chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: The patient was vaccinated on the left thigh secondary to extensive tattoos of the deltoid areas.  The patient reported to the ED 10 days later with a  CC "redness and swelling of the area 4 cm around the site". He also had inguinal lymphadenopathy.  The patient was treated with 2grams of Ancef and kept overnight for observation. Thereafter he was released without/with unknown ABX therapy. The diagnosis was unclear  but seemed to be cellulits vs smallpox reaction.
Age: 0.0
Sex: F
Vaccine: SMALL
Symptoms: Joint range of motion decreased, Pain, Shoulder pain
Clinical narrative: Aching in left shoulder and extension of "deep bone type" pain/ache from elbow to shoulder reported on May 20, 2003 is now bilateral (worse on the left) and progressed to the point that there is limited movement, predominantly in the left shoulder.  Saw MD 2/3/04 who diagnosed adhesive capsulitis, placed on Mobic bid, and referred to specialist.  Specialist seen 2/9, confirmed the diagnosis, placed on reducing doses of prednisone, and referred to PT.  Low dose Elavil subsequently prescribed as well.
Age: 9.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Chills, Cough, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Pyrexia/ Fever, Rigors/chills, Rhinorrhea/Runny Nose, Cough, Pain. This report was received from the Center for Biologics Evaluation and Research (VAERS ID number 214972). Information regarding flumist 2003-4 formula influenza virus vaccine, live intranasal 2003-4 formula nasal solution frozen was received from a healthcare professional via a regulatory authority regarding a 9 year old male patient who experienced chills, body aches, high fever, runny nose and cough. At 9 years of age, the patient received the first dose f 22-Dec-2003. On 25-Dec-2003, the child developed chills/rigors, body aches/pain, high fever/pyrexia, runny nose/rhinorrhoea and cough. He was treated with Triaminic for flu, cold and cough. No additional information was available at the time of this report.
Age: 10.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Rash
Clinical narrative: Rash. This report was received from the Center for Biologics Evaluation and Research (VAERS ID number 216186). Information regarding Flumist 2003-4 formula influenza virus vaccine, live intranasal 20003-4 formula nasal solution frozen was received from a healthcare professional via a regulatory authority regarding a ten year old male patient who experienced a rash. At ten years of age, the patient received the first dose on 27/jan/2004. On 01/27/04, the child developed a rash near his nose after the vaccine was administered. The next day, the rash was on the side of his face. The reporter indicated that the child was in no distress. No additional information was available at the time of this report.
Age: 5.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Drug ineffective, Dyskinesia, Headache, Laboratory test abnormal, Pain
Clinical narrative: PYREXIA/FEVER. HEADACHE. PAIN/ACHE. Information regarding Flumist 2003-2004 influenza virus vaccine, live intranasal 2003-2004 formula nasal solution (frozen) was received from a healthcare professional regarding a 5 year old male patient who experienced fever 103  deg F, headache and body ache. At 5 years of age, the patient received the first dose on 07-Jan-2004. On 16-Feb-2004, the patient experienced fever 103 deg F, pyrexia, headache and body ache/pain; he had received his first dose of Flumist on 07-jan-2004. The patient was taken to the emergency room. A urine analysis and unspecified blood work were performed. Rocephin was administered and the patient was discharged. On 17-Feb-2004 the patient's temperature was registering "subnormal" and he was awake and alert. No additional information was available at the time of this report. Follow up: On 17FEB2004, he was taken to the emergency room where laboratory tests were performed. The patient's white blood cell count was 37.1x10^3/mm^3. While awaiting blood culture results, the patient began treatment with Rocephin (ceftriaxone). A nasal swab performed at this time returned positive for influenza A&B. The patient was discharged on the same day. Repeat laboratory tests done on 25FEB2004 showed a white cell count of 13.5x10^3 and neutrophil and lymphcyte percentages of 37.5% and 54.4% respectively. It was noted that the patient recovered.
Age: 5.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: PYREXIA/FEVER. HEADACHE. PAIN/ACHE. Information regarding Flumist 2003-2004 influenza virus vaccine, live intranasal 2003-2004 formula nasal solution (frozen) was received from a healthcare professional regarding a 5 year old male patient who experienced fever 103  deg F, headache and body ache. At 5 years of age, the patient received the first dose on 07-Jan-2004. On 16-Feb-2004, the patient experienced fever 103 deg F, pyrexia, headache and body ache/pain; he had received his first dose of Flumist on 07-jan-2004. The patient was taken to the emergency room. A urine analysis and unspecified blood work were performed. Rocephin was administered and the patient was discharged. On 17-Feb-2004 the patient's temperature was registering "subnormal" and he was awake and alert. No additional information was available at the time of this report. Follow up: On 17FEB2004, he was taken to the emergency room where laboratory tests were performed. The patient's white blood cell count was 37.1x10^3/mm^3. While awaiting blood culture results, the patient began treatment with Rocephin (ceftriaxone). A nasal swab performed at this time returned positive for influenza A&B. The patient was discharged on the same day. Repeat laboratory tests done on 25FEB2004 showed a white cell count of 13.5x10^3 and neutrophil and lymphcyte percentages of 37.5% and 54.4% respectively. It was noted that the patient recovered.
