chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.08
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Irritability
Clinical narrative: 07/05/02 mom called to report that child received shots on 07/03/02 and today she noticed her child's upper left arm was red (approx size of hen's egg) swollen, and had small area of hardness in center. Mom reports no fever, but child was fussy and c/o arm hurting. Gave Tylenol to child-PHN referred to PMD.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: 06/12/01-1st shot no adverse reaction. 07/12/01-2nd shot no adverse reaction. 08/08/01-09/15/01-bloody stool (went away on own). 12/28/01 last shot no adverse reaction. 01/26/02 intense bloody diarrhea.
Age: 0.6
Sex: M
Vaccine: MMR
Symptoms: Drug administration error
Clinical narrative: 7 mo old given MMR #1 by mistake. Given too early.
Age: 4.4
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Injection of DTaP given on 04/23/02. Parent noticed rxn on 04/24/02. Right deltoid swollen 2"x4" with redness and itching.
Age: 15.0
Sex: F
Vaccine: JEV
Symptoms: Urticaria
Clinical narrative: Pt developed hives on torso, legs, arms and buttocks. Mother gave 2 tablets of Benadryl. Hives have completely gone this AM. JEV given at 11:15 on 07/10/02. Hives developed at 6:30pm on 07/10/02. Benadryl given 10:30pm on 07/10/02.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness entire left top of thigh warm to touch, swollen.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Discomfort, Eructation
Clinical narrative: Pt began with minor aches and pains 6-8 hrs post injection. 3 days later, she had fever of 102 deg F with upper abdominal and gastric pains with belching. No features, no change in BM. She c/o some discomfort over "liver." 5 days post injection, she stayed in bed with same discomfort and chills and mild fever. She did not take temp. She spoke with a nurse practitioner who was uncertain if reaction due to injection or other problems. 1wk and 2 days later she still has upper abdomen and gastric and has discomfort. She will consult with nurse practitioner tomorrow.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Pyrexia
Clinical narrative: Pt began with minor aches and pains 6-8 hrs post injection. 3 days later, she had fever of 102 deg F with upper abdominal and gastric pains with belching. No features, no change in BM. She c/o some discomfort over "liver." 5 days post injection, she stayed in bed with same discomfort and chills and mild fever. She did not take temp. She spoke with a nurse practitioner who was uncertain if reaction due to injection or other problems. 1wk and 2 days later she still has upper abdomen and gastric and has discomfort. She will consult with nurse practitioner tomorrow.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Acne, Bursitis, Gastrooesophageal reflux disease, Haemorrhoids, Headache
Clinical narrative: While I was in the army station overseas. We had to have the anthrax immunization lot # FAV020 subcutaneous injection on the following dates #1 on 16 April 1998, #2 on 30 April 1998 and #3 on 14 May 1998. The shot gave me a burning pain in both arms and headache then it went away. After a few years I was discharged from the military, gave me an exam and gave me 40% disability. 10% for lower back pain, 10% for right ankle problems, 10% gastroesophageal reflux disease with hiatal hernia, 10% PTSD, Bursitis right shoulder, cystic acne, hemorrhoids and both knees ptellofemoral. My LIPID TRIG is very high and had a colonoscopy done on june 2001 and had polyps removed no-cancer. I'm taking 100 MG of zolof for PTSD. Its hard to say if any of my problems I have was caused by the anthrax shots. But I do know my health has not been the same and not getting better since the immunizations.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Hiatus hernia, Pain
Clinical narrative: While I was in the army station overseas. We had to have the anthrax immunization lot # FAV020 subcutaneous injection on the following dates #1 on 16 April 1998, #2 on 30 April 1998 and #3 on 14 May 1998. The shot gave me a burning pain in both arms and headache then it went away. After a few years I was discharged from the military, gave me an exam and gave me 40% disability. 10% for lower back pain, 10% for right ankle problems, 10% gastroesophageal reflux disease with hiatal hernia, 10% PTSD, Bursitis right shoulder, cystic acne, hemorrhoids and both knees ptellofemoral. My LIPID TRIG is very high and had a colonoscopy done on june 2001 and had polyps removed no-cancer. I'm taking 100 MG of zolof for PTSD. Its hard to say if any of my problems I have was caused by the anthrax shots. But I do know my health has not been the same and not getting better since the immunizations.
Age: 12.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Convulsion, Syncope
Clinical narrative: Mother states that child "was out for one half hour" after an apparent seizure.  She did not witness this activity.  She was told this by another family member.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Erythema, Injection site hypersensitivity, Injection site warmth, Oedema, Pain
Clinical narrative: Swelling, pain, red, and hot to the touch left deltoid @ injection site 9 hours after injection.
Age: 70.0
Sex: M
Vaccine: HEPAB, IPV, MEN, TD, TYP
Symptoms: Urticaria
Clinical narrative: Received vaccines 7-11-02 approx. 10:20 a.m.--developed hives Saturday 7-13-02 early a.m. (exact time unknown)--no other signs/symptoms.  Did not take anything for hives.  Called 7-15-02 to report to health dept.--hives no better or worse.  Has thme on legs, buttocks and up to waist.  Wife has same  , she also received vaccines.
