chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a woman in a health department concerning may patients (demographics unspecified) who were vaccinated with a dose of varicella virus vaccine live (site unknown). It was reported that there was an unspecified adverse event due to improper storage. It was noted that the vaccine was stored at 33 degrees F for 119 days. The patients did not seek medical attention.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 15 to 18 month old male who in April 2001, was vaccinated with one dose of varicella virus vaccine live. On 13 JUL 2000 the patient experienced greater than 20 crusted and dry lesions. The lesion looked like varicella. Medical attention was sought. It was noted that his two siblings were not immunized and had varicella in the past few weeks prior to the patient's experience. In follow up, the reporter stated that there was in fact no true diagnosis of varicella in these children--the had an allergic reaction to detergent. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a consumer concerning her 9 year old daughter who in approximately 1998 was vaccinated with varicella virus vaccine live. On 28 JUN 2001 the patient broke out. The patient experienced 2.5 days of a 102.6 temperature and lesions in her mouth, throat and eyelids. The mother described this as a moderate case. Unspecified medical attention was sought. The mother reports that varicella ia spreading wildly through the community. It was noted that the patients brother (WAES #01071096) had a similar reaction after vaccination with varicella virus vaccine live and a subsequent exposure to chicken pox. Follow up information has been received from a physician indicating that the patient did not come to the office for evaluation. The physician reported that the vaccine was given in 1998, but not in his office.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who in 1995 was vaccinated with one dose of varicella virus vaccine live (lot 608582/0410B). Three to four years later, the patient experienced herpes zoster. The physician expressed a concern regarding the lot number. The physician noted that the vaccine was stored properly. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional patients were reported with adverse events following vaccination with varicella virus vaccine live (WAES01032473 and 01071648-01071649).
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning eight patients who in 1995 were vaccinated with one dose of varicella virus vaccine live (lot 608582/0410B). Three to four years later, the patients experienced attenuated chicken pox. The physician expressed a concern regarding the lot number. The physician noted that the vaccine was stored properly. The physician noted that half of the attenuated cases of varicella were from lot 608582/0410B which represented only about 5-10% of my varicella vaccine total doses used in the last 5 years. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional patients were reported with adverse experiences following vaccination with varicella virus vaccine live (WAES01032473, 01071647, and 01071649).
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a company representative concerning an unspecified number of patients who in 1995 were vaccinated with one dose of varicella virus vaccine live. Three to four years later, the patients experienced attenuated chickenpox. The physician expressed a concern regarding the lot number. The physician noted that the vaccine was stored properly. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional patients were reported with adverse experiences following vaccination with varicella virus vaccine live (WAES01032473 and 01071647-01071648).
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Rash, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 02 MAR 1999, at 14:00 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot #628184/1328H). It was unknown if there was any illness at the time of vaccination. On 12 JUL 2001 the patient was seen by the doctor with full blown chicken pox. The chicken pox was diagnosed by sight. There was no information on the number of lesions or treatment given. Follow up information was received from a health professional who reports that the rash started on her back on 07 JUL 2001 and by 08 JUL 2001 had spread to her face, abdomen, legs and hands. On 09 JUL 2001 she had a temperature of 102.8. It was reported that the rash with vesicles continued and that there were different stages of the rash. No laboratory tests were done and there was no hospitalization. Subsequently, on an unknown date, the patient recovered.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes simplex, Lip ulceration
Clinical narrative: Information has been received from a pharmacist concerning a 9 year old healthy female who was vaccinated with varicella virus vaccine live. Subsequently, one week after vaccination, she developed a very large cold sore on her mouth and lip. It was noted that the patient never had a cold sore before, Unspecified medical attention was sought. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 6 year old female patient who on 04 JUN 1997 was vaccinated with varicella virus vaccine live (lot #622972/0418E). There were no concomitant vaccines that day. On approximately 29 JUN 2001 the patient experienced more than 50 lesions. The patient had not yet been seen by a doctor. It was noted that the patient's three cousins (WAES #'s 01071354; 01071706; 01071707) had similar experiences after receiving varicella virus vaccine live. No further information was provided. Unspecified medical attention was sought. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 19 year old female who in early May 2001 was vaccinated with the first dose of varicella virus vaccine live. The physician reported that two weeks later, the patient developed a 20 to 30 varicella lesions scattered on her body and adenopathy, but was not ill. The physician reported that the condition has resolved. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a patient who on 21 JUN 2000 was vaccinated with varicella virus vaccine live (lot #634506/1770J). On approximately 29 JUN 2001 the patient experienced more than 50 lesions. The patient was not yet seen by a physician. It was also reported that unspecified medical attention was sought. It was noted that the patient's three cousins (WAES #'s 01071354; 01071705; 01071707) had similar experiences after receiving varicella virus vaccine live. No further information has been provided. Additional information has been request
Age: 1.75