Age: 5.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Drug ineffective, Headache, Pain, Pyrexia, Viral infection
Clinical narrative: PYREXIA/FEVER. HEADACHE. PAIN/ACHE. Information regarding Flumist 2003-2004 influenza virus vaccine, live intranasal 2003-2004 formula nasal solution (frozen) was received from a healthcare professional regarding a 5 year old male patient who experienced fever 103  deg F, headache and body ache. At 5 years of age, the patient received the first dose on 07-Jan-2004. On 16-Feb-2004, the patient experienced fever 103 deg F, pyrexia, headache and body ache/pain; he had received his first dose of Flumist on 07-jan-2004. The patient was taken to the emergency room. A urine analysis and unspecified blood work were performed. Rocephin was administered and the patient was discharged. On 17-Feb-2004 the patient's temperature was registering "subnormal" and he was awake and alert. No additional information was available at the time of this report. Follow up: On 17FEB2004, he was taken to the emergency room where laboratory tests were performed. The patient's white blood cell count was 37.1x10^3/mm^3. While awaiting blood culture results, the patient began treatment with Rocephin (ceftriaxone). A nasal swab performed at this time returned positive for influenza A&B. The patient was discharged on the same day. Repeat laboratory tests done on 25FEB2004 showed a white cell count of 13.5x10^3 and neutrophil and lymphcyte percentages of 37.5% and 54.4% respectively. It was noted that the patient recovered.
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Condition aggravated, Gastrointestinal disorder, Headache, Nausea, Respiratory distress
Clinical narrative: From initial information received on 4/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a Imovax Rabies vaccination, lot number W1419-3, administered IM in  the left arm at 10:00 AM on 12/12/03. This dose was given in the Emergency Room after receiving a cat bite. Two hours later, the patient felt nauseated, developed a headache, gastrointestinal distress, leading to a respiratory distress like an asthma attack. The patient did not seek medical attention. The symptoms decreased the next day but the gastrointestinal disturbance continued. The patient has a history of gastrointestinal problems including chronic pancreatitis and GERD. Additional information has been requested. From additional information received on 14Apr04 through a telephone contact with the reporter it was reported that the pt was hospitalized for cellulitis of the hand secondary to a cat bite, from 30Nov03 to 03Dec03. Medications included Doxycycline, Bentyl, Isordil, Creon-20, Beconase and Zyrtec. Previous history includes chronic pancreatitis with chronic abdominal pain, GERD, irritable bowel syndrome and she is a smoker. The pt thinks the antibiotic treatment exacerbated her IBS and chronic abdominal pain, however, she did not want to continue the rabies series. The doctor agreed to discontinue since the cat was not a wild animal. It was a neighbors cat who had been declawed and was wearing a collar. She had received the first two rabies doses in the hospital (dates, route and lot numbers not reported) and the third dose on 12/12/03 at the doctor's office. Information on the first two doses is unavailable. No other information was reported. The pt has recovered from this event.  From additional information received on 18May04 from a health care professional, the pt's full name, address and telephone number were provided. The responsible physician's telephone number was also provided. Per the reporter, the pt did not have any adverse reaction to the rabies vaccines given at the hospital. Her adverse reaction occurred after receiving a dose of the vaccine at the doctor's office on 12Dec03, due to which she declined additional vaccines. The pt also declined receiving recommended vaccine to complete the series because of her adverse reaction. She had no previous reaction to the rabies vaccine. The pt did not receive any treatment therapy for the symptoms. The reporter stated that she did not have information regarding the dose or site of vaccination provided by the hospital. She did not have the manufacturer nor the lot number of the vaccines provided by the hospital either. No further information is anticipated, this case is considered closed.
