chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pruritus, Tenderness
Clinical narrative: This case was reported by a pharmacist and described  the occurrence of swelling injection site in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject's medical history included goldenhar's syndrome and asthma. Concurrent medications included Salbutamol sulphate (Albuterol), Budesonide (Pulmicort) and Glycopyrronium bromide (Glycopyrrolate). On 24Jan06 at 4:00PM, the subject received 4th dose of Infanrix in the right leg (lot AC14B013AA). On 24Jan06, the subject also received injections of inactivated poliomyelitis virus vaccine (Ipol, lot Y0265) and measles mumps and rubella vaccine, strain not specified (MMRII; lot 0464R). The injection sites for the Ipol and MMRII were not provided. On 25Jan06 at 3:00PM, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction at the site of admin of Infanrix characterized as swelling, tenderness, warmth, redness, and pruritis. The subject was seen at a physician's office. At the time of initial reporting 01Feb06 the events were ongoing.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Aggression, Anorexia, Clumsiness, Irritability, Pyrexia
Clinical narrative: Lethargy;clumsiness;decreased appetite;pyrexia; inappropriate schedule of drug administration; irritability Information has been received from a a consumer concerning her 20 month old grandson with no known history or allergies who was vaccinated with a first dose and inadvertently vaccinated with a second dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 16-FEB-2006 and 02-MAR-2006 respectively. There was no concomitant medication. After the second dose on 02-MAR-2006, the patient experienced mild temperature, lethargy and decreased appetite. Additional information was received from the patient's mother who reported that her son was very clumsy and irritable. He has had an intermittent fever. At the time of the report, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's mother reported that he ahs had a reaction (fever and irritable behavior) "to all the vaccines has been administered." The patient developed a large welt on his leg after administration with hepatitis B virus vaccine rHBsAG (yeast) (manufacturer unknown) and Hib conj vaccine (OMPC) (manufacturer unknown) (WAEC #0604USA02116). No further information is available.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Rash, Somnolence
Clinical narrative: Lethargy;clumsiness;decreased appetite;pyrexia; inappropriate schedule of drug administration; irritability Information has been received from a a consumer concerning her 20 month old grandson with no known history or allergies who was vaccinated with a first dose and inadvertently vaccinated with a second dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 16-FEB-2006 and 02-MAR-2006 respectively. There was no concomitant medication. After the second dose on 02-MAR-2006, the patient experienced mild temperature, lethargy and decreased appetite. Additional information was received from the patient's mother who reported that her son was very clumsy and irritable. He has had an intermittent fever. At the time of the report, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's mother reported that he ahs had a reaction (fever and irritable behavior) "to all the vaccines has been administered." The patient developed a large welt on his leg after administration with hepatitis B virus vaccine rHBsAG (yeast) (manufacturer unknown) and Hib conj vaccine (OMPC) (manufacturer unknown) (WAEC #0604USA02116). No further information is available.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Body temperature increased, Clumsiness, Decreased appetite, Irritability, Lethargy
Clinical narrative: Lethargy;clumsiness;decreased appetite;pyrexia; inappropriate schedule of drug administration; irritability Information has been received from a a consumer concerning her 20 month old grandson with no known history or allergies who was vaccinated with a first dose and inadvertently vaccinated with a second dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 16-FEB-2006 and 02-MAR-2006 respectively. There was no concomitant medication. After the second dose on 02-MAR-2006, the patient experienced mild temperature, lethargy and decreased appetite. Additional information was received from the patient's mother who reported that her son was very clumsy and irritable. He has had an intermittent fever. At the time of the report, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's mother reported that he ahs had a reaction (fever and irritable behavior) "to all the vaccines has been administered." The patient developed a large welt on his leg after administration with hepatitis B virus vaccine rHBsAG (yeast) (manufacturer unknown) and Hib conj vaccine (OMPC) (manufacturer unknown) (WAEC #0604USA02116). No further information is available.
