chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: Report 20010190851 described arthralgias in a 45 year old female who received Lymerix. On March 13, 2001 the pt received a 0.5 mg IM dose of Lymerix, it was not known whether she received a previous doses of Lymerix. On March 14, 2001 the pt experienced arthralgias and fatigue. Lymerix was discontinued. As of August 7, 2001, the outcome of the adverse event was unknown. The adverse event of 'arthralgias' does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Age: 31.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Report 20010192221 described joint achiness in a 32 year old male who received Lymerix. This report was received from the pt's wife and has not been confirmed by a physician or other health professional. In January and February 1999, the pt received his first and second doses of Lymerix without adverse event. In January 2000, the pt received his third dose of Lymerix. Subsequently, he reportedly experienced general stiffness and achiness in the joints. Reportedly the pt's joint complaints have not been evaluated by a physician and he has not received any treatment for the joint complaints. Reportedly as of August 8, 2001, the outcome of the events was unresolved. The adverse events of joint achiness and joint stiffness do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
Sex: U
Vaccine: LYME
Symptoms: Drug ineffective, Erythema, Injury, Oedema, Pain
Clinical narrative: Reportedly, the patient received a 3 shot series of Lymerix in the spring of 1999. On 07/23/2001, reportedly, the patient was stung/bitten by an unidentified insect through the shirt at the right scapula. The patient experienced small, instant swelling and redness after the initial sting. There was no pain after the sting until redness and the affected area increased to about 80-100mm. Reportedly, there never was any sign of a tick despite careful checks. On 07/29/2001, reportedly, a double bull's-eye rash appeared. On 07/30/2001 the patient was diagnosed with Lyme disease, for the third time. Ceftin was prescribed for 21 days. On 07/31/2001 at 02:00 experiencing major discomfort in the precise area of the original attack which subsided by 06:00. The patient has had no recurrence so far and was continuing Ceftin. The patient doubts the diagnosis but not the treatment. As of 08/01/2001, the outcome of the event was resolved.
Sex: U
Vaccine: LYME
Symptoms: Rash
Clinical narrative: Reportedly, the patient received a 3 shot series of Lymerix in the spring of 1999. On 07/23/2001, reportedly, the patient was stung/bitten by an unidentified insect through the shirt at the right scapula. The patient experienced small, instant swelling and redness after the initial sting. There was no pain after the sting until redness and the affected area increased to about 80-100mm. Reportedly, there never was any sign of a tick despite careful checks. On 07/29/2001, reportedly, a double bull's-eye rash appeared. On 07/30/2001 the patient was diagnosed with Lyme disease, for the third time. Ceftin was prescribed for 21 days. On 07/31/2001 at 02:00 experiencing major discomfort in the precise area of the original attack which subsided by 06:00. The patient has had no recurrence so far and was continuing Ceftin. The patient doubts the diagnosis but not the treatment. As of 08/01/2001, the outcome of the event was resolved.
Age: 25.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: A 26 year old female became pregnant approximately 8 months following receipt of Lymerix. The pt reported that she had no significant medical history. Concurrent conditions and medications were not specified. The pt reported that she received to injections of Lymerix in the year 2000, the last injection administered in approximately August 2000. Exact dates of immunization were not provided. She had no adverse experiences following receipt of the two vaccine injections. The pt subsequently learned that she was pregnant. Her last menstrual period began on 25-MAR-2001. Date of positive pregnancy test not reported. Her estimated delivery date is 31-DEC-2001. As of 10/10/01, the pregnancy was progressing normally, without complications. On 12/10/01, the vaccinee delivered a male infant via "normal vaginal delivery." The infant weighed 7 lbs. 3 oz and measured 20 inches in length. On 1/9/02, the obstetrician reported "no problems with mom or baby."
Age: 25.0
Sex: F
Vaccine: LYME, TTOX
Symptoms: Blood glucose decreased, Loss of consciousness
Clinical narrative: On 21-JUN-2001, a 25 year old female, with low blood sugar, receives a Lymerix vaccination while unknowingly pregnant. Pt also received an injection of tetanus toxoid. Concurrent conditions include asthma, unspecified allergies, an irregular menstrual cycle and polycystic ovary syndrome. The pt had no known drug allergies and no known prior pregnancies. It is not known if she had previous Lyme disease. Concurrent medication included Singulair, Vanceril and Proventil. The pt had been prescribed a course of doxycycline for an unknown indication in June 2001.  At 6pm on 21-JUN-2001, the pt passed out and was taken to the local ER. A diagnosis of low blood sugar was made and the pt was treated with "some food". An unspecified pregnancy test was positive. It was determined that the pregnancy was at 24 weeks gestation; the pt reported that she did not know she was pregnant earlier in the day, when she was immunized. Her last menstrual period was in December 2000; her estimated delivery date  is 06-OCT-2001. The ER physician did "not relate incident (low blood sugar) to vaccines". The pt was released from the ER. Additional information was received from the pt's obstetrician on 28-AUG-2001. The OB first saw the pt on 15-JUL-2001; she reported to him that she did not appreciate that she was pregnant until "a few days" prior. She reported to the OB that her last menstrual period had been in "late November 2000";the pt did not recall her last prior menstrual period. She had received no prior prenatal care and had not taken prenatal vitamins. Estimated date of confinement to be 06-OCT-2001. The follow up states the emergency room physician did "not relate incident (low blood sugar) to vaccines." The vaccinee was released from the ER. Additional info was received from the vaccinee's obstetrician on 8/28/01. The obstetrician first saw the vaccinee on 7/15/01; she reported to him that she did not appreciate that she was pregnant until "a few days" prior. She reported to the obstetrician that her last menstrual period had been in "late November 2000"; the vaccinee did not recall her last prior menstrual period. She had received no prior prenatal cars, and had not taken prenatal vitamin supplements. Estimated date of confimement was confirmed to be 10/6/01. The most recent info was received from the vaccinee on 2/1/02. She reported that she delivered a female infant on 10/6/01. The vaccinee stated, "No complications with preganncy after the day of the injection. Baby was born full term on he rdue date. Baby's health seems to be perfect to date. Mom is also doing fine."
