chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pain
Clinical narrative: Right thigh - swelling, induration 10.2cm x 6.5cm, tender, erythematous at 48 hours presentation.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Dyspnoea, Face oedema
Clinical narrative: Pt was administered Hepatitis B vaccine and left clinic within 15 minutes feeling fine. Within 25 minutes, her lips swelled, she felt shortness of breath and mild chest pain. Within 10 minutes, pt obtained Benadryl tablet (25mg?) from the nurse at her job. All symptoms disappeared. About 45 minutes later, the lip swelling occurred again and the pt took 1/2 tablet of Benadryl. The symptom resolved, and the pt did not have any further problems. The only other intake during this time was iced tea, which pt says she drinks all of the time.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Td vaccine given 10/6/03 in left arm on morning of 10/8/03. Site noted to be red/warm and swollen. No induration. Symptoms did not start until at least 36-40 hours after vaccine given. Tx'd with ice and Benadryl.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Crying, Dyskinesia
Clinical narrative: 4 month old received 2nd set of vaccines. Received DTaP #2, IPV #2, Comvax #2, Prevnar #2. Two hours post vaccines, started crying inconsolably for 2 1/2-3 hours. Brief 5-10 second episode of arms jerking or twitching.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Agitation, Crying, Irritability
Clinical narrative: Extreme fussiness, inconsolable evening of immunizations given.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site induration, Pyrexia
Clinical narrative: Local reaction with induration at injection site right thigh. Fever.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Loss of consciousness, Pallor, Vision blurred
Clinical narrative: Following injection, pt c/o dizziness, blurred vision. LOC <15 seconds. Pt pale. Lungs clear.
Age: 0.92
Sex: M
Vaccine: IPV, MMR
Symptoms: Irritability
Clinical narrative: MMR 1 week ago. T 100.2 max. Irritable, clingy. No other symptoms.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Left building and had cigarette after donation and receiving shot. Came back in and became lightheaded, pale and diaphoresis. Hadn't eaten in last 6 hours. Had her sit down, ice packs applied to chest and neck and water given. Felt OK to leave in 15 minutes.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Pyrexia, Rash
Clinical narrative: 10/7/03 received Varicella and MMR. 10/9/03 104 temp. Febrile seizure, to ER, though may be a virus. 10/15/03: rash on trunk, T 99 with children's Tylenol.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pain, Skin irritation
Clinical narrative: dT given on 10/9/03 about 6-7 hours later pt began complaining of irritation/pain at injection site. F/U on 10/15/03 showed area of erythema about 4cm x 5cm and some induration about 2 x 2cm. Counseled pt to take Ibuprofen for pain and swelling.
Age: 1.17
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection
Clinical narrative: Pt had strep pneumo onoset of 9/29/03. Diagnosed as Bacteremia. He had 3 previous pneumococcal conjugate vaccinations. Possible vaccine failure, isolate sent to CDC.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: Chicken pox - break through case
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Pallor
Clinical narrative: Approx 15 minutes after immunizations, pt had 1 minute episode of pallor and "not breathing" requiring stimulation. No resuscitation performed. Event witnessed by additional adult.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR
Symptoms: Face oedema, Injection site erythema, Pyrexia, Rash macular
Clinical narrative: Pt with macular erythematous rash, fever, facial swelling
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Severe burning, aching, debilatating pain in and around site of injection, starting approximately 30 minutes following vaccination and continuing for about 7 hours. No relief with 350mg acetaminophen-codeine. Symptoms improved during following day, then reoccured upon arising at approximately 54 hours post-injection and continued to present.  Pain in shoulder includes both severe pain without movement, as well as inability to raise or move arm without extreme pain and stiffness.  No edema, rash, or inflamation is present.  However, mild to moderate body and headache occured during first 48 hours post-injection.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Headache, Joint range of motion decreased, Pain, Skin burning sensation
Clinical narrative: Severe burning, aching, debilatating pain in and around site of injection, starting approximately 30 minutes following vaccination and continuing for about 7 hours. No relief with 350mg acetaminophen-codeine. Symptoms improved during following day, then reoccured upon arising at approximately 54 hours post-injection and continued to present.  Pain in shoulder includes both severe pain without movement, as well as inability to raise or move arm without extreme pain and stiffness.  No edema, rash, or inflamation is present.  However, mild to moderate body and headache occured during first 48 hours post-injection.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: broke out in hives 2-3 days after receiving vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Injection site oedema
Clinical narrative: As the needle was being withdrawn after injection, blood started to come out of the arm and I noticed a little swelling and bruising to the area surrounding the site about 1 in. in diameter. procedure for injection was followed and done correctly. I as the patient how she felt, and if she was currently on coumadin or aspirin products, she felt fine and she was not doing any of those meds.  We gave benadryl for the swelling and watched her for a while until we were sure the swelling had stopped. We informed her of what side effects to look for after having the influenza vaccine and told her what to do if the swelling started back.  We also told her that we would call later in the afternoon to see how she was doing.  I spoke to a medical Dr. at the maker of the vaccine, just to see if a rxn such as this is reported frequently or not.  Dr agreed that we did the right things for the patient and advised as I did to tell the patient to see her local dr. and get get her blood count check to assess whether there are any bleeding disorders, etc.  I called the patient back in the afternoon and she was still fine and I informed her of my conversation with dr. at manufacturer and she agreed that she would go visit her Dr. for the blood count assessment. get a
Age: 50.0
Sex: F
Vaccine: DT
Symptoms: Arthralgia, Chills, Difficulty in walking, Erythema, Musculoskeletal stiffness
Clinical narrative: Joint Pain, increase skeletal Pain, Fever, Chills, Stiffneck, difficulty Walking. Started 8Hrs after injection. Aem Swelling/Redness from elbow to shoulder, Tylenol/ASA for pain.
