chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella Information has been received from a registered nurse (RN) concerning a 9 year old male who on 08-APR-1997 was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (Oka/Merck) (Lot #617695/0776D). There was no illness at the time of the vaccination. The RN reported that on 01-OCT-2005, the patient developed breakthrough varicella characterized by less than 30 varicella lesions that spread to his face and neck. The patient was noted to be afebrile. On 04-Oct-2005 the patient was seen by a dermatologist, but no treatment or laboratory/diagnostic tests were required. In 2005, the patient's breakthrough varicella spontaneously resolved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Convulsion Information has been received from a physician concerning a 12 month old white male who on 16-SEP-2005 at approximately 14:45 was vaccinated in the left thigh with the first dose of varicella virus vaccine live (Oka/Merck) (Lot #649441/0117R). Secondary suspect vaccinations on that same day included a dose of measles virus vaccine live (Ender-Edmonston) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot #647563/0578R). The physician reported that on 25-SEP-2005 the patient experienced a seizure. The patient was taken to the Emergency Room (ER) and released. Subsequently, the patient recovered from the seizure. The physician felt that the patient's seizure was related to vaccination with varicella virus vaccine live (Oka/Merck) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Upon review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 9 year old white male with developmental delay and no allergies who on 6/8/01 was vaccinated in the left thigh with a dose of varicella virus vaccine live (lot # 638649/1889K). There was no illness at the time of vaccination and there was no concomitant medication. On 9/22/05, the patient developed chicken pox breakthrough. Unspecified medical attention was sought. Subsequently, the patient recovered on 9/29/05. No diagnostic laboratory tests were performed. It was noted that the patient nor his sister had any adverse events following prior vaccination. A product quality complaint was not involved. No further information is expected. It was also noted that the patient's sister developed chicken pox after vaccination with varicella virus vaccine live (WAES0510USA06240).
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 4 year old female who at 1 year of age was vaccinated with a dose of varicella vaccine live. Concomitant vaccination most likely included a dose of MMR. Subsequently, the patient developed Zoster in the genital area, buttocks, and down one leg. The pain was one sided. A culture was taken to differentiate with Herpes Simplex virus, and differentiated that it was Varicella Zoster virus. The patient was afebrile. Unspecified medical attention was sought. The patient was treated with acetaminophen (+) codeine phosphate, which did not relieve the pain, and acyclovir. The patient received no other medicines and was not hospitalized. It took one week before resolution. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 13 year old white female with allergies to sulfa, cephalosporins, sulfamethoxazole (+) trimethoprim, cefaclor, and sufrax, who on 1/4/96 was vaccinated with a SC first dose of varicella virus vaccine live (lot # 610257/0750B). There was no known illness at the time of vaccination. It was reported that a first lesion was noted on 9/17/05. On 9/23/05the patient broke out in shingles on her left abdomen, under her breast, and with one on her right thigh. She had about 14 total lesions on her abdomen and one on her thigh. It was noted that the patient would be put on antivirals if it recurred in the future. Subsequently, the patient recovered. There were no laboratory or diagnostic tests performed. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old white male, with no medical history and no allergies, who on 11/20/02, at 10:00, was vaccinated with a first SC dose in the left deltoid of varicella virus vaccine live (lot # 643084/0472M). There was no concomitant medication and no illness at the time of vaccination. It was reported that on 10/9/05 the patient's mother called the office regarding a rash that the patient developed on 10/9/05. The mother described the rash as red bumps, initially red and then cloudy white blisters. There were 30 to 60 lesions. The patient was seen by the physician, today, on 10/10/05. The physician confirmed the diagnosis of chicken pox. No treatment was ordered. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. Follow up information indicated that the outcome was unknown. Additional follow up indicated that the office had not heard from the family since the office visit on 10/10/05. Details of the illness and recovery status are unknown. Additional follow up from a health professional indicated that this child is not in their database and she has no additional information on this case. No further information is available.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning an 11 year old white male, with no medical history and no allergies, who on 9/18/95 was vaccinated with 1, 0.5ml SC dose in the left arm of varicella virus vaccine live (lot # 608588/0415B). Concomitant vaccine administered on the same day included a dose in the right arm of MMR (lot # 615324/0620B). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 10/10/05, the patient presented with a vesicular rash of about 40 lesions. The patient was being treated with over the counter diphenhydramine hydrochloride. At the time of the report, the patient was recovering. The patient was to follow up with a nurse practitioner. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that on 10/9/05, the patient was afebrile and a rash started with 30-40 scattered papules and vesicles. Treatment included diphenhydramine hydrochloride and avena. It was reported that the patient recovered. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 1/7/05 was vaccinated with a dose of varicella virus vaccine live. On 9/22/05, the patient's brother developed chicken pox (WAES0510USA04952). On 10/7/05, the patient developed chicken pox breakthrough. Additional information has been requested.
