chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Lethargy, Pallor
Clinical narrative: At 5:45 he was very white, appeared to be barely breathing and was limp. He did not respond to noise or physical stimulation. He was more responsive in ER but lethargic and had a weak cry. On 02/21/2002 mom said he was still pale and quieter than usual. Instructed to take into the physician's office. He was seen in the doctor's. Pt seems he has recovered but did have an adverse event.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Feeling hot, Injection site swelling, Urticaria
Clinical narrative: Pt presented with some isolated hives on face, injection side left deltoid area slightly raised and warm to touch. Member presents to medical 45mins after injection given. Pt was observed for 30 mins and triaged to the medical center for evaluations.
Age: 85.0
Sex: M
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: A report received on 10/30/2001, concerning an 85 year old male pt who experienced pneumonia which was considered to be medically significant, 1 day after receiving the fluvirin vaccine on 10/04/2001. relevent concomitant medications taken include bisoprolol fumarate and leuprorelin acstate. On 10/05/2001, the patient experienced pneumonia, which was considered to be medically significant 1 day after receiving the fluvirin vaccine on 10/04/2001. The pt has recovered without sequelae. There was insufficient info to determine the reporter's causality assessment. Follow-up report received on 02/28/2002 indicated that the pt was diagnosed with left sided lobar pneumonia, viral. There were no results of investigations documented. The pt had a history of prostatic carcinoma. The pt was treated with levofloxacin and augmentin for the event. OMIC
Age: 79.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: On 2/10/02, pt called me and said she had been unable to sleep the night before because of soreness in her arm where Td was given (Right deltoid). Stated that she had a fever of 100.5 degrees F. Said her arm was red and swollen at the time of her call-5 pm. Told pt to use cool compresses and  take Tylenol and see MD if it got worse. By 2/11/02, improving and today pt states it's better right deltoid has 50 mm area of redness-heat.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site reaction, Pyrexia
Clinical narrative: Erythema, irritation, local warmth, and tenderness of 7cm diameter surrounding the injection site of MMR. Pt also had fever of 105 degrees F.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Skin irritation
Clinical narrative: Erythema, irritation, local warmth, and tenderness of 7cm diameter surrounding the injection site of MMR. Pt also had fever of 105 degrees F.
Age: 0.9
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Pt developed fever within 1 hour of receiving vaccine which rose to 104 deg. F. Trated with Motrin, alternating with Tylenol. Fever continued to stay at 104 deg F. and above. Listless on second day following vaccines. Pt sent to the ER.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: On 03/01/2002, the pt presents generalized itching, hives, erythema, and urticaria. She had a rabies vaccine that day. On 20:00 the pt states itching is decreased and redness is subsiding.
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Rash
Clinical narrative: Pt developed rash like bumps up and down left leg with stiffness around the site of injection.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Balance disorder, Otitis media, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: On 02/18/2002, pt received DTap in the right leg. Had high fever which began on 02/19/2002. Had low fluid intake; seemed "off balance" to mom. Had a runny nose. Exam consistent with otitis media. Also had a fine 1mm papular exanthem on back (100.7 deg F. at the time). Mom was concerned it was related to the vaccine.
Age: 2.3
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Erythema, Injection site induration
Clinical narrative: Left thigh redness and induration of 8cm in diameter.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Large urticaria left arm (local rxn)
Age: 17.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Back pain, Pyrexia
Clinical narrative: Lower back pain started early morning after immunization, progressing during the day. Fever 3/5/02 eve. up to 101 degree F. He took acetaminophen to help with pain and fever-developed into chest cold on 3/7/2002.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Headache, Pyrexia, Rash, Rhinitis
Clinical narrative: 6:30 pm- throat started feel tight, 7 pm head-fullness, dizzy, fever, 8 pm and 9 pm-1 Buprofer/Benadryl combination   3/6 runny nose Resp; CTA ENT swelling rash/hives. Started on Benadryl 25 PO every six hours
Age: 12.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Throat tightness, Urticaria
Clinical narrative: 6:30 pm- throat started feel tight, 7 pm head-fullness, dizzy, fever, 8 pm and 9 pm-1 Buprofer/Benadryl combination   3/6 runny nose Resp; CTA ENT swelling rash/hives. Started on Benadryl 25 PO every six hours
Age: 1.7
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective
Clinical narrative: The pt developed chicken-pox 8 months after receiving vaccine.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: 10 cm raised area, red. Pt reports pain and swelling. 2/26/02. improvement but not resaolved on 3/11/02 pm, nearly resolved 3/1/02.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness and swollen in area given lump under skin on right thigh. Advised to give warm compresses and Motrin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site mass, Swelling
Clinical narrative: Redness and swelling, lump under skin. Parent was advised to give Motrin and apply warm compressed in the right thigh.
