chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity
Clinical narrative: Seen 11/29/2001 for vaccine. Doing fine until 12/07/2001. Red, hot to touch, itchy 6 diameter circle. Treatment Zyrtec and Amoxil.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injection site hypersensitivity, Oedema, Pyrexia
Clinical narrative: Fever, chills, area of slight swelling but very tender and red at vaccine site. As of 12/12/2001 oval with 5" diameter of erythema, heat and tenderness.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Rash macular
Clinical narrative: Five cm erythematous raised macule.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Blister, Erythema, Headache, Injection site induration, Joint range of motion decreased
Clinical narrative: Fever, headache, swelling at injection site with redness and burning pain. Pt seen again after injection...blister positive and drain. Still indurated on deltoid, lack of full range of motion, 1 cm base, blister evident, deltoid are itching.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Oedema, Pain, Pruritus, Pyrexia
Clinical narrative: Fever, headache, swelling at injection site with redness and burning pain. Pt seen again after injection...blister positive and drain. Still indurated on deltoid, lack of full range of motion, 1 cm base, blister evident, deltoid are itching.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Erythema multiforme, Injection site induration, Oedema, Pruritus
Clinical narrative: DTaP given on 12/7/2001. On 12/08/2001 at left deltoid pt with redness and swelling. On 12/09/2001 pt with increased itching, erythema and induration. Size about 4 by 4 cm per Mom. Benadryl 1 tsp given once with decreased itching. On 12/10/2001 AM noted to have decreased erythema and swelling but with erythema ring. Erythema multiforme with rash around original...
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: DTaP given on 12/7/2001. On 12/08/2001 at left deltoid pt with redness and swelling. On 12/09/2001 pt with increased itching, erythema and induration. Size about 4 by 4 cm per Mom. Benadryl 1 tsp given once with decreased itching. On 12/10/2001 AM noted to have decreased erythema and swelling but with erythema ring. Erythema multiforme with rash around original...
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Bronchitis, Conjunctivitis, Irritability, Pyrexia, Rash
Clinical narrative: Chicken pox like rash with low grade fever, cough, irritability-mild. Tow bacterial conjunctivitis treated with no smoking and opthalmic solution and Zithromax for bronchitis.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Pain in right arm, up shoulders and into neck at 7 PM 12/11/2001.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Present vesicles and papules on buttocks, inner thighs. Lesions lower legs some on pharynx.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Mild erythema of left upper arm with swelling. Local warm compress and Motrin PRN.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Swelling of left arm mild redness.
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Vasodilation procedure
Clinical narrative: Hospital employee given influenza vaccine, then went home. Injection site became red, hot, raised (about 3 inches by 4 inches). Reported to infection control nurse on 12/12/2001. Still red and hot.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Abasia, CSF test abnormal, Coordination abnormal, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: This report was received from the center for biologics evaluation and research (Vaers ID 175201). It was reported that a 15 mo old female rec'd a 4th dose of Prevnar vaccine for immunization on 7/23/01. Concurrent illness includes a upper respiratory infection beginning in August. Additional suspect medication includes Act-HIB (Aventis Pasteur) (Haemophilus B conjugate vaccine) and MMR-II (MSD) (measles, mumps and rubella vaccine). On 8/13/01, the child began to stumble and sometimes was unable to walk with questionable limping. She was examined on 8/14/01 and 8/16/01, with normal exam results. She was again examined on 8/22/01 and noted weakness in the lower extremities with absent deep tendon reflexes. She was given a diagnosis of Guillain-Barre Syndrome. The pt was treated with intravenous immunoglobulin (manufacturer unknown) on 8/28/01 and 8/29/01. Lab tests and data included MRI of the brain (negative) and a lumbar puncture (elevated protein in spinal fluid).She was hospitalized for 8 days. No additional information was available as of the date of this report.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Muscular weakness
Clinical narrative: This report was received from the center for biologics evaluation and research (Vaers ID 175201). It was reported that a 15 mo old female rec'd a 4th dose of Prevnar vaccine for immunization on 7/23/01. Concurrent illness includes a upper respiratory infection beginning in August. Additional suspect medication includes Act-HIB (Aventis Pasteur) (Haemophilus B conjugate vaccine) and MMR-II (MSD) (measles, mumps and rubella vaccine). On 8/13/01, the child began to stumble and sometimes was unable to walk with questionable limping. She was examined on 8/14/01 and 8/16/01, with normal exam results. She was again examined on 8/22/01 and noted weakness in the lower extremities with absent deep tendon reflexes. She was given a diagnosis of Guillain-Barre Syndrome. The pt was treated with intravenous immunoglobulin (manufacturer unknown) on 8/28/01 and 8/29/01. Lab tests and data included MRI of the brain (negative) and a lumbar puncture (elevated protein in spinal fluid).She was hospitalized for 8 days. No additional information was available as of the date of this report.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC, HIBV, MMR, PNC
Symptoms: Asthenia, CSF test abnormal, Gait disturbance, Guillain-Barre syndrome, Hyporeflexia
