chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.71
Sex: M
Vaccine: DTPIHI
Symptoms: Crying, Pyrexia
Clinical narrative: 6/13/06, Pt caregiver brings client in for recheck and c/o last visit for immunizations ran 104 and up fever, inconsolable crying and screaming. Provider feels this is pertussis reaction.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received DTAP at the PHD, 2 days prior to being seen in our office. Came to office with left shoulder, red and swollen, tender to touch.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Injection site urticaria, Nausea, Pruritus
Clinical narrative: Approximately, 20 minutes after receiving MMR vaccine, pt c/o itching all over and nausea. Urticaria found at injection site and her abdomen. Pt was taken to her PMD and received "an injection" and diphenhydramine capsules. Client states sx resolved within an hour and was released.
Age: 2.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Got chickenpox. Already had vaccine.
Age: 1.26
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Got chickenpox. Already had vaccine.
Age: 1.01
Sex: M
Vaccine: MMR, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 7 1/2cm (3") area of erythema R proximal arm where Prevnar was given. No tenderness, a little warm.
Age: 5.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Rash
Clinical narrative: Rash on face.
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Dehydration, Diarrhoea, Febrile convulsion, Otitis media, Vomiting
Clinical narrative: Pt received vaccines (DTAP, PedvaxHIB, MMR and Varivax) on 3/16/06 in MD office. Pt was seen on 3/18/06 for seizure with fever, vomiting and diarrhea X 12. Seen again 3/19/06 at ER for dehydration/vomiting. 3/27/06, Pt had another seizure with fever 102.6. Dx'd with ROM. 5/25/06 Pt had another seizure with fever 103. Pt being evaluated for seizures.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Papular vesicular rash on trunk, approximately 10 lesions.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria within 1 hours of vaccine. Treated with Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Swelling to R thigh by the time pt got home from the clinic. Pt with warmth, swelling and pain in R thigh. R knee swollen as well. No erythema. Tylenol, ibuprofen, etc to area. (Recovering). Saw pt the next day. Swelling still apparent in joint, etc.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rec'd MMR and Varivax 5/31/06. Rash over entire body on 6/9. No fever. Still has prominent rash on face, body and extremities but father states it looks better today. Has given Benadryl.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, VARCEL
Symptoms: Bacterial infection, Injection site reaction
Clinical narrative: Pt developed impetigo at injection site of Comvax. Started on antibiotic. Presented 6/14/06.
Age: 0.79
Sex: M
Vaccine: HEP
Symptoms: Erythema, Injection site reaction, Urticaria
Clinical narrative: Between one to two hours after Hepatitis B vaccine was given in the office, patient developed redness/urticaria all over face while eating baby food given by parents (baby had that baby food many times before).  Baby was brought back to our medical office, baby was then given benadryl.  Baby was sent home and later received several other doses of benadryl as directed.  Baby also has slight local reaction at the injection site.  Patient was seen in the office the next day, most symptoms subsided.  Mother was instructed to put cool compress on injection site.  Phone follow-up on the following day reveals almost complete resolution of symptoms according to mother. Today, mothers says over the phone that patient is completely back to normal.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Atrial fibrillation, Cardio-respiratory arrest, Myocardial infarction
Clinical narrative: Patient had M.I. No known history of illness. Received records from county health department with no new info. 7/13/06 Received old medical records from prior hospital visits which reveal patient was a smoker & had hx of back pain.  Chest pain dx as costochondritis & also intermittent atrial fibrillation.  Cardiac enzymes were neg. 8/18/06 Received ER medical records which revealed patient had been found by family member & had been down for approx 45 min prior to arrival in ER.  Was in full arrest upon arrival & resuscitation was unsuccessful. 8/18/06 Received Death Certificate which revealed COD as acute MI/ss
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Candidiasis, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: Reported on 12 Nov 05-Sore throat, fever, headache, myalgias, diarrhea, cough, diarrhea, fatigue.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Reported on 12 Nov 05-Sore throat, fever, headache, myalgias, diarrhea, cough, diarrhea, fatigue.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Balance disorder, Convulsion, Hemiparesis, Staring, Tremor
Clinical narrative: Patient developed a seizure without fever consisting of one sided arm and leg shaking with staring and head turning to same side for 1-2 minutes.  This was followed by 10 minutes of poor balance on sitting/weakness on that side.  This occurred the night after the patient received DTaP, HiB, PCV, IPV, HepB vaccines.