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Asthma, Cellulitis, Gastrointestinal disorder, Headache, Nausea
Clinical narrative: From initial information received on 4/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a Imovax Rabies vaccination, lot number W1419-3, administered IM in  the left arm at 10:00 AM on 12/12/03. This dose was given in the Emergency Room after receiving a cat bite. Two hours later, the patient felt nauseated, developed a headache, gastrointestinal distress, leading to a respiratory distress like an asthma attack. The patient did not seek medical attention. The symptoms decreased the next day but the gastrointestinal disturbance continued. The patient has a history of gastrointestinal problems including chronic pancreatitis and GERD. Additional information has been requested. From additional information received on 14Apr04 through a telephone contact with the reporter it was reported that the pt was hospitalized for cellulitis of the hand secondary to a cat bite, from 30Nov03 to 03Dec03. Medications included Doxycycline, Bentyl, Isordil, Creon-20, Beconase and Zyrtec. Previous history includes chronic pancreatitis with chronic abdominal pain, GERD, irritable bowel syndrome and she is a smoker. The pt thinks the antibiotic treatment exacerbated her IBS and chronic abdominal pain, however, she did not want to continue the rabies series. The doctor agreed to discontinue since the cat was not a wild animal. It was a neighbors cat who had been declawed and was wearing a collar. She had received the first two rabies doses in the hospital (dates, route and lot numbers not reported) and the third dose on 12/12/03 at the doctor's office. Information on the first two doses is unavailable. No other information was reported. The pt has recovered from this event.  From additional information received on 18May04 from a health care professional, the pt's full name, address and telephone number were provided. The responsible physician's telephone number was also provided. Per the reporter, the pt did not have any adverse reaction to the rabies vaccines given at the hospital. Her adverse reaction occurred after receiving a dose of the vaccine at the doctor's office on 12Dec03, due to which she declined additional vaccines. The pt also declined receiving recommended vaccine to complete the series because of her adverse reaction. She had no previous reaction to the rabies vaccine. The pt did not receive any treatment therapy for the symptoms. The reporter stated that she did not have information regarding the dose or site of vaccination provided by the hospital. She did not have the manufacturer nor the lot number of the vaccines provided by the hospital either. No further information is anticipated, this case is considered closed.
Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Respiratory distress
Clinical narrative: From initial information received on 4/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 47 year old female patient received a Imovax Rabies vaccination, lot number W1419-3, administered IM in  the left arm at 10:00 AM on 12/12/03. This dose was given in the Emergency Room after receiving a cat bite. Two hours later, the patient felt nauseated, developed a headache, gastrointestinal distress, leading to a respiratory distress like an asthma attack. The patient did not seek medical attention. The symptoms decreased the next day but the gastrointestinal disturbance continued. The patient has a history of gastrointestinal problems including chronic pancreatitis and GERD. Additional information has been requested. From additional information received on 14Apr04 through a telephone contact with the reporter it was reported that the pt was hospitalized for cellulitis of the hand secondary to a cat bite, from 30Nov03 to 03Dec03. Medications included Doxycycline, Bentyl, Isordil, Creon-20, Beconase and Zyrtec. Previous history includes chronic pancreatitis with chronic abdominal pain, GERD, irritable bowel syndrome and she is a smoker. The pt thinks the antibiotic treatment exacerbated her IBS and chronic abdominal pain, however, she did not want to continue the rabies series. The doctor agreed to discontinue since the cat was not a wild animal. It was a neighbors cat who had been declawed and was wearing a collar. She had received the first two rabies doses in the hospital (dates, route and lot numbers not reported) and the third dose on 12/12/03 at the doctor's office. Information on the first two doses is unavailable. No other information was reported. The pt has recovered from this event.  From additional information received on 18May04 from a health care professional, the pt's full name, address and telephone number were provided. The responsible physician's telephone number was also provided. Per the reporter, the pt did not have any adverse reaction to the rabies vaccines given at the hospital. Her adverse reaction occurred after receiving a dose of the vaccine at the doctor's office on 12Dec03, due to which she declined additional vaccines. The pt also declined receiving recommended vaccine to complete the series because of her adverse reaction. She had no previous reaction to the rabies vaccine. The pt did not receive any treatment therapy for the symptoms. The reporter stated that she did not have information regarding the dose or site of vaccination provided by the hospital. She did not have the manufacturer nor the lot number of the vaccines provided by the hospital either. No further information is anticipated, this case is considered closed.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEP, MMR, VARCEL, HBHEPB, MMR, VARCEL
Symptoms: Pneumonia, Pyrexia
Clinical narrative: URI began 03/20/2004 and child was better by 3/24/2004. 3/29/04 low grade fever began. Pneumonia dx 4/4/04 which was the 6th day of the fever. Fever was 104 degrees on 3/29/04. Also there was one blister at injection site 3/29/04. Treated with Zithromax x 5 days.