Age: 62.0
Sex: F
Vaccine: HEPAB, IPV, MEN, TD, TYP
Symptoms: Urticaria
Clinical narrative: Received vaccines 7-11-02 around 10:30 a.m.--developed hives Friday 7-12-02 early afternoon, no other signs/symptoms.  Took 2 Benadryl tabs 7-14-02, Called health dept 7-15-02 to report, hives no better and no worse.  Occuring on legs, back and abdomen.  Husband had same and he also received vaccines
Age: 28.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Rash
Clinical narrative: Rash stomach/cheek. No local reaction.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Autism, Bronchitis, Dermatitis contact, Ecchymosis, Upper respiratory tract infection
Clinical narrative: Report A0372406A describes autism in a 6 year old female who received hepatitis B vaccine (brand name unknown). This report was received as part of the litigation proceedings, with forwarding of medical records. The medical history included otitis media, multiple upper respiratory infections, and rhinitis. Developmental history: It was noted that the vaccinee did not roll over at 6 months of age. At 10 months of age she stood while holding on and sat up. At 12 months of age, she stood and walked while holding on. Following the reported onset of autism, the vaccinee experienced upper respiratory infections, viral syndromes, bronchitis, contact dermatitis, sprained finger, eyelid ecchymosis, and foreign body in the ear canal. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. On an unspecified date, 7/28/1999 and 12/09/1999, the vaccinee received her first, second, and third injections of hepatitis B vaccine (brand name unknown), respectively. On 09/28/2000, 11/24/2000, 01/26/1991, 2/14/1992, and 08/26/1994, the vaccinee received her first, second, third, fourth and fifth injections of diphtheria tetanus and pertussis vaccine (brand name unknown), respectively. On 09/28/1990, 11/24/1990, 2/14/1992, and 03/09/1994, the vaccinee received her first, second, third and fourth doses of poliomyelitis virus vaccine (brand name unknown), respectively. On 7/24/1991 and 8/29/1994, the vaccinee received her first and second injections of MMR respectively. On 7/28/199 and 4/27/2000, the vaccinee received her first and second injections of hepatitis A vaccine (brand name unknown), respectively. On 10/11/1999, the vaccinee received her first injection of influenza virus vaccine. The vaccinee's attorney alleged that the vaccinee was injected with multiple childhood vaccinations which unbeknownst to the parents, contained the dangerous and highly toxic mercury based preservative, thimerosal.... As a result of the mercury in the thimerosal-containing vaccinations that the vaccinee received as an infant, the vaccinee now suffers and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. Autism and hyperactive attention deficit disorder were first documented in 1996, when the vacinee was six years of age. Autism is considered medically serious.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Viral infection
Clinical narrative: Report A0372406A describes autism in a 6 year old female who received hepatitis B vaccine (brand name unknown). This report was received as part of the litigation proceedings, with forwarding of medical records. The medical history included otitis media, multiple upper respiratory infections, and rhinitis. Developmental history: It was noted that the vaccinee did not roll over at 6 months of age. At 10 months of age she stood while holding on and sat up. At 12 months of age, she stood and walked while holding on. Following the reported onset of autism, the vaccinee experienced upper respiratory infections, viral syndromes, bronchitis, contact dermatitis, sprained finger, eyelid ecchymosis, and foreign body in the ear canal. These events were not reported as adverse events due to vaccine administration, but were found during the course of review of the vaccinee's medical records. Therefore, they are not listed as adverse events. On an unspecified date, 7/28/1999 and 12/09/1999, the vaccinee received her first, second, and third injections of hepatitis B vaccine (brand name unknown), respectively. On 09/28/2000, 11/24/2000, 01/26/1991, 2/14/1992, and 08/26/1994, the vaccinee received her first, second, third, fourth and fifth injections of diphtheria tetanus and pertussis vaccine (brand name unknown), respectively. On 09/28/1990, 11/24/1990, 2/14/1992, and 03/09/1994, the vaccinee received her first, second, third and fourth doses of poliomyelitis virus vaccine (brand name unknown), respectively. On 7/24/1991 and 8/29/1994, the vaccinee received her first and second injections of MMR respectively. On 7/28/199 and 4/27/2000, the vaccinee received her first and second injections of hepatitis A vaccine (brand name unknown), respectively. On 10/11/1999, the vaccinee received her first injection of influenza virus vaccine. The vaccinee's attorney alleged that the vaccinee was injected with multiple childhood vaccinations which unbeknownst to the parents, contained the dangerous and highly toxic mercury based preservative, thimerosal.... As a result of the mercury in the thimerosal-containing vaccinations that the vaccinee received as an infant, the vaccinee now suffers and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning. Autism and hyperactive attention deficit disorder were first documented in 1996, when the vacinee was six years of age. Autism is considered medically serious.
