reduce the amount of medication that I am taking. All the tests perform indicate that heart is structurally normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia, Sinus tachycardia, Thyroid function test normal, Tonsillar hypertrophy
Clinical narrative: On March 14, 2014 I received ZOSTAVAX, the shingles vaccine. About 4-6 days later I was achy, had a headache and was running a fever of about 101-102. I kept the fever for a two or more days and my glands were swollen in my neck as well as my tonsils. About a week from the onset of the fever on 3/24/14, I went to my Doctor because I couldn't seem to get my glands clear. I did not have any sinus issues, runny nose, earache and my lungs were clear. Just swollen glands in my neck and swollen and painful tonsils. My doctor gave me a prescription for antibiotics, but suggested I could beat this and would not need to fill it. I waited a few more days, but when my tonsils were so bad that it was very difficult to swallow, I filled the prescription. My Doctor did agree that I must have had a reaction to the vaccine. Within a few days to a week I was fine. On June 15th I started having irregular heartbeats and went to see my doctor on the 16th. He verified the irregular heartbeats and scheduled a visit with a cardiologist. I was not able to see the cardiologist until Sept 5th. (I went to immediate care in July due to dizziness, heart ache, shortness of breath and heart arrhythmia. A thyroid test was done and it was fine. He prescribed a beta blocker, but I was reluctant to take it since my blood pressure and pulse are normally low. I continued to limit caffeine, alcohol, and I did not take any other medicines.) On Sept 5th I met with the cardiologist and he prescribed a 2 week heart monitor. I took the monitor home with me on the 5th. On Sept 8th I went to our local hospital emergency room. I had shortness of breath, pain in my left shoulder and arm, heart ache, racing heart. The hospital ER treated me like I was in cardiac distress and admitted me for more tests. I had an electrocardiogram and a stress test. My arrhythmia doctor noted the rapid pulse rate increase from the stress test and said that it appears that I have inappropriate sinus node tachycardia. But, that I would have to of had a virus that would have caused this. I told him about having the shingles vaccine I received in March and he is now treating me for this condition. I have been taking a beta blocker since September 9, 2014 until now. I am much better and trying to reduce the amount of medication that I am taking. All the tests perform indicate that heart is structurally normal.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: On March 14, 2014 I received ZOSTAVAX, the shingles vaccine. About 4-6 days later I was achy, had a headache and was running a fever of about 101-102. I kept the fever for a two or more days and my glands were swollen in my neck as well as my tonsils. About a week from the onset of the fever on 3/24/14, I went to my Doctor because I couldn't seem to get my glands clear. I did not have any sinus issues, runny nose, earache and my lungs were clear. Just swollen glands in my neck and swollen and painful tonsils. My doctor gave me a prescription for antibiotics, but suggested I could beat this and would not need to fill it. I waited a few more days, but when my tonsils were so bad that it was very difficult to swallow, I filled the prescription. My Doctor did agree that I must have had a reaction to the vaccine. Within a few days to a week I was fine. On June 15th I started having irregular heartbeats and went to see my doctor on the 16th. He verified the irregular heartbeats and scheduled a visit with a cardiologist. I was not able to see the cardiologist until Sept 5th. (I went to immediate care in July due to dizziness, heart ache, shortness of breath and heart arrhythmia. A thyroid test was done and it was fine. He prescribed a beta blocker, but I was reluctant to take it since my blood pressure and pulse are normally low. I continued to limit caffeine, alcohol, and I did not take any other medicines.) On Sept 5th I met with the cardiologist and he prescribed a 2 week heart monitor. I took the monitor home with me on the 5th. On Sept 8th I went to our local hospital emergency room. I had shortness of breath, pain in my left shoulder and arm, heart ache, racing heart. The hospital ER treated me like I was in cardiac distress and admitted me for more tests. I had an electrocardiogram and a stress test. My arrhythmia doctor noted the rapid pulse rate increase from the stress test and said that it appears that I have inappropriate sinus node tachycardia. But, that I would have to of had a virus that would have caused this. I told him about having the shingles vaccine I received in March and he is now treating me for this condition. I have been taking a beta blocker since September 9, 2014 until now. I am much better and trying to reduce the amount of medication that I am taking. All the tests perform indicate that heart is structurally normal.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Burning sensation, Constipation, Fall, Incontinence