Age: 1.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, swelling at injectionsite with appearance of small fluid filled vesicles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Face oedema, Hypersensitivity, Rash
Clinical narrative: Received a phone call from the pts mother around 2:50 pm on 03/04/2002. He informed out translator that the pt started breaking out in a rash and her face was swellling. Nurse instructed her to go to the ER. At 4pm that day, the reporter received a call from ER physician. He stated that the mother told him that the pt started with rash about 10 mins after receiving immunizations. He stated that he diagnosed as an allergic reaction and gave her Benadryl.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Agitation
Clinical narrative: Marked irritablity started Ga, after vaccination lasted 4 hours; inconsolable for 1 hr.
Age: 67.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Eye swelling, Pruritus, Rash, Tongue oedema
Clinical narrative: The pt developed itching approx 58 hours after TD vaccine along with swelling of tongue, eyes, difficulty breathing, followed by rash over entire body.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: All immunizations administered at about 10:00 on 05/Mar/02 Patient began to have repeated emesis at about 20:00 on 05 Mar 02 Remained febrile. Emesis continued for few hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Rash maculo-papular
Clinical narrative: Pt was seen for well child visit on 02/19/2002 and was given MMR #2, IPV#4, and DTaP #5. On 02/21/2002, pt developed significant area of erythema 10cm x 14cm on right thigh (at the site of injection) She also developed mild maculo paular eruption on upper left thigh.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site inflammation, Injection site reaction
Clinical narrative: Itching, hot, redness, soreness at the site of injection was noted on 02/27/2002. Induration extends 1 inch from shoulder down approx. half way to elbow, followed 3 inches of redness aroused area. These symptoms lasted till 03/01/2001 am, pt reports the symptoms resolved after Benadryl was taken.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Pruritus
Clinical narrative: Itching, hot, redness, soreness at the site of injection was noted on 02/27/2002. Induration extends 1 inch from shoulder down approx. half way to elbow, followed 3 inches of redness aroused area. These symptoms lasted till 03/01/2001 am, pt reports the symptoms resolved after Benadryl was taken.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: urticaria on both side of face without respiratory distress
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis
Clinical narrative: On 09/14/2001, lab report indicate Hep BSAgt eventhough HBIG and series of 3 Hep B vaccine given within approx. time frame. HBIG and HBV#1 given on 07/29/2000, HBV #2, and HBV#3.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Asthma
Clinical narrative: Pt has allergy to wheat and asthma. Mom reports after receiving her Hep B #2 imm at 1600 hours. the child had a sudden onset of asthma occuring at 04:00 hours on 2/26/02. This sudden onset atypical.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Pt presents with 50 plus chicken pox lesions all over face and body on 03/08/2002
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction, Injection site swelling
Clinical narrative: Pt presents red, raised, hard to touch, swollen rash on 1/2 of upper arm (injection site arm) and was treated with ice compress
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash
Clinical narrative: Pt presents red, raised, hard to touch, swollen rash on 1/2 of upper arm (injection site arm) and was treated with ice compress
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Information has been received from a consumer concerning a 17 year old male with eosinophilic gastroenteritis, Celaic disease and unspecified food allergies who was vaccinated with a first, second and third dose of hep B vaccine recombinant in August 1997, September 1997 and November 1997, respectfully, Shortly after his third dose, the pt experienced vomiting daily. It was reported that the pt had sought medial attention. In October 1998, the pt was vaccinated with a fourth dose of hep b vaccine recombinant. It was reported that the pt's vomiting gradually declined and that he currently vomits approximately once a month. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Erythema, Hypersensitivity, Rash, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 6 month old female with an oatmeal allergy who on 07/17/2002 was vaccinated IM in the right thigh with the second dose of hep B vaccine recombinant. Concomitant vaccine therapy included the first dose IM in the left thigh of Prevnar vaccine, the third dose IM in the right thigh of Hib-titer vaccine, and the third dose IM in the left thigh of Acel-Imune. There were no other concomitant medications. The pt had no illness at the time of the vaccinations. On 07/19/2000, within 48 hours post immunization, the pt developed a rash and hives. Subsequently, the pt recovered on 07/26/2000. Additional info has been received from a health professional who reported that the child broke out in a rash at approx. 5pm on 07/20/2001. It was described as large red welts over neck and chest that progressed quickly. The parents reported that it was the same rash that the child had 3 weeks previous. There was no shortness of breath or difficulty breathing. The child was vocalizing well. It was noted that the parents had recently started introducing new foods to her. The child's mother took her to the ER on 07/20/2001 where she was prescribed Benadryl. Her similac was stopped and they were instructed not to give the child any new foods. She was diagnosed with an "allergic reaction."