Age: 1.7
Sex: M
Vaccine: MMR, MMR
Symptoms: Pyrexia
Clinical narrative: Lethargy;clumsiness;decreased appetite;pyrexia; inappropriate schedule of drug administration; irritability Information has been received from a a consumer concerning her 20 month old grandson with no known history or allergies who was vaccinated with a first dose and inadvertently vaccinated with a second dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 16-FEB-2006 and 02-MAR-2006 respectively. There was no concomitant medication. After the second dose on 02-MAR-2006, the patient experienced mild temperature, lethargy and decreased appetite. Additional information was received from the patient's mother who reported that her son was very clumsy and irritable. He has had an intermittent fever. At the time of the report, the patient had not recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The patient's mother reported that he ahs had a reaction (fever and irritable behavior) "to all the vaccines has been administered." The patient developed a large welt on his leg after administration with hepatitis B virus vaccine rHBsAG (yeast) (manufacturer unknown) and Hib conj vaccine (OMPC) (manufacturer unknown) (WAEC #0604USA02116). No further information is available.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left groin and Inner thigh requiring hosp for 23 hours received IV Clindamycin.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema
Clinical narrative: Both thighs erythematous 5x7 cm extension.
Age: 89.0
Sex: M
Vaccine: FLUX
Symptoms: Hypokinesia, Injection site pain, Medication error
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 5/11/2006 from a health care professional. An 89 year old male patient with an unknown medical history, had received an influenza vaccine in the right deltoid on an unspecified day in Sept 2005. the trade name, manufacturer, lot number, and route of administration were not reported. Within a week of receiving the influenza vaccine, the patient developed right shoulder pain and was unable to move his arm. He required medical evaluation, and was treated with steroid injections. Per the reporter the patients influenza vaccination was administered with a 25g one inch needle and may have been administered higher up on the deltoid near the shoulder joint than in the recommended area of the deltoid muscle. At the time of this report, the patient was in rehabilitation and the range of motion in his right arm was improving. The reporter stated that another patient experienced the same reaction following vaccination, but may have only received pneumococcal vaccine. No patient identification or other details were provided for this second patient.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Cardiac disorder, Dizziness, Dyspnoea, Hypertension
Clinical narrative: A 57 year old male patient, born on 7/11/1948 reported age at time of event 48 years, was vaccinated with the fourth dose of RabAvert on 4/29/2006 due to a cut on his hand which had been exposed to the saliva of a potential rabid calf. On 5/1/2006 he showed very high blood pressure, dizziness, shortness of breath, heart palpitations, low grade fever, weakness and he felt weird (funny). It was reported that he felt weird (funny) after each of the four dosed. The outcome is unknown Company assessment: Seriousness criterion medically significant (OMIC). Causality not related.
Age: 58.0
Sex: M
Vaccine: RAB
Symptoms: Malaise, Palpitations, Pyrexia, Vaccine positive rechallenge
Clinical narrative: A 57 year old male patient, born on 7/11/1948 reported age at time of event 48 years, was vaccinated with the fourth dose of RabAvert on 4/29/2006 due to a cut on his hand which had been exposed to the saliva of a potential rabid calf. On 5/1/2006 he showed very high blood pressure, dizziness, shortness of breath, heart palpitations, low grade fever, weakness and he felt weird (funny). It was reported that he felt weird (funny) after each of the four dosed. The outcome is unknown Company assessment: Seriousness criterion medically significant (OMIC). Causality not related.
Age: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: Given Daptacel instead of Adacel. Daptacel for ages <7 yrs. No reported fever, no unusual soreness at injection site. Pt had no adverse reactions per parents. Thought this was significant to report given vaccine not indicated for his age.
Age: 1.07
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Skin ulcer, Viral infection
Clinical narrative: PRESENTED IN OFFICE WITH >50 LESIONS :DX:VARICELLA. BROKE OUT X 48 HRS AGO. ITCHING ,WATERY LESIONS
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Dry skin, Pruritus, Rash, Skin nodule
Clinical narrative: Mom reported on 5/19/06 that patient experienced a rash on legs after each set of vaccines. "Pruritis with knots." Bilateral thighs with dry raised rash and excoriated areas.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Child received vaccine 05/12/2006 had redness and blisters to area between dtap and mmr not in direct line with vaccine 2 large blisters ruptured and appeared dry 05/16/2006. Child in no distress.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Rash pruritic
Clinical narrative: The patient received Hepatitis A vaccine alone on 5/19/06. Some 30 hours later she developed a pruritic rash over the entire trunk. Her mother gave her diphenhydramine orally and applied a first aid spray.  The next morning the rash was fading and a day later has disappeared. There were no other exposures to medicines, new foods, or stinging insects in the interim.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Pain, Swelling
Clinical narrative: SATURDAY MORNING CLIENT C/O R ARM HURTING. MOM SAID ARM SWOLLEN ABOUT THE SIZE OF TENNIS BALL, RED,& HOT. NO FEVER. NO OTHER SYMPTOMS.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Muscle spasms, Musculoskeletal stiffness, Pain, Sleep disorder
Clinical narrative: Deep pain in upper arm/muscle spasms in back and neck for 2 weeks following shot. (no redness or visible swelling of arm) unable to sleep or move freely without pain. Negatively interfered with all aspects of life, including work (I am a sales rep who drives 900 miles/week).  From 4/28 to now, continuous deep ache in upper arm (feels like in bone area).  Also, neck and back has been stiff, achy and cracking (neck) since date of vaccination. Still cannot lay or lean on right arm - sore to touch.  Still taking pain meds multiple times during day.
