chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Injection site mass, Nausea, Rash
Clinical narrative: "knot" on arm at site of injection, rash on arms and both legs, nausea, dizziness and light-headed.
Age: 6.0
Sex: F
Vaccine: DTAP, MMR, OPV
Symptoms: Drug ineffective, Infection
Clinical narrative: History of varicella within 1 year of age per mom. Varivax given by HD on 8/3/99 and MD confirmed case of varicella on 4/28/01.
Age: 36.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Back pain, Erythema, Lymphadenopathy, Myalgia
Clinical narrative: Began having mid to lower back discomfort on 4/7/01 about 14:00. Continued with joint (knee and right hip) and general muscle aches. On 4/10/01 about 12:00, noted rash that was flat and pint to red on face and neck. Temperature was 99.5F. On 4/11/01, rash to arms and hands (non-palmer surface) and temperature was 100F. On 4/12/01, rash also on chest and back. Noted swollen glands behind ears and back of neck on right side more than left side. On 4/12/01, states feeling some better today, but "itchy". Some pain in right ear today.
Age: 36.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Began having mid to lower back discomfort on 4/7/01 about 14:00. Continued with joint (knee and right hip) and general muscle aches. On 4/10/01 about 12:00, noted rash that was flat and pint to red on face and neck. Temperature was 99.5F. On 4/11/01, rash to arms and hands (non-palmer surface) and temperature was 100F. On 4/12/01, rash also on chest and back. Noted swollen glands behind ears and back of neck on right side more than left side. On 4/12/01, states feeling some better today, but "itchy". Some pain in right ear today.
Age: 36.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Ear pain, Lymphadenopathy, Musculoskeletal discomfort, Myalgia
Clinical narrative: Began having mid to lower back discomfort on 4/7/01 about 14:00. Continued with joint (knee and right hip) and general muscle aches. On 4/10/01 about 12:00, noted rash that was flat and pint to red on face and neck. Temperature was 99.5F. On 4/11/01, rash to arms and hands (non-palmer surface) and temperature was 100F. On 4/12/01, rash also on chest and back. Noted swollen glands behind ears and back of neck on right side more than left side. On 4/12/01, states feeling some better today, but "itchy". Some pain in right ear today.
Age: 44.0
Sex: F
Vaccine: HEPA
Symptoms: Influenza like illness, Injection site haemorrhage, Injection site swelling
Clinical narrative: Flu-like symptoms. My arm was bruised and swollen and I missed 2 days of work.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Would be considered "side effect" and not significant adverse event. Child received DTAP vaccine in left upper thigh. Within 18 hours, developed 6cm X 8cm area of redness/swelling. Was seen 36 hours, post vax, and noted to have local reaction, no cellulitis or "urticarial" type reaction. No other sequela noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Redness, induration, warmth in left deltoid area, 1 day, post vax. Suspect reaction to Diphtheria component. Symptomatic treatment and empiric treatment for cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Swollen left upper leg/thigh 38cm; right leg 31cm. Reaction to DTAP. R/o cellulitis. Pt was afebrile. Treated with Rocephin, 1 gram, right thigh, in office. Sent to ER the same afternoon. Right thigh, parents claims, is increased in swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm, red and swollen at (DTAP) injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Local erythema and induration at injection site involving 2/3 of right lateral thigh around DTAP injection. Treated on 4/26/01 by Family NP with Augmentin. No fever or other systemic symptoms.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pallor, Vomiting
Clinical narrative: Very noticeable pale pallor; onset about 5 minutes, post vax, resolved in 1 hour. Able to talk, walk, normal pulse and BP. Vomited a small amount of emesis, post vax.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site inflammation, Injection site mass
Clinical narrative: Reported "small knot" and inflammation now at injection site on left arm. Has noted "knot" since injection. Inflammation for the past 3 days. Area at measures 8mm.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, VARCEL
Symptoms: Rash papular
Clinical narrative: Varicella vaccine received on 4/4/01. Developed red, papular rash, no vesicles. Brother developed chickenpox rash on 4/16/01 and 2nd brother also developed chickenpox.
Age: 20.0
Sex: U
Vaccine: UNK
Symptoms: Chest pain, Ecchymosis, Hypoaesthesia, Injection site pain, Migraine
Clinical narrative: Soreness in the arm (left arm where received shot); deep muscular pain; half of body went numb (left side); left arm turned purple; splotchy coloring in hands; chest pains and tightness; hives; swelling in lips and cheeks and a migraine.
