chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.63
Sex: M
Vaccine: DT
Symptoms: Insomnia, Mental retardation severity unspecified, Pyrexia, Rash, Restlessness
Clinical narrative: Child was normal until given his first vaccine DT at 7 1/2 months of age. Later that day mod fever, very irritable, lot of screaming. Parents felt that by 2 weeks he was a changed child, later dx'd autistic. Pt's caregiver reports: I was pt's mother's caregiver during pregnancy. It was a normal pregnancy. Pt was born by cesarean section because of cephalopelvic disproportion. He showed normal growth and development for the first 7 1/2 months after birth. At his 7 1/2 months visit his development was normal and in fact exceptional in some respects-he was using the potty upon his parents command! He enjoyed peek-a-boo, was laughing, responding to his name. Enjoyed books, etc and was generally cheerful. There was no indication of any neurological or other difficulty. Also at that visit (7 1/2 months) he was given an injection of a single vaccine 0.5 of pediatric diphtheria/tetanus toxoid (DT). He had an immediate reaction to the vaccination that included fever and inconsolable crying. This incident appears to have marked a turning point in pt's development. He changed from a good natured, happy child to one who had became increasingly irritable and difficult. The next time I saw him was about 1 month after the vaccination. His chief complaint was a persistent cough. His parents reported that he had displayed unusually severe crying for about a week after the shot, and irritability, restlessness, poor sleep, etc. was continuing. My conclusion at that time was that he had had a significant neurological reaction to the vaccine. I saw him again about 3 1/2 months after the vaccination. His chief complaint at that time was fever with rash which we diagnosed as a viral exanthem. The irritability etc. was continuing. The next time we saw him was when he was 26 months old. It was obvious at that time that he was suffering from a developmental delay that stemmed from the time of the vaccination, and we recommended that he get specialized diagnosis and treatment. DX with autism about 8 months later. I haven't seen the child lately (in the past 3 years). I believe he is still autistic. The connection between the vaccination and the behavior/neurological disorder is obvious.
Age: 0.63
Sex: M
Vaccine: DT
Symptoms: Screaming
Clinical narrative: Child was normal until given his first vaccine DT at 7 1/2 months of age. Later that day mod fever, very irritable, lot of screaming. Parents felt that by 2 weeks he was a changed child, later dx'd autistic. Pt's caregiver reports: I was pt's mother's caregiver during pregnancy. It was a normal pregnancy. Pt was born by cesarean section because of cephalopelvic disproportion. He showed normal growth and development for the first 7 1/2 months after birth. At his 7 1/2 months visit his development was normal and in fact exceptional in some respects-he was using the potty upon his parents command! He enjoyed peek-a-boo, was laughing, responding to his name. Enjoyed books, etc and was generally cheerful. There was no indication of any neurological or other difficulty. Also at that visit (7 1/2 months) he was given an injection of a single vaccine 0.5 of pediatric diphtheria/tetanus toxoid (DT). He had an immediate reaction to the vaccination that included fever and inconsolable crying. This incident appears to have marked a turning point in pt's development. He changed from a good natured, happy child to one who had became increasingly irritable and difficult. The next time I saw him was about 1 month after the vaccination. His chief complaint was a persistent cough. His parents reported that he had displayed unusually severe crying for about a week after the shot, and irritability, restlessness, poor sleep, etc. was continuing. My conclusion at that time was that he had had a significant neurological reaction to the vaccine. I saw him again about 3 1/2 months after the vaccination. His chief complaint at that time was fever with rash which we diagnosed as a viral exanthem. The irritability etc. was continuing. The next time we saw him was when he was 26 months old. It was obvious at that time that he was suffering from a developmental delay that stemmed from the time of the vaccination, and we recommended that he get specialized diagnosis and treatment. DX with autism about 8 months later. I haven't seen the child lately (in the past 3 years). I believe he is still autistic. The connection between the vaccination and the behavior/neurological disorder is obvious.
Age: 0.23
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash only, No fever.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Had chicken pox like brother 04/01/05, less than 10 lesions.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Nonspecific reaction, Skin warm
Clinical narrative: Local reaction to DTaP hot and painless 4 1/2 x 3 1/2cm. Benadryl 8cc Q 6H PRN, warm comress to area.
