chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a pharmacist concerning a 24 month old white child with no known drug allergies and no past medical history who on 03/24/03 at approximately 11:30AM was vaccinated SC in the right leg with a first dose of varicella virus vaccine live (Lot # 640071/1317L). There was no illness at the time of vaccination. The reporter indicated that the pt was inadvertently given an expired dose of the vaccine. Unspecifed medical attention was sought. Follow up information received from a RN indicated that no adverse reactions occurred. It was noted that the "expiration date was 03/18/03-dose administered 03/24/03".  No diagnostic tests or lab data were reported. No further information is expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old white female with no known drug allergies and no past medical history who on 10/25/95, when she was 10 years and 11 months, was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot #608667/0426B). There was no illness at the time of vaccination. There was no concomitant medication. On 3/22/03, the patient broke out with a rash which was described as approximately 25 chicken pox that were small. Unspecified medical attention was sought. Follow up information received from a licensed practical nurse indicated that on 3/24/03 in the Am the patient developed a modified case of varicella. On 3/31/03 the patient recovered. No further information was expected.
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female who on 3/22/03, was vaccinated with a dose of varicella virus vaccine live. The RN reported that in March 2003, the patient developed an itchy elbow. The patient was seen in the health room and after examinations, the RN also found small red vesicles around the patient's itchy elbow. The school physician was called. It was noted that the patient had no other symptoms. The RN also reported that the patient's mother indicated that the patient had been exposed to poison the day before the symptoms started. The area was normal the next day. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old Caucasian male patient who on 1/13/99 was vaccinated (at previous doctor's office) with a dose of varicella virus vaccine live. No concomitant therapies noted on previous records. Approximately 7 months later, he developed full blown varicella described as extensive chicken pox. On 3/14/03, the patient developed chicken pox described as, a rash over a good bit of the body, breaking out in crops with red bases and vesicles. No tests were completed. It was noted that this was not a reaction to the vaccine but rather that the patient had developed chicken pox twice since vaccination and that chicken pox was going around school. It was unknown if medical attention was sought. The physician also reported on another patient. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an adult female with a history of varicella exposure who in approximately 2001 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that antibody testing showed that she failed to seroconvert. It was reported that the patient did not have documentation of the vaccination, but had verbalized that she was vaccinated. Unspecified medical attention was sought. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Rash macular
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old male patient with upper respiratory tract infection, and no medical history who on 5/29/96 was vaccinated by SC injection in the arm with a first dose of varicella virus vacine live (lot # 609287/0393B). Concomitant medication administered on the same day, 5/29/96 via SC injection in the right arm included a first dose of MMR (lot # 616874/0104D). The reporter indicated the patient broke out in a varicella rash, described as pruritic, maculopapular vesicular lesions, approximately 50 lesions on 3/23/03, (also reported by the health professional as began 3/24/03). It was noted no laboratory tests were done. The reporter noted the patient recovered.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Rash, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 47 month old Caucasian male patient with a medical history of RAD who on 3/27/00, (previously reported as 3/27/02) was vaccinated with a SC first dose in the left thigh of varicella virus vaccine live (lot number 632054/1447J). Illnesses at the time of vaccination were a URI and conjunctivitis. Concomitant therapy on 3/27/00, (previously reported as 3/27/02) included a SC first dose in the right thigh of MMR (lot number 634040/1715J). On 3/11/03 in the AM, the patient developed chicken pox described as a rash with 12-15 red papular lesions which never really vasiculated or crusted, and the patient had no fever. There was no relevant diagnostic laboratory data. It was als noted that the child was at the physician's office and was clinically diagnosed with croup, also described as URI/Croup-like illness, 48 hours prior to eruption. Unspecified medical attention was sought. On 3/14/03, the patient recovered. There was no product quality complaint involved. The physician also reported on two other siblings that developed chicken pox. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerninga 5 year old female Caucasian patient with no relevant medical history and no known allergies who on 9/1/99 was vaccinated with a first dose of varicella virus vaccine live, only, lot number no available. It was unknown if illness was present at the time of vaccination. The child developed chicken pox described as 20 lesions, which was vesicular, pruritic and crusted over within 48 hours and no other symptoms were noted. There was no relevant diagnostic data. It was noted that the physician stated that this case was the most like a typical varicella case. Unspecified medical attention was sought. on 3/14/03, the patient recovered. There was no product quality complaint involved. The physician also reported on two other siblings that developed chicken pox. No further information is expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Injection site rash, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received from a registered nurse and a physician concerning a 31 year old normal healthy white female employee with quinine and seasonal allergies and no significant medical history (including no immunosuppression, no history of chicken pox, and no known recent varicella or shingles exposure) who on 3/6/03 at 2:00 PM was vaccinated SC in the left upper arm with a 0.5cc first dose of varicella virus vaccine live (lot 640553/0799M). There was no concomitant medication. There was no illness at the time of vaccination. It was also noted that no rash occurred at the site of injection post-vaccination. On 9/13/02, the patient had a negative varicella titer prior to vaccination with varicella virus vaccine live. Also on 9/13/03 a serum hepatitis B surface antigen test was negative. On 3/24/03 the patient had greater than 150 lesions, described as multiple discrete papules. The physician indicated that a lesion sample which they were attempting to grow was direct fluorescent antibody positive. At the time of the report, nothing had grown from the sample. Unspecified medical attention was sought. Follow up information from the registered nurse indicated that on 3/22/03 at 3:00 PM the patient developed a maximum oral temperature of 101.4 F. On Monday the patient went to the doctor's office after a rash developed. Chicken pox was diagnosed. The lesions were red and raised and some were pustular with small amounts of drainage. Itching was described. There were 15 lesions on each leg, 46 on the trunk, 46 on the back, 13 on the right arm, 10 on the left arm, 10 on the head, 10 on the face, and two to three on the neck. On 3/23/03 the patient was seen by an infectious disease/infection control medical doctor. Preliminary results of direct fluorescent antibody testing of the lesion showed no varicella zoster virus isolated to date. On 3/26/03 the final report of the direct fluorescent antibody testing was positive for varicella zoster virus antigen. The reporter indicated that the lesion cultures had not grown. It was noted that the patient recovered on 4/4/03. Additional information was received which indicated that on 3/26/03  a specimen was obtained from a papule lesion and on 5/6/03 (also reported as 3/26/03), was sent for varicella zoster virus identification. Follow up information was received from a physician indicating that the patient had a wide distribution of lesions that were pretty much healed at this point. Follow up information was received which indicated that it was an adequate specimen and a polymerase chain reaction test was negative for varicella zoster virus. It was noted that the specimen was retested and was still found to be negative. No further information is expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse and a physician concerning a 31 year old normal healthy white female employee with quinine and seasonal allergies and no significant medical history (including no immunosuppression, no history of chicken pox, and no known recent varicella or shingles exposure) who on 3/6/03 at 2:00 PM was vaccinated SC in the left upper arm with a 0.5cc first dose of varicella virus vaccine live (lot 640553/0799M). There was no concomitant medication. There was no illness at the time of vaccination. It was also noted that no rash occurred at the site of injection post-vaccination. On 9/13/02, the patient had a negative varicella titer prior to vaccination with varicella virus vaccine live. Also on 9/13/03 a serum hepatitis B surface antigen test was negative. On 3/24/03 the patient had greater than 150 lesions, described as multiple discrete papules. The physician indicated that a lesion sample which they were attempting to grow was direct fluorescent antibody positive. At the time of the report, nothing had grown from the sample. Unspecified medical attention was sought. Follow up information from the registered nurse indicated that on 3/22/03 at 3:00 PM the patient developed a maximum oral temperature of 