Clinical narrative: This report was received from the center for biologics evaluation and research (Vaers ID 175201). It was reported that a 15 mo old female rec'd a 4th dose of Prevnar vaccine for immunization on 7/23/01. Concurrent illness includes a upper respiratory infection beginning in August. Additional suspect medication includes Act-HIB (Aventis Pasteur) (Haemophilus B conjugate vaccine) and MMR-II (MSD) (measles, mumps and rubella vaccine). On 8/13/01, the child began to stumble and sometimes was unable to walk with questionable limping. She was examined on 8/14/01 and 8/16/01, with normal exam results. She was again examined on 8/22/01 and noted weakness in the lower extremities with absent deep tendon reflexes. She was given a diagnosis of Guillain-Barre Syndrome. The pt was treated with intravenous immunoglobulin (manufacturer unknown) on 8/28/01 and 8/29/01. Lab tests and data included MRI of the brain (negative) and a lumbar puncture (elevated protein in spinal fluid).She was hospitalized for 8 days. No additional information was available as of the date of this report.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Cyanosis, Haematemesis, Hypotonia, Vomiting
Clinical narrative: This report was rec'd from the center for biologics evaluation and research (Vaers ID 175328), It was reported that a 3 mo old male rec'd 2nd dose of Prevnar vaccine on 8/20/01. additional suspect medication included Infanrix (SK) (diphtheria vaccine/pertussis vaccine/tetanus vaccine). Comvax (MSD) (haemophilus B conjugate vaccine/hepatitis B vaccine). and polio vaccine "Pasteur" (Aventis Pasteur) (poliomyelitis vaccine inactivated) On 8/20/01 at 23:45, the infant vomited his stomach contents and continued vomiting until it was pink streaked bile-like substance. On 8/21/01, at approximately 01:00, the parents brought the infant to the ER. The infant became limp and dusky in color. While waiting in the ER, the child returned to a normal state. He was discharged to home with his parents. No additional information was available as of the date of the date of this report. This case was considered serious since hematemesis, hypotonia and dusky color were considered medically important in this case.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Febrile convulsion
Clinical narrative: A five year old male received injections of Prevnar (1st dose), HIB-Titer, Infanrix and IPV on 07-SEP-2001. He had no preexisting illnesses and was receiving no medications concomitantly. Following vaccination the child developed fever, then "possibly" had a febrile seizure. Febrile seizure is considered to be a medically important event. Follow up information received on 10-DEC-2001 regarding results of HIB-Titer quality assurance testing. There were the adverse event reported. No samples were returned for evaluation. No retained samples were examined due to complaint being received after product expiry.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: A five year old male received injections of Prevnar (1st dose), HIB-Titer, Infanrix and IPV on 07-SEP-2001. He had no preexisting illnesses and was receiving no medications concomitantly. Following vaccination the child developed fever, then "possibly" had a febrile seizure. Febrile seizure is considered to be a medically important event. Follow up information received on 10-DEC-2001 regarding results of HIB-Titer quality assurance testing. There were the adverse event reported. No samples were returned for evaluation. No retained samples were examined due to complaint being received after product expiry.
Age: 0.8
Sex: M
Vaccine: PNC, PNC
Symptoms: Cough, Respiratory rate increased, Rhinorrhoea, Sneezing, Wheezing
Clinical narrative: A mother reported that her 10 mo old son rec'd his 3rd dose of Prevnar on 9/19/01, subsequently he developed a high fever, difficulty breathing, coughing, wheezing, vomiting a fast heart beat and high blood pressure. The infant was seen in an ER and hospitalized. No further information was available at the date of this report. Follow up info was received from a physician on 12/20/01. The child received his first doses of IPV and Prevnar in the physician's office on 4/19/01 without any problems. He received his second and third doses of Prevnar at a public clinic and not in the physician's office. Two days following the third dose of Prevnar, he was hospitalized. He was discharged on albuterol and prednisone with a differential diagnosis of bronchiolitis vs. obstructive airway disease. Chest x-ray revealed no active disease. Respiratory syncytial virus titer was negative. The child was seen in the office for follow up on 9/24/01 where mild rhinitis and mild diffuse wheezing were noted on exam. He was seen again on 9/28/01 with minimal wheezing. The child's overall assessment by the physician was improved.
Age: 0.8
Sex: M
Vaccine: PNC, PNC
Symptoms: Cough, Dyspnoea, Hypertension, Pyrexia, Tachycardia
Clinical narrative: A mother reported that her 10 mo old son rec'd his 3rd dose of Prevnar on 9/19/01, subsequently he developed a high fever, difficulty breathing, coughing, wheezing, vomiting a fast heart beat and high blood pressure. The infant was seen in an ER and hospitalized. No further information was available at the date of this report. Follow up info was received from a physician on 12/20/01. The child received his first doses of IPV and Prevnar in the physician's office on 4/19/01 without any problems. He received his second and third doses of Prevnar at a public clinic and not in the physician's office. Two days following the third dose of Prevnar, he was hospitalized. He was discharged on albuterol and prednisone with a differential diagnosis of bronchiolitis vs. obstructive airway disease. Chest x-ray revealed no active disease. Respiratory syncytial virus titer was negative. The child was seen in the office for follow up on 9/24/01 where mild rhinitis and mild diffuse wheezing were noted on exam. He was seen again on 9/28/01 with minimal wheezing. The child's overall assessment by the physician was improved.
