chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Tenderness
Clinical narrative: Patient c/o (L) arm being very swollen, red, painful and itchy 24 hours after varicella immunization given. During exam on 7-29-10, patient's (L) arm very tender and warm to the touch. See #12 for treatment.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient c/o injection site being very swollen, red, painful, and hot to the touch. Patient presented on 7-28-10 with above symptoms. Upon exam, patients (L) arm has blisters around injection area. Also had clear yellow drainage from both injection sites on (L) arm. Patient was given KEFLEX, Prednisone, Hydrocortisone cream.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Patient c/o injection site being very swollen, red, painful, and hot to the touch. Patient presented on 7-28-10 with above symptoms. Upon exam, patients (L) arm has blisters around injection area. Also had clear yellow drainage from both injection sites on (L) arm. Patient was given KEFLEX, Prednisone, Hydrocortisone cream.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Patient had shot of DTAP on left deltoid last week Friday and had redness reaction on the shot area. Notified attending physician.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Immunization site-Lt upper arm developed 1/2" x 2" area of redness increased warmth and firmness. These symptoms except for redness. Started Thursday 7/29/10. Redness developed 7/30/10 AM. Pain started 7/29/10.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Gaze palsy, Pallor, Posturing, Unresponsive to stimuli
Clinical narrative: Patient in waiting room following vaccination to wait 15 minutes as recommended. Under 5 minutes following vaccination according to mother, patient for 10 seconds unresponsive, blew bubbles from mouth, back arched and left arm and hand ?. Mother called nurse. Patient pale, non-responsive for approx. 5 min with glazed look. No prior seizure history according to mother.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abdominal pain, Chromosome analysis normal, Constipation, Developmental delay, Dysstasia
Clinical narrative: Developmental delay, colic, severe constipation, low muscle tone all vaccines. 6 month vaccines, quit standing, making sounds and eye contact.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonia, Normal newborn
Clinical narrative: Developmental delay, colic, severe constipation, low muscle tone all vaccines. 6 month vaccines, quit standing, making sounds and eye contact.
Age: 24.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Nausea, Pain, Pyrexia, Rash erythematous
Clinical narrative: Talked to pt. 7-30-10; 4 days ago developed headache, worse with eye movement, fever and "really achy", also nausea 4-5 days ago; on 7-29-10 had red splotchy raised rash - large splotches on torso progressing to small on lower half of body - no itching.
Age: 24.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Rash macular
Clinical narrative: Talked to pt. 7-30-10; 4 days ago developed headache, worse with eye movement, fever and "really achy", also nausea 4-5 days ago; on 7-29-10 had red splotchy raised rash - large splotches on torso progressing to small on lower half of body - no itching.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large swelling, erythema picture included.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Additional immunizations given - (duplicated) - Patient had 2 accounts in the Grits - same name.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Convulsion, Cyanosis, Dysstasia, Electrocardiogram
Clinical narrative: Daughter collapsed and could not get up by herself. Low grade fever, shaky, seizure type symptoms. Complains of racing heart, blue hands, tingling hands and feet.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nervousness, Palpitations, Paraesthesia, Pyrexia, Syncope
Clinical narrative: Daughter collapsed and could not get up by herself. Low grade fever, shaky, seizure type symptoms. Complains of racing heart, blue hands, tingling hands and feet.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Fatigue, Injection site pain, Muscle rigidity
Clinical narrative: Approximately five minutes after receiving vaccinations patient, who was sitting in a chair, became rigid *for approximately equal to three seconds (*rigid limbs with some jerking present). Patient aroused; was oriented to person, place, time. States did not eat breakfast today.  Mom states patient was "nervous" about vaccinations. Vital signs monitored. Had pt rest on exam table. Pt. was given Sprite to drink/crackers to eat. Left clinic without difficulty at 10:05 AM - pt states feels "tired". Requested mom call this RN to inform of pt. status later today. Approximately equal to 4:30 PM - 8/4/10 - phone call to mom. Mom states pt. "doing fine" / "she's fine" but has some injection site soreness. 8/5/10 2:10P Phone call to parent of client - left voice msg. Re: follow up post injections. Requested call back from parent. 8/5/10 3:05P Return call from parent - States "she is fine and she is acting just like normal".