Age: 1.12
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Varicella, Post- vaccination. Seen in our office 04/04/2005 and DX by DR with Varicella. Had vaccine in 1999. Developed rash 4-2-05 and fever of 101 degrees Fahrenheit 4-3-05. Has approximately 30 lesions with small central vesicles, some crusted. Follow-up Information 12-APR-2006: Varicella vaccine break-through. Rash on neck, abdomen and legs on 4-6-06. No fever. Diagnosed with Varicella by Doctor. Less than 50 lesions. Patient age: 7.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Rash, Rash erythematous
Clinical narrative: Red, raised rash on extremities, trunk which started evening of- went to bed after taking Benadryl- Awoke to find rash much worse the next day, plus, hands and feet swollen, went to ER and RX'd Prednisone, Benadryl, kept for observation and sent home on above meds plus Zantac.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Injection site mass, Medication error, Wrong drug administered
Clinical narrative: Mom states pt has a red knot where injection was given. No adverse reaction. Pt was given adult pneumococcal vaccination on 03/30/2005.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site mass, Injection site reaction
Clinical narrative: 03/30/2005- started redd. swollen, hard area size of an orange (per mom) Temp normal 98.6, seen on 03/31/2005 in office and examined by DR- documented 6x6cm erythema and induration around injection site. Probable reaction to DTaP.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Oedema
Clinical narrative: 03/30/2005- started redd. swollen, hard area size of an orange (per mom) Temp normal 98.6, seen on 03/31/2005 in office and examined by DR- documented 6x6cm erythema and induration around injection site. Probable reaction to DTaP.
Age: 33.0
Sex: F
Vaccine: TTOX
Symptoms: Headache, Injection site mass, Injection site pain, Myalgia
Clinical narrative: headache-lasted 72 hours, muscle aching, soreness, hardness, lasted 72 hours
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Pruritus, Rash papular, Rash vesicular
Clinical narrative: Post vaccine varicella, child was seen in our office on 04/04/05 by DR and diagnosed with varicella. Had vaccine in 1997. Rash started 04/02/05 and spread to trunk, scalp, neck, and extremities. Had approximately 30 itchy lesions, mix of papules and vesicles with some crusting. Afebrile.
Age: 0.87
Sex: F
Vaccine: PNC, FLU3, PNC
Symptoms: Diarrhoea, Rash
Clinical narrative: 24 hours after vaccine pt started with diarrhea and rash
Age: 50.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Erythema, Nonspecific reaction, Oedema peripheral
Clinical narrative: Pt came in for blood work on 04/01 stating that left arm (upper) swollen and red. Iced area day before. Adverse reaction to pneumovax. To use cold compress x 48 hours, then warm.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Sat. 03/26- couple of bumps on her, Sun and Mon 03/27-03/28-more came on her forehead, hair line, and ear. Small red bump pus came out.
Age: 1.11
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash 03/28/2005
Age: 29.0
Sex: F
Vaccine: HEPAB, TD
Symptoms: Throat tightness
Clinical narrative: Within 24 hours of administration of vaccine pt stated "her throat started to swell shut" pt saw Nurse Practicioner who gave Benadryl and 3 day course of Steroids
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pyrexia, Rash, Tongue disorder, Vomiting
Clinical narrative: Received DTaP, Hep A, IPV, MMR on 02/25/2005. Started running fever, vomiting, and rash 03/07/2005 Strawberry tongue 03/09.
Age: 0.38
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Face/neck sl raised non papular rash began 3/2. Infant was scratching it. Low grade fever, rash completely gone by Saturday 3/5/05. With interpreter, parent explained baby had rash nowhere else on body. States she had not changed soaps, lotions, etc. Fever was 99.6 rectal. Suggested Tylenol before next appt. Child received no sequelae.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Dizziness
Clinical narrative: Approx 3 hrs after admin Td, developed lightheaded. Self treatment water, candy, coffee with sugar with effect.
Age: 33.0
Sex: F
Vaccine: HEPAB, TD, TYP
Symptoms: Back pain, Dizziness, Headache, Nausea, Pain
Clinical narrative: Pt had pain in both arms, back pain, dizziness, headache, nausea and vomiting the evening following her immunizations.
Age: 33.0
Sex: F
Vaccine: HEPAB, TD, TYP
Symptoms: Vomiting
Clinical narrative: Pt had pain in both arms, back pain, dizziness, headache, nausea and vomiting the evening following her immunizations.
Age: 12.0
Sex: M
Vaccine: HEP, TD
Symptoms: Pruritus, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: Mother reports: one week after his shots, pt had a 102 F fever and hives, red raised itchy rash on chest and legs and arms. She gave her son Tylenol and Benadryl for 2 days. The symptoms resolved.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Nausea, Rash papular, Syncope
Clinical narrative: On 4/5/05 in AM within 5 min of vaccines, pt was walking out and fainted. Mother shook pt and she opened eyes within 10 sec. No breathing problem. Then red papular rash began on both upper arms near injection sites. Benadryl given for 48 hrs. Pt nauseated and continued to have red upper arms.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Rec'd DTaP #5 and IPV #4 in left arm on 04/05/2005. RTC today with redness, edema from shoulder to near elbow, warm and hard to touch. Mom gave Tylenol 4/5 and 4/6 referred to PMD.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: Slight swelling (1/4" high) red and hot 2 1/2 diameter with some itching.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 1 hr after getting DTaP red and swelling at site spreading upper arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site urticaria, Pyrexia
Clinical narrative: Erythema, induration, and urticaria at injection site (right arm). Temp was 99. Seen 48 hrs post injection, symptoms occurred 24 hours post injections.
