chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from nurse practitioner concerning a healthy 8 year old male student with no allergies and no past medical history who on 18Aug99  was vaccinated SC in the right arm with a dose of varicella virus vaccine live. Concomitant vaccination on 18Aug99 included a second SC dose in the right arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  a fifth oral dose of poliovirus vaccine live oral and a fifth IM dose in the right thigh of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia). On 16Oct03, the pt developed varicella. The pt presented to the clinic with a fever that lasted one day and approx. 80 to 100 vesicular lesions on the back, chest, and face, but no oral lesions. The pt was treated with diphenhydramine hydrochloride (Benadryl Elixir), calamine lotion and acetaminophen (Tylenol). The pt had a varicella titer during the week and the results were pending. The reporter noted that the pt's two sisters had not experienced symptoms. A product quality complaint was not involved. The reporter also mentioned that the pt's two brothers developed varicella illness post vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: DPP, HIBV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from nurse practitioner concerning a healthy 7 year old male student with no allergies and no past medical history who on 03Nov98  was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on 03Nov99 included a dose of Hib conj vaccine and a dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid. On 16Oct03, the pt developed varicella. The pt presented to the medical office with a history of fever and more than 100 vesicular lesions on his back, chest, face and 4 to 6 in his mouth. The pt was treated with diphenhydramine hydrochloride (Benadryl Elixir), calamine lotion and acetaminophen (Tylenol). The pt had a varicella titer during the week and the results were pending. Subsequently, the pt recovered. The reporter noted that the pt's two sisters had not experienced symptoms. A product quality complaint was not involved. The reporter also mentioned that the pt's two brothers developed varicella post vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 6 year old male patient with no known medical history who on 22Jan98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 11Oct2003 the pt developed a full blown case of varicella. Unspecified medical attention was sought and the pt was seen for a Dr. visit. Subsequently, the pt recovered from full blown case of varicella. Additional information has been requested. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 4 year old female who on 03Mar2000 was vaccinated SC with a first dose of varicella virus vaccine live. On 15Oct2003 the pt experienced varicella with 36 lesions. "one week later" the pt recovered. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 5 year old male who on 25May99  was vaccinated with a dose of varicella virus vaccine live. On 16Oct2003 the pt presented to the office with a vesicular rash of a moderate number of lesions in generalized dissemination. No other symptoms were noted. No treatment was required. Unspecified medical attention was sought.  There was no product quality complaint involved. No other information was available. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 34 month old white female with no past medical history and no known drug allergies who on 30Nov2001 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant vaccinations included a first dose in the right anterior thigh of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  and a fourth dose in the left anterior thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR).   On 21Oct 2003 the pt presented to the Dr's office with chickenpox, described as 10 to 15 itchy, papular vesicular lesions on the chest and right leg. The child was also noted to have a fever. In addition, it was noted that the child had an ear infection which was being treated with amoxicillin.  Unspecified medical attention was sought.  There was no product quality complaint. Follow up information indicated that the adverse event onset was 17Oct2003. On 21Oct2003, the pt presented to the physician's office with 10-15 lesions (first lesions spotted 4 days prior) and was afebrile. The pt was also diagnosed with left otitis media. She was treated with amoxicillin. No further information was available as of 05Nov2003. Follow up information from the nurse indicated that as of 18Nove2003 no further information was available.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a child who on an unspecified date was vaccinated with a dose of varicella virus vaccine live. The physician reported that several months later, the child developed a severe case of varicella. The physician reported that the case of varicella was so severe that it scared her to the point that she thought it could be "small pox". The physician would not pull the pt's chart to disclose or provide the release of any additional information, and cited the regulations. The lot number was not available. No other information was provided. It was unknown as to whether prescription medication was required and if the adverse event abated. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 9 yea old male patient who on 30Apr96 was vaccinated in the left thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 16Oct2003, the pt developed varicella and presented to the medical office with less than 50 lesions. Laboratory tests were not performed. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 4 year old white male pt with no allergies and no past medical history who on 18Oct01 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 13Oct2003, the pt developed varicella. On 16Oct2003, the pt presented to the medical office with 50 to 100 lesions that were noted by the medical doctor. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning an adult female patient who on approximately 02Oct2003 was vaccinated with a first dose of varicella virus vaccine live. Seven days post vaccination,on approximately 09Oct2003 the pt developed a mild case of chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Eczema
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.5mL dose of varicella virus vaccine live. The physician reported that 10 days after receiving vaccination with varicella virus vaccine live the pt had a mild breakthrough of chickenpox. Additional information from the physician reported that the pt developed a rash 15 days after the vaccination varicella virus vaccine live and his parents took him to an emergency dept. where the parents were told the pt had chickenpox. The pt was not admitted. The physician reported the pt was then seen by him three days after the ER visit and he indicated that he disagreed with the diagnosis of chickenpox and he sent the child to a dermatologist. The dermatologist diagnosed the pt with eczema. The physician does not think the eczema had anything to do with the vaccination. It was unknown whether treatment was required for the adverse event. The adverse event abated, and the pt fully recovered.  No additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old white female with an allergy to ciprofloxacin hydrochloride (Ciloxan) opthamologic drops who on 07Jun2000 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. The pt had a minor papular dermatitis diaper rash that was unresponsive at the time of vaccination. Neither the pt nor her brother had any adverse events following previous vaccinations. On 22Oct2003 the pt's mother brought the pt into the physician's office to have her right ear rechecked and stated that the pt had a rash on her arms and legs. The pt was taking amoxicillin (+) clavulanate potassium (Augmentin). It was reported that the pt was exposed to chickenpox (also reported as varicella) at preschool in the last month. The physician diagnosed the rash most likely appears to be some type of varicella variant with less than 20 lesions. It was also reported that the pt had developed breakthrough chickenpox rash with approximately 20 pox on her arms and legs. On 27Oct2003 the pt recovered. No product quality complaint was involved. No further information is expected.
Age: 34.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a RN at a county health dept concerning a 34 year old male refugee from another country who was exposed to an outbreak of varicella in the refugee camp prior to coming to this country, and has no preexisting allergies or medical conditions, who on 29Sep2003 was seen by a health care professional for an assessment. On 02Oct2003 at 13:00 PM he was vaccinated SC in the left arm with a dose (previous doses unknown) of varicella virus vaccine live. Concomitant vaccines administered at 13:00PM on 02Oct2003 included a dose (previous doses unknown) of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) administered SC in the right arm, and an IM dose (previous doses unknown)  of diphtheria toxoid (+) tetanus toxoid administered in the left deltoid. On 09Oct2003 the pt started feeling tired and developed a slight fever. On 10Oct2003 he developed a rash on his trunk, back and neck. On 11Oct2003 he was seen in the ER and was diagnosed with full blown chicken pox. The RN reported that the pt was seen in the ER for evaluation, given an unspecified treatment and sent home. The RN reported that initially there was concern that the vaccination had caused the disease. The nurse reported that she then received notice from an organization which sponsors the refugee, that there had been a varicella outbreak in the refugee camp prior to the pt coming to this country and prior to him receiving the vaccination. It was noted that as part of the refugee organization screening program, the pt had the following diagnostic tests performed: CBC, hepatitis, TB, HIV, and syphilis screening. The RN reported that as of 28Oct2003 the pt's recovery status was unknown. Follow up information received from a RN reported that while in the ER the pt had a basic blood test and he was given an antihistamine. The RN reported that the pt was without illness at the time of vaccination and it was unknown as to whether the pt had an adverse event following prior vaccinations. The pt's outcome is recovered. NO additional information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 12 month old female who on 22Oct2003 was vaccinated with a dose of varicella virus vaccine live. On 24Oct2003 the pt vomited and as of 27Oct2003 has continued vomit once a day. Unspecified medical attention was sought and it was indicated that prescription drugs were not required. A product quality complaint was not involved. Follow up information from the medical assistant indicated that the pt recovered in about one week. The reporter also indicated that another pt had a similar experience following exposure to varicella virus vaccine live. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female with no medical history and no allergies who on 05-Sep-2001 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (lot #638654/0565L). There was no concomitant medication. On 22-Oct-2003 the patient developed a chickenpox rash. On 23-Oct-2003 the patient was seen in the office where it was noted that the patient had less than 20 lesions. No treatment was required. No diagnostic studies were performed. No product quality complaint was involved. On 21-Nov-2003 it was reported that there was no further information. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 year old male patient with no allergies and no past medical history who on 24-Oct-2003 was vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot #644723/0073N). There was no concomitant medication. On 27-Oct-2003, the school nurse called the doctor's office to report that the patient had broken out in a rash all over his body with a few spots and a lesion or two. The reporter stated that they believed the rash was caused by flea bites. An onset date of 27-Oct-2003 was noted. The patient presented to the office the next day and the physician confirmed it was flea bites. No treatment was given. The reporter confirmed this was not an adverse reaction to the vaccine. A product quality complaint was not involved. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: DTP, MMR, VARCEL
Symptoms: Blister, Erythema, Rash papular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 10-year old white female with no known drug allergies and no past medical history who on 28-Aug-1997 was vaccinated with a second dose of varicella virus vaccine live (Lot #622850/0537E). There was no illness at the time of vaccination. Concomitant therapy that day included a second dose of measles-mumps-rubella vaccine (Lot #622896/0740E), and a second dose of diphtheria toxoid (+) pertussis whole cell vaccine (+) tetanus toxoid (Tri-immunol) (Batch #445539). On 16-Oct-2003 the patient developed widely scattered red papules, described as less than 20 lesions- one with a vesicle and several were scabed. It was noted to be varicella post vaccination. There were no relevant diagnostic tests or laboratory data reported. The outcome was reported as recovered. No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site inflammation, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male student with no medical history and no allergies who on 05-Sep-2000 was vaccinated subcutaneously in the left arm with a 0.5 ml first dose of varicella virus vaccine live (lot #632726/0088K). There was no illness at the time of vaccination. On 17-Oct-2003 the patient developed new red, itchy, spots appearing on his trunk, legs, and buttocks. On 24-Oct-2003 the patient was seen in a clinic where it was noted that the red spots had reddened areas surrounding them with the beginnings of scabs. There were 1-2 vesicles with clear fluid in the center that appeared inflammed. Most appeared "scratched". There was no fever. The nurse reported that the patient developed a possible breakthrough disease of chickenpox. There were no diagnostic tests performed. The diagnosis was based on a visual exam and history. No prescription drug or treatment was required. It was also reported that the patient's pediatrician did not give the vaccine and had not yet seen the patient regarding this AE. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male student with no medical history and no allergies who on 05-Sep-2000 was vaccinated subcutaneously in the left arm with a 0.5 ml first dose of varicella virus vaccine live (lot #632726/0088K). There was no illness at the time of vaccination. On 17-Oct-2003 the patient developed new red, itchy, spots appearing on his trunk, legs, and buttocks. On 24-Oct-2003 the patient was seen in a clinic where it was noted that the red spots had reddened areas surrounding them with the beginnings of scabs. There were 1-2 vesicles with clear fluid in the center that appeared inflammed. Most appeared "scratched". There was no fever. The nurse reported that the patient developed a possible breakthrough disease of chickenpox. There were no diagnostic tests performed. The diagnosis was based on a visual exam and history. No prescription drug or treatment was required. It was also reported that the patient's pediatrician did not give the vaccine and had not yet seen the patient regarding this AE. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 9-year-old female with a history of chickenpox "when she was very young" who "sometime after that infection" was vaccinated with a dose of varicella virus vaccine live. On approximately 22-Oct-2003 the patient was seen in office and diagnosed with a rash caused by shingles. At that time, the shingles "was almost healed". PCR analysis was offered but declined because the doctor "did not believe a specimen was currently available". Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as recovered. Additional information has been requested.