Age: 1.5
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Decreased appetite, Diabetes mellitus, Respiratory rate increased, Tonsillitis
Clinical narrative: Information has been received from a physician concerning a 15 month old pt who was vaccinated with varicella virus vaccine live. Concomitant suspect therapy included MMR and other unspecified vaccines. Subsequently, one month post-vaccination, the pt developed type I diabetes mellitus. The pt's type I diabetes mellitus persisted. The physician reported that he felt that the type I diabetes mellitus may have to do with one of the vaccines the pt was given. Upon internal review, the type I diabetes mellitus was considered to be an other important medical event. Additional info has been requested. Additional info has been received from the physician. The physician reported that child's mother had a scar from thyroid surgery years ago and that her pregnancy was uneventful without any complications or gestational diabetes. The physician reported that diabetes was not in the family's history and that the child's father was healthy. The child was born a normal healthy baby weighing 8lbs. 8oz. and was breast and bottle fed. The physician reported that the child's first visit with him was on 01/22/01 as a new pt. The child was a normal healthy infant and he received his 2 month, 4 month and 8 month vaccinations as recommended. The child did not have any problems with these vaccines or any allergies. The child was only in the office for well visits and immunizations. The physician reported that after the 8 month visit the child was lost to follow-up. On 04/19/02 the child was seen again when he was vaccinated with varicella virus vaccine live, MMR vaccine and Haemophilus B conjugate vaccine+hepatitis B vaccine recombinant. On 05/31/02 the child was back in the office with rapid breathing, decreased appetite and a red throat. The child was diagnosed with tonsillitis and was prescribed Augmentin. On 06/02/02 the child became ill with vomiting and was taken to the ER. In the ER the child was found to have an elevated blood sugar. The child was hospitalized for seven days and was diagnosed with type 1 diabetes mellitus. The physician reported that the child was now doing better since he has been on insulin. The reporting physician felt that the type 1 diabetes mellitus required hospitalization, was a life-threatening, and was a disabling event. Additional info has been requested. Additional information has been received from the physician. The physician reproted that the child had also been treated with Ibuprofen. Additional information is not expected.
Age: 1.4
Sex: M
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: Information has been received from a nurse and the mother concerning a 2 year old male who on 12/05/00 was vaccinated with MMR. On 10/09/01 and 10/18/01, the child had appointments at the pediatric department of a hospital for the Bayley's Scale of Infant Development. It was reported that the results were the child's motor skills were within normal limits, but his expressive language skills were at 12-18 month level. The child was noted to express speech delay and has been receiving speech therapy since 10/01. The child was recently referred to an ENT specialist fort a hearing test due to recurrent otitis media infections. On 05/15/02, the child had a hearing test and the results were reported  as normal. the child's expressive language disorder persisted. Upon internal review, the expressive language disorder was considered to be an other important medical event. Additional information has been requested. Additional information has been received from a physician who reported that he had no information on this matter. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Conjunctivitis, Corneal disorder, Dermatitis bullous, Pruritus
Clinical narrative: Information has been received from a physician concerning a 15 month old male with no allergies or past medical history who on 10/23/01 was vaccinated with varicella virus vaccine live (lot 635600/1248K). Concomitant therapy included MMR vaccine. On appropriately 05/28/02, the child developed chicken pox with more than 100 lesions on his face and body that were itchy and typical in appearance. The child also had one lesion on his right eye which resulted in a severe case of conjunctivitis. It was reported that the child was now being followed for cloudiness of his cornea. The child was seen in the office on 06/25/02 and his lesions were drying up. Upon internal review, the corneal haze was considered to be an other important medical event (OMIC). *F/UP report on 10/10/02: Additional info has been received from the MD. The MD reported that the child had developed chicken pox. He also reported that the child was seen in the office and he had 1 lesion on his eye, which resulted in conjunctivitis. The child was Dx'd w/varicella keratitis. The child has since recovered and was reported as doing fine. Add'l info. is not expected.*
Age: 1.08
Sex: F
Vaccine: HEP, MMR
Symptoms: Difficulty in walking, Injection site mass, Pain, Tremor
Clinical narrative: Developed lump on left leg after shots. Looked strange. Approx. 1 week later, refused to walk, severe pain. Tremors from pain. Started walking after 3 weeks of this. Is walking with a lean to the left side. Stumbles a lot. No diagnosis yet.  Follow up 07/22/2002: "Child was admitted to pediatric floor and empirically begun on Rocephin every 12 hours.  Nystatin cream was applied to the perineum, and Rondec DM drops were also given.  The child had a gradual defervescence with improved mouth intake.  On rounds on the 22nd, she was playful and in no distress.  She was changed to by mouth Pediazole and continued to do well.  On rounds on the 23rd, the child was afebrile, lying quietly in bed with mother.  She was taking by mouth well including medications.  It was felt she was ready for discharge."
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Blood albumin decreased, Blood calcium decreased, Blood cholesterol decreased, Blood creatinine increased, Blood disorder
Clinical narrative: Child with mucolipidosis type II, encephalomalacia and developmental delay. Received vaccinea AM 07/08/02, PM of same day, had seizure that reportedly last 15 mins, temp 101 in ER. May need to have an MRI.  Follow uP:  Encephalomalacia. The annual follow up received on 8/4/03 states the pt has some neurological deterioration in the last 1 yr, but this is most likely due to her underlying diagnosis and not the vaccines.