Age: 4.0
Sex: M
Vaccine: DTP, MMR
Symptoms: Cellulitis, Oedema, Rash
Clinical narrative: Information has been received from a physicians assistant concerning a 4.5 year old male who on approximately 5/2/2006 was vaccinated SC with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot 649232/0028R). Concomitant therapy included a dose of diphtheria toxoid + pertussis vaccine unspecified + tetanus toxoid. On approximately 5/5/2006, the patient experienced cellulitis, edema and a rash. The patient was hospitalized for an unspecified time frame and was treated with antibiotics and diphenhydramine hydrochloride (Benadryl). A product quality complaint was not involved. Cellulitis, edema, and rash were considered to be other important medical events (OMIC) by the reporter due to treatment with antibiotics and diphenhydramine hydrochloride Benadryl. No further information is available.
Sex: U
Vaccine: DTAP
Symptoms: Lethargy
Clinical narrative: This case was reported by a physician and described the occurrence of lethargy in a subject of unspecified age and gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine for prophylaxis. On an unspecified date before 16May05, the subject received a dose of Dtpa (dose number and lot number not reported). At an unspecified time after vaccination with Dtpa, on an unspecified date on or before 16May06, the subject experienced lethargy. The subject was hospitalized. The outcome of the event was not reported. Report received via manf.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthma, Condition aggravated, Cough, Hypoxia, Rhinorrhoea
Clinical narrative: Pt has history of asthma but no attack x 1 yr. Had runny nose at time of visit but no cough. Within 2 hrs of vaccines had cough, wheezing. Was seen in office spirometry showed severe airway obstruction, 02 sat 92% on room air. Reviewed-5 pages of office notes for 4/28 and 4/29/06, immunization records. Visit with Dr on 4/28/06 documents well 12 year. c/o nasal drainage and 'tick' bite. Returned to office on 4/29/04 1 day after vaccine of Adacel and Menactra-c/o coughing and wheezing since 4/28/06-assessment documents expiratory wheezes throughout, unlabored breathing. History of asthma (no attack in past year)treated with Albuteral inhaler 1 hour prior to office visit.  DC from office visit with RX Prednisone dose pack. DX Wheeze, cough, allergic rhinitis.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Wheezing
Clinical narrative: Pt has history of asthma but no attack x 1 yr. Had runny nose at time of visit but no cough. Within 2 hrs of vaccines had cough, wheezing. Was seen in office spirometry showed severe airway obstruction, 02 sat 92% on room air. Reviewed-5 pages of office notes for 4/28 and 4/29/06, immunization records. Visit with Dr on 4/28/06 documents well 12 year. c/o nasal drainage and 'tick' bite. Returned to office on 4/29/04 1 day after vaccine of Adacel and Menactra-c/o coughing and wheezing since 4/28/06-assessment documents expiratory wheezes throughout, unlabored breathing. History of asthma (no attack in past year)treated with Albuteral inhaler 1 hour prior to office visit.  DC from office visit with RX Prednisone dose pack. DX Wheeze, cough, allergic rhinitis.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Speech disorder
Clinical narrative: 11/05 started having speech difficulty. Hoarse speech ever since.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: CSF test abnormal, Multiple sclerosis, Skin ulcer
Clinical narrative: Multiple sclerosis diagnosed in Feb 2006. Will require chronic therapy.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, MNQ
Symptoms: Laboratory test abnormal, Multiple sclerosis
Clinical narrative: Multiple sclerosis diagnosed in Feb 2006. Will require chronic therapy.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Mom called today, stated pt's arm is very reddened and has a lump where inj was given. Arm is stiff and very sore and swollen. Bruised at inj site.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness
Clinical narrative: Mom called today, stated pt's arm is very reddened and has a lump where inj was given. Arm is stiff and very sore and swollen. Bruised at inj site.
Age: 1.83
Sex: M
Vaccine: PNC, TDAP, VARCEL
Symptoms: Medication error
Clinical narrative: Tetanus Toxoid Reduced Diphtheria toxoid and Acellular pertussis vaccine TDAP Boostrix given to a 22 month old.