Age: 12.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 year old male pt who on 01/02/2001 was vaccinated with hep B vaccine recombinant IM in the left deltoid and MMR vaccine in the left arm. On 01/02/2001 the pt experienced vomiting and abdominal pain. The pt did not received medical care. Subsequently, the pt recovered. Additional info has been requested.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Erythema, Hypersensitivity
Clinical narrative: Information has been received from a health professional concerning a 41 year old female with allergies to sulfa, penicillin, mango and who has a mitral valve prolapse, hypertension, borderline diabetes and arthritis who on 01/17/2001 was vaccinated with a first dose of hep B vaccine recombinant in the left deltoid IM at approx. 11am. Concomitant therapy included digoxin (Lanoxin), enalapril maleate, and a second tuberculin purified protein derivative. It was also noted that the pt had her second PPD checked. On 01/17/2001 at approx. 12pm, the pt complained of shortness of breath and redness in face and chest. It was noted that the pt contacted the employee health service three hours later. The pt denied itching and airway obstruction. The pt was later referred to the ER and was diagnosed with an allergic reaction and given Benadryl and Medrol. The pt was kept for one hour for observation, and was released with a prescription for Prednisone. The pt was considered to be recovered on 01/17/2001. No further info is expected.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 02/26/2001 was vaccinated with a third dose of hep B vaccine recombinant. There was no concomitant medication. On 02/27/2001 the pt developed a papular rash on both her wrists and forearms and on the front and back of each leg. There were no other symptoms noted and no site reaction noted. Unspecified medical attention was sought. Additional info has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with no past medical history who on 01/17/2001 was vaccinated IM in left arm with a first dose of hep B vaccine recombinant. There was no illness at the time of vaccination. On 01/19/2001 the pt developed hives on her back, neck and legs and a fever. Pt was seen by a physician and therapy with hydroxyzine was initiated. On 01/22/2001 the pt temp was 103 and she had a sore throat. The pt was seen by a physician and therapy with azithromycin and a cough syrup was prescribed. On 01/23/2001 the pt still had an increased temp and hives. On 01/29/2001 the pt went back to school but continues with hives and the hydroxyzine treatment. On 02/05/2001 her temp decreased and hives persisted. The nurse wondered if the pt had scarred from the hives. The nurse also reported a male developed hives and fever after receiving hep B vaccine recombinant.
Sex: F
Vaccine: HEP
Symptoms: Acne, Bronchiolitis, Cough, Ear pain, Rash
Clinical narrative: Information has been received from a consumer concerning her 20 day old white female daughter, with food allergies (wheat/barley) and eczema  who on on 11-May-2000, 17-Jun-2000, and an unspecified date was vaccinated IM with the first  (lot # 634862/0009K), second (lot # 635517/0431K), and third (lot # not reported) doses of hepatitis B vaccine recombinant (yeast), respectively. There were no concomitant medications reported. Subsequently, on 27-May-2000, (previously reported as 'In a few days") she reportedly had a "rash outbreak" all over her body. It was reported that the pediatrician gave them cream to use. Following the second dose, on 27-JUN-2000, "the rash (on her arms and back) came back again and the pediatrician said it was baby acne, they went to a dermatologist and he said, it was not . " Following the third dose, on an unspecified date, the patient developed an earache, cough and bronchiolitis. It was further reported that the patient also received "other shots" that "she also reacted to". It was indicated that the mother had sought medical attention for her daughter it was reported that the patient recovered.  Follow-up information reported tha on 30-Oct-2001 the baby was seen by her physician for follow-up. It was noted that the physician would like to give the baby monovalent MMR vaccine and that the baby should receive the shots without preservative.  No further information is available.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Chest discomfort, Eye pain, Paraesthesia, Sensation of heaviness
Clinical narrative: Information has been received from a health professional concerning a 59 year old female pt with a sulfa allergy and no other past medical history who on 08/22/2001 at 7:30pm, was vaccinated in the left arm with a first dose of hep B vaccine recombinant. Concomitant medication included unspecified hormone replacement therapy. There was no illness noted at the time of vaccination. Almost immediately post vaccination, at 8pm, the pt experienced a strange sensation and pain in her left eye, heaviness in her left arm, some chest discomfort, tingling all over her body and an increase in blood pressure to 150/90. It was reported that she normally runs low blood pressures. The physician reported that the duration lasted for about 2 hours and the pt's treatment was observation and blood pressure checks. It was reported that the pt's date of recovery was 08/22/2001. On 08/23/2001 the nurse spoke with the pt and per her conversation the pt was fine. It was reported that there were no other reactions with this pt to any injection in the past. A hep B titer was planned to be done in one month. No further information is expected.
