chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: HEPAB
Symptoms: Rectal haemorrhage
Clinical narrative: This case was reported by a medical assistant and described the occurrence of ulcerative colitis in a 56 year old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine. Concurrent medications included Protonix, Effexor, Lactinex and Questran. Medical history was notable for no bowel problems prior to administration of Twinrix. On 3/10/04, the patient received the first dose of Twinrix. Approximately one day following the administration of the first dose of Twinrix, on 3/11/04, the patient developed blood in the stool, rectal bleeding, abdominal pain/cramping, gas and diarrhea. On 3/17/04, the patient was hospitalized with a diagnosis of ulcerative colitis. The colitis resolved on 3/19/04 and the patient was discharged from the hospital. On 4/9/04 the patient received the second dose of Twinrix. The following day, on 4/10/04, the patient experienced return of blood in the stool, rectal bleeding, abdominal pain/cramping, gas and diarrhea. She was hospitalized on 4/12/04 and prescribed prednisone, 40mg daily. By 4/20/04, she was supposed to begin tapering her dose of prednisone. By 4/22/04, when her dose of prednisone was tapered to 6 tablets, her symptoms began to return. As of 4/29/04, she was experiencing gas and white mucous in stools. Outcome of the other reported events was not specified.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Drug ineffective, Laboratory test abnormal, Pharyngitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 11/4/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced breakthrough chicken pox with 10 to 200 lesions and coinciding strept pharyngitis and cellulitis. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available at this time. Follow up information indicated that there was no adverse event rather breakthrough disease (varicella) years after immunization - (as) with cellulitis and strep throat. The report indicated that a rapid strep test was positive. It was also reported that in March 2004 the patient developed disease with typical lesions > 100 and some with cellulitis - mild to moderate. Because the child had a high fever, a strep test was done and was positive. The reporter stated that the strep throat was incidental. He was treated with antibiotic and the patient recovered. The reporter considered the patient's varicella, cellulitis and pharyngitis to be other important medical events (OMIC). Information received on 4/30/04 contained the following adverse experiences: strep throat (March 2004).
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 11/4/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced breakthrough chicken pox with 10 to 200 lesions and coinciding strept pharyngitis and cellulitis. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available at this time. Follow up information indicated that there was no adverse event rather breakthrough disease (varicella) years after immunization - (as) with cellulitis and strep throat. The report indicated that a rapid strep test was positive. It was also reported that in March 2004 the patient developed disease with typical lesions > 100 and some with cellulitis - mild to moderate. Because the child had a high fever, a strep test was done and was positive. The reporter stated that the strep throat was incidental. He was treated with antibiotic and the patient recovered. The reporter considered the patient's varicella, cellulitis and pharyngitis to be other important medical events (OMIC). Information received on 4/30/04 contained the following adverse experiences: strep throat (March 2004).
Age: 2.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Autism, Drug toxicity, Medication error
Clinical narrative: Information has been received from a dental hygenist concerning her approximately 2 year old son who was vaccinated with the fourth dose of hepatitis B virus vaccine. Secondary suspect vaccinations included a dose of MMR. Other concomitant vaccinations included all of the others. The patient's mother reported that her son was subsequently diagnosed as being autistic around his second birthday. The patient's mother also reported that her son may have received the fourth dose of hepatitis B virus vaccine in error. Unspecified medical attention was sought and at the time of this report the outcome was unknown. The patient's mother felt that her child's condition was a result of the cumulative effects of thimerosal that her son had received as a child. At the time of this report, the patient was 5 years old. Upon internal review, autism was considered to be an other important medical event (OMIC). No further information is available.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cerebellar ataxia, Gait disturbance, Petechiae
Clinical narrative: Information has been received from a physician concerning a 13 month old female with no allergies who on 08Apr2004 was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot #646901/0952N). Secondary suspect vaccinations on that same day included a dose of varicella virus vaccine live (Oka/Merck) (MSD) (Lot #647269/1101N). Other concomitant therapy included amoxicillin and albuterol. Illness at the time of vaccination included and ear infection. the physician reported that on 28 Apr 2004, the patient had changes in her gait and was hospitalized later that same night as a diagnosis of cerebellar ataxia was made. At that time, a computed axial tomography (CT), spinal tap, complete blood count (CBC) and a urine test were performed (results not provided). The physician also reported that some petechiae was noted on the patient's face and neck, but it was unknown if it was a related symptom or from the the patient crying during procedures. On 29Apr2004, at 0200, the patient showed improvement but hours later her condition declined but was noted to be better than the previous day. Later that same day, a repeat CBC was normal and a toxicology screen was negative. Additional information has been requested. Follow up on 05/25/04 states: "Upon follow up the physician stated that the child developed cerebellar ataxia and had a rash when her blood was drawn. At that time, petechiae were noted on the pt's face and neck, but it was suspected that it was related to the pt crying during the procedure. The child's CBC including platelets, PT and PTT were all normal. No other etiology was discovered, however, the physician felt it was unlikely that it was secondary to the vaccines. The physician also felt that the pt's "recovery was so quick that it may have been a potential ingestion that caused the ataxia." The physician stated that "although the urine drug screen was negative it would not necessarily have capture all agents." The pt was discharged from the hospital and was seen on 05/03/04 and displayed no residual effects. Subsequently, the pt had recovered. The results of the PCR analysis of the CSF were negative for VZV. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Autism, Drug toxicity, Neurological symptom
Clinical narrative: Information has been received regarding a case in litigation concerning a female minor child who was exposed to thimerosal by virtue of the hepatitis B virus vaccine on 11/29/95 (lot # 129LA) and 1/30/96 (lot # 613800/1291A). It is believed that as a result of the child's exposure to thimerosal, and the mercury contained in the thimerosal from the above vaccinations, she sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. Upon internal review, neurological injuries and autism spectrum disorder were considered to be other important medical events (OMIC).
Sex: F
Vaccine: HBHEPB
Symptoms: Autism, Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a female minor child who was exposed to thimerosal by virtue of the hepatitis B virus vaccine (+) HIB conjugate vaccine that was administered on 6/1/98 (lot # 624776/0166H), 7/31/98 (626889/0738H), and 4/5/99 (lot # 630228/1918H). It is believed that as a result of the child's exposure to thimerosal, and the mercury contained in thimerosal from the above vaccinations, she sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. Upon internal review, neurological injuries and autism spectrum disorder were considered to be other important medical events (OMIC).
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Abdominal pain upper, Abnormal behaviour, Alopecia, Amnesia, Diarrhoea
Clinical narrative: From initial information received on 4/27/04 regarding an adverse event occurring in the USA, it was reported that a four year old male patient received an IPOL vaccination, lot number W0460, administered in the right thigh, an MMR II vaccination, lot number 644415/1008M, administered in the left arm, a VAQTA vaccination, lot number 643816/1061M, administered in the right thigh, and an INFANRIX vaccination, lot number SS7A2, administered in the left thigh on 2/10/03. 15 days later on 2/25/03, a registered dietitian reported that in February 2003, the patient lost all of his hair. The patient's mother noticed a patch on the back of the boy's head the day after vaccination, and within two weeks all of his hair was gone. On 1/14/04, the patient's hair had not returned. In follow up information received from the patient's mother, it was reported that the patient had allergies to soy and peanut products. She also reported that on 2/10/03, the patient received his second dose of VAQTA. The first dose was given on 12/11/03. It was reported that the patient was not ill at the time of vaccination. The reporter indicated that the patient received four shots in one day and about two weeks later, on 2/25/03, the patient had bad stomach aches and had to go to the doctor for diarrhea. Reportedly, the patient woke up with a bald spot the size of a quarter and within three months he had no hair, eyebrows, or eyelashes. The patient's mother noticed a different behavior, almost like she had a different child. She reported that the patient had memory loss on and off. The change in the patient's behavior was noticed by the mother after vaccination with VAQTA on 2/10/03. According to the reporter, the physician diagnosed the patient with alopecia. The patient's experiences were considered to be disabling by the patient's mother. Additional information has been requested. The patient has not recovered from these events. From additional information received on 10/May/2004 from another manufacturer, ID number WAES0401USA01070, it was reported that the change in the patient's behavior was noticed by the mother after vaccination with the first dose of hepatitis A virus vaccine inactivated (manufacturer, lot number and administration information not reported) on 11/Dec/2002 (also reported as 11/Dec/2003) and the hair loss after vaccination with the second dose of hepatitis A virus vaccine inactivated on 10/Feb/2003. This report was previously sent to PLA V205C.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Crying, Cyanosis, Hypotonia, Irritability
Clinical narrative: Dx: ALTE. Evening of vaccine, patient became limp and cyanotic after a period of fussiness. No fever. No seizure activity reported. Mom gave CPR; rescue breaths. 911 contacted. Patient began crying shortly after CPR. Seen in ED; lumbar puncture. Nurse follow up on 06/02/04 states: Acute life threatening event.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Laboratory test abnormal
Clinical narrative: Dx: ALTE. Evening of vaccine, patient became limp and cyanotic after a period of fussiness. No fever. No seizure activity reported. Mom gave CPR; rescue breaths. 911 contacted. Patient began crying shortly after CPR. Seen in ED; lumbar puncture. Nurse follow up on 06/02/04 states: Acute life threatening event.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Acidosis, Convulsion, Dyskinesia, Hypocalcaemia, Hypovitaminosis
Clinical narrative: Mom describes 2 seizures at 0630 and 0730. Jerking motions of head and arms, lethargic after. Mom spoke to emergency room and brought child to our office, arriving about 0830. Child immediately escorted to emergency room upon arrival to office.  Nurse follow up on 07/12/04 states: "Rickets, hypocalcemia, vitamin D deficiency, metabolic acidosis, febrile illness."
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lethargy, Pyrexia, Rickets
Clinical narrative: Mom describes 2 seizures at 0630 and 0730. Jerking motions of head and arms, lethargic after. Mom spoke to emergency room and brought child to our office, arriving about 0830. Child immediately escorted to emergency room upon arrival to office.  Nurse follow up on 07/12/04 states: "Rickets, hypocalcemia, vitamin D deficiency, metabolic acidosis, febrile illness."
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Anaphylactic reaction, Erythema, Face oedema, Hypoventilation, Mental impairment
Clinical narrative: Anaphylactic reaction - swollen lips, decreased mental status, hypoventilation. Aborted with SC Epi followed by IV Benadryl and steroids. Nurse follow up on 06/08/04 states: Rash, erythema, vomiting. Medical record states stupor, tachycardia, anaphylaxis, vasodilate. msv
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Rash, Stupor, Tachycardia, Vasodilatation, Vomiting
Clinical narrative: Anaphylactic reaction - swollen lips, decreased mental status, hypoventilation. Aborted with SC Epi followed by IV Benadryl and steroids. Nurse follow up on 06/08/04 states: Rash, erythema, vomiting. Medical record states stupor, tachycardia, anaphylaxis, vasodilate. msv
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTP, IPV, MMR
Symptoms: Face oedema, Loss of consciousness, Rash, Shock, Vomiting
Clinical narrative: Anaphylactic reaction - swollen lips, decreased mental status, hypoventilation. Aborted with SC Epi followed by IV Benadryl and steroids. Nurse follow up on 06/08/04 states: Rash, erythema, vomiting. Medical record states stupor, tachycardia, anaphylaxis, vasodilate. msv
Age: 5.0
Sex: M
Vaccine: DTAP, MEN, MMR, DTP, IPV, MMR
Symptoms: Dyspnoea, Erythema, Flushing, Pruritus, Wheezing
Clinical narrative: Patient became flush with red, swollen lips. Was having fight wheezes and reported difficulty breathing. Gave him 0.1cc of 1/1000 epinephrine and 12.5cc of oral Benadryl and symptoms resolved within 30 minutes. Nurse follow up on 06/08/04 states: Remove edema lip, Add itching foot.
Age: 5.0
Sex: M
Vaccine: DTAP, MEN, MMR, DTP, IPV, MMR
Symptoms: Loss of consciousness, Rash, Shock, Swelling face, Vomiting
Clinical narrative: Patient became flush with red, swollen lips. Was having fight wheezes and reported difficulty breathing. Gave him 0.1cc of 1/1000 epinephrine and 12.5cc of oral Benadryl and symptoms resolved within 30 minutes. Nurse follow up on 06/08/04 states: Remove edema lip, Add itching foot.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Feeling hot, Injection site induration, Swelling, Tenderness
Clinical narrative: Swelling, erythema , minimal tenderness, marked warmth, mild induration Left upper outer arm extending from just below shoulder to just below elbow on day after injection, increasing throughout the day. Seen around 3:40 after injection.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Viral infection
Clinical narrative: Chicken pox
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Viral infection
Clinical narrative: Varicella
Age: 4.5
Sex: M
Vaccine: MMR
Symptoms: Crying, Erythema, Pruritus, Rash, Swelling
Clinical narrative: cc: itching all over, swollen lip, intense crying and very upset causing emesis. Exam: erythema, rash entire body, swollen lips, chest clear. No obvious stridor. Treatment: Orapred 2tsp given in office; Benadryl 1 tsp every 6-8hrs at home.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Difficulty in walking, Erythema, Swelling
Clinical narrative: Left thigh red, swollen with difficulty walking 24hours after injection was given. Temp 98.9. Plus soft tissue swelling.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Cold sweat, Flushing, Gait disturbance, Pallor, Pruritus
Clinical narrative: At 3:15PM MMR vaccine given into left arm as in protocol. Pt tolerated well. No color change. Able to walk and talk normally. Walked out of office when dad brought pt back in- slight limp and moaning. Fell flushed, clammy, pale. Breathing without difficulty. welts on cheeks, abdomen and arm. --itching around 3:30 BP: 70/54, RR = 18/min. Epi (1mg/ml 1:1000) 0.15. Oxygen mask given. Pt given SQ in right arm. Welts decreased within 5-10 minutes. 911 called. Transported to hospital.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: At 3:15PM MMR vaccine given into left arm as in protocol. Pt tolerated well. No color change. Able to walk and talk normally. Walked out of office when dad brought pt back in- slight limp and moaning. Fell flushed, clammy, pale. Breathing without difficulty. welts on cheeks, abdomen and arm. --itching around 3:30 BP: 70/54, RR = 18/min. Epi (1mg/ml 1:1000) 0.15. Oxygen mask given. Pt given SQ in right arm. Welts decreased within 5-10 minutes. 911 called. Transported to hospital.
Age: 3.4
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Erythema, Hypersensitivity, Laboratory test abnormal, Swelling, Tenderness
Clinical narrative: Swelling right arm (15x15cm) noted during 4-29-04 office visit. Right upper arm red and tender. Started on warm compresses and Keflex 250mg 3 times a day by mouth, and Motrin prn. Improved at 4/30/04 office visit.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Rash erythematous, Rash macular, Urticaria
Clinical narrative: Immunization at around 10.30AM. 4yo hiiponic female with presents within 40-50 minutes symptoms of itching and mom noted rash. Noted with erythematous macular. No difficulty of breathing, No edema noted. of review. N1 exam otherwise. Diagnosed urticaria.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety
Clinical narrative: Anxiety disorder requiring Ativan 1mg IM
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular, Viral infection
Clinical narrative: Fever (high) and maculopapular rash (cephalocaudal distribution). No Koplik  spots. No conjunctival infection. Most likely measles. Will do titers when he recovers.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain, Swelling
Clinical narrative: L leg swollen, red, painful gave Benedryl and Motrin x 3days. Also warm compresses to thigh
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot
Clinical narrative: Given DTaP, IPV left arm on 5/3/04. Developed warmth, erythema by 5/5/04. Diagnosed cellulitis vs 122 rxn. Received Keflex x 10 days
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Pain and redness right deltoid: diagnosed with cellulitis
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyskinesia, Pyrexia, Upper respiratory tract infection
Clinical narrative: Father states she felt warm 3 days after vaccine approximately. Had fever (face warm off and on -doing better today, but her hard jerks started at 1AM and dad noticed it in her sleep 1+ entire today. Otherwise sit, normal+ eating well today. First PC was 1.5-2.0 years ago. Taken to ER. Dr states viral respiratory illness. Will go to COH. 3-14-04: dad states she's better. Did not go to Dr. Father states he doesn't feel symptoms are vaccine related.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Swelling
Clinical narrative: Student received third hepatitis B shot of series during school based program. He reported to school nurse approx 2.5hrs after shot was given with complaints of swollen left arm and hand. School nurse informed health dept supervisor. Nurses from health department went to school and assessed child. He was noted to have swollen left hand. Student stated his hand was numb. Denied injury to hand. No swelling noted at vaccination site. 4/15 student back to school. No swelling or complaint. Did not see doctor.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration, Pain, Tenderness
Clinical narrative: Redness, induration, tenderness worsening after third injection. Neck and shoulder ached on day of injection. Pending recovery.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Bone pain, Breast tenderness, Pain, Pain in jaw
Clinical narrative: Sore ribs. Sore joints (shoulder, hip, knee, jaw). Sore throat / hurts to swallow. Symptoms came on after tetanus shot (4/24/04) and progressed over weekend. Better today. Mainly ribs are sore 4/26/04. Doing better.
Age: 19.0
Sex: M
Vaccine: TD
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Sore ribs. Sore joints (shoulder, hip, knee, jaw). Sore throat / hurts to swallow. Symptoms came on after tetanus shot (4/24/04) and progressed over weekend. Better today. Mainly ribs are sore 4/26/04. Doing better.
Age: 38.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Pain, Swelling
Clinical narrative: Received adult Td on 3/26/04. Arm was sore for several days but continues to be sore through range of motion. Biceps area feels swollen to touch. No redness . Pt states is painful to touch.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Small erythematous papular eruption bilateral temporal area also small area forehead.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, feverish area around injection site approximately 10cm in diameter.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: 8cm redness and swelling left arm. Benadryl and cold compresses recommended.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Left leg 13.5 inch thigh, red, swollen, mildly tender at site of redness (RL-12 inch). Treatment: Tylenol, ice tonight, then apply heat.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Pt states she noticed symptoms upon arrival at home at about 11:30.  With 10 tingling and numbness to left face, left arm and chest discomfort. Pt states took a nap and when she woke up her symptoms were improved, no shortness of breath, no rash.  Still complains of left chest discomfort, very mild symptoms.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia
Clinical narrative: Pt complained of arm numbness post vaccination x20 minutes, no shortness of breath, no rash. Called pt at home at 1:35pm, pt reported symptoms subsided.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Injection site induration, Injection site warmth
Clinical narrative: Cellulitis: red, warm to the touch, hard, right leg 9.5x7.5. Benadryl monitor.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Swelling, redness x6cm.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Urticaria, Vaccine positive rechallenge
Clinical narrative: Itchy welts on chest and abdomen 6 days after 2nd Rabies injection-subsided spontaneously-same event occurred after 3rd Rabies injection, 7 days after-Both times started upper body and moved down to feet-lasted 2 days. Used Hydrocortisone cream with some help, no fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Onset of pain and significant swelling, redness in right upper arm on 05/01/04.  Parent contacted physician instructed to use ice to area, Benadryl and pain reliever.  Much improved in 36-48 hours. Rechecked 05/03/2004.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Fatigue, Injection site reaction
Clinical narrative: Large local reaction in arm receiving DTAP within 24 hours.  Local reaction vs. cellulitis. Treatment with Augmentin x 2 days, late development of tiredness.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Varicella Vaccine administered 04/22/04.  Pt developed generalized vesicular rash starting 8 days post vaccine. Also intermitt fever to 102.  Please note 2nd episode same lot # varicella.
Age: 37.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Visual disturbance
Clinical narrative: Became light-headed, saw black spots, sweaty and pale after leaving clinic. Also said she felt a little nauseated.  BP: 110/72. Brought back to clinic. Later 104/64 which she said is normal for her.  Given fluids after nauseated subsided. Rested 10-15 minutes. Felt better. States she has felt fine since.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Mom called stating chicken pox going around in school and contracted a mild case of Varicella.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt had vaccine several years ago for Varicella. Going around outbreaks, in school sibling had outbreak and now pt with >300 lesions of Varicella for past few days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Mother states over telephone that left upper arm was swollen and red from shoulder to 1/2 way towards elbow.  Noted on 04/20/04.  Call received 04/23/04. Benadryl, Motrin, Ice to site ordered.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Dysphemia
Clinical narrative: Began stuttering shortly after immunizations, has continued 1 month later.  Has never stuttered before.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 3 inch diameter erythema, tenderness on upper left thigh, also hot to the touch-onset was approximately 36 hours after vaccinations were given and lasted 3-4 days.
Age: 18.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash, Vasculitis
Clinical narrative: Rash started on ankles, moved up to calf area of legs. Some rash around elbows on both arms. Did not appear anywhere else on body. Saw MD at student health center on 02/06/04. Diagnosed with Vasculitis.  MD felt it was vaccine related as stated by pt.  Prescribed Prednisone for 2.5 weeks and Zertec.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Diarrhoea, Headache, Hypokinesia, Injection site pain
Clinical narrative: Day 1) Local soreness where vaccine was administered.  Day 2 & 3) Increased soreness, unable to use arm. Day 4) Beginnings at abdomen px, soreness traveled to neck and left arm. Day 6 & 7) Nausea, abd px and soreness to arms and neck.  Day 8) Abd px, vomiting, headache. Day 8) Vomiting, headache, diarrhea, soreness increased.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Day 1) Local soreness where vaccine was administered.  Day 2 & 3) Increased soreness, unable to use arm. Day 4) Beginnings at abdomen px, soreness traveled to neck and left arm. Day 6 & 7) Nausea, abd px and soreness to arms and neck.  Day 8) Abd px, vomiting, headache. Day 8) Vomiting, headache, diarrhea, soreness increased.
Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Hypersensitivity, Pyrexia, Rash
Clinical narrative: Mother called and stated pt was having an allergic reaction (rash and temperautre), "I need to know what you gave him so I can tell the ER."
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Raised, red bumps on left upper arm spreading down to elbow to around to inside of arm. Complained of some dizziness, went to private physician. Physician prescribed Zyrtec, Cortisone cream-may also use Benadryl as needed.  Rash spread from arm across back to chest to right arm.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Pyrexia, Rash, Somnolence
Clinical narrative: Sleep more than normal 1st 48 hours after vaccinations. Tylenol given x1 next day of immunizations, rash noted by mother next AM. Described as red, fine, bumpy rash. Rash decreased after mother gave 1 dose of Benadryl.  Fever of 99.5F.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Inflammation, Rash
Clinical narrative: 05/04/04: Rash now. Grandmother states it was red/inflammed and warm to touch. On right thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot, Inflammation
Clinical narrative: Left arm-inflammed, red and warm to touch 4x5 inch area.
Age: 2.7
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Rash macular, Swelling
Clinical narrative: Child's arm appear swollen, red and blotchy from shoulder to elbow. Dr treated with Zyrtec. Mom reports she gave pt Zyrtec for 3 days, swelling and redness were gone after 2 days.
Age: 37.0
Sex: F
Vaccine: MEN
Symptoms: Dyspnoea, Fatigue, Pruritus, Swelling
Clinical narrative: Pt complained in ER of difficulty breathing, swollen throat, extreme weakness, dizziness and itching. Given 2 dose of Benadryl and monitored. Discharged to home with Benadryl.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain, Pruritus
Clinical narrative: Approximately 6 hours post injection (p.i.) a 2.5 inch circular area of erythema appeared around the injection site. Intensely pruritic, but painful.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: 3 classic satellite lesions on left face; not involving eye; mild systemic symptoms. Only known treatment is observation
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Chest pain, Cough, Dyspnoea
Clinical narrative: Sore joints, cough, chest heaviness, shortness of breath, sore arm. No fever. Reports that three other paeople in his unit experienced the same post-vaccination symptoms.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Dizziness, Dyspnoea, Pharyngolaryngeal pain
Clinical narrative: 12:50 pm Td given with no prior memory of adverse events to vaccine.  1:45 pm sharp pains in throat, felt like it was closing. 4:00 pm called to report above syptoms, was told to go to ER, dizzy-SOB- Dr. told her anaphylaxis "prednisone" shot in arm to follow with 5 days of clariton once daily.  to ER #2 pain in back and thighs. 05/03/04 patient is okay now.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Mother called. took child to ER Friday 5/7. C/o of right arm being red from shoulder to about 1" above elbow, warm to touch, and firm. She was instructed to use cool compresses and give child Benadryl. She said the arm is better now.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Angioneurotic oedema, Urticaria
Clinical narrative: Urticaria pigmentosa 7 days following injection of 1-ml IMOVAX RABIES. This was the final dose in the series. OTC H1 blockers were not effective, an injection of Kenalog was received in ECU, which did provide relief. Giant hives are resolving.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Doctor ordered Pneumonia shot since patient did not remember when she had last been innoculated.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Injection site inflammation, Oedema, Shoulder pain
Clinical narrative: On the 18th of April 2004 I was immunizied for the 6th time for the Anthrax series. Within hrs I had began to experience joint pain in my shoulders and knees. My left Knee experienced the most inflamation and edema. Doctor examined me and said it was an acute reaction and should subside within 10 days. I asked at that time to have it recorded in my medical record.symptoms were within 3 hrs of the innoculation. It has been a month and the symptoms have not subsided.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Sudden infant death syndrome
Clinical narrative: From initial information received on 2/23/04 regarding an adverse event occurring in an unspecified country during one of their clinical trials, it was reported that a 2 month old female patient received POLIOMYELITIS VACCINE INACTIVATED on 11/28/00. It was not specified whether the patient received an injectable or oral form of the vaccine. Three days post-immunization, the patient unexpectedly died. No other information was provided. Corrective report on 3/2/04: From additional information received on 3/2/04 from internal e-mail correspondence, it was reported that this case is no longer internally classified as a study case, but is considered a spontaneous report. The study sponsor is a manufacturer and the events occurred during one of their clinical trials. No new medical information was provided. From additional information received on 3/18/04 from an internal e-mail correspondence, the identification number was provided. On 11/28/00 the patient was vaccinated with a dose of hepatitis B virus vaccine. On 12/1/00, the patient died of an unexpected death. The association between the hepatitis B virus vaccine and the unexpected sudden death was not provided. No other information was given. From additional information received on 4/30/04 from another manufacturer, it was reported that the patient received her first dose of IPOL vaccine, lot number T0118-2, administered in the left arm and a dose of Hepatitis B vaccine, lot number 1376K, administered in the left thigh on 11/28/00. It was also reported that an autopsy was performed on 12/2/00 and revealed pulmonary edema, congestion and visceral organ congestion. There were no congenital anomalies. The investigator reported the cause of death as SIDS, however, the coroner reported the cause of death as unexpected sudden death in a two month old infant. No further information is anticipated, this case is considered closed.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Unevaluable event
Clinical narrative: From initial information received on 2/23/04 regarding an adverse event occurring in an unspecified country during one of their clinical trials, it was reported that a 2 month old female patient received POLIOMYELITIS VACCINE INACTIVATED on 11/28/00. It was not specified whether the patient received an injectable or oral form of the vaccine. Three days post-immunization, the patient unexpectedly died. No other information was provided. Corrective report on 3/2/04: From additional information received on 3/2/04 from internal e-mail correspondence, it was reported that this case is no longer internally classified as a study case, but is considered a spontaneous report. The study sponsor is a manufacturer and the events occurred during one of their clinical trials. No new medical information was provided. From additional information received on 3/18/04 from an internal e-mail correspondence, the identification number was provided. On 11/28/00 the patient was vaccinated with a dose of hepatitis B virus vaccine. On 12/1/00, the patient died of an unexpected death. The association between the hepatitis B virus vaccine and the unexpected sudden death was not provided. No other information was given. From additional information received on 4/30/04 from another manufacturer, it was reported that the patient received her first dose of IPOL vaccine, lot number T0118-2, administered in the left arm and a dose of Hepatitis B vaccine, lot number 1376K, administered in the left thigh on 11/28/00. It was also reported that an autopsy was performed on 12/2/00 and revealed pulmonary edema, congestion and visceral organ congestion. There were no congenital anomalies. The investigator reported the cause of death as SIDS, however, the coroner reported the cause of death as unexpected sudden death in a two month old infant. No further information is anticipated, this case is considered closed.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, IPV, IPV, HEP, IPV, DTAP
Symptoms: Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: From initial information received on 2/23/04 regarding an adverse event occurring in an unspecified country during one of their clinical trials, it was reported that a 2 month old female patient received POLIOMYELITIS VACCINE INACTIVATED on 11/28/00. It was not specified whether the patient received an injectable or oral form of the vaccine. Three days post-immunization, the patient unexpectedly died. No other information was provided. Corrective report on 3/2/04: From additional information received on 3/2/04 from internal e-mail correspondence, it was reported that this case is no longer internally classified as a study case, but is considered a spontaneous report. The study sponsor is a manufacturer and the events occurred during one of their clinical trials. No new medical information was provided. From additional information received on 3/18/04 from an internal e-mail correspondence, the identification number was provided. On 11/28/00 the patient was vaccinated with a dose of hepatitis B virus vaccine. On 12/1/00, the patient died of an unexpected death. The association between the hepatitis B virus vaccine and the unexpected sudden death was not provided. No other information was given. From additional information received on 4/30/04 from another manufacturer, it was reported that the patient received her first dose of IPOL vaccine, lot number T0118-2, administered in the left arm and a dose of Hepatitis B vaccine, lot number 1376K, administered in the left thigh on 11/28/00. It was also reported that an autopsy was performed on 12/2/00 and revealed pulmonary edema, congestion and visceral organ congestion. There were no congenital anomalies. The investigator reported the cause of death as SIDS, however, the coroner reported the cause of death as unexpected sudden death in a two month old infant. No further information is anticipated, this case is considered closed.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hemiparesis, Hypertension, Pain, Tendon disorder
Clinical narrative: 11/29/00 Flu shot approximately 2:00 PM. Pain started in upper left arm 2:20 PM. 11/30/00 OBGYN appointment. Blood pressure up - within normal range but higher than usual for me. Pain in upper left arm continued. 12/7/00 Pain had increased, blood pressure close to high level. 1/23/01 Blood pressure very high, pain extremely high and went from left shoulder to finger tips. No grip strength in left hand. X-rays and blood tests for muscle diseases normal. 1/30/01 Pain unbearable, now into shoulder. Unable to sleep. unable to type with left hand due to pain. Blood pressure dangerously high. 2/1/01 Started on Vicodin pain pills. EMG normal. 2/14/01 through 4/2/01 Treatment at rehab clinic. Ultrasound, electronic stimulation, and message therapy. Arm was better but would have pain off and on. Arm was weak. Blood pressure never came back down to rate before flu shot. 6/29/03 Arm started to hurt and pain just kept increasing. 6/30/03 Tendonitis in lower left arm. Given generic Vicodin. Got sick from pain pills. Stopped taking. Told to use moist heat. Pain continued to increase. 7/7/03 Tendonitis in lower left arm caused by muscle damage in upper left arm from flu vaccine. Use ice. Do stretching exercises. Pain in muscle upper left arm continues off and on. Tendonitis in lower left arm flares up regularly. Left arm is weak and not much grip strength in left hand.
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Blood pressure increased, Muscular weakness, Pain, Sleep disorder, Tendonitis
Clinical narrative: 11/29/00 Flu shot approximately 2:00 PM. Pain started in upper left arm 2:20 PM. 11/30/00 OBGYN appointment. Blood pressure up - within normal range but higher than usual for me. Pain in upper left arm continued. 12/7/00 Pain had increased, blood pressure close to high level. 1/23/01 Blood pressure very high, pain extremely high and went from left shoulder to finger tips. No grip strength in left hand. X-rays and blood tests for muscle diseases normal. 1/30/01 Pain unbearable, now into shoulder. Unable to sleep. unable to type with left hand due to pain. Blood pressure dangerously high. 2/1/01 Started on Vicodin pain pills. EMG normal. 2/14/01 through 4/2/01 Treatment at rehab clinic. Ultrasound, electronic stimulation, and message therapy. Arm was better but would have pain off and on. Arm was weak. Blood pressure never came back down to rate before flu shot. 6/29/03 Arm started to hurt and pain just kept increasing. 6/30/03 Tendonitis in lower left arm. Given generic Vicodin. Got sick from pain pills. Stopped taking. Told to use moist heat. Pain continued to increase. 7/7/03 Tendonitis in lower left arm caused by muscle damage in upper left arm from flu vaccine. Use ice. Do stretching exercises. Pain in muscle upper left arm continues off and on. Tendonitis in lower left arm flares up regularly. Left arm is weak and not much grip strength in left hand.
Sex: F
Vaccine: OPV
Symptoms: Brain neoplasm malignant, Malaise, Neoplasm malignant, Viral infection
Clinical narrative: Information regarding poliovirus vaccine live oral trivalent solution was received from an attorney regarding a deceased female who received a dose on an unspecified date. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. An attorney alleges that the polio vaccine received by the decedent contained a harmful prohibited animal virus known as Simian Virus 40 (SV40). The attorney also alleges that the decedent became ill with Simian Virus 40 -related disease, including malignant brain cancer, and subsequently died on 1/26/02. No additional information was available at the time of this report.
Sex: F
Vaccine: OPV
Symptoms: Neoplasm malignant, Viral infection
Clinical narrative: Information regarding poliovirus vaccine was received from an attorney regarding a female patient who developed malignant mesothelioma. Relevant medical history was not provided. Indication for poliovirus vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. On an unspecified date, the plaintiff developed malignant mesothelioma. The attorney alleges that Simian Virus 40 (SV40) contained within the polio vaccine was the cause of the malignant mesothelioma. No additional information was available at the time of this report.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Difficulty in walking, Infection
Clinical narrative: From initial information received on 5/4/04 from the patient's daughter regarding an adverse event occurring in the USA, it was reported that a 73 year old female patient received a dose of FLUZONE, administered in the deltoid on the first week of December 2003. The lot number and route of administration were not reported. Two to three weeks later, the patient began tripping, which occurred three times, and developed short term memory loss. The patient resides overseas but was visiting USA at the end of November 2003. She returned overseas at the beginning of March 2004, and is currently hospitalized due to a brain infection. Reportedly, the patient was treated with Solu-Medrol. The patient's recovery status was not reported.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Developed ITP on 3/29/04 with diffuse petechial rash and platelet count of 15,000. Patient admitted for 1 day to hospital for IVIG therapy. Nurse follow up on 05/12/04: "None".
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Febrile convulsion, Grand mal convulsion, Hypoxia, Pyrexia
Clinical narrative: Woke up from high fever (103.9). Began staring off in space. Started seizing. Called ambulance immediately. Taken to emergency room. Give phenobarbital and tube placed down airway. Flown to hospital. Seizures lasted 40 min. Admitted to Pediatric Intensive Care Unit. Weaned off phenobarbital after 24 hrs. Nurse follow up on 05/13/04 states no new information. Nurse follow up on 06/07/04 states: ADD: febrile seizure ADD: status epilepticus.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Staring
Clinical narrative: Woke up from high fever (103.9). Began staring off in space. Started seizing. Called ambulance immediately. Taken to emergency room. Give phenobarbital and tube placed down airway. Flown to hospital. Seizures lasted 40 min. Admitted to Pediatric Intensive Care Unit. Weaned off phenobarbital after 24 hrs. Nurse follow up on 05/13/04 states no new information. Nurse follow up on 06/07/04 states: ADD: febrile seizure ADD: status epilepticus.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Arthralgia, Coordination abnormal, Guillain-Barre syndrome, Joint stiffness, Laboratory test abnormal
Clinical narrative: About 4 days after receiving DTaP #5 and MMR #2, patient complained of bilateral knee pain, body shaking with heaving. Symptoms. Evaluated by doctor about 3 days later and found to have neck stiffness with position change, lower extremitiy areflexia, ataxia, shaking at rest when sitting. Diagnosed with GBS. Rx IVGG  Nurse follow up on 06/17/04 states: "Pain."   As Per annual follow up report: have not seen Pt or spoken to family since 08/04 as family has moved. (called mother 05/14/05 stated pt doing well) Recommend contacting family for follow up at new address.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pain, Tremor
Clinical narrative: About 4 days after receiving DTaP #5 and MMR #2, patient complained of bilateral knee pain, body shaking with heaving. Symptoms. Evaluated by doctor about 3 days later and found to have neck stiffness with position change, lower extremitiy areflexia, ataxia, shaking at rest when sitting. Diagnosed with GBS. Rx IVGG  Nurse follow up on 06/17/04 states: "Pain."   As Per annual follow up report: have not seen Pt or spoken to family since 08/04 as family has moved. (called mother 05/14/05 stated pt doing well) Recommend contacting family for follow up at new address.
Age: 0.03
Sex: M
Vaccine: HBPV, IPV
Symptoms: Autism, Croup infectious, Dermatitis, Diarrhoea, Faeces pale
Clinical narrative: Swelling of limb and foot, rapid breathing, excessive sleep, food allergies, dermatitis, croup, improper immune response, vomiting, diarrhea, lost weight, poor growth 55th%, toes swelling and peeling, rashes, lethargy, pink stools, autism. Severe gastrointestinal difficulties.
Age: 0.03
Sex: M
Vaccine: HBPV, IPV
Symptoms: Gastrointestinal disorder, Hypersensitivity, Immune system disorder, Laboratory test abnormal, Lethargy
Clinical narrative: Swelling of limb and foot, rapid breathing, excessive sleep, food allergies, dermatitis, croup, improper immune response, vomiting, diarrhea, lost weight, poor growth 55th%, toes swelling and peeling, rashes, lethargy, pink stools, autism. Severe gastrointestinal difficulties.
Age: 0.03
Sex: M
Vaccine: HBPV, IPV
Symptoms: Oedema peripheral, Rash, Respiratory rate increased, Skin exfoliation, Somnolence
Clinical narrative: Swelling of limb and foot, rapid breathing, excessive sleep, food allergies, dermatitis, croup, improper immune response, vomiting, diarrhea, lost weight, poor growth 55th%, toes swelling and peeling, rashes, lethargy, pink stools, autism. Severe gastrointestinal difficulties.
Age: 0.03
Sex: M
Vaccine: HBPV, IPV
Symptoms: Vomiting, Weight decreased
Clinical narrative: Swelling of limb and foot, rapid breathing, excessive sleep, food allergies, dermatitis, croup, improper immune response, vomiting, diarrhea, lost weight, poor growth 55th%, toes swelling and peeling, rashes, lethargy, pink stools, autism. Severe gastrointestinal difficulties.