Age: 50.0
Sex: F
Vaccine: DT
Symptoms: Oedema, Pain, Pyrexia
Clinical narrative: Joint Pain, increase skeletal Pain, Fever, Chills, Stiffneck, difficulty Walking. Started 8Hrs after injection. Aem Swelling/Redness from elbow to shoulder, Tylenol/ASA for pain.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia
Clinical narrative: erythmia,warm to touch, increases swelling, soreness, mild fever.
Age: 39.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Two erythematous papules at Varicella vaccine injection site
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node on left clavicle.  Patient given Keflex 500mg qd for 5 days.  Swelling decreased.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Tremor
Clinical narrative: Vaccine given in early afternoon. Pt. went home and laid down.  Reported rigors and extreme muscle tremors all night.  Currently complaining of joint aches and "locked knees."  Fiancee administered tylenol and benedryl.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Extreme dizziness upon waking at 5:45 a.m. the day after injection.  Dizziness reduced and gone by 2:00 p.m.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia
Clinical narrative: Slight redness noted on right deltoid with swelling.  area felt warm to the touch.  oral temp 99.2 on 10/8, BP 110/60 patient going to pmd for check up
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Fatigue, Myalgia, Pyrexia, Urinary hesitation
Clinical narrative: Approx. 2 days following vaccination, pt. experienced minor systemic fatigue and muscle ache. At day 3, pt. developed a cough with continued fatigue. At day 4, pt. developed a worsening cough with yellowish, thick sputum, 100.7 fever and urinary hesitancy. On days 4-6, productive cough persisted with fever ranging 100.7-101.4. By day 7, pt. reported improving condition and temperature within normal limits.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Daugher of patient called stating patient had a reaction to the pneumonia vaccine.  Patient in to the clinic.  Right arm with swelling at sight, heat, pain on abduction and to the touch.  Patient putting alcohol on site.  Swelling, heat, pain, and reddness with induration noted.  Patient instructed to take motrin and apply ice to site.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Joint range of motion decreased, Pain, Pyrexia, Rash
Clinical narrative: Administered 10/8/03 in left arm By 10/9/03, extremely sore arm; unable to lift arm at all. Severe headache developed by evening; temp of 100.1 at 11 pm that evening. Large welt and rash on left arm where shot administered. On 10/10/03, temp of 100.2 at 6 am; other symptoms (sore arm, headache, welt, rash) continued. On 10/11/03, temp back to normal; arm still sore but able to lift somewhat; welt and rash still visible. Welt and rash on arm still visible until 10/16/03. Arm sore, but pain diminishing. Had influenza shot same day; no symptoms.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Administered 10/8/03 in left arm By 10/9/03, extremely sore arm; unable to lift arm at all. Severe headache developed by evening; temp of 100.1 at 11 pm that evening. Large welt and rash on left arm where shot administered. On 10/10/03, temp of 100.2 at 6 am; other symptoms (sore arm, headache, welt, rash) continued. On 10/11/03, temp back to normal; arm still sore but able to lift somewhat; welt and rash still visible. Welt and rash on arm still visible until 10/16/03. Arm sore, but pain diminishing. Had influenza shot same day; no symptoms.
Age: 0.8
Sex: F
Vaccine: HIBV, MEN
Symptoms: Abnormal behaviour, Anorexia, Crying, Pyrexia, Vomiting
Clinical narrative: Developed persistent crying/unusual behavior immediately; fever and loss of appetite within 1-12 hours of vaccination; vomiting after 36 hours.  This was our childs FIRST vaccine which occurred at 9 months of age.