Age: 1.0
Sex: F
Vaccine: HBHEPB, HEP, MMR, VARCEL, HBHEPB, MMR, VARCEL
Symptoms: Injection site vesicles, Pneumonia, Pyrexia, Upper respiratory tract infection
Clinical narrative: URI began 03/20/2004 and child was better by 3/24/2004. 3/29/04 low grade fever began. Pneumonia dx 4/4/04 which was the 6th day of the fever. Fever was 104 degrees on 3/29/04. Also there was one blister at injection site 3/29/04. Treated with Zithromax x 5 days.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dehydration, Febrile convulsion, Hydronephrosis, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: High fever 104.5 degrees F rectally 3rd day after vaccination. Face and lips turned white, body stiffness and positive trembling of arms for less than 5 minutes. Nurse follow up on 05/18/2004 states: pyelonephritis, febrile seizure, hydronephrosis, Vesicoureteral reflux, Dehydration. Nurse follow up on 05/18/04 states: sleepy, cold extremities.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pallor, Paraesthesia, Pyelonephritis, Pyrexia, Somnolence
Clinical narrative: High fever 104.5 degrees F rectally 3rd day after vaccination. Face and lips turned white, body stiffness and positive trembling of arms for less than 5 minutes. Nurse follow up on 05/18/2004 states: pyelonephritis, febrile seizure, hydronephrosis, Vesicoureteral reflux, Dehydration. Nurse follow up on 05/18/04 states: sleepy, cold extremities.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor, Urinary tract disorder, Urine abnormality
Clinical narrative: High fever 104.5 degrees F rectally 3rd day after vaccination. Face and lips turned white, body stiffness and positive trembling of arms for less than 5 minutes. Nurse follow up on 05/18/2004 states: pyelonephritis, febrile seizure, hydronephrosis, Vesicoureteral reflux, Dehydration. Nurse follow up on 05/18/04 states: sleepy, cold extremities.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaemia, Convulsion, Dehydration, Dyspnoea, Faecal incontinence
Clinical narrative: Vaccine reaction with rescusitation. 4 year old boy here for annual physician/screening received DTaP, Polio (IM), MMR 21 hours ago. Subsequently, child noted to become limp, vomited, and had a BM about 15 minutes after administration of above vaccine. The child was placed on the couch, opened eyes spontaneously to his name, pulse fast for about 10 minutes, RR 30-40. Approximately 10-15 minutes later, had a second episode of vomiting, child went limp, pulse not palpable, sat 67%. Started on O2 4L/anbubag IV line started. About 20cc NS given. Sat climbed up to 90%, HR 144, lungs: grunting sounds but clear. Spontaneous pulse after about 5 minutes of cardiac compressing. Child transferred to ER. Per discharge summary, pt experienced hypoglycemia, hypokalemia, dehydration, seizure and anemia.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypoglycaemia, Hypokalaemia, Hypotonia, Hypoxia, Pulse absent
Clinical narrative: Vaccine reaction with rescusitation. 4 year old boy here for annual physician/screening received DTaP, Polio (IM), MMR 21 hours ago. Subsequently, child noted to become limp, vomited, and had a BM about 15 minutes after administration of above vaccine. The child was placed on the couch, opened eyes spontaneously to his name, pulse fast for about 10 minutes, RR 30-40. Approximately 10-15 minutes later, had a second episode of vomiting, child went limp, pulse not palpable, sat 67%. Started on O2 4L/anbubag IV line started. About 20cc NS given. Sat climbed up to 90%, HR 144, lungs: grunting sounds but clear. Spontaneous pulse after about 5 minutes of cardiac compressing. Child transferred to ER. Per discharge summary, pt experienced hypoglycemia, hypokalemia, dehydration, seizure and anemia.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Tachycardia, Vomiting
Clinical narrative: Vaccine reaction with rescusitation. 4 year old boy here for annual physician/screening received DTaP, Polio (IM), MMR 21 hours ago. Subsequently, child noted to become limp, vomited, and had a BM about 15 minutes after administration of above vaccine. The child was placed on the couch, opened eyes spontaneously to his name, pulse fast for about 10 minutes, RR 30-40. Approximately 10-15 minutes later, had a second episode of vomiting, child went limp, pulse not palpable, sat 67%. Started on O2 4L/anbubag IV line started. About 20cc NS given. Sat climbed up to 90%, HR 144, lungs: grunting sounds but clear. Spontaneous pulse after about 5 minutes of cardiac compressing. Child transferred to ER. Per discharge summary, pt experienced hypoglycemia, hypokalemia, dehydration, seizure and anemia.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Erythema, Nausea, Salivary hypersecretion
Clinical narrative: 4/8/04 Patient presented to office nurse for preschool immunizations. Patient was given DTaP, MMR, and IPV. As patient was leaving he became nauseated, foaming at the mouth, red spots on back. Physician notified. Given SC Epinephrine and continued to deteriorate. Pulse and Heart rate 10 and O2 administered. Epi 1 was administered IV, as well as Decadron and Benadryl. Patient began to stabilize and was transported to ER via ambulance with doctor. Discharge Summary received on 4/27/2004 states anaphylaxis.