101.4 F. On Monday the patient went to the doctor's office after a rash developed. Chicken pox was diagnosed. The lesions were red and raised and some were pustular with small amounts of drainage. Itching was described. There were 15 lesions on each leg, 46 on the trunk, 46 on the back, 13 on the right arm, 10 on the left arm, 10 on the head, 10 on the face, and two to three on the neck. On 3/23/03 the patient was seen by an infectious disease/infection control medical doctor. Preliminary results of direct fluorescent antibody testing of the lesion showed no varicella zoster virus isolated to date. On 3/26/03 the final report of the direct fluorescent antibody testing was positive for varicella zoster virus antigen. The reporter indicated that the lesion cultures had not grown. It was noted that the patient recovered on 4/4/03. Additional information was received which indicated that on 3/26/03  a specimen was obtained from a papule lesion and on 5/6/03 (also reported as 3/26/03), was sent for varicella zoster virus identification. Follow up information was received from a physician indicating that the patient had a wide distribution of lesions that were pretty much healed at this point. Follow up information was received which indicated that it was an adequate specimen and a polymerase chain reaction test was negative for varicella zoster virus. It was noted that the specimen was retested and was still found to be negative. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 6 year old white female student who on 3/15/01 was vaccinated with a dose of varicella virus vaccine live. On 3/22/03 (previously reported as 3/24/03) the patient broke out with chicken pox with 15-20 lesions with vesicles. Unspecified medical attention was sought. On 4/5/03, the patient recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from an epidemiologist with the county health department concerning a patient who was vaccinated with varicella virus vaccine live. The reporter indicated a physician stated a patient was vaccinated with varicella virus vaccine live, and now has shingles. The reporter indicated she does not have the physician name or demographics at this time, and the patient was not in the physician's office at the time of this report. The reporter indicated that she had no other information at this time. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information ahs been received from a physician concerning a child who was vaccinated with two doses of varicella virus vaccine live "just a few days apart." Then "just recently the child came down with a bad case of chicken pox." This was approximately two years after the vaccinations. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer, the mother, concerning her nine year old son who in 1995 was vaccinated with a dose of varicella virus vaccine live. The reporter stated recently her son was "exposed" to someone with chickenpox, and broke out in doctor diagnosed "mild case of chickenpox on 22-MAR-2003". It was reported there was no fever. The reporter declined to give demographics or physician information.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Convulsion, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 month normal, healthy female with no significant medical history including no immunosuppression and no recent exposure to chickenpox, shingles, or other viruses who on 03/21/03, previously report as 06/21/03, was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 643593/0868M).  The physician indicated that she was not aware of the child experiencing any post-vaccination rash, fever, or injection site pain following vaccination.  On 03/25/03, the child started vomiting. On 03/26/03, the child had a 2-3 minute generalized seizure, which was the first of five 2-3 minute generalized seizures. The child was then admitted to the hospital. The reporter indicated that a CSF sample was sent out for PCR analysis. It was also noted that a prescription drug was required, the events were considered life threatening, and unspecified medical attention was sought. Follow up information received on 03/28/03 from a physician indicated that on 03/25/03 the child began to vomit and have seizures. It was noted that the child had a total of 5 seizures, each lasting 2-3 minutes.  She reported that the child did not have any fever prior to having the seizures; however she had "1-2 temperature spikes during some of the seizures". No rash was noted. The child was hospitalized in the intensive care unit and was undergoing a complete evaluation, including blood cultures. Additionally, while hospitalized, the child continued to have some vomiting, and had also developed loose stools. The physician noted that they were investigating possible GI sources for the child's sign/symptoms. The physician indicated on 03/28/03 that "to date, they do not have a diagnosis". As of 03/28/03, the child was much improved and was out of intensive care and back on a regular floor. It was noted that the child was sitting up and eating, though there was still no final diagnosis.  