chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaemia, Convulsion, Fall, Febrile convulsion, Haematuria
Clinical narrative: 21 days post vax, the pt was brushing teeth and fell into mothers arms and began having seizure like activity. Ambulance called and delivered the pt to the ER. Mother concerned about link with immunizations. Mother reports Cat scan within normal limits. Scheduled to follow-up with primary MD on 01/29/2001. ER report shows pt discharged with febrile seizure activity and anemia and hematuria.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaemia, Febrile convulsion, Haematuria
Clinical narrative: 21 days post vax, the pt was brushing teeth and fell into mothers arms and began having seizure like activity. Ambulance called and delivered the pt to the ER. Mother concerned about link with immunizations. Mother reports Cat scan within normal limits. Scheduled to follow-up with primary MD on 01/29/2001. ER report shows pt discharged with febrile seizure activity and anemia and hematuria.
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Skin disorder
Clinical narrative: Subsequent to receiving vax pt experienced redness and swelling of arm. Pt was seen in the office 01/26/2001, with left deltoid injection site red, warm to touch and skin taut. Instructed to go to family doctor. Parent states that arm was not as red as it was the previous day. A follow up report received 10/02/2002 adds: This was originally reported by a registered nurse. Upon follow-up, it was reported that no further info was known. No further info is expected.
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Subsequent to receiving vax pt experienced redness and swelling of arm. Pt was seen in the office 01/26/2001, with left deltoid injection site red, warm to touch and skin taut. Instructed to go to family doctor. Parent states that arm was not as red as it was the previous day. A follow up report received 10/02/2002 adds: This was originally reported by a registered nurse. Upon follow-up, it was reported that no further info was known. No further info is expected.
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Erythema, Feeling hot, Infection, Injection site erythema, Injection site pain
Clinical narrative: Subsequent to receiving vax pt experienced redness and swelling of arm. Pt was seen in the office 01/26/2001, with left deltoid injection site red, warm to touch and skin taut. Instructed to go to family doctor. Parent states that arm was not as red as it was the previous day. A follow up report received 10/02/2002 adds: This was originally reported by a registered nurse. Upon follow-up, it was reported that no further info was known. No further info is expected.
Age: 4.0
Sex: F
Vaccine: MMR, TYP, DTAP, MMR, DTAP, MMR
Symptoms: Injection site swelling, Joint swelling
Clinical narrative: Subsequent to receiving vax pt experienced redness and swelling of arm. Pt was seen in the office 01/26/2001, with left deltoid injection site red, warm to touch and skin taut. Instructed to go to family doctor. Parent states that arm was not as red as it was the previous day. A follow up report received 10/02/2002 adds: This was originally reported by a registered nurse. Upon follow-up, it was reported that no further info was known. No further info is expected.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, RAB
Symptoms: Agitation
Clinical narrative: Parent states that pt was crying inconsolably for 4-5 hours on evening of vax and irritable for 1-2 days.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Subsequent to receiving vax, the pt presented to clinic with varicella type rash and temperature of 100.4.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Injection site erythema, Paraesthesia
Clinical narrative: 5 minutes post vax, pt felt tingling in right arm. School nurse checked and found redness at injection site. One day post vax, the pt complained of numbness 2 inches above right elbow to fingertips. Has full use of arm and hand.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Febrile convulsion
Clinical narrative: Pt experienced febrile seizure.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: Pt experienced tremors on hands, feet and lips accompanied by fever of 104F.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Eyelid ptosis
Clinical narrative: Ptosis close upper lid only 40% open for 24 hrs.
Age: 3.0
Sex: F
Vaccine: MMR, TD
Symptoms: Agitation, Pyrexia
Clinical narrative: Approximately 4 hours post vax, the pt experienced an elevated temp, parent gave acetaminophen and the highest recorded temp was 101. The pt also experienced unconsolable crying. The pt was taken to the ER. Symptoms resolved on 1/26.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Screaming
Clinical narrative: The pt experienced an intermittent high pitched cry for one day post vax.
Age: 33.0
Sex: M
Vaccine: IPV, TYP
Symptoms: Hyperhidrosis, Malaise, Nausea, Syncope, Syncope vasovagal
Clinical narrative: The pt experienced vagal symptoms, diaphoretic, syncope. No long term problem. The pt was "ill" and nauseous for 3 days post vax.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Facial palsy
Clinical narrative: The pt was seen in the ER on 1/28 and diagnosed with Bells Palsy.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypertension, Muscular weakness
Clinical narrative: Following vax, the pt became weak and was assisted to the floor. At 10:33 B/P was 142/88. At 10:35 B/P was 140/96 and P 80. The pt began feeling better. At 10:40 B/P was 136/92 and P 64. The pt experienced pain on the left side of head.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, OPV, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: On 1/9/01, the pt developed 20 or so lesions typical of chicken pox. These were not infected.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: The pt experienced a fever of 102, headache, dizziness. Went to the ER and pt felt better 3 hours later.