Age: 1.03
Sex: M
Vaccine: HBHEPB, PNC
Symptoms: Oedema peripheral, Pyrexia, Rash
Clinical narrative: On day 8 of Amoxicillin. Then generalized rash starting 2 hrs after receiving vaccines. Spread over body next 24 hrs with hand and feet swelling. Seen in urgent care. Given IV Solumedrol and Benadryl with PO meds for 5 days. Temp of 100.1, improving.
Age: 1.26
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Blister, Dry skin, Pyrexia, Rash pruritic, Skin ulcer
Clinical narrative: Low grade fever x 2 days: onset 3 days after immunization then 15 days after, pt developed vesicle on leg,a anus and 5-6 more lesions on body x 2d with low grade fever of 99. By the 19th d post vaccination itchy pinpoint vesicles erupted all over chest/back over 2 days, rash pruritic, skin rough; all lesions scabbed by 22nd day post vaccination. Pt was not seen here, but was see by mother's family practitioner who diagnosed pt with classic chickenpox.
Age: 1.26
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Viral infection
Clinical narrative: Low grade fever x 2 days: onset 3 days after immunization then 15 days after, pt developed vesicle on leg,a anus and 5-6 more lesions on body x 2d with low grade fever of 99. By the 19th d post vaccination itchy pinpoint vesicles erupted all over chest/back over 2 days, rash pruritic, skin rough; all lesions scabbed by 22nd day post vaccination. Pt was not seen here, but was see by mother's family practitioner who diagnosed pt with classic chickenpox.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Pain, swelling, temp. 100.2 apr.9. Rx.with warm and cold commpress.  given Tylenol.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic shock
Clinical narrative: Following Hepatitis B vaccine she immediately went in to aniphylactic shock.
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Pt had rash x 1 day, fever x 2 days, itchy
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Started with three big spots which spread to trunk, itchy tx with Zovirax
Age: 1.8
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Started with fever on 4/8/05 3 hrs after vaccines taken to ER. 4/10/05 104 on 4/10/05 106. Today 4/11/05 103. Lab and x-rays ordered 4/11/05.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Pruritus
Clinical narrative: Two days after immunizations pt called answering service with c/o redness at immunization site as wide as thigh and 3 inches in ht. Pt c/o redness hot and hardness and itching (left thigh).
Age: 50.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Formication, Hypoaesthesia, Muscle spasms, Tinnitus
Clinical narrative: Joint pain, numbness in extremities, ringing in ears, feels like bugs are crawling all over all the time.
Age: 50.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Arthralgia, Formication, Hypoaesthesia, Tinnitus
Clinical narrative: Joint pain, numbness in extremities, ringing in ears, feels like bugs are crawling all over all the time.
Age: 0.87
Sex: F
Vaccine: PNC, FLU3, PNC
Symptoms: Diarrhoea, Rash
Clinical narrative: Rash and Diarrhea
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Dehydration, Irritability, Vomiting, White blood cell count increased
Clinical narrative: Reported emesis causing dehydration, increased white count, crankiness and excessive crying.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Chest pain, Electrocardiogram abnormal, Laboratory test abnormal, Pericarditis, Ventricular extrasystoles
Clinical narrative: Member experienced chest pain over 18-19 Feb, was seen/treated in ER/admitted to cardiology. Discharge diagnoses: Pericarditis. Information added includes pain, PVC's. msv
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Fatigue, Paraesthesia
Clinical narrative: The morning after receiving a flu shot, Pt reports she awoke with no sensation from hips thru toes and elbows through finger tips. Has fatigue and episodes of loss of balance since then. Resolving, partially according to Pt.
Age: 0.92
Sex: M
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Diagnosed with Influenza 03/21/2005.
Age: 1.58
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Diagnosed with Influenza 03/29/2005.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Injection site pain
Clinical narrative: According to pt, she have experienced pain at injeciton site, arm and hand since the day she received her Flu shot (6 months). She saw her doctor a month later after the day of injection and took ibuprofen for 2 weeks after that they put her on cortisone shots and now she is in physical therapy.
Age: 10.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Influenza
Clinical narrative: Diagnosed with Influenza 03/19/2005
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Left arm with large area of redness, warmth and swelling from injection site to above elbow.
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Chills, Drug ineffective, Nausea, Urticaria
Clinical narrative: Symptoms of sever urticaria, head to toe, nausea, hives, chills.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Developed chicken pox on 04/01/2005,  like younger brother. Pt has at least 30 lesions.
Age: 1.49
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Anorexia, Cough, Lymphoedema, Pyrexia
Clinical narrative: Shots given 03/31/2005. Pt came to office on 04/04/05 with fever, not eating, and coughing. Arrived again to office on 04/06/05 with swollen lymph node in the groin area.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Erythematous wheal and flare pruritic. Prescribed Benadryl and Keflex.
Age: 16.0
Sex: M
Vaccine: HEP, TD
Symptoms: Diplopia, Pruritus, Urticaria
Clinical narrative: 04/05/05- While at school, student c/o double vision on 04/05. Parent was called and stated the pt had itching and hives of right arm on 04/04/05. Mother gave Benadryl and Tylenol. She was instructed to contact DR and make appt. but did not keep appt. States pt ok 04/07/2005.