Additional follow up information indicated that "the results of the PCR analysis showed that it was an adequate specimen and that it was negative for both the wild-type varicella zoster virus and the vaccine strain virus".  It was also noted that the CSF specimen was obtained on 03/26/03, and the results showed that the VZV DNA was not amplified and the B-globin DNA was not amplified. Follow up information also indicated that on 03/26/03 the pt had a maximum temperature of 100.0F.  It was reported that the pt recovered. Additional follow up information received from a physician indicated that the CSF was negative and that the child has not had any further seizures associated with the vaccination. However the physician felt that it was necessary to report this adverse experience and investigate the VZV ID program since the vaccine had been administered 5 days prior to the onset of the seizures. Since the fever had occurred after the seizure, the physician did not consider these febrile seizures. It was noted that the physician felt the child had completely recovered. No further information is expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 23AUG1995 was vaccinated with a dose of varicella virus vaccine live. On approximately 19MAR2003 the patient developed a breakthrough case of chickenpox. It was reported that the patient presented to the doctor's office on 19MAR2003 with "scattered fluidy bumps". Unspecified medical attention was sought.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Information has been received from a registered nurse RN concerning a 4 year old male who on 12FEB2003 was vaccinated with a dose of varicella virus vaccine live (lot 643593/0868M). The RN reported that on 15FEB2003, the patient developed several vesicular lesions at the injection site. Unspecified medical attention was sought. At the time of this report, the outcome was unknown.  The RN also reported that the patient's 7 month old sibling also developed vesicular lesions after being exposed to the brother's vesicular lesions (WAES0303ISA002901). Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from the mother of a nine year old male with an allergy to insect bites who in 1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 28-MAR-2003, the patient's mother believed that her son developed chicken pox "today". No medical attention was sought. On 20-MAY-2003, it was reported that the physician's office did not give the immunization and that they were unaware of any adverse reaction. No further information is available.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning a 10 year old male patient with no allergies and no past medical history who in 1996 was vaccinated with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. On 26-MAR-2003, the patient developed a "brea out rash" that included 2 lesions under his left upper arm. 4 on his face, a couple on his stomach and a couple in the genital area. Unspecified medical attention was sought. Follow up information from the physician indicated that there is no record of vaccination with varicella virus vaccine live for this patient. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pain, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no medical history who on 25NOV1996, at 0910, was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot 620620/1107D). There was no illness at the time of vaccination. The physician reported that on 25-MAR-2003, the patient began complaining of hip pain and then began breaking out with blisters, atypical, not crossing the midline similar to herpes zoster At an office visit on that same day, it was noted that the lesions progressed form the left lumbar region over the groin to the anterior region of the thigh, left knee and left ankle. There was apparent L5-S1 involvement. The patient also developed a low grade fever. The physician also reported that the the patient developed generalized lesions consistent with chickenpox. The physician felt that the patient had a combination of herpes zoster and chickenpox. The physician indicated that, for about a day or so, the patient could not extend her leg or hip and could not walk because the herpes zoster lesions extended under her feet. The patient's parents carried her because of this. It was also noted that some of the patient's lesions contained pus. No laboratory tests were performed. Calamine, diphenhydramine HCl (Benadryl) and Cephalexin (KEFLEX) were prescribed. As of 27MAR2003, the patient seemed to be getting better as she could extend her leg and the lesions appeared to be healing. On 07-APR-2003, the patient recovered. No further information is available.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a consumer who is a 32 year old female patient with seasonal allergies and no relevant medical history who in approximately 2001 was vaccinated with two doses of varicella virus vaccine live and had blood work done that showed no antibodies. There was no concomitant medication. Unspecified medical attention was sought.