Age: 13.0
Sex: M
Vaccine: LYME
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: On 09/05/2001 a 13 year old male received a Lymerix vaccination. In September 2000, the pt reportedly received his first dose of Lymerix without adverse event. On 06-SEP-2001 the pt reportedly experienced a slight fever and 1/2 to 1 inch redness at the injection site. The reporter stated that the vaccine "was not in a clinical trial". As of 06-SEP-2001, the outcome of the adverse events was unknown.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Pernicious anaemia
Clinical narrative: A 61 year old male received Lymerix. Reportedly, the pt was allergic to penicillin and bees. Also the pt's medical history included cervical and back problems. Reportedly on 28-APR-1999, the pt received his first dose of Lymerix. Reportedly three days later he experienced fatigue. On 28-MAY-1999, the pt received his second dose of Lymerix. Reportedly post vaccination his fatigue continued and he was found to have pernicious anemia. Reportedly, he was treated with Nascobal Nasal gel one squeeze per week and his fatigue and anemia subsequently "resolved". Reportedly, on 28-APR-2000, the pt received his third dose of Lymerix without adverse event. "Follow up labs taken on 23-AUG-2000 were all normal". As of 05-SEP-2001, the adverse event had reportedly resolved. The follow up states on 1/22/02, the responsible physician reported that the vaccinee had experienced tiredness in August 1999 which was moderate in intensity and possibly related to LYMErix. The vaccinee's vitamin B12 level in 1999 was reported aa 168pg/ml. Responsible physician stated that the vaccinee was subsequently found to have pernicious anemia.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Otitis media, Rash, Rash erythematous, Rash morbilliform
Clinical narrative: Received MMR and Varivax 10/02/2001. OM diagnosed 10/5, put on Amox, red spots on 10/12/2001, increased spots over next several days. ER 10/14 to give Benadryl PO. 10/15 rash worse. Extensive moribilliform rash on face, trunk and extremities. Slightly raised erythmacules 3- 6 mm in size. Zero target lesions.
Age: 59.0
Sex: F
Vaccine: DTAP
Symptoms: Anaemia
Clinical narrative: Described anemia (NOS) in a 59-year-old female who received Lyme disease vaccine recombinant OspA (LYMErix). This report was received from the vaccinee and has not been verified by a [hysician or other health care professional. Reportedly, the vaccinee was allergic to ampicillin, and dextropropropoxcyphene (Darvocet). Vaccinee had anemia (NOS) at times.  The follow up states the vaccinee had lactose intolerance beginning in 1999. The vaccinee reported that she received her first left deltoid dose of LYMErix on 4/28/99. Three days later she felt fatigued. Reportedly, on 5/28/99, the vaccinee received her second left deltoid dose of LYMErix. She reported that, on 6/6/99, she experienced a drop in red blood cell and hematocrit counts. Her fatigue continued. Reportedly, on 8/9/99 and 8/10/99, repeat lab tests showed continued decrease in red blood cells, white blood cells, and hematocrit. The vaccinee stated that a diagnosis of anemia was made "because I had low RBC, WBC, and HCT counts. Her "B12" was normal, reportedly. She stated that she underwent three occult blood tests, esophagogastroduodenoscopy, and colonoscopy. These tests were reportedly normal. Reportedly, on 9/2/99, lab tests were repeated: WBC was normal, and RBC and HCT were "almost normal." Reportedly, on 10/25/99, WBC, RBC and HCT were all "dropping." No treatment was given. Reportedly, 4/13/00, all lab values were normal. On 1/20/02, the reporting physician stated that on 8/10/99, the vaccinee reported fatigue to  him. Lab analyses performed in August 1999 showed HCT 30%, WBC 3300/cumm, and platelet count of 141,000/cumm. Reporting physician stated htat the fatigue was moderate in intensity and was possibly related to LYMErix. Reportedly on 4/28/00, the vaccinee received her third left deltoid dose of LYMErix. oN 8/23/00, her WBC was "low," and her RBC and HCT were normal. In February 2001, all labs were reportedly normal. As of 9/5/01, the vaccinee's symptoms had resolved.