Age: 11.0
Sex: F
Vaccine: DT, MMR
Symptoms: Dizziness, Hyperventilation, Hypoventilation, Nausea, Shock
Clinical narrative: Information has been received from a health professional concerning an 11 year old female with no medical history and no allergies who on Aug 22, 2002 at 08:20 was vaccinated subcutaneously in the right arm with a second dose of MMR II. On Aug 22, 2002 at 08:20 the patient was also vaccinated intramusculary in the left deltoid with a first dose of diptheria toxoid tetanus toxoid (batch U0382AA). It was reported that 5 minutes after the vaccination, the patient developed dizziness, nausea, and shallow breathing- signs and symptoms of shock. Epinephrine 0.3ml SQ was given. The patient became more responsive. Emergency technicians arrived and oxygen on 2 L/min was started. Pulse oximetry was 98%. The patient was stable by 09:00 and released to her mother. The patient  was still stable at 14:30 with no complaint. On Sept 29, 2003 it was reported that this was all information available regarding this adverse event case. Upon internal medical review shock, dizziness, nausea, and hypoventilation were considered other important medical events (OMIC). It was also reported that a 15 year old male was vaccinated with a second dose of MMR II (lot #639915/14/0L) and developed a vasovagal response (WAES0310USA00995). No further information is expected. the case is closed.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Drug administration error, Foetal distress syndrome, Unintended pregnancy
Clinical narrative: Information has been received through a pregnancy registry from a 37 year old female consumer with no allergies and no medical history who on 12/2/02 was vaccinated with a dose of varicella virus vaccine live (lot # not reported). There were no concomitant medications. It was noted that she had her last period on 11/28/02 and that she is presently pregnant. Unspecified mediacl attention was sought. Follow up information indicated that an ultrasound performed on 1/21/03 showed S=D+FH and an amniocentisis performed on 3/28/03 showed fetal demise - no amnio performed. The patient had 2 previous pregnancies with 2 full term births. No birth defects occurred in any previous pregnancy. No stillbirth or miscarriage occurred in any previous pregnancy. There was no local reaction at the vaccination site and no varicella or herpes zoster symptoms post vaccination. It was noted that the mother has a spontaneous abortion 17 weeks her LMP. The products of conception were examined and the fetus was normal. No other medications was used during this pregnancy. No feature of congenital varicella zoster syndrome was noted on the fetus. No further information is expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Dyspnoea, Hypokinesia, Injection site pain, Nasal congestion
Clinical narrative: Information has been received from a health professional concerning a 66 year old male with a history of chronic shoulder pain, a history of chest pain, shoulder bursitis, and who was seen in the past by a neurologist for his left shoulder pain who on 7/22/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 7/24/03 the pt could not move his arm, with no swelling or tenderness. On 8/15/03 the pt developed a sore throat, congestion, shortness of breath and pain in left shoulder with tenderness in the shoulder, with full range of motion, a slight tenderness at injection site, and was diagnosed with right deltoid bursitis. The pt was given cortisone injection in the bursa and rofecoxib, 50mg daily for 4 days and then 25mg daily. It was also noted that he was treated with anti-inflammatories in the past. The doctor wanted to determine if the lot that was given to the pt had any similar problems. Although the physician vaccinated the pt, he did not record the lot number in the chart, so the reporter was unable to provide this information. It was also noted that the physician felt that the bursitis was not related to the pneumococcal 23v polysaccharide vaccine, but he was trying to determine whether the vaccine aggravated the pt's condition. Upon internal review, the pt's conditions of "he could not move his arm," pain in the left shoulder of increased intensity, and right deltoid bursitis, were considered important medical events (OMIC). Additional info has been requested. Follow up on 10/28/2003: "This is an amended report.  The adverse event section now reads "injection site tenderness" instead of "injection site discomfort".  This is a corrected report as amended."
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pharyngolaryngeal pain, Shoulder pain, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 66 year old male with a history of chronic shoulder pain, a history of chest pain, shoulder bursitis, and who was seen in the past by a neurologist for his left shoulder pain who on 7/22/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 7/24/03 the pt could not move his arm, with no swelling or tenderness. On 8/15/03 the pt developed a sore throat, congestion, shortness of breath and pain in left shoulder with tenderness in the shoulder, with full range of motion, a slight tenderness at injection site, and was diagnosed with right deltoid bursitis. The pt was given cortisone injection in the bursa and rofecoxib, 50mg daily for 4 days and then 25mg daily. It was also noted that he was treated with anti-inflammatories in the past. The doctor wanted to determine if the lot that was given to the pt had any similar problems. Although the physician vaccinated the pt, he did not record the lot number in the chart, so the reporter was unable to provide this information. It was also noted that the physician felt that the bursitis was not related to the pneumococcal 23v polysaccharide vaccine, but he was trying to determine whether the vaccine aggravated the pt's condition. Upon internal review, the pt's conditions of "he could not move his arm," pain in the left shoulder of increased intensity, and right deltoid bursitis, were considered important medical events (OMIC). Additional info has been requested. Follow up on 10/28/2003: "This is an amended report.  The adverse event section now reads "injection site tenderness" instead of "injection site discomfort".  This is a corrected report as amended."