Age: 1.08
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Acute fever, diarrhea, vomiting, x 7 days. (temp. 102 degrees Fahrenheit)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swollen red thigh. (left).
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: One hour after DTaP, developed rash over head, back and chest. Also erythema to injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: local arm swelling and redness at injection site.
Age: 1.51
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Pt started running fever 03/29 101.2, on 03/30 103.5, on 03/31 mom noticed blisters/bumps on pt body. 14 days to the day after her immunization
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Rash papular, Rash vesicular
Clinical narrative: 20-30 papular vesiculat lesions. Break through Varicella.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Red. Swollen thigh (left)
Age: 1.51
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: red, swollen leg (thigh area) (left)
Age: 1.55
Sex: F
Vaccine: DTAP, PPV, VARCEL
Symptoms: Injection site oedema, Injection site reaction, Pyrexia, Upper respiratory tract infection, Vomiting
Clinical narrative: Toddler seen at clinic 02Apr05 AM for fever, swelling at immunization site, Lt (DTaP). Rx: PCN and Tylenol. Seen in ER 02Apr05 PM due to fever 103/vomiting. Dx: probable viral URI, immunization site okay, mother 04Apr05.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Pyrexia
Clinical narrative: Redness, elevated skin temp 24 hrs after vaccination, fever, Benadryl and Keflex.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Child was brought in by mom one week after getting immunization at Dr office with a rash on face, arms and legs x 2 days. No meds were given and told to return 1 week to date all rash had faded.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varicella adm 07/27/01, mother states had chicken pox 07/2004.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Joint stiffness, Oedema
Clinical narrative: Developed generalized edema from hip to knee and involving the knee with mild erythema and decreased flexion of knee joint. Slight bruising at injection site over course of 2 days.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Induration mild/erythema x 3cm
Age: 4.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Myalgia, Pain
Clinical narrative: Leg pain, fatigue, muscle in legs hurt also, joint pain in legs.
Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Influenza like illness, Myalgia
Clinical narrative: Muscle and joint pain, numbness, fatigue, flu-like symptoms, tingling-aches all over body.
Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Paraesthesia
Clinical narrative: Muscle and joint pain, numbness, fatigue, flu-like symptoms, tingling-aches all over body.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass
Clinical narrative: 7cm x 9cm area of induration at left deltoid 2 days after vaccine admin. Pt was treated with a 10 day course of Augmentin 600/5 1 tsp PO bid.
Age: 1.26
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Mom stated pt had rash after last vaccines in 01/06/2005. Had at that time Prevnar, MMR, Varivax. We instructed mom to wait 20 minutes after vaccines given today. After 15 minutes red raised rash started only around injection site. 2 inches by 2 inches.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: 7x10cm area of erythema, induration, warmth surrounding injection site, no systemic sx, onset  1 day after immunization Rx'd with Benadryl and Prednisone and Keflex.
Sex: M
Vaccine: TD
Symptoms: Chills, Dyspnoea, Headache, Myalgia, Vomiting
Clinical narrative: Chills, body and headaches, vomiting, shortness of breath, for 24 hrs after vaccine.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Agitation, Arthralgia, Crying, Headache, Injection site pain
Clinical narrative: Pain in arm which received injection 45 mins after injection. 2AM woke up crying, pain in arm, severe headache, ibuprofen given. Aches and pains in joints and muscles. Fever 102.5F. Rash and hives in arm that received injection.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site rash, Myalgia, Pyrexia, Sleep disorder, Urticaria
Clinical narrative: Pain in arm which received injection 45 mins after injection. 2AM woke up crying, pain in arm, severe headache, ibuprofen given. Aches and pains in joints and muscles. Fever 102.5F. Rash and hives in arm that received injection.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Hypersensitivity, Influenza like illness, Pain, Pyrexia
Clinical narrative: Pain in arm which received injection 45 mins after injection. 2AM woke up crying, pain in arm, severe headache, ibuprofen given. Aches and pains in joints and muscles. Fever 102.5F. Rash and hives in arm that received injection.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rash
Clinical narrative: Pain in arm which received injection 45 mins after injection. 2AM woke up crying, pain in arm, severe headache, ibuprofen given. Aches and pains in joints and muscles. Fever 102.5F. Rash and hives in arm that received injection.
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left arm red and sore area approx 10"x6", no broken area noted or no red streaking from area.
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Herpes zoster, Neuritis
Clinical narrative: Shingles with neuritis on left leg shingles diagnosed clinically on 04/01/05. Varivax given on 04/19/00 given right arm. No family history of chicken pox disease.
Age: 22.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Vision blurred
Clinical narrative: 10 min after shot given donor became dizzy and had blurred vision. Donor laid on bed and legs elevated cool clothe and juice given.