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Blood glucose increased, Blood sodium decreased, Blood urea increased, Cerebral atrophy, Convulsion
Clinical narrative: Child with mucolipidosis type II, encephalomalacia and developmental delay. Received vaccinea AM 07/08/02, PM of same day, had seizure that reportedly last 15 mins, temp 101 in ER. May need to have an MRI.  Follow uP:  Encephalomalacia. The annual follow up received on 8/4/03 states the pt has some neurological deterioration in the last 1 yr, but this is most likely due to her underlying diagnosis and not the vaccines.
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Electroencephalogram abnormal, Haemoglobin decreased, Heart rate increased, Laboratory test abnormal, Nervous system disorder
Clinical narrative: Child with mucolipidosis type II, encephalomalacia and developmental delay. Received vaccinea AM 07/08/02, PM of same day, had seizure that reportedly last 15 mins, temp 101 in ER. May need to have an MRI.  Follow uP:  Encephalomalacia. The annual follow up received on 8/4/03 states the pt has some neurological deterioration in the last 1 yr, but this is most likely due to her underlying diagnosis and not the vaccines.
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Pyrexia, Respiratory rate increased, White blood cell count increased
Clinical narrative: Child with mucolipidosis type II, encephalomalacia and developmental delay. Received vaccinea AM 07/08/02, PM of same day, had seizure that reportedly last 15 mins, temp 101 in ER. May need to have an MRI.  Follow uP:  Encephalomalacia. The annual follow up received on 8/4/03 states the pt has some neurological deterioration in the last 1 yr, but this is most likely due to her underlying diagnosis and not the vaccines.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Autism, Insomnia, Pyrexia
Clinical narrative: 5/16/01 Fever. Up all night. A lot of tossing and turning. Onset of autism.
Age: 18.0
Sex: F
Vaccine: HEPA, TD, TYP, YF
Symptoms: Dizziness, Headache, Injection site erythema, Injection site rash, Lethargy
Clinical narrative: Client stated that approx 6 hrs after administration of vaccines she started feeling light-headed and dizzy. She stated she vomited several times during the night and into the next day. Presently has a "bad" headache, c/o lethargy and arm red with "non-raised" rash on her face. Client referred to the ER.
Age: 23.0
Sex: U
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Hives
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Hives covering legs bilaterally within 5 minutes of receiving (Comvax , DPT, IPV and Prevnar). Benadryl was given 10 mins post vaccine. Hives faced over next 45 mins.   Follow up: No notation of what caused general hives.
Age: 0.2
Sex: M
Vaccine: DTP, HEP, HIBV, IPV, PNC
Symptoms: Antisocial behaviour, Aphasia, Decreased appetite, Irritability
Clinical narrative: The pt became unsociable, decreased eating habits, cranky/fussy, stopped cooing and making sounds, flat affect personality, non-responsive to attempts to get him to react with smiles or cooing. Sx lasted 3-4 weeks.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia, Urinary tract infection
Clinical narrative: Vaccines administered 06/28/02 pt went to ER 06/29/02 with seizures, undetermined cause of seizure-? vaccine, possible UTI with fever. First seizure began 06/28/02-went to ER with second 06/29/02.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Irritability, Screaming, Sleep disorder
Clinical narrative: Very fussy and crying all day long until early evening, decreased appetite, won't take naps well.
Age: 1.03
Sex: M
Vaccine: HBPV, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Patient awoke with a fever of 103.8 F  taken under his arm. We gave him Tylenol, Within 1 hour his temperature was 102.2. 3 hours later his temperature was 103.3, Gave Tylenol, again this went on until 9:00 pm 5/21/02.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 06/27/2002- 6/29/02- Morbid swelling  and erythema to latent thigh
Age: 18.0
Sex: M
Vaccine: RAB
Symptoms: Brain neoplasm
Clinical narrative: Patient took a Rabies shot and the next day, reported this (brain tumor) event to us.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pneumococcal vaccine 1043L-exp 06/16/02. Temp 101.3.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site oedema, Injection site reaction
Clinical narrative: Localized edema, cellulitis to left arm.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm described as swollen and red at injection site. Pneumovax was administered to pt day 06/06/02.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm described as swollen and red at injection site. Pneumovax was administered the previous day. 06/16/02.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: 5x7cm erythema left thigh 24 hrs after DTaP.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and mild edema at site of injection and extending lateral and inferiorly across soft tissue of right thigh 2 injection in right thigh reaction only at site of lower injection.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema
Clinical narrative: Left deltoid muscle swelling within 24 hrs of vaccine, measures 5x4cm.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 60x60mm erythema and warmth at injection site left arm.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, treated with Tylenol
Age: 4.25
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Severe hives, shots for school received on 06/18th at 9:30pm on 06/21st began breaking out over entire body, was taken to ER. Given steroids and a prescription for steroids, hives lasted until Monday 24th of June. ER DR stated believed Polio vaccine has cause due to redness.