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a male with no medical history or allergies who in 1995 at the age of 2.5 to 3 year old was vaccinated with a dose of MMR II. There was no concomitant medication at the time of vaccination. Subsequently the pt was diagnosed as having highly functioning autism. Medical attention was sought and the pt was placed on therapy with Ritalin to treat the autism. The pt's highly functioning autism persisted. The reporter did not have any further information. Upon internal review, highly functioning autism was determined to be an other important medical event (OMIC). Additional info has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Dyspnoea, Hypertension
Clinical narrative: Information has been received from a pharmacist concerning a 52 year old female patient with an allergy to eggs, hypertension and chronic asthma with frequent exacerbations, who on 10/01/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number not available). Concomitant therapy included losartan potassium-HCTZ, pravastatin Na, fluticasone propionate (+) salmeterol xinafoate and albuterol. The patient complained of shortness of breath and had developed uncontrollable hypertension at the time of admission to the hospital. The pharmacist reported the patient was admitted to the hospital on either 10/1/03 or 10/2/03 in the evening. It was noted that treatment was required for the adverse event. The pharmacist reported that the patient has since responded to corticosteroids and is stabilized at the present. The patient was only hospitalized for a couple of days. She recovered and was discharged from the hospital on 10/4/03. Additional information was received via a follow up telephone conversation with the pharmacist who reported that the patient's experience sounded like anaphylaxis, however she truly did not think it was an adverse drug reaction because the patient's experience occurred more than 24 hours post vaccination. The pharmacist reported that because of the patient's egg allergy she has never and will never receive the flu vaccine. The pharmacist indicated that she had notified the patient's health care provided that she was reporting the patient's experience, and she indicated the lot number was unavailable because the vaccine was given in the physician's office. The pharmacist was unable to provide any additional information. There was no product quality complaint reported. Additional information is expected.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Diabetes mellitus, Drug administration error, Laboratory test abnormal, Unintended pregnancy
Clinical narrative: Information has been received from a health professional concerning a 36 year old female patient, with chronic hypertension with a history of 2 pregnancies with delivery at 25 weeks with multiple defects and one death associated with her hypertension, who on 12/10/02, when on her menstrual period, was vaccinated with a dose of MMR (second generation) ( lot # 642645/0527M). Concomitant therapy included hydrochlorothiazide (+) valsartan, vitamins and aspirin. Subsequently, she became pregnant. Her last menstrual period was reported as 12/7/02. The patient delivered prematurely, on 6/16/03 (previously reported as 6/18/03), a healthy, normal baby with no congenital defects or complications. It was reported that the premature delivery was related to the patient's hypertension. Follow up information from the nurse practitioner indicated that the patient delivered a 2 pound female baby at 28 weeks gestation due to preeclampsia. It was reported that the patient was diagnosed with gestational diabetes 12 weeks from LMP on approximately 2/28/03. Other concomitant medication included amlodipine besylate (+) benazepril hydrochloride from 12/7/02 until 1/28/03 and the patient was then switched to methyldopa on 1/28/03. Lab and diagnostic studies included a positive urine pregnancy test on 1/28/03, and an ultrasound done at 8.2 weeks gestation which showed a single viable in vitro pregnancy with ultrasound age of approximately 7 weeks and 2 days and ultrasound EDD of 9/20/03. Upon internal review, premature delivery at 28 weeks was considered to be an important medical event (OMIC). A 15-day follow up report received 11/13/2003 adds: In follow up info from the nurse practitioner it was reported that the pt did not experience any adverse events following prior vaccination. It was also noted that "no adverse events occurred and mother and baby are fine." According to the reporter, the pt recovered on 06/16/2003. Upon internal review, premature delivery at 28 weeks was considered to be an important medical event.
Age: 1.25
Sex: M
Vaccine: DTP, MMR
Symptoms: Blood pressure increased, Coma, Convulsion, Heart rate increased, Malaise
Clinical narrative: Information has been received on 9/20/02 from a health professional concerning a 15 month old male patient with no reported medical history, who on an unknown date was vaccinated SC in the right arm with a second dose of MMR (lot # 640635/1480L). Concomitant therapy included a first dose of diphtheria toxoid/tetanus toxoid (batch # U0381AA) administered IM in the left deltoid (no vaccination date was provided). It was reported that 5 minutes after the vaccination, the patient complained of feeling sick and slumped in the chair, had a petit mal seizure for 3-4 seconds and was unresponsive on the floor. Oxygen was started at 2L/minute via a mask, and epinephrine was given SC in the right arm. The patient's vital signs were reported as blood pressure 100/60, pulse 60, and respiration 28. An ambulance arrived 10 minutes later to transport the patient to the ER. The patient was stable. It was noted that he was diagnosed with vasovagal response. In additional information received from the reporter via a telephone conversation, the telephone and fax numbers for the responsible physician had been provided and the reporter indicated the original information on the VAERS was all the information available. The reporter also indicated that five immunization clinics stopped giving MMR and diphtheria toxoid/tetanus toxoid as policy and have not seen reactions as in this report. It was noted the adverse event coding was updated. The same reporter also mentioned another case with similar experiences following vaccination with MMR and diphtheria toxoid/tetanus toxoid. The reporter considered the petit mal seizure, vasovagal response, and feeling sick to be other important medical events (OMIC). No further information is anticipated, the case is closed.