Age: 20.0
Sex: U
Vaccine: UNK
Symptoms: Myalgia, Skin discolouration, Swelling face, Urticaria
Clinical narrative: Soreness in the arm (left arm where received shot); deep muscular pain; half of body went numb (left side); left arm turned purple; splotchy coloring in hands; chest pains and tightness; hives; swelling in lips and cheeks and a migraine.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Took varicella vaccine on 4/30/01. Broke out with varicella rash on 5/10/01. (Blister rash over head, trunk, face and extremities).
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Pruritus, Pyrexia
Clinical narrative: Within hours developed fever, dizziness, itchy and developed hives on legs and ankles, small amount on torso. Then developed trouble breathing and heart was racing. Client went to Urgent Care for evaluation. Was given epinephrine injection and a prescription. Was off work for 2 days.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Within hours developed fever, dizziness, itchy and developed hives on legs and ankles, small amount on torso. Then developed trouble breathing and heart was racing. Client went to Urgent Care for evaluation. Was given epinephrine injection and a prescription. Was off work for 2 days.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Diarrhoea, Ear pain, Eye swelling, Headache
Clinical narrative: Pt went to Urgent Care with complaints of swollen eyes, slight hives, headache, earache, weakness and rapid heart beat. Pt states, she was given Kenalog and "another shot" to combat reaction"; also had face swelling, vomiting and diarrhea. Pt took OTC Benadryl before going to MD.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Heart rate increased, Urticaria, Vomiting
Clinical narrative: Pt went to Urgent Care with complaints of swollen eyes, slight hives, headache, earache, weakness and rapid heart beat. Pt states, she was given Kenalog and "another shot" to combat reaction"; also had face swelling, vomiting and diarrhea. Pt took OTC Benadryl before going to MD.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Eye movement disorder, Fatigue, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Seizure, 1 week, post vax, lasting about 30-40 seconds. Eyes rolled back, fell unconscious, mild shaking of limbs. Very fatigued for several hours after seizure. On 4/28/01, had 2nd seizure about 30-40 seconds long and fell unconscious, eyes did not roll back and mild stiffness of extremities. Not yet recovered.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: Seizure, 1 week, post vax, lasting about 30-40 seconds. Eyes rolled back, fell unconscious, mild shaking of limbs. Very fatigued for several hours after seizure. On 4/28/01, had 2nd seizure about 30-40 seconds long and fell unconscious, eyes did not roll back and mild stiffness of extremities. Not yet recovered.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Joint stiffness, Joint swelling, Rash
Clinical narrative: Rash on lower arms and lower legs the day after injection X 5 days. 2 days, post vax, knees and elbows stiff X 1 1/2 days. On the 3rd day, post vax, fingers, ankles and feet swollen which lasted a couple of days. Notified MD. Pt refused treatment of cortisone. Took Tylenol for aching. No symptoms after 1 week.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema, warmth from elbow to shoulder.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Dizziness, Myalgia, Pyrexia
Clinical narrative: Feverish, weakness, significant generalized myalgias, light-headedness. Probable fever X 1-2 days.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Oral intake reduced, Pyrexia, Weight decreased
Clinical narrative: Mother called HD on 4/27/01 to report that child had a reaction to MMR given on 4/4/01. She states she took child to MD who was initially doubtful that symptoms were from vaccine. Symptoms of temperature of 104F X 4 days and poor appetite with weight loss during event (small amount of 2 lbs). Onset of symptoms was on 4/10/01.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Asthma, Chest pain, Dyspnoea, Flushing
Clinical narrative: The pt received Hep B on 4/23/01. Mother states the pt woke the next morning and was having trouble breathing and chest hurt. He  thought he was dreaming. He also complained of chin hurting. He thought he may have asthma like some one else he knows. The pt's face turned pale and then flushed. He also complained of a stomach ache.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pain, Pallor
Clinical narrative: The pt received Hep B on 4/23/01. Mother states the pt woke the next morning and was having trouble breathing and chest hurt. He  thought he was dreaming. He also complained of chin hurting. He thought he may have asthma like some one else he knows. The pt's face turned pale and then flushed. He also complained of a stomach ache.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hypoaesthesia, Rash
Clinical narrative: The pt experienced numbness, red rash, tingling the afternoon of the vax.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site urticaria
Clinical narrative: On 5/2/01 the pt woke with hives to injection site and both legs. No itching, no restlessness, afebrile, no dyspnea. Not at 9:20 has urticaria to her back, hands, arms, wrists as reported by mother and pediatrician. No treatment given at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: The pt experienced redness, swelling and pain at the site of injection.
