chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 21 year old female student with no medical history who on 12/14/87 and 3/10/93 was vaccinated SC with the first and second doses, respectively, of varicella virus vaccine live. There was no illness at the time of vaccination. The vaccinations were given as part of a medical research grant and yearly serum varicella zoster virus specific glycoprotein antigen based ELISA antibody titers were done through 1995. In 1993 the patient's titer was 880 and in 1995, the titer result was 187. In the spring of 2004, the patient was diagnosed as having a serious case of varicella. Unspecified medical attention was sought and the patient required hospitalization. At the time of this report, the patient had recovered. No product quality complaint was involved. No additional information was provided. Additional information is not expected.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Croup infectious
Clinical narrative: Information has been received from a registered pharmacist concerning a 12 month old male with a past medical history who on 6/2/04 was vaccinated with varicella virus vaccine live. There were no concomitant medication. On 6/3/04, the patient developed a croupy cough. The pediatrician prescribed the patient corticosteroid and azithromycin to treat the condition. No product quality complaint involved. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 1.22
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 47 month old male who on 5/24/01 was vaccinated with a dose of varicella virus vaccine live. On 2/17/04, the patient experienced a rash for 5 days. It was reported that he had just visited cousins who had chicken pox. There were approximately 50 spots, scattered and scabbed. Symptomatic treatment was given and the patient subsequently recovered from the rash. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 10 year old female with asthma who was vaccinated with a dose of varicella virus vaccine live. On 3/4/04, the patient experienced 4-6 lesions on her back. Symptomatic treatment was given and the patient subsequently recovered. Additional information is not expected.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with no allergies or medical conditions who on 6/28/99 was vaccinated SQ with a first dose of varicella virus vaccine live (lot # 630675/0424J). There was no concomitant medication. There was no illness at the time of vaccination. On 5/25/04, the patient experienced 10-15 lesions on the torso described as classic various stages. No diagnostic studies were done. Symptomatic treatment was provided. It was reported that the patient recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood albumin decreased, Blood bilirubin increased, Jaundice
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female with diabetes mellitus insulin-dependent and chronic obstructive pulmonary disease and whose husband was noted to be waiting for a liver transplant since he has hepatitis B, who on 3/16/05 and 4/15/05 was vaccinated IM with the first and second 1ml doses of hepatitis B virus vaccine (lot #'s 648213/0597P and 647274/0205P, respectively). Concomitant therapy included furosemide, potassium, lisinopril, albuterol, insulin, oxybenzone, and benzonatate. On approximately 4/22/05, the patient experienced nausea, vomiting, jaundice, and was hospitalized. On 4/22/05, laboratory tests showed: total bilirubin 0.5; AST 20; ALT 20; and albumin 3.8. On 5/16/05, laboratory tests showed: total bilirubin 16.9; AST 2178; ALT 2299; and albumin 2.7. At the time of the report, it was unknown if the vaccine was involved with the elevated LFT's. The outcome was reported as not recovered. No additional information was available. There was no product quality complaint. The events were considered to be other important medical events (OMIC) by the reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female with diabetes mellitus insulin-dependent and chronic obstructive pulmonary disease and whose husband was noted to be waiting for a liver transplant since he has hepatitis B, who on 3/16/05 and 4/15/05 was vaccinated IM with the first and second 1ml doses of hepatitis B virus vaccine (lot #'s 648213/0597P and 647274/0205P, respectively). Concomitant therapy included furosemide, potassium, lisinopril, albuterol, insulin, oxybenzone, and benzonatate. On approximately 4/22/05, the patient experienced nausea, vomiting, jaundice, and was hospitalized. On 4/22/05, laboratory tests showed: total bilirubin 0.5; AST 20; ALT 20; and albumin 3.8. On 5/16/05, laboratory tests showed: total bilirubin 16.9; AST 2178; ALT 2299; and albumin 2.7. At the time of the report, it was unknown if the vaccine was involved with the elevated LFT's. The outcome was reported as not recovered. No additional information was available. There was no product quality complaint. The events were considered to be other important medical events (OMIC) by the reporter. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: MMR
Symptoms: Irritability, Lethargy, Medication error, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 13 week old male with no known allergies and reported to be otherwise healthy who on 5/9/05 was vaccinated with MMR (lot # 648461/1306N). There were no reported concomitant medications. On approximately 5/9/05 the patient developed a fever as high as 104 F, was lethargic, and cranky. It was reported that the patient sought unspecified medical attention and his fever was treated with ibuprofen. It was reported that the patient's fever had waxed and waned since the immunization and seemed to rise without regard to dosing of ibuprofen. The nurse reported that the patient's injection site was unremarkable. At the time of this report, the patient had not recovered from the events. The registered nurse considered the events to be other important medical events (OMIC). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Balance disorder, Chest discomfort, Dizziness