Age: 1.75
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Nasal congestion, Rash papular
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 month-old white male with no medical history and no known drug allergies who on 11-Aug-2003 was vaccinated subcutaenously with a first dose of varicella virus vaccine live (Lot #644721/0018N). On 11-Aug-2003, concomitant medication included a subcutaneous first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #644585/1015M), (previously reported as there was no concomitant medication). There was no illness at the time of vaccination. On 25-Oct-2003, the patient was seen with a rash on the trunk of 10-20 scattered papules that the doctor believed was chickenpox. It was also noted that the child had a stuffy nose also described as congestion. There was no prescription drug treatment required. Unspecified medical attention was sought. It was noted that the patient had recovered. There was no product quality complaint involved. No further information is requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection, Injection site reaction, Malaise
Clinical narrative: Information has been received from a public health nurse concerning a child who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child experienced a case of chickenpox that was not mild and involved a systemic reaction and malaise. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. The public health nurse also reported an unspecified number of children who developed breakthrough chickenpox after therapy with varicella virus vaccine live. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed cellulitis at the site of the vaccination. Unspecified medical attention was sought. No further information was available. No product quality complaint was involved. On 26-Dec-2003 the physician reported that no information was available; he "lost his name" of the patient. No further information is expected.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Bronchiolitis, Convulsion, Dyspnoea, Hypersensitivity, Hypoxia
Clinical narrative: Vaccine administered 11-12-03, hospitalized      11-19-03 for difficulty breathing,weight loss, diagnosis of bronchiolitis and put on oxygen for two days.  Noticed first head tick/seizure 11-29-03. Office visit with the pediatrician and referred to neurologist who ordered EEG which gave diagnosis of seizures/partial complex seizures.  Put on Lamictal to control seizures, had to discontinue because of allergic reaction.  Admitted back to the hospital on 01-18-04 for further testing and put on phenobarbitol.  Admitted back to the hospital on 03-01-04 for more testing, EEG,CT scan.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: Tic, Weight decreased
Clinical narrative: Vaccine administered 11-12-03, hospitalized      11-19-03 for difficulty breathing,weight loss, diagnosis of bronchiolitis and put on oxygen for two days.  Noticed first head tick/seizure 11-29-03. Office visit with the pediatrician and referred to neurologist who ordered EEG which gave diagnosis of seizures/partial complex seizures.  Put on Lamictal to control seizures, had to discontinue because of allergic reaction.  Admitted back to the hospital on 01-18-04 for further testing and put on phenobarbitol.  Admitted back to the hospital on 03-01-04 for more testing, EEG,CT scan.
Age: 1.7
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child received his 4th DTaP vaccination on 5/17/2004 around 2:00pm. Extensive Swelling Reaction was noted the next morning around the area of injection in the left thigh. Child had no fever, normal activity level but redness and swelling were noted and increasing over time.  Due to in the increase of swelling and redness, this prompted a visit to the medical center for evaluation.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Injection site mass
Clinical narrative: AVA # 1 09 Jan 2000 Little nodule size of a nickel. No other problems noted AVA # 2 12 Feb 2000 Same as above AVA # 3 26 Feb 2000 Left arm became swollen red and hot from shoulder to wrist. He had tingling in his hand with symptoms lasting a couple of wks. He missed 1 week of work and he did file a VAERS. Reported fever and a headache. He sought medical evaluation and was placed on antibiotics. He stated that his headache lasted a couple of wks. No history of headaches. AVA # 4Subcutaneous tricep area 01 May 04 He states that he noticed slight swelling on 02 May and that the area was warm to touch. By the third the area became the size of a "grapefruit." Later that night he stated that he had increased swelling from elbow to armpit and that the area doubled in size. On 04 May the swelling extended about 2 inches below the elbow and that his lymph nodes became enlarged and tender to touch. He also reported a low-grade fever, despite taking ibuprofen regularly. He reports feeling tired and drained and a headache that is being controlled with ibuprofen. He also states that he has had itching along his arm. On 05 May he reports that his symptoms are improving.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Lymphadenopathy, Oedema peripheral, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: AVA # 1 09 Jan 2000 Little nodule size of a nickel. No other problems noted AVA # 2 12 Feb 2000 Same as above AVA # 3 26 Feb 2000 Left arm became swollen red and hot from shoulder to wrist. He had tingling in his hand with symptoms lasting a couple of wks. He missed 1 week of work and he did file a VAERS. Reported fever and a headache. He sought medical evaluation and was placed on antibiotics. He stated that his headache lasted a couple of wks. No history of headaches. AVA # 4Subcutaneous tricep area 01 May 04 He states that he noticed slight swelling on 02 May and that the area was warm to touch. By the third the area became the size of a "grapefruit." Later that night he stated that he had increased swelling from elbow to armpit and that the area doubled in size. On 04 May the swelling extended about 2 inches below the elbow and that his lymph nodes became enlarged and tender to touch. He also reported a low-grade fever, despite taking ibuprofen regularly. He reports feeling tired and drained and a headache that is being controlled with ibuprofen. He also states that he has had itching along his arm. On 05 May he reports that his symptoms are improving.