Age: 0.2
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC, HBHEPB, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Sudden infant death syndrome
Clinical narrative: This report concerns a 10 week old female who on 09/27/2001 was vaccinated with one dose of Haemophilus B conjugate vaccine hepatitis B vaccine recombinant. On 10/14/2001 the pt experienced sudden infant death syndrome and died. This was originally reported by a physician. Additional info has been requested. A follow up report received 3/26/2002 adds: It has been determined that WAES #0202USA02896 is a duplicate of WAES #0201USA00430. Therefore, WAES #0202USA02896 is being deleted from our files and the reports consolidated into WAES #0201USA00430.
Age: 0.2
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC, HBHEPB, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report concerns a 10 week old female who on 09/27/2001 was vaccinated with one dose of Haemophilus B conjugate vaccine hepatitis B vaccine recombinant. On 10/14/2001 the pt experienced sudden infant death syndrome and died. This was originally reported by a physician. Additional info has been requested. A follow up report received 3/26/2002 adds: It has been determined that WAES #0202USA02896 is a duplicate of WAES #0201USA00430. Therefore, WAES #0202USA02896 is being deleted from our files and the reports consolidated into WAES #0201USA00430.
Age: 0.2
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC, HBHEPB, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Atrial septal defect, Petechiae, White blood cell count decreased
Clinical narrative: This report concerns a 10 week old female who on 09/27/2001 was vaccinated with one dose of Haemophilus B conjugate vaccine hepatitis B vaccine recombinant. On 10/14/2001 the pt experienced sudden infant death syndrome and died. This was originally reported by a physician. Additional info has been requested. A follow up report received 3/26/2002 adds: It has been determined that WAES #0202USA02896 is a duplicate of WAES #0201USA00430. Therefore, WAES #0202USA02896 is being deleted from our files and the reports consolidated into WAES #0201USA00430.
Age: 13.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Erythema, Injection site erythema, Injection site rash, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female adolescent who on 08/28/2001 was vaccinated with hep B vaccine recombinant. There was no concomitant medication. On 08/28/2001, later that day following her vaccination, the pt developed a rash on her chest and on her back. Within two days, the pt recovered from her rash. No other symptoms were reported. It was indicated that the pt had sought medical attention regarding her symptoms. No further info was provided.
Age: 13.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female adolescent who on 08/28/2001 was vaccinated with hep B vaccine recombinant. There was no concomitant medication. On 08/28/2001, later that day following her vaccination, the pt developed a rash on her chest and on her back. Within two days, the pt recovered from her rash. No other symptoms were reported. It was indicated that the pt had sought medical attention regarding her symptoms. No further info was provided.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Drug ineffective, Irritability, Pneumonia, Pyrexia, Sepsis
Clinical narrative: This report was rec'd concerning a pt who on 1/7/02 was vaccinated with one dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. Concomitant therapy that same day included 1 dose of hepatitis B. On 1/21/02 the pt developed streptococcal septicemia, fever, vomiting and irritability which were reported as medically important. This report was originally reported by a physician. Additional info has been requested. It has been determined that WAES0202USA02894 is a duplicate of WAES0202USA01910. Therefore, WAES0202USA02894 is being deleted from our files and the reports consolidated into WAES0202SUA01910.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Vomiting
Clinical narrative: This report was rec'd concerning a pt who on 1/7/02 was vaccinated with one dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. Concomitant therapy that same day included 1 dose of hepatitis B. On 1/21/02 the pt developed streptococcal septicemia, fever, vomiting and irritability which were reported as medically important. This report was originally reported by a physician. Additional info has been requested. It has been determined that WAES0202USA02894 is a duplicate of WAES0202USA01910. Therefore, WAES0202USA02894 is being deleted from our files and the reports consolidated into WAES0202SUA01910.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Bacterial infection, Irritability, Pyrexia, Sepsis, Vomiting
Clinical narrative: This report was rec'd concerning a pt who on 1/7/02 was vaccinated with one dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. Concomitant therapy that same day included 1 dose of hepatitis B. On 1/21/02 the pt developed streptococcal septicemia, fever, vomiting and irritability which were reported as medically important. This report was originally reported by a physician. Additional info has been requested. It has been determined that WAES0202USA02894 is a duplicate of WAES0202USA01910. Therefore, WAES0202USA02894 is being deleted from our files and the reports consolidated into WAES0202SUA01910.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, HEP, PNC, HBHEPB, HEP, DTAP, HBHEPB, HEP, PNC, DTAP
Symptoms: Irritability, Laboratory test abnormal, Pneumonia, Pyrexia, Sepsis