Clinical narrative: Nowdays, what I will call " attacks" will come at random, and at more and more frequent intervals starting with a dull headache, a distant almost inperceptible rumbling sensation down the spine and slight trembling of the hands that will slowly spread to both arms and legs. In order to ease the pain and discomfort, I usually stay in a fetal position during the attack. I remember one or 2 weeks before the attacks started at all, I was on a more than one occasion surprised by the strange fact that while lying down in bed, I felt my head jerk ever so slightly though I was not at all conscious of moving my head. The attacks themselves started with a feeling of being very weak, followed by hand and feet sweating and then slow but pervasive numbness in my limbs, dull aches in the bones, burning sensations at the joints, tingling and pins and needles feelings in the fingers and toes followed by impression of stiffness in the fingers. All these symptoms started on 04/28/05 at around 10:00 AM. . The whole crisis lasted for about 1/ hour on that day. The second crisis happened on 04/30/05, this time on top of the symptoms described above, my neck and head felt very heavy. The crisis lasted for 2 long hours. Ever since then the symptoms showed on and off every few days. There is less stiffness in the fingers and toes, but I feel like my legs will not be able to support me if I stand on them during the symptoms. I further feel dizzy and nauseas during or after the attacks. As the symptoms did not subside, on  05/08/05 I went to consult with an MD and from his POV I was as healthy as possible and could not be DX with anything serious. He, however, advised a blood test and promised to contact me soonest if something serious was detected from the blood test. So far the MD did not contact me. I was once again subjected to a very serious crisis on 05/12/05, all my arms and legs felt weak, I suffered from dizziness, tightness in the chest, severe nausea and lack of breath and almost collapsed. I had to be taken for emergency exam, was tested  for urine and blood and was retained for an overnight stay in the hospital for a further cardiology test. All hospital test results were negative. I was released as no serious life threatening disease was discovered, yet once home the next day 05/13/05 I experienced the same attacks as described above, and I decided to contact the number given on the information sheet given to me by the clinic staff. The pains I experienced during the crisis are not sharp, excruciating pains, but rather dull, pervasive and debilitating. As if I am shrouded in numbness and unable to get out of it. As far as I can rememeber I have not experieced the type of attacks and physical distress I have described in my entire life.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Dyskinesia, Dyspnoea, Gait disturbance, Headache, Hyperhidrosis
Clinical narrative: Nowdays, what I will call " attacks" will come at random, and at more and more frequent intervals starting with a dull headache, a distant almost inperceptible rumbling sensation down the spine and slight trembling of the hands that will slowly spread to both arms and legs. In order to ease the pain and discomfort, I usually stay in a fetal position during the attack. I remember one or 2 weeks before the attacks started at all, I was on a more than one occasion surprised by the strange fact that while lying down in bed, I felt my head jerk ever so slightly though I was not at all conscious of moving my head. The attacks themselves started with a feeling of being very weak, followed by hand and feet sweating and then slow but pervasive numbness in my limbs, dull aches in the bones, burning sensations at the joints, tingling and pins and needles feelings in the fingers and toes followed by impression of stiffness in the fingers. All these symptoms started on 04/28/05 at around 10:00 AM. . The whole crisis lasted for about 1/ hour on that day. The second crisis happened on 04/30/05, this time on top of the symptoms described above, my neck and head felt very heavy. The crisis lasted for 2 long hours. Ever since then the symptoms showed on and off every few days. There is less stiffness in the fingers and toes, but I feel like my legs will not be able to support me if I stand on them during the symptoms. I further feel dizzy and nauseas during or after the attacks. As the symptoms did not subside, on  05/08/05 I went to consult with an MD and from his POV I was as healthy as possible and could not be DX with anything serious. He, however, advised a blood test and promised to contact me soonest if something serious was detected from the blood test. So far the MD did not contact me. I was once again subjected to a very serious crisis on 05/12/05, all my arms and legs felt weak, I suffered from dizziness, tightness in the chest, severe nausea and lack of breath and almost collapsed. I had to be taken for emergency exam, was tested  for urine and blood and was retained for an overnight stay in the hospital for a further cardiology test. All hospital test results were negative. I was released as no serious life threatening disease was discovered, yet once home the next day 05/13/05 I experienced the same attacks as described above, and I decided to contact the number given on the information sheet given to me by the clinic staff. The pains I experienced during the crisis are not sharp, excruciating pains, but rather dull, pervasive and debilitating. As if I am shrouded in numbness and unable to get out of it. As far as I can rememeber I have not experieced the type of attacks and physical distress I have described in my entire life.