Age: 1.13
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old patient who on 9/18/98 was vaccinated with a dose of varicella virus vaccine live (lot # 627330/1052H). Concomitant therapy that day included MMR and monovacc. On 10/5/05 the patient developed chicken pox breakthrough. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 17 month old female with no allergies and no reported medical history who in May 2005, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot # 648750/0446P). There was no concomitant medication. On 10/11/05 the patient presented with shingles. A culture is being sent for lab diagnostics. The adverse event did not improve and the patient is not recovered. There was no product quality complaint reported. Follow up information received on 11/23/05 from a health professional reported that the results to the PCR diagnostic test was vaccine type. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Feeling hot, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 month old male with no pertinent medical history and no drug reactions/allergies who on 10/3/05 was vaccinated SC in the right arm with a 0.5mL dose of varicella virus vaccine live (lot # 649643/0421R). There was no illness at the time of vaccination. There was no concomitant medication. On 10/8/05 (also reported as 10/9/05), the patient's mother reported that she walked into the patient's room and thought he had a seizure. She indicated that she did not witness the seizure, but has experienced seizures in children, and the patient has appeared to have just had a seizure. The child felt hot to touch. She gave the child acetaminophen, and then noticed he had spots on his face, trunk, and legs. The mother called the physician on 10/10/05, and the child was seen on 10/11/05. The physician confirmed that the lesions were chickenpox. No treatment was ordered. No other information was available. There were no lab diagnostic studies performed. The physician indicated that the patient was stable. There was no product quality complaint. Follow up information received from a licensed practical nurse indicated that the patient recovered. There were no adverse events following prior vaccinations of the patient or siblings. Upon internal review, seizures was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 43 year old female who on 10/30/04 was vaccinated SC with a 0.5mL first dose of varicella virus vaccine live and on 8/1/05 was vaccinated SC with a 0.5mL second dose of varicella virus vaccine live (lot # 651280/0408R). Concomitant therapy included metformin HCl and insulin. IN approximately August 2005, the patient failed to seroconvert. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 2.9
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a physician concerning a 35 month old male who was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live. Subsequently, the pt  experienced shingles. Unspecified medical attention was sought. The pt's shingles persisted. A product quality complaint was not involved. Additional info has been requested.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 7 year old white female pt with no medical history who on 6/3/99 was vaccinated, SC, in the right arm with a 0.5ml, 1st dose of varicella virus vaccine live (lot 629615/0310J). Concomitant vaccination given on that same day included a 1st dose of MMRII (lot 630629/0352J) given, SC, in the left arm. There was no illness at the time of vaccination. On 10/3/05, the pt developed breakthrough chickenpox characterized by less than 15 papules/vesicles on her trunk and extremities. Unspecified medical attention was sought. It was reported that the pt fully recovered as of 10/15/05. No product quality complaint was involved. Additional info is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a physician concerning a 5 year old white female who on 3/5/01 was vaccinated with a 1st 0.5ml, SC, dose of varicella virus vaccine live. On 10/10/05, the pt presented with breakthrough chickenpox involving over 50 lesions and a fever on the 1st day. The pt was treated with Benadryl. It was noted that, at the time of the