Age: 2.2
Sex: M
Vaccine: IPV, TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed a localized reaction to #4 DTAP characterized by a 5cm x 5cm red, hot area on left thigh.
Age: 32.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion
Clinical narrative: Information has been received through the pregnancy registry from a physician concerning a 32 year old Asian female who on 11/20/00 was vaccinated with varicella virus vaccine live. Concomitant therapy included measles - mumps - rubella vaccine. She was pregnant at the time of vaccination. LMP was 10/23/2000. Expected date of delivery is 07/30/2001. On 12/23/2000 at 8 weeks from LMP the patient had an elective termination.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Immunization was given on 12/12/2000; weight 11lbs 10ozs, temperature 97.0. The infant died of SIDS on 12//23/2000.
Age: 0.9
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Brain oedema, Influenza like illness, Myocarditis, Viral infection
Clinical narrative: Report 20010027841 describes acute viral myocarditis and diffuse brain swelling in an 11 month old male. This report was received from an attorney, and the attorney's "medical expert", and has not been verified by a physician or other health professional. The vaccinee and his family had no history of drug allergies or vaccine reactions. The vaccinee was healthy with no prior or current illness. He was taking no medications except for the vaccines listed below. On 04/05/1999, the vaccinee received vaccinations of IPV OPV, and Hib (reportedly non-Smithkline Beecham products) in addition to Infanrix. On 04/05/1999, the vaccinee received the unspecified dose of Infanrix. At an unspecified time thereafter, the vaccinee developed flu-like symptoms (nos). His symptoms worsened, and he was transported to the hospital on 04/11/1999. During transport, the vaccine "coded" and could not be resuscitated. He was pronounced dead on arrival at the hospital. An autopsy revealed acute myocarditis and diffuse brain swelling. Reportedly, post-mortem viral titers were "uninformative" (nos). The reporter indicated that he believed that the events were most likely related to the OPV / IPV vaccinations, and not to Infanrix. Cause of death given as acute viral myocarditis. Also, there was brain swelling.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal behaviour, Agitation, Cerebrovascular disorder, Confusional state, Muscular weakness
Clinical narrative: A telephone report was received from a pharmacist on 01/26/01, regarding adverse events possibly related to administration of Fluvirin. Approximately one month after receiving Fluvirin, an 86 year old female developed: muscle weakness in her legs, cerebral vasculitis (confirmed at lumbar puncture) psychotic behavior, and was confused and agitated. This patient has a history of: untreated Parkinson's disease, hypertension, non-malignant brain tumor, atrial fibrillation, and has had "2 breastectomies". She has recently been diagnosed with lumbar disc disease; the brain tumor has been further identified as an acoustic tumor. Attempts to gather additional data have been unsuccessful.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Psychotic disorder
Clinical narrative: A telephone report was received from a pharmacist on 01/26/01, regarding adverse events possibly related to administration of Fluvirin. Approximately one month after receiving Fluvirin, an 86 year old female developed: muscle weakness in her legs, cerebral vasculitis (confirmed at lumbar puncture) psychotic behavior, and was confused and agitated. This patient has a history of: untreated Parkinson's disease, hypertension, non-malignant brain tumor, atrial fibrillation, and has had "2 breastectomies". She has recently been diagnosed with lumbar disc disease; the brain tumor has been further identified as an acoustic tumor. Attempts to gather additional data have been unsuccessful.