Age: 60.0
Sex: F
Vaccine: TTOX
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Noted deep aching pain in left deltoid muscle area extending to shoulder, beginning 4-15-04 and continuing.  also noted limited ROM in left shoulder beginning 5-1-04 which has continued
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye disorder, Paraesthesia
Clinical narrative: Vaccination given 5/17/04 at approx. 9:00am.  Came to work on 5/18/04 at 6:45am. 7:30 am started to C/O problen with left eye and some tingling in left arm. Injection site was left arm.  Sent to ER for evaluation at 7:50am.  Labs and CT done. Referred to ophth.  Saw ophth on 5/19/04.  Ophth referred to neurologists.  Appoint scheduled for 6/1/04.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT. RECEIVED DAPTCELL VACCINE IN L. DELTOID. AFTER 48 HOURS PT. RETURNED TO OFFICE TO HAVE PPD READ & PARENT STATED INJECTION SITE WAS RED, SLIGHTLY SWOLLEN & WARM TO THE TOUCH.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Mother reports the day after immunization given, injection site became red, swollen, hot.  Swelling increased on second day,patient reported site "itchy" on second day, and itching is still being reported by patient.  Mother states patient was seen by family MD, MD verified was a reaction vs. infection.  Site observed on 05/19/2004 by this RN and faint redness noted, skin normal temperature.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: LEFT ARM WHERE IMMUNIZATIONS OF DTAP, AND IVP WERE ADMINISTERED BECAME RED WARM AND SORE TO TOUCH. VERY EDEMATOUS APPRO 6IN IN DIAMETER.
Age: 1.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Coordination abnormal, Gait disturbance
Clinical narrative: Information has been received from a physician concerning a 12 month old female pt who on 11/12/03 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included influenza virus vaccine (unspecified), which she was given because of her history of asthma. The physician noted that on the day of vaccination, the child had a cold (runny nose and cough but no other signs/symptoms). The pt had a history of asthma for which she had been on "zobinex" and unspecified steroids in the past; however, she had not received either medication within several months prior to vaccination with varicella virus vaccine live. The pt's mother indicated on 11/12/03, by the time they drove home from the MD's office, which was less than 1 hour after the vaccinations, the child was extremely ataxic.  Her balance was very off and she was "constantly falling over like she was drunk". Prior to his, the child was able to balance/stand without difficulty. The severe ataxia persisted through 11/13/03, and as of 11/14/03 had slightly improved though not substantially. At the time of the report, the child remains at home and has not been hospitalized. The physician planned to continue to monitor the pt to see if the ataxia would resolve spontaneously. At the time of the report, she had no plans to do a lumbar puncture. The physician indicated that she believes the timing of the ataxia onset less than 1 hour post-vaccination with varicella virus vaccine live and/or the influenza virus vaccine".  The physician also reported that to her knowledge, the child did not have any exposure to varicella or other viruses prior to vaccination, nor did she had any history of trauma, specifically head trauma. Upon internal review, the pt's experience was considered an important medical event (OMIC). Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 16 month old female with no pertinent medical history who on 11/11/03 was vaccinated in the right anterior lateral thigh with a dose of varicella virus vaccine live (Lot # 643823/0869M).  Concomitant therapy included a fourth dose in the right thigh of Prevnar. There was no other concomitant medication. Subsequently, she developed a local site reaction of 3-4 cm wide, and raised reddened area along the side of the vaccination. The child presented at the MD's office on 11/14/03 and was given Tylenol and Motrin as needed. It was reported that the pt's first three doses of Prevnar were given without adverse effects. The child was considered not recovered. No product quality complaint was involved.  Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blood pressure increased, Fatigue, Pruritus, Rash, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 45 year-old female patient with no known drug allergies and on 19-Oct-2003, a medical history of exposure to chickenpox who on 20-Oct-2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (645578/0439N). There was no illness at the time of vaccination. Other medications included estrogens, conjugated (Premarin) cram (previously reported as no concomitant medication). On 11-Nov-2003, "about three weeks later", the patient developed a chickenpox rash described as "red, quarter size swelling, with white over" and 1 on the finger. 3 on the lower back, 2-3 on the thigh, 1 on the leg, head itching, fatigue, no fever and "B/P elevated", previously reported as "no other symptoms were noted". There was no prescription drug treatment required. Unspecified medical attention was sought. The outcome was recovered. There was no product quality complaint involved.  No further information is requested.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blood pressure increased, Erythema, Fatigue, Infection, Oedema
Clinical narrative: Information has been received from a registered nurse concerning a 45 year-old female patient with no known drug allergies and on 19-Oct-2003, a medical history of exposure to chickenpox who on 20-Oct-2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (645578/0439N). There was no illness at the time of vaccination. Other medications included estrogens, conjugated (Premarin) cram (previously reported as no concomitant medication). On 11-Nov-2003, "about three weeks later", the patient developed a chickenpox rash described as "red, quarter size swelling, with white over" and 1 on the finger. 3 on the lower back, 2-3 on the thigh, 1 on the leg, head itching, fatigue, no fever and "B/P elevated", previously reported as "no other symptoms were noted". There was no prescription drug treatment required. Unspecified medical attention was sought. The outcome was recovered. There was no product quality complaint involved.  No further information is requested.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 45 year-old female patient with no known drug allergies and on 19-Oct-2003, a medical history of exposure to chickenpox who on 20-Oct-2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (645578/0439N). There was no illness at the time of vaccination. Other medications included estrogens, conjugated (Premarin) cram (previously reported as no concomitant medication). On 11-Nov-2003, "about three weeks later", the patient developed a chickenpox rash described as "red, quarter size swelling, with white over" and 1 on the finger. 3 on the lower back, 2-3 on the thigh, 1 on the leg, head itching, fatigue, no fever and "B/P elevated", previously reported as "no other symptoms were noted". There was no prescription drug treatment required. Unspecified medical attention was sought. The outcome was recovered. There was no product quality complaint involved.  No further information is requested.
Age: 77.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Anxiety, Asthenia, Decreased appetite, Fall, Headache
Clinical narrative: Per patient report day after receiving flu vaccine, became too weak to walk, fell and was vomiting. On 2/4/04 was admitted to hospital for 2 days.
Age: 77.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Hypokalaemia, Malaise, Myalgia, Rash, Vomiting
Clinical narrative: Per patient report day after receiving flu vaccine, became too weak to walk, fell and was vomiting. On 2/4/04 was admitted to hospital for 2 days.
Age: 77.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Fall, Muscular weakness, Vomiting
Clinical narrative: Per patient report day after receiving flu vaccine, became too weak to walk, fell and was vomiting. On 2/4/04 was admitted to hospital for 2 days.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site oedema, Injection site pain, Pyrexia, Viral infection
Clinical narrative: High fever, swollen area around wound (size of golf ball), wound (size of nickel), throbbing sensation at site.
Age: 27.0
Sex: M
Vaccine: RAB
Symptoms: Rash, Urticaria
Clinical narrative: Started with hives/rash at waist line which gradually moved up his side that evening. By the next morning, the rash had spread over his entire body. Pt went to the Er and was given epi, Zyrtec, prednisone. No previous reactions to drugs or vaccines.