report, the pt was still recovering. No product quality complaint was involved. No other info was provided. Follow-up info from a physician indicated that on 10/10/05, the pt had in excess of 50 lesions on the 1st day of breakthrough. Additional info has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 4 year old female who on 11/1/01 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/8/05, the pt presented to the office with a case of breakthrough characterized by greater than 50 lesions. The pt was noted to be afebrile. No medication was given to treat the breakthrough. At the time of this report, the outcome was unknown. Additional info has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Info has been received from an RN concerning her 8 year old son who was vaccinated, SC, with a 0.5 ml dose of varicella virus vaccine live. Subsequently, in 2/05, the pt experienced fever and 20 lesions on legs, stomach and face. Unspecified medical attention was sought and the pt was treated with Tylenol. Subsequently, the pt recovered. No product quality complaint was involved. Additional info has been requested.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Info has been received from a health professional concerning a 36 year old white male with profound mental retardation, "spastic quad", convulsion disorder, dysphagia with aspiration, chronic UTI and hydronephrosis who on 5/10/05 at 16:00 was vaccinated, IM, in the right deltoid with a 1st dose of varicella virus vaccine live (lot 646535/0575N). Concomitant therapy included tuberculin purified protein derivative (lot C2114AB( given, SC, in the left forearm at 10:00 on 5/12/05; polyethylene glycol 3350 (Miralax) daily, bisacodyl (Dulcolax) tablets daily, levofloxacin (Levaquin) 500mg daily (discontinued on 5/3/05), baclofen 10mg BID, famotidine (Pepcid) tablets 20mg BID and phenobarbital 162mg IVS. The pt was treated for a UTI sepsis 1-2 weeks prior to the vaccination. On 5/28/05, at 09:35, the pt experienced a red rash noted on his entire trunk. It was reported that he developed fluid filled vesicles and fever and was treated with isolation, Tylenol, increased fluids and calamine lotion. New areas developed daily, his entire body was covered. Subsequently, the pt recovered as of 6/5/05. Additional info is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Info has been received from an RN concerning a healthy 36 month old female pt with no allergies, who on 2/7/05 was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live (lot 646817/1063N). There was no concomitant vaccine administered on 2/7/05. Beginning on 10/10/05, the pt developed a fever and by 10/11/05, she had also developed "spots" which numbered about 30 by 10/12/05. No treatment was recommended. There were no lab studies completed. Additional info has been requested.
Age: 1.07
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 6 year old female with no known drug allergies who on 6/27/00 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The RN reported that on 10/10/05, developed itchy white bumps on different areas of her body X 2-3 days. The pt was noted to be afebrile. The pt subsequently, developed 14 isolated papules on her neck, chest and right underarm. A diagnosis of mild breakthrough was made. Unspecified medical attention was sought and the pt was treated with calamine lotion. No lab/diagnostic tests were performed. In 2005, the pt's breakthrough subsequently, resolved. Additional info is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a pediatric pt who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/13/05, the pt developed a mild case of breakthrough chickenpox. Unspecified medical attention was sought. At the time of this report the outcome was unknown. Additional info has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a physician concerning an 11 year old female who was vaccinated with a dose of varicella virus vaccine live. In July 2005, the pt developed shingles. Unspecified medical attention was sought. The pt's status was unknown. There was no product quality complaint involved. Additional info has been requested.