Clinical narrative: Received Flu vaccine on 1/24/14. Symptoms started to appear round 2/9/14. Started as weak and heavy legs, intense burning. Progressed to constipation and legs getting weaker through March 2014. Saw Dr. during this time and he diagnosed as Neuropathy-started me on Gabapentin. Legs continued getting weaker. Referred to Dr. 5/9/14-still diagnosed with Neuropathy. Continued getting worse. Dr. did MRI's, blood work and a "lumbar puncture". Showed possible MS, Tumor, or TM. Outpatient I.V. steroids for 3 days and oral prednisone for 2 weeks. Started P.T. 10/07/14. Incontinence and falls started to occur. Referred to different neurologists and after having another fall, I went to E.R. Spent 6 days with staff neurologists. Another MRI, blood work and lumbar puncture. Received I.V. steroids again for 5 days. Neurology team said, "TM due to Flu Shot". They advised looking into the Vaccine Compensation Fund.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Limb discomfort, Lumbar puncture, Muscular weakness, Myelitis transverse, Neuropathy peripheral
Clinical narrative: Received Flu vaccine on 1/24/14. Symptoms started to appear round 2/9/14. Started as weak and heavy legs, intense burning. Progressed to constipation and legs getting weaker through March 2014. Saw Dr. during this time and he diagnosed as Neuropathy-started me on Gabapentin. Legs continued getting weaker. Referred to Dr. 5/9/14-still diagnosed with Neuropathy. Continued getting worse. Dr. did MRI's, blood work and a "lumbar puncture". Showed possible MS, Tumor, or TM. Outpatient I.V. steroids for 3 days and oral prednisone for 2 weeks. Started P.T. 10/07/14. Incontinence and falls started to occur. Referred to different neurologists and after having another fall, I went to E.R. Spent 6 days with staff neurologists. Another MRI, blood work and lumbar puncture. Received I.V. steroids again for 5 days. Neurology team said, "TM due to Flu Shot". They advised looking into the Vaccine Compensation Fund.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Received Flu vaccine on 1/24/14. Symptoms started to appear round 2/9/14. Started as weak and heavy legs, intense burning. Progressed to constipation and legs getting weaker through March 2014. Saw Dr. during this time and he diagnosed as Neuropathy-started me on Gabapentin. Legs continued getting weaker. Referred to Dr. 5/9/14-still diagnosed with Neuropathy. Continued getting worse. Dr. did MRI's, blood work and a "lumbar puncture". Showed possible MS, Tumor, or TM. Outpatient I.V. steroids for 3 days and oral prednisone for 2 weeks. Started P.T. 10/07/14. Incontinence and falls started to occur. Referred to different neurologists and after having another fall, I went to E.R. Spent 6 days with staff neurologists. Another MRI, blood work and lumbar puncture. Received I.V. steroids again for 5 days. Neurology team said, "TM due to Flu Shot". They advised looking into the Vaccine Compensation Fund.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac monitoring, Dermatologic examination, Electrocardiogram, Neurological examination, Nuclear magnetic resonance imaging brain
Clinical narrative: None stated.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging spinal, Pulmonary function test, Unevaluable event
Clinical narrative: None stated.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site dermatitis
Clinical narrative: Localized dermatitis reaction to injection site on (L) upper arm. Onset 48 degrees after injection. Reactoin not classified as severe and requiring minimal office visit with provider ordered tx.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood glucose normal, Full blood count normal, Lethargy, Mononucleosis heterophile test negative, Pyrexia
Clinical narrative: Fever 104-105, lethargy, and vesicular rash. Fever/lethargy, began 1/1/15, and rash 1/2/15.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Fever 104-105, lethargy, and vesicular rash. Fever/lethargy, began 1/1/15, and rash 1/2/15.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Fatigue, Influenza virus test, Pain, Pain in extremity
Clinical narrative: Employee phoned into office c/o fever 100.5, generalized achiness fatigue. Cough, sore arm, but that was mild. Plans to follow-up with primary care provider if does not get better reported on-set  was Saturday for tx. Encouraged to see doctor.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Employee phoned into office c/o fever 100.5, generalized achiness fatigue. Cough, sore arm, but that was mild. Plans to follow-up with primary care provider if does not get better reported on-set  was Saturday for tx. Encouraged to see doctor.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Atrophy, Balance disorder, Cervicogenic headache, Condition aggravated