Age: 39.0
Sex: F
Vaccine: LYME
Symptoms: Unevaluable event
Clinical narrative: There was no significant medical history, known allergy or concomitant medications. The pt received her third injection of Lymerix on approximately 22-JUL-2001. She was seen by an OB on 27-AUG-2001 and determined to be pregnant, at 11 weeks gestation. The pregnancy was, therefore, at 6 weeks gestation at the time of Lymerix administration. The pt's last menstrual period was on 09-JUN-2001. Estimated delivery date is 16-MAR-2002. The follow up states the vaccinee delivered a normal, full-term female on 3/5/02 (39 weeks gestation). Birth weight was 7 pounds 12 ounces.
Age: 2.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Abnormal behaviour
Clinical narrative: This child developed Pervasive Developmental Disorder (NOS); (An Autistic Spectrum Disorder).
Age: 2.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Foetal disorder
Clinical narrative: This child developed Pervasive Developmental Disorder (NOS); (An Autistic Spectrum Disorder).
Age: 2.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: This child developed Pervasive Developmental Disorder (NOS); (An Autistic Spectrum Disorder).
Age: 2.0
Sex: F
Vaccine: ANTH, ANTH, ANTH, ANTH
Symptoms: Abnormal behaviour, Cardiac disorder, Neurodevelopmental disorder, Speech disorder, Ventricular septal defect
Clinical narrative: This child developed Pervasive Developmental Disorder (NOS); (An Autistic Spectrum Disorder).
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Intussusception, Pyrexia, Screaming
Clinical narrative: It was reported that a 2 month old female received a 1st dose of Prevnar on 7/17/01. She also received a 1st dose of Comvax, Polio (inactivated poliomyelitis vaccine) and Infanrix on the same day. Post vax, the infant developed inconsolable crying for several hours and a "low-grade" temperature. The infant was admitted to the hospital for 24 hours for observation. No additional information was available as of the date of this report.  Diagnosed with reaction to Pertussis vaccine
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: It was reported that a 2 month old female received a 1st dose of Prevnar on 7/17/01. She also received a 1st dose of Comvax, Polio (inactivated poliomyelitis vaccine) and Infanrix on the same day. Post vax, the infant developed inconsolable crying for several hours and a "low-grade" temperature. The infant was admitted to the hospital for 24 hours for observation. No additional information was available as of the date of this report.  Diagnosed with reaction to Pertussis vaccine
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pain, Pneumonia, Pyrexia, Wheezing
Clinical narrative: Pt developed a fever of 102F-103F, 24 hours, post vax. The fever lasted 6 days (101F-102F). She had extreme body/muscle aches and was dx'd with pneumonia, 5 days, post vax. Followup states coughing and wheezing, treated with Tilade
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt developed fullness about injection site on right anterior, lateral thigh with minimal redness (? secondary to Prevnar or HIB) per MD's note.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: Within three hours of receiving the vaccine, the patient developed a fever of 103F and hives head-to-toe. The patient was treated with Ibuprofen.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Post vax, the patient had a "high fever". The patient's mother did not check the patient's temperature. The patient developed a pinpoint rash on her upper arms and chest and red blisters on her buttocks.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Blister, Lacrimation increased, Ocular hyperaemia, Pruritus, Pyrexia
Clinical narrative: On 09/22/2001 the patient broke out with approximately 3 large vesicles and complained of pruritus. On 09/24/2001 smaller vesicles appeared on the patient's back, legs, stomach, face and chest. The patient's fever was up to 102.7F. The patient had red, watery eyes with exudation from his eyes.
Age: 0.3
Sex: M
Vaccine: DT, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Irritability, Pain
Clinical narrative: Within 5-6 hrs post vax, pt noted to have redness, warmth and induration around immunization area. Pt also was fussy and whimpered when right thigh moved. He was brought back in to office 6 hrs after immunization for recheck on area. A very faint, circumscribed area around IPOL with faint blue ring with clear center (2" in diameter) noted. He was treated with Benadryl. Site of reaction treated with warm moist compresses.
Age: 0.3
Sex: M
Vaccine: DT, HIBV, IPV, PNC
Symptoms: Skin discolouration
Clinical narrative: Within 5-6 hrs post vax, pt noted to have redness, warmth and induration around immunization area. Pt also was fussy and whimpered when right thigh moved. He was brought back in to office 6 hrs after immunization for recheck on area. A very faint, circumscribed area around IPOL with faint blue ring with clear center (2" in diameter) noted. He was treated with Benadryl. Site of reaction treated with warm moist compresses.