Age: 1.12
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 yr old male with no medical history who on 18May98 was vaccinated with a dose of varicella virus vaccine live (lot 625043/1567E). There was no concomitant medication. On 10Oct05 the pt experienced a mild case of breakthrough varicella with less than 50 lesions. Some of the lesions were crusted over. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 yr old female who on 05Sep01 was vaccinated with a dose of varicella virus vaccine live (lot638729/0238L). On 21Sep05, the pt developed mild break through  chickenpox characterized by approx 10 lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a female who was vaccinated with varicella virus vaccine live. The RN reported that in Oct 2005, the pt developed chickenpox. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Headache, Injection site erythema, Rash pruritic, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 46 yr old female with no medical history or known allergies who on 26Sep05 was vaccinated SC in the left arm with the first 0.5mL dose of varicella virus vaccine live (Lot651174/0422R). There was no concomitant therapy. It was noted that the pt had received a tetanus vaccine one month prior to vaccination with varicella virus vaccine live. The LPN reported that on 27Sep05, the pt developed a headache, vomiting, weakness and a red, itchy rash on her left arm. The pt was noted to be afebrile. Unspecified medical attention was sought, but no treatment of laboratory/diagnostics tests were required. On 28Sep05, the pt recovered from her events. Additional information is not expected.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Nasal congestion, Pruritus, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 4 yr old male with no medical history or allergies who on 16Jul02 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy or illness at the time of vaccination. The CMA reported that on the evening of 13Oct05, the pt developed itchy, red bumps on his head that began spreading. On 14Oct05, the pt presented to physician's office with a few erythematous papules and vesicles on his head, hand, scalp, and neck and nasal congestion. No fever was noted. A diagnosis of breakthrough chickenpox was made. The pt was treated with oral diphenhydramine HC1 (Benadryl) and acetaminophen (Tylenol) as needed. No laboratory/diagnostic tests were performed. Subsequently, the pt's chickenpox resolved. Additional information is not expected.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 4 yr old male with no medical history or allergies who on 16Jul02 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy or illness at the time of vaccination. The CMA reported that on the evening of 13Oct05, the pt developed itchy, red bumps on his head that began spreading. On 14Oct05, the pt presented to physician's office with a few erythematous papules and vesicles on his head, hand, scalp, and neck and nasal congestion. No fever was noted. A diagnosis of breakthrough chickenpox was made. The pt was treated with oral diphenhydramine HC1 (Benadryl) and acetaminophen (Tylenol) as needed. No laboratory/diagnostic tests were performed. Subsequently, the pt's chickenpox resolved. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash macular, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 9 yr old male pt with no medical history, who on 01Mar01 was vaccinated with a first dose of varicella virus vaccine live (lot636360/1334K). There was no concomitant medication. The pt was not ill at the time of vaccination. On 08Oct05 the pt developed chickenpox lesions on his back and within 48 hrs they spread all over his body 50-75 lesions in different stages, macular, vesicular, scabbed over arms, legs, trunk and groin area, toes and scalp. There were no lab tests performed. The pt did not seek medical attention. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 or 9 yr old male with diabetes who was vaccinated at 4 years of age with a dose of varicella virus vaccine live. On 06Sep05 the pt experienced a mild case of chickenpox. Subsequently, the pt recovered. It was noted that the father had developed shingles that required an ER prior to the child's outbreak. Unspecified medical attention was sought. No product quality complaint was involved. The pt's sister (WAES0510USA04275) also developed chicken pox after vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 7 yr old female who on 01May00 was vaccinated with a dose of varicella virus vaccine live. On 30Sep05 the pt had a chickenpox breakthrough. It was reported that the pt's mother called the school the report that the child had a generalized rash over her body, with about 30 pox and a temp of 103. The pt was out of school the week of 03Oct05, and returned back to school on 11Oct05. The pt fully recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that there was no additional information to be reported. Additional information is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Croup infectious, Diarrhoea, Lymphopenia, Nasal congestion