Age: 0.97
Sex: M
Vaccine: HEP, PNC
Symptoms: Ear infection, Hypersensitivity, Pyrexia, Rash, Urticaria
Clinical narrative: hives around neck/ high fever/ rash/ took back to doctor/ she told me ear infection/ high fever and vomiting continued/ returned to doctor/ second doctor admitted allergic reaction
Age: 0.97
Sex: M
Vaccine: HEP, PNC
Symptoms: Vomiting
Clinical narrative: hives around neck/ high fever/ rash/ took back to doctor/ she told me ear infection/ high fever and vomiting continued/ returned to doctor/ second doctor admitted allergic reaction
Age: 29.0
Sex: F
Vaccine: DTP
Symptoms: Chills, Injection site pain, Injection site swelling, Muscle spasms, Muscle twitching
Clinical narrative: Developed a fever, chills and felt achy all over.  Had a fever for close to 10 hours.  At the injection site, my muscle begain twitching/spasming at around noon. This continued for the next 48 hours.  The muscle in the shoulder where the shot was administered became swollen and painful.
Age: 29.0
Sex: F
Vaccine: DTP
Symptoms: Pain, Pyrexia
Clinical narrative: Developed a fever, chills and felt achy all over.  Had a fever for close to 10 hours.  At the injection site, my muscle begain twitching/spasming at around noon. This continued for the next 48 hours.  The muscle in the shoulder where the shot was administered became swollen and painful.
Age: 38.0
Sex: M
Vaccine: DTAP, HEPA, MEN
Symptoms: Lip swelling, Urticaria
Clinical narrative: Lip swelling and hives to arms and back.  IV Benadryl, Solumedrol, and Pepcid administered.
Age: 68.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: At the vacination site red, swollen, and says she has a fever.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Redness, Inflammation, Swelling @ site of injection.
Age: 1.63
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Child began to develop a reddened area on the left thigh post vaccinations (same day of vaccinations 8/03/10).  Child experienced a fever of 102 in the pm of 8/3/10; he was treated with Tylenol and the fever returned on 8/04/10.  Child presented to clinic on 8/04/10 at 3:48 pm with a continued fever of 102.  He was in no acute distress. The left anterior thigh revealed a 4" x 3.75" area of cellulitis, irregular border with mild patchy induration palpated throughout the area of cellulitis with the largest induration being approx. one cm in size with two tiny puncture sites approx. in the middle of the erythematic area. There was no induration palpated under the puncture sites, no drainage observed; the left thigh is warmer to touch than the right thigh.  The child was treated with Keflex, Tylenol and ice; upon returning to the clinic on 8/5/10, it was noted that the child was in no acute distress, the cellulitis had diminished in size, was less erythematic, no induration palpated, the cellulitis was resolving and the parent was instructed to continue course of antibiotics, Tylenol and ice and to present child to clinic if not improving, or worsens.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Rash macular
Clinical narrative: Soreness under the arm on the day of vaccination.  The next day broke out in red patches/blotches about an area of 3 inches in diameter.  Weather was hot.  Blotches were gone by the time she called public health office on 8/6/2010.  No treatment.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Local hives on both arms, Benadryl given.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Ran a fever of about 101.4 and the area around where the shot was administered is swelled. Now running a slight fever of about 100 and the area is still swelled.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: 8x4 cm reddened lump with bumps around area, painful to touch.  Cellulitis vs. vaccine reaction per MD. Treated with PCN 250mg/5cc - 2tsp Q6hrs
Age: 14.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Dyspnoea, Eye swelling, Oedema peripheral, Oropharyngeal pain, Rash generalised
Clinical narrative: Broke out in rash/hives all over body. Swelling of the face/eyes and hands, sore throat and difficulty breathing.