Age: 47.0
Sex: F
Vaccine: MU
Symptoms: Laboratory test abnormal, Malaise, Musculoskeletal stiffness, Parotid gland enlargement, Rhinitis
Clinical narrative: Head Cold, swollen right parotid gland, stiff neck and general malaise. No fever.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Somnolence
Clinical narrative: Irritable, increased sleepiness, 1 1/2 days after receiving vaccinations
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Immz given on 03/29/2005 PM. Mother noticed redness and swelling on 3/30/05 early PM. Lasted x 24 hrs. Now has resolved.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: 12/10/04- pt c/o nausea and vomiting, fever, chills, pain in left upper arm since 12/06/04. Pt went to ER 12/10/04. Diagnosis: Cellulitis. Treatment with Anaprox DS 550mg 1 PO BID, Cehphalexin 500mg 1 PO QID, Keflex 500mg 1 PO
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Rash, Rash erythematous, Urticaria
Clinical narrative: 10-15 minutes after getting the vaccines pt cough, and developed a wheal like rash faintly on the arms and face. EMS was called and pt was taken to the ER. Pt alert and in no acute distress. ER called and DR in ER stated Pt was doing well. Pt received Epinephrine and Benadryl and rash is resolved, pt will be discharged home.
Age: 1.06
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Pt developed Zoster of left arm/ treated with oral and local Zovirax
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Rash vesicular, Skin ulcer
Clinical narrative: Pt developed bumps which then developed into vesicular lesions on the body. Pt presented to the office the 2nd day of the breakout.
Age: 1.57
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Acute swelling and erythema left upper thigh with fever. Information from missing data report states: sudden onset shortly after vaccine was given.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Joint stiffness, Pruritus, Rash, Urticaria
Clinical narrative: 24 hours after injection pt noted rash around ankles- red, not raised, itchy. Over the next 24 hours rash spread to neck area and generalized over trunk. Itchy and uncomfortable. Pt also c/o stiff, sore joints. Pt also in track practice, running outside beginning this week. Benadryl seems to relieve itching.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin discolouration, Swelling
Clinical narrative: After 3 hours after shot was given, arm swelled and was tight.  This continued until Sunday and started turning light green on back of arm and red on the rest of the arm.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia, Rash papular, Rhinitis, Rhinorrhoea
Clinical narrative: Coryza/rhinorrhea/fever to 103.7 X 2-3days prior to onset of papular rash that spread from head towards toes.  Diarrhea X 2days. No treatment at this time.  Supportive Care. Patient taking multivitamins daily.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: Mother called on 4/12/2005 to report that after her son received his immunizations on the AM of 4/11/05, he retruned to school. She stated that when she picked him up from school at 3:30 pm, he was c/o of generalized itching and was beginning to break out in hives. She states she took him to his dr's office where he was given Benadryl, and itching subsided. She reports that @ about 9:30 pm, the child c/o difficulty breathing, and she called 911. She further reports that the paramedics gave the child O2, his breathing got better, and she refused to have the child transported to the ER opting to take the child back to her pediatrician on 4/12/05. She reports that she kept the child home from school today 4/12/05, and has a 1:45 pm appt. She denies that the child was having any difficulty breathing this morning. She also added that she had a 10 month old cousin that died after receiving immunizations, but did not know all of the circumstances.
Age: 15.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Arrhythmia, Cardio-respiratory arrest, Injury, Loss of consciousness, Shock
Clinical narrative: Student received Td vaccine approx 1:45pm.  At approx. 4pm student was at track practice running up and down a hill for long distance running, he collapsed.  Hitting his head.  He never regained consciousness. Medical records received from ER which revealed patient arrived in full arrest & was unable to be resuscitated.  Additional information from autosy report rec'd 06/13/2005-- arrhythmia.
Age: 15.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Student received Td vaccine approx 1:45pm.  At approx. 4pm student was at track practice running up and down a hill for long distance running, he collapsed.  Hitting his head.  He never regained consciousness. Medical records received from ER which revealed patient arrived in full arrest & was unable to be resuscitated.  Additional information from autosy report rec'd 06/13/2005-- arrhythmia.
Age: 15.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Arrhythmia, Cardio-respiratory arrest, Injury, Loss of consciousness, Shock
Clinical narrative: STUDENT WAS PRACTICING FOR LONG DISTANCE IN TRACK AND COLLAPSED RUNNING UP A HILL.  NEVER REGAINED CONSCIOUSNESS.  DIED.