Age: 34.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Pruritus, Shoulder pain, Tenderness
Clinical narrative: Presented to Medical Treatment Facility on 6/14/06 c/o L shoulder pain related to reaction to anthrax immunization. L shoulder with 34.5cm redness and L bicep with 30cm of redness. Area tender to touch and pruritic. Diagnosed as severe local reaction to anthrax immunization. Quarters x 24 hours, Z pack, and Benadryl ordered. RTC prn.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Skin nodule, Tenderness
Clinical narrative: Patient presented with lump on L clavicle that started on 6/11/06. Received Smallpox vaccination on 6/7/06. Lump tender to touch. 2cm circumcised lesion palpated. ROM within normal limits. Ibuprofen 800mg tid with food, ice to affected area prn.
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth, Obesity
Clinical narrative: Heat and swelling in left deltoid with possible surface blistering in an approx 5 cm area around injection site, this blistering occured on day 2 after injection.  Patient is an obese 5 yr old and after injection some vaccine oozed to surface of arm.  Pt recieved DTaP to left Deltoid where reaction occured.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: High-pitched crying, Irritability, Pyrexia
Clinical narrative: Post Vaccination Child became irritable high pitch crying for 2 days- high fever reported by parents.
Age: 1.24
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: FNP contacted local county health department and reported toddler non temperature of 100 degree F next day and by weekend temp was 105 degree F.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 11cm X 7cm red induration with moderate tenderness, warm to touch. Injections were given 6/12/06.
Age: 67.0
Sex: F
Vaccine: JEV
Symptoms: Injection site erythema, Injection site nodule, Injection site rash, Petechiae, Rash pruritic
Clinical narrative: Pt noted some redness and tenderness of upper right arm following receipt of her 1st JEV vaccination and 05/17/06, but not additional symptoms recalled). Around 2 weeks following her 2nd JEV vaccine (5/24/06), she noted a rash which started on her left arm. She described the rash as starting as redness like a sunburn and then developing red bumps-whelps. Red bumps appear suddenly and resolve within hours; they have appeared on and off for over 6 weeks, primarily on her arms, chest and legs. Most of the time the rash is pruritic. Also notes some petechiae type lesions on her legs that she says are new and not normally there. Denies associated signs and symptoms such as rhinorrhea, wheezing or breathing difficulties, angioedema, headaches, metallic taste, diarrhea or vomiting, hoarseness, cough or tightness of throat. Denies new or unusual foods prior to onset of rash. Denies personal history of asthma, eczema, or environmental or food allergies; specifically denies gelatin allergy.
Age: 67.0
Sex: F
Vaccine: JEV
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Pt noted some redness and tenderness of upper right arm following receipt of her 1st JEV vaccination and 05/17/06, but not additional symptoms recalled). Around 2 weeks following her 2nd JEV vaccine (5/24/06), she noted a rash which started on her left arm. She described the rash as starting as redness like a sunburn and then developing red bumps-whelps. Red bumps appear suddenly and resolve within hours; they have appeared on and off for over 6 weeks, primarily on her arms, chest and legs. Most of the time the rash is pruritic. Also notes some petechiae type lesions on her legs that she says are new and not normally there. Denies associated signs and symptoms such as rhinorrhea, wheezing or breathing difficulties, angioedema, headaches, metallic taste, diarrhea or vomiting, hoarseness, cough or tightness of throat. Denies new or unusual foods prior to onset of rash. Denies personal history of asthma, eczema, or environmental or food allergies; specifically denies gelatin allergy.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Livedo reticularis, Pyrexia
Clinical narrative: Red, hard, mottled area left thigh, temp 101 (day 1- day 10) painful. No abscess, no antibiotics used or needed.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pallor, Pyrexia, Rash maculo-papular
Clinical narrative: Pt has diffuse erythematous maculopapular rash with fever, all over body, pale, extremities including palms and soles, after took 6/16/06 ///.
Sex: U
Vaccine: UNK, MMR
Symptoms: Rash
Clinical narrative: Rash noted yesterday over bilateral upper arm and bilateral thighs. No fever, no URI sx, no conjunctivitis.
Age: 33.0
Sex: F
Vaccine: UNK, MMR
Symptoms: Rash
Clinical narrative: Rash noted yesterday over bilateral upper arm and bilateral thighs no fever no uri sx no complaints.