Age: 24.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Abdominal pain, Arthralgia, Asthenia, Chills, Diarrhoea
Clinical narrative: Weakness, chills, nausea, diarrhea, abdominal pain, vomited x 1, dizziness, joint pain.
Age: 24.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Dizziness, Laboratory test abnormal, Nausea, Vomiting
Clinical narrative: Weakness, chills, nausea, diarrhea, abdominal pain, vomited x 1, dizziness, joint pain.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Associate came for treatment of burn on 07/01/02. Tetanus vaccine was given in left deltoid. Associate returned 07/12/02 r/t continued pain, swelling, and redness at vaccine administration site. Her left deltoid area had an induration measuring 50mmx45mm and erythema measuring 10mmx20mm. Tx-Keflex 500mg po bid x 7 days, Tylenol, cool compresses. Improving, anticipated recovery.
Age: 59.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Hypoaesthesia, Joint swelling, Pain, Swelling
Clinical narrative: MMR given 06/04/02. Joint pain and swelling in knees and large joints began 06/20/02. Now has numbness, pain and swelling in hands.
Age: 1.1
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Fever 102.5, local rxn of erythema, induration. Rx Motrin, Tylenol.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Abnormal behaviour, Injection site nodule, Irritability, Pyrexia, Rash
Clinical narrative: Developed low grade fever on 07/01 and 07/02, then became very irritable for entire week. Not sleeping well, clingy, cranky, not acting like herself, not smiling. Developed rash on face on 07/07 and on back on 07/08. Was given Tylenol but vomited meds. Examined on 07/09/02-fully, hard nodules on thighs, less interactive. Rest of exam-nl.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Sleep disorder
Clinical narrative: Developed low grade fever on 07/01 and 07/02, then became very irritable for entire week. Not sleeping well, clingy, cranky, not acting like herself, not smiling. Developed rash on face on 07/07 and on back on 07/08. Was given Tylenol but vomited meds. Examined on 07/09/02-fully, hard nodules on thighs, less interactive. Rest of exam-nl.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Eyelid oedema, Pruritus
Clinical narrative: The pt's eyelids swelled and began to itch. He was given Benadryl IM-symptom improved with in 40 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Edematous swelling, erythema and warmth of left deltoid to elbow. Started 20 hrs after vaccination. No other symptoms.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Antisocial behaviour, Aphasia
Clinical narrative: Per mother, pt stopped talking and interacting with parents 24-36 hrs after receiving vaccines on 04/20/00. Mother told pediatrician, who said he was reacting to the birth of his sister (born 03/08/00). Missing vaccine information the mother related this information well after the fact . Since health dept did not give the immunizations we have no access to the manufacturer or lot number of vaccines given.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: 6/18/02 immunizations given. 06/19/01 noted hives that am. 06/20/02 mother brought child to HD to see child and show where residual "hives" were scattered to lower legs bilaterally. Mother treated child with Benadryl as prescribed by pharmacist (06/19/02). Doctor notified of reaction pt advised that his clinic plans to start giving immunization by the end of the month (July). MD prefers next immunizations be given at MD office.
Age: 1.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Edema with erythema
Age: 0.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Returned to clinic on 07/05/02 with left thigh swelling.10x8cm induration and erythema left thigh =29cm, right thigh=26cm. Pt examined by FNP. Ibuprophen and moist heat recommended and told to call for fever > 100.5.
Age: 5.3
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site oedema, Pruritus
Clinical narrative: Erythema, itching, swelling, induration thigh left.
Age: 2.9
Sex: M
Vaccine: DTAP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Marked swelling, minimal tenderness or erythema (L) lower leg (above knee).
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Chest pain, Dyspnoea, Headache, Myalgia
Clinical narrative: Approx. 12 hours after shot, severe pain from elbow to neck (no redness or swelling), fever (100F0101F), vomiting, deep muscle pain in legs (back of calves, back of thighs), some lower back pain, at one point pain around ribs and hurt to breathe (that stopped within 30 minutes) and headache. Family history (paternal) of rheumatoid arthritis.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Neck pain, Pain, Pyrexia, Red blood cell sedimentation rate increased, Vomiting
Clinical narrative: Approx. 12 hours after shot, severe pain from elbow to neck (no redness or swelling), fever (100F0101F), vomiting, deep muscle pain in legs (back of calves, back of thighs), some lower back pain, at one point pain around ribs and hurt to breathe (that stopped within 30 minutes) and headache. Family history (paternal) of rheumatoid arthritis.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: (L) lateral thigh erythema, induration and temperature of 100.2F.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Within 1 minute, developed quarter size wheal/hive at IZ site of Varivax (left arm).
Age: 1.5
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema
Clinical narrative: 9cm X 11cm reddened area at site left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus, Skin ulcer
Clinical narrative: Developed red, raised, warm, pruritic lesion over left deltoid after DTAP and IPV in that area.