Clinical narrative: This report was rec'd concerning a pt who on 1/7/02 was vaccinated with one dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. Concomitant therapy that same day included 1 dose of hepatitis B. On 1/21/02 the pt developed streptococcal septicemia, fever, vomiting and irritability which were reported as medically important. This report was originally reported by a physician. Additional info has been requested. It has been determined that WAES0202USA02894 is a duplicate of WAES0202USA01910. Therefore, WAES0202USA02894 is being deleted from our files and the reports consolidated into WAES0202SUA01910.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: SIDS 3/5/02
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old female who on 01/31/2001 was vaccinated with one dose of varicella virus vaccine live. On 05/21/2001, the pt learned that she was approximately 6 weeks pregnant. Follow-up information indicated that the pt was tested for varicella antibodies prior to vaccination with varicella virus vaccine live. The pt's prior pregnancies all resulted in full term births with no birth defects. The pt did not experience a local reaction at the vaccination site or varicella or herpes zoster symptoms post vaccination. On 12/27/2001 at 40 weeks gestation she gave birth to a male. His birth weight was 8 lb. 4 oz. He was born with an accessory digit attached to his left pinky. There were no complications during pregnancy, labor/delivery. An ultrasound was done during the pregnancy but the results were not reported. A maternal serum alpha fetal protein test on 07/19/2001 was negative x 3. There were no illnesses or infections during the pregnancy and not concurrent medical conditions or concomitant medications. Follow up information received from the pediatrician's office manager who reported that the infant's medical record notes that aside from the notation of the supernumerary digit, the baby appears to be healthy and normal. The ligation procedure took place in the hospital prior to the newborn's discharge and was not well documented in the pediatric record. A biopsy was done on the tissue from the left digit skin tag. The digit was described as small, pink, nodular tissue measuring 0.7cm overall. Microscopic examination of the tissue sections showed skin and subcutaneous tissue with cartilage and focal ossification. The diagnosis was Digit from left hand. Excision consistent with accessory digit. Follow up information received on 11/11/02 stated that the mother was a gravide 6 para 5 who following an 8 hour and 29 minute labor and artificial rupture of membranes with clear fluid, had a vaginal delivery of a boy with 8/9 Apgar's. The infant's birth weight was 8lbs 4ozs and length of 20 inches. On 12/27/01, the infant had a ligation and excision of a supernumerary digit on the left hand. At the same time, a Gomco circumcision was performed. Blood loss was estimated as minimal, and the infant was reported to be in good condition with no complications following the procedures. At 2 weeks of age, the infant weighed 8lbs 14ozs, was 21 inches in length, and had a head circumference of 38cm. This case is part of the pregnancy registry. Additional info has been requested.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Bacterial infection, Sepsis
Clinical narrative: This report was rec'd concerning a pt who on 10/5/01 was vaccinated with MMR. Concomitant therapy that same day included one dose of varicella. On 10/6/ the pt developed septicemia streptococcal and was hospitalized. This was originally reported by a physician. Additional info has been requested. Follow-up information from the physician noted that he was only notified through adverse reaction reports that the patient had an event. It was noted that all available data has already been forwarded. The physician noted, "I did not admit this patient to hospital and am unsure if they even were hospitalized". No further information is available. Follow-up information noted that no further diagnostic data or work-up was available.
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been rec'd from the father of a child who was vaccinated as a toddler with a dose of MMR. Subsequently, the pt was diagnosed with autism. The pt's autism persisted. At the time of this report the pt was 10 yrs old. Upon internal review, autism was considered an other medical event. Additional info has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever of 105.5F (Rectal) and febrile seizure on 3/3/02 at approx. 12:00. Mom reports that pt was taken ER approx. 19:30, 3/2/02 for fever and treated for the fever. Mom says pt was started on po Augmentin. Pt was then released home. Mom says, "I thought, maybe, he was having a seizure then but was told he wasn't". Mom reports that pt was treated for fever and released home. Mom reports that on 3/3/02 at 01:30 and at approx. 12:00, she took the pt back to ER, "because he was having a seizure". Mom say pt was seen and treated admitted to the hospital. She says pt was given IV fluids and kept on his Augmentin, as well as treated for the fever he had. Mom says, "They said he may have pneumonia, from the CXR". She reports pt was discharged from the hospital on 3/4/02 at approx. 14:00. Mom says pt is still on Augmentin po and she is alternating Tylenol and Motrin q 3 hours. Mom says pt "has had no fever in the past 2 days and has a cough with a runny nose". Mom says pt is to F/U with MD at the end of this week and she has been out of the office. Mom plans to call later in the week to schedule F/U appt.