Age: 3.0
Sex: F
Vaccine: DTAPH, MMRV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Right leg red and swollen at injection site.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Viral infection
Clinical narrative: Pt vaccinated with Varivax at appropriate age. Presented clinically with chicken pox with multiple vesicles on trunk back, face and extremities.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rec'd 1st dose Hep B at 4:00 pm on May 11th. At 5:30 pm began to itch and soon after broke out in rash on arms and legs. Phoned her physician advised to take Benadryl. On May 12th some urticaria continued and rash continued. May 15th follow up still rash primary upper arm and lower leg.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Patient has chicken pox. First noticed yesterday 5/16/06
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site warmth, Pruritus
Clinical narrative: Itching, redness, warmth by report of pt seen by Dr placed on Benadryl OTC.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Reaction noted on 5/2 lt arm with 14 1/2 x 18 1/2 cm erythema around lt deltoid with 3cm induration.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Face oedema, Pruritus, Urticaria
Clinical narrative: Lips swelling, hives, itching.
Age: 1.0
Sex: F
Vaccine: DTAPH, HEPA, MMR, PNC, VARCEL
Symptoms: Purpura, Rash
Clinical narrative: Generalized purpura rash developed 2 days after vaccines.
Age: 10.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme on day after received 1st Hep A. No meds No URI sx or other evidence of infection.
Age: 10.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Rash pruritic
Clinical narrative: Erythema multiforme on day after received 1st Hep A. No meds No URI sx or other evidence of infection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Edema, warm to touch, red and tender.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 4 year old male received DTaP, IPV left leg on Tuesday 5/9/2006 and developed local erythema, mild swelling at injection site. Area of erythema 6 cm Diameter. no F/C no neurovascular compromise.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Agitation, Anxiety, Asthenia, Condition aggravated
Clinical narrative: Patient did report anxiety with shots in the par, wanted MMR anyway. Immediately after injection was given she c/o ringing in her ears, lightheaded and blurry vision. She was then sweaty, cool, abdominal cramps, then diarrhea. Patient unable to sit still throughout, skin pale, warm, dry. TC to DR with update observe for 30 mins with return TC to DR to report no difficulty with breathing ore swallowing, patient feeling OK. Mother and father have calmed her down. Patient came into our office with her step father, she was crying. Stated she things she is having a reaction to MMR vaccine. Very anxious C/o of weakness, cramps, however no SE at this time. Pt denied any stiffness, rash and no swelling of glands. She continues to cry. Step father and pt stated that she dose have anxiety and panic attacks. Was referred to her DR and an appointment was made for this afternoon. 5/11/06 TC from her DR she never showed for her appointment.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Diarrhoea, Dizziness, Dry skin, Feeling hot
Clinical narrative: Patient did report anxiety with shots in the par, wanted MMR anyway. Immediately after injection was given she c/o ringing in her ears, lightheaded and blurry vision. She was then sweaty, cool, abdominal cramps, then diarrhea. Patient unable to sit still throughout, skin pale, warm, dry. TC to DR with update observe for 30 mins with return TC to DR to report no difficulty with breathing ore swallowing, patient feeling OK. Mother and father have calmed her down. Patient came into our office with her step father, she was crying. Stated she things she is having a reaction to MMR vaccine. Very anxious C/o of weakness, cramps, however no SE at this time. Pt denied any stiffness, rash and no swelling of glands. She continues to cry. Step father and pt stated that she dose have anxiety and panic attacks. Was referred to her DR and an appointment was made for this afternoon. 5/11/06 TC from her DR she never showed for her appointment.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Hyperhidrosis, Pallor, Panic reaction, Peripheral coldness, Psychomotor hyperactivity
Clinical narrative: Patient did report anxiety with shots in the par, wanted MMR anyway. Immediately after injection was given she c/o ringing in her ears, lightheaded and blurry vision. She was then sweaty, cool, abdominal cramps, then diarrhea. Patient unable to sit still throughout, skin pale, warm, dry. TC to DR with update observe for 30 mins with return TC to DR to report no difficulty with breathing ore swallowing, patient feeling OK. Mother and father have calmed her down. Patient came into our office with her step father, she was crying. Stated she things she is having a reaction to MMR vaccine. Very anxious C/o of weakness, cramps, however no SE at this time. Pt denied any stiffness, rash and no swelling of glands. She continues to cry. Step father and pt stated that she dose have anxiety and panic attacks. Was referred to her DR and an appointment was made for this afternoon. 5/11/06 TC from her DR she never showed for her appointment.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Patient did report anxiety with shots in the par, wanted MMR anyway. Immediately after injection was given she c/o ringing in her ears, lightheaded and blurry vision. She was then sweaty, cool, abdominal cramps, then diarrhea. Patient unable to sit still throughout, skin pale, warm, dry. TC to DR with update observe for 30 mins with return TC to DR to report no difficulty with breathing ore swallowing, patient feeling OK. Mother and father have calmed her down. Patient came into our office with her step father, she was crying. Stated she things she is having a reaction to MMR vaccine. Very anxious C/o of weakness, cramps, however no SE at this time. Pt denied any stiffness, rash and no swelling of glands. She continues to cry. Step father and pt stated that she dose have anxiety and panic attacks. Was referred to her DR and an appointment was made for this afternoon. 5/11/06 TC from her DR she never showed for her appointment.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: History of vomiting 6-7 time since this morning 5/16/06 called CPC ans stated 4% kids having vomiting.