Sex: F
Vaccine: TYP
Symptoms: Dyspnoea, Hot flush, Nausea, Pain, Pyrexia
Clinical narrative: Pain radiating from fingertips to neck on side/deltoid of injection site (right) with hot flashes and nausea followed by low grade fever, difficulty breathing within 5 minutes. Resolved with 6L O2 and Epipen. Symptoms returned requiring hospitalization about 15:30.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Swelling, redness warm to touch. Treatment with Benadryl/ and rest.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Neck pain, Rash
Clinical narrative: Rash on neck and face. Pain in back of neck.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Entire thigh erythema and edema with do not interfere with walking. Augmentin 400/5 1 top bed x 10, Benadryl 1 1/2 tsp every 6 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema
Clinical narrative: Entire thigh erythema which do not interfere with walking.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: Marked swelling/redness/fever to 103.6. 48 hours after DTaP + IPV injection in left deltoid muscle.
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Crying, Cyanosis, Eczema, Erythema, Feeling hot
Clinical narrative: Initial episode occurred 5/1/99. Patient awakened from sleep screaming. Legs noted to be red and warm to touch. The entire right leg and the left leg mid-calf distal. The screaming lasted 10 minutes. The redness subsided but purple spots remained. The parents brought the infant to the Emergency Room. The examination revealed an afebrile, alert smiling infant. He was well-hydrated and moving both lower extremities well. Good groin and pedal pulses were palpated and confirmed with hand-held doppler. Toes revealed 4 sec capillary refill. The ventral surfaces of the lower extremities revealed diffuse petecchiae, involving the entire right leg and mid-calf left leg. No other ecchymotic areas were noted. Left elbow revealed an eczematous rash otherwise the remaining skin was clear of rash. Firm non-fluctuant nodules were noted on the anterior thighs at the immunization sites. The nodules were tender but the remaining portion was non-tender. The remainder of the infants e am was normal. Enclosed are the infants lab results. In the following week, the infant had three more episodes, 1-5/2/99 and - 5/6/99. One episode was witnesses in the clinic. The infant started with crying, his lower body from umbilicus to toes symmetrically turned mottled and cyanotic, the left groin pulse was normal. The duration of mottling was 3-5 minutes and 2-3 sec capillary refill was noted on the sole of the foot. After cessation of crying, hyperemia of the lower extremities, about 10 minutes in duration, was noted. The episodes after 5/1/999 did not result in petecchiae. The parents did not notice any further events until a brief episode after an insect bite on 5/30/99. The patient was seen by a pediatric cardiologist on 5/5/99. A doppler ultrasound was performed of the lower extremity vasculature and it was read as normal. The report is enclosed. The patient was seen on 6/4/99 and noted to be in good health. Family history is negative for vasculitis and autoimmune disease. Antenatal history is remarkable for mother having gestational diabetes. She received Isulin and Prosac during prenancy.
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Hyperaemia, Injection site mass, Livedo reticularis, Petechiae, Rash
Clinical narrative: Initial episode occurred 5/1/99. Patient awakened from sleep screaming. Legs noted to be red and warm to touch. The entire right leg and the left leg mid-calf distal. The screaming lasted 10 minutes. The redness subsided but purple spots remained. The parents brought the infant to the Emergency Room. The examination revealed an afebrile, alert smiling infant. He was well-hydrated and moving both lower extremities well. Good groin and pedal pulses were palpated and confirmed with hand-held doppler. Toes revealed 4 sec capillary refill. The ventral surfaces of the lower extremities revealed diffuse petecchiae, involving the entire right leg and mid-calf left leg. No other ecchymotic areas were noted. Left elbow revealed an eczematous rash otherwise the remaining skin was clear of rash. Firm non-fluctuant nodules were noted on the anterior thighs at the immunization sites. The nodules were tender but the remaining portion was non-tender. The remainder of the infants e am was normal. Enclosed are the infants lab results. In the following week, the infant had three more episodes, 1-5/2/99 and - 5/6/99. One episode was witnesses in the clinic. The infant started with crying, his lower body from umbilicus to toes symmetrically turned mottled and cyanotic, the left groin pulse was normal. The duration of mottling was 3-5 minutes and 2-3 sec capillary refill was noted on the sole of the foot. After cessation of crying, hyperemia of the lower extremities, about 10 minutes in duration, was noted. The episodes after 5/1/999 did not result in petecchiae. The parents did not notice any further events until a brief episode after an insect bite on 5/30/99. The patient was seen by a pediatric cardiologist on 5/5/99. A doppler ultrasound was performed of the lower extremity vasculature and it was read as normal. The report is enclosed. The patient was seen on 6/4/99 and noted to be in good health. Family history is negative for vasculitis and autoimmune disease. Antenatal history is remarkable for mother having gestational diabetes. She received Isulin and Prosac during prenancy.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site swelling
Clinical narrative: Area of erythema and slight rising above skin right deltoid area 4 to 5 cm- instructed to use ice pack and Benadryl.
Age: 6.42
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Contusion, Injection site erythema, Injection site induration
Clinical narrative: Redness, induration anterior thigh with mild bruising at injection site. Given Keflex and Benadryl.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema
Clinical narrative: 7 cm x 9 cm red area noted at injection site along with small blister like areas. Started out as small red dot getting larger with each day.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Rash maculo-papular, Rash papular, Skin ulcer
Clinical narrative: Spots noticed on 3-21-04- came to our office 3-24-04 with papular pustules and oral lesions. No fever.