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a healthy professional concerning an approximately 21 month old female patient who on 10/27/00 was vaccinated with a dose of varicella virus vaccine live. concomitant therapy that day included a dose of MMRII and a dose of Prevnar. On approximately 06/29/01, the patient experienced more than 50 lesions. She has not yet been seen by a physician. It was noted that the patient's three cousin's (WAES #'s 01071354,01071705, 01071706) had a similar experiences after receiving varicella virus vaccine live. Unspecified medical attention was sought. Additional information has bee request.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning a patient who was vaccinated with varicella virus vaccine live. Subsequently the patient developed shingles. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a 10 year old white female, with no medical history, no known illness at the time of vaccination and no known allergies who on 06/15/2001 was vaccinated with the first dose of varicella vaccine in the arm. There was no concomitant medication. On 06/21/2001 the pt developed a "full blown classic case" of chicken pox. The pt sought unspecified medical attention. It was reported that the pt recovered on 07/01/2001. No further info is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin ulcer, Upper respiratory tract infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white female child with a sulfamethoxazole (+) trimethoprim (Bactrim) allergy who on 16 AUG 1999 was vaccinated "H" in the left arm with a first dose of varicella virus vaccine live (lot #631067/0447J). The child was reported to have been well at the time of vaccination. On 29 JUN 2001 the child erupted with 25-50 fluid filled lesions and complained of mild itching. It was noted that the child a afebrile. The child was treated with benzocaine (+) triclosan (+) camphor (Solarcaine), calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), and calamine (+) camphor (+) diphenhydramine hydrochloride (CALADRYL). It was noted that the child had mild upper respiratory symptoms for a few days prior to the experience. On 05 JUL 2001 the patient recovered. It was reported that the child had a sibling that died from a heart defect. No further information is available.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning a female child who on 02/06/2001 was vaccinated with varicella vaccine. Subsequently, the pt developed chicken pox with approx. 50 lesions. The pt sought medical attention. The registered nurse also discussed the experience of two other children after vaccinated with varicella vaccine. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning now a five year old male pediatric pt who on 01/29/1997 was vaccinated SC in his left arm with the first dose of varicella vaccine. Concomitant therapy included tuberculin purified protein derivative. On 05/22/2001, the pt developed chicken pox (30 lesions). The pt sought medical attention and was treated with Zovirax. Subsequently, the pt recovered from his chicken pox. The licensed practical  nurse also discussed the experience of two other children after vaccination with varicella virus vaccine. No further info is available.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash pustular
Clinical narrative: Information has been received from a health professional concerning a 14 month old male with no known drug allergies who on 7/9/01 was vaccinated with varicella virus vaccine live (lot 638243/0557L). A registered nurse reported that on 7/10/01, the pt developed a rash with pustules. The pt was seen by the physician on 7/14/01 with 50 scattered vesicles on his head, face, cheeks, upper extremities and he was afebrile. The pt was diagnosed with varicella. No treatment was ordered. Follow-up info received from the registered nurse indicated that the pt recovered without any problems and was seen in the office on 8/14/01 for a well child visit. Additional info is not expected.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Blister, Rash papular, Skin ulcer
Clinical narrative: Information has been received from a medical assistant concerning a 3 year old patient w/ NKDA who on 03/91./99 was vaccinated with varicella virus vaccine live. On 07/18/01, the patient presented to the doctor's office with "break thru chicken  pox", a papular rash and a few vesicular lesions on the torso, extremities and task. Additional infomation has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female pt who on 10/03/2000 and 11/08/2000 was vaccinated with variella vaccine. The pt then had a titer drawn and had no titer level. On 05/01/2001 and 05/13/2001, the pt was revaccinated with varicella vaccine. Subsequently the pt still did not have titer level. Additional info has been requested.
Age: 2.9
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 33 month old female who on 29 OCT 1999 was vaccinated with varicella virus vaccine live. On 18 JUL 2001, the patient presented with a "break-through" chicken pox rash on the trunk of her body, with no fever. The health professional also reported about another patient (WAES #01072287). No further information is available.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning now a six year old male who on 07/11/1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/07/2001, the pt was diagnosed with a "mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further info is available.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning now a five year old female who on 10/22/1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/14/2001 the pt was diagnosed with a "mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 27 JAN 1999 was vaccinated with one dose of varicella virus vaccine live (site unknown) (lot # unknown). Subsequently it was reported that on 14 MAY 2001 the patient was diagnosed with a mild case of chicken pox. Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that the vaccine lot numbers were not similar in the other cases reported. Subsequently the patient recovered. No further information is available.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning now a six year old male who on 07/18/1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/16/2001, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 03/03/1997 was vaccinated with one dose of varicella virus vaccine live (site unknown). Subsequently, it was reported that on 05/17/01, the patient was diagnosed with " a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the Spring, 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the patient recovered.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning now a five year old female who on 09/19/1996 was vaccinated one dose of varicella vaccine. Subsequently, it was reported that on 05/17/2001, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 27 JAN 1999 was vaccinated with one dose of variella virus vaccine live (site unknown) (lot # unknown). Subsequently, it was reported that on 14 MAY 2001 the patient was diagnosed with a mild case of chicken pox. Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that the vaccine lot numbers were not similar in the other cases reported. Subsequently the patient recovered. No further information is available.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 44 month old male pt who on 09/21/1998 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/12/2001 the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning now a five year old female who in September 1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that in May 2001, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 5 year old female, who on 29 OCT 1996 was vaccinated with one dose of varicella virus vaccine live (site unknown) (lot # unknown). Subsequently, it was reported that in May 2001, the patient was diagnosed with a mild case of chicken pox. Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently the patient recovered. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning now an approximately 4 year old male who on 05/19/1998 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that in the spring 2001, in approx. May, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 9 year old female who on 02 NOV 1996 was vaccinated with one dose of varicella virus vaccine live (site unknown) (lot #617912/0782D). Subsequently it was reported that on 04 JUN 2001 the patient was diagnosed with a mild case of chicken pox. Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that the vaccine lot numbers were not similar in the other cases reported. Subsequently, the patient recovered. No further information is available.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning now a 6 year old male who on 03/12/1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 06/04/2001, the