Age: 14.0
Sex: F
Vaccine: HPVX, MNQ, TDAP
Symptoms: Swelling face, Urticaria
Clinical narrative: Broke out in rash/hives all over body. Swelling of the face/eyes and hands, sore throat and difficulty breathing.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: LEFT ARM RED/SWOLLEN/HOT TO TOUCH/ITCHY; REDNESS MEASURED APPROX 100CM X 77 CM; SWELLING/INDURATION MEASURED APPROX 77CM X 82CM; TX WITH CLARITIN AND BENADRYL
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: LEFT ARM RED/SWOLLEN/HOT TO TOUCH/ITCHY; REDNESS MEASURED APPROX 100CM X 77 CM; SWELLING/INDURATION MEASURED APPROX 77CM X 82CM; TX WITH CLARITIN AND BENADRYL
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fall, Jaw fracture, Loss of consciousness, Skin laceration, X-ray abnormal
Clinical narrative: Patient received immunizations.  Sat in Injection Room for a few minutes while nurse completed the paperwork.  Appreared to be fine.  Walked out to the check out window and passed out while standing at the window.  Fell face-forward and cut his chin.  Patient had c-spine stabilized, oxygen placed via nasal cannula.  Chin dressed with sterile gauze and transported to Hospital per ambulance.  Patient received 7 stitches in chin and Xrays revealed jaw fracture.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Pain, Skin warm
Clinical narrative: 2CM WARM RED NODULE, MILD /MOD PAIN
Age: 33.0
Sex: F
Vaccine: DTAP
Symptoms: Dysphonia, Rash generalised, Wrong drug administered
Clinical narrative: RASH ON TRUNK BODY AND NECK, HOARSE VOICE
Age: 54.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Immediate post-injection reaction, Injection site pain, Periarthritis, Rotator cuff syndrome
Clinical narrative: Immediate onset of pain at time of injection. Never got any better. Progressed to Impingement syndrome and frozen shoulder. 3 other people in clinic also affected but their pain resolved after 4 months.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness, tenderness to right deltoid where Tdap injection was given and low grade fever.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Rash
Clinical narrative: patient has rash on back and chest
Age: 55.0
Sex: M
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Donor recieved injection on 8/3/10 donor stated when he woke up on 8/4/10 his arm was hurting, swollen, hot to the touch and red at injection site.
Age: 0.73
Sex: M
Vaccine: HIBV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Pt broke out into hives on face and at injection site.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Local reaction, Rash
Clinical narrative: Skin rash, localized to arms.  ? if related to vaccine.
Sex: U
Vaccine: TDAP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced uveitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. This literature article summarizes the results of an open, prospective, observational study that was carried out. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical Td controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Sex: U
Vaccine: TDAP
Symptoms: Autoimmune thyroiditis, Laboratory test abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of Hashimoto's thyroiditis in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Medical records showed that symptoms and or clinical suspicion such as fatigue or abnormal laboratory results were present either on or before the day of vaccination, or family history of thyroid disease was present. On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced Hashimoto's thyroiditis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667868A, B0667869A, B0667867A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 3 subjects who onset Hashimoto's thyroiditis. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with histological TD controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical TD recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Sex: U
Vaccine: TDAP
Symptoms: Autoimmune thyroiditis, Laboratory test abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of autoimmune thyroiditis in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). Medical records showed that symptoms and or clinical suspicion such a fatigue or abnormal laboratory results were present either on or before the day of vaccination, or family history of thyroid disease was present. On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced autoimmune thyroiditis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667868A, B0667867A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 2 subjects who onset autoimmune thyroiditis. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received Tdap vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematologic events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of Tdap vaccination by comparing with historical Td controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the Tdap and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following Tdap vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of Tdap, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after Tdap. No deaths occurred in the Tdap cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with Tdap.
Sex: U
Vaccine: TDAP
Symptoms: Systemic lupus erythematosus
Clinical narrative: This case was reported in a literature article and described the occurrence of systemic lupus erythematous in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced systemic lupus erythematous. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A, B0667866A, B0667867A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical TD controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical TD recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Sex: U
Vaccine: TDAP
Symptoms: Asthma exercise induced