Age: 0.75
Sex: F
Vaccine: DTAP, IPV
Symptoms: Grand mal convulsion, Hypotonia, Rash
Clinical narrative: Mom states the next day, infant "lost control of head and had jelly limbs" and also red spots on lower left side and back. Mom held and infant "returned to normal". On 11/18/00, the same thing happened but also went into grand mal seizure. Was hospitalized on 11/18/00. On 11/19/00, had another seizure.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Dehydration, Foetal disorder, Growth retardation, Herpes zoster, Infection
Clinical narrative: This patient was reported to have secondary transmission, dehydration, fetal growth retardation, fever, varicella, vomiting, herpes zoster, pneumonia, and a respiratory condition. Information has been received from a mother who had experienced secondary transmission of varicella after her 12 month old daughter was vaccinated with varicella virus vaccine live. Two weeks after the child developed chicken pox (WAES # 01011852), the mother also got chicken pox. At the time, approximately 02/24/00, it was noted that the mother was in her first trimester of pregnancy. The mother was admitted into the hospital by her infectious disease doctor to monitor the fetus. The mother was unable to keep food down, was very dehydrated, developed shingles, pneumonia, and a temperature of 105 F. The patient was in the hospital about two weeks. After being in the hospital, the fetus that she was carrying "wasn't really growing" and then started growing later. As of 01/19/2001, the baby that she was carrying was 4 months old and was just in the hospital with respiratory problems. the mother also stated that "the baby doesn't keep down food but is still gaining weight". The mother stated "that she would like to know if all of this is related to the (varicella virus vaccine live) her oldest daughter got". Follow up information from the child's pediatrician stated that she indicated that because both the mother and the child had developed chicken pox at the same time, she felt that they must have both been exposed to the same source of wild type varicella and that the child's chicken pox had been modified because of the vaccine. In July 2000, the vaccinee was seen in the pediatrician's office for an 18 month visit, however there was no mention of the mother having to be hospitalized, nor any mention of the other adverse experiences which the mother described herself as having. No further information is available.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact, Pneumonia, Pyrexia, Respiratory disorder, Vomiting
Clinical narrative: This patient was reported to have secondary transmission, dehydration, fetal growth retardation, fever, varicella, vomiting, herpes zoster, pneumonia, and a respiratory condition. Information has been received from a mother who had experienced secondary transmission of varicella after her 12 month old daughter was vaccinated with varicella virus vaccine live. Two weeks after the child developed chicken pox (WAES # 01011852), the mother also got chicken pox. At the time, approximately 02/24/00, it was noted that the mother was in her first trimester of pregnancy. The mother was admitted into the hospital by her infectious disease doctor to monitor the fetus. The mother was unable to keep food down, was very dehydrated, developed shingles, pneumonia, and a temperature of 105 F. The patient was in the hospital about two weeks. After being in the hospital, the fetus that she was carrying "wasn't really growing" and then started growing later. As of 01/19/2001, the baby that she was carrying was 4 months old and was just in the hospital with respiratory problems. the mother also stated that "the baby doesn't keep down food but is still gaining weight". The mother stated "that she would like to know if all of this is related to the (varicella virus vaccine live) her oldest daughter got". Follow up information from the child's pediatrician stated that she indicated that because both the mother and the child had developed chicken pox at the same time, she felt that they must have both been exposed to the same source of wild type varicella and that the child's chicken pox had been modified because of the vaccine. In July 2000, the vaccinee was seen in the pediatrician's office for an 18 month visit, however there was no mention of the mother having to be hospitalized, nor any mention of the other adverse experiences which the mother described herself as having. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic steatosis, Pancreatitis, Pharyngitis, Vomiting
Clinical narrative: This patient was reported to have pancreatitis, fatty liver, pharyngitis, and vomiting. Information has been received from Glaxo Smithkline regarding information previously reported by a physician and the patient's mother concerning an 11 year old female who on 12/04/97 was vaccinated with a dose of Hepatitis B vaccine recombinant (yeast) (lot # 622792 / 0312E). It was reported that the patient developed pharyngitis, and was seen by her physician on 01/10/98. The patient's mother reported that the patient was treated with Amoxicillin / Clavulanate. Subsequently, she developed vomiting and was seen in the emergency room on 01/14/98. She was hospitalized with a diagnosis of pancreatitis. After 2.5 weeks, she was transferred to a tertiary care center for placement of a central venous catheter and total parenteral nutrition. It was reported that the patient has been hospitalized due to pancreatitis several times since, most recently from 10/06/00 to 10/09/00. The patient's mother reported that the patient currently has a fatty liver. The patient's mother attributed to the development of pancreatitis to the administration of Hepatitis B vaccine recombinant (yeast0. No further information is available. Other reference number is EB2001000505-1.
Age: 1.25
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Cellulitis, Infection, Injection site erythema, Injection site vesicles, Nasal congestion