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Joint stiffness, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Nowdays, what I will call " attacks" will come at random, and at more and more frequent intervals starting with a dull headache, a distant almost inperceptible rumbling sensation down the spine and slight trembling of the hands that will slowly spread to both arms and legs. In order to ease the pain and discomfort, I usually stay in a fetal position during the attack. I remember one or 2 weeks before the attacks started at all, I was on a more than one occasion surprised by the strange fact that while lying down in bed, I felt my head jerk ever so slightly though I was not at all conscious of moving my head. The attacks themselves started with a feeling of being very weak, followed by hand and feet sweating and then slow but pervasive numbness in my limbs, dull aches in the bones, burning sensations at the joints, tingling and pins and needles feelings in the fingers and toes followed by impression of stiffness in the fingers. All these symptoms started on 04/28/05 at around 10:00 AM. . The whole crisis lasted for about 1/ hour on that day. The second crisis happened on 04/30/05, this time on top of the symptoms described above, my neck and head felt very heavy. The crisis lasted for 2 long hours. Ever since then the symptoms showed on and off every few days. There is less stiffness in the fingers and toes, but I feel like my legs will not be able to support me if I stand on them during the symptoms. I further feel dizzy and nauseas during or after the attacks. As the symptoms did not subside, on  05/08/05 I went to consult with an MD and from his POV I was as healthy as possible and could not be DX with anything serious. He, however, advised a blood test and promised to contact me soonest if something serious was detected from the blood test. So far the MD did not contact me. I was once again subjected to a very serious crisis on 05/12/05, all my arms and legs felt weak, I suffered from dizziness, tightness in the chest, severe nausea and lack of breath and almost collapsed. I had to be taken for emergency exam, was tested  for urine and blood and was retained for an overnight stay in the hospital for a further cardiology test. All hospital test results were negative. I was released as no serious life threatening disease was discovered, yet once home the next day 05/13/05 I experienced the same attacks as described above, and I decided to contact the number given on the information sheet given to me by the clinic staff. The pains I experienced during the crisis are not sharp, excruciating pains, but rather dull, pervasive and debilitating. As if I am shrouded in numbness and unable to get out of it. As far as I can rememeber I have not experieced the type of attacks and physical distress I have described in my entire life.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Neck pain, Pain, Paraesthesia, Skin burning sensation
Clinical narrative: Nowdays, what I will call " attacks" will come at random, and at more and more frequent intervals starting with a dull headache, a distant almost inperceptible rumbling sensation down the spine and slight trembling of the hands that will slowly spread to both arms and legs. In order to ease the pain and discomfort, I usually stay in a fetal position during the attack. I remember one or 2 weeks before the attacks started at all, I was on a more than one occasion surprised by the strange fact that while lying down in bed, I felt my head jerk ever so slightly though I was not at all conscious of moving my head. The attacks themselves started with a feeling of being very weak, followed by hand and feet sweating and then slow but pervasive numbness in my limbs, dull aches in the bones, burning sensations at the joints, tingling and pins and needles feelings in the fingers and toes followed by impression of stiffness in the fingers. All these symptoms started on 04/28/05 at around 10:00 AM. . The whole crisis lasted for about 1/ hour on that day. The second crisis happened on 04/30/05, this time on top of the symptoms described above, my neck and head felt very heavy. The crisis lasted for 2 long hours. Ever since then the symptoms showed on and off every few days. There is less stiffness in the fingers and toes, but I feel like my legs will not be able to support me if I stand on them during the symptoms. I further feel dizzy and nauseas during or after the attacks. As the symptoms did not subside, on  05/08/05 I went to consult with an MD and from his POV I was as healthy as possible and could not be DX with anything serious. He, however, advised a blood test and promised to contact me soonest if something serious was detected from the blood test. So far the MD did not contact me. I was once again subjected to a very serious crisis on 05/12/05, all my arms and legs felt weak, I suffered from dizziness, tightness in the chest, severe nausea and lack of breath and almost collapsed. I had to be taken for emergency exam, was tested  for urine and blood and was retained for an overnight stay in the hospital for a further cardiology test. All hospital test results were negative. I was released as no serious life threatening disease was discovered, yet once home the next day 05/13/05 I experienced the same attacks as described above, and I decided to contact the number given on the information sheet given to me by the clinic staff. The pains I experienced during the crisis are not sharp, excruciating pains, but rather dull, pervasive and debilitating. As if I am shrouded in numbness and unable to get out of it. As far as I can rememeber I have not experieced the type of attacks and physical distress I have described in my entire life.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Tremor