Clinical narrative: This case was reported in a literature article and described the occurrence of exercise induced asthma in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced exercise induced asthma. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667819A, B0667865A B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 34 subjects who onset exercise induced asthma. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcome among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical Td controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Sex: U
Vaccine: TDAP
Symptoms: Asthma
Clinical narrative: This case was reported in a literature article and described the occurrence of cough variant asthma in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced cough variant asthma. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of 11 cases (B0643778A, B0667819A, B0667867A B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 5 subjects who experienced cough variant asthma. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions, and new onset of chronic illnesses) following administration of a single dose of TDAP, BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13, 427 10 to 18-year-old adolescents who received TDAP vaccinations as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical Td controls match for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the Tdap and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical Td recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Sex: U
Vaccine: TDAP
Symptoms: Asthma
Clinical narrative: This case was reported in a literature article and described the occurrence of asthma in a subject aged between 10 and 18 years of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX. Within 6 months of vaccination with BOOSTRIX, the subject experienced asthma. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case is one of the 11 cases (B0643778A, B0667867A, B0667865A B0667866A, B0667868A, B0667869A, B0667870A, B0667867, B0667872A and B0667873A) described in the literature article and classified as 'new onset of chronic illness'. The case referred to 52 subjects who onset asthma. This literature article summarizes the results of an open, prospective, observational study that was carried out in a Health Maintenance Organization. The primary aim of this study was to estimate the incidence of specific categories of adverse events (medically attended neurologic and hematologic events, allergic reactions and new onset of chronic illnesses) following administration of a single dose of BOOSTRIX (GlaxoSmithKline) to adolescents in a postlicensure setting. The study monitored safety outcomes among 13,427 10 to 18-year-old adolescents who received TDAP vaccination as part of their normal health care. The subjects were evaluated using self-control analysis comparing days 0 to 29 to days 30 to 59 post-vaccination for neurological events, hematological events and allergic reactions. Furthermore the study evaluated new onset chronic illnesses within 6 months of TDAP vaccination by comparing with historical TD controls matched for age at vaccination, season, sex, and geographic area. The study also compared the incidence of events of interest between the TDAP and historical cohorts as exploratory analyses. The study showed no increased risk for medically attended neurological or allergic reactions following TDAP vaccination when comparing the first 30 postvaccination days to the second 30 postvaccination days. There was one hematologic event within 30 days of TDAP, compared with 0 events within days 30 to 59. When compared with matched historical TD recipients, no increase in new onset chronic illnesses was seen after TDAP. No deaths occurred in the TDAP cohort during the study. In conclusion, this study provided no evidence for an increased risk for neurological, hematological, allergic events, or new onset of chronic illnesses among adolescents vaccinated with TDAP.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site rash, Oedema peripheral
Clinical narrative: Swelling of left leg with rash spreading to feet and arms.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient came in our office c/o left arm pain radiating up to her left side neck glands. The vaccine site was very red (large) and very hot to the touch she also had a red spot on her face the size of a quarter after getting this vaccine.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: Patient came in our office c/o left arm pain radiating up to her left side neck glands. The vaccine site was very red (large) and very hot to the touch she also had a red spot on her face the size of a quarter after getting this vaccine.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Blood culture negative, C-reactive protein normal, Injection site inflammation, Injection site swelling, Lymphocyte count normal
Clinical narrative: (L) shoulder swelling after vaccine (PCV 13), localized inflammation, but never tender lymphangitis.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Monocyte count increased, Neutrophil count normal, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: (L) shoulder swelling after vaccine (PCV 13), localized inflammation, but never tender lymphangitis.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever onset 7/30/10 and continuing today 8/6/10 at 104.F.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Inflammation, Pain in extremity, Skin warm, Swelling
Clinical narrative: (R) arm 10 x 10 cm inflammation circumference (+) warm (+) swelling (+) painful. No Rx.
Age: 32.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Lethargy, Loss of consciousness, Spinocerebellar ataxia
Clinical narrative: SCA (Spin Cerebellar Ataxia) care given came in requesting Meningococcal Inj per Dr request 2 mins after receiving the injection he became dizzy, lethargic and perfusely sweating. We called 911 and pt began to gain consciousness approximately 10 mins later. He had not eating (his stomach was empty).