Age: 1.25
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever of 105.5F (Rectal) and febrile seizure on 3/3/02 at approx. 12:00. Mom reports that pt was taken ER approx. 19:30, 3/2/02 for fever and treated for the fever. Mom says pt was started on po Augmentin. Pt was then released home. Mom says, "I thought, maybe, he was having a seizure then but was told he wasn't". Mom reports that pt was treated for fever and released home. Mom reports that on 3/3/02 at 01:30 and at approx. 12:00, she took the pt back to ER, "because he was having a seizure". Mom say pt was seen and treated admitted to the hospital. She says pt was given IV fluids and kept on his Augmentin, as well as treated for the fever he had. Mom says, "They said he may have pneumonia, from the CXR". She reports pt was discharged from the hospital on 3/4/02 at approx. 14:00. Mom says pt is still on Augmentin po and she is alternating Tylenol and Motrin q 3 hours. Mom says pt "has had no fever in the past 2 days and has a cough with a runny nose". Mom says pt is to F/U with MD at the end of this week and she has been out of the office. Mom plans to call later in the week to schedule F/U appt.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia, Respiratory failure
Clinical narrative: The pt received a Fluvirin vaccination on 10/23/98 and on 5/29/99 experienced pneumonia and respiratory failure and subsequently died, as a result the adverse event was considered serious. The reporter assessed the causality as possibly related. No more information has been provided.
Age: 0.25
Sex: F
Vaccine: DTP
Symptoms: Epilepsy, Grand mal convulsion, Neurodevelopmental disorder, Oral intake reduced
Clinical narrative: Seizures and mental retardation after 1st DPT. Also had a poor appetite before and after vaccination. The 1st seizure occurred 20 minutes after vaccination of routine DPT. A month later, she had another seizure and grand mal seizures every 3-4 days after, for 17 years but less in the last year. Follow up letter state: MD was not pt's doctor in 1984. He became her doctor on 08/15/1987.  Pt's MD before was taken over by New MD who never saw pt.
Age: 21.0
Sex: F
Vaccine: FLU3, HEP, MEN, PPV
Symptoms: Cellulitis, Myalgia, Oedema, Rash
Clinical narrative: Muscle soreness, edema, rash left upper arm, diagnosis- upper arm cellulitis, left
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever,102.1 degrees F
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Mom called describing fever (103.1 (R)), SOB, rapid heart rate evening /early morning (1AM-3/6/02 Parent treated @ home with Motrin and warm compresses-doing better on 3/6/02-later in day-some leg stiffness.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Lethargy, Pallor, Somnolence, Urticaria
Clinical narrative: 2-23-02 Mom noticed babe being lethargic and sleeping a lot more than usual. Sunday -skin was pale and then broke out in hives, Mom made report on 03-02-2002. Dr. notified. Hives were fading so just observed at that time.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Swollen , hives, itchness all over body. Hives all over. Has retained over 40 lbs of water since shot was given on 30 Oct 01. ER visit 3 Nov 01
Age: 41.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Oedema
Clinical narrative: Pt presented to medical squandron c/o large amount of swelling on right upper arm where she received her typhoid immunization. Also with four scratch-like marks above swollen area, approximately 3 inches long
Age: 43.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: Pt telephoned two days post vaccination stating te shot went into the "back" of her arm and has a quarter size mark at the injection site that is red, swollen and itchy. Pt is given Tylenol for pain, applied ice to the affected area. PCP states it was a localized reaction.
Age: 29.0
Sex: M
Vaccine: ANTH, FLUX, TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus, Rash
Clinical narrative: I have developed skin rashes that reoccur on a regular basis. I received my first anthrax shot on 10/21/1999 and continued the series that ended with shot 4 on 04/25/2000. My rashes began shortly there after on my torso, neck, back and arms along with soreness, swelling, itching at the site of injection.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Lung disorder
Clinical narrative: A health professional form was received on 02/28/2002 concerning a 75 year old male pt who experienced exacerbation of chronic obstructive pulmonary disease, which was considered medically significant 4 days after receiving a flvirin injection on 12/01/1998. The pt experienced exacerbation of chronic obstructive pulmonary disease on 12/05/1998 after receiving a fluvirin vaccine on 12/01/1998. The reporter assessed the causality as possibly related. No more information has been provided.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Hypokinesia, Pain
Clinical narrative: Pain and difficulty noted in elbow and hand.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Diarrhoea, Musculoskeletal stiffness, Rectal haemorrhage
Clinical narrative: Stiffening of the right side from the shoulder to the arm on the first day. Stiffening of the hand and shoulder 3 days later. Diarrhea on everyday for about 10 days. Bleeding in anal area. Abdominal cramps on left side and rash on chest were also noted.
Age: 2.0
Sex: F
Vaccine: HEP, PPV, VARCEL
Symptoms: Drug ineffective, Pyrexia
Clinical narrative: Had varicella vaccination on 12/20/2000. On 03/07/2002, the pt developed low grade fever and now has approx. 20-30 pox.