Age: 1.25
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis (R) arm s/p vaccines, local reaction only. Rx'd Keflex 125 qid X 10 d. Prescribed on 6/28/02. Adverse event onset date is unknown.
Age: 13.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Unintended pregnancy
Clinical narrative: PT GIVEN MMR. THE URINE PREGNANCY TEST AT THE TIME WAS NEGATIVE. ONE WEEK LATER A NEW PREGNANCY TEST WAS POSITIVE. The follow up states: To date there is no adverse (reaction) event but I was told to report this for tracking by the CDC because a live virus was given to a pregnant female.
Age: 0.08
Sex: F
Vaccine: DTP
Symptoms: Haemolytic anaemia, Heart rate increased, Irritability, Lethargy, Pallor
Clinical narrative: Information has been received on 07/11/02 from a published literature article(Transfusion support with RBCs from Mk homozygote in a case of autoimmune hemolytic anemia following diphtheria-pertusis-tetanus vaccination. Transfusion 2002; 42 (5); 567-571) regarding a 1 month old female who received her first injection of diphtheria-pertussis-tetanus vaccine. Five days post-immunization, she was hospitalized with a diagnosis of autoimmune hemolytic anemia. Prior to admission, she had a 2 day history of lethargy, irritability, occasional vomiting and pallor. On admission, she appeared to be in acute distress with pulse of 160 beats per minute, a respiratory rate of 48 breaths per minute, a systolic blood pressure of 80 torr, and a temp of 37.2 deg C. Lab results included a hematocrit of 9.4%, a white blood count of 21,900 per uL, and a platelet count of 928,000 per uL. A peripheral blood smear revealed moderate nisocytosis, poikilocytosis, polychromatophilia, and spherocytes. The LDH was 477 U per L. The reticulocyte count was 3.3 percent. hepatoglobin was zero. Total Bilirubin was 2.7 mg per dL, and her creatinine was 0.3mg per dL. Complement levels (C3, C4, and CH50) were normal. A standard cold agglutinin titer was less than eight. Marrow examination revealed erythroid hyperplasia. The direct antiglobulin test was positive (3+) with anti-3C only. Antibody detection and identification tests showed her serum reactive (3+) with all red blood cells tested at all phases. The direct antiblobulin test and antibody detection test had been negative at birth. Treatment included daily transfusions and/or exchange transfusions for 3 weeks with whole blood, frozen red blood cells from an Mk homozygote, and red blood cells from a donor homozygous for Mi. VII. Other treatment medications included Solu-Medrol, intravenous gammaglobulin, and Cytoxan. Six months after the initial presentation, she recovered. The reporter indicated that there was a temporal relationship between the event and DPT administration. The literature article is attached to the regulatory form.
Age: 0.08
Sex: F
Vaccine: DTP
Symptoms: Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Information has been received on 07/11/02 from a published literature article(Transfusion support with RBCs from Mk homozygote in a case of autoimmune hemolytic anemia following diphtheria-pertusis-tetanus vaccination. Transfusion 2002; 42 (5); 567-571) regarding a 1 month old female who received her first injection of diphtheria-pertussis-tetanus vaccine. Five days post-immunization, she was hospitalized with a diagnosis of autoimmune hemolytic anemia. Prior to admission, she had a 2 day history of lethargy, irritability, occasional vomiting and pallor. On admission, she appeared to be in acute distress with pulse of 160 beats per minute, a respiratory rate of 48 breaths per minute, a systolic blood pressure of 80 torr, and a temp of 37.2 deg C. Lab results included a hematocrit of 9.4%, a white blood count of 21,900 per uL, and a platelet count of 928,000 per uL. A peripheral blood smear revealed moderate nisocytosis, poikilocytosis, polychromatophilia, and spherocytes. The LDH was 477 U per L. The reticulocyte count was 3.3 percent. hepatoglobin was zero. Total Bilirubin was 2.7 mg per dL, and her creatinine was 0.3mg per dL. Complement levels (C3, C4, and CH50) were normal. A standard cold agglutinin titer was less than eight. Marrow examination revealed erythroid hyperplasia. The direct antiglobulin test was positive (3+) with anti-3C only. Antibody detection and identification tests showed her serum reactive (3+) with all red blood cells tested at all phases. The direct antiblobulin test and antibody detection test had been negative at birth. Treatment included daily transfusions and/or exchange transfusions for 3 weeks with whole blood, frozen red blood cells from an Mk homozygote, and red blood cells from a donor homozygous for Mi. VII. Other treatment medications included Solu-Medrol, intravenous gammaglobulin, and Cytoxan. Six months after the initial presentation, she recovered. The reporter indicated that there was a temporal relationship between the event and DPT administration. The literature article is attached to the regulatory form.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Blood amylase increased, Lipase increased, Nausea, Vomiting
Clinical narrative: Report A0374099A describes elevated amylase and lipase concentrations in a 36 year old female who received hep b vaccine recombinant. Medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the vaccinee received an injection of Engerix B (lot ENG5206B6); it was not known if she had received previous injections of Engerix B. Within 24 hours post-immunization, she experienced "severe" nausea and vomiting. Amylase and lipase concentrations were found to be elevated, and the vaccinee was hospitalized. Treatment and outcome were not provided.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose increased, Injection site erythema, Injection site oedema, Ketoacidosis, Nausea