Age: 32.0
Sex: U
Vaccine: TDAP
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Hospital employee had been given TDAP and next day had extreme flu like symptoms, fever, body aches, chills.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area where KINRIX given erythematous and slightly warm and tender
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Loss of consciousness, Tremor
Clinical narrative: Fell off exam table and was shaking x 15-30 seconds. Then in elevator-passed out for 5 seconds.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Skin lesion
Clinical narrative: Left upper thigh red, warm to touch. Redness extends entire frontal side of thigh and into medial side of left thigh. Slight edema noted. Red area approx 13-14 cm. Also noted several small open sores to right lower leg and left thigh and leg.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Blood triglycerides, Full blood count, Lip oedema, Metabolic function test, Pruritus generalised
Clinical narrative: Vaccinated on 7/23/10 at 10AM. C/o rash and itching beginning 7/23/10 pm. Seen in ED 7/25/10 for generalized rash and itching. Employee was treated and released. Continued with itching, generalized rash and lip edema. No resp. issues. Continues f/u with OH/MD as of 7-29-10.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Vaccinated on 7/23/10 at 10AM. C/o rash and itching beginning 7/23/10 pm. Seen in ED 7/25/10 for generalized rash and itching. Employee was treated and released. Continued with itching, generalized rash and lip edema. No resp. issues. Continues f/u with OH/MD as of 7-29-10.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Area of redness, tenderness, warmth, slight induration at site of injection (upper outer left arm) 24 hours after vaccine given, increased to 4cm x 8cm size by 48 hours, with fever 101. Headache. No body aches. PE otherwise normal.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Area of redness, tenderness, warmth, slight induration at site of injection (upper outer left arm) 24 hours after vaccine given, increased to 4cm x 8cm size by 48 hours, with fever 101. Headache. No body aches. PE otherwise normal.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Chest discomfort, Injection site pain, Injection site warmth, Lymph node pain
Clinical narrative: C/o chest heaviness for a few hours after receiving immunization. T-102. Tenderness at site with warmth, tender area axillary area- eval in office- Enlarged (L) lymph node no resp problem monitor- OV if persist
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphadenopathy
Clinical narrative: C/o chest heaviness for a few hours after receiving immunization. T-102. Tenderness at site with warmth, tender area axillary area- eval in office- Enlarged (L) lymph node no resp problem monitor- OV if persist
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: R upper arm swelling, redness, warm to touch.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Large, flat erythematous, warm, pruritic patch B/L arms following vaccine administration. (L) arm lesion 4cm diameter. (R) arm lesion 2.5cm. Advised BENADRYL and heat.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial palsy, Lacrimation increased, Paraesthesia oral, Scan brain
Clinical narrative: Paresthesias (L) peri-oral with (L) sided mouth droop and (L) eye tearing.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Entire upper arm red, hot and very firm to touch. Photo taken. Child afebrile & is able to move arm & play.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: 9 x 5.5 cm firm edema and erythema. Pain with ambulation; limping.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Pallor, Syncope
Clinical narrative: Pt at well child exam, had Hemoglobin finger stick test done followed by HEPATITIS A vaccination. Pt became pale, experienced syncope, but did not lose consciousness, was placed in supine position given juice to drink - then recovered.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at site on evening of 8/5/10 and noted also on 8/6/10.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Irritability, Pyrexia
Clinical narrative: High fever, fussiness.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: None evident.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Right arm, deltoid area tender, large red patch. DX: Cellulitis TX: KEFLEX.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Infection, No reaction on previous exposure to drug, Swelling, Vaccination site erythema
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with no known drug allergies and "long medical history" who on 05-JAN-2010 was vaccinated IM with a second dose of PNEUMOVAX 23 (lot# 663889/0632Y). Concomitant therapy included vitamins (unspecified) and calcium (unspecified) supplements. On 06-JAN-2010 the patient experienced an infection, raised and elevated and red area that looked like it could have developed into cellulitis. Intervention was the physician giving an unspecified treatment. The patient did not have any problems after the first dose of PNEUMOVAX 23 given by another office. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. Cellulitis was considered to be an other important medical event. Follow up information has been received from the medical assistant who confirmed that the patient received on 05-JAN-2010 the second dose of PNEUMOVAX 23, (Lot # 663889/0632Y) IM at 2:50 PM. The same day, the patient experienced 4 cm of erythema, warmth, and pain at the site of vaccination. Later, the same day the patient had worse. The patient was treated with trimetoprim and SEOTRA DS and KEFLEX 5 mg, both for 7 days. The patient had recovered on 12-JAN-2010 from all the symptoms. Further follow up information has been received from the medical assistant, who confirmed that the first dose of PNEUMOVAX 23 was given elsewhere (location, date, lot # unknown). The patient had no problem with that first dose. The second dose was given in the reporter's office on 05-JAN-2010. The reaction happened after the second dose. No cultures were performed. The cellulites was diagnosed based on examination. Antibiotics were given to prevent serious criteria. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with no known drug allergies and "long medical history" who on 05-JAN-2010 was vaccinated IM with a second dose of PNEUMOVAX 23 (lot# 663889/0632Y). Concomitant therapy included vitamins (unspecified) and calcium (unspecified) supplements. On 06-JAN-2010 the patient experienced an infection, raised and elevated and red area that looked like it could have developed into cellulitis. Intervention was the physician giving an unspecified treatment. The patient did not have any problems after the first dose of PNEUMOVAX 23 given by another office. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. Cellulitis was considered to be an other important medical event. Follow up information has been received from the medical assistant who confirmed that the patient received on 05-JAN-2010 the second dose of PNEUMOVAX 23, (Lot # 663889/0632Y) IM at 2:50 PM. The same day, the patient experienced 4 cm of erythema, warmth, and pain at the site of vaccination. Later, the same day the patient had worse. The patient was treated with trimetoprim and SEOTRA DS and KEFLEX 5 mg, both for 7 days. The patient had recovered on 12-JAN-2010 from all the symptoms. Further follow up information has been received from the medical assistant, who confirmed that the first dose of PNEUMOVAX 23 was given elsewhere (location, date, lot # unknown). The patient had no problem with that first dose. The second dose was given in the reporter's office on 05-JAN-2010. The reaction happened after the second dose. No cultures were performed. The cellulites was diagnosed based on examination. Antibiotics were given to prevent serious criteria. No further information is available.