Age: 0.8
Sex: M
Vaccine: PNC, PNC
Symptoms: Vomiting, Wheezing
Clinical narrative: A mother reported that her 10 mo old son rec'd his 3rd dose of Prevnar on 9/19/01, subsequently he developed a high fever, difficulty breathing, coughing, wheezing, vomiting a fast heart beat and high blood pressure. The infant was seen in an ER and hospitalized. No further information was available at the date of this report. Follow up info was received from a physician on 12/20/01. The child received his first doses of IPV and Prevnar in the physician's office on 4/19/01 without any problems. He received his second and third doses of Prevnar at a public clinic and not in the physician's office. Two days following the third dose of Prevnar, he was hospitalized. He was discharged on albuterol and prednisone with a differential diagnosis of bronchiolitis vs. obstructive airway disease. Chest x-ray revealed no active disease. Respiratory syncytial virus titer was negative. The child was seen in the office for follow up on 9/24/01 where mild rhinitis and mild diffuse wheezing were noted on exam. He was seen again on 9/28/01 with minimal wheezing. The child's overall assessment by the physician was improved.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Blood pressure increased, Flushing, Heart rate increased, Hypothermia, Pruritus
Clinical narrative: Pt presented at ER same day as flu shot with erythema, scattered hives, pruritis, throat swelling.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Respiratory rate increased, Stridor, Throat tightness
Clinical narrative: Pt presented at ER same day as flu shot with erythema, scattered hives, pruritis, throat swelling.
Age: 57.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Erythema, Laryngospasm, Pruritus, Urticaria
Clinical narrative: Pt presented at ER same day as flu shot with erythema, scattered hives, pruritis, throat swelling.
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Pt. states first day hot, hard and itchy. second day hives under left o-- and spread to breasts & legs. third day arm very swollen, could not bend, hot to touch and very red. Went to ER on 12/01/01. given Benadryl, so
Age: 59.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Feeling hot, Pruritus, Urticaria
Clinical narrative: Pt. states first day hot, hard and itchy. second day hives under left o-- and spread to breasts & legs. third day arm very swollen, could not bend, hot to touch and very red. Went to ER on 12/01/01. given Benadryl, so
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Myelitis transverse, Paraesthesia
Clinical narrative: A phamacist reported that a 53 year old female received an injection of Flu Shield on 29-NOV-2001. Within one hour of vaccination, the pt developed paresthesia in her right foot which "traveled up her right side". She was hospitalized where an MRI showed transverse myelitis. No further information was available at the date of this report. The follow up states MRI of her spine showed a 1cm area of plaque at the T2 level. An MRI of the brain was normal. An analysis of her cerebrospinal fluid showed no abnormalities. A diagnosis of transverse myelitis was made. A visual evoked response potential test was normal. Somatosensory evoked potential of the posterior tibial area showed no reproducible cortical activity on the right. As of March 2002, the pt had "nearly complete resolution of symptoms"; however, she still complains of "occasional episodes of tingling in the leg."
Age: 0.8
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Aphasia
Clinical narrative: On 21-JUL-2000 the child received an injection of a Engerix-B. Subsequently, on an unspecified date he received an injection of a Recombivax-HB. In October 2001, the child's parent reported that he "started showing signs of autism" including not making eye contact, "several" unspecified developmental delays " a lot of" repetitive behavior and lack of speech. The parent reported that the child had been evaluated by a physician. Autism is considered medically serious.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: On an unspecified date, the child received an injection of Engerix-B; it was not known if the child had received previous injections of Engerix-B. The child also received injections of diphtheria and tetanus toxoids and acellular pertussis vaccine (see 20010297472), inactivated poliomyelitis virus vaccine, MMRII and Haemophilus influenza type b conjugate vaccine. Dates of immunization, and number of doses of each vaccine, were not provided. The child also received a tuberculosis purified protein derivative skin test on an unspecified date. The child's parent reported that, at 3.5 years of age, the child had a delay in the ability to speak and had a vocabulary of approx. 12 words. The child "was evaluated by the local school district, which stated that the child shows signs of autism and that can be caused by mercury poisoning". The parent reported that the child had not been evaluated by a physician. Possible autism and possible mercury poisoning in this report are considered to be "Other Important Medical Events".