Age: 0.25
Sex: M
Vaccine: HIBV, IPV
Symptoms: Eye swelling, Rash
Clinical narrative: 1 1/2 hours after vaccination, pt's eyes were puffy and rash developed on body and face. After Benadryl was given, symptoms subsided.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Thrombocytopenic purpura
Clinical narrative: ITP (idiopathic thrombocytopenic purpura) on 03/01/2002, platelet count 19k and resolved on 03/06/2002.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Anorexia, Erythema, Pyrexia
Clinical narrative: waited 20 minutes following immunization on way home child told mom he did not feel well child was bright red. fever 101-103 degrees F, during night decreased with Tylenol, but when 2-3 hours are up, fever increased again. child c/o no appetite.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: At 24 hours, redness, swelling of left arm deltoid with 4.5 diameter. At 48 hours, less redness and swelling of the area. At 72 hours, rash all over body given Benadryl
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Left thigh swelling with erythema warmth extending to anterior, medial, lateral aspects of left extremity. pt received Rocephin for possible cellulitis.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Started around shot area and grew to 1 inch from elbow, wrapping around arm, leaving about  1 inch from edge to edge on inside of arm very red, swollen and hot, very painful, and unable to raise arm. lasted about 3 days.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: 3-5-02 left deltoid swollen cold compresses, 3/6/02 am swelling moved down towards elbow, cold and warm compresses Tylenol every hours, Advil, ice and heat, left arm bicep 9 inches right arm 7 ins, redness from top of deltoid to elbow's circumferential, swelling
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness with local swelling at injection site 5cm x 7cm.
Age: 1.4
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Pt was fussy with crying for 3 hours starting at bedtime. She continued to have redness and swelling approx 1 1/2" x 2" in diameter in left lateral aspect of leg. Fever was no higher than 100.2 deg. F. The nurse instructed parent to continue using anti-inflammatory every 6-8 hours with Motrin and start using warm and cold compression on left leg.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash macular
Clinical narrative: Local rash 4mm all the way around injection site, total 8 mm blotchy rash (not raised). Rash occurred within 15 mins of injection and was gone within hours after Benadryl was given.
Age: 2.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Contusion, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Received MMR and chicken pox on 2-11-02. On 3-3-02, pt had petchial hemophagus throughtout body. Hospitalized with thrombocytopenia surpura with decreased platelets and bruising, IVIG given Transferred from one hospital to another on 3-5-02
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Pneumonia, Pruritus, Pyrexia, Scar, Skin ulcer
Clinical narrative: Pneumonia-first part of October, Fever. Also had a few lesions and a few lesions in mid-February Itching scattered. Left a scar (not indented)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema peripheral
Clinical narrative: Right deltoid very swollen-free ROM  of arms over tricep. Red, hot, very swollen Gave Motrin and Tylenol
Sex: M
Vaccine: HBHEPB, VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Numerous vesicles on red bases -4 1/2 yrs post Varivax. clinical chicken poc, symptomatic treatment
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles, Rash papular
Clinical narrative: Per Mom, developed diffuse papular rash about 3/1/02 on trunk and extremities, went away 3/6/02. On 3/6/02, developed redness and blisters left anterior thigh at site of Varivax injection.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Agitation, Crying, Irritability, Pyrexia, Swelling
Clinical narrative: Fever began at 16:30 on 03/07/2002 (99 deg. F) and was given Tyleno. At 5:30 am, the temp was 101 deg. F. Pt was irritable and crying all night. He was taken to the medical center with swollen thigh on exam at 16:45, erythema.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Rash vesicular
Clinical narrative: 12 days after vaccine presented with localized vesicular lesion with surrounding erythema.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site swelling
Clinical narrative: Swelling and warmth over left thigh at the site of injection with no erythema.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: The injection site became inflamed, reddened, and induration on 03/03/2002 and the vaccine was administered two days prior.
Age: 1.0
Sex: M
Vaccine: HIBV, MEA
Symptoms: Pyrexia
Clinical narrative: Fever 100.4 to 101.5
Age: 1.7
Sex: M
Vaccine: DTAP
Symptoms: Muscle twitching, Pyrexia, Tremor
Clinical narrative: 24 hours post vaccination, child had fever to 100.7 deg. F. and left arm twitching followed by entire body shaking, lasting 5 minutes.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective
Clinical narrative: Child diagnosed with chicken pox eventhough he previously received the vaccine.