Age: 0.2
Sex: F
Vaccine: PNC, HBPV, IPV, PNC
Symptoms: Eructation, Insomnia, Irritability
Clinical narrative: Based upon report received from caller her 2 month old female baby was inadvertantly administered two doses of Prevnar instead of one dose of Prevnar and one dose of DTaP vaccine. Caller stated the pt was fussy, had increased wet burps and had restless sleep. The Prevnar injections were given on 10/16/2001 and the onset of reactions were on 10/17/2001. Field alert being issued for a medication error that resulted in an adverse event.
Age: 0.2
Sex: F
Vaccine: PNC, HBPV, IPV, PNC
Symptoms: Accidental overdose
Clinical narrative: Based upon report received from caller her 2 month old female baby was inadvertantly administered two doses of Prevnar instead of one dose of Prevnar and one dose of DTaP vaccine. Caller stated the pt was fussy, had increased wet burps and had restless sleep. The Prevnar injections were given on 10/16/2001 and the onset of reactions were on 10/17/2001. Field alert being issued for a medication error that resulted in an adverse event.
Age: 5.0
Sex: F
Vaccine: PNC
Symptoms: Asthma, Cough, Diarrhoea, Otitis media, Pneumonia
Clinical narrative: A mother reported, via a company representative, that her 4.5 year old daughter received an initial dose of Prevnar vaccine in DEC-2000. In DEC-2000, she developed wheezing and coughing. In JAN-2001, the child developed a "barking" cough that did not resolve for months. The child has also been on antibiotics every month since receiving Prevnar for ear infections. The HCP told the mother that the child's lungs were clear. In APR-2001, the child developed bilateral ear infections, cough and was diagnosed with pneumonia. The child developed a fever of 104 degrees, of 6 days duration. After 2 days of fever, was treated with Zithromax with no resolution of fever. The child developed "violent" vomiting for 3 days and then developed "severe" diarrhea. The fever was treated with Tylenol or Advil and it resolved. No additional information was available as of this report. Follow up information received 7 JUL 2001, stated that child had several ER visits. Additional information received 7 SEP 2001, stated that the child was given a diagnosis of asthma in July 2001.
Age: 5.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Vomiting, Wheezing
Clinical narrative: A mother reported, via a company representative, that her 4.5 year old daughter received an initial dose of Prevnar vaccine in DEC-2000. In DEC-2000, she developed wheezing and coughing. In JAN-2001, the child developed a "barking" cough that did not resolve for months. The child has also been on antibiotics every month since receiving Prevnar for ear infections. The HCP told the mother that the child's lungs were clear. In APR-2001, the child developed bilateral ear infections, cough and was diagnosed with pneumonia. The child developed a fever of 104 degrees, of 6 days duration. After 2 days of fever, was treated with Zithromax with no resolution of fever. The child developed "violent" vomiting for 3 days and then developed "severe" diarrhea. The fever was treated with Tylenol or Advil and it resolved. No additional information was available as of this report. Follow up information received 7 JUL 2001, stated that child had several ER visits. Additional information received 7 SEP 2001, stated that the child was given a diagnosis of asthma in July 2001.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Swelly, redness and warmth right deltoid.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Face oedema, Nausea, Neck pain, Oedema peripheral
Clinical narrative: Back pain, swollen right arm, face swollen, right side, neck pain, nausea went to ER - Diagnosed with local reaction Taken within Demerol, amonicillin. For spider bite on foot 10 days old (left foot). Went to ER also on 10/20/2001. Taken with phenerean and Demerol.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Fever, chills times 3 days, acetaminophen 500 mg every 8 hours.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nasal congestion, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, body ache, headache, congestion.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Diarrhoea, Dyspnoea, Pyrexia, Urticaria
Clinical narrative: Hives on Saturday. Asthma, SOB, fever and diarrhea.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Cough, Eye irritation, Fatigue, Headache
Clinical narrative: Tiredness, sneezing, stuffy nose, cough, sweating, itchy and watery eyes, headache, sensitivity to light, loss of appetite and sore throat for seven days.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Lacrimation increased, Nasal congestion, Pharyngolaryngeal pain, Photosensitivity reaction
Clinical narrative: Tiredness, sneezing, stuffy nose, cough, sweating, itchy and watery eyes, headache, sensitivity to light, loss of appetite and sore throat for seven days.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Tiredness, sneezing, stuffy nose, cough, sweating, itchy and watery eyes, headache, sensitivity to light, loss of appetite and sore throat for seven days.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Heart rate increased, Hyperhidrosis, Hyperventilation, Hypotension
Clinical narrative: Approximately three to four hours after administration, pt was sweating, rapid heart rate, rapid, shot breathing, low blood pressure and feeling weak.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Warm, red, raised area at injection site, 24cm in diameter, no respiratory distress, note 18.5 hours later.