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: It is reported that a 2 mo old female would not respond to her mother following receipt of diptheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). this report was rec'd from the infant's mother and has not been verified by a physician or other healthcare professional.  On 12/10/01, the infant rec'd her 1st injection of Infanrix. on that date, she also rec'd injections of Haemophilus influenza type b conjugate vaccine (brand name unknown), inactivated poliomyelitis virus vaccine (IPOL) Aventis Pasteur), and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle labs). It was not known if she had rec'd previous injections of these vaccines. The parent reported that 1 hr post immunization the infant developed diarrhea., later that evening, an unspecified time post immunization she reportedly developed a fever of 104.7F and would not respond to her mother. The infant was hospitalized from 12/10 to 12/13/01. The parent reported that it was not determined what was wrong with her as of 12/13 the fever and diarrhea had resolved, but the infant still is not acting normal. The mother reported that the infant rec'd Infanrix lot DTPA522284A, however this is not a valid lot number.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Grunting, Hypoxia, Pyrexia, Thrombocythaemia, Vomiting
Clinical narrative: Information has been received from a LPN concerning a 21 month old pediatric pt who on 9/28/01, at 11:00, was vaccinated SC, in her right thigh, with varicella virus vaccine live (lot 638491/1901K). At that time, the pt's temperature was 97.5F. On follow-up, it was reported that on 9/28/01, at 15:00, 4 hours, post vax, the pt developed a fever and excessive vomiting. The pt was taken to her physician's office for medical attention for her symptoms. At 15:43, the pt's temperature was 102.7F. The pt developed grunting (respiratory distress( because of her rapid rise in temperature. She was placed on a pulse oximeter which revealed an oxygen saturation of 87%. The pt was placed on oxygen therapy and sent to the ER via ambulance. After 1 hour of oxygen therapy, the pt recovered. Her oxygen saturation via pulse oximeter was 99%. Upon internal review, respiratory distress was considered to be an "Other Important Medical Event". In a few hours, after her arrival in the ER, the pt was sent home with a low-grade fever (99.0F to 100F) which lasted 2 days. Subsequently, the pt recovered from her symptoms. No further information was reported. Further follow up info was received from a physician. The child was evaluated on 10/26/01 for thrombocytosis. At the time of evaluation, he did not have any clinical symptoms. His physical exam and lab studies were within normal limits (HGS 12.7, WBC 7,700 and platelet count 359,000). It was documented that he was first noted to have an elevated platelet count "earlier this year," that elevated between 700 to 100,00 at times of viral infections or infectious processes and resolved when the infections subsided. He was diagnosed with reactive thrombocytosis. The physician indicated that the child would be followed on an "as needed" basis. Additional follow up inof revealed that the child had Pre-existing asthma. He was seen on 11/6/01 and it was reported that he seemed to have "done well with regard to asthma symptoms over the summer." It was reported that the physician thought the pt needed to use his nebulizer once. It was not known what the trigger was in that instance. On the whole, the child had not needed to use the nebulizer. It was noted that generally, he has more trouble during the child season. At the time of this evaluation, the child's chest was clear. The physician noted that varicella virus vaccine live "does not contain any egg proteins" and that if the child reacted to the vaccine, it might be attributed to another component, "possibly the gelatin." He further noted that he was not quite sure to what the child reacted. In addition, it was noted that the child had tolerated vaccination with MMR II without problems. No further info is available.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Ovarian cancer, Renal vasculitis, Vasculitis
Clinical narrative: In 11/00, the pt was hospitalized due to leucocytoclastic vasculitis affecting skin and kidneys. Ovarian cancer was dx'd while in the hospital and the pt had a good response to chemotherapy (pallilative). The event resolved in 4/01 and the pt recovered. There was insufficient information to determine the reporter's causality assessment.