Clinical narrative: Nowdays, what I will call " attacks" will come at random, and at more and more frequent intervals starting with a dull headache, a distant almost inperceptible rumbling sensation down the spine and slight trembling of the hands that will slowly spread to both arms and legs. In order to ease the pain and discomfort, I usually stay in a fetal position during the attack. I remember one or 2 weeks before the attacks started at all, I was on a more than one occasion surprised by the strange fact that while lying down in bed, I felt my head jerk ever so slightly though I was not at all conscious of moving my head. The attacks themselves started with a feeling of being very weak, followed by hand and feet sweating and then slow but pervasive numbness in my limbs, dull aches in the bones, burning sensations at the joints, tingling and pins and needles feelings in the fingers and toes followed by impression of stiffness in the fingers. All these symptoms started on 04/28/05 at around 10:00 AM. . The whole crisis lasted for about 1/ hour on that day. The second crisis happened on 04/30/05, this time on top of the symptoms described above, my neck and head felt very heavy. The crisis lasted for 2 long hours. Ever since then the symptoms showed on and off every few days. There is less stiffness in the fingers and toes, but I feel like my legs will not be able to support me if I stand on them during the symptoms. I further feel dizzy and nauseas during or after the attacks. As the symptoms did not subside, on  05/08/05 I went to consult with an MD and from his POV I was as healthy as possible and could not be DX with anything serious. He, however, advised a blood test and promised to contact me soonest if something serious was detected from the blood test. So far the MD did not contact me. I was once again subjected to a very serious crisis on 05/12/05, all my arms and legs felt weak, I suffered from dizziness, tightness in the chest, severe nausea and lack of breath and almost collapsed. I had to be taken for emergency exam, was tested  for urine and blood and was retained for an overnight stay in the hospital for a further cardiology test. All hospital test results were negative. I was released as no serious life threatening disease was discovered, yet once home the next day 05/13/05 I experienced the same attacks as described above, and I decided to contact the number given on the information sheet given to me by the clinic staff. The pains I experienced during the crisis are not sharp, excruciating pains, but rather dull, pervasive and debilitating. As if I am shrouded in numbness and unable to get out of it. As far as I can rememeber I have not experieced the type of attacks and physical distress I have described in my entire life.
Age: 13.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Patient received MMR and Menactra 5/10/05. Then seen 5/12/05, 24 hours later developed high fever 104. Seen 5/12/05 P/E were normal. Febrile illness. Resolved in 36 hours. Follow up on 7/19/05: Also complained of new onset headache associated with AE.
Age: 0.26
Sex: M
Vaccine: PNC
Symptoms: Cyanosis, Dyspnoea, Staring, Tachycardia
Clinical narrative: Staring, loss of breath, blue lips and tachycardia.
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal, Muscle contractions involuntary
Clinical narrative: Pain, paresthesia hand and feet, muscle fasciculations left arm and legs. Pain and swelling and erythema around injection site (local reaction.
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Pain, Paraesthesia
Clinical narrative: Pain, paresthesia hand and feet, muscle fasciculations left arm and legs. Pain and swelling and erythema around injection site (local reaction.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Demyelination, Diarrhoea, Dizziness, Encephalitis, Muscle contractions involuntary
Clinical narrative: Paresthesias in hands and feet. Raynaud's in hands and feet, muscle fasciculations, diarrhea, nausea, dizziness, pain behind ears and temples. Began after second dose of rabies vaccine. Progressed to involved arms and legs thought to be immune encephalomyelitis or autoimmune demyelination polyneuropathy due to rabies vaccine.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pain, Paraesthesia, Polyneuropathy, Raynaud's phenomenon
Clinical narrative: Paresthesias in hands and feet. Raynaud's in hands and feet, muscle fasciculations, diarrhea, nausea, dizziness, pain behind ears and temples. Began after second dose of rabies vaccine. Progressed to involved arms and legs thought to be immune encephalomyelitis or autoimmune demyelination polyneuropathy due to rabies vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Chills, Influenza, Malaise, Pain, Pyrexia
Clinical narrative: I'm writing to report what occurred to me after my last flu vaccine shot. I have received the same shot before, usually at my doctor's office or a place of work. Sometime in the last few days of December 2004, I received permission to receive it from our local DPH branch. I received a flier, which noted that I received "inactivated influenza vaccine 5/24/2004". Within three days of receiving the shot I became ill with progressive symptoms of a quite severe flu episode with fever, malaise, chills, aches, respiratory symptoms, etc. Although I was well before the shot, I have come to think I had the virus before the shot was administered. I would probably have expected in such case to have had a milder case of flu. I also wonder to what extent the vaccine might not have given me all my symptoms. I have consistently relied on this vaccine every year but have wondered what to do for the upcoming season. I also wonder if there might have been something wrong with the lot of the vaccine available in 2004.  Thank you for your attention to this matter.