Age: 0.6
Sex: U
Vaccine: VARCEL
Symptoms: Medication error, Rash vesicular
Clinical narrative: Information has been received from a registered nurse RN concerning a 7 month old patient who on 22MAR2003, developed 8-9 vesicular lesions after being exposed to the brother who developed several vesicular lesions on 15FEB2003 after being vaccinated with varicella virus vaccine live on 12FEB2002 (WAES0303USA02761). Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician's assistant concerning a 13 year old male student with attention deficit/ hypersensitivity disorder and a "sulfa" allergy who on 02JUN1995 was vaccinated with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included methlyphenidate HCl (RITALIN) 10mg q AM and q noon. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. On 22MAR2003, the patient developed herpes zoster, which was noted to be on his right thigh. The patient was seen in the physician's office The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. It was noted that the child had no fever, quantified his pain at a 5-6 (0 being the least; 10 being the most), and complained of itching. The patient was placed on famciclovir (FAMVIR) for seven days. After one month, the patient recovered from the herpes zoster. Results of PCR analysis revealed that the zoster lesion contained the WT varicella zoster virus. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse RN concerning a 5 year old white female who on 10JAN2000 was vaccinated subcutaneously in the left arm with a dose of varicella virus live (lot 632037/1355J). There was no concomitant therapy. The patient was noted to be well at the time of vaccination. The RN reported that, in March 2003, the patient developed 25 spots which were considered to be mild as per the patient's father. The patient was not seen at that time. The patient was treated with diphenhydramine HCl (Benadryl) , calamine+camphor+pramoxine (AVEENO) and acetainophen (tylenol). In March 2003, patient subsequently recovered. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female patient who on 27OCT1997 was vaccinated with a dose of varicella virus vaccine live (lot 624062/0809E). The reporter indicated the patient developed a rash on 29-MAR-2003, and subsequently she was seen at another location of this physician's office on 31-MAR-2003, and was diagnosed with varicella (also reported by registered nurse as mild chicken pox diagnosed on 01APR2003). Follow up information received from the registered nurse reported there was no "follow-up" in this case of "mild" chicken pox break through post vaccination with varicella virus vaccine live.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received form a registered nurse concerning a female patient who on 14DEC1998 was vaccinated with a dose of varicella virus vaccine live (lot number 0668M). On 31-MAR-2003 the patient broke out with chickenpox. It was noted as a mild case and there were 6 lesions on her stomach and some on her back. Unspecified medical attention was sought.  Follow up information revealed that the office could not provide further information without the patient's name. No further information is expected.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 month old white male who on 10FEB2003 at 2pm was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot 641788/0595M). Concomitant vaccinations that day included a dose of measles mumps rubella vaccine (MSD) administered in the left thigh. ON 22FEB2003 the child broke out in a "chicken pox type rash" which cleared up. The reporter indicated that "today", 31MAR2003, the child presented with "new chicken spots" and a fever off and on. It was noted that unspecified medical attention was sought, however the reporter indicated that the child underwent no treatment or interventions and no prescription drug was required. Follow up information received form the certified medical assistant indicated that on 22FEB2003 at 1.45pm, 12 days after vaccination, the patient had an "outbreak". The outbreak then scabbed over. It was reported that "he seemed to be getting over it then on Monday , 31MAR2003, new spots started." It was noted that the patient came to the hospital where the reporter met him in the parking lot. The patient was diagnosed with chickenpox. No relevant diagnostic tests or laboratory data were reported. Additional follow up information received from the certified medical assistant indicated that the patient was referred to a dermatologist and "we don't think it's chickenpox anymore."  Additional information form a dermatological consultation was received from an advanced registered nurse practitioner which indicated that the patient was seen on 02MAY2003 for concerns of an erythematous papular eruption that involved the upper posterior neck, the cheeks bilaterally, the anterior neck and the upper and lower extremities. This was most prevalent on the lower extremities, however. These were erythematous crusting lesions. It was noted that the patient's chest, abdomen, mid-lower back and buttock area were completely spared. These did appear to be suspicious for an insect bite and the mother stated that she had an indoor/outdoor cat in the house and that she had seen fleas on the animal, as well as in the home. An assessment revealed erythematous papular dermatitis, most likely related to fea bites. The plan was to prescribe desonide ointment 0.05%. The patient's mother was to apply to the affected areas sparingly one to two times for the next seven to ten days. Steroid precautions were discussed at length. Additionally, it was recommended that they have the cat, as well as the house, treated for fleas. On 23JUN2003 the nurse practitioner telephoned the patient. Per the telecommunication, the mother reported that she had the house "bombed" for fleas and the papular eruption resolved. They have since however noted a reoccurence of some fleas and are now noting increasing bites again. It was recommended that she follow up with an exterminator regarding this. The nurse practitioner noted the patient's rash resolved with "bombing" for fleas in the house.