Clinical narrative: Information has been received from a physician concerning a 15 month old male with a history of Hepatitis B vaccine recombinant (yeast) (MSD) vaccination and a Haemophilus B conjugate vaccine (MSD) vaccination who on 12/18/00 was vaccinated with Haemophilus B conjugate vaccine (+) Hepatitis vaccine recombinant (yeast) in his left thigh. Concomitant therapy included varicella virus live, in the right  thigh. Subsequently a few hours later on 12/18/2000, the patient experienced superficial 3/4 cm clear fluid blister at the injection site on his left thigh and an erythema at the injection site on the right thigh. The physician suspects a super imposed Staph scalded-type localized infection. The patient was placed on therapy with Cephalaxin (Keflex) to cover for Staph and Strep cellulitis. The source of admininstration was contacted and an internal investigation did not reveal any other cases. On 01/16/00, the patient was seen at the office for a "routine cold" that included a stuffy nose, and fever, subsequently the patient recovered. Upon internal review, Staph scalded-type localized infection was determined to be an other medical event. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Pyrexia, Skin exfoliation, Skin necrosis
Clinical narrative: Information has been received from a physician concerning a 15 month old male with a history of Hepatitis B vaccine recombinant (yeast) (MSD) vaccination and a Haemophilus B conjugate vaccine (MSD) vaccination who on 12/18/00 was vaccinated with Haemophilus B conjugate vaccine (+) Hepatitis vaccine recombinant (yeast) in his left thigh. Concomitant therapy included varicella virus live, in the right  thigh. Subsequently a few hours later on 12/18/2000, the patient experienced superficial 3/4 cm clear fluid blister at the injection site on his left thigh and an erythema at the injection site on the right thigh. The physician suspects a super imposed Staph scalded-type localized infection. The patient was placed on therapy with Cephalaxin (Keflex) to cover for Staph and Strep cellulitis. The source of admininstration was contacted and an internal investigation did not reveal any other cases. On 01/16/00, the patient was seen at the office for a "routine cold" that included a stuffy nose, and fever, subsequently the patient recovered. Upon internal review, Staph scalded-type localized infection was determined to be an other medical event. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Lymphadenopathy, Nausea, Pain, Swelling
Clinical narrative: An RN reported that, post vax, the 50 year-old Caucasian female with lymphoma and a history of cancer (type unspecified), chemotheraoy which ended in mid-September 2000. Upper extremity edema after receiving a tetanus injection and steroid therapy (prednisone) which stopped the last week of September 2000, who on 11/16/2000 was vaccinated with pneumococcal vaccine 23 polyvalent. (Lot 3 6945K invalid) intramuscularly in the left deltoid. Concomitant vaccination on 11/16/2000 included influenza virus vaccine (E64710HA) intramuscularly in the right deltoid. The pt experienced intermittent symptoms of achy left arm and pain that radiated down the left arm. The pt told the RN that once "the arm ached so bad that it made her sick to her stomach". She also reported that the outer aspect of the elbow was sore to the touch but the pt stated that "the elbow is better now". The pt told the RN that she had a lump under her left arm "that comes and goes". The RN reported that the pt thinks the lump under her arm "had to do with her lymph system". Unspecified medical attention was sought. In follow-up, the RN reported that on 11/16/00, shortly after receiving pneumococcal vaccine 23 polyvalent, the pt's left arm became sore and radiated downward toward the hand. She reported that a month later, the outer aspect of the elbow was sore to the touch, "which comes and goes". She reported that the pt had enlarged lymph nodes which ached to the point of causing nausea, which she states "occurs on and off". She stated that the pt's arm swelled when touched. The RN reported that the outcome of the pt's experiences were unknown. The sore arm, elbow sore to touch, enlarged lymph nodes, nausea and arm swelling were determined to be an "Other Important Medical Event. F/U In follow up the registered nurse reported that the pt was seen by her private family physician and the pt was treated with antibiotics. The symptoms persisted. The pt was sent back to her oconlogist. Lymphoma had reoccurred. The pt has since undergone a bone marrow transplant. The worsening lymphoma required hospitalization and was considered life threatening. The sore arm, elbow sore to touch, enlarged lymph nodes, nausea and arm swelling were determined to be an other important medical event.  In FOLLOW-UP, the registered nurse reported that the patient had returned to teaching and was doing well as the time of the current report. She reported that the patient had a bone marrow implant in the summer of 2001 and had recovered from her experience No further information is available.