Sex: F
Vaccine: FLUX
Symptoms: Respiratory disorder
Clinical narrative: I'm writing to report what occurred to me after my last flu vaccine shot. I have received the same shot before, usually at my doctor's office or a place of work. Sometime in the last few days of December 2004, I received permission to receive it from our local DPH branch. I received a flier, which noted that I received "inactivated influenza vaccine 5/24/2004". Within three days of receiving the shot I became ill with progressive symptoms of a quite severe flu episode with fever, malaise, chills, aches, respiratory symptoms, etc. Although I was well before the shot, I have come to think I had the virus before the shot was administered. I would probably have expected in such case to have had a milder case of flu. I also wonder to what extent the vaccine might not have given me all my symptoms. I have consistently relied on this vaccine every year but have wondered what to do for the upcoming season. I also wonder if there might have been something wrong with the lot of the vaccine available in 2004.  Thank you for your attention to this matter.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Infection, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5/18/05 Parents here with child reporting called health department this morning as Mom noticed child had redness and swelling to right upper arm and it felt warm. Instructed per RN to use ice pack and Tylenol and if not better to notify MD. Mom says it got worse and they took to doctor and she said it was infection and started Keflex TID for 7 days and instructed her to report to health department. Noted right upper arm slightly swollen, warm to touch, and redness to entire right upper arm.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Mother reports that child has had crying episode after all 3 doses of vaccines; 7/13/04, 9/29/04, and 12/07/04. Tells me on 5/17/05 that episodes have lasted 3 hours or more and child ran 101 temp. Said she mentioned it to pediatrician but was told that happens sometimes and didn't think anything of it. Reviewed DTaP VIS form with mother on 5/17/05 and told mother I will find out if ok to continue to receive DTaP with next vaccines. Spoke with doctor and medical director and she stated unless other SE to go ahead and give DTaP (preferably DTaP/HIB) and next immunization visit but to fill out VAERS form.
Age: 18.0
Sex: M
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: 5/18 1600 PM Erythema firm nodule left lower arm (5.5 x 5.5 cm). Warm to touch, itchy. Benadryl 50 mg given PO. 5/19 1530 PM - Reaction- size decreased to 2.5 cm, mild redness with firm nodule, warm pack Benadryl continued.
Age: 1.25
Sex: F
Vaccine: MMR, MMR
Symptoms: Nonspecific reaction, Rash
Clinical narrative: Reaction to shot, Rash.
Age: 1.25
Sex: F
Vaccine: MMR, MMR
Symptoms: Face oedema, Pallor, Pyrexia, Rash, Respiratory rate increased
Clinical narrative: Reaction to shot, Rash.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Nonspecific reaction, Oedema peripheral
Clinical narrative: Left thigh became swollen and red, 24 hours after injections. Was treated with Keflex. Pt recovered.
Age: 1.56
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: 05/21/2005- A few lesions appeared on face, neck, chest, and arms. By 05/23/2005, vesicles on scalp and trunk as well. (30-40 lesions total) DX: Varicella.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Chickenpox- Per MD as was reported by parent. Breakthrough Chicken pox- had Varivax 10/18/1998.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Developed urticaria without other systemic symptoms. Suspect of DTaP as most redness was around that injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity, Injection site oedema, Oedema peripheral
Clinical narrative: Redness and swelling on left thigh 24 hours after vaccines. Was treated with Keflex. Improved after TX.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site reaction, Skin warm
Clinical narrative: Right arm erythematous at upper arm surrounding injection site. Non Tender, Increased skin temp. Benadryl and Tylenol given.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: 48 hours after immunizations, had redness and itching on left thigh with 10" induration. Given Keflex and Zyrtec on 05/20/2005.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at injection site 24 hours after vaccination (left leg). Treated with Keflex oral antibiotic and cool compresses. Cellulitis improved 24 hours after initial antibiotic dose.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site hypersensitivity, Oedema peripheral
Clinical narrative: Redness and swelling on one thigh 2 days after immunizations. Advised to apply warm compresses. Pt is doing better.