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Dysphagia, Hypersensitivity, Injection site erythema, Pharyngeal oedema, Subcutaneous nodule
Clinical narrative: Immunization given @ approx. 9:00am on 04/13/06 swelling of neck, tongue and throat at 10:30pm on 04/13/06 in E.R. 11:15pm given IV solumedrol, IV Benadryl, (sub q) epinephrine and showed significant improvement within 1-2 hours. Hospitalized overnight, discharged, symptoms returned 04/23/06 treated in E.R. and discharged, symptoms resolved. 06/27/2006-3 page DC Summary and 10 page ED report received from Bay Regional Medical Center-DC DX: acute allergic reaction probably secondary to immunizations.  ED report documented patient noted to have swelling of neck, tongue and throat. Onset 10:30 p.m. the evening of 4/13/06 (date of vaccination). Onset abrupt and worsening to point that his tongue would not even fit in his mouth. Patient stated he could not swallow but had no difficulty breathing. RX in ED included IV Solu-Medrol 100 mg and subsequent 40mg IV, and Benadryl, epinephrine 0.3mg SQ. Observed in ED for 2 hours, swelling decreasing, admitted for observation. Physical exam revealed little redness around the site of the immunizations but not marked. No known allergies, avoid aspirin and anti inflammatories due to hemophilia. Temperature in ED 99, tonsils 2+ without inflammation. Small less than 1 cm nodes scattered across the anterior and posterior chains of the neck. Remainder of physical exam normal. DC instructions included Medrol Dosepak and Benadryl OTC to obtain at local pharmacy. krk
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Tongue oedema
Clinical narrative: Immunization given @ approx. 9:00am on 04/13/06 swelling of neck, tongue and throat at 10:30pm on 04/13/06 in E.R. 11:15pm given IV solumedrol, IV Benadryl, (sub q) epinephrine and showed significant improvement within 1-2 hours. Hospitalized overnight, discharged, symptoms returned 04/23/06 treated in E.R. and discharged, symptoms resolved. 06/27/2006-3 page DC Summary and 10 page ED report received from Bay Regional Medical Center-DC DX: acute allergic reaction probably secondary to immunizations.  ED report documented patient noted to have swelling of neck, tongue and throat. Onset 10:30 p.m. the evening of 4/13/06 (date of vaccination). Onset abrupt and worsening to point that his tongue would not even fit in his mouth. Patient stated he could not swallow but had no difficulty breathing. RX in ED included IV Solu-Medrol 100 mg and subsequent 40mg IV, and Benadryl, epinephrine 0.3mg SQ. Observed in ED for 2 hours, swelling decreasing, admitted for observation. Physical exam revealed little redness around the site of the immunizations but not marked. No known allergies, avoid aspirin and anti inflammatories due to hemophilia. Temperature in ED 99, tonsils 2+ without inflammation. Small less than 1 cm nodes scattered across the anterior and posterior chains of the neck. Remainder of physical exam normal. DC instructions included Medrol Dosepak and Benadryl OTC to obtain at local pharmacy. krk
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Oedema, Pharyngeal oedema, Tongue oedema
Clinical narrative: Immunization given @ approx. 9:00am on 04/13/06 swelling of neck, tongue and throat at 10:30pm on 04/13/06 in E.R. 11:15pm given IV solumedrol, IV Benadryl, (sub q) epinephrine and showed significant improvement within 1-2 hours. Hospitalized overnight, discharged, symptoms returned 04/23/06 treated in E.R. and discharged, symptoms resolved. 06/27/2006-3 page DC Summary and 10 page ED report received from Bay Regional Medical Center-DC DX: acute allergic reaction probably secondary to immunizations.  ED report documented patient noted to have swelling of neck, tongue and throat. Onset 10:30 p.m. the evening of 4/13/06 (date of vaccination). Onset abrupt and worsening to point that his tongue would not even fit in his mouth. Patient stated he could not swallow but had no difficulty breathing. RX in ED included IV Solu-Medrol 100 mg and subsequent 40mg IV, and Benadryl, epinephrine 0.3mg SQ. Observed in ED for 2 hours, swelling decreasing, admitted for observation. Physical exam revealed little redness around the site of the immunizations but not marked. No known allergies, avoid aspirin and anti inflammatories due to hemophilia. Temperature in ED 99, tonsils 2+ without inflammation. Small less than 1 cm nodes scattered across the anterior and posterior chains of the neck. Remainder of physical exam normal. DC instructions included Medrol Dosepak and Benadryl OTC to obtain at local pharmacy. krk
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site warmth, Oedema
Clinical narrative: Left thigh-redness, warmth swollen.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Injection site erythema, Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: ADACEL vaccine given on 6/13/06 to right arm. By 6/16/06 had pain erythema itching right arm within 1 day had cough. Was not seen in ER was seen today in outpatient clinic
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Received 3 vaccinations about 1145hrs. Within 75 minutes returned to clinic with hives to axilla bilaterally, to abdomen, and to popliteal fossa. Was given 1 tsp of Claritin children's syrup at return to office and prescription for orapred. Advised to use benadryl for itching. Follow-up phone call 2 hr after leaving office, father states child sleeping after cool bath; no trouble breathing and lessing of rash, despite not having given orapred or benadryl.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Grand mal convulsion
Clinical narrative: Taken to local hospital for a grand mal seizure post vaccine administration.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: MD reported that patient received vaccination within 2 years of previous shot and had diffuse immunological reaction to left arm with red swollen tender hot area,  "immunological memory".  6/16 arm better; less red, less swollen; positive antineutrophil cytoplasmic antibody
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Dyspnoea, Pruritus, Rash macular, Throat tightness
Clinical narrative: Pharmacy tech who was given a dose of MMR due to recent Mumps outbreak.  She reports no previous history of adverse reactions to the vaccine but about 40 minutes after the vaccine she started itching in the palms.  She reports being itchy and having blotchy skin and feeling warm.  She started to drive and then she started having shortness of breath and feeling tight in the throat.  She also reports some stomach cramps and reported to the allergy clinic.  No recent ingestion of foods.  No other medications.