Age: 1.26
Sex: M
Vaccine: DTAPH, MMR
Symptoms: Erythema
Clinical narrative: About 15 minutes after DTaP/Hib, MMR, father called to say child had redness around mouth and redness on abdomen and in diaper area. Nothing at site of injection. By the time child returned to office, no redness of face, mild erythema of abdomen. No urticaria. Gave single dose of Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Red, swollen, itchy decreased RT arm.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rash pustular, Skin ulcer
Clinical narrative: Started 2 days few bite appearing rash, now individual lesions varying small papules, Pustules no fever mild viral SX.
Age: 0.56
Sex: F
Vaccine: HIBV, IPV, PNC
Symptoms: Rash
Clinical narrative: Rash on body
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Local vaccine reaction. Left shoulder to bend of elbow red, warm, indurated, mildly tender to touch about 9cm in width around mid arm.
Age: 1.1
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: Papules, vesicles, but mostly scabs primarily on trunk, few on face, more on legs and arms office visit 5/15/06.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm redness, warm, some swelling
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: 2 x 3 1/2 redness, swollen, hot to touch. Rx: Cephalexin.
Age: 1.26
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Broke out in lesions on face and torso which Dr feels is related to receiving Varivax vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: T 105.5 starting late in evening of 5/15/06 with vomiting and headache that night actually 2:30AM only. 5/16/06. High fever lasted until 5/16/06 at 6PM. OK since.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash all over body, starting 12 days after Proquad (MMR-Varivax) injection. No fever, no systemic illness.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sx fever starting 3/14/06, woke with fever. Fever x 4 days 103. Highest reading at injection site c/o muscle soreness, felt like arm was going to fall off.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Knot on arm, pain, radiates down arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Mild redness to upper left arm mild immunization reaction.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: 24 hr low grade temp followed by 12-24 hrs of 102-103T.
Age: 1.04
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash vesicular, Viral infection
Clinical narrative: Seen in office on 4/26/06, vesicular spots surrounded by redness in different corps. Dx'ed Varicella.
Age: 1.02
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash developed 7 days after MMR, no cough or congestion, no fever, started on scalp and moved down to feet in 24 hrs. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: 3 cm diam. lump, redness at Dtap site R thigh 1 hr 20 min after injection, pt had itching at waist band vs wnl. SP02 98% room air. No fever. Benadryl 1 1/2 tsp given based on wt of 44 lbs at 4:10PM. Mom to rpt dose at 10PM.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Rt arm redness 1/2" diameter some swelling and just noted. Client was seen in ER at hospital by Dr. Benadryl steroids and Bactrim per mom.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Lymphadenopathy, Rash maculo-papular
Clinical narrative: Koplisla spots, diffuse maculopapular rash and Bilateral posterior cervical lymph node enlarge and posterior phogeal exdural
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Back pain, Diarrhoea, Vomiting
Clinical narrative: Approx 30 hrs after receiving 2nd hep B vaccine, diarrhea, stomach cramp, took Gas x at home, 2 hrs later for vomiting, back pain. Approx 4 hrs after receiving injection went to outpt clinic, received an EKG and Maalox, belladana and lidocaine which helped decrease symptoms immediately. 20 hrs later denies pain or rx at injection site, no nausea, vomiting, diarrhea.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Palpitations, Somnolence, Vaccine positive rechallenge
Clinical narrative: Rabies 1 had palpitation episode x 60m; Rabies 2 had aching all over episode and sleepiness x 2 days. Vaccine given due to place of employment.