Age: 1.09
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: The pt had a seizure on 12/18/01, 6 hours post vax. She was admitted to the hospital for observation and further testing. Neurologist to comment. Still in the hospital on 10/19/01. Per 1 year follow up: Pt did not recover. Pt continues with a seizure disorder. She is followed by neurologist on Phinobarb and Vulparic acid. Pt also see another MD at the hospital.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Asthma, Cough, Irritability, Oral intake reduced, Photophobia
Clinical narrative: This is a 1 year old male concerning a possible measles contraction from an MMR vaccine. He received IV Solu-Medrol while at ER and was on a po steroid taper, finished 10/15/01. He received an MMR vaccine and had a fever to 104F the 3 days, following vaccination. He was in his usual state of health until 11/9/01, when he developed a temperature of 102F. A macular rash was noted on his face 11/9/01, and by 11/10/01, had spread to his legs and trunk. He was treated with Benadryl and Tylenol as an outpatient but 11/12/01, was noted by his paternal grandmother to have increased irritability and decreased po intake along with photophobia. He was sent to the ER and transferred to the hospital. He had mild rhinitis and a cough consistent with his asthma that was nonproductive. No other known contacts regarding measles. The infectious disease dept was consulted and felt that serology would not help in the dx as IgM would be positive both after vaccination and with a wild-type exposure. The pt was observed overnight and remained stable and was discharged on 11/13/01, in the care of his guardian, his grandmother. He was to continue his Pulmicort bid and his albuterol prn and was instructed to call MD's office for a follow-up appointment.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash macular, Rhinitis
Clinical narrative: This is a 1 year old male concerning a possible measles contraction from an MMR vaccine. He received IV Solu-Medrol while at ER and was on a po steroid taper, finished 10/15/01. He received an MMR vaccine and had a fever to 104F the 3 days, following vaccination. He was in his usual state of health until 11/9/01, when he developed a temperature of 102F. A macular rash was noted on his face 11/9/01, and by 11/10/01, had spread to his legs and trunk. He was treated with Benadryl and Tylenol as an outpatient but 11/12/01, was noted by his paternal grandmother to have increased irritability and decreased po intake along with photophobia. He was sent to the ER and transferred to the hospital. He had mild rhinitis and a cough consistent with his asthma that was nonproductive. No other known contacts regarding measles. The infectious disease dept was consulted and felt that serology would not help in the dx as IgM would be positive both after vaccination and with a wild-type exposure. The pt was observed overnight and remained stable and was discharged on 11/13/01, in the care of his guardian, his grandmother. He was to continue his Pulmicort bid and his albuterol prn and was instructed to call MD's office for a follow-up appointment.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Lethargy, Malaise, Pyrexia
Clinical narrative: 12/17/2001 11:30 Rapid pulse, chills, shortness of breath, fatigue, malaise and fever  of 104 .took ASA and slept.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Rash
Clinical narrative: 11/13/2001 *:00 am-Awakened with a headache, took two Advil tablets 8:30 headache 3:00 pm received the Flu vaccine 3:30 pm took two Tylenol tablets 6:30 pm  while changing clothes had red, very raised blotched areas from armpit and below, nipple line to neckline  7:00 pm took Benedryl 8:30 pm asleep to 11/14/2001 at 7:00 am, without rash.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Heart rate increased, Nasal congestion, Wheezing
Clinical narrative: Approx. 1 hours and 45 minutes, post vax, the pt experienced rapid heart beat, wheezing, congestion, heaviness in mid-chest. No history of asthma. The pt thought the room where symptoms occurred had a strong "moldy smell". The time course was 45 minutes then wheezing stopped, congestion gone and heaviness had diminished. She refused treatment.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: The pt received vaccines on 12/11/01 and post vax, her mother noted a red and warm area on her right thigh and called the office, She was instructed to apply compresses and give Tylenol. She called 24 hours later and came in for appointment. The right thigh was erythematous, indurated and warm (about 10cm X 8cm area). It was very swollen and erythematous (2cm X 2cm area at center of induration with a small scratch. No fever. She was started on Keflex X 7 days. 24 hours later, she had decreased erythema. No fever. Follow-up to be in 72 hours. The site of cellulitis is at Prevnar injection.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: TaP given on 12/11/2001 in LT. On 12/13/01 a red area, measuring 9 cm X 5.5 cm and warm to the touch appeared at the injection site.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site rash
Clinical narrative: The pt developed a rash around right leg vaccine site and on cheeks approx. 15 minutes, post vax.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Eye disorder, Headache, Muscle twitching, Photophobia
Clinical narrative: The pt developed an onset of headache, photophobia and eyelid twitching about 5-6 hours, post vax. No history of similar symptoms.
Age: 28.0
Sex: F
Vaccine: HEPAB, IPV, TD, TYP
Symptoms: Abdominal pain, Nausea
Clinical narrative: The pt called the clinic on 12/9/01 to report abdominal cramping and with an urge to vomit (no emesis) several hours, post vax, of taking 1st dose (capsule) of oral Typhoid (on 12/3/01). This resolved spontaneously. (No rash or itching). It was taken on an empty stomach as per instructions.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: After 1 full week, the pt had a fever of 99.8F max, lethargic (mom had to wake baby up to feed). Mom took her outside in the sun to wake baby up.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: 11/30/2001-Rash on abnormal up to patient's neck 12/01/2001-Welts on patient's back
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Blood pressure increased, Injection site erythema, Injection site induration
Clinical narrative: The pt's symptoms were observed at company health care on 11/30/01 on her left upper arm. There is a 7mm area of induration and redness centrally with 3cm redness and slight induration peripherally at the site of vaccine. No drainage, open lesions or lymphangitis. No systemic symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On 12/5/01, the pt's right arm reddened. On 12/6/01, the entire upper arm was swollen, skin taut and reddened. He was taken to ER and given Keflex and Benadryl. On 12/7/01, the swelling was extended past his elbow. He denies pain. Child is active.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Hypoaesthesia
Clinical narrative: The vaccine was administred at 2:45. In one hour, patient experienced pain in that arm; numbness at injection site and down to her finger tips. There was no discoloration. she couldn't move her fingertips for two hours. Two hours after the injection, her nose felt swollen, though this symptom couldn't be visually verified. She states that it was difficult for her to pass air through her nostrils. Patient saw urgent care. 11/15/2001 3:30 pm states reaction to Hep. B vaccine. 11/16/2001 Patient saw her M.D., who prescribed steroid & antihistamine for treatment. Two hours after treatment-no change was noted.