Clinical narrative: The symptoms began the morning after 10/15/14. Included: Severe flare to lipodystrophy with nerve pain and more atrophy. Legs below knees numb and nerve pain with balance problems. Severe pain in hands and wrists. Throat muscles hurt. Cervicogenic headache becomes deeper and more severe. Increased fatigue.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hypoaesthesia, Lipodystrophy acquired, Myalgia, Neuralgia
Clinical narrative: The symptoms began the morning after 10/15/14. Included: Severe flare to lipodystrophy with nerve pain and more atrophy. Legs below knees numb and nerve pain with balance problems. Severe pain in hands and wrists. Throat muscles hurt. Cervicogenic headache becomes deeper and more severe. Increased fatigue.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: The symptoms began the morning after 10/15/14. Included: Severe flare to lipodystrophy with nerve pain and more atrophy. Legs below knees numb and nerve pain with balance problems. Severe pain in hands and wrists. Throat muscles hurt. Cervicogenic headache becomes deeper and more severe. Increased fatigue.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling on each arm where shots were administered.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Rash over whole body with red bumps that were relieved by BENADRYL. Patient also complained of itching. This was patient's 2nd flu shot in lifetime.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: IIIrd nerve paralysis, Nuclear magnetic resonance imaging brain
Clinical narrative: 1 day following administration of FLUARIX QUADRIVALENT vaccine, developed third nerve palsy left eye - transient.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Nausea
Clinical narrative: Palm sized redness around injection site w/ 3" x 1" darker red spot at site. Fatigue and nausea lasting for 3 days. Still has redness at injection site but improving only low grade temp.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site erythema, Myalgia, Neuralgia
Clinical narrative: Palm sized redness around injection site w/ 3" x 1" darker red spot at site. Fatigue and nausea lasting for 3 days. Still has redness at injection site but improving only low grade temp.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chills, Influenza
Clinical narrative: Called and said he had severe chills and needed to lay down, claimed to have anaphylactic reaction, with symp. noted above. Did not need to take any medications or ER visit. Follow up with him on 1/3/15, said he took BENADRYL and now has the flu that his wife had.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Patient was administered a vaccine after refrigerator temperature dropped below desired range. Patient reported no adverse symptoms. On 1-5-15 when temps were discovered Merck was contacted and vaccine was determined to be stable. Case # 1-13179412640.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Chills, nausea, vomiting, fever. Red, blotchy rash. Passed out. Back (between shoulders) and back of legs hurt.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash macular, Vomiting
Clinical narrative: Chills, nausea, vomiting, fever. Red, blotchy rash. Passed out. Back (between shoulders) and back of legs hurt.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Pt. reports approx 8PM she started feeling itchy and developed hives on her face, legs and at the injection site. She took a ZYRTEC tablet symptoms diminished and were fully gone by the next morning.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Pityriasis rosea, Rash generalised
Clinical narrative: Bad rash over whole body (pityriasis rosea) - steroids for 7 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site joint pain, Injection site swelling, Injection site warmth
Clinical narrative: Hot and swollen post lateral left arm from above injection site down to just at elbow level site of injection is size of quarter and much more erythematous, (+) pain to elbow.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Crying, Panic attack, Tremor
Clinical narrative: Patient received vaccination after discussing with her about egg sensitivity. Her MD requested she receive shot. Pt came back to the pharmacy shaking and crying. We sat her down and had her take deep breaths and focus. She didn't continue to calm so we called 911 for assistance. They determined she was having a panic attack and eventually sent her home.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Severe aching in right arm, especially in forearm and inside arm area at elbow. Took ADVIL (400mg) with little relief after 60 min. Pain radiates throughout mid to lower arm (right arm).