Age: 4.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Condition aggravated, Febrile convulsion
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR. Subsequently, the patient experienced an unspecified adverse experience. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been received on 6/13/06 from a physician concerning a 4 year old white female patient who on 3/29/06 at 13:00, was vaccinated SC with a second dose of MMR (lot # 649677/0291R). It was reported that at the time of vaccination, the patient had a fever of 102.7 degrees F. Subsequently, in the morning of 3/30/06, the patient experienced a grand mal seizure. Medical attention was sought and an MRI of the brain was done with negative results. The physician reported that the patient recovered as of 3/30/06. Upon internal review, the grand mal seizure was determined to be an other important medical event (OMIC). No further information is provided.
Age: 4.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR. Subsequently, the patient experienced an unspecified adverse experience. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been received on 6/13/06 from a physician concerning a 4 year old white female patient who on 3/29/06 at 13:00, was vaccinated SC with a second dose of MMR (lot # 649677/0291R). It was reported that at the time of vaccination, the patient had a fever of 102.7 degrees F. Subsequently, in the morning of 3/30/06, the patient experienced a grand mal seizure. Medical attention was sought and an MRI of the brain was done with negative results. The physician reported that the patient recovered as of 3/30/06. Upon internal review, the grand mal seizure was determined to be an other important medical event (OMIC). No further information is provided.
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Dysphagia, Hypersensitivity, Injection site erythema, Pharyngeal oedema, Subcutaneous nodule
Clinical narrative: Immunization at 9 AM 4/13/06, swelling of neck, tongue, throat at 10:30PM 4/13/06. ER 11:15PM given IV Solumedrol. IV Benadryl, 2 epi, significantly improved within 1-2 hrs. Hospitalized over night, discharged, symptoms returned 4/23/06, treated ER, discharged, symptoms resolved.
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Tongue oedema
Clinical narrative: Immunization at 9 AM 4/13/06, swelling of neck, tongue, throat at 10:30PM 4/13/06. ER 11:15PM given IV Solumedrol. IV Benadryl, 2 epi, significantly improved within 1-2 hrs. Hospitalized over night, discharged, symptoms returned 4/23/06, treated ER, discharged, symptoms resolved.
Age: 13.0
Sex: M
Vaccine: TD, TD
Symptoms: Oedema, Pharyngeal oedema, Tongue oedema
Clinical narrative: Immunization at 9 AM 4/13/06, swelling of neck, tongue, throat at 10:30PM 4/13/06. ER 11:15PM given IV Solumedrol. IV Benadryl, 2 epi, significantly improved within 1-2 hrs. Hospitalized over night, discharged, symptoms returned 4/23/06, treated ER, discharged, symptoms resolved.
Age: 54.0
Sex: F
Vaccine: HEP, TYP, YF
Symptoms: Injection site erythema
Clinical narrative: Pt reported blotchy redness at site of injection of Yellow Fever vaccine. No swelling or bumps. Approx. size 4.5cm wide, 2-3cm long. Pt noticed site on same day of vaccination 6/5/06. No general ill feelings noted. F/U on 6/14/06, no s/s present.
Age: 7.0
Sex: M
Vaccine: MNQ, TYP, YF
Symptoms: Chills, Oedema peripheral
Clinical narrative: Pt developed marked L perio-intal edema within 1 hr of vaccinations. He complained also of chills but highest temperature 37.1. Improving at this time.