Age: 1.04
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Pyrexia, Rash, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female with no medical history or drug allergies who on 28-MAY-2009 was vaccinated with a half a dose of PNEUMOVAX 23, 0.25 ml. There was no concomitant medication. On 29-MAY-2009 the patient developed a fever as high as 103.7 degrees F. The patient sought medical attention by phone call. The nurse had spoken with the mother and the patient had recovered on 01-JUN-2009. Follow up information has been received from a licensed practical nurse concerning the patient with no illness at time of vaccination and no pre-existing allergies, birth defects, medical condition who on 28-MAY-2009 at 08:00AM was vaccinated with the first half dose of PNEUMOVAX 23 in the right upper thigh, 0.25 ml. On 29-MAY-2009 at 08:00AM the patient developed rash and a fever as high as 102 degrees F (previously reported as 103.7 degrees F). The patient had recovered on 02-JUN-2009 (previously reported as 01-JUN-2009). No further information is available.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema
Clinical narrative: Information has been received from a physician concerning a 40 year old female patient with breast cancer, hepatitis c and leukocytosis and a history of splenectomy who in approximately October 2009, was vaccinated with a second dose of PNEUMOVAX 23 (Lot # not provided). The physician stated that the patient received the second dose of PNEUMOVAX 23 one month ago and soon afterward developed a red spot and a temperature of 102 degrees. It was not specified if the red spot was at the injection site or not. The patient was admitted to the hospital where was given an intravenous unspecified antibiotic, and soon afterward she recovered. Follow up information has been received from the physician concerning this patient. It was reported that the patient was 46 year old (previously reported as 40 years old). The vaccine was administered on 20-OCT-2009, IM left deltoid (Lot # unknown) at 12:15 pm. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative, Urine analysis abnormal
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot number not reported). Subsequently the patient failed to developed proper titer. At the time of reporting the patient outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning her mother who was vaccinated with a dose of PNEUMOVAX 23 approximately 5 years ago. It was unknown if the patient had a reaction to that dose. The patient also received a dose of PNEUMOVAX 23 approximately 1 year ago. The patient had a significant injection site reaction including cellulitis. The patient sought medical attention. At the report time the patient had recovered. No further information is available.
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray, Injection site cellulitis, Injection site reaction, Injection site swelling, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a 7 year old male patient with chronic sinusitis, asthma, low immunoglobulin and immunocompromized who on approximately 18-NOV-2009 (18-NOV-2009 or 19-NOV-2009) was vaccinated with PNEUMOVAX 23 (Lot # not provided). Concomitant therapy included montelukast sodium (MSD), SYMBICORT, FLONASE and BACTRIM. The physician reported that the patient received PNEUMOVAX 23 and on 19-NOV-2009 experienced an injection site reaction with cellulitis. The patient was treated with BENADRYL. The patient was admitted to the hospital on 23-NOV-2009 when there was no improvement. He has been treated with 2 doses of IV vancomycin but the area of the arm has increased in size with increased swelling, afebrile, White count was 8.3. It was not known if the patient received PNEUMOVAX 23 prior to this. Patient remained in the hospital. Chest x-rays were performed without results. Injection site reaction and cellulitis were considered to be an other important medical event by the physician. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning two male patients who on 17-JUN-2009 were subcutaneously vaccinated with PNEUMOVAX 23. Subsequently the patients developed cellulitis in the injection arm. The patients were seen on 20-JUN-2009 and the diagnosis was confirmed. The patients were not recovered at the time of reporting. Follow-up information was received from the pharmacist. The pharmacist provided the lot number 662840/1577X but clearly stated that after talking to her supervisor, the name of the patient would not be provided. This is one of several reports from the same source. No further information was available.