Age: 1.02
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site erythema, Rash morbilliform
Clinical narrative: Morbilliform rash developing 2 days after PREVNAR vaccine, with larger area of erythema surrounding vaccine injection site. No signs of secondary infection or severe allergic reaction.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized swelling, erythema, soreness at injection site with both injections.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 60-year-old female patient who received FLULAVAL (batch number XZ3SP, expiry date 30th June 2015). On 29th October 2014, the patient received FLULAVAL 1 ml. On an unknown date, the dose was an unknown dose. On 29th October 2014, an unknown time after receiving FLULAVAL, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown. Additional information received: A patient was administered with 1.0 ml of FLULAVAL inadvertently instead of 0.5 ml. No adverse events had occurred as a result
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a adult female patent who received FLULAVAL. On 24th December 2013, the patient FLULAVAL. On 24th December 2013, an unknown time after receiving FLULAVAL, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLULAVAL. The caller was asking for a 2013 PI so her allergist could see what the ingredients were.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Cough, Diarrhoea, Erythema, Local swelling
Clinical narrative: Fever, joint aches, localized swelling, redness, diarrhea, cough, congestion.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, joint aches, localized swelling, redness, diarrhea, cough, congestion.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity
Clinical narrative: Aching discomfort per RUE s/p flu vaccination progressing to guarded ROM from date of vaccination, resolving as of 1/6/15.
Age: 36.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient received FLUMIST on 1-5-15 after completing screening questionnaire on which she stated she was not pregnant. Patient called office today, 1-12-15, and stated she took a pregnancy test today which was positive. Call made to CDC. They advised to call VAERS. I spoke to staff at VAERS and she advised me to tell patient to contact her health care provider and complete VAERS form. Patient informed to contact physician.
Age: 10.0
Sex: M
Vaccine: HEPA, HPV4, MMRV, TDAP
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: After the client received his immunization of Tdap, HAV, HPV and Proquad he felt weak and dizzy. He also turned pale and diaphoretic.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: FEVER SLIGHTLY OVER 100 DEGREES. HEADACHE. UPSET STOMACH. AS OF TODAY (1/12/15), PATIENT'S SYMPTOMS ARE GONE WITH EXCEPTION OF A LOW GRADE FEVER. PATIENT DID NOT RECEIVE MEDICAL TREATMENT FOR EVENT.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: On 1/5/15 mother called in that pt had fever with redness and swelling and pain at injections site.  Seen that same day and antibiotics started for cellulitis.  Rechecked 1/12/15 and s/s have resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Baseball size swelling to Left upper arm after vaccines given, swelling has gone but tenderness is till there.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse symptoms.  Patient is over 7 years old and was given the DTaP vaccine instead of Tdap.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient states lifting her left arm causes pain, inquired if nerves were affected on 01/12/2015.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site hard, red, painful, itching, warm to touch, 3" in diameter.
Age: 29.0
Sex: F
Vaccine: FLU3, HEPAB
Symptoms: Lymph node pain, Middle insomnia, Nausea, Swelling, Tenderness
Clinical narrative: STATES AWOKE NAUSEATED AT MIDNIGHT, NOTED SWELLING TO RIGHT SHOULDER W/ TENDER LYMPH NODES NOTED UNDER RIGHT CLAVICLE.  ENTIRE RIGHT ARM TENDER. NO SWELLING NOTED TO INJECTION SITE.
Age: 45.0
Sex: F
Vaccine: FLUN4
Symptoms: Diarrhoea, Stool analysis normal, Ultrasound biliary tract, Ultrasound scan normal, Vomiting
Clinical narrative: After eating eggs I have diarrhea and vomiting for several hours.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure like phenomena
Clinical narrative: Seizure like activity x 4 mins upon waking.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Blister, Oral herpes, Thyroid disorder
Clinical narrative: Yellowing blisters similar to cold sores /herpes!
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Ear discomfort, Ear pain, Headache, Hypoaesthesia, Lymphadenopathy
Clinical narrative: HEADACHE, EAR PAIN AND PRESSURE, TINGLING, NUMBNESS SIDE OF FACE, SWOLLEN GLANDS.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia
Clinical narrative: HEADACHE, EAR PAIN AND PRESSURE, TINGLING, NUMBNESS SIDE OF FACE, SWOLLEN GLANDS.