Age: 1.45
Sex: M
Vaccine: MMR
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician concerning an 18 month old male who in approx June 1985, was vaccinated SC with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. In approx June 1985, the pt experienced an arthritic reaction. Subsequently, the pt recovered from arthritic reaction, however it was unk how long it took before the arthritic reaction went away. No further information was available. There was no product quality complaint. Arthritic reaction was considered to be disabling by the physician. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Autism, Convulsion, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 18 yr old niece who was vaccinated SC with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot unk). There was no concomitant medication. Subsequently, shortly after vaccination, the pt developed a high fever and seizures. The pt was diagnosed with Ashberger's. Unspecified autism testing was done (results not reported). Unspecified medical attention was sought. The outcome was reported as not recovered. No additional information was available. There was no product quality complaint. Upon internal review, seizures and Ashberger's were considered to be other important medical events (OMIC). No additional information was available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: Information has been received from a 66 year old female consumer with history of reaction to [loratadine] (CLARITIN) and IgA who 8 years ago was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Subsequently, three and a half years ago, the patient reportedly was not immune and experienced pneumonia. She reportedly received two other doses of pneumococcal 23v polysaccharide vaccine after she was hospitalized. At the time of the report, the patient was considered to be not recovered. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Lacrimation increased, Urticaria
Clinical narrative: Information has been received from a RN concerning a 4 yr old male with eczema who on 05Jun06 was vaccinated SC in the left arm with a 0.5mL second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live at 15 months of age. There was no concomitant medication. On 05Jun06, within 5 minutes of vaccination, the pt became teary eyed, developed hives, and became short of breath. He was treated in the office with dexamethasone and diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered. No other information was available. The nurse requested a lot check on Lot653317/0211F. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. The nurse considered the events to be other important medical events (OMIC). Additional information has been requested.
Sex: M
Vaccine: HIBV, PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a consumer, a relative of a male patient who received a dose on an unspecified date along with a dose of Prevnar also administered on an unspecified date. The patient was reported as being mildly autistic. Relevant medical history was not provided. Indication for Hib-Titer Vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included Prevnar. Concomitant medications were not reported. On unspecified dates, the patient received a dose of Hib-Titer and a dose of Prevnar. On 6/13/06, the patient was reported as being mildly autistic. The onset date of the event was not reported. The patient's outcome is unknown. No additional information was available at the time of this report.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Paraesthesia, Swelling face
Clinical narrative: Pt reports the development of patchy areas around his chin where hair was not growing back since his anthrax shot of Dec2004/Jan05. Pt noticed his beard hair problem since mid Feb 2005. Pt also described the development of recurring right outer lower or upper lip swelling and tingling for the past several months. No sore throat or painful swallowing reported. Alopecia (hair loss) Start: 02/2005 End: 11/2005.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling under left arm to chest muscle. Some edema, slight redness to skin. No infection. One swollen gland under arm, slight tenderness. No fever.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Erythema, Lymphadenopathy, Oedema, Swelling, Tenderness
Clinical narrative: Swelling under left arm to chest muscle. Some edema, slight redness to skin. No infection. One swollen gland under arm, slight tenderness. No fever.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Back pain, Depression, Diabetes mellitus, Hypertension
Clinical narrative: Thyroid, skin rash, pruritus ani, insomnia, back pain, depression, diabetes, high blood pressure, joint aches, etc. For more information contact hospital.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Insomnia, Pruritus, Rash, Thyroid disorder
Clinical narrative: Thyroid, skin rash, pruritus ani, insomnia, back pain, depression, diabetes, high blood pressure, joint aches, etc. For more information contact hospital.
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Erythema around shot site. No tenderness.
Age: 19.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Heart rate increased, Tremor
Clinical narrative: Pt began experiencing involuntary shaking of her right hand 22 hours after the vaccine administration. She's also reporting a pulsating sensation from her hand up to her right forearm.
Age: 1.03
Sex: M
Vaccine: MMRV
Symptoms: Febrile convulsion
Clinical narrative: Fever started on 6/14/06. Fever persisted through 6/16/06. At approximately 20:00 on 6/15/06, had a tonic/clonic seizure lasting 10 seconds with fever. Went to ER. Temp 106.1 in ER.
Age: 11.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Pt started with red rash to entire body accompanied by itching.