Age: 1.25
Sex: M
Vaccine: DTP, MMR
Symptoms: Respiratory rate increased, Syncope vasovagal
Clinical narrative: Information has been received on 9/20/02 from a health professional concerning a 15 month old male patient with no reported medical history, who on an unknown date was vaccinated SC in the right arm with a second dose of MMR (lot # 640635/1480L). Concomitant therapy included a first dose of diphtheria toxoid/tetanus toxoid (batch # U0381AA) administered IM in the left deltoid (no vaccination date was provided). It was reported that 5 minutes after the vaccination, the patient complained of feeling sick and slumped in the chair, had a petit mal seizure for 3-4 seconds and was unresponsive on the floor. Oxygen was started at 2L/minute via a mask, and epinephrine was given SC in the right arm. The patient's vital signs were reported as blood pressure 100/60, pulse 60, and respiration 28. An ambulance arrived 10 minutes later to transport the patient to the ER. The patient was stable. It was noted that he was diagnosed with vasovagal response. In additional information received from the reporter via a telephone conversation, the telephone and fax numbers for the responsible physician had been provided and the reporter indicated the original information on the VAERS was all the information available. The reporter also indicated that five immunization clinics stopped giving MMR and diphtheria toxoid/tetanus toxoid as policy and have not seen reactions as in this report. It was noted the adverse event coding was updated. The same reporter also mentioned another case with similar experiences following vaccination with MMR and diphtheria toxoid/tetanus toxoid. The reporter considered the petit mal seizure, vasovagal response, and feeling sick to be other important medical events (OMIC). No further information is anticipated, the case is closed.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Convulsion
Clinical narrative: This case was reported by a health professional and described the occurrence of a seizure in her 6 month old daughter who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The patient had no concurrent conditions or medical history. On 5/14/03 the patient received the 3rd dose of Infanrix. On the same date, the patient also received an injection of inactivated poliomyelitis virus vaccine. Approximately 2 weeks post immunization, the patient experienced a seizure and was hospitalized. The event resolved.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Atelectasis, Febrile convulsion, Pharyngitis, Rhinitis
Clinical narrative: He devloped febrile seizure following day after he received influenzae shot. Child was taken to ER, blood work and physical exam were normal. Child was sent home. Medical records state atelectacis, cold, rhinnitis. msv
Age: 17.0
Sex: M
Vaccine: MMR, TD
Symptoms: Discomfort, Fatigue, Headache, Laboratory test abnormal, Malaise
Clinical narrative: Pt is a 17 year old male who presented to the ER at my request after his mother called reporting that he had a fever of 103.5, vomiting, severe headache and some neck stiffness at home. In the ER he underwent a spinal tap which was found to be consistent with a viral meninigitis type picture. He was admitted for control of nausea, vomiting, and pain. Pt had received an MMR vaccination and Tetanus booster the day prior to the symptom onset and his mother had initially wondered the two could be related. Complaints of fever, malaise, and fatigue. No vision changes. Severe headache and neck discomfort. No congestion, rhinorrhea or facial pressure. No cough, wheeze or shortness of breath. Complains of nausea and vomiting. No diarrhea and no abdominal pain. No problems with urination. Generalized aches and pains. Temperature is 99.2, heart rate 72, respirations 16 and blood pressure is 128/59. Alert and oriented 17 year old male in no apparent distress, non toxic. Eyes:Extraocular movements are intact. CENT:onjunctivae clear. Tympanic membranes examination by the ER physician. Oropharynx is clear. Nares are patent. Neck: is supple this morning without rigidity. Chest: Clear to auscultation bilaterally without wheezes, rhonchi, or rales. Cardiovascular: Regular rate and rhythm without murmurs, rubs or gallops. Abodomen: Is soft, non tender and non-distended. No masses and no hepatosplenomegaly. Musculoskeletal: No clubbing, cyanosis or edema. Skin: No rash.
Age: 17.0
Sex: M
Vaccine: MMR, TD
Symptoms: Meningism, Musculoskeletal stiffness, Nausea, Pain, Pyrexia
Clinical narrative: Pt is a 17 year old male who presented to the ER at my request after his mother called reporting that he had a fever of 103.5, vomiting, severe headache and some neck stiffness at home. In the ER he underwent a spinal tap which was found to be consistent with a viral meninigitis type picture. He was admitted for control of nausea, vomiting, and pain. Pt had received an MMR vaccination and Tetanus booster the day prior to the symptom onset and his mother had initially wondered the two could be related. Complaints of fever, malaise, and fatigue. No vision changes. Severe headache and neck discomfort. No congestion, rhinorrhea or facial pressure. No cough, wheeze or shortness of breath. Complains of nausea and vomiting. No diarrhea and no abdominal pain. No problems with urination. Generalized aches and pains. Temperature is 99.2, heart rate 72, respirations 16 and blood pressure is 128/59. Alert and oriented 17 year old male in no apparent distress, non toxic. Eyes:Extraocular movements are intact. CENT:onjunctivae clear. Tympanic membranes examination by the ER physician. Oropharynx is clear. Nares are patent. Neck: is supple this morning without rigidity. Chest: Clear to auscultation bilaterally without wheezes, rhonchi, or rales. Cardiovascular: Regular rate and rhythm without murmurs, rubs or gallops. Abodomen: Is soft, non tender and non-distended. No masses and no hepatosplenomegaly. Musculoskeletal: No clubbing, cyanosis or edema. Skin: No rash.