Age: 1.3
Sex: F
Vaccine: DT, HIBV, PNC
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: 2-3 days post vax the pt experienced swelling of the left thigh accompanied by a fever of 103+.
Age: 0.08
Sex: F
Vaccine: PNC
Symptoms: Unevaluable event
Clinical narrative: A 2 week old female received Prevnar at an age less than recommended by US package insert. This report was a received on the day of immunization; no adverse event had occurred at that time.  No adverse experience had occurred after 2 weeks post vax.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Pt experienced swelling, redness, fever and hardening of left thigh. Pt was treated with antibiotic therapy.
Age: 1.8
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Pt experienced swelling, redness, warmth and hardening of the thigh; cellulitis. Put on omnicef. Pt treated with antibiotic therapy.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, PNC, HEP, IPV, MMR, PNC
Symptoms: Dyskinesia, Lymphadenopathy, Pyrexia, Restlessness, Somnolence
Clinical narrative: Within 48 hours post vax, the pt began to shake his head violently from side to side and jerk forward uncontrollably. Episodes lasted less than a minute and occurred many times a day for approximately 2.5 weeks before gradually subsiding. Pt also experienced a mild fever and slept restlessly during this time. In addition the pt had swollen lymph nodes, especially in the groin area.  The swelling was quite noticeable 2 weeks post vax.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, PNC, HEP, IPV, MMR, PNC
Symptoms: Tremor
Clinical narrative: Within 48 hours post vax, the pt began to shake his head violently from side to side and jerk forward uncontrollably. Episodes lasted less than a minute and occurred many times a day for approximately 2.5 weeks before gradually subsiding. Pt also experienced a mild fever and slept restlessly during this time. In addition the pt had swollen lymph nodes, especially in the groin area.  The swelling was quite noticeable 2 weeks post vax.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, PNC, HEP, IPV, MMR, PNC
Symptoms: Dyskinesia, Insomnia, Lymphadenopathy, Pyrexia, Tremor
Clinical narrative: Within 48 hours post vax, the pt began to shake his head violently from side to side and jerk forward uncontrollably. Episodes lasted less than a minute and occurred many times a day for approximately 2.5 weeks before gradually subsiding. Pt also experienced a mild fever and slept restlessly during this time. In addition the pt had swollen lymph nodes, especially in the groin area.  The swelling was quite noticeable 2 weeks post vax.
Age: 4.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt experienced swelling and redness at injection site.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Dry skin, Injection site erythema, Injection site vesicles, Rhinorrhoea
Clinical narrative: On 4/26 with 7-9 MP erythematous lesions. A few are vesicular and 2 with crusting. No fever, slight runny nose. No other complaints except a dry rough patch of skin on scrotum. All resolved 5 days later.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: The pt experienced a seizure lasting 5 minutes one day post vax. Temperature in ER was 101.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Pyrexia, Somnolence
Clinical narrative: The pt developed a fever on 4/25/01 through 4/26/01. The pt was drowsy also. The temp was 103.4 in the office.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site oedema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: The pt experienced a large local reaction starting immediately after the vax lasting 3 weeks. The next morning (24 hours later) the pt developed generalized hives, swelling, and itching which lasted 48 hours.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Sensory disturbance
Clinical narrative: The pt experienced a line (1-3 inches) mostly maculo-papular with an unusual sensation before rash. No pain. Lasted three days. Healed within 4 weeks.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Coma, Pneumonitis
Clinical narrative: Infant died in his sleep. Infant found unresponsive. Autopsy states cause of death as undetermined. Interstitial pneumonitis was a contributing factor in the death. Also noted were subdural neomembranes.
Sex: M
Vaccine: PPV
Symptoms: Hypoxia, Injury, Rash
Clinical narrative: Information has been received from a pharmacist concerning a male who was hospitalized and had a splenectomy due to trauma in early April 2001. On April 07, 2001, he received the 1st dose of Pneumococcal vaccine 23 polyvalent, 2nd dose on an unspecified date before 05/04/01, the patient's oxygen saturation levels began to decrease and he was placed on a ventilator. Additional info has been requested. After the fourth dose, the pt developed a rash on his upper body and at the same time his oxygen saturation levels began to decrease. he was transferred to the intensive care unit and was placed on a ventilator. The pharmacist felt that it was unknown if the rash was associated with the excessive number of doses of pneumococcal vaccine as an overdose an allergic reaction or if it was coincidental that it occurred after the fourth dose. On 05/17/2001, th ept remained hospitalized and it was unknown if the pt was still on the ventilator. Additional info has been requested.