Age: 1.6
Sex: M
Vaccine: DTAPH, MMR
Symptoms: Ear pain, Infection
Clinical narrative: The child's mother called 2-12-02 stating child had been seen on 2-8-02 by a doctor and diagnosed with ear infection. Child had awakened during the night screaming and covering his ears. Child has had ear infections in the past. He was at the end of his course of antibiotics on 2-1-02 when immunizations were given. Healthy at that time. Mom states that the doctor didn't think there was any connection to immunization. On another antibiotic at present for the ear infection. Has follow-up doctor appointment scheduled.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Ear pain, Infection, Pyrexia, Rash
Clinical narrative: Infant's mother telephoned 2-13-02 stating infant became ill Monday night and she took her to the doctor on 2-12-02. "She has ear infection again-7th time since October. The doctor didn't think it had to do with her shots." She had just had a "little bit of a temperature and a little rash on her leg after the shots"
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Muscular weakness, Staring, Tremor
Clinical narrative: Mother states child developed a staring spell for 2-3 days with occasional shaking-stopped cooing-lost grasp grasping resumed in 10-14 days.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: 103 degree fever for 4 days
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: Returned to office  two hours after immunization with generalized urticaria. Vital signs-normal, pulse ox 99. Given Benadryl and observed in office with good resolution. No respiratory symptoms. to continue with Atarax @ home
Age: 56.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dizziness, Hyperhidrosis
Clinical narrative: Chills, sweats, and light-headedness.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Inflammation, Myalgia
Clinical narrative: Marked redness at shoulder down to elbow with hot to touch and sore.
Age: 0.7
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Induration and pain at the site of injection starting the following day of vaccination lasting at least three days.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Abdominal pain upper, Arthralgia, Injection site erythema, Injection site hypersensitivity, Injection site swelling
Clinical narrative: DTaP and MMR was administered on 03/07/2002. On 03/05/2002, the pt developed swelling, erythema, and intense itch of the right arm (DTaP arm). Then over the next 24 hours she had 6 episodes of knee and toe pain, with 2-3 episodes of stomach pain.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pain, Pruritus
Clinical narrative: DTaP and MMR was administered on 03/07/2002. On 03/05/2002, the pt developed swelling, erythema, and intense itch of the right arm (DTaP arm). Then over the next 24 hours she had 6 episodes of knee and toe pain, with 2-3 episodes of stomach pain.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Overdose
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female who on 12/27/2000 was vaccinated with her second dose of hep B vaccine recombinant IM. The pt experienced discomfort in her arm for several days. The pt was inadvertently given the hep B vaccine recombinant dialysis formulation (1 ml). The registered nurse classified the incorrect dosing as an overdose. No further information is available.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Cold sweat, Dizziness, Feeling cold, Headache, Hypotension
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old male with no past medical history who on 03/20/1990 was vaccinated intramuscularly with hep B vaccine recombinant for the first dose. There were no illnesses at the time of vaccination. The registered nurse reported that subsequently the pt developed flu like symptoms. On 07/06/2000, the pt was vaccinated intramuscularly with hep B vaccine recombinant for the second dose. The registered nurse reported that several hours after the injection of the second dose, the pt's skin was cold, clammy, the pt developed headache, lightheadedness, nausea without vomiting, vertigo, tachcardia and his blood pressure fell (hypotensive). The registered nurse reported that the pt was treated with Advil times two, fluids were forced two liters, a candy bar and the pt sat in a chair for an hour. The registered nurse reported that no rash, respiratory distress or hysphagia were noted. The pt recovered from the cold, clammy skin, nausea, vertigo, headache, tachcardia, lightheadedness and hypotension on 07/06/2000 and 07/07/2000. No further info is available.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Influenza like illness, Nausea, Tachycardia, Vertigo
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old male with no past medical history who on 03/20/1990 was vaccinated intramuscularly with hep B vaccine recombinant for the first dose. There were no illnesses at the time of vaccination. The registered nurse reported that subsequently the pt developed flu like symptoms. On 07/06/2000, the pt was vaccinated intramuscularly with hep B vaccine recombinant for the second dose. The registered nurse reported that several hours after the injection of the second dose, the pt's skin was cold, clammy, the pt developed headache, lightheadedness, nausea without vomiting, vertigo, tachcardia and his blood pressure fell (hypotensive). The registered nurse reported that the pt was treated with Advil times two, fluids were forced two liters, a candy bar and the pt sat in a chair for an hour. The registered nurse reported that no rash, respiratory distress or hysphagia were noted. The pt recovered from the cold, clammy skin, nausea, vertigo, headache, tachcardia, lightheadedness and hypotension on 07/06/2000 and 07/07/2000. No further info is available.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Muscle atrophy
Clinical narrative: Information has been received from a Pharm.D concerning a 38-year-old female who in approximately 1998 was vaccinated with Hepatitis B vaccine recombinant (yeast) (manufacturer unknown). The patient was given her first shot in the deltoid muscle. Subsequently, she experienced muscle atrophy at the injection site. The atrophy resolved on its own. The third shot was given in her gluteal muscle. The patient reported that she again had deltoid muscle atrophy even though the shot was given at a different site. At the time of the report, the atrophy resolved. The patient sought unspecified medical attention.  Addi tional information has been requested.