Age: 15.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Loss of consciousness, Syncope
Clinical narrative: STUDENT WAS PRACTICING FOR LONG DISTANCE IN TRACK AND COLLAPSED RUNNING UP A HILL.  NEVER REGAINED CONSCIOUSNESS.  DIED.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Hypersensitivity, Pain, Pruritus, Swelling
Clinical narrative: Received the vaccination on 3/24/05 there was no reaction until 3/30/05 when arm became red, ichy, swollen and sore.  Called the doctor and was told to come in that day. At the exam I was told to take ibuprofen and let them know if it got any worse.  3/31/05, the redness and swelling had grown as well as the dull ache. called the on-call doctor, did not receive a call until the morning.  Was told to come in ASAP, went in at 3:00 pm I was told at this time that I was having an allergic reaction to the tetanus shot and was given a prescription for antibiotics.  Also, doctor outlined the affected area to be able to confirm if the swelling decreased.  it did.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Hypersensitivity, Swelling
Clinical narrative: 4/12/2005  MOTHER CALLED AND SAID "MY DAUGHTER RECEIVED HER KINDERGARTEN SHOTS ON THURSDAY AND HER RIGHT ARM WAS RED, SWOLLEN, AND FEVERISH BETWEEN HER SHOULDER AND ELBOW, BUT IT'S BETTER NOW. MY FRIEND WHO IS A NURSE PRACTITIONER LOOKED AT IT AND SAID IT MIGHT BE AN ALLERGIC REACTION. "SHE WAS NOT SEEN BY HER PHYSICIAN AND REQUIRED NO FURTHER TREATMENT PER MOTHER.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Pyrexia
Clinical narrative: Uncontrollable crying all night until 7:30 AM with no fever, then at 3:00 PM on 4/12/05 had a fever of 103.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, PPV
Symptoms: Difficulty in walking, Injection site pain, Urticaria
Clinical narrative: Difficulty walking, pain and hives around injection sites.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Convulsion, Gastrooesophageal reflux disease, Gaze palsy, Lethargy
Clinical narrative: Lethargic/unresponsive 02/25/05, staring, seizure like symptoms 02/09/05, Diagnosis: Acid Reflux and Torticollis. Information from 60 day report states she still has spasms and Torticollis felt still in pt. Is there a safe way to test to see if she will have future reactions before we put more in her?
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Torticollis
Clinical narrative: Lethargic/unresponsive 02/25/05, staring, seizure like symptoms 02/09/05, Diagnosis: Acid Reflux and Torticollis. Information from 60 day report states she still has spasms and Torticollis felt still in pt. Is there a safe way to test to see if she will have future reactions before we put more in her?
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: No adverse event reported.
Age: 1.49
Sex: M
Vaccine: UNK
Symptoms: Erythema, Rash papular, Rash vesicular
Clinical narrative: varicella like rash, red, scattered papules on face, arms, and legs.
Age: 1.93
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema, Urticaria
Clinical narrative: Patient developed edema and redness, (a hive-like area) next to site of injection within 5 minutes of injection. Ice applied to area and swelling went down signifigantly.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Erythema, Injection site erythema, Pruritus, Pyrexia, Skin reaction
Clinical narrative: Upper right arm red, warm to touch. Area covers approximately 1/3 of upper outer aspect of arm. Child is scratching site. Parent reports low grade fever. Site is firm to touch, skin is taut. Denies pain at site.
Age: 42.0
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Hepatitis C virus, Laboratory test abnormal
Clinical narrative: As a volunteer at Gateway Med Research,I was tested 04/2004, 07/2004, 09/2004, 11/2004, 01/2005, for Hep C= all negative. After 3 dosages of Twinrix HAB265B6 on 03/10/05 lab tests for Hep C with Gateway were positive further testing as recommended with negative results.
Sex: F
Vaccine: ANTH
Symptoms: Malaise
Clinical narrative: Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I wish to comment regarding the anthrax immunization. I am still ill from the injections. I was a nurse in the reserves. The job was wonderful and not a day goes by that I do not miss it. I am not able to work in the hospital. I can no longer stand for great lengths of time. If interested in a detailed listing of my nightmare illness, I would be happy to send you a summary. But something tells me the FDA could care less or you would stop this nonsense anthrax immunization program. The listing of ill troops is already available to your organization. This is one former troop who wants you to know I am still sick and the anthrax immunization is the cause.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Rash erythematous, Rash macular
Clinical narrative: This case was reported by a nurse and described the occurrence of an allergic reaction in a 6 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The nurse reported this case directly. The pt's medical history included shoulder dystocia with a brachial plexus injury at birth. The pt has no known drug allergies. At the time of the third administration of Pediarix, on 29Dec04, the pt had diaper rash. On 19Oct04, the pt received the second dose of Pediarix in the left thigh (lot 21928A2). The mother reported to the nurse that following the second dose of Pediarix, on an unspecified date in Oct 2004, the pt developed a mild rash on her body that resolved in one day. The nurse reported that this rash required no treatment. On 29Dec04 the pt received the third dose of Pediarix in the left thigh at 10:15AM (lot AC21A004AA). At about 6:00PM on 29Dec04, the pt experienced a facial rash described as red blotches on the face. The following day, on 30Dec04, the pt experienced a facial rash over her entire body. The nurse described the rash as a thick blotchy