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site hypersensitivity, Pruritus, Throat tightness, Urticaria
Clinical narrative: Client states has been feeling a "tightness" in her throat since 8am this morning & "an itchy rash on the under side of the left arm, the same area I got the shot in". Client was encouraged to follow up with her doctor immediately   11/13/2001-Client went to her doctor. He gave her Benadryl & a creme to lessen the urticaria
Age: 38.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Hyperacusis, Myalgia, Pain, Paraesthesia, Restlessness
Clinical narrative: Tingling to the jaw, Later got muscular aches & pains, insomnia, restlessness, sensitivity to sounds. Next day she got swellings under the arms. 12/07/01 her s/s have eased but sill has heaviness in her legs.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Myalgia, Pharyngolaryngeal pain
Clinical narrative: Neck muscles soreness one week after vaccine Headache,sore throat, runny nose nine days after vaccine. persistent headache  eleven to twelve days after vaccine.
Age: 69.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site swelling, Rash
Clinical narrative: 11/20/2001-Patient received a tetantus vaccine after a foot laceration had occurred. 12/07/2001-Patient is seen for a 7 cm area of swelling and rash at the injection site.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Swelling face, Urticaria
Clinical narrative: 12/03/2001 Received Havrix Hep A vaccine. On 12/09/2001 developed diarrhea x2, 12/10/2001 Temp 101.8 and mother gave Motrin. Fifteen minutes after Motrin patient had two large hives, tightness of both thumbs and one foot and swelling of lips. Mom took patient to ER where he was given liquid Benadryl & told he had fluid behind ears". Mother reports she is allergic to Motrin.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Child developed varicella 12/11/2001. Rash scattered on face, chest and back. More than sixty lesions present.
Age: 16.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Bronchospasm, Ear pain, Eye swelling, Hypersensitivity, Throat tightness
Clinical narrative: Pt developed periorbital swelling, urticaria to face and neck, tightness in throat and wheezing. Given albuterol by nebulizer X 1; IM Solu-Medrol.
Age: 16.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Urticaria
Clinical narrative: Pt developed periorbital swelling, urticaria to face and neck, tightness in throat and wheezing. Given albuterol by nebulizer X 1; IM Solu-Medrol.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Contusion, Haemolytic anaemia, Infection, Leukaemia, Platelet disorder
Clinical narrative: Information has been received from a health professional concerning an approx. 2 month old female who on 7/25/96 was vaccinated with hepatitis b vaccine recombinant (yeast) (lot 0375D). Concomitant vaccinations on 7/25/96 included diphtheria toxoid/pertussis vaccine/tetanus (lot 5F71109), poliovirus vaccine (Orimune) (lot 7078R) and Hib conjugate vaccine (lot 6M61051). On 7/25/96, the pt developed a high fever, bruised thighs and high-pitched crying. The reporter stated that her daughter has had recurring infection and fever ever since. The pt received a total of 4 doses of DTP. The last dose was administered in 11/97. The pt's mother refused the 5th dose and any and all vaccination since. In 6/98, the pt presented with signs and symptoms of leukemia, which had been ruled out. The pt was dx'd with hemolytic anemia, splenomegaly and platelet disorder, which she feels, based on her research are the results of receiving DTP vaccine. The pt is currently under the care of a physician. The pt's experiences were considered to be "Other Important Medical Events". Follow-up information indicated that the patient also experienced autoimmune disorder (no details provided). No further information is available. (OMIC)
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Pyrexia, Screaming, Splenomegaly
Clinical narrative: Information has been received from a health professional concerning an approx. 2 month old female who on 7/25/96 was vaccinated with hepatitis b vaccine recombinant (yeast) (lot 0375D). Concomitant vaccinations on 7/25/96 included diphtheria toxoid/pertussis vaccine/tetanus (lot 5F71109), poliovirus vaccine (Orimune) (lot 7078R) and Hib conjugate vaccine (lot 6M61051). On 7/25/96, the pt developed a high fever, bruised thighs and high-pitched crying. The reporter stated that her daughter has had recurring infection and fever ever since. The pt received a total of 4 doses of DTP. The last dose was administered in 11/97. The pt's mother refused the 5th dose and any and all vaccination since. In 6/98, the pt presented with signs and symptoms of leukemia, which had been ruled out. The pt was dx'd with hemolytic anemia, splenomegaly and platelet disorder, which she feels, based on her research are the results of receiving DTP vaccine. The pt is currently under the care of a physician. The pt's experiences were considered to be "Other Important Medical Events". Follow-up information indicated that the patient also experienced autoimmune disorder (no details provided). No further information is available. (OMIC)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Pt developed ITP within 10 days, post vax.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The pt developed generalized rash which started at noon on 12/05/01. Flu shot given at 09:00 on 12/5/01.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The pt developed a severe local reaction. Entire upper arm edema, induration, heat, erythema and pain. Her husband had the identical reaction from the same vial. Also, she had a systemic fever X 24 hours.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: About 5 days, post vax, the pt developed neck pain radiating into his left scapula, left deltoid and left axilla. No symptoms in the days immediately following the administration of the vaccine. Still symptomatic.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Heart rate increased, Rash
Clinical narrative: 5 minutes, post vax, the pt developed a rash to her torso (front and back). Her BP was increased at 170/90 and pulse increased at 120. Her lungs were clear and she denied shortness of breath. No pharyngeal edema noted. Her vital signs returned to baseline after 15 minutes. Observed for 45 minutes.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: The pt developed a hot fever, throwing up and a headache. Her husband called the hospital.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Heart rate increased
Clinical narrative: The pt developed "chills, headache and a fast heartbeat which started last night (12/13/01)". She still has a headache and chills and feel tired. "Fast heart beat is resolved. Called my family physician to report and then notified Employee Health."