Clinical narrative: Information has been received from a physician concerning a 12 month old health white female, with no allergies, who on 04Oct05 was vaccinated with a 0.5ml SC first dose in her left arm of varicella virus vaccine live (lot648087/0099P). Concomitant vaccination that day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. That afternoon on 04Oct05, the pt developed a low grade fever. Cefdinir (Omnicef) was given to the pt for potential infection. On 10Oct05 the pt was seen in the office. He had a runny nose on and off, diarrhea x 1 day, a rare cough and pharyngitis. The pt was treated with ibuprofen (Advil) at 8:30AM. Urinalysis, urine culture and CBC were performed. It was reported that the CBC was consistent  with a virus, see lab section. The pt's chest was clear and she did not have a rash. On 14Oct05 the pt presented to the office. Her temp was 101 at home and 98.1 axillary at the office. She did not have a fever yesterday. She was more sleepy acting today. She was given ibuprofen (Motrin) at 12:25. The pt had pharyngitis with a clear chest and no cough. A urinalysis was done that was ok. She was treated with cefdinir (Omnicef) 125/5, 1/2 tsp. BID for 5 days. On 17Oct05 the pt was seen in the office. Her temp was 98.7 axillary, it was 100.2 in the morning. She did not have a cough and her chest was clear, but her nose was congested. She had mild pharyngitis without a rash. A CBC was performed, see lab results. On 18Oct05 the pt was seen in the office with a croup cough. There was no wheezing or stridor. Her chest was clear. She was treated with chlorpheniramine maleate (+) phenylephrine hydrochloride (+) phenyltoloxamine citrate (Nalex) 1.5 to 2mL every 6 hrs, at night PRN for bad cough, and albuterol (unspecified) 2mL PO every 6 hrs and PRN for tight cough or wheeze. On 19Oct05 the pt was seen in the office. Her temp  was 97.8 and her respiratory rate was 26. She sounded more croupy and congested. She had mild stridor with crying and pharyngitis, and her chest was clear. She was given acetaminophen (Tylenol) at 5:30. She was treated with azithromycin (Zithromax) 200/5, 3/4 tsp everyday for 4 days, and prednisolone sodium phosphate (Orapred) 15/5, 3/4 tsp everyday for 4 days. It was reported that on 20Oct05 the pt's fever resolved. The pt's outcome was recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Pharyngitis, Platelet disorder, Pyrexia, Respiratory rate decreased, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning a 12 month old health white female, with no allergies, who on 04Oct05 was vaccinated with a 0.5ml SC first dose in her left arm of varicella virus vaccine live (lot648087/0099P). Concomitant vaccination that day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. That afternoon on 04Oct05, the pt developed a low grade fever. Cefdinir (Omnicef) was given to the pt for potential infection. On 10Oct05 the pt was seen in the office. He had a runny nose on and off, diarrhea x 1 day, a rare cough and pharyngitis. The pt was treated with ibuprofen (Advil) at 8:30AM. Urinalysis, urine culture and CBC were performed. It was reported that the CBC was consistent  with a virus, see lab section. The pt's chest was clear and she did not have a rash. On 14Oct05 the pt presented to the office. Her temp was 101 at home and 98.1 axillary at the office. She did not have a fever yesterday. She was more sleepy acting today. She was given ibuprofen (Motrin) at 12:25. The pt had pharyngitis with a clear chest and no cough. A urinalysis was done that was ok. She was treated with cefdinir (Omnicef) 125/5, 1/2 tsp. BID for 5 days. On 17Oct05 the pt was seen in the office. Her temp was 98.7 axillary, it was 100.2 in the morning. She did not have a cough and her chest was clear, but her nose was congested. She had mild pharyngitis without a rash. A CBC was performed, see lab results. On 18Oct05 the pt was seen in the office with a croup cough. There was no wheezing or stridor. Her chest was clear. She was treated with chlorpheniramine maleate (+) phenylephrine hydrochloride (+) phenyltoloxamine citrate (Nalex) 1.5 to 2mL every 6 hrs, at night PRN for bad cough, and albuterol (unspecified) 2mL PO every 6 hrs and PRN for tight cough or wheeze. On 19Oct05 the pt was seen in the office. Her temp  was 97.8 and her respiratory rate was 26. She sounded more croupy and congested. She had mild stridor with crying and pharyngitis, and her chest was clear. She was given acetaminophen (Tylenol) at 5:30. She was treated with azithromycin (Zithromax) 200/5, 3/4 tsp everyday for 4 days, and prednisolone sodium phosphate (Orapred) 15/5, 3/4 tsp everyday for 4 days. It was reported that on 20Oct05 the pt's fever resolved. The pt's outcome was recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Somnolence, Weight increased, Wheezing, White blood cell disorder