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood pressure increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On 12/5/00, post vax, the pt experienced a reaction on her arm. She presented with diffuse erythema of upper right arm extending into axilla and down to her elbow. It was tender to palpation and hard to touch. In follow-up, the PA reported that the pt was seen on 12/7/00. The pt told the PA that she thought she was having an allergic reaction to the pneumococcal vaccine 23 polyvalent. She reported that within a few hours, post vax, she noticed redness, swelling and pain in the arm. This had progressed over the past day and now she had redness down the elbow and up into the axilla and back onto the right shoulder. On exam, the PA noted she had confluent, erythematous and a somewhat fluctuant area extending from the right axilla down to the right elbow. The fluctuance was mainly over the biceps but the tenderness to palpation was more noticeable in the right axilla and right posterior arm at the base of the right shoulder. The pt stated that she had some chills on 12/6/00. The pt took some extra strength Tylenol on 12/6/00. Pt reported she did not feel ill, just occasionally felt feverish. The affected area did not blanche to palpation. At this time the PA assessed the pt's condition as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was given Benadryl 50mg IM and was advised to take 25-50mg every 6 hours. A line of demarcation was drawn around the erythematous area. The pt was advised not to take any acetaminophen if she started to feel like she had a fever until she took her temperature and to record it. If her temperature was over 100F she was to take acetaminophen. On 12/8/00, the pt was seen again by the PA. The pt reported that she was "much improved" and had no further chills. Her temperature has been normal and the redness was "resolving nicely". On exam, PA noted that the erythema was fading, however, it had spread down her upper arm to just below the elbow but was resolving on the shoulder area and upper arm. He noted that the area "looks much better than yesterday". The PA's assessment of the pt's condition was that she had an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was advised that she should take Benadryl on an as needed basis. The pt was also advised not to be vaccinated with this vaccine in the future. Additional information has been requested. The allergic reaction, diffuse erythema of the upper right arm extending into axilla and down to her elbow, and tender to palpation were considered to be an "Other Important Medical Event." F/U The pt's adverse experiences were considered to be other important medical events by the reporter. Follow -up info rec'd from the physician's assistant indicated that the pt adverse events improved with Benadryl and tylenol. It was reported that the pt recovered on 12/7/00. No further info is expected.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: On 12/5/00, post vax, the pt experienced a reaction on her arm. She presented with diffuse erythema of upper right arm extending into axilla and down to her elbow. It was tender to palpation and hard to touch. In follow-up, the PA reported that the pt was seen on 12/7/00. The pt told the PA that she thought she was having an allergic reaction to the pneumococcal vaccine 23 polyvalent. She reported that within a few hours, post vax, she noticed redness, swelling and pain in the arm. This had progressed over the past day and now she had redness down the elbow and up into the axilla and back onto the right shoulder. On exam, the PA noted she had confluent, erythematous and a somewhat fluctuant area extending from the right axilla down to the right elbow. The fluctuance was mainly over the biceps but the tenderness to palpation was more noticeable in the right axilla and right posterior arm at the base of the right shoulder. The pt stated that she had some chills on 12/6/00. The pt took some extra strength Tylenol on 12/6/00. Pt reported she did not feel ill, just occasionally felt feverish. The affected area did not blanche to palpation. At this time the PA assessed the pt's condition as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was given Benadryl 50mg IM and was advised to take 25-50mg every 6 hours. A line of demarcation was drawn around the erythematous area. The pt was advised not to take any acetaminophen if she started to feel like she had a fever until she took her temperature and to record it. If her temperature was over 100F she was to take acetaminophen. On 12/8/00, the pt was seen again by the PA. The pt reported that she was "much improved" and had no further chills. Her temperature has been normal and the redness was "resolving nicely". On exam, PA noted that the erythema was fading, however, it had spread down her upper arm to just below the elbow but was resolving on the shoulder area and upper arm. He noted that the area "looks much better than yesterday". The PA's assessment of the pt's condition was that she had an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was advised that she should take Benadryl on an as needed basis. The pt was also advised not to be vaccinated with this vaccine in the future. Additional information has been requested. The allergic reaction, diffuse erythema of the upper right arm extending into axilla and down to her elbow, and tender to palpation were considered to be an "Other Important Medical Event." F/U The pt's adverse experiences were considered to be other important medical events by the reporter. Follow -up info rec'd from the physician's assistant indicated that the pt adverse events improved with Benadryl and tylenol. It was reported that the pt recovered on 12/7/00. No further info is expected.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Leukocytosis, Pain, Pharyngeal oedema
Clinical narrative: The patient had vaccination, 3 days after her injection she noted a rash in her lower extremities, severe abdominal pain, and diarrhea followed. She saw an immunologist on 11/07/00. The doctor did a skin test  ( had throat swelling). Diagnosed with hypersensitivity vasculitis from the Flu vaccine. Recurrence more rash in the upper abdominal area, pain, diarrhea on 11/09/00. Finally the patient was admitted on 11/11/00 for 3 days.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Vasculitis
Clinical narrative: The patient had vaccination, 3 days after her injection she noted a rash in her lower extremities, severe abdominal pain, and diarrhea followed. She saw an immunologist on 11/07/00. The doctor did a skin test  ( had throat swelling). Diagnosed with hypersensitivity vasculitis from the Flu vaccine. Recurrence more rash in the upper abdominal area, pain, diarrhea on 11/09/00. Finally the patient was admitted on 11/11/00 for 3 days.