Age: 17.0
Sex: F
Vaccine: DTP, FLU3, HEP
Symptoms: Dyspnoea, Rash
Clinical narrative: Fine rash around sit ot tight deltoid. Pt reported short loss of breath all day attended school didn't visit school nurse. Called health department at 1500, referred for shortness of breath. Possibly allergic reaction. Treated 10/23/2001 with Decadrom IM and Preventil. Nebulizer treatment. Sent home with Prednisane pack and Proventil Inhaler.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Disturbance in attention, Malaise, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Spontaneous report received on November 16, 2000, from Medical Assistant in a Dermatologist office, regarding adverse event possibly related to administration of Fluvirin. On October 06, 2000, this 83 year old female received a Fluvirin injection. "Shortly after" receiving the injection, she developed a temperature of 102 degrees, chills and general malaise. These symptoms lasted approximately four days. In mid October, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orobase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens Johnson Syndrome has been made. The reporter stated that the Dermatologist's office has treated this patient for over ten years. She indicates that the pt is normally very "mentally there" but that the pt "hasn't been herself". She describes pt as being "easily confused and forgetful".  Additional information has been requested from the physician. Follow up information from Primary care physician received on October 11, 2001 by Evans Vaccines: "The additional adverse events of sore throat and swollen lip were identified. PT has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Skin ulcer, Stevens-Johnson syndrome, Swelling face
Clinical narrative: Spontaneous report received on November 16, 2000, from Medical Assistant in a Dermatologist office, regarding adverse event possibly related to administration of Fluvirin. On October 06, 2000, this 83 year old female received a Fluvirin injection. "Shortly after" receiving the injection, she developed a temperature of 102 degrees, chills and general malaise. These symptoms lasted approximately four days. In mid October, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orobase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens Johnson Syndrome has been made. The reporter stated that the Dermatologist's office has treated this patient for over ten years. She indicates that the pt is normally very "mentally there" but that the pt "hasn't been herself". She describes pt as being "easily confused and forgetful".  Additional information has been requested from the physician. Follow up information from Primary care physician received on October 11, 2001 by Evans Vaccines: "The additional adverse events of sore throat and swollen lip were identified. PT has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Mouth ulceration, Myalgia
Clinical narrative: Pt developed sores in mouth and aching in muscles and joints and was also tired.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal distension, Back pain, Chills, Fatigue, Movement disorder
Clinical narrative: Pt developed extreme fatigue, lower back pain, and abdominal area swelled. Pt complained of severe pain, nausea, chills, and inability to move. Pt went to ER on 9/28/01 at 5 AM and was given pain pills. She was told to go to ER if not better in 2 days. She was given a referral to a specialist.
Age: 40.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Pain
Clinical narrative: Pt developed extreme fatigue, lower back pain, and abdominal area swelled. Pt complained of severe pain, nausea, chills, and inability to move. Pt went to ER on 9/28/01 at 5 AM and was given pain pills. She was told to go to ER if not better in 2 days. She was given a referral to a specialist.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Pt broke out in chicken pox and fever.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: On 10/5, pt developed a fever to 103. Pt developed a maculopapular rash on face and trunk onset 10/8/01.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site induration, Injection site pain, Injection site urticaria
Clinical narrative: Pt developed acute pain, redness and induration of entire lateral shoulder with urticaria locally. Pt also had chills, diaphoresis, and low grade fever resolving after 2nd day.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt developed acute pain, redness and induration of entire lateral shoulder with urticaria locally. Pt also had chills, diaphoresis, and low grade fever resolving after 2nd day.
Age: 4.6
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Febrile convulsion, Rash macular, Skin irritation
Clinical narrative: Pt developed fever of 105 with seizures one week post vax. Pt also developed "blotchy, irritated" area on back and legs. Pt was seen in ER.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Onset of fever 1 hour after hepatitis B vaccination, intermittent with high of 102 degrees for 48 hours. Now with urticaria on 10/17/01 visit.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Cough, Rash erythematous, Rash maculo-papular
Clinical narrative: Cough, erythematous, macular-papular rash, extensive, non prurtic.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Fatigue, Oedema peripheral, Pain
Clinical narrative: The pt experienced swollen feet, hands, fatigue, aches, headache, fever, joint pain, memory loss. The pt states he has been sick since 8/98. Treated with Doxycillian, Vioxx, and Tylenol. Follow up information received 04/25/2003 states: Eyesight failing, hearing loss, memory loss increased, low grade fever daily, face numbness, rash, arthritis progressed, blank staring daily. Depression. Short patience. Constant head sweats.
Age: 52.0
Sex: M
Vaccine: LYME
Symptoms: Pyrexia
Clinical narrative: The pt experienced swollen feet, hands, fatigue, aches, headache, fever, joint pain, memory loss. The pt states he has been sick since 8/98. Treated with Doxycillian, Vioxx, and Tylenol. Follow up information received 04/25/2003 states: Eyesight failing, hearing loss, memory loss increased, low grade fever daily, face numbness, rash, arthritis progressed, blank staring daily. Depression. Short patience. Constant head sweats.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Cough, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Fot Flu shot 10/16/2001. On 10/21/2001 had coughing, hot feeling, sweating, flem in throat, light headedness and weakness. Has lasted four days so far. Not real sick, just slightly.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth, Nausea
Clinical narrative: Pt had very sore left pectoral muscle, up into left armpit. Had fever at the site of the injection, mild nausea and pulsating pain in left pectoris, onset the day after injection.