Age: 0.67
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Erythema, Oedema
Clinical narrative: Thigh swollen red.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Urticaria
Clinical narrative: Immediate local reaction- red wheal approx 6 inch diameter- sent home with instruction to take Benadryl PO.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Partial complex seizure (right side) assoc with fever. Thought to be a typical febrile seizure- work up pending (248 hours after immunization).
Age: 8.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Eye discharge, Infection, Nasal congestion, Ocular hyperaemia
Clinical narrative: Beginning 3/01/04 left eye red, clear discharge, nasal congestion, fever, 3/13/04 skin lesions scalp, neck and left wrist. Chickenpox diagnosed.
Age: 8.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Beginning 3/01/04 left eye red, clear discharge, nasal congestion, fever, 3/13/04 skin lesions scalp, neck and left wrist. Chickenpox diagnosed.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Localized reaction to tetanus vaccination no systemic response 4 cm x 6 cm red indurated area, at site of vaccination.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Nasal congestion, Pyrexia, Screaming
Clinical narrative: Fever 100- Congestion & phlegm. Crying for 3 hours non-stop 5 min break for 2.
Age: 3.0
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Papular rash appeared 2 days ago on trunk now starting to look more vesicular-parent was unable to report staging of rash. Rash appears as "crop" or single papules neck and thru.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Positive redness, positive tenderness right lateral thigh left HIB site
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash maculo-papular, Swelling
Clinical narrative: Developed swelling of right lower ext. from groin to mid calf. Pink, blanching maculopapular rash around 13cm in diameter on mid thigh, medially, distant to vaccine site.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Pyrexia, Swelling
Clinical narrative: Left shoulder swelling. Warm to touch. Low grade fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Upper arm red and swollen around site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Morning after immunization pt woke with itchiness and then right upper arm was swollen, red and warm to the touch. Parents applied ice to arm.
Age: 7.7
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular, Rash vesicular, Viral infection
Clinical narrative: Pt presented with small scattered papules on back and trunk, arms and face. Diagnosed with chickenpox.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Rash erythematous, Rash macular, Skin nodule, Urticaria
Clinical narrative: Firm red nodule left lateral thigh 4.5x3.0cm. Macular/Reticular rash inner thigh left 11x10cm and Macular reticular rash inner thigh right 25x11 cm = urticaria resolved per mom. 4/15/2004 PM.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash
Clinical narrative: Rash on thigh area 10x12cm
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: Rash, pink papular 2-4 mm over face then spreading down trunk and limbs. No URI symptoms, No fever. Otherwise well.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Medication error, Nasopharyngitis, Pyrexia, Upper respiratory tract infection, Viral infection
Clinical narrative: Nasopharyngitis, Wheezing, Medication error. This case was reported by a pharmacist and described the occurrence of an upper respiratory tract infection in a patient who received diptheria and tetanus toxoids and acellular pertusis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On an unspecified date, the patient received the first dose of Pediarix. Approximately four days later, the patient received the second dose of Pediarix. This is sooner than the recommended schedule of six to eight weeks between the first and second doses. At an unspecified time following the second dose of Pediarix, the patient experienced an upper respirator tract infection, fever, a common cold and wheezing and was examined at a physician's office. The outcome of the events is unknown.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wheezing
Clinical narrative: Nasopharyngitis, Wheezing, Medication error. This case was reported by a pharmacist and described the occurrence of an upper respiratory tract infection in a patient who received diptheria and tetanus toxoids and acellular pertusis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On an unspecified date, the patient received the first dose of Pediarix. Approximately four days later, the patient received the second dose of Pediarix. This is sooner than the recommended schedule of six to eight weeks between the first and second doses. At an unspecified time following the second dose of Pediarix, the patient experienced an upper respirator tract infection, fever, a common cold and wheezing and was examined at a physician's office. The outcome of the events is unknown.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HIBV
Symptoms: Injection site erythema, Injection site necrosis, Injection site oedema, Injection site reaction, Muscle atrophy
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of possible muscular atophy or fat necrosis in a 7-month-old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On 24 November 2003, the patient received the second dose of Pediarix in his right thigh (lot 21893D9). On the same day, the patient received Haemophilus influenze type b conjugate vaccine (manufacturer unknown) and Influenza virus vaccine (manufacturer unknown). The site for the administration of Haemophilus influenzae type b conjugate vaccine and Influenza virus vaccine was not specified. On the same day, the patient experienced redness, and swelling at the injection site. On 26 November 2003, approximately two days after administration of Pediatrix, the swelling and redness at the injection site resolved and the patient developed "what appeared to be" and indentation at the injection site and "possible muscle atrophy or fat necrosis." Approximately two months later, " the patient was examined at the physician's office." The nurse practitioner considered the events to possibly be related to vaccination with Pediarix.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLUX, HIBV
Symptoms: Necrosis
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of possible muscular atophy or fat necrosis in a 7-month-old male patient who received diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On 24 November 2003, the patient received the second dose of Pediarix in his right thigh (lot 21893D9). On the same day, the patient received Haemophilus influenze type b conjugate vaccine (manufacturer unknown) and Influenza virus vaccine (manufacturer unknown). The site for the administration of Haemophilus influenzae type b conjugate vaccine and Influenza virus vaccine was not specified. On the same day, the patient experienced redness, and swelling at the injection site. On 26 November 2003, approximately two days after administration of Pediatrix, the swelling and redness at the injection site resolved and the patient developed "what appeared to be" and indentation at the injection site and "possible muscle atrophy or fat necrosis." Approximately two months later, " the patient was examined at the physician's office." The nurse practitioner considered the events to possibly be related to vaccination with Pediarix.