Age: 17.0
Sex: M
Vaccine: MMR, TD
Symptoms: Vomiting
Clinical narrative: Pt is a 17 year old male who presented to the ER at my request after his mother called reporting that he had a fever of 103.5, vomiting, severe headache and some neck stiffness at home. In the ER he underwent a spinal tap which was found to be consistent with a viral meninigitis type picture. He was admitted for control of nausea, vomiting, and pain. Pt had received an MMR vaccination and Tetanus booster the day prior to the symptom onset and his mother had initially wondered the two could be related. Complaints of fever, malaise, and fatigue. No vision changes. Severe headache and neck discomfort. No congestion, rhinorrhea or facial pressure. No cough, wheeze or shortness of breath. Complains of nausea and vomiting. No diarrhea and no abdominal pain. No problems with urination. Generalized aches and pains. Temperature is 99.2, heart rate 72, respirations 16 and blood pressure is 128/59. Alert and oriented 17 year old male in no apparent distress, non toxic. Eyes:Extraocular movements are intact. CENT:onjunctivae clear. Tympanic membranes examination by the ER physician. Oropharynx is clear. Nares are patent. Neck: is supple this morning without rigidity. Chest: Clear to auscultation bilaterally without wheezes, rhonchi, or rales. Cardiovascular: Regular rate and rhythm without murmurs, rubs or gallops. Abodomen: Is soft, non tender and non-distended. No masses and no hepatosplenomegaly. Musculoskeletal: No clubbing, cyanosis or edema. Skin: No rash.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizures times 1 for 10 seconds. Fever for 2 hours; acetaminophen. Ceftriaxone 50np/kg, 295 mp IV 24 hours. CBC, blood c/s.
Age: 4.0
Sex: F
Vaccine: FLU3, HIBV, MMR
Symptoms: Rash
Clinical narrative: Per school personnel, pt has red rash over face
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Malaise, Pyrexia
Clinical narrative: Feels "cruppy", wobbly and weak and thinks he may have a fever, but has no thermometer. Lasted approx 12-14 hours.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Contusion, Injection site oedema
Clinical narrative: As the needle injected was being removed from arm, pt began to bleed and bruise around area of injection about 1" in diameter, and slight swelling occurred. Pt felt fine, we gave Benadryl oral and (unreadable). Advised her on what to do if swelling started again. And we called later that evening to see what the status of her condition was and she was fine.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Large area of redness, denies SOB
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Large area redness, denies SOB.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema
Clinical narrative: 1:45 right arm immediate reddened area 4" x 2" for 1 1/2 hours. Parent called. Physician called. Ice to arm. 3 PM Benadryl 150mg po given. Reddened area decreased.
Age: 6.0
Sex: M
Vaccine: DTAP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: 4 x 3 inch red, hot, firm swelling right arm.  Resolved in3 days.
Age: 4.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Laboratory test abnormal, Nonspecific reaction
Clinical narrative: None vaccine related.  Had viral respiratory infection at time of visit.
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Varicella exanthem
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash papular, Rhinorrhoea, Skin ulcer
Clinical narrative: 7 days following vaccine the patient developed a fever of 102.5, runny nose and approximately 20 erythematous papular lesions, some with centriole vesicles on trunk and lower extremities.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Oedema, Pruritus
Clinical narrative: DTAP given 10/14/2003. Developed progressive swelling and itching of right arm in the ensuing 48 hours.  Arm is non-tender, no fever.  Full range of motion shoulder/elbow.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: DTAP given 10/14/2003. Developed progressive swelling and itching of right arm in the ensuing 48 hours.  Arm is non-tender, no fever.  Full range of motion shoulder/elbow.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Injection site induration, Rash pruritic
Clinical narrative: Patient reports increased redness of area of immunization with induration/itch, of injection.  Today with improved symptoms.  PG ? and rash ? and ? 2 cm area.  Slight induration, no ? tenderness.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Viral infection
Clinical narrative: Patient seen in our office on 10/08/2003 for scattered papules.  Temperautre 100.8.  Diagnosis: Chicken pox.
Age: 2.2
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Patient received Pneumovax 23 on 10/09/2003 in right thigh.  By the next day, entire lower leg/knee on that side swollen to size of large orange; also red/warm.  No obvious infection.  Initially patient limping; seen today and now ambulatory normally end swelling about gone.