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, MMR
Symptoms: Abnormal behaviour, Immunoglobulins increased, Insomnia, Neurodevelopmental disorder, Psychomotor hyperactivity
Clinical narrative: This child spiked a temp approximately 1 week later. He became more hyperactive, ceased taking daily naps, between 16 months and 18 months of age. Severe ADHD w developmental delay.
Age: 1.3
Sex: M
Vaccine: DTP, HIBV, MMR
Symptoms: Pyrexia
Clinical narrative: This child spiked a temp approximately 1 week later. He became more hyperactive, ceased taking daily naps, between 16 months and 18 months of age. Severe ADHD w developmental delay.
Age: 1.5
Sex: M
Vaccine: DTP, HIBV, OPV
Symptoms: Aphasia, Autism, Balance disorder, Drug level increased, Pyrexia
Clinical narrative: A mother reported that her son (now 13 years of age) received doses of Orimune, Tri-Immunol and HIB (Coww) vaccines on 4/20/89, when he was 18 months old. She indicated that her son "immediately" developed a fever, loss of speech and loss of balance. He was subsequently dx'd with autism. She indicated that her son was born "gifted" and was walking at 6 months of age. Post vax, he needed speech therapy to relearn words that he knew prior to immunization. He is presently receiving chelation therapy to remove mercury from his system and, according to his mother, he has made great progress. She also reported that her son developed redness at the Tri-Immunol site. Autism was considered "Medically Important". F/U 7/3/01 no updated info rec'd.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: On 5/2/01 PM, red area around injection site (4" around). At 03:00 AM, awoke complaining of pain to left leg and it was still red. Temperature was 99.6F. On 5/3/01 at 09:00, went to health dept with left leg very swollen, red, hot to touch, discomfort to touch, blue to purple color (area of injection) and skin felt thickened. Referred to MD. Dx'd with cellulitis. Temperature of 99F. Medications given were Omnicef 125mg 5ml (2 tsp) daily x 6 days therapy; prednisolone 150mg 1/1 tsp twice a day x 5 days. On 5/4/01, improvement of 25% or more, less swelling and red coloring was lightened. On 5/7/01, slight purple color about nickel-sized, no pain and no swelling. No fever; almost gone. Information from grandmother.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: On 5/2/01 PM, red area around injection site (4" around). At 03:00 AM, awoke complaining of pain to left leg and it was still red. Temperature was 99.6F. On 5/3/01 at 09:00, went to health dept with left leg very swollen, red, hot to touch, discomfort to touch, blue to purple color (area of injection) and skin felt thickened. Referred to MD. Dx'd with cellulitis. Temperature of 99F. Medications given were Omnicef 125mg 5ml (2 tsp) daily x 6 days therapy; prednisolone 150mg 1/1 tsp twice a day x 5 days. On 5/4/01, improvement of 25% or more, less swelling and red coloring was lightened. On 5/7/01, slight purple color about nickel-sized, no pain and no swelling. No fever; almost gone. Information from grandmother.
Age: 0.2
Sex: M
Vaccine: HEP, HIBV, IPV, PNC, TD
Symptoms: Unevaluable event
Clinical narrative: None- This patient needs to have DTaP ASAP.
Age: 1.9
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This patient's left lateral thigh had a reddened area 3 inches x 3 inches; painful to touch.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, PNC
Symptoms: Pyrexia, Rash, Rash macular
Clinical narrative: This infant had a fever, and a blotchy rash all over her body.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Irritability, Listless, Pyrexia, Vomiting
Clinical narrative: At 2:30 Pm, this infant had an IM PCV-7; at 6 :00 Pm he was vomiting, listlessness, fever, and irritable. On 05/02/01 at 2:45 AM, he had vomiting 6 - 7 times. The patient was directed to the ER. The patient was hydrated with pedialyte p.o. and given suppository to stop the vomiting and was released.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Erythema, Oedema
Clinical narrative: This patient came in for a routine well visit. Vaccines were given approximately 15 minutes later the child was still crying and her right leg was noted to be very swollen and red from the thigh area to near the top of the knee area. The patient was extremely fussy. Provider notified. Monitored the patient, no other signs and symptoms at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This child's right arm was swollen with redness and warm to touch at the injection site (deltoid area).
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash morbilliform, Skin discolouration
Clinical narrative: On 04/01 this infant had a rash all over her body. She had a fever of 101 the day after her vaccination. Her face and neck proceeded to rest of her body, pinkish not in palms. Measle like rash consistent with vaccine.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: This patient presented tot he office 48 hours after administration with a 7 cm edematous area on his right deltoid, the site was warm to touch. Temp Wnl 98.9. Complains of pain at the site. The patient is to return to the office in two weeks for a follow up.
Age: 16.0
Sex: M
Vaccine: HIBV
Symptoms: Asthma, Pruritus, Urticaria
Clinical narrative: Pneumovax recommended by MD at school physical exam. History of asthma. PPD also administered a the same time, approximately 3 PM on 04/11/01. By the evening the patient developed generalized itching, and hives, covering most of his body. Physician unavailable that evening. The patient was seen at neighboring clinic, where he was given Benadryl IM, then oral Benadryl every 4 - 6 hours. The hives were present on 04/12/01 in the AM,but reportedly resolving.
Age: 1.6
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Erythema, Oedema
Clinical narrative: On 03/28/01, telephone call from mother states left leg red and swollen. CHN visited, left leg swollen down to and including the knee. The child playing and walking. Pedal pulse was present, good pulse to leg and the foot. Instructed mom to use ice and Tylenol. Call PMD if worse.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Blister
Clinical narrative: T 2 -3 1 - 3 inch band of vesicles, no pain, lasted less than 4 weeks.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Blister, Gait disturbance, Otitis media
Clinical narrative: The pt experienced dermatome, 1-3 inch wide vesicles, limping and right otitis media.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Injection site inflammation, Injection site oedema, Injection site warmth
Clinical narrative: This child was swollen, inflammed, tissue (warm to touch), at the site of the DTaP and MMR vaccination (left deltoid). Rx: Augmentin.
Age: 16.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: This patient received a call on 03/29/01, from the patient's parent. The parent reports the patient had her menstrual period on 02/26/01. Received MMR on 02/12/01 pregnancy is confirmed at the present. Reviewed information - no known problems after receiving MMR. The mother had spoken with OB / Gyn also. Call was made to Merck to report incident. EDC 12/03/01.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Insomnia, Nausea, Pain
Clinical narrative: Mom states that after 1st Hep B series received, the child complained of leg pain and sick in stomach; lasted that night and the next day. In the past he had "growing pains" and felt coincidental. Gave 2nd series of Hep B, same thing occurred but much more worse. Severe leg pain, ankles to knees. The patient couldn't sleep all night, nauseated. It was worse the next day then it went away. None since.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt experienced right upper arm redness, swelling and warmth to the touch from shoulder to elbow per physicians report.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Erythema, Lacrimation increased, Pyrexia, Rash maculo-papular
Clinical narrative: The pt contacted the health department to report the following: The pt developed a fever 10 days post vax varying in range from 99-102. Followed by a red maculo-papular rash all over with olive sized nodules behind ears, watery eyes, nose and joint pain.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rhinorrhoea, Skin nodule
Clinical narrative: The pt contacted the health department to report the following: The pt developed a fever 10 days post vax varying in range from 99-102. Followed by a red maculo-papular rash all over with olive sized nodules behind ears, watery eyes, nose and joint pain.
Age: 45.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Arthralgia, Lacrimation increased, Myalgia, Pyrexia, Rash maculo-papular
Clinical narrative: The pt contacted the health department to report the following: The pt developed a fever 10 days post vax varying in range from 99-102. Followed by a red maculo-papular rash all over with olive sized nodules behind ears, watery eyes, nose and joint pain.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: This child had swelling and tenderness in her left arm it hurts to lift her arm, very painful redness. The patient instructed to take Tylenol and use warm compresses 15-20 minutes every 2 - 3 hours. Call if not better.
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This infants left leg had swelling, redness, and heat. Tylenol and Benadryl.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This child had 5.5 x 4.5 cm warmth, red, and tender area of right deltoid; cellulitis. Treated with Cephalexin for 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site rash, Injection site warmth, Pruritus
Clinical narrative: This child was given DTaP on 05/11/01 in the left upper thigh. A rash developed at the injection site on 05/13/01. Seen at the office on 05/14/01. 5 cm x 5 cm circular erythematous rash with central clearing, (+) warmth, (-) tenderness, (-) firmness, pruritic.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The pt experienced a 2 inch area of redness and is hot to the touch.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Rash papular
Clinical narrative: The pt received vaccines on 5/3/01. According to mom the pt developed a rash on left arm. No swelling, no redness. Only five papular rash extending 2-3" on left arm.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Coma, Convulsion, Drooling, Dyskinesia, Facial palsy
Clinical narrative: The mother called to say the child had a "kinda" seizure. Right arm had jerking movements. Drooling and drooping of mouth. Unresponsive for a few seconds. No fever noted.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Ear disorder, Infection, Speech disorder
Clinical narrative: Information has been received concerning fraternal twins that had the same shots on the same day. One child suffered ear infections and displayed speech and behavior regressing and the other did not. The only difference in their medical histories was that the regressed child had the hepatitis B vaccine (manufacture unknown) at 1 month of age and his twin sister had the hepatitis B vaccine (manufacture unknown) at 6 months of age. Upon internal review, behavioral disturbance and speech disorder were considered to be "Other Medical Events". No further information was reported.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Dehydration, Hypoaesthesia, Livedo reticularis, Mononeuritis
Clinical narrative: A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Peroneal nerve palsy, Red blood cell sedimentation rate increased, Renal failure, Thrombosis
Clinical narrative: A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Type IV hypersensitivity reaction, Vasculitis
Clinical narrative: A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Antinuclear antibody positive, Arthralgia, Ecchymosis, Paraesthesia
Clinical narrative: A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vasculitis
Clinical narrative: A 57 year old female reported that she received Flu-Shield ('00-'01 formula) on 11/29/00. On 11/30/00, she experienced pain and numbness in her right leg and foot. She was seen by her physician "who was more concerned about her elevated blood pressure." On 12/20/00, the pain reportedly intensified and had spread to her left leg. She was admitted to the hospital where a dx of vasculitis was made. She was treated with cyclophosphamide and was released. On 1/25/01, she developed kidney failure, dehydration and clots and was re-admitted to the hospital. She was told that a virus attacked her T-cells. She underwent a cardiac catheterization to look for clots. She was discharged; however, as of 5/14/01, she was still experiencing pain and numbness in both of her legs. Following changes were made: no other vaccines were given within 4 weeks, this event was considered life-threatening. Follow-up info received from the physician on 08/15/2001, indicated that the pt was diagnosed with mononeuritis multiplex, livedo reticularis, and foot drop. Test results revealed an elevated erythrocyte sedimentation rate, elevated C-reactive protein, and a positive p-antineutrophil cytoplasmic antibody.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Abdominal pain, Blood disorder, Blood glucose increased, Blood iron decreased, Diarrhoea
Clinical narrative: A parent reported that her 24 month old son received an injection of Prevnar on 5/9/01. On 5/10/01, at approx. 02:00 AM, he awoke with "severe" stomach cramps. At 09:00 AM, he developed a temperature of 103F and was given Tylenol. At 11:00 AM, he experienced lethargy and a seizure. Between 13:00 PM and 13:15 PM, he experienced 2 additional seizures. The reporter described the seizures as "jerks". The child's physician was notified and indicated that these were febrile seizures. The child was seen by the physician and blood work allegedly showed "low" iron and "low" RBC's. The child was hospitalized on 5/11/01; his mother indicated that her son was dx'd with "erythroblastemia". He received a transfusion and later released to home. On 5/14/01, the mother reported that her son developed "severe" diarrhea. No further information was available at the date of this report. F/U info received from the physician on 10/16/01, provided office and hospital medical records. On 5/10/01, the physician noted that the child was very fussy and lethargic and had a fever of 101.4F. During the exam, while the mother was holding the child, he experienced 3 separate episodes where his body jerked about 3 times each, followed by some crying. During these episodes, the child remained awake and did not lose consciousness. The physician noted that the child was pale and referred the child to the ER for a hematologic evaluation. The physician suspected a viral illness, possible febrile seizures and severe anemia. The following day, the child was transferred to a hospital. A primary dx of severe anemia, probable transient erythroblastopenia of childhood (TEC) was made. Associated dxs included fever and convulsions. He was transfused with 1 pedipak of packed RBC's and if well tolerated, 3 additional pedipaks were planned. The child was discharged to home and scheduled to return to the center within 7 to 10 days for a repeat CBC.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Dyskinesia, Febrile convulsion, Haemoglobin decreased, Irritability, Lethargy
Clinical narrative: A parent reported that her 24 month old son received an injection of Prevnar on 5/9/01. On 5/10/01, at approx. 02:00 AM, he awoke with "severe" stomach cramps. At 09:00 AM, he developed a temperature of 103F and was given Tylenol. At 11:00 AM, he experienced lethargy and a seizure. Between 13:00 PM and 13:15 PM, he experienced 2 additional seizures. The reporter described the seizures as "jerks". The child's physician was notified and indicated that these were febrile seizures. The child was seen by the physician and blood work allegedly showed "low" iron and "low" RBC's. The child was hospitalized on 5/11/01; his mother indicated that her son was dx'd with "erythroblastemia". He received a transfusion and later released to home. On 5/14/01, the mother reported that her son developed "severe" diarrhea. No further information was available at the date of this report. F/U info received from the physician on 10/16/01, provided office and hospital medical records. On 5/10/01, the physician noted that the child was very fussy and lethargic and had a fever of 101.4F. During the exam, while the mother was holding the child, he experienced 3 separate episodes where his body jerked about 3 times each, followed by some crying. During these episodes, the child remained awake and did not lose consciousness. The physician noted that the child was pale and referred the child to the ER for a hematologic evaluation. The physician suspected a viral illness, possible febrile seizures and severe anemia. The following day, the child was transferred to a hospital. A primary dx of severe anemia, probable transient erythroblastopenia of childhood (TEC) was made. Associated dxs included fever and convulsions. He was transfused with 1 pedipak of packed RBC's and if well tolerated, 3 additional pedipaks were planned. The child was discharged to home and scheduled to return to the center within 7 to 10 days for a repeat CBC.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Pallor, Red blood cell count decreased
Clinical narrative: A parent reported that her 24 month old son received an injection of Prevnar on 5/9/01. On 5/10/01, at approx. 02:00 AM, he awoke with "severe" stomach cramps. At 09:00 AM, he developed a temperature of 103F and was given Tylenol. At 11:00 AM, he experienced lethargy and a seizure. Between 13:00 PM and 13:15 PM, he experienced 2 additional seizures. The reporter described the seizures as "jerks". The child's physician was notified and indicated that these were febrile seizures. The child was seen by the physician and blood work allegedly showed "low" iron and "low" RBC's. The child was hospitalized on 5/11/01; his mother indicated that her son was dx'd with "erythroblastemia". He received a transfusion and later released to home. On 5/14/01, the mother reported that her son developed "severe" diarrhea. No further information was available at the date of this report. F/U info received from the physician on 10/16/01, provided office and hospital medical records. On 5/10/01, the physician noted that the child was very fussy and lethargic and had a fever of 101.4F. During the exam, while the mother was holding the child, he experienced 3 separate episodes where his body jerked about 3 times each, followed by some crying. During these episodes, the child remained awake and did not lose consciousness. The physician noted that the child was pale and referred the child to the ER for a hematologic evaluation. The physician suspected a viral illness, possible febrile seizures and severe anemia. The following day, the child was transferred to a hospital. A primary dx of severe anemia, probable transient erythroblastopenia of childhood (TEC) was made. Associated dxs included fever and convulsions. He was transfused with 1 pedipak of packed RBC's and if well tolerated, 3 additional pedipaks were planned. The child was discharged to home and scheduled to return to the center within 7 to 10 days for a repeat CBC.
Age: 1.7
Sex: M
Vaccine: DTP, IPV, PNC
Symptoms: Bacterial infection, Pyrexia, Sepsis
Clinical narrative: A nurse reported that a 20 month old male received his 2nd dose of Prevnar along with DTP and Poliomyelitis inactivated in December 2001. In April, 2001, he developed a fever and was taken to his pediatrician. Blood cultures were drawn and were positive for S. Pneumonia. Serotypes were not available on the date the report was submitted. Septicemia streptococcal was considered to be medically important. Follow up information received from vaccine provider on 05/15/01 provided the diagnosis of strep pneumococcal pneumoniae; the date of adverse event onset, as well as, the complete dates and lot numbers for each of the two Prevnar administrations. the reporter indicated that the patient recovered. Additional info from the reporter on 05/29/2001 provided the pt's name and date when the pt was hospitalized.  The hospital laboratory could not provide a serotype. The pt remained recovered.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a medical assistant concerning an 84 year old female with an allergy to sulfa and Codeine who on 04/25/01, was vaccinated with Pneumococcal vaccine 23 polyvalent. Concomitant therapy included Losartan Potassium (Cozaar) (MSD), furosemide (Lasix) and diltiazem hydrochloride (Dilacor XR). Subsequently in April or May 2001, the patient experienced swelling and redness at the injection site and cellulitis. The patient was treated with ceftriaxone sodium (Rocephin) IM for two days. Subsequently, the patient recovered from swelling at the injection site, redness at the injection site and cellulitis. Upon internal review cellulitis was determined to be an Other important Medical Event. Additional info has bee requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Apnoea, Hypoxia, Nervous system disorder, Somnolence, Vomiting
Clinical narrative: The pt vomited and appeared apneic about 1 hour post vax. The rescue squad delivered bag/valve mask ventilation. In the ER the pt had normal Physical exam except the pt experienced somnolence. The pt returned to normal mental status in ER was admitted to hospital overnight.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Apnoea, Vomiting
Clinical narrative: The pt vomited and appeared apneic about 1 hour post vax. The rescue squad delivered bag/valve mask ventilation. In the ER the pt had normal Physical exam except the pt experienced somnolence. The pt returned to normal mental status in ER was admitted to hospital overnight.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Epilepsy, Status epilepticus
Clinical narrative: This patient received immunizations on the day prior to admission. On the day of admission she was taken to the ED in status epilepticus. She was being treated for epilepsy with Zonisamide and Klonopin. The father reports epilepsy began with the first DTP. Diagnosed with carbamazepine overdose.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Bronchospasm, Cough, Wheezing
Clinical narrative: The child developed bronchospastic cough approximately 45 minutes after immunization. On lung exam, she had diffuse wheezing which was not present on initial exam. She was treated with Prelone and given three Albuterol nebulizer treatments. After which she had minimal wheezing. Then approximately 2 hours later the patient developed persistent cough and diffuse wheezing on exam. Therefore was sent to the ER for further management.
Age: 72.0
Sex: M
Vaccine: PPV, TD
Symptoms: Dizziness, Oedema, Pyrexia
Clinical narrative: This patient complained of swelling, dizziness, and subjective fever per mother. The patient went to the hospital and was admitted .
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chest pain, Guillain-Barre syndrome
Clinical narrative: The pt was diagnosed with chest and abdominal pain. Then went into Guillain Barre Syndrome.
Age: 1.3
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling noted by mom, the afternoon following DTAP injection. Area was approx. 2" in diameter. Spontaneously resolving now. By the next day, redness gone and swelling decreased.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC
Symptoms: Erythema, Eye disorder, Lymphocytosis, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Fine, erythema, maculopapular rash all over body. Injection of the conjunctiva and profuse rhinorrhea.
Age: 1.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Hives on torso and arms which began approx. 8 hours, post vax. Did not appear to cause discomfort. No treatment. By morning, gone, except for a couple patches of redness.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dyskinesia, Pyrexia, White blood cell count increased
Clinical narrative: Vaccines given 5/8/01 afternoon. Pt slept all afternoon and night. On 5/9/01 AM, pt had several jerking movements of head, hands and feet for a few seconds duration with 10-15 minute intervals. Pt febrile.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The pt had mild erythema, pain on palpitations. Injection was given on 5/15/01 and the pt was seen for reaction. The pt was prescribed Atarax, Keflex and Triamcinolone.
Age: 0.4
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Mother states child developed temperature > 102F. Rash noted on torso but resolved within 24 hours. Child was irritable for 1 week, post vax. No reaction from 1st set of shots.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Intermittent fevers X 1 year. She states symptoms started after receiving anthrax vaccination.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Chest pain, Cough, Depression, Diarrhoea
Clinical narrative: Within 10-12 hours, onset of diarrhea, tightness in throat, non-productive persistent cough, feeling of choking in base of throat, hot feeling in lungs, chest pains in upper left chest, laryngitis, anxiety, depression; treatment with prednisone, Diflucan, quaifenisen, codeine cough syrup, Ativan. At present, still have cough, diarrhea and anxiety. On 1/10/01 had yeast infection in mouth, throat and vocal cords; treated with Diflucan (3 rounds). On 5/8/01, had 12 day prednisone treatment begun with Diflucan in case of reoccurrence of yeast.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Fungal infection, Laryngitis, Throat tightness
Clinical narrative: Within 10-12 hours, onset of diarrhea, tightness in throat, non-productive persistent cough, feeling of choking in base of throat, hot feeling in lungs, chest pains in upper left chest, laryngitis, anxiety, depression; treatment with prednisone, Diflucan, quaifenisen, codeine cough syrup, Ativan. At present, still have cough, diarrhea and anxiety. On 1/10/01 had yeast infection in mouth, throat and vocal cords; treated with Diflucan (3 rounds). On 5/8/01, had 12 day prednisone treatment begun with Diflucan in case of reoccurrence of yeast.