Clinical narrative: Information has been received from a physician concerning a 12 month old health white female, with no allergies, who on 04Oct05 was vaccinated with a 0.5ml SC first dose in her left arm of varicella virus vaccine live (lot648087/0099P). Concomitant vaccination that day included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). There was no illness at the time of vaccination. That afternoon on 04Oct05, the pt developed a low grade fever. Cefdinir (Omnicef) was given to the pt for potential infection. On 10Oct05 the pt was seen in the office. He had a runny nose on and off, diarrhea x 1 day, a rare cough and pharyngitis. The pt was treated with ibuprofen (Advil) at 8:30AM. Urinalysis, urine culture and CBC were performed. It was reported that the CBC was consistent  with a virus, see lab section. The pt's chest was clear and she did not have a rash. On 14Oct05 the pt presented to the office. Her temp was 101 at home and 98.1 axillary at the office. She did not have a fever yesterday. She was more sleepy acting today. She was given ibuprofen (Motrin) at 12:25. The pt had pharyngitis with a clear chest and no cough. A urinalysis was done that was ok. She was treated with cefdinir (Omnicef) 125/5, 1/2 tsp. BID for 5 days. On 17Oct05 the pt was seen in the office. Her temp was 98.7 axillary, it was 100.2 in the morning. She did not have a cough and her chest was clear, but her nose was congested. She had mild pharyngitis without a rash. A CBC was performed, see lab results. On 18Oct05 the pt was seen in the office with a croup cough. There was no wheezing or stridor. Her chest was clear. She was treated with chlorpheniramine maleate (+) phenylephrine hydrochloride (+) phenyltoloxamine citrate (Nalex) 1.5 to 2mL every 6 hrs, at night PRN for bad cough, and albuterol (unspecified) 2mL PO every 6 hrs and PRN for tight cough or wheeze. On 19Oct05 the pt was seen in the office. Her temp  was 97.8 and her respiratory rate was 26. She sounded more croupy and congested. She had mild stridor with crying and pharyngitis, and her chest was clear. She was given acetaminophen (Tylenol) at 5:30. She was treated with azithromycin (Zithromax) 200/5, 3/4 tsp everyday for 4 days, and prednisolone sodium phosphate (Orapred) 15/5, 3/4 tsp everyday for 4 days. It was reported that on 20Oct05 the pt's fever resolved. The pt's outcome was recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 12 month old pt who was vaccinated SC once with a 0.5mL dose of varicella virus vaccine live. The physician reported that the pt broke out with shingles one week later. No other details were provided regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 15 year old son with no medical history or allergies who in May of 1999 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. On 9/25/2005 the patient experienced a breakthrough case of chickenpox. Unspecified medical attention was sought and no diagnostic or laboratory test were performed. The patients breakthrough case of chickenpox persisted. No product quality complaint was involved. No further information was provided. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 month old male with no pertinent medical history and no drug reactions/allergies who on approx 17Sep05 was vaccinated with a 0.5mL dose of varicella virus vaccine live (lot651045/0324R). There was no concomitant medication. On approx 07Oct05 the pt developed 40 lesions located on various parts of his body. The outcome was reported as not recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. No further information was available at the time of the report. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash, Lymphadenopathy, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an incident involving a child who was vaccinated last month (Sept 2005) with varicella virus vaccine live and developed lesions around the injection site, reported as a rash and lymphadenopathy in the groin after vaccination. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a male child who approx two weeks ago, in Oct 2005, was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt was seen at the office, yesterday on 17Oct05, with chickenpox with more than 30 lesions over his body. The child was being treated with acyclovir and a follow up visit was scheduled for next week. At the time of the report the pt had not recovered. No product quality complaint was involved. No other information was provided. The reporter considered chickenpox to be an other important medical event (OMIC). Additional information has been requested. The pt's classmates experienced chickenpox following exposure to varicella virus vaccine live (WAES0510USA08437).