red area similar to a sunburn located on her trunk. The nurse also stated that the rash was not warm to touch. On 04Jan04 the pt developed fever of 99.7 F and was seen in the ER. The pt was diagnosed with an ear infection, dermatitis after immunizations, and the diaper rash that had appeared prior to the immunizations was diagnosed as monilial diaper rash. The pt was prescribed Benadryl, Amoxil and Nystatin cream. The ER physicians stated that the rash is likely an allergic type reaction possibly to the recent immunizations. On 05Jan05, the pt experienced worsening of her rash and was seen in an ER. Lab investigations were notable for decreased neutrophils at 20.1 percent and elevated monocytes at 16.9 percent. Metabolic profile, urinalysis, and all other hematological analysis were normal. The physician agreed with the previous diagnoses of an allergic reaction, otitis media and monilial diaper rash. the pt continued her therapy with Benadryl, Amoxil, Nystatin cream. The pt was prescribed baby oil bath rubdown. On 06Jan05, the pt was seen in the physician's office. Therapy with Amoxil was discontinued. Approx nine days following the third administration of Pediarix, on 07Jan05 the pt developed a fever of 100.1 F, a worsening of the rash, bruising of her arms, decreased appetite, respiratory problems, and a bluish coloring on hands and was again seen in the ER. A throat culture was negative for beta hemolytic Streptococci and positive of yeast, probably Candida albicans. The pt was treated with Benadryl and Prelone. The nurse stated that the pt underwent blood tests which were negative. The pt was diagnosed with an allergic reaction to the DTPa component of Pediarix. The allergic reaction was considered to require clinically serious intervention. The ear infection resolved on 07Jan05 and the allergic reaction resolved on 21Jan05.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Bacterial infection, Contusion, Cyanosis, Decreased appetite, Erythema
Clinical narrative: This case was reported by a nurse and described the occurrence of an allergic reaction in a 6 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The nurse reported this case directly. The pt's medical history included shoulder dystocia with a brachial plexus injury at birth. The pt has no known drug allergies. At the time of the third administration of Pediarix, on 29Dec04, the pt had diaper rash. On 19Oct04, the pt received the second dose of Pediarix in the left thigh (lot 21928A2). The mother reported to the nurse that following the second dose of Pediarix, on an unspecified date in Oct 2004, the pt developed a mild rash on her body that resolved in one day. The nurse reported that this rash required no treatment. On 29Dec04 the pt received the third dose of Pediarix in the left thigh at 10:15AM (lot AC21A004AA). At about 6:00PM on 29Dec04, the pt experienced a facial rash described as red blotches on the face. The following day, on 30Dec04, the pt experienced a facial rash over her entire body. The nurse described the rash as a thick blotchy red area similar to a sunburn located on her trunk. The nurse also stated that the rash was not warm to touch. On 04Jan04 the pt developed fever of 99.7 F and was seen in the ER. The pt was diagnosed with an ear infection, dermatitis after immunizations, and the diaper rash that had appeared prior to the immunizations was diagnosed as monilial diaper rash. The pt was prescribed Benadryl, Amoxil and Nystatin cream. The ER physicians stated that the rash is likely an allergic type reaction possibly to the recent immunizations. On 05Jan05, the pt experienced worsening of her rash and was seen in an ER. Lab investigations were notable for decreased neutrophils at 20.1 percent and elevated monocytes at 16.9 percent. Metabolic profile, urinalysis, and all other hematological analysis were normal. The physician agreed with the previous diagnoses of an allergic reaction, otitis media and monilial diaper rash. the pt continued her therapy with Benadryl, Amoxil, Nystatin cream. The pt was prescribed baby oil bath rubdown. On 06Jan05, the pt was seen in the physician's office. Therapy with Amoxil was discontinued. Approx nine days following the third administration of Pediarix, on 07Jan05 the pt developed a fever of 100.1 F, a worsening of the rash, bruising of her arms, decreased appetite, respiratory problems, and a bluish coloring on hands and was again seen in the ER. A throat culture was negative for beta hemolytic Streptococci and positive of yeast, probably Candida albicans. The pt was treated with Benadryl and Prelone. The nurse stated that the pt underwent blood tests which were negative. The pt was diagnosed with an allergic reaction to the DTPa component of Pediarix. The allergic reaction was considered to require clinically serious intervention. The ear infection resolved on 07Jan05 and the allergic reaction resolved on 21Jan05.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Hypersensitivity, Laboratory test abnormal, Otitis media, Pyrexia, Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of an allergic reaction in a 6 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The nurse reported this case directly. The pt's medical history included shoulder dystocia with a brachial plexus injury at birth. The pt has no known drug allergies. At the time of the third administration of Pediarix, on 29Dec04, the pt had diaper rash. On 19Oct04, the pt received the second dose of Pediarix in the left thigh (lot 21928A2). The mother reported to the nurse that following the second dose of Pediarix, on an unspecified date in Oct 2004, the pt developed a mild rash on her body that resolved in one day. The nurse reported that this rash required no treatment. On 29Dec04 the pt received the third dose of Pediarix in the left thigh at 10:15AM (lot AC21A004AA). At about 6:00PM on 29Dec04, the pt