Age: 1.53
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None yet
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Agitation, Bacterial infection, Crying, Decreased appetite, Haematochezia
Clinical narrative: Information has been received from a physician concerning a 2 month old male with acid reflux and a history of respiratory syncytial virus RSV (beginning of March 2006) who on 4/4/2006, at a well baby visit, was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). Concomitant vaccinations administered on that same day included standard vaccines given at 2 months of age (physician did not provide actual product name). Other concomitant therapy included lansoprazole Prevacid. At the time of vaccination the patient was noted to be fine. On 4/7/2006 the patients parents phoned the physician indication that their son had been vomiting excessively. He also noted to be pale, listless at times and was sometimes crying as he seemed to be crampy. The physician instructed the parents to take their son to the ER. In the ER the patient was treated with dextrose + electrolytes unspecified Pedialyte and was released. ON 4/8/2006 the patient was seen in the physicians office and was still having episodes of vomiting. On 4/11/2006, the patient was again seen in the physicians office. At that time, his vomiting had improved but his appetite was somewhat decreased. The parents noted seeing small streaks of blood in their sons stool. The patients stool was tested and wag guaiac positive. The physician indicated that the stools were not grossly bloody and the patient was afebrile at that time. On 4/13/2006, the patients formula was changed to Alimentum. After the change in formula, the patients symptoms were noted to have greatly improved. On 5/5/2006 the the patient was vaccinated PO with the second dose of  rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). at the time of dose two, the patient was doing fine and was noted to be gaining weight. The physician was unsure if the patients events were related to a possible protein sensitivity or rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). At the time of this report, the physician was not totally convinced of either. The reporting physician considered excessive vomiting to be other important medical event (OMIC). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Listless, Muscle spasms, Occult blood positive, Pallor, Sepsis
Clinical narrative: Information has been received from a physician concerning a 2 month old male with acid reflux and a history of respiratory syncytial virus RSV (beginning of March 2006) who on 4/4/2006, at a well baby visit, was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). Concomitant vaccinations administered on that same day included standard vaccines given at 2 months of age (physician did not provide actual product name). Other concomitant therapy included lansoprazole Prevacid. At the time of vaccination the patient was noted to be fine. On 4/7/2006 the patients parents phoned the physician indication that their son had been vomiting excessively. He also noted to be pale, listless at times and was sometimes crying as he seemed to be crampy. The physician instructed the parents to take their son to the ER. In the ER the patient was treated with dextrose + electrolytes unspecified Pedialyte and was released. ON 4/8/2006 the patient was seen in the physicians office and was still having episodes of vomiting. On 4/11/2006, the patient was again seen in the physicians office. At that time, his vomiting had improved but his appetite was somewhat decreased. The parents noted seeing small streaks of blood in their sons stool. The patients stool was tested and wag guaiac positive. The physician indicated that the stools were not grossly bloody and the patient was afebrile at that time. On 4/13/2006, the patients formula was changed to Alimentum. After the change in formula, the patients symptoms were noted to have greatly improved. On 5/5/2006 the the patient was vaccinated PO with the second dose of  rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). at the time of dose two, the patient was doing fine and was noted to be gaining weight. The physician was unsure if the patients events were related to a possible protein sensitivity or rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). At the time of this report, the physician was not totally convinced of either. The reporting physician considered excessive vomiting to be other important medical event (OMIC). Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 2 month old male with acid reflux and a history of respiratory syncytial virus RSV (beginning of March 2006) who on 4/4/2006, at a well baby visit, was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). Concomitant vaccinations administered on that same day included standard vaccines given at 2 months of age (physician did not provide actual product name). Other concomitant therapy included lansoprazole Prevacid. At the time of vaccination the patient was noted to be fine. On 4/7/2006 the patients parents phoned the physician indication that their son had been vomiting excessively. He also noted to be pale, listless at times and was sometimes crying as he seemed to be crampy. The physician instructed the parents to take their son to the ER. In the ER the patient was treated with dextrose + electrolytes unspecified Pedialyte and was released. ON 4/8/2006 the