Age: 49.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Feeling hot, Rash
Clinical narrative: Pt went to the ER with large welts. He had chills and felt feverish, but had no temperature. His rash started early AM on 3/28/04 and progressed. Went to ER on 3/29/04 at 2am.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Pt described a localized reaction that included a large swollen, red, itchy and pain area around the site of injection that measures approximately 3 to 4 inches lateral for 7 days post vaccination.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Muscle spasms, Urticaria
Clinical narrative: Pt received Hep B Aelurt dose #1.  No dyspnea.  Reports hives (generalized), lightheadedness, and cramps several hours later.  Questions allergic reaction to Hep B: To take Benadryl.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Itchy rash. Multiple papules in various stages. Face, back, and trunk.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Dry skin, Infection, Pyrexia
Clinical narrative: Rash, fever-sib with chicken pox, skin itchy. Approximately 20 red papules scattered with clear vesicles on trunk.
Age: 0.1
Sex: M
Vaccine: HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: 102 fever resulting in lab test, UA, UC, BC, CBC
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Edema and erythema of right arm. Prescribed with ABX and prednisone and Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Red welp developed at site of DTAP injection on evening after vaccine.  when seen at office on 05/14/04, red, warm, raised area 13x10cm on left anteolateral thigh at site with small hives around peripheral. No rash, no fever else where on body, no itching. Treatment: Cool compress, Zyrtec, Keflex.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Oedema, Pyrexia, Urine glucose false positive
Clinical narrative: Vaccinated with IPV and DTAP from health department on 05/12/04.  Mother brought pt into our office on 05/14/04 with complaints of increased edema, increased redness, increased warm to touch-gradually getting worse (+) fever up to 101F.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Seen at ER 05/09/04 for swelling and redness of left arm.  Diagnosed with DTAP reaction vs. Cellulitis. Treated with Cephalexin 250mg per mouth four times daily for 7 days.  Much less red, swollen and hard today (05/10/04).  Had DTAP #5 in left arm 05/07/04.
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Pt had varicella vaccine and developed chicken pox 05/10/04.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Pt received vaccination at 24 hours later developed a 1-2 mm erythematous blanching discreet rash on knees.  The following day spread to elbows. 7 days status post vaccination, erupted on face and shoulders.
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: Blister, Cough, Rash
Clinical narrative: Developed cough 04/29/04. Developed fluid filled blister like rash on trunk and face on 04/30/04.  Afebrile. Areas scabbed in 2-3 days. Using over the counter Claritin as needed.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Elevated temperature and fine rash on trunk, extremities and cheeks.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abnormal behaviour, Blood pressure decreased, Body temperature decreased, Pallor, Syncope
Clinical narrative: Immunizations were given at about 8:30AM.  Pt was fine and had walked out to waiting room area and was talking and answering questions and suddenly had a syncopal episode and slumped to the floor. She was picked up immediately by the RN and was taken to an exam table approximately 20 feet away where she was laid down and a nurse elevated her legs and feet. She was alert and oriented. Her color was pale and her skin was warm and dry. BP: 86/50, Pulse: 108, RR: 18; Temperature: 92 after 2 oz of orange juice.  After a few minutes of sitting on her mother's lap, she went to the bathroom with her mother and voided. When her mother brought her back to the exam room she was pale again, skin warm and dry and was responsive but sluggish to react. At that point we called 911 for a rescue squad and administered O2 via a mask and monitored vital signs until the rescue squad transported her to medical center for evaluation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left arm red, swollen, hot at site of DTAP injection silver 1/2 dollar.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: 19 days after received below vaccines, pt developed post-vaccination Varicella-like rash which was generalized.  (Started at injection site).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Arm swollen and warm to the touch.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Small dime shaped reddened, raised area on right thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left thigh red and swollen. Benadryl per mouth.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: High temperature, swollen leg, cried all day, pain in right leg.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness, swelling, itch of right thigh. Keflex 250/5 1.5tsp po BIDx 10 days 150 ml
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Decreased appetite, Erythema, Fatigue, Irritability, Rash
Clinical narrative: Fussiness, Tiredness, Vomiting, Rash, Redness, and swollen where shot was given and very poor appetite.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Swelling, Vomiting
Clinical narrative: Fussiness, Tiredness, Vomiting, Rash, Redness, and swollen where shot was given and very poor appetite.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Feeling hot
Clinical narrative: area of erythema and warmth 5x6 inches at site of injection within 24 hours. Treatment: cool compresses, antibiotic for cellulitis; DTaP antihistamine.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Erythema, swelling, itchiness. Rx: Benadryl prn.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site induration, Pyrexia, Screaming, Swelling
Clinical narrative: Fever:16 hrs after immunization lasting 6-8 hours. Excessive crying with screaming continuous when awake- starting at 16 hours post immunization and lasting at least 36 hours. Did sleep for 9 hours in middle of period. Left thigh swollen and indurated: no erythema.