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Labyrinthitis, Nausea, Pyrexia, Vomiting
Clinical narrative: The pt developed a fever, chills, nausea and vomiting. Dx'd with labyrinthitis and rx'd meclizine and compazine.
Age: 33.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The client attended a health clinic at a community center on 11/14/01 where she received a TD booster. She complained of swelling to the left arm, face and neck. She was seen be an RN at the office at 15:30. Her left arm had redness to the deltoid area of approx. 2" in diameter with moderate swelling. No swelling to face, neck or chest, as she had stated. Her arm was warm to touch. Advised her to apply warm and wet soaks.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Tremor
Clinical narrative: The pt received vaccines on 12/4/01 and on 12/6/01, her parent witnessed a 30 second long episode of shaking of her entire body. This resolved spontaneously. The pt was afebrile. Dx: probable seizure.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: The pt developed rash, hives, edema to bilateral hands and feet and a temperature of 101.8F (R). The pt went to ER at approx. 23:00.
Age: 1.08
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: On 12/10/01, the pt developed a fever with max of 102F on 12/10, 12/11, 12/12/ and 12/13/01. She had a rash consistent with varicella on my exam on 12/12/01. The rash resolved by 12/14/01. No crusting.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Crying, Hypersensitivity
Clinical narrative: The pt had screaming and 2 seizures. The 1st one lasted about 1 minutes and the 2nd one lasted 2-3 minutes. He was treated with Tylenol q 4 hours. This could be a reaction to pertussis.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Rash
Clinical narrative: The pt developed a fine, red rash over his face, scalp, back, chest, abdomen at bilateral upper extremities. No involvement of lower extremities. No fever or diarrhea. No cold symptoms.
Age: 1.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site swelling
Clinical narrative: The pt's mother called to state that the child's arm was swollen from shot site to elbow. That call came in on 12/12/01. The RN called family on 12/14/01, to see how the child was doing and the mother stated there was much more swelling. Mother was advised to give child Tylenol and put a cold compress on shot site.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: The vaccinee did not have gout, psoriasis, Crohn's disease, or history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. The vaccinee received an injection of Lymerix approx. 1 year ago; exact date of immunization and number of previous Lymerix injections was unknown. The reporter stated that the vaccinee began to experience joint pain "recently". IThe joint complaints were evaluated by a physician. No swollen or warm joints were noted on physical examination. Joint fluid was not obtained. The vaccinee was treated with naproxen (Naprosyn) 500 mg twice daily orally from 12/18/01 to 1/4/02 and with celecoxib (Celebrex) 200 mg twice daily orally from 1/4/02. As of 1/4/02, the outcome of the event was unknown. It was not known if he had sought medical treatment. No further information was available at the date of this report.  The adverse event "joint pain" does not meet serious criteria but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles after Varivax. No history of exposure to active disease.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: child broke out with chicken pox on approx. 12/13/2001.  Verified by nurse on 12/14/01
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Nine days after receiving MMR vaccine, the pt's temperature went up. When he was seen in the evening, a "generalized febrile seizure" was noted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Hypersensitivity reaction to immunization resulting in cellulitis swollen right arm for two days with itchiness and occasional pain pt. denies fever & restriction of movement.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Four days after receiving DTaP #4 and MMR #2, this pt. developed cellulistis on her right upper arm. she was given a ten day course of Keflex.
Age: 1.9
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: DTaP, IPV,MMR given on 12/1/2001. On 12/14/2001, pt's right thigh was red, warm, swollen and afebrile. He saw a doctor who prescribed Benadryl and repeat appointment.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site induration, Oedema, Pain, Pyrexia
Clinical narrative: systemic fever, rigor, severe local reaction with edema, heat, pain, induration of entire upper arm, wife got identical reaction from same vial.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Herpes Zoster (Unilateral band of red papules, painful, dermatomaz approximately T11) onset 12/18/2001. Culture obtained 12/19/2001, started on Acyclovir.