patient was seen in the physicians office and was still having episodes of vomiting. On 4/11/2006, the patient was again seen in the physicians office. At that time, his vomiting had improved but his appetite was somewhat decreased. The parents noted seeing small streaks of blood in their sons stool. The patients stool was tested and wag guaiac positive. The physician indicated that the stools were not grossly bloody and the patient was afebrile at that time. On 4/13/2006, the patients formula was changed to Alimentum. After the change in formula, the patients symptoms were noted to have greatly improved. On 5/5/2006 the the patient was vaccinated PO with the second dose of  rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653754/0139F). at the time of dose two, the patient was doing fine and was noted to be gaining weight. The physician was unsure if the patients events were related to a possible protein sensitivity or rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). At the time of this report, the physician was not totally convinced of either. The reporting physician considered excessive vomiting to be other important medical event (OMIC). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Injection site cellulitis This case was reported by a nurse and described the occurrence of injection site cellulitis in a 5 year old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). At the time of the administration of Infanrix on 06 April 2005, the patient "had strep throat." Concurrent medications included Amoxicillin "for the strep." On an unspecified date in April 2005, on or before 08 April 2005, the patient received a dose of Infanrix on the left arm (dose number not specified lot AC14A009BA). At an unspecified time following the administration of Infanrix on 06 April 2005, the patient experienced injection site cellulitis in the arm of the Infanrix injection. The patient was seen at a physician's office and was treated with diphenhydramine and an unspecified "topical medication." The nurse considered the injection site cellulitis to be related to vaccination with Infanrix.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Injection site cellulitis; pharmaceutical product complaint This case was reported by a health professional and described the occurrence of injection site cellulitis in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix). The patient had no pre-existing medical conditions. On 07 February 2005, the patient received the fifth dose of Infanrix in the "left leg" (lot DTPA620B9). On 07 February 2005 the patient also received injections of measles, mumps and rubella virus vaccine (MMR II Merck) and inactivated poliomyelitis virus vaccine (IPOL, Aventis Pasteur). The health professional stated that the MMR II and IPOL injections were administered "in separate areas" from the site of the Infanrix administration. At an unspecified time following the fifth dose of Infanrix, on 07 February 2005, the patient experienced swelling and redness at the injection site of Infanrix. The patient was seen in an emergency room and was diagnoses with injection site cellulitis. The patient was treated with hydroxyzine hydrochloride (Atarax). The outcome of the injection site cellulitis was not reported. The vaccine provider considered the injection site cellulitis to be possibly related to this lot of Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Injection site cellulitis; This case was reported by a nurse and described the occurrence of injection site cellulitis in a 5-year-old female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). On 20 April 2005, the patient received the fifth dose of Infanrix in the left deltoid (lot AC14A009BA). On 20 April 2005, the patient also received subcutaneous injections of inactivated poliomyelitis virus vaccine (IPOL Aventis Pasteur, lot 40240) and measles, mumps and rubella  vaccine (MMR II, Merck, lot 037P). The injection sites for IPOL and MMR II were not provided. Approximately one day following the fifth dose of Infanrix on 21 April 2005, the patient experienced injection site reaction to the site of the Infanrix administration characterized as red and "warm to touch." The patient was seen at a physician's office and then was seen in the emergency room. The patient was diagnoses with injection site cellulitis and was treated with cephalexin (Keflex). The injection site cellulitis resolved on 21 April 2005. The nurse considered the injection site cellulitis to be related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5 yr old male subject who was vaccinated with adsorbed diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. Concomitant vaccination included inactivated poliomyelitis virus vaccine (IPOL), left arm given on 02May05, and measles, mumps and rubella virus vaccine (MMRII), left arm given on 02May05. On 02May05 the subject received 5th dose of Infanrix (lotAC14A010BA), .5ml, to the right arm. On 03May05, 1 day after vaccination with Infanrix, the subject experienced cellulitis at the site of Infanrix injection and presented to the physician's office. The physician felt the event jeopardized the subject and required medical intervention (not specified at the time of reporting) (OMIC). The nurse stated the clinic...feels there is a problem with this lot number of Infanrix. On 07May05, the event resolved. The healthcare professional considered the event was related to vaccination with Infanrix.