Age: 45.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin irritation
Clinical narrative: Patient stated that his skin became red and irritated and spread over the next day.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site injury, Injection site pain
Clinical narrative: SIRVA Shoulder Injury from Vaccine. Flu shot in right arm was administered high on the deltoid. Hurt a great deal. Followed a few hours later with intense pain and limited range of motion that interfered with daily activity. Continuing for 8 days, with lessening pain and gradual increased ROM. Took Advil and applied warm compresses on Day 2.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Ageusia, Dysgeusia
Clinical narrative: This case was reported by a consumer and described the occurrence of taste loss in a 69-year-old female patient who received BOOSTRIX (batch number STN9R, expiry date 13th December 2016). The patient's past medical history included whooping cough (about two years ago). Concurrent medical conditions included penicillin allergy. Concomitant products included SYNTHROID. On 13th November 2014 09:30, the patient received BOOSTRIX. On 14th November 2014, 1 days after receiving BOOSTRIX, the patient experienced taste loss (serious criteria disability), dysgeusia and taste bitter. On an unknown date, the outcome of the taste loss and taste bitter were not recovered/not resolved and the outcome of the dysgeusia was recovering/resolving. It was unknown if the reporter considered the taste loss, dysgeusia and taste bitter to be related to BOOSTRIX. Additional details provided: In the initial report received from consumer call the AE reported was lost sense of taste after vaccination with BOOSTRIX which was considered by the reporter as disabling. On the same day (05 January 2015) follow-up information was received from the consumer and physician: The consumer said that the bitter taste tasted like metal. Since this occurred on Saturday, she was unable to see her HCP. She went to urgent care to see a doctor there. The doctor recommended seeing a neurologist or an EENT specialist. The patient has an appointment tomorrow with the EENT specialist. The consumer asked for information about the issue and ingredients in the vaccine. She was referred to discuss the information with the specialist but noted to view the prescribing information to answer some of the questions she asked. She did say that there had been a slight change in taste, but it was on 5% to 10% in change. The bitter taste still remains.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Injection site mass
Clinical narrative: Received ZOSTAVAX vaccine on Tuesday 1/6/15 at 6:11 pm. Went to ER Thursday 1/8/15 with large lump on arm at injection site. Was told he had slow anaphylactic reaction and was kept overnight for monitoring.
Age: 1.52
Sex: F
Vaccine: FLU3, HEPA, MMRV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt's mother called in for a phone triage c/o rash on pt - small, red, itchy bumps that started on pt's neck and spread to trunk of back, mother stated it looks like a heat rash. Mother denied pt having a fever, difficulty breathing, and any other s/s. No new foods, soaps, lotions have been introduced that mother is aware of. Pt had MMRV, flu, Hep A 10 days ago. Advised mother may be an allergic reaction, give pt cool bath w/ Aveeno, baking soda, or oatmeal. Advised of UC/ER precautions, mother stated she will bring pt into UC. Left msg advised of Children's BENADRYL 12.5 mg/tsp, 1 tsp by mouth every 6 hours based on pt's age, clarified by RN.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain in extremity
Clinical narrative: 1-9-15 Client phoned health unit to complain of left arm pain that started 4 to 5 hours after receiving flu shot. She took inflammation and pain med. Next day c/o lower back pan and left arm pain. Rub - ICY HOT on lower back. Today 1-12-15 still c/o being a little sore to left arm and back.
Age: 1.26
Sex: M
Vaccine: DTAP, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Rash
Clinical narrative: Pt was given Rotavirus out of range preferred pt is 15 months, pt broke out with rash on stomach.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local swelling
Clinical narrative: 4.5" red, swollen, reaction under injection site.