Age: 4.75
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Erythema, swelling , itchiness. Rx: Benadryl PRN.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Heart rate irregular, Pyrexia
Clinical narrative: On 5/11/04 at 10 pm, she had a fevr of 102.0F and it sounded like her heart was beating fast. So, I took her to the hospital. They gave her a pill in her butt for the fever and he said her heart beat is okay.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Swelling
Clinical narrative: Local rxn, with swelling involving the entire deltoid.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Pruritus, Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Had varicella vaccine 5/3/04: developed red raised papular rash chest 5/12/04: vesicular: face, scalp, and mild on arms and legs. Mild, itchy and no fever, mildly irritable.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Rash erythematous, Rash maculo-papular, Rash pustular
Clinical narrative: 2 days post initial vaccination. Pt noticed pustules on arm, pruritic with paps now scabbed over. Today pt noticed onset of scattered , asymmetrical maculopaplar erythemic rash on extremities and torso. Some pustules noted.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia
Clinical narrative: On 5/19 fever had fever of 102.5degrees, parents gave pt juice and fever started to decrease. Pt woke up at night and was given children's tylenol by parent, parent reports other behavior besides fever was normal. On 5/20 parent contacted doctor who recommended medicine with ibuprofen. Pharmacist gave parent motrin.
Age: 5.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Convulsion, Erythema, Pyrexia, Rash, Respiratory disorder
Clinical narrative: Patient had a seizure (first ever) 5-16-04 with a low grade fever (100.6 at highest)He had the fever the day before as well and it lasted a total of 3 days. After the third day, his fever broke and he had a rash all over his body. Small red bumps which were mostly on his belly, back and neck. During the seizure he stopped breathing for about 30 seconds to 1 minute. Was taken into emergency room. Doctor ruled out febrile seizure because fever was too low. Doctor also ruled out being a reaction to vaccines because it was too long after the shots were administerd. (8 days) (which is contrary to the info I reviewed from CDC) I did not have a copy of his vaccinations at the emergency room available for doctor. Doctor did standard tests to check blood and a chest X-ray.
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Crying, Flushing
Clinical narrative: After leaving clinic, child began crying and thrashing around in car seat. Very brightly flushed all over. 9:50 AM Returned to clinic and evaluated by family doctor. Child observed for 1 hour there and then to hospital for further observation. Only medication given was Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Injection site inflammation, Injection site reaction
Clinical narrative: Local reaction at site of left arm. Inflammation/ erythema and warmth. Reactions > 48hours.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12-month old male with no medical history or no known drug allergies (NKDA) who on 29-Oct-2003, at approximately 14:45, was vaccinated SQ in the right deltoid with the first dose of varicella virus vaccine live (Lot #646228/0537N). Concomitant vaccinations on that same day at approximately 14:45 included the fourth dose IM in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (Lot #490-895). There was no illness at the time of vaccination. The physician reported that on 29-Oct-2003, at approximately at 14:46, the patient developed a single 2 cm hive on his right arm one inch below the injection site. No respiratory distress was noted. The patient was immediately treated with 1 teaspoon of diphenhydramine HC1 (Benadryl) and was observed for 20 minutes. No laboratory/diagnostic tests were performed. On that same day, the patient recovered. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Injection site rash
Clinical narrative: Information has been received from a physician concerning an 8-year-old male with no allergies or medical history who on 17-Oct-2003 was vaccinated with a dose of varicella virus vaccine (lot #644563/1147M). There was no concomitant medication. The reporter indicated tat 14 days after vaccination the patient developed a varicella like rash at the injection site. There were about three or four lesions at the site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.