Age: 1.21
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Accidental overdose, Erythema, Injection site pain, Vomiting
Clinical narrative: This case was reported by a nurse and described a 14-month-old male subject who inadvertently received separate injections of diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) and diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) on the same day. On 09 May 2005 the subject received the third dose of Pediarix. The subject then inadvertently received an injection of Infanrix (lot number and injection site not specified). On 09 May 2005, the patient also received injections of Haemophilus influenzae type b conjugate vaccine (PedvaxHIB, Merck), measles, mumps, rubella virus vaccine (MMRII, Merck), varicella virus vaccine (Varivax, Merck), and 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs). The nurse reported that "the next day," on 10 May 2005,the subject experienced vomiting and a small amount of redness and soreness at the injection site of Infanrix. The outcomes of the vomiting and injection site redness and soreness were not reported. The nurse considered the events to be related to the vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site reaction, Oedema peripheral
Clinical narrative: Edema peripheral, Erythema. Injection site swelling, Injection site reaction. This case was reported by a nurse and described the occurrence of swelling of the arm in a 4-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, Glaxo SmithKline) for prophylaxis.  The subject had no pre-existing physician diagnoses allergies, birth defects, or medical conditions. The subject's concurrent medications were not reported. On 03 May 2005, the subject received the 5th dose of Infanrix in an unspecified arm (lot AC14A011AA). On 05 May 2005, two days after the administration of Infanrix, the nurse reported that the subject experienced, "extensive swelling from the injection site to the elbow lasting from one to five days." The subject also experienced erythema (11x8 cm area). The subject was treated with warm compress. The events resolved on an unspecified date in May 2005. The nurse considered the swelling and erythema related to vaccination with Infanrix.
Age: 1.09
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling, Oedema peripheral
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of the thigh in a 1-year-old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 11 May 2005, the subject received the 5th dose of Infanrix (lot AC14A009BA) in the left thigh. Concurrently the patient also received haeomophilus influenzae tetanus toxoid conjugate vaccine (ACTHib) in the right arm. On 12 May 2005, one day after vaccination with Infanrix the nurse reported that the subject experienced "whelping which was hard, red and swollen" at the injection site. The subject was treated with a warm compress. The events "resolved within a few day", on an unspecified date in May 2005. The nurse considered the events to be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of swelling of the arm in a 5 year old female who was vaccinated with DTAP for prophylaxis. On 5/26/05, the subject received the 5th dose of Infanrix (lot AC14A011AA) in the left arm. Concurrently the pt also received IPV, in the right arm and MMRII, in the right arm, SC. At an unspecified time later, on 5/6/05, after vaccination with Infanrix, the nurse reported that the subject experienced, a "local reaction" manifested as swelling, redness and warmth at the injection site. The subject also complained of a stomach ache. The events resolved on an unspecified date in May 2005. The nurse considered the events to be related to vaccination with Infanrix.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of arm swelling in a 4 year old female subject who was vaccinated with Infanrix for prophylaxis. On 6/08/05, the subject received the 4th dose of Infanrix, the subject experienced swelling at the injection site and "swelling in the left arm". The subject was seen at a physician's office and was treated with paracetamol (Tylenol), Benadryl and ice pack. On 6/13/05, the events resolved. The nurse considered the event to possibly be related to vaccination with Infanrix.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site swelling in a 5 year old male subject who was vaccinated with Infanrix for prophylaxis. On 6/6/05, the subject received the 4th dose of Infanrix in the right arm (lot DTPA614A9). On 6/8/05, 2 days after vaccination, the subject experienced injection site swelling and was seen at a physician's office. The nurse reported that, "the swelling was up to 5cm in the right arm". On 6/13/05, the events resolved. The nurse considered the injection site swelling to possibly be related to vaccination with Infanrix.
Age: 15.0
Sex: M
Vaccine: DTAP, HEP, MMR
Symptoms: Injection site pain, Injection site reaction, Medication error
Clinical narrative: This case was reported by a physician and described the occurrence of injection site soreness in a 15 year old male subject who was inadvertently vaccinated with Infanrix for prophylaxis. On 6/14/05, the subject inadvertently received a dose of Infanrix in an unspecified arm (dose and lot number not provided) rather than the intended administration of TD. Infanrix is not recommended for immunizing individuals 7 years of age or older. On 6/14/05, the subject also received injections of Hep-B and MMRII in the "other arm". At an unspecified time following the administration of Infanrix, on 6/14/06, the subject experienced injection site soreness at the site of the Infanrix injection. The immunization series with Infanrix was discontinued. The injection site soreness was ongoing at the time of reporting, 6/15/05.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of injection site swelling in a 4 year old male subject who was vaccinated with Infanrix. On 6/20/05, the subject received the 5th dose of Infanrix (lot AC14A011AA). On 6/20/05, the subject also received injections of MMRII and IPOL. The sites of injection for the 3 immunizations were not provided. On 6/21/05, 1 day after vaccination with Infanrix, the subject experienced swelling at the injection site of Infanrix and was seen at a physician's office. The injection site swelling resolved on an unspecified date after 6/22/05 and on or before 7/25/05. The physician considered the injections site swelling to possibly be related to vaccination with Infanrix.