Age: 6.0
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer concerning a 6 year old male patient who on 26AUG1997 was vaccinated with a first dose of varicella virus vaccine live. Concomitant vaccination included a diphtheria toxoid+pertussis vaccine+tetanus toxoid and a dose of Haemophilus B conjugate vaccine (HIBTITER). On 28MAR2003, the patient developed a "slight break out of the chicken pox virus". The reporter noted that the patient was not brought to see the physician. Follow up information from a woman in a medical office indicated that the patient was not vaccinated at their office, but the office was notified of the patient's experience by the parent. The reporter described the event as a minor case of varicella and noted that this was "not a vaccine reaction". Subsequently in March 2003, the patient recovered. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Hypoaesthesia, Pain, Paraesthesia, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old black female employee with no allergies, no past medical history, no history of adverse events following prioer vaccination, no history of chickenpox and no recent exposure to chickenpox or herpes zoster who on 10MAR2003 at 17:00 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot 642877/0416M). There was no illness at the time of vaccination. Prior to vaccination on 25FEB2003, laboratory tests results included the following :varicella zoster virus  IgG antibody EIA 0.60 ISR (less than 0.91 is negative); measles IgG antibodies 3.03 ISR (greater than or equal to 1.10 is positive); rubella IgG antibodies 2.00 ISR (greater tan 1.09 is immune). On 19MAR2003, the patient developed pain (rated as 10 on a scale of 0 to 10), numbness and tingling in the abdominal and back area. On 22MAR2003, the patient was seen in the emergency room and was treated with naproxen (NAPROSYN). On 29MAR2003, the patient broke out with a rash of 20 lesions on her right side under the breast and on the lower back. On 01APR2003, the patient went to her primary medical doctor. Shingles and was diagnosed with an onset date of 19MAR2003. No laboratory tests were performed and a photo was not taken. A few weeks after onset, the patient recovered. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 45 year old black female employee with no allergies, no past medical history, no history of adverse events following prioer vaccination, no history of chickenpox and no recent exposure to chickenpox or herpes zoster who on 10MAR2003 at 17:00 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot 642877/0416M). There was no illness at the time of vaccination. Prior to vaccination on 25FEB2003, laboratory tests results included the following :varicella zoster virus  IgG antibody EIA 0.60 ISR (less than 0.91 is negative); measles IgG antibodies 3.03 ISR (greater than or equal to 1.10 is positive); rubella IgG antibodies 2.00 ISR (greater tan 1.09 is immune). On 19MAR2003, the patient developed pain (rated as 10 on a scale of 0 to 10), numbness and tingling in the abdominal and back area. On 22MAR2003, the patient was seen in the emergency room and was treated with naproxen (NAPROSYN). On 29MAR2003, the patient broke out with a rash of 20 lesions on her right side under the breast and on the lower back. On 01APR2003, the patient went to her primary medical doctor. Shingles and was diagnosed with an onset date of 19MAR2003. No laboratory tests were performed and a photo was not taken. A few weeks after onset, the patient recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that three days after vaccination, the patient developed 40 lesions. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 4 year old female patient with no allergies and no past medical history who on 12-Jul-1999 was vaccinated subcutaneously in the left anterior thigh with a first dose of varicella virus vaccine live (Lot #630574/0423J). There was no illness at the time of vaccination. On 02-Apr-2003, the patient was diagnosed with chicken pox. On day 1, the patient had more than 100 varicella lesions covering her body, scalp and in her ears. The patient had a low grade fever of 101 F. Unspecified medical attention was sought, but no other diagnostic tests were performed. On 08-Apr-2003 , the patient recovered. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a registered nurse through the manufacturer pregnancy registry concerning a 29 year old Caucasian female with a history of 2 pregnancies (one live birth and one spontaneous aborting) who on 02-Oct-2002 and on 07-Nov-2003 was vaccinated with a first and second dose of varicella virus vaccine live (site unknown) (lot #643122/0549M) (0.5 mL), respectively. Other therapy included, sertraline HCl (Zoloft) 25 mg) (from 26-Nov-2002 to 05-Dec-2002) (number of dose taken = 9) and nitrofuratoin (MACROBID) (5X/BID number of 10). It was noted that when the patient was vaccinated there was no local reaction at vaccination site, varicella (chichen pox) symptoms post vaccination, or herpes zoster (shingles) symptoms post-vaccination. It was reported that the patient received the first dose "14 days before conception." On 02-Apr-2003 it was reported that "the patient is now 21 weeks pregnant" (LMP = 06-Nov-2003, EDD= 13-Aug-2003). On 31-Jan-2003 the patient had a first trimester screening which was reported to be "within normal limits" (Negative for Down's risk, negative for trisomy 18). On 05-Mar-2003 the patient's MSAFP was negative (negative for NTD). On 21-Mar-2003 an ultrasound was performed due to exposure to varicella virus vaccine live and was reported to be normal. On 02-Apr-2003 it was reported that "at this point, the fetus is experiencing a slow heart rate." The patient sought unspecified medical attention. On 07-Aug-2003, 39 weeks from LMP, the patient gave birth to a normal male weighing 7 pounds 13 ounces. There were no other reported complications during pregnancy, or complications during labor/delivery, and no reported diagnostic test during pregnancy. There were no reported infections or illnesses during pregnancy and there were no concurrent medical conditions during pregnancy. It was also noted that the patient had a spontaneous abortion 0n 27-Oct-2000 (8 weeks and 5 days from LMP). On 01-Jun-2001 the patient was tested for varicella antibodies prior to being vaccinated and was negative (non-reactive (.48)). It was noted that a birth defect did not occur in any past pregnancy. On 01-Oct-2001 the patient had given birth to a male, weighing 8 pounds 6 1/2 ounces, 39 weeks from LMP. The infant was reported to be normal. There was a reported C-section breech with this pregnancy. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning a child patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed chickenpox. The child was taken to the emergency room three times related to chickenpox. The reporter also mentioned that they have been seeing "alot" of cases of chickenpox post vaccination with varicella virus vaccine live (WAES #0304USA01562). Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning an approximately 12-month-old female who on 06-Feb-2003 was vaccinated with a dose of varicella virus vaccine live (Lot # 642635/0270M). On approximately 20-Feb-2003, two weeks later, the child developed mild varicella. The child was treated with calamine (+) cmphor (+) pramoxine hydrochloride (AVEENO), diphenhydramine hydrochloride (Benadryl), and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females were vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00480), WAES #0304USA00481, WAES #0304USA00482. WAES #0304USA00483). Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash pruritic
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6-year-old male who on 04-Oct-1999 was vaccinated with a dose of varicella virus vaccine live (Lot #631165/0712J). On 02-Apr-2003 the child presented to the doctor's office with chickenpox, which was described as a generalized itchy rash all over his body and a mild fever. The child was treated with diphenhydramine hydrochloride (Benadryl) for the itch. Unspecified medical attention was sought. The reporter indicated that one other patient was vaccinated with a dose of varicella virus vaccine live and developed a generalized rash and a fever (WAES #0304USA00494). No additional information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 7 year old Semitist female who on 06-Dec-2002 was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient was on concomitant therapy but no medications were listed. On 03-Apr-2003 at 1000 the patient developed a mild case of chicken pox that the physician described as breakthrough varicella disease with greater than 30 pox/vesicles on the first day (also reported as less than 50 breakthrough lesions). On day 1 the patient was afebrile. No prescription drug treatment was required. Medical attention was sought and on 03-Apr-2003 it was reported that the patient's experience is still being treated. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Unintended pregnancy
Clinical narrative: Information has been received from an office manager through a manufacturer pregnancy registry concerning a 22-year old female who on 13-Jan-2003 was vaccinated with a dose of varicella virus vaccine live. The reported indicated that the patient may have been pregnant at the time of vaccination. No medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blister, Rash macular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a "well" 4-year-old white female with no medical history or allergies who on 13-Aug-1999 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot #0450J- invalid). Concomitant vaccination the same day included a third dose IM in the right arm of hepatitis B vaccine. recombinant (Engerix-B) (lot # 2941A2). The reporter indicated that in the a.m. of 29-Mar-2003 the patient developed scattered macules, vesicles and scabbed lesions on the arms, face and trunk. A doctor's visit was required. Calamine treatment was provided. Subsequently, the patient recovered. There were no diagnostic tests or laboratory results. It was unknown if the patient or her sibling had any adverse events following prior vaccinations.