Age: 0.2
Sex: M
Vaccine: DT, HIBV, PNC
Symptoms: Face oedema, Urticaria
Clinical narrative: This infant had periorbital edema, hives on his arms and legs, and lip edema.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Irritability, Screaming
Clinical narrative: This child had 1st dose of DPT (Acel-Immune), IPOL, Comvax, and Prevnar vaccine. He developed irritability and crying episode for 4 - 5 hours on the same day, evening after the immunization.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Gait disturbance, Injection site erythema, Injection site oedema, Injection site pain, Irritability
Clinical narrative: This child had pain, redness, and swelling to the injection site; the pain was radiating down his leg. The child did not want to bear weight on his leg. His fever was controlled with 1 dose of Advil, no temp at office, fussy at home. The child was alert, verbal, and active at the office visit.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: This child had pain, redness, and swelling to the injection site; the pain was radiating down his leg. The child did not want to bear weight on his leg. His fever was controlled with 1 dose of Advil, no temp at office, fussy at home. The child was alert, verbal, and active at the office visit.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: This baby received vaccines on 12/20/00 at 3 PM. The mother states that a "rash" started at midnight and "came and went" ; the baby also did not sleep all night. The patient presented to the Health Dept Pediatrics 12/21/00 and was seen by 6:30 PM. The doctor sent the father to Osco to get Benadryl so a dose could be given and the baby observed. Hives progressed to the point that the doctor wanted the baby to go to the ER. 911 was called and the baby was transported before Benadryl was given.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Generalised oedema, Pyrexia
Clinical narrative: This infant had a fever and generalized swelling all over his body. The patient was seen in the local emergency room.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Dizziness, Headache, Neoplasm malignant, Vision blurred
Clinical narrative: This patient is reported to have dizziness, headaches, joint pains, decreased eyesight. Report 2001002642-1 describes dizziness in a 54 year old male who received an injection of Lyme disease vaccine (Lymerix). This report was received from the patient's spouse and has not been confirmed by a physician or other health care professionals. Concurrent medical conditions included prostate cancer diagnosed "years ago" and allergy to Leuprolide (Lupron). The patient has no history of Lyme disease. The patient has no personal or family history of gout, Crohn's disease, psoriasis, rheumatoid arthritis, or lupus erythematosus. Concurrent medications included an unspecified hormonal injection. The reporter stated that the patient received his first injection of Lymerix approximately on year prior to 02/01/01; however, she is unsure of the date of administration, and the information supplied does not comply with the recommended dosing schedule for Lymerix. At an unspecified time following receipt of the first injection, the patient developed dizziness, headaches, and joint pains. These symptoms persisted. The patient then received his second injection of Lymerix, also "approximately one year ago" from 02/01/01. The dizziness, headaches, and joint pains continued to persist. The patient received his third injection of Lymerix in June 2000. The dizziness, headaches, and joint pains persisted. The reporter stated that all the patient's joints are affected. No joints are red or swollen. The patient has not had a physical examination within the last year. On 01/22/01, the patient experienced decreased eyesight with blurred vision. He was seen by an "eye doctor", who reportedly was "puzzled" by the "extreme" change in the patient's eyesight, which was "down by five". As of 02/01/01, the dizziness, headaches, joint pains, and decreased eyesight persisted. The adverse events of dizziness, headaches, and joint pains do not meet ICH serious criteria, but being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Visual acuity reduced
Clinical narrative: This patient is reported to have dizziness, headaches, joint pains, decreased eyesight. Report 2001002642-1 describes dizziness in a 54 year old male who received an injection of Lyme disease vaccine (Lymerix). This report was received from the patient's spouse and has not been confirmed by a physician or other health care professionals. Concurrent medical conditions included prostate cancer diagnosed "years ago" and allergy to Leuprolide (Lupron). The patient has no history of Lyme disease. The patient has no personal or family history of gout, Crohn's disease, psoriasis, rheumatoid arthritis, or lupus erythematosus. Concurrent medications included an unspecified hormonal injection. The reporter stated that the patient received his first injection of Lymerix approximately on year prior to 02/01/01; however, she is unsure of the date of administration, and the information supplied does not comply with the recommended dosing schedule for Lymerix. At an unspecified time following receipt of the first injection, the patient developed dizziness, headaches, and joint pains. These symptoms persisted. The patient then received his second injection of Lymerix, also "approximately one year ago" from 02/01/01. The dizziness, headaches, and joint pains continued to persist. The patient received his third injection of Lymerix in June 2000. The dizziness, headaches, and joint pains persisted. The reporter stated that all the patient's joints are affected. No joints are red or swollen. The patient has not had a physical examination within the last year. On 01/22/01, the patient experienced decreased eyesight with blurred vision. He was seen by an "eye doctor", who reportedly was "puzzled" by the "extreme" change in the patient's eyesight, which was "down by five". As of 02/01/01, the dizziness, headaches, joint pains, and decreased eyesight persisted. The adverse events of dizziness, headaches, and joint pains do not meet ICH serious criteria, but being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye irritation, Nausea, Oedema peripheral, Pain
Clinical narrative: On 11/22/00, this patient was nauseated and achy all over. On 11/23/00, she felt achy and feverish, her left arm reddened and edematous; a bit larger than a 1/2 dollar. The edema went down gradually over several days. The patient complained of eyes feeling itchy on 11/24/00. The patient took Benadryl for several days.