Age: 20.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt c/o LD pain started on 9/18/01 after vaccine. Pt has had temperature, soreness and swelling to LD since 9/18/01 and has been taking Tylenol but ineffective. this sx continue from 9/18/01 to now.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Received TD booster on 11/5/01. Right deltoid developed arm pain and stiffness and stiffness into her neck and shoulder.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Conjunctival haemorrhage, Erythema, Eye swelling, Fatigue
Clinical narrative: After being vaccinated today this pt developed a sore throat, nasal congestion, and left sided facial swelling. The pt denies any throat swelling or difficulty swallowing. No shortness of breath. No chest pain or chest tightness. the pt is now here for evaluation concerned that she is having an allergic reaction to her vaccination. She returned to the ER on 8/11 with complaints of continued nasal congestion, development of fever and achiness. She called again and said and said that both eyes were bloody looking and swollen and she was vomiting again. She was instructed to come to the office where she also stated that she felt like her joints were stiff in her knees, and a little in other joints. She appears to be somewhat fatigued. She also has subconjunctival hemorrhages suspected from the coughing and vomiting. She has significant rhinorrhea. Her oropharynx shows diffuse erythema of the posterior pharynx. She had developed a fine maculopapular rash throughout that was also petechial on her bilateral lower extremities. It was decided that she had developed a serum sickness like rxn on put on prednisone.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Nasal congestion, Pain, Pharyngolaryngeal pain, Pyrexia, Rash maculo-papular
Clinical narrative: After being vaccinated today this pt developed a sore throat, nasal congestion, and left sided facial swelling. The pt denies any throat swelling or difficulty swallowing. No shortness of breath. No chest pain or chest tightness. the pt is now here for evaluation concerned that she is having an allergic reaction to her vaccination. She returned to the ER on 8/11 with complaints of continued nasal congestion, development of fever and achiness. She called again and said and said that both eyes were bloody looking and swollen and she was vomiting again. She was instructed to come to the office where she also stated that she felt like her joints were stiff in her knees, and a little in other joints. She appears to be somewhat fatigued. She also has subconjunctival hemorrhages suspected from the coughing and vomiting. She has significant rhinorrhea. Her oropharynx shows diffuse erythema of the posterior pharynx. She had developed a fine maculopapular rash throughout that was also petechial on her bilateral lower extremities. It was decided that she had developed a serum sickness like rxn on put on prednisone.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Rhinorrhoea, Serum sickness, Swelling face, Vomiting
Clinical narrative: After being vaccinated today this pt developed a sore throat, nasal congestion, and left sided facial swelling. The pt denies any throat swelling or difficulty swallowing. No shortness of breath. No chest pain or chest tightness. the pt is now here for evaluation concerned that she is having an allergic reaction to her vaccination. She returned to the ER on 8/11 with complaints of continued nasal congestion, development of fever and achiness. She called again and said and said that both eyes were bloody looking and swollen and she was vomiting again. She was instructed to come to the office where she also stated that she felt like her joints were stiff in her knees, and a little in other joints. She appears to be somewhat fatigued. She also has subconjunctival hemorrhages suspected from the coughing and vomiting. She has significant rhinorrhea. Her oropharynx shows diffuse erythema of the posterior pharynx. She had developed a fine maculopapular rash throughout that was also petechial on her bilateral lower extremities. It was decided that she had developed a serum sickness like rxn on put on prednisone.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Local rxn to left arm. Large amount of redness, swelling and warm to touch. Tx with Augmentin Followed up in office in 2 days.