Age: 1.54
Sex: F
Vaccine: DTAP
Symptoms: Ecchymosis, Erythema, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: Left thigh noted to be reddened, swollen and warm to the touch, with harddened ecchymatic area in center. SP DTaP on 05/17/05. Advised to give Motrin and apply cold compresses to area.
Age: 1.54
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Left thigh noted to be reddened, swollen and warm to the touch, with harddened ecchymatic area in center. SP DTaP on 05/17/05. Advised to give Motrin and apply cold compresses to area.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site hypersensitivity, Injection site warmth, Rash
Clinical narrative: 8.0 x 7.0 cm red warm rash on right deltoid area on 05/12/2005
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration
Clinical narrative: 6.5cm red, slightly indurated left deltoid area noted 48 hours after administration of IPV, DTaP, to left deltoid. No nodule, ?
Age: 9.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Skin ulcer
Clinical narrative: Red, swollen , warm oval lesion around site of Td injection on left upper arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 yr. old white male with no pre-existing allergies, birth defects, or medical conditions who on 03/15/2002 was vaccinated SQ in the left arm with a first dose of varicella virus vaccine, live. Concomitant therapy included a 2nd dose of MMR, administered SQ in the LA, a 5th dose of DTaP (Tripedia) administered IM in the RA, a fourth dose of poliovirus vaccine inactivated, administered SQ in the RA. On  05/11/2004, the pt developed a mild case of varicella. An emergency room/MD visit was required. Subsequently, the pt recovered. There were no relevant diagnostic tests or lab data. There were no adverse events following prior vaccinations. No further information is expected.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 37 month old male who on 04/24/02 was vaccinated SQ in the RA with a 1st dose of varicella virus vaccine, live. Concomitant therapy that day included a 1st dose of MMR vaccine administered SQ in the LA. On approximately 05/19/2004 the pt developed breakthrough chickenpox. The reporter indicated that the pt was seen in the office with lesions and was Dx: chickenpox. No fever was noted and no TX was given. It was noted that the pt recovered and that his chickenpox lasted 4-5 days. No further information is expected.
Age: 0.87
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer
Clinical narrative: Information has been received from a woman at a physician's office concerning a 4 year old white male with no allergies and no medical history who on 08/09/2000 was vaccinated in the right thigh with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 05/13/2004 the patient developed 2 spots on his neck and broke out overnight with 40-50 spots in his scalp.  There was no fever.  It was also noted that the patient was very sleepy.  The physician diagnosed the patient at home.  The patient was treated with diphenhydramine liquid, pramoxine hydrochloride, zinc acetate lotion and ibuprophen.  On 05/20/2004 the patient recovered.  No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction, Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live.  Within 24 hours of vaccination, the parents called to report the patient had developed an injection site rash.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: DPP, VARCEL
Symptoms: Injection site erythema, Skin ulcer, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old white female patient with reflux and no allergies who on 06/07/2004 at 10:30AM was vaccinated with a first dose of varicella virus vaccine live subcutaneously.  Concomitant vaccination included diphtheria toxoid, pertussis vaccine, tetanus toxoid given in the right arm.  On 06/07/2004, within 5 minutes of vaccination the patient developed a local reaction with 2 raised, swollen and reddened spots, size of little fingernail on upper left arm.  The patient also experienced slight redness in the right arm at the diphtheria toxoid, pertussis vaccine, tetanus toxoid injection site.  Medical attention was sought and the patient was administered diphenhydramine hcl.  No product quality complaint involved.  Follow up information indicated that on 06/07/2004 at 10:32am the patient developed 3 inch welts at the injection site.  The patient was given diphenhydramine hcl.  No hives or wheezing was noted.  Decreased redness was noted soon afterwards.  The patient recovered on 06/07/2004.  No further information is expected.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Erythema, Malaise, Pyrexia
Clinical narrative: Information has been received form a RN concerning a 29 month old male pt with no allergies and no past medical Hx who on 01/28/2003 was vaccinated with a 1st dose of varicella virus vaccine, live. Illness at the time of vaccination included fever. There were no adverse events following prior vaccinations of the pt or the pt's siblings. On 06/07/04 at 1:56PM, the pt developed fever, rash, and wheezing. On 06/07/04, the pt presented to the physician's office with malaise, a fever of 101 F, a runny nose, and an itchy red rash that was spreading. The pt was noted to have a breakthrough case of chickenpox. Laboratory tests were not performed. The pt was treated with diphenhydramine hydrochloride )(Benadryl) and avena (Aveeno). Subsequently on approximately 06/07/04, the pt recovered. A product quality complaint was not involved.  The pt's sibling experienced chickenpox following vaccination with varicella virus vaccine, live. (WAES 0406USA00884). Additional information is not expected.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, Rhinorrhoea, Viral infection