Age: 18.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Dizziness, Musculoskeletal stiffness, Nausea, Syncope, Vomiting
Clinical narrative: Vaccinated about 8:10 AM. Approx. 8:15, student stated that she felt dizzy. She was sitting down and began to faint. Eased child to lay down on bench. Body stiffened for about1 sec. Rested on bench with feet up for a few minutes. School doctor was paged at this time and twice more in the course of the incident. Awake, alert and oriented to PPT. Child then sat up and felt nauseated and vomited X 2. Child brought back to clinic room to rest. Father present. Child ambulatory. Rested 20 more minutes or so. She felt better and wanted to leave. Father advised to call PMD and our clinic number given if he had further questions. The father was advised to take the student to ER anyway. but he said she was at home and doing fine.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: BLANK
Age: 1.06
Sex: M
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Diarrhoea, Irritability, Nausea, Pyrexia, Tremor
Clinical narrative: 103 temp, fussy, n/v/d X 2-3 days. Parents stated "shaking head against things like his head was hurting".
Age: 1.06
Sex: M
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: 103 temp, fussy, n/v/d X 2-3 days. Parents stated "shaking head against things like his head was hurting".
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Apparent allergic reaction to Proquad. Area of erythema approx. 4cm with induration (hive) approx. 1cm at site of injection. Appeared within 5 min. of immunization being given L arm. Given 12.5mg Benadryl po and gradual dissipation in size of induration. (Local allergic reaction).
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Knot at site of injection. Tender to touch. Redness.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling and itching at site of injection.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Hives <24 hrs after vaccine admin.
Age: 0.68
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: Urticarial-like rash with low-grade fever. R/o HSP/SBI.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: MMR, DTAP, IPV and Hep-A administered at 14:00 on 6/12/06 and nurse noted redness on L thigh. 6/12/06 (19:00)-6 inch diameter red, warm induration noted. 6/14/06-non-tender.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis upper limb (left), redness, swelling, very hot to touch. On Septra 200mg/5ml (1 1/2 tsp Bid X 10 days). Benadryl Syrup PRN. (Probably reaction to DTAP).
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema
Clinical narrative: Area redness on
Age: 1.01
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: 8 days after receiving shots, pt began a high fever (to 103) and rash on trunk and limbs.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: "Bright red, swollen, hot lump on arm (8cm X 8cm X 9cm)-not especially tender."
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pruritus, Rash, Rash maculo-papular
Clinical narrative: 1 day history of itching rash to face and upper back. Small 2mm maculopapular area noted c/w Varicella. OTC Benadryl.
Age: 1.16
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: MMR given 5/10/06. Pt brought in 5/15/06 with report of severe hives on following day, Thursday, Friday and Saturday. Provider Dx: Delayed hypersensitivity to MMR. Event unreported, found during chart reviews.
Age: 0.08
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling face, Urticaria, Wheezing
Clinical narrative: Hives, facial swelling, wheezing within 1 hour of vaccine administration.
Age: 32.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Pt called to report that 24 hrs after receiving TD injection, she developed swelling, raised rash, itch/pruritis, redness and pain at injection site. Symptoms were ongoing for more than 3 weeks. Pt reports 32 days after symptoms presented, she sough medical care for pain. Received prescription for ibuprofen per pt report.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Has cellulitis from injections, red, developed day after shots, given Zithromax.
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Injury
Clinical narrative: Rec'd. bad cut, contusion to R ankle on 6/10/06. To ER for X-ray and tx. No break just tendon tear. Splint to R ankle and TD booster given. 6/11/06 evening observed small knot at injection site. By 6/12/06 evening, area increased 3 X prior size, red, hot upper arm, severely swollen. Returned to ER. Script for cefalexin. Advised to call health dept to report incident.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Given Td on 6/11/06 after fish hook accident to ear. 30 minutes after injection, felt chest tightness, shortness of breath, worsened throughout week - presented on 6/15/05 to clinic; increased shortness of breath and pain to chest - no congestion or fever noted. Treatment with Pecadion and sent home. Return if needed.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Pruritus, Rash maculo-papular
Clinical narrative: Patient developed raised, erythematous well circumscribed lesion on right lateral thigh at site of varicella injection. Mom reported that patient has been scratching area. Area was also hot and had palpable macules within confluent erythema. Patient also had 3 macular papular lesions on right cheek and chin. Lesion on chin had vesicle-like center.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Patient developed raised, erythematous well circumscribed lesion on right lateral thigh at site of varicella injection. Mom reported that patient has been scratching area. Area was also hot and had palpable macules within confluent erythema. Patient also had 3 macular papular lesions on right cheek and chin. Lesion on chin had vesicle-like center.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash
Clinical narrative: Red, raised bumps to trunk of body within an hour of receiving immunizations. Treated with Benadryl by mouth.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness in upper left arm, 5cm width x4cm length for 3 days where the DTaP was given.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: Approximately 1.5 hours after injection, patient began having right arm pain and headache over the next few hours. Patient began having 102 fever, nausea, aching, and headache became worse. Patient was unable to get out of bed for 4 days. 6 days after injection, patient still had a headache. By the 7th day, headache went away. Patient also complained of nausea, diarrhea, and abdominal cramping for 5 days.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Approximately 1.5 hours after injection, patient began having right arm pain and headache over the next few hours. Patient began having 102 fever, nausea, aching, and headache became worse. Patient was unable to get out of bed for 4 days. 6 days after injection, patient still had a headache. By the 7th day, headache went away. Patient also complained of nausea, diarrhea, and abdominal cramping for 5 days.