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: On 11/22/00, this patient was nauseated and achy all over. On 11/23/00, she felt achy and feverish, her left arm reddened and edematous; a bit larger than a 1/2 dollar. The edema went down gradually over several days. The patient complained of eyes feeling itchy on 11/24/00. The patient took Benadryl for several days.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This patient received a Flu vaccine on 12/04/00. The patient noticed hives on his back on 12/06/00. The hives continued to worsen, no respiratory distress involved. He was seen by the Doctor on 12/08/00. The patient couldn't verify if it was flu shot or not causing the hive episode.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: This patient developed hives after receiving the Flu vaccine after about 4 hours. There was no respiratory distress, nothing else new or different in her life. This was her first flu shot.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Pain, Paraesthesia
Clinical narrative: This patient began feeling achy within 5 hours after receiving vaccine. The patient also noticed headache, chills; within 2 more hours hands felt tingly, and hands and feet felt cold. Her temperature was 100.5 the next AM and then 2 days later 101.3 in the AM, it resolved by the 3rd day. The patient still felt drug out and fatigued.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Pyrexia
Clinical narrative: This patient began feeling achy within 5 hours after receiving vaccine. The patient also noticed headache, chills; within 2 more hours hands felt tingly, and hands and feet felt cold. Her temperature was 100.5 the next AM and then 2 days later 101.3 in the AM, it resolved by the 3rd day. The patient still felt drug out and fatigued.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Pain, Paraesthesia
Clinical narrative: This patient had tingling in his arm, pain, and inability to use his right arm.
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: This patient has diffuse paresthesia from the chest down, numbness of the fingers and toes. Lasting continually for 2 weeks.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Arthritis, Arthropathy, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within hours of injection, patient developed pain, slight swelling, and some erythema at left deltoid. She experienced loss of abduction and limited flexion and extension of left shoulder. She was referred to PT for rehabilitation of left shoulder. She had 50% improvement in range of motion within 48 hours. Her diagnosis was arthritic reaction versus injection into rotator cuff.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Joint range of motion decreased
Clinical narrative: Within hours of injection, patient developed pain, slight swelling, and some erythema at left deltoid. She experienced loss of abduction and limited flexion and extension of left shoulder. She was referred to PT for rehabilitation of left shoulder. She had 50% improvement in range of motion within 48 hours. Her diagnosis was arthritic reaction versus injection into rotator cuff.
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Cough, Rash, Rash erythematous
Clinical narrative: Patient developed a hoarse cough and elevated pink/red rash on trunk of body. The incident was reported to physician and family was instructed to give Benadryl. On 2/2/01 the rash was reported to be gone. Patient's mother felt this was a reaction to Varivax because the patient developed a rash on left thigh
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Patient developed a fever of 103 to 104 degrees and severe diarrhea 3 to 4 days after receiving vaccine. The episode lasted 3 to 4 days.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Patient developed a rash all over her body.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: Patient developed an all over body rash after first and second sets.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed a 5 X 3cm area surrounding site of injection on right thigh. The area was red, warm to the touch, and slightly swollen and raised.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Patient developed soreness at site of injection and under arm in one area only on right side.
Age: 25.0
Sex: F
Vaccine: MEA
Symptoms: Drug ineffective
Clinical narrative: Patient was vaccinated on 3/13/00 with one dose of measles virus vaccine live. In 1993, the patient had received a first dose of measles-mumps-rubella in Ukraine. On 3/17/00 the patient had her titer checked and was found to be non-imune. On 5/27/00 a repeat titer was drawn which revealed that the patient had not developed immunity.
Age: 35.0
Sex: F
Vaccine: MEA
Symptoms: Arthralgia, Drug ineffective, Headache, Pyrexia
Clinical narrative: Patient received a fourth dose of measles virus vaccine live. The patient was a "non-responder" to the first three doses of measles virus vaccine live. After the fourth dose, the patient developed a fever, joint pain, and a headache. The patient had these symptoms for approximately 3 weeks. On 7/18/00, the patient was scheduled for a visit to a physician.
Sex: U
Vaccine: MEA
Symptoms: Drug ineffective
Clinical narrative: Patient received a first and second dose of measles virus vaccine live. Subsequently, following the second dose, a titer done by the hospital lab was <0.9 (>=0.9 was considered positive). The patient sought unspecified medical attention.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Vomiting
Clinical narrative: The pt experienced vomiting episodes (multiple) within 24 hours of immunizations.
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Anaphylactic reaction, Dyspnoea, Hypotension, Pulmonary function test decreased, Stridor
Clinical narrative: A physician reported that a 24 month old male received an injection of Prevnar on 1/26/01. Approx. 4 to 6 hours later, the child developed hypotension, stridor, retraction in all lung fields, delayed capillary refill and "severe" depression in breathing. The physician described this as an anaphylactic reaction. The child was seen in an ER. He was treated with fluids, Decadron and Benadryl. The child was hospitalized and discharged the next day. Anaphylactic reaction is considered "Medically Important".
Age: 2.0
Sex: M
Vaccine: PNC, PNC
Symptoms: Hypotension, Pyrexia, Respiratory distress
Clinical narrative: A physician reported that a 24 month old male received an injection of Prevnar on 1/26/01. Approx. 4 to 6 hours later, the child developed hypotension, stridor, retraction in all lung fields, delayed capillary refill and "severe" depression in breathing. The physician described this as an anaphylactic reaction. The child was seen in an ER. He was treated with fluids, Decadron and Benadryl. The child was hospitalized and discharged the next day. Anaphylactic reaction is considered "Medically Important".