Clinical narrative: Information has been received form a RN concerning a 29 month old male pt with no allergies and no past medical Hx who on 01/28/2003 was vaccinated with a 1st dose of varicella virus vaccine, live. Illness at the time of vaccination included fever. There were no adverse events following prior vaccinations of the pt or the pt's siblings. On 06/07/04 at 1:56PM, the pt developed fever, rash, and wheezing. On 06/07/04, the pt presented to the physician's office with malaise, a fever of 101 F, a runny nose, and an itchy red rash that was spreading. The pt was noted to have a breakthrough case of chickenpox. Laboratory tests were not performed. The pt was treated with diphenhydramine hydrochloride )(Benadryl) and avena (Aveeno). Subsequently on approximately 06/07/04, the pt recovered. A product quality complaint was not involved.  The pt's sibling experienced chickenpox following vaccination with varicella virus vaccine, live. (WAES 0406USA00884). Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 20 year old healthy female who on 06/11/02 and 07/29/02 was vaccinated with the 1st and 2nd doses of varicella virus vaccine, live. A titer was drawn on 05/19/04, and it was negative for VZVIGG. No other information is available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Erythema, Infection
Clinical narrative: Information has been received from a nurse concerning a 4 year old male with no pre-existing physician diagnosed allergies, birth defects, or medical conditions who on 10/02/2000 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy that day included a dose of hepatitis b virus vaccine rHBag.  There was no other vaccinations within 4 weeks prior to 10/02/2000.  On 05/22/2004 in the PM, the patient developed red spots all over his body, and it was getting worse.  The patient was diagnosed with chickenpox.  The patient was treated with diphenhydramine hydrochloride and aveeno as needed.  There were no relevant diagnostic or laboratory tests.  The outcome was reported as recovered.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Otitis externa, Otitis media, Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant concerning a 5 year old white female patient with no pertinent medical history, who on 06/29/1999 was vaccinated subcutaneously in the arm with a dose of varicella virus vaccine live.  Concomitant vaccine therapy administered on 06/29/1999 included a dose of measles virus vaccine live, mumps virus vaccine live, and rubella virus vaccine live, administered subcutaneously in the arm.  The patient was not ill at the time of vaccination.  On 06/08/2004 the patient developed chickenpox.  The registered nurse reported that the patient had generalized multiple red vesicular papules on her face, chest, and scattered on her legs.  It was noted the patient was seen on 06/07/2004 for a right otitis media-otitis externa.  The patient was treated with amoxicillin and ofloxacin otic drops.  No laboratory or diagnostic studies were performed.  The chickenpox did not abate and the patient is not recovered.  It was noted that therapy was discontinued.  No other information regarding the patient was given.  There was no product quality complaint reported.  Follow up information received from the certified medical assistant reported the patient recovered on 06/12/2004.  No additional information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Malaise, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 35 month old white female with no pertinent medical history or past drug reactions or allergies who on 06/29/2001 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live.  The patient presented to the physician's office with a breakthrough case of chickenpox.  She was noted to have a rash on her chest and breast, and have malaise and a fever of 101 degrees.  She was treated with Benadryl and Aveeno.  Unspecified medical attention was sought.  There was no product quality complaint.  The outcome was reported as not recovered.  Follow up information received from a registered nursed indicated that the child presented to the office on 06/07/2004 with a fever, and a rash on her chest, breast, axilla, and both arms.  Malaise was noted 2 days prior.  The child was treated with Aveeno bath and Benadryl 12.5mg/5ml; 0.5 teaspoon 2 times per day by mouth for itchiness.  The outcome was reported as recovered.  The patient's sibling experienced chickenpox and wheezing following vaccination with varicella virus vaccine live.  No further information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 35 month old white female with no pertinent medical history or past drug reactions or allergies who on 06/29/2001 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live.  The patient presented to the physician's office with a breakthrough case of chickenpox.  She was noted to have a rash on her chest and breast, and have malaise and a fever of 101 degrees.  She was treated with Benadryl and Aveeno.  Unspecified medical attention was sought.  There was no product quality complaint.  The outcome was reported as not recovered.  Follow up information received from a registered nursed indicated that the child presented to the office on 06/07/2004 with a fever, and a rash on her chest, breast, axilla, and both arms.  Malaise was noted 2 days prior.  The child was treated with Aveeno bath and Benadryl 12.5mg/5ml; 0.5 teaspoon 2 times per day by mouth for itchiness.  The outcome was reported as recovered.  