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Anorexia, Antisocial behaviour, Diarrhoea, Lethargy, Vomiting
Clinical narrative: Vomiting, Diarrhea, Lethargy, Anorexia, Disturbance in social behavior. This case was reported by a consumer and described the occurrence of vomiting in a 9 month old male patient who received diptheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. The reporting consumer is the patient's mother. A physician or other health care professional has not verified this report. On 23 February 2004 the patient received the first dose of Pediarix administered in the right leg. The consumer noted that the patient had received two previous vaccinations with the components of Pediarix, but administered as individual components rather than the combined vaccine. Each of the two previous immunizations were administered in the patient's left leg. The day after receiving Pediarix vaccination, on 24 February 2004, the patient experienced vomiting, diarrhea, lethargy and lack of appetite. The mother consulted the patient's physician and Pedialyte was initiated. The consumer stated that her son was "not himself" and wanted to be held "all the time". The events were unresolved at the time of reporting.
Sex: F
Vaccine: FLUN3
Symptoms: Accident, Medication error
Clinical narrative: SKIN LACERATION; ACCIDENTAL EXPOSURE. Information regarding Flumist 2003-2004 Formula (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a nurse who was administering the vaccine and experienced the syringe breaking  lacerating her thumb. A nurse, who was administering the vaccine, experienced the syringe breaking and lacerating her thumb (skin laceration) (accidental exposure). The reporter indicated that "she is fine now." No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Medication error, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: PYREXIA. Medication error. Rhinorrhoea, Runny Nose. Sneezing. Information regarding Flumist 2003-2004 Formula (influenza virus vaccine, live intranasal 2003-2004 formula nasal solution frozen was received from a mother regarding her 24 month old son who accidentally received Flumist, and experience a runny nose, sneezing, a fever of 102 degrees F and looks like a "sick kid". At 24 months of age, the patient received a dose in early December 2003. Approximately 5 days post-immunization, the child developed a runny nose and sneezing. On 30-Dec-2003, he developed a fever of 102 degrees F and was treated with Children's Motrin (Ibuprofen). On 31-Dec-2003, he developed a fever of 102 degrees F and was treated with Children's Motrin (ibuprofen). On 31-Dec-2003, the fever resolved, but the mother stated he looked like a sic kid. As of 5-Jan-2004, the runny nose persisted. No additional information was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Bronchitis, Sinusitis
Clinical narrative: Bronchitis. Sinusitis. Information regarding Flumist 2003-2004 formula influenza virus vaccine live intranasal 2003-2004 formula nasal solution frozen was received from a consumer regarding a male patient who experienced sinusitis and bronchitis. The patient received the first dose on an unspecified date. See related case HQWYE879510FEB04 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 31.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Feeling hot, Rhinorrhoea
Clinical narrative: RHINORRHOEA/RUNNYNOSE; FATIGUE/TIREDNESS; FEELING HOT/FEELING OF WARMTH; FEELING COLD/CHILLINESS; FEELING ABNORMAL. Information regarding flumist 2003-2004 formula influenza virus vaccine, live intranasal solution frozen was received from a 31 year old female consumer who developed a runny nose. She also felt funny and uncomfortable as well as warm, chilly and tired, after exposure to a "sick" person. The patient received a dose on 19-Dec-2003. On 19-Dec-2003, the day of vaccination, the patient developed a runny nose which "lasted until the last few days." Then on 03-Jan-2004, she began to "feel a little funny, tired, warm, chilly and uncomfortable, " after being exposed to someone sick on 01-Jan-2004. No additional information was available at the time of this report.