Clinical narrative: Report A0374097A describes diabetic ketoacidosis in a 39 year old female who received hep b vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the vaccinee received an injection of Engerix B (lot ENG5260B6). The number of previous injections of Engerix B was not provided. Within twelve hours post-immunization, she experienced "severe" nausea and vomiting and lapsed into diabetic ketoacidosis. The vaccinee was hospitalized in an intensive care unit. Treatment and outcome were not provided. The follow up states that the pt's medical history also included type II diabetes mellitus and hypothyroidism.. There was no history of alcohol or tobacco use. Concurrent medications included insulin, Armour Thyroid, Levoxyl and Premarin. On 5/13/02, the pt received her third injection of Engerix B. On the morning of 5/14/02, she experienced dry mouth. She also developed an injection site reaction characterized by erythema, edema and a 4-inch wheal. Serum glucose was found to be elevated. These events resolved after an unspecified period of time. The reporting physician considered the events to be related to Engerix B administration.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria, Vomiting
Clinical narrative: Report A0374097A describes diabetic ketoacidosis in a 39 year old female who received hep b vaccine recombinant (Engerix B). Medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date, the vaccinee received an injection of Engerix B (lot ENG5260B6). The number of previous injections of Engerix B was not provided. Within twelve hours post-immunization, she experienced "severe" nausea and vomiting and lapsed into diabetic ketoacidosis. The vaccinee was hospitalized in an intensive care unit. Treatment and outcome were not provided. The follow up states that the pt's medical history also included type II diabetes mellitus and hypothyroidism.. There was no history of alcohol or tobacco use. Concurrent medications included insulin, Armour Thyroid, Levoxyl and Premarin. On 5/13/02, the pt received her third injection of Engerix B. On the morning of 5/14/02, she experienced dry mouth. She also developed an injection site reaction characterized by erythema, edema and a 4-inch wheal. Serum glucose was found to be elevated. These events resolved after an unspecified period of time. The reporting physician considered the events to be related to Engerix B administration.
Age: 0.2
Sex: M
Vaccine: HEP, HIBV, IPV
Symptoms: Apnoea, Autism, Neuropathy, Overdose, Schizophreniform disorder
Clinical narrative: Information has been received regarding a case in litigation which concerns a male pt who was vaccinated with injections containing toxic mercury in the form of thimerosal in approximately 15 doses between 3 months of age and two years of age. It is alleged that the pt has been diagnosed iwth neurological injuries, including "disintegrative" (or "regressive," "late onset," "degenerative") autism. A hospital discharge summary was received as follow-up info. Per the record, the pt was inoculated with diphtheria, tetanus, pertussis, polio, haemophilus influenza type b and hep b vaccine recombinant on 12/27/98. On 01/11/99, synagis was administered. The pt has a history of being born prematurely at 27 weeks old five days of gestation. He was considered a borderline "small for gestational age" male infant and was one of a set of triplets. The pt suffered with respiratory insufficiency and needed to use mechanical ventilation from birth to day three of his life, and then again from day eight through day 15 due to persistent apnea. On days four through eight the required aid from nasal continuous positive pressure air for respiration. "Apnea of prematurity" was medically treated with aminophylline on days two through nine, and then with caffeine citrate on day 26 through day 75 (01/05/99). His last documented episode of apnea was 12/31/99. He also suffered with patent ductur arteriosus that resolved on its own by 11/17/98. In addition the pt has a history of an episode of supraventricular tachycardia which lasted 30-60 seconds and resolved with suctioning, sinus tachycardia on day 23. Echocardiogram on 11/12/98 revealed hyperdynamic contractility and poor filling, pt was treated with Inderal from 11/17/98 through 12/12/98. Other history included transient hyperbilirubinemia with total bilirubin maximum level was 6.8 and was treated with phototherapy on days 2 through 5, anemia (requiring three units of packed red blood cells), epoetin alfa on 11/19/98 through 12/18/98 and ferrous sulfate on 11/19/98; and neutropenia with an absolute neutrophil count of 948 on 01/11/99. Upon internal review, autism was determined to be another important medical event. No further info is available.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Joint swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: Joint pain/swelling, fatigue, pain in arms, legs, shoulder, feet, knees, hands, hip pain, pain all over arms, neck, stiffness in hands, neck, ankles and feet; symptoms are similar to rheumatoid arthritis and Lyme. 10/1/02 Per review of medical records a thyroid nodule was found on exam in 4/2002 and later determined by fine needle biopsy to be benign. The opinion of one specialist was that the patient had a reactive arthritis syndrome secondary to Lymerix vaccine in spite of the lack of genetic or inflammatory markers.