Age: 91.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Left upper extremity cellulitis developed over a 4-5 day period following the injection.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Vaccines given IM approximately 3:00 PM 6/12/06. Per mom, persistent fever, irritability started within 10-15 minutes of vaccine completions. Fever became somewhat persistent through evening with temp max of 102+. Trin qq+ until broke approximately 1:30 PM 6/13/06. Continued irritability throughout. Mom gave PO Motrin drops, massaged sites with cold compresses.
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Cellulitis, Injection site abscess, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: The day after she received vaccination, she started developing erythema and swelling on the site of injection, which became tender, and started spreading slowly over deltoid area. When seen 3 days after vaccination, had cellulitis developed on right deltoid area, 3 fluctuation/abscess. I do not believe this was a reaction of vaccine per se, as any injection can break skin and become a site of entry to S. aureus infection.
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Injection site swelling
Clinical narrative: The day after she received vaccination, she started developing erythema and swelling on the site of injection, which became tender, and started spreading slowly over deltoid area. When seen 3 days after vaccination, had cellulitis developed on right deltoid area, 3 fluctuation/abscess. I do not believe this was a reaction of vaccine per se, as any injection can break skin and become a site of entry to S. aureus infection.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient received tetanus booster in ER after cat bite. Had nausea, weakness 24 hours after. Then right deltoid site red and hot. Came to PCP's office. 6/15/06 Follow up via phone: not as red or swollen; itchy and peeling but better.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Pruritus
Clinical narrative: Patient received tetanus booster in ER after cat bite. Had nausea, weakness 24 hours after. Then right deltoid site red and hot. Came to PCP's office. 6/15/06 Follow up via phone: not as red or swollen; itchy and peeling but better.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Seen 6/9/06 at office; rash on legs, trunk and arms. No new exposures but received Hep A 6/6/06. Rash began 6/7/06; no fever, chills.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Red, swollen, painful knot the size of a quarter where shot was given in the left arm. Advised warm compresses to area and give Benadryl. Call office if area becomes infected.
Age: 1.02
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: About 4cmx3cm area of erythema on thigh just distal to injection site. Began about 24 hours after immunization. Treated with Keflex, Bactroban, and warm compresses.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left outer thigh - large area of redness 8-10cm, area of induration 6-8cm. Area of shot administration.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Left upper leg red, swollen, warm to touch.
Age: 0.88
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: Mother reported child had hives and 101 temp after 1st set of immunizations when she returned for 2nd set in May. Child referred to MD for follow up immunizations. Vaccine transferred to MD and at that time has received DTaP. No problem other than slight fever.
Age: 0.18
Sex: F
Vaccine: HIBV, PNC
Symptoms: Apnoea, Bradycardia, Decreased appetite, Lethargy, Livedo reticularis
Clinical narrative: Patient developed increasing apnea and bradycardia requiring intubation.  Patient had decreased appetite and became pale, mottled and lethargic.  Temp max at onset of symptoms: 38.4 C.  Infection ruled out (no positive blood cultures, but chest x-ray was hazy).  Recovered in ~3 days.
Age: 0.18
Sex: F
Vaccine: HIBV, PNC
Symptoms: Pallor, Pyrexia
Clinical narrative: Patient developed increasing apnea and bradycardia requiring intubation.  Patient had decreased appetite and became pale, mottled and lethargic.  Temp max at onset of symptoms: 38.4 C.  Infection ruled out (no positive blood cultures, but chest x-ray was hazy).  Recovered in ~3 days.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Visual disturbance
Clinical narrative: Nausea, headache, dizziness and visual problems on 6-19-06 referred to hospital er.
Age: 1.4
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Aphasia, Aphasia, Ataxia, Audiogram normal, Autism
Clinical narrative: Fever and illness following vaccines.  Grand mal seizure requiring paramedic recessutation. More seizures in emergency room. LOSS of SPEECH and autistic like behavior. 8/3/06-DC Summary 4/18-4/19/02 DC DX: Seizure             Gastroenteritis HX Present Illness: emesis and diarrhea for approximately 5 days and fever up to 103 at home prior to admission. On day of admission she had 2 generalized tonic/clonic type seizures with her eyes rolling back. 1st seizure at home followed by 30 second seizure in ER. Per parent patient had been wobbling and had an unsteady gait over last 3 days prior to admission. PE: Temp 98 pulse 126, alert, playful and in no distress. Neuro exam showed a slightly unsteady gain but was nonfocal. HX of gastroenteritis bacterial enteritis that is Shigella. Follow up neuro office visit 5/20/02: 2 brief unprovoked seizures in close proximity. This as a first time seizure since her seizures were back to back. Her ataxia is most consistent with parainfectious cerebellar ataxia.  Neuro office vitis 4/21/03: One episode prior to this appointment, appeared to be overstimulated or overtired, her eyes appeared dilated and glassy and she had a dazed look, mother left room to get her a drink and upon return she was sleeping on floor and continued to remain limp and slept for several hours. Possible additional episode at her speech pathologist. DX with aphasia with delays of both expressive and receptive language.  Review of symptoms negative.  Per inforrmation received from the 60 day follow up: She suffered from aphasia and required 3 years of speech therapy, OT and tow years of Early Childhood Special Education. She still has some sensory issues but her brain has recovered and she is in a regular kindergarten class. I believe that subjecting babies & toddlers to multiple vaccinations is harmful to many. I've lived in fear and gave her everything possible to heal her from this damage. My opinion after years of personal research and talking with parents of Autistic children is that some children are suscepitable to Autism & a threshold is broken when imunated with multiple vaccines. I wish there were a blood test to identify children at risk and I wish that parents wouldn't be pressued to vaccinate on such a trict schedule. I have vaccinated my youngest son 1 at a time and made sure he was very healthy with each shot. Doctors do not want to get involved so there must be many unreported cases. Our lives were affected by this more that I could ever say and look at the fact that she is just now becoming a statistic. Please research!
Age: 1.4
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Blood creatine phosphokinase normal, CSF glucose normal, CSF protein decreased, Computerised tomogram normal, Convulsion
Clinical narrative: Fever and illness following vaccines.  Grand mal seizure requiring paramedic recessutation. More seizures in emergency room. LOSS of SPEECH and autistic like behavior. 8/3/06-DC Summary 4/18-4/19/02 DC DX: Seizure             Gastroenteritis HX Present Illness: emesis and diarrhea for approximately 5 days and fever up to 103 at home prior to admission. On day of admission she had 2 generalized tonic/clonic type seizures with her eyes rolling back. 1st seizure at home followed by 30 second seizure in ER. Per parent patient had been wobbling and had an unsteady gait over last 3 days prior to admission. PE: Temp 98 pulse 126, alert, playful and in no distress. Neuro exam showed a slightly unsteady gain but was nonfocal. HX of gastroenteritis bacterial enteritis that is Shigella. Follow up neuro office visit 5/20/02: 2 brief unprovoked seizures in close proximity. This as a first time seizure since her seizures were back to back. Her ataxia is most consistent with parainfectious cerebellar ataxia.  Neuro office vitis 4/21/03: One episode prior to this appointment, appeared to be overstimulated or overtired, her eyes appeared dilated and glassy and she had a dazed look, mother left room to get her a drink and upon return she was sleeping on floor and continued to remain limp and slept for several hours. Possible additional episode at her speech pathologist. DX with aphasia with delays of both expressive and receptive language.  Review of symptoms negative.  Per inforrmation received from the 60 day follow up: She suffered from aphasia and required 3 years of speech therapy, OT and tow years of Early Childhood Special Education. She still has some sensory issues but her brain has recovered and she is in a regular kindergarten class. I believe that subjecting babies & toddlers to multiple vaccinations is harmful to many. I've lived in fear and gave her everything possible to heal her from this damage. My opinion after years of personal research and talking with parents of Autistic children is that some children are suscepitable to Autism & a threshold is broken when imunated with multiple vaccines. I wish there were a blood test to identify children at risk and I wish that parents wouldn't be pressued to vaccinate on such a trict schedule. I have vaccinated my youngest son 1 at a time and made sure he was very healthy with each shot. Doctors do not want to get involved so there must be many unreported cases. Our lives were affected by this more that I could ever say and look at the fact that she is just now becoming a statistic. Please research!