Age: 1.7
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of wrong vaccine administered in a 20-month-old female patient who received KINRIX (batch number AC20B235AA, expiry date 15th January 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: A 20 month old female patient was inadvertently administered KINRIX.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a 16-year-old patient who received HAVRIX 1440. On an unknown date, the patient received HAVRIX 1440 at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX 1440, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details provided: This was 1 of the 2 cases received from the same reporter.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Exposure during pregnancy, Myalgia, Wrong technique in drug usage process
Clinical narrative: This is a prospective pregnancy case. This 34-year-old female subject was enrolled in a study. The subject received BOOSTRIX (injection) .5 ml on 17th October 2014 11:32. Co-suspect products included FLUVIRIN. Concurrent medical conditions included epilepsy. Concomitant products included LAMICTAL and Prenatal Vitamins. The subject's last menstrual period was on 24th January 2014 and estimated date of delivery was 31st October 2014. The subject received BOOSTRIX at week 38 of the pregnancy and during the third trimester of pregnancy. On 18th October 2014, 1 days after receiving BOOSTRIX the subject developed muscle soreness (Non-serious). Additional event(s) included vaccine exposure during pregnancy and inappropriate preparation of medication. The outcome of muscle soreness was recovered/resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown) and inappropriate preparation of medication (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the muscle soreness to be related to BOOSTRIX. Additional information received on 09 October 2014: The patient received a dose of BOOSTRIX and FLUVIRIN mixed in the same syringe at clinic. The last menstrual period was not reported but was calculated with the due date of 31 October 2014.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a female patient on her late 70's. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, expiration date unspecified), per instructed in the prescribing information, subcutaneous. On an unknown date the patient experienced redness at the injection site, after receiving ZOSTAVAX. The outcome of redness at the injection site was reported as recovered/resolved on an unknown date. No treatment was given. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Upper respiratory tract infection
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No pertinent medical history of the patient was reported. On 21-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # K009773, expiry date: 09-OCT-2015, 0.65 ml, subcutaneous (site of administration was unspecified). There were no concomitant medications reported. On an unknown date in January 2015, reported as within the last week, the patient experienced an upper respiratory infection. The patient sought medical attention by visiting the emergency room (ER) at the hospital and was prescribed with prednisone (manufacturer unknown) and the patient was also treated with azithromycin. There was no product quality complaint involved. The outcome of upper respiratory infection was unknown. The causality of the event was not reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Lymphadenopathy, Skin irritation, Vertigo
Clinical narrative: This spontaneous report as received from a 72 year old female patient refers to herself. The patient had drug reactions / allergies for Penicillin. The patient had a prior history of shingles in approximately 2000 (reported as "between 12 to 14 years ago"). On 18-DEC-2014 the patient was vaccinated with ZOSTAVAX (dose, frequency and route unknown). There was no concomitant medication. After few days a receiving ZOSTAVAX, on 22-DEC-2014 the patient experienced severe vertigo. The patient also experienced a very mild irritation ("C" shaped non-raised, red patch) on the area of her hip, where she had shingles around 14 years ago. She also reported that "her glands were swollen" before she took back to back airline flights on 23-DEC-2014 and 27-DEC-2014 respectively as well. The patient sought to medical attention to explain she had vertigo by calling. Her physician recommended the patient took an unspecified decongestant for the events. The patient was told by her physician to come into the office for a patient visit if the vertigo did not resolve itself. No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered. The relationship between ZOSTAVAX and the events was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender with inflammatory bowel disease. Medical history was not reported. On an unknown date in December 2014 the patient was vaccinated with PNEUMOVAX lot # K009809, expiration date: 16-MAY-2015, (strength, dosage, and route were not reported). Concomitant therapy was not reported. On an unknown date the patient developed redness and tenderness at the injectio site, the patient was seen by the physician the following day on an unspecified date and he/she had redness, tenderness and pain that radiated down the arm from the injection site. The physician determined to be a cellulitis. The patient was prescribed an unspecified antibiotic. There were not laboratories diagnostics performed. A lot check was requested for this adverse event. The outcome of the event was unknown. 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 healthcare worker refers to an unspecified patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored VARIVAX (Merck) (subcutaneously, 0.5 ml, lot # and expiration date not reported). No adverse events were reported after improperly stored VARIVAX (Merck) was administered. No further information was provided. Additional information has been requested.