The patient's sibling experienced chickenpox and wheezing following vaccination with varicella virus vaccine live.  No further information is expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest pain, Herpes zoster, Infection, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a 28 year old female registered nurse who in 1997 had a pre-vaccination titer drawn for varicella which was negative.  In December 1997 and in 1998 the patient was vaccinated with a first and second dose of varicella virus vaccine live.  It was unknown if there was illness at time of vaccination.  In 2000 the patient had a post-vaccination titer drawn which was negative.  On 06/06/2004 the patient broke out in shingles.  On 06/07/2004 the patient went to see a nurse practitioner and was diagnosed with shingles.  She had an itchy rash over a band on her right side with millions of bumps.  She was treated with valacyclovir hydrochloride (Valtrex).  On 06/09/2004 the patient reported that she was feeling somewhat better.  It was reported that the patient was recovering with sequalae.  No product quality complaint was involved.  Follow up information received from medical records indicated that on 06/06/2004, the patient noticed that she had pain on the right side of her chest wall when washing her car.  That night, she noted that it itched quite a bit, and on the morning of 06/07/2004 she presented to the physician's office with a vesicular rash similar to zoster.  The patient was not aware if she had previously had the chickenpox.  It was noted that on 10/08/1997, a varicella-zoster AB (IGM) was normal and a varicella-zoster AB (IgG) was negative.  No diagnostic tests were performed or ordered.  The patient was diagnosed with zoster, and was treated with valacyclovir hydrochloride (Valtrex) 1, 3 times a day for 7 days and danekonat solution.  The patient declined pain medication.  The outcome was reported as recovered.  No further information is expected.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a woman at a physician's office concerning an 8 year old female patient who on 08/12/1996 was vaccinated subcutaneously with a first dose of varicella virus vaccine live.  Concomitant therapy administered on 08/12/1996 included a subcutaneous first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 04/08/2004 the patient developed chickenpox.  It was reported that the patient recovered.  No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who in approximately 2202 was vaccinated with a second dose of varicella virus vaccine live.  The nurse reported vaccine failure and indicated that a person off the street came in to ask for a vaccination of varicella virus vaccine live.  The patient explained that she had the vaccine twice before, and as recently as two years prior, but still had a negative titer.  Unspecified medical attention was sought and no treatment was required.  A product quality complaint was not involved.  Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 16 month old white male with no allergies or medical history who on 05/28/2004 was vaccinated in the right lateral thigh with a first dose of varicella virus vaccine live.  Concomitant vaccination on the same day included a dose of measles-mumps-rubella vaccine and a dose of Hib conj vaccine.  There was no other concomitant medication.  Illness at the time of vaccination, per the patient's mother, included fever.  On 06/09/2004, the patient was seen in the doctor's office with red, itchy spots on his back, stomach, arms, legs, and ears.  He was afebrile and had less than 50 lesions.  Unspecified medical attention was sought and no treatment was ordered.  A product quality complaint was not involved.  Follow up information was received from the registered nurse who indicated that in the am of 06/09/2004, the patient experienced malaise and an intermittent temperature from 06/06/2004 to 06/09/2004.  The patient developed a red rash on the stomach and back with sever itching.  Scattered red macules were seen on the patient in the office and diagnosed as a vaccine reaction.  No treatment was ordered.  Subsequently, the patient recovered on an unspecified date.  The patient had no adverse events following prior vaccination.  No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine live.  Subsequently the patient developed varicella wildtype breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint involved.  The patient's sister and uncle also developed adverse events after vaccination with varicella virus vaccine live.  Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a male who had never been immunized or had never developed wildtype varicella in the past and was exposed to his niece who developed varicella wildtype breakthrough.  After exposure, the patient was subsequently vaccinated with a dose of varicella virus vaccine live and still developed the wildtype infection.  Unspecified medical attention was sought.  The patient's nephew also developed an adverse event after vaccination with varicella virus vaccine live.  Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning his 11 year old son who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on 06/01/2004, the patient developed chickenpox breakthrough.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The physician mentions a friend of his son also developed chickenpox post vaccination with varicella virus vaccine live.  The reporting physician also mentioned that he, himself, had negative titers post vaccination with varicella virus vaccine live.  Additional information has been requested.