Age: 43.0
Sex: F
Vaccine: LYME
Symptoms: Pain
Clinical narrative: Joint pain/swelling, fatigue, pain in arms, legs, shoulder, feet, knees, hands, hip pain, pain all over arms, neck, stiffness in hands, neck, ankles and feet; symptoms are similar to rheumatoid arthritis and Lyme. 10/1/02 Per review of medical records a thyroid nodule was found on exam in 4/2002 and later determined by fine needle biopsy to be benign. The opinion of one specialist was that the patient had a reactive arthritis syndrome secondary to Lymerix vaccine in spite of the lack of genetic or inflammatory markers.
Age: 66.0
Sex: M
Vaccine: HEPAB, IPV, TD, TYP, YF, HEPAB, IPV, TD, YF
Symptoms: Fatigue, Pyrexia
Clinical narrative: Two weeks after vaccination, started fever,101 F and Fatigue continue 2 weeks finally recovered.
Age: 66.0
Sex: M
Vaccine: HEPAB, IPV, TD, TYP, YF, HEPAB, IPV, TD, YF
Symptoms: Asthenia, Pyrexia
Clinical narrative: Two weeks after vaccination, started fever,101 F and Fatigue continue 2 weeks finally recovered.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, PNC
Symptoms: Diarrhoea
Clinical narrative: Pt keeps getting bad diarrhea after vaccines are given. Received DTAP/Hib #4 on 1/10/02. Received Prevnar #3, IPV #3 and Hep-A #1 on 7/10/02.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site mass, Skin discolouration, Skin necrosis
Clinical narrative: Knot on (L) thigh, dark color. Dx'd fat necrosis, 1 month after immunizations. Pt was referred to Pediatric Surgery.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Skin ulcer
Clinical narrative: Shot give on left leg on 07/03/02, On 07/09/02, site was red, swollen, slight warm to touch, target lesion, erythema, raised, slight tender 3 X 3 in size,  07/05/2002 Advised to use Motrin and ice compresses.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Dyspnoea, Injection site erythema, Pain, Pyrexia
Clinical narrative: Localized redness; fever of 100F; body achy and SOB.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Mother called the day after vaccines administered to report that patient had temp of 103 degrees F. Mother advised to give Tylenol or Ibuprofen and bring patient in for evaluation. No other treatment needed.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Mom phoned 5/22/02 and said the pt has chicken pox.
Age: 0.1
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Crying, Injection site swelling, Injection site warmth, Skin discolouration, Vomiting
Clinical narrative: Three hours after immunization, right leg was swollen and hot and cried continuously and color "wasn't right" for several hours. Slept well. the next day seemed ok, but was not his usual self". Mom was very concerned (Probable local reaction). After receiving Dtap, Hib, and IPV pt became ill. He had less PO, appeared pale, threw up once and was "not himself". Mom reported it at the next visit- 7/10/02. It lasted only 24 hrs.
Sex: F
Vaccine: TD
Symptoms: Erythema, Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Right arm 2 inch circular area of erythema, swelling and pain on deltoid area. Plus fever of 101 degrees F, nausea, vomiting.
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Right arm 2 inch circular area of erythema, swelling and pain on deltoid area. Plus fever of 101 degrees F, nausea, vomiting.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rash erythematous, Rash macular, Skin ulcer
Clinical narrative: Macular lesions within watery centers surrounded by red areas. Began 06/23/2002 on back, Progressed to crusted area ands another outbreak of lesions 06/25/2002.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Paralysis
Clinical narrative: Development of right sixth cranial nerve palsy within 2 weeks of immunization at 4 mos of age 10/06/00 DTaP #1 Hib #1 Hep b #2 and IPV #1 were all given. This problem has been recurrent. There is literature to suggest this can be related to vaccines. Still not complete recovery. She has had several opthalmoloy and neuropathalmiology and nerurology exams.
Age: 0.2
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: One week after Varivax administered, the pt began developing varicella type rash which by the next day was almost confluent on both anterior chins and right upper arm and more scattered right chest. Placed on Acyclover 200 mg QID x 5 days.
Age: 5.3
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left thigh swollen, taught, around entire circumference of thigh 2 1/2" diam and of erythema at injection site over mid-lateral.
Age: 4.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approximately 2inch reddened area at injection site. Hot to touch, pt denies pain.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Agitation, Anorexia, Cough, Diarrhoea, Gait disturbance
Clinical narrative: Developed loose stool x 7. Rash on face, arms, back, chest, arthralgia, crying, won't eat. Coughing congestion. Unsteady gait.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Nasal congestion, Rash
Clinical narrative: Developed loose stool x 7. Rash on face, arms, back, chest, arthralgia, crying, won't eat. Coughing congestion. Unsteady gait.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Noted swelling/erythema of right thigh severe that improved after 48-+2 hours post injection , no systemic signs, no fever.
Age: 1.25
Sex: F
Vaccine: HBHEPB
Symptoms: Hypotonia, Muscular weakness, Pain
Clinical narrative: Neuromuscular weakness with hypotonia. Pain on right leg.  Follow up: Diagnosed with GBS; pain in left leg.