experienced a facial rash described as red blotches on the face. The following day, on 30Dec04, the pt experienced a facial rash over her entire body. The nurse described the rash as a thick blotchy red area similar to a sunburn located on her trunk. The nurse also stated that the rash was not warm to touch. On 04Jan04 the pt developed fever of 99.7 F and was seen in the ER. The pt was diagnosed with an ear infection, dermatitis after immunizations, and the diaper rash that had appeared prior to the immunizations was diagnosed as monilial diaper rash. The pt was prescribed Benadryl, Amoxil and Nystatin cream. The ER physicians stated that the rash is likely an allergic type reaction possibly to the recent immunizations. On 05Jan05, the pt experienced worsening of her rash and was seen in an ER. Lab investigations were notable for decreased neutrophils at 20.1 percent and elevated monocytes at 16.9 percent. Metabolic profile, urinalysis, and all other hematological analysis were normal. The physician agreed with the previous diagnoses of an allergic reaction, otitis media and monilial diaper rash. the pt continued her therapy with Benadryl, Amoxil, Nystatin cream. The pt was prescribed baby oil bath rubdown. On 06Jan05, the pt was seen in the physician's office. Therapy with Amoxil was discontinued. Approx nine days following the third administration of Pediarix, on 07Jan05 the pt developed a fever of 100.1 F, a worsening of the rash, bruising of her arms, decreased appetite, respiratory problems, and a bluish coloring on hands and was again seen in the ER. A throat culture was negative for beta hemolytic Streptococci and positive of yeast, probably Candida albicans. The pt was treated with Benadryl and Prelone. The nurse stated that the pt underwent blood tests which were negative. The pt was diagnosed with an allergic reaction to the DTPa component of Pediarix. The allergic reaction was considered to require clinically serious intervention. The ear infection resolved on 07Jan05 and the allergic reaction resolved on 21Jan05.
Age: 0.56
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Rash macular, Respiratory distress, Sepsis
Clinical narrative: This case was reported by a nurse and described the occurrence of an allergic reaction in a 6 month old female pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The nurse reported this case directly. The pt's medical history included shoulder dystocia with a brachial plexus injury at birth. The pt has no known drug allergies. At the time of the third administration of Pediarix, on 29Dec04, the pt had diaper rash. On 19Oct04, the pt received the second dose of Pediarix in the left thigh (lot 21928A2). The mother reported to the nurse that following the second dose of Pediarix, on an unspecified date in Oct 2004, the pt developed a mild rash on her body that resolved in one day. The nurse reported that this rash required no treatment. On 29Dec04 the pt received the third dose of Pediarix in the left thigh at 10:15AM (lot AC21A004AA). At about 6:00PM on 29Dec04, the pt experienced a facial rash described as red blotches on the face. The following day, on 30Dec04, the pt experienced a facial rash over her entire body. The nurse described the rash as a thick blotchy red area similar to a sunburn located on her trunk. The nurse also stated that the rash was not warm to touch. On 04Jan04 the pt developed fever of 99.7 F and was seen in the ER. The pt was diagnosed with an ear infection, dermatitis after immunizations, and the diaper rash that had appeared prior to the immunizations was diagnosed as monilial diaper rash. The pt was prescribed Benadryl, Amoxil and Nystatin cream. The ER physicians stated that the rash is likely an allergic type reaction possibly to the recent immunizations. On 05Jan05, the pt experienced worsening of her rash and was seen in an ER. Lab investigations were notable for decreased neutrophils at 20.1 percent and elevated monocytes at 16.9 percent. Metabolic profile, urinalysis, and all other hematological analysis were normal. The physician agreed with the previous diagnoses of an allergic reaction, otitis media and monilial diaper rash. the pt continued her therapy with Benadryl, Amoxil, Nystatin cream. The pt was prescribed baby oil bath rubdown. On 06Jan05, the pt was seen in the physician's office. Therapy with Amoxil was discontinued. Approx nine days following the third administration of Pediarix, on 07Jan05 the pt developed a fever of 100.1 F, a worsening of the rash, bruising of her arms, decreased appetite, respiratory problems, and a bluish coloring on hands and was again seen in the ER. A throat culture was negative for beta hemolytic Streptococci and positive of yeast, probably Candida albicans. The pt was treated with Benadryl and Prelone. The nurse stated that the pt underwent blood tests which were negative. The pt was diagnosed with an allergic reaction to the DTPa component of Pediarix. The allergic reaction was considered to require clinically serious intervention. The ear infection resolved on 07Jan05 and the allergic reaction resolved on 21Jan05.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP
Symptoms: Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fontanel bulging in a 4 month old male pt who received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hep B recombinant and inactivated poliovirus vaccine combined (Pediarix). The physician reported that two other pt's experienced bulging fontanel following the admin of Pediarix, however, the pt identifiers were not provided. On 06Dec04, the pt received the second dose of Pediarix (lot 21920C9). Approx 2 days following the second administration of Pediarix, on 08Dec04 the pt experienced fontanel bulging and a fever. The events resolved on or before 01Feb04. The reporting physician considered the events to possibly be related to vaccination with Pediarix.