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: EPISTAXIS/NOSEBLEED. A nurse reported that a male child received a dose of flumist influenza virus vaccine, live intranasal 2003-2004 formula nasal solution frozen on 07-jan-2004 and experienced a nosebleed. The reporter described the nosebleed as "just a few drops of blood". The night before Flumist vaccination, the patient experienced a nosebleed in the same nostril; the reporter indicated that "the Flumist probably loosened a clot" from the previous night's nosebleed. It is unknown if Flumist was administered into the second nostril. No additional information was available at the time of this report.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Laboratory test abnormal, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Follow-up information received from the physician revealed results of an orthopaedic consultation on 12/15/03, including lab and diagnostic test results.  Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal solution (frozen) was received from a nurse regarding an 11 year old male pt who experienced a fever of 104 deg F., left ankle pain, elevation of ESR (erythrocyte sedimentation rate), and elevation of CRP (C-Reactive Protein).  The pt received a dose on 12/12/03.  The pt was reported as "healthy".  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 0.5mL (IN).  Concomitant medications were not reported.  On 12/14/03, 2 days post-immunization, the pt developed a fever of 104 deg. F. (pyrexia), and anteromedial lower left leg pain proximal to the ankle joint (arthralgia).  His fever was controlled with ibuprofen.  On 12/15/03, he was seen by an orthopaedic surgeon.  Abnormal lab values included an erythrocyte sedimentation rate of 21mm, and a C-reactive protein of 5 mg/dL.  Nuclear magnetic resonance imaging (MRI) of the left lower leg was normal.  On 12/18/03, the erythrocyte sedimentation rate was 35mm and on 12/19/03, the C-reactive protein was 6.18 mg/dL.  On 12/30/03, values of all labs drawn were within NL limits.  He was treated "symptomatically".  Continued observation and activity as tolerated was recommended.  As of 01/07/04, the child's symptoms had resolved completely.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug ineffective, Influenza
Clinical narrative: A nurse reported that a 6 year old female pt received a dose of Flumist (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) on an unspecified date and developed the flu.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose.  Concomitant medications were not reported.  One day post-immunization, a female pt "became sick with the flu" (influenza).  The pt "was not tested for positive flu type".  The reporter indicated that the pt's sibling was diagnosed via nasal swab for Type A/B flu, exposing the pt to the flu days prior to vaccination.  The reporter stated that a health care professional determined the pt's flu was related to exposure to her sibling prior to Flumist administration.  No additional information was available at the time of this report.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Fatigue, Headache, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 6 year old daughter who developed fever, headache, runny nose, sore throat, cough, muscle aches, fatigue and a sinus infection.  The pt received the first dose in Oct 2003.  The child had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered in October 2003.  Dose regimen was 0.5mL (IN).  Concomitant therapy included a 2nd dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) on 12/03/03.  On 11/01/2003, seven to ten days after receiving her first dose of Flumist, the pt developed a fever (pyrexia), tiredness (fatigue) and a cough (cough).  She also had a headache, runny nose, muscle aches (myalgia) and sore throat (pharyngolaryngeal pain).  The headache occurred "on and off" approximately 3-4 times a week. She was diagnosed with a sinus infection (sinusitis) after being seen by the physician on 8 separate occasions.  She was treated with four different regimens of antibiotics.  After receiving her second dose of Flumist on 12/03/03, the symptoms continued.  As of 02/24/04, the headache, runny nose, muscle aches and tiredness remain. The sore throat and cough resolved approximately three weeks prior to 02/24/04.  No additional information was available at the time of this report.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Pyrexia, Rhinorrhoea, Sinusitis
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a mother regarding her 6 year old daughter who developed fever, headache, runny nose, sore throat, cough, muscle aches, fatigue and a sinus infection.  The pt received the first dose in Oct 2003.  The child had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered in October 2003.  Dose regimen was 0.5mL (IN).  Concomitant therapy included a 2nd dose of Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) on 12/03/03.  On 11/01/2003, seven to ten days after receiving her first dose of Flumist, the pt developed a fever (pyrexia), tiredness (fatigue) and a cough (cough).  She also had a headache, runny nose, muscle aches (myalgia) and sore throat (pharyngolaryngeal pain).  The headache occurred "on and off" approximately 3-4 times a week. She was diagnosed with a sinus infection (sinusitis) after being seen by the physician on 8 separate occasions.  She was treated with four different regimens of antibiotics.  After receiving her second dose of Flumist on 12/03/03, the symptoms continued.  As of 02/24/04, the headache, runny nose, muscle aches and tiredness remain. The sore throat and cough resolved approximately three weeks prior to 02/24/04.  No additional information was available at the time of this report.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Drug ineffective, Influenza like illness
Clinical narrative: Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding his 6 year old son who received a dose of vaccine and experienced flu-like symptoms. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was not provided.  Concomitant medications were not reported.  The pt experienced flu-like symptoms (influenza like illness) immediately following receipt of vaccine (date unspecified).  His "flu-like" symptoms lasted about one week.  No additional information was available at the time of this report.