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a female between the ages of 9-years-old and 12-years-old who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a severe case of varicella, and was "covered" with lesions. The child was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), diphenhydramine hydrochloride (Benadryl), and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females (2 of which are the child's sisters) were vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00481, WAES #0304USA00482, WAES #0304USA00483). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a female between the ages of 9-years-old and 12-years-old who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a severe case of varicella, and was "covered" with lesions. The child was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEEN0), diphenhydramine hydrochloride (Benadryl), and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females (2 or which are the child's sisters) were vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00480, WAES #0304USA00482, WAES #0304USA00483). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning a female between the ages of 9-years-old and 12-years-old who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a severe case of varicella, and was "covered" with lesions. The child was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), diphenhydramine hydrochloride (Benadryl(, and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females (2 of which are the child's sisters) were not vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00480, WAES #0304USA00481, WAES #0304USA00483). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning an 11-year-old female who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a mild case of varicella. The child was treated with calamine (+) camphore (+) camphor (+) pramoxin hydrochloride (AVEENO), diphenhydramine hydrochloride (Benadryl), and acetaminophen (Tylenol) prn. Unspecified medical attention was sought. Additional information is not available at this time. The reporter indicated that 4 other females were vaccinated with a dose of varicella virus vaccine live from different lot numbers and experienced varicella (WAES #0304USA00358, WAES #0304USA00480, WAES #0304USA00481, WAES #0304USA00482). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a pharmacist concerning a her 12-month old male son who one and a half weeks ago, on approximately 25-Mar-2003, was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that her son has broken out in a chickenpox rash. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15-month-old female who on 24-Mar-2003 was vaccinated with a dose of varicella virus vaccine live (Lot #542676/0421M). On 03-Apr-2003 the child presented to the doctor's office with a generalized rash, described as being mostly on her chest and back, but some on her face, arms, and and legs. It was noted that the child has "no fever now", but the mother of the child stated the child had a fever up to 102 degrees on 01-Apr-2003, "two nights ago". No treatment was prescribed. Unspecified medical attention was sought. The reporter indicated that one other patient was vaccinated with a dose of varicella virus vaccine line and developed a generalized rash and a fever (WAES #0304USA00366). No further information is expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anxiety, Dermatitis bullous, Erythema, Infection, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old white female patient with no known allergies who on 24-Mar-2003 at 11 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live (Lot #644032/1059M). Concomitant vaccination included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There was no other concomitant medication. Two to three days post vaccination on approximately 26-Mar-2003, the patient developed "break through chickenpox" with a low grade fever and a small pox-like rash at the injection site. The patient sought medical attention and was treated with prescription diphenhydramine and acetaminophen (APAP). Follow-up information indicated that the patient developed a diffuse red rash with a low grade fever on 03-Apr-2003 at 15:15, ten days after the vaccine. It was noted that the patient was anxious. The reporter stated that this "also may be due to [measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)]". The reporter stated that there was no "clinically significant adverse event" and it was cleared in a few days. It was noted that the patient recovered from the diffuse red rash with a low grade fever. The reporter also mentioned a second patient that developed break through chickenpox post vaccination with a dose of varicella virus vaccine live (Lot #644032/1059M) (WAES #0304USA01917). Additional information is not expected.