Age: 1.03
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Nasal congestion, Pharyngitis, Pyrexia, Rhinitis, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 40 month old premature female with Down's syndrome, a transitional AV canal, and no allergies who on 04Jun03 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot643592/0807M). Concomitant vaccination on the same day included an IM fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (lot491577). There was no illness at the time of vaccination. On 09Oct05, the pt developed a fever, congestion, and one lesion. Over the next few days she was not feeling well and on 11Oct05 she was taken to the doctor's office. She had developed more lesions and had a continuing fever. The maximum number of lesions was 14. Treatment was symptomatic relief and isolation. On 18Oct05, she developed four new lesions after the initial lesions crusted over. No diagnostic laboratory tests were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow up information was received from the RN who reported that on 09Oct05, the pt was seen in the office for cold symptoms, fever and vomiting on 04Oct05 and 07oct05. On 09Oct05, she was noted to have pimples on her face. She was seen in the office again on 11Oct05 for crusty lesions on her face. She was diagnosed with probable varicella on 18Oct05. She was seen again in the office on 19Oct05 for infected pox on her face. She was put on mupirocin (Bactroban) for impetigo. She was isolated until all the pox crusted. The pt recovered on 24Oct05. Neither the pt or her sibling had any adverse events following prior vaccination. Probable varicella and impetigo were considered to be other important medical events by the reporter (OMIC). No further information is expected.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 14 month old male with no pertinent medical history and no allergies who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (on an unspecified date). There was no concomitant medication. Subsequently, the pt experienced mild breakthrough varicella (date unspecified). Unspecified medical attention was sought and no diagnostic or lab tests were performed. The present status of the pt was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a male pt who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt experienced a mild breakthrough of chickenpox, characterized by about 20 lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 29Nov99 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live (lot 628697/1838H). On 09Oct05 the pt presented with about 42 vesicular lesions over her body. It was reported that the child has since fully recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that there was no additional information to be reported on the pt. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 25 yr old female who on 04Oct05, at 14:15, was vaccinated in the right arm with a first dose of varicella virus vaccine live (lot 651280/0408R). On approx 18Oct05 the pt experienced generalized vesicular rash, fever and URI symptoms that were self resolving. This occurred on approx 18Oct05, about 14 to 21 days post vaccination. Subsequently, the pt recovered. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Facial palsy
Clinical narrative: Information has been received from a pharmacist concerning an adult male pt who two to four weeks ago on an unspecified date in Sept 2005, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. On 14Oct05 he presented to his physician with was seems to be Bell's palsy. No other information was available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 yr old white female with a penicillin allergy who on 08Mar01 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot632719/1241K). There was no illness at the time of vaccination. On 12Oct05 the pt was diagnosed with breakthrough chickenpox. The child had about 40 lesions that have crusted over. No fever was present. The outcome was reported as recovering. There was no product quality complaint. No further information was available. Follow up information indicated that the pt recovered on 20Oct05. There were no relevant  diagnostic test or laboratory data. There were no adverse events following prior vaccinations of the pt. No additional information is expected.
Age: 1.31
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: Info has been received from a CMA concerning a 16 month old white female with no medical history who on 10/7/05 was vaccinated, SC in right arm, with a 0.5ml dose of varicella virus vaccine live (lot 647952/0985P). Concomitant vaccinations on that same day included a 3rd dose, in the right thigh of Hib conj vaccine (OMPC), (lot 651475/0205R). There was no illness at the time of vaccination. The CMA reported that on 10/19/05, the pt developed 10 scattered papules on her thigh, chest and arms. On 10/20/05, the pt presented to the physician's office with a fever and 7 vesicular lesions. No other symptoms were noted. The pt was treated with Benadryl prn. The pt's scattered papules subsequently resolved. At the time of this report, the pt was recovering from the fever and vesicular lesions. Additional info is not expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Laboratory test abnormal
Clinical narrative: Info has been received from a heath professional concerning a 30 year old female (White and Hispanic) with a history of idiopathic thrombocytopenic purpura that resulted in a splenectomy who on 7/21/05, at 13:00, was vaccinated, SC, in the left upper arm with a 1st dose of varicella virus vaccine live (lot 044P). There was no concomitant medication that day and no illness at the time of vaccination. Concomitant vaccinations on 7/1/05, at 13:00, included a 3rd dose, IM in the left deltoid of Engerix-B (lot 650454/0751P). On 8/11/05, the pt experienced breakthrough after vaccination with 10 lesions that were vesicular, papular and crusted over. The pt had no systemic symptoms. It was noted that on 5/18/05, a Zoster IGG was negative and 1 done on 9/12/05 was positive. No product quality complaint was involved. Follow-up info indicated that the pt began to have vesicular lesions about 8/11/05. She thought they were insect bites but more developed. At the time, the pt was seen on 8/16/05, there were about 10 lesions which the pt thought were not insect bites since they were in areas where she was always clothed. She had no constitutional symptoms. It was noted that the pt believes she had a reaction to the varicella vaccine. There were about 6 visible lesions, one of the earliest is noted on the lower leg and appears as an impetigo lesion. There are small non-purulent papules about 3mm in diameter on the hands and feet. The 6 lesions are in various stages of healing. The 2 on the calf and arm are crusted with an "erythematous" base. The two on the palm and sole of the foot are papular and without serious fluid present as are the others on the neck and arm. One lesion on the chest has a small amount of serous fluid. The assessment was "a possible reaction to varicella beginning 21 days after the administration of the vaccine. "See lab section for relevant lab results. The pt recovered on an unknown date. Additional info is not expected.