Age: 43.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site induration, Injection site warmth, Rash erythematous
Clinical narrative: Got phone call from patient, states right upper arm at site of injection Friday 05/09 redness, injection on Sunday 05/11/2003, site became red, raised and hot to touch.  Patient started Advil II tabs Q10, Benadryl 50mg, applied cold compresses to area.  Patient seen in office on 05/13/2003 by MD.  Td injection site had 3 x 4 cm pale red indurated rash.  Patient to continue Benadryl 50mg, 3-4 times per day and Advil 2 tabs 2 times a day.  patient to follow up per PRN.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Nausea, Oedema, Pain, Vomiting
Clinical narrative: Arm soreness, warmth, swelling, nausea, vomiting, started on 10/15/2003.  Treatment Tylenol, Ice packs and ibuprofen.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Patient received varivax 11/24/1995.  Patient has never had wild chicken post.  Patient presented to clinic 10/15/2003 with diagnosis of herpes zoster.  Patient was seen at clinic on 10/15/2003.  Follow up on 10/28/2003: "This immunization was not done at our office.  The fax we received did not have info on it.  Immunization was done at another clinic, who is no longer in practice."
Age: 1.5
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: On 10/15/2003,, administered MMR right thigh and varivax left thigh at 5:00 pm (17:00).  Approximately 17:05, mom noticed welts on both thighs at injection sites.  MD gave Benadryl 12.5 mg at 17:10.  Patient left office at 17:30.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Contusion, Injection site mass
Clinical narrative: This report describes the occurrence of an injection site reaction in a 7 month old female patient who received DTaP, Heb B recombinant and IPV combined Pediarix for prophylaxis.  This report was received from the patient's mother and has not been verified by a physician or other healthcare professional.  On May 2003 the patient received the 1st dose of Pediarix.  At an unknown time post-immunization, in May 2003, the patient experienced an injection site reaction characterized by a bruise and a "knot".  The events were unresolved as of 06/16/2003.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 4 month old patient who received DTAP, Hep B recombinant, and IPV combined Pediarix for prophylaxis.  On an unspecified date when the patient was 2 months of age, the patient received the first injections of Pediarix, Hib (manufacturer unknown), and 7-valent pneumococcal conjugate vaccine (Prevnar).  At an unspecified time post-immunization, the patient developed a fever of 101 degrees F.  The fever resolved after an unspecified period of time.  On 06/16/2003 the patient received the 2nd doses of Pediarix, Hib (manufacturer unknown) and 7-valent pneumococcal conjugate vaccine (Prevnar).  On 06/17/2003, one day post-immunization, the patient experienced a fever of 104 degrees F.  The patient's mother telephoned the vaccine provider for guidance.  The outcome of the episode of fever is unknown.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Pyrexia, Rash macular
Clinical narrative: This case was reported by a nurse and described the occurrence of macular rash in a 4 month old male patient who received DTAP, Hep B recombinant and IPV combined Pediarix for prophylaxis.  The patient had no known drug allergies, relevant medical history, concurrent conditions, concurrent medications, or adverse experience following receipt of the first dose of Pediarix.  On 06/17/2003 the patient received the 2nd dose of Pediarix.  On that date, he also received injections of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs) and Hib vaccine (manufacturer unknown).  One day post-immunization, on 06/18/2003, the patient experienced a red, macular rash on his upper chest and lower abdomen, and low-grade fever.  The patient was seen by the physician.  The events resolved on 06/22/2003.  The reporter considered the events to be possibly related to Pediarix, or to a "viral illness-but not typical to viral exanthem".
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: High-pitched crying
Clinical narrative: This case was reported by a consumer and described the occurrence of high-pitched crying in a 2 month old male patient who received DTAP, Hep B recombinant and IPV combined Pediarix for prophylaxis.  A physician or other health care professional has not verified this report.  The patient reportedly had no relevant medical history, concurrent conditions or concurrent medications.  Family history was significant for an unspecified "reaction to pertussis" in an older sibling; the sibling did not complete the pertussis immunization serious.  In 2003, when the patient was 2 months of age, he received the 1st dose of Pediarix.  Two hours post-immunization, the patient experienced "screeching".  The "screeching" resolved after four or five hours.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Agitation, Crying, Irritability, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a patient who received DTAP, Hep B recombinant and IPV, combined Pediarix for prophylaxis.  On an unspecified date, the patient received injections of Pediarix (Lot # 21881C9) and Hib (PedvaxHIB, Merck).  At an unknown time post-immunization, the patient experienced fever of 102-104 degrees F, irritability, and inconsolable crying.  The patient was seen by the physician.  The events resolved after an unspecified period of time. Comment: The reporter indicated that "at least 25" patients experienced these events following receipt of Pediarix Lot # 21881C9.  However, they are not presently identifiable.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Application site oedema, Irritability, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a patient who received DTAP, Hep B recombinant and IPV combined Pediarix for prophylaxis.  On an unspecified date in January 2003, the patient received the 1st dose of Pediarix (Lot # 21883b2) in the right leg.  On that date, the patient also received injections of Hib (manufacturer unknown) and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs) in the left leg.  The patient's parents telephoned the physician to report that, six to eight hours post-immunization, the patient experienced fever of 102 to 103 degrees F, irritability, and swelling at the site of Pediarix administration.  The events resolved later on the date of immunization.  The reporting physician considered the events were probably related to vaccination with Pediarix Lot # 21883B2.  Comment:  The reporter indicated that, during January 2003 and February 2003, approximately 15 patients out of 30 vaccinees experienced these events following receipt of Pediarix Lot # 21883B2 for the first or second dose in the immunization series.  However, they are not presently identifiable.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a patient who received DTAP, Hep B recombinant and IPV combined Pediarix for prophylaxis.  On an unspecified date, the patient received an injection of Pediarix.  On the same day, the patient also received an injection of HIB (PedvaxHIB, Merck).  At an unknown time post-immunication, the patient experienced fever of 101.3 degrees Fahrenheit. The outcome of the event was unknown.
Age: 0.6
Sex: M
Vaccine: DTAP, IPV
Symptoms: Grand mal convulsion
Clinical narrative: This case was reported by a health professional and described the occurrence of grand mal seizures in a 7 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 5/14/03, the patient received the 3rd dose of Infanrix. On the same date, the patient also received an injection of inactivated poliomyelitis virus vaccine. On 5/16/03 the patient experienced a grand mal seizure and was hospitalized. The event improved. The patient experienced subsequent seizures and, as of 10/3/03, was receiving an unknown medication for control of seizures. Information from Annual Follow-up report states no further information available. Reporter no longer with clinic.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Leukocytosis
Clinical narrative: PATIENT DEVELOPED FEVER TO 102F, MYALGIAS, CHILLS AND ARM SWELLING AND SORENESS, BEGINNING DAY OF VACCINE (GIVEN SUBCUTANEOUSLY IN RIGHT ARM).  PATIENT IS DIABETIC, AND HAD SIGNIFICANT HYPERGLYCEMIA WITH ILLNESS.  PATIENT WAS SEEN 2 DAYS AFTER VACCINE, AND HAD LARGE, RED, ERYTHEMATOUS INJECTION SITE, FEVER, AND LEUKOCYTOSIS.  CLINICAL IMPRESSION IS CELLULITIS.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Pyrexia, Swelling
Clinical narrative: PATIENT DEVELOPED FEVER TO 102F, MYALGIAS, CHILLS AND ARM SWELLING AND SORENESS, BEGINNING DAY OF VACCINE (GIVEN SUBCUTANEOUSLY IN RIGHT ARM).  PATIENT IS DIABETIC, AND HAD SIGNIFICANT HYPERGLYCEMIA WITH ILLNESS.  PATIENT WAS SEEN 2 DAYS AFTER VACCINE, AND HAD LARGE, RED, ERYTHEMATOUS INJECTION SITE, FEVER, AND LEUKOCYTOSIS.  CLINICAL IMPRESSION IS CELLULITIS.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Patient's symptoms include swollen throat
Age: 1.4
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling with warmth at injection site, approximately 6 x 8 cm.  No fluctuance or drainage
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: Arm was red, hot and swollen within an hour after injection.Called MD and was told to watch. Swelling and heat spread down to elbow & caused old smallpox scar on arm to become outlined. Applied ice & took a non-aspirin tab. Arm continues to be red and sore after 8 days, but swelling is gone.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest discomfort, Hypoventilation
Clinical narrative: pt experienced 10/10 lower back pain across her upper buttocks, bilaterally and extending across the spine, 30 seconds after administration of flu and pneumovax.  Never had similar pain before.  Lasted about 5 minutes.  Normal vitals during attack, including O2 sat, exept rapid shallow respirations due to the pain.  After that, noted mid upper chest pressure for about 3 minutes, without SOB, diaphoresis or radiation.  Symptoms occurred while seated; made her squirm and moan and very distressed, due to the intensity of the pain.  Significant PMHx:  yearly flu shots without reaction, osteoporosis on Fosamax.
Age: 1.7
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: about 7 hours post administration of MMR, Varivax, Prevnar, and DTaP had a febrile seizure
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Heart rate increased
Clinical narrative: Pt returned to Mobile Health Unit 10 mins after vaccine administered with SOB, and heaviness in chest area. VS BP 120/80, P-140, R-26. EMS activated. Pt transported to SIUH-N ED. Follow up call made and pt verbalized that ED administered Benadryl. Spoke to pt at home and she stated she no longer has any acute distress
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid area red, swollen, and warm to touch.
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Irritability, Pyrexia
Clinical narrative: Red, swollen, tender lump at site of DTaP injection.  Also developed mild Varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles that subsequently crusted over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.
Age: 1.4
Sex: M
Vaccine: DTAP, VARCEL, DTAP, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Red, swollen, tender lump at site of DTaP injection.  Also developed mild Varicella-like symptoms including low-grade fever, fussiness and varicella rash with vesicles that subsequently crusted over.  Varicella rash was very sporadic in body coverage area, i.e. - very few vesicles in relation to typical findings in natural infection.