Sex: U
Vaccine: PNC
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported that a patient received an injection of Prevnar and subsequently developed cellulitis at the injection site. The patient was hospitalized. No further information was available at the date of this report. Manufacturer's comment: The reporter indicated that 3 patient's experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Diabetes mellitus, Injection site pain, Pyrexia
Clinical narrative: Pt had a fever, soreness (immediate) and Diabetes Type I (developed over time). Dx'd on 11/20/1999.
Age: 0.7
Sex: M
Vaccine: HEP, MMR
Symptoms: Demyelination, Encephalitis, Laboratory test abnormal
Clinical narrative: The pt experienced acute demyelinating encephalomyelitis.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Herpes zoster, Hypoaesthesia, Infection, Nervous system disorder
Clinical narrative: A pharmacist reported that a 30 year old male received an injection of Flu Shield '00-'01 on 11/1/00. On 11/3/00, the pt developed a fever, headache and shingles. On 11/13/00, he experienced numbness. An MRI showed plaques on the spinal cord that are similar to multiple sclerosis. The reporter also indicated that a neurologist believes that the pt's symptoms are a central nervous system disturbance. As of the date of this report, the pt still had a sensory disturbance of his lower extremities. Neurological disorder is considered "Medically Important".
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: A pharmacist reported that a 30 year old male received an injection of Flu Shield '00-'01 on 11/1/00. On 11/3/00, the pt developed a fever, headache and shingles. On 11/13/00, he experienced numbness. An MRI showed plaques on the spinal cord that are similar to multiple sclerosis. The reporter also indicated that a neurologist believes that the pt's symptoms are a central nervous system disturbance. As of the date of this report, the pt still had a sensory disturbance of his lower extremities. Neurological disorder is considered "Medically Important".
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Atrial fibrillation, Pain, Polymyalgia rheumatica, Pyrexia
Clinical narrative: A spouse reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks post vax. He was then prescribed Lasix for his heart, Coumadin for his blood, prednisone for his PMR and synthroid for his thyroid. He had previously not been on any medication and had no medical problems. He has has previous flu shots in the past without any problems. His symptoms included achiness in his hips, thighs and calves. He normally works out at a club three times per week, but has not been able to return to that activity. Additional information has been requested. Follow-up information received on 4/24/01, states that the physician identified as PCP wrote: "I did not administer a flu shot to this patient". Additional information received on 06/05/2001, states that the day after receiving the flu vaccine, the pt woke up with severe pain in thighs, calves, and hips. A few days later, joint pain began. This pt also had fever to 102 and lost 22 lbs. The family physician started him on prednisone, plaquenil,and NHAID with good effect. As of 06/22/2001, his positive RF has persisted.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Thyroid disorder, Weight decreased
Clinical narrative: A spouse reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks post vax. He was then prescribed Lasix for his heart, Coumadin for his blood, prednisone for his PMR and synthroid for his thyroid. He had previously not been on any medication and had no medical problems. He has has previous flu shots in the past without any problems. His symptoms included achiness in his hips, thighs and calves. He normally works out at a club three times per week, but has not been able to return to that activity. Additional information has been requested. Follow-up information received on 4/24/01, states that the physician identified as PCP wrote: "I did not administer a flu shot to this patient". Additional information received on 06/05/2001, states that the day after receiving the flu vaccine, the pt woke up with severe pain in thighs, calves, and hips. A few days later, joint pain began. This pt also had fever to 102 and lost 22 lbs. The family physician started him on prednisone, plaquenil,and NHAID with good effect. As of 06/22/2001, his positive RF has persisted.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Patient developed fussiness at 2 AM on 1/6/01 followed by a fever of 103 degrees and inconsolable crying for 1.5 hours at 4 AM on 1/6/01. Patient was given Tylenol at 2 AM.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: The pt experienced a tonic-clonic seizure 2 minutes post vax, lasting a few seconds. The pt has no hx of seizure activity and no other contributing past medical hx. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Headache, Nausea, Ocular hyperaemia
Clinical narrative: At 7:00PM the pt experienced s cough, then severe chills, nausea and headache lasting 12 hours. Her eyes were red, no white visible for 36 hours. Went to bed and took store brand Excedrin.
Age: 1.2
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The pt had a sterile reaction with swelling and erythema of the right anterior thigh.
Age: 25.0
Sex: F
Vaccine: CHOL
Symptoms: Dizziness, Erythema, Rash, Rash maculo-papular
Clinical narrative: The pt experienced a rash around the neck within one week of vax. The pt also experienced faintness, erythema, splotchy. Was treated with Claritin. Symptoms have resolved.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: The pt experienced morbilliform rash to trunk, face, extremities. 12 days post vax.