Age: 1.14
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Bacterial infection, Infection
Clinical narrative: Info has been received from a CMA concerning a 13 month old male with no medical history or allergies who on 9/16/05 was vaccinated, SC in the left arm, with the 1st 0.5mL dose of varicella virus vaccine live (lot 650230/1113P). Concomitant vaccinations on that same day, included the 1st, SC dose in the left arm of MMRII (lot 647562/0573R) and the 4th, IM dose in the left thigh, of Prevnar (lot A74406B(. There was no other concomitant therapy. The CMA reported that on 10/14/05, the pt developed chickenpox characterized by 12 lesions. It was noted that there was no known exposure to wild-type varicella. On 10/17/05, the pt was seen in the physician's office. No treatment or lab/diagnostic tests were required. At that time, the pt was also noted to have a secondary case of impetigo which was treated with Bactroban ointment and cephalexin. In 2005, the pt subsequently recovered from the chickenpox and impetigo. Additional info is not expected.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 16 month old female with no pertinent history and no allergies who was vaccinated, SC with a 0.5ml dose of varicella virus vaccine live (on an unspecified date). There was no concomitant medication. Subsequently, the pt experienced breakthrough varicella (date unspecified). Unspecified medical attention was sought and no diagnostic or lab tests were performed. The present status of the pt was not reported. No product quality complaint was involved. Additional info has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Info has been received from a physician concerning a 12 month old white female twin who on 1/3/01 was vaccinated, SC with the 1st 0.5ml dose of varicella virus vaccine live. Concomitant vaccinations on that same day included the 1st dose of MMRII. There was no illness at the time of vaccination. The physician reported that on approximately 1/10/01, 7-10 days, post vaccination, the pt developed 40 varicella skin lesions without significant systemic illness. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. Subsequently, the pt recovered from the varicella skin lesions. Additional info is not expected.
Age: 2.3
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Info has been received from an RN concerning a 27 month old female who in 7/04, at one year of age, was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 10/17/05, the pt developed a generalized rash. It was noted that the pt was exposed to chickenpox in July 2005. On 10/19/05, the pt was seen by a physician, but no treatment was ordered. At the time of this report, the pt was recovering from the generalized rash. Additional info has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a mother concerning her 12 year old son who had no medical history or allergies who in 9/95, was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The pt's mother reported that on 10/15/05, her son developed chickenpox. Unspecified medical attention was sought and a throat culture was done (results not provided. On 10/21/05, the pt recovered from the chickenpox. Additional info has been requested.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Info has been received from an RN concerning a 4 year old female who on 6/24/02, at 12 months of age, was vaccinated, IM in the left arm, with the 1st dose of varicella virus vaccine live (lot 641794/0209M). The RN reported that on 10/11/05, the pt developed breakthrough varicella. Medical attention was not sought. The pt was treated with Atarax for the itching. The pt subsequently recovered from the breakthrough varicella. Additional info is not expected.