Age: 42.0
Sex: F
Vaccine: SMALL
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: The pt experienced palpitations, irregular heartbeat on 10/13 and 10/14. Seen in ER on 10/13 but symptoms subsided during that time and reoccurred approximately 2 hours later.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Skin discolouration
Clinical narrative: Patients feet right and left turned purple after injection. Time about 24 hour later. Took patient in doctor dismissed it. Took him in again doctor sent him to the hospital. On 10/27/01, hospitalized over night until afternoon of the next day. The patient was given antibiotics. Diagnosed with idiopathic reaction to vaccine.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Coma, Hypotonia, Respiratory depression
Clinical narrative: It was reported that a 2 month old female received a 1st dose of Prevnar vaccine on 07/13/01. She also received Tripedia, Act-HIB, and Polio vaccines on 07/13/01. Approximately 5 hours post immunization, the infant was found hypotonic / unresponsive with poor respiratory effort. The infant was admitted to the hospital to rule out sepsis. She was discharged from the hospital after the cultures were negative for 48 hours. A full blood count, urinalysis, eletrocardiogram, electroencephalogram, echocardiogram and lumbar puncture were normal. No additional info was available as of the date of this report. F/U states the ER dx on 7/13/01 was tachypnea and decreased respiratory rate, hypotonia, emesis and diarrhea. Child was admitted on 7/13/01 and discharged on 7/16/01. The pt was treated with ampicillin and gentamicin. Child is back to normal per mom.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Coma, Diarrhoea, Hypotonia, Respiratory rate decreased, Tachypnoea
Clinical narrative: It was reported that a 2 month old female received a 1st dose of Prevnar vaccine on 07/13/01. She also received Tripedia, Act-HIB, and Polio vaccines on 07/13/01. Approximately 5 hours post immunization, the infant was found hypotonic / unresponsive with poor respiratory effort. The infant was admitted to the hospital to rule out sepsis. She was discharged from the hospital after the cultures were negative for 48 hours. A full blood count, urinalysis, eletrocardiogram, electroencephalogram, echocardiogram and lumbar puncture were normal. No additional info was available as of the date of this report. F/U states the ER dx on 7/13/01 was tachypnea and decreased respiratory rate, hypotonia, emesis and diarrhea. Child was admitted on 7/13/01 and discharged on 7/16/01. The pt was treated with ampicillin and gentamicin. Child is back to normal per mom.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Vomiting
Clinical narrative: It was reported that a 2 month old female received a 1st dose of Prevnar vaccine on 07/13/01. She also received Tripedia, Act-HIB, and Polio vaccines on 07/13/01. Approximately 5 hours post immunization, the infant was found hypotonic / unresponsive with poor respiratory effort. The infant was admitted to the hospital to rule out sepsis. She was discharged from the hospital after the cultures were negative for 48 hours. A full blood count, urinalysis, eletrocardiogram, electroencephalogram, echocardiogram and lumbar puncture were normal. No additional info was available as of the date of this report. F/U states the ER dx on 7/13/01 was tachypnea and decreased respiratory rate, hypotonia, emesis and diarrhea. Child was admitted on 7/13/01 and discharged on 7/16/01. The pt was treated with ampicillin and gentamicin. Child is back to normal per mom.
Age: 52.0
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Myalgia, Neuralgia, Paraesthesia
Clinical narrative: The pt experienced tingling in legs, which increased to shooting nerve pains with memory loss. Treated with Amoxicillin for 6-8 weeks. The annual follow up states, "I still have nervous system shooting sensations and muscle pain. My joint pain is controlled by Voltaren. This is eventhough I was on IV antibiotics x 12 weeks."
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Balance disorder, Blindness, Multiple sclerosis
Clinical narrative: The pt experienced a sudden loss of vision, (over night - blurred). The pt experienced a problem with balance and memory. Vision was lost for 3 days following 2nd shot. Diagnosis of multiple sclerosis verified in medical records. follow up report received 11/20/02 states "vision & balance, sudden loss of vision occurred about 4 days after second shot". Per review of medical records: MS (multiple sclerosis) was diagnosed sometime between 10/11/1999 when MRI ordered, and 04/2000.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: The pt's mom called on 10/24/01 at 11:00 am with a temp of 100.2, was fussy. Given Tylenol and advised to call if there are changes.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt developed a 12.5 x 10 cm area of redness, a 6.5 x 5 cm area of swelling and tenderness to touch on left lateral thigh. Pt was able to ambulate. Pt was treated with cool compresses for 24 hrs and then warm compresses and with Motrin. Pt was to follow up in 2-3 days.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Abnormal behaviour, Erythema, Mood swings, Swelling
Clinical narrative: Pt developed a red, swollen area on arm, bizarre behavior and mood swings.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: Pt had immunization 9/26 and Barium x-ray 9/27. Pt was seen due to rash and diagnosed with urticaria (vaccine vs Barium). Pt was treated with Benadryl, 3cc by mouth every 6 hours. Visit with doctor 4 days after onset revealed rash has resolved.
Age: 30.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Influenza like illness, Pain
Clinical narrative: flu like symptoms and arthritic pain in knees, ankles , elbows, hands and shoulders.
Age: 42.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Tenderness
Clinical narrative: Lymerix injection on 9/11. Achiness particularly in legs within 24 hours. No treatment. By 9/17/01 muscles still just a little tender. Hunter wanted vaccination for prophylaxis.
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Myalgia, Pain, Pyrexia
Clinical narrative: Felt chills and aches next morning. Left work to rest and slept until 3pm. Visited physician. Body aches, stomach aches. Physician advised pt she had "stomach virus". Pt reports fever. Went to ER. Had diarrhea. Advised to take Tylenol and liquids.
Sex: F
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: Felt chills and aches next morning. Left work to rest and slept until 3pm. Visited physician. Body aches, stomach aches. Physician advised pt she had "stomach virus". Pt reports fever. Went to ER. Had diarrhea. Advised to take Tylenol and liquids.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Urticaria
Clinical narrative: The client had injection at 13:00. Called at 15:30 and stated "hives on throat, chest and right arm. Client taken by security to health office. Vital signs: temperature 98; P-64; BP-114/70; R-20. Report to MD and administered Benadryl 50mg, IM and called EMS. Pt taken to ER for evaluation. A follow up report received 10/31/2001 adds: Nurse associate of the reporter states she has followed the pt who continued to use Benadryl to control the hives which she has had following the flu shot. This pt has never had a flu shot before. Last report was that she had no worsening of her symptoms; had had hives on her back the morning after she was seen in the ER.
Age: 46.0
Sex: F
Vaccine: RV
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Pt stated he lost much use of left arm. Pt had stiffness and pain if left arm.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt reports pain, itching, H.A., warmth in right arm from shoulder to elbow 2 hours following injection of Pneumococcal vaccine. Later noticing swelling, redness. Pt notified her physician on 10/16/2001. He prescribed Benadryl 50 mg TID, cold packs, nurse advised Tylenol.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus
Clinical narrative: Pt reports pain, itching, H.A., warmth in right arm from shoulder to elbow 2 hours following injection of Pneumococcal vaccine. Later noticing swelling, redness. Pt notified her physician on 10/16/2001. He prescribed Benadryl 50 mg TID, cold packs, nurse advised Tylenol.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pain
Clinical narrative: Pain in arm. A follow up report received 10/31/2001 adds: Reporter states Pt had been to Urgent Care before coming to office. Office notes indicate some warmth at site but no redness or associated symptoms. Pt received no other injection at that date and had no other vaccines in the previous 4 weeks.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Myalgia, Oedema
Clinical narrative: Injection received 10/19/2001, at 1600 pm. On 10/20/2001 at 2:30 pm, noticed swelling and redness at left arm area. Also consist of biceps muscle aching. Described as the size of a 50 cent piece. On 10/20/2001, also developed headache and diarrhea which lasted approximately 1 day and then resolved.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Vasodilation procedure
Clinical narrative: Received a flu shot in the am (10/17/01) Within waking night slept. Went home to sleep came back to work at 10 PM that night. Felt itchy all over her body. Noticed redness but no rash or hives. Took Benadryl. It improved. Took Benadryl. It improved. Took 2 more doses of Benadryl over next 24 hours. Redness went away and 24 hours itching stopped.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash on arms and thighs on 9/30/01 at 22:30. Took Atarax 10mg prn itching.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Convulsion, Pyrexia, Vaccination complication, Viral infection
Clinical narrative: On 10/24/01 at 11:30, child was brought to ER having a seizure. Temperature was 101F and Advil was given. Seen RN in office for F/U on 10/25/01. Questionable viral illness/reaction to immunization.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pruritus
Clinical narrative: Eruption of about 100 blisters on 08/14/2001, about 150 more blisters on 09/12/2001, about 25 blisters on 09/21/2001 and severe itching with no fever.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Laryngospasm, Respiratory disorder
Clinical narrative: On 09/21/2001, pt received Hep B , 1st dose, IM in the left deltoid. Approximately 4 hours later, client "having trouble breathing" and "difficulty swallowing". Went to ER, X-rays taken showed swelling in throat, per mother. Rx given: Prednisone and Benadryl. No history of food or medicine allergies.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Physician of pt called to report that pt came in on 08/29/2001 to her office with left deltoid swollen, erythematous and complaint of itching. No report of pain or fever. Placed on steroid cream. Child returned to doctor office on 08/31/2001 with resolution.
Age: 11.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Cough, Eyelid oedema, Hypoaesthesia
Clinical narrative: Pt RTC within about 15 minutes of administration of vaccines with significant bilateral edema of both sets of eyelids. Complained that started feeling bad with cough and numbness of eyelids. Lungs CTA, no respiratory distress and no hives noted.
Age: 3.7
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Pyrexia, White blood cell count increased
Clinical narrative: Received TC from RN at ER that, per mom, child had seizure in car after leaving the clinic. Went directly to ER and had rectal temp at 103.3, in postictal state.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Broke out in hives in evening all over body. Given Benadryl, little relief. Seen by MD on 09/18/2001. IM Solu-medrol and no improvement. Referral to allergist. Seen 09/19/2001. Allergist prescribed Allegra and Zyrtec. Zyrtec to be used in evening if no improvement after Allegra. Rash remained on 09/20/2001. Itching somewhat better. History of allergic reaction in past to food and other allergens. Allergist desires to see child in one month and will test to see if child hypersensitive to vaccine per mother. Mother child to complete hep A series but advised her to follow advise of physician on that issue. Sent mother information on components in vaccines and study history from manufacturer. Was to call back in if rash worsened. No call received.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: On 10/02/2001 Hep B#3 given left arm IM; reactions occurred 7:50 am the next morning of 10/04/2001; 5x5 paresthesia (numbness and tingling) in lower back, both arms and left leg; afebrile. Was taken to ER; Prednisone prescribed, no history of allergies to drugs or foods.
Age: 1.8
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: 14:10 pm Varicella given SC. in upper outer aspect of right arm - 20 minutes after injection pt developed a 1 cm hive with redness, 3/4 tsp Benadryl given at 14:30 pm.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Skin ulcer
Clinical narrative: Mom noticed a few lesions approximately 4 days after receiving varicella vaccine, now with approximately 25 lesions. Tx: Neosporin ointment.