Age: 10.75
Sex: M
Vaccine: TD
Symptoms: Syncope
Clinical narrative: 12/11/2001-client received vaccine at school. Very tense within ten minutes. Started to leave the room, looked back and then fainted. Revised, leg elevated for five minutes. then client was assisted to a chair. School LPN took client to cafe. Where he told her he had not eaten that morning. Client return to (his home)room when the RN felt that he was alright. Mother didn't feed him. 12/12/2001-client was at school without complaints.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Urticaria
Clinical narrative: 12/12/2001-client's mother called health center. She stated that the client had broken out in "hives" vaccine had been administered on 12/11/2001. Doctor called mother and instructed to give Benadryl. Mother states that the doctor feels like the medicine (Cephalosporin) which the child was taking at time of the vaccination was the cause of the rash. 12/13/2001-Child was without any symptoms
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Diarrhoea, Hypersensitivity, Pallor, Pyrexia
Clinical narrative: It was reported that a 7 month old male received a second dose of Prevnar vaccine on 19-FEB-2001. The infant has a past medical history of torticollis. Additional suspect medication included Infanrix, Pedvax-HIB and Polio vaccine. On 19-FEB-2001, post immunization the infant developed a high fever of 103 degrees, vomiting, no appetite, pale color, diarrhea and "kept dozing off:. He was hospitalized for 3 days and treated with IV Suprax. According to the family physician, these events were a "severe" reaction to Prevnar. No additional information was available as of the date of this report.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sleep disorder, Vomiting
Clinical narrative: It was reported that a 7 month old male received a second dose of Prevnar vaccine on 19-FEB-2001. The infant has a past medical history of torticollis. Additional suspect medication included Infanrix, Pedvax-HIB and Polio vaccine. On 19-FEB-2001, post immunization the infant developed a high fever of 103 degrees, vomiting, no appetite, pale color, diarrhea and "kept dozing off:. He was hospitalized for 3 days and treated with IV Suprax. According to the family physician, these events were a "severe" reaction to Prevnar. No additional information was available as of the date of this report.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Anorexia, Diarrhoea, Pallor, Pyrexia, Sleep disorder
Clinical narrative: It was reported that a 7 month old male received a second dose of Prevnar vaccine on 19-FEB-2001. The infant has a past medical history of torticollis. Additional suspect medication included Infanrix, Pedvax-HIB and Polio vaccine. On 19-FEB-2001, post immunization the infant developed a high fever of 103 degrees, vomiting, no appetite, pale color, diarrhea and "kept dozing off:. He was hospitalized for 3 days and treated with IV Suprax. According to the family physician, these events were a "severe" reaction to Prevnar. No additional information was available as of the date of this report.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Vomiting
Clinical narrative: It was reported that a 7 month old male received a second dose of Prevnar vaccine on 19-FEB-2001. The infant has a past medical history of torticollis. Additional suspect medication included Infanrix, Pedvax-HIB and Polio vaccine. On 19-FEB-2001, post immunization the infant developed a high fever of 103 degrees, vomiting, no appetite, pale color, diarrhea and "kept dozing off:. He was hospitalized for 3 days and treated with IV Suprax. According to the family physician, these events were a "severe" reaction to Prevnar. No additional information was available as of the date of this report.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Atelectasis, Coma, Eye discharge, Liver disorder, Nasal congestion
Clinical narrative: Parent reports that the pt "did not have any problems after his shots." He had an upper respiratory infection about 2-3 weeks ago and completed antibiotics about 1 week ago. (Seen in ER) The hospital will fax health dept report. The pt was fed a bottle of Enfamil with iron about 10:00 and was found unresponsive and pronounced DOA at he hospital at 11:41. The baby was found by coroner with bottle propped, in the crib with pillow and stuffed animals.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Nephritis, Petechiae, Pulmonary congestion, Pulmonary oedema
Clinical narrative: Parent reports that the pt "did not have any problems after his shots." He had an upper respiratory infection about 2-3 weeks ago and completed antibiotics about 1 week ago. (Seen in ER) The hospital will fax health dept report. The pt was fed a bottle of Enfamil with iron about 10:00 and was found unresponsive and pronounced DOA at he hospital at 11:41. The baby was found by coroner with bottle propped, in the crib with pillow and stuffed animals.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Coma
Clinical narrative: Parent reports that the pt "did not have any problems after his shots." He had an upper respiratory infection about 2-3 weeks ago and completed antibiotics about 1 week ago. (Seen in ER) The hospital will fax health dept report. The pt was fed a bottle of Enfamil with iron about 10:00 and was found unresponsive and pronounced DOA at he hospital at 11:41. The baby was found by coroner with bottle propped, in the crib with pillow and stuffed animals.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema
Clinical narrative: Left upper extremity cellulitis immune reaction to stated vaccinations given on 12/7/01.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Left upper extremity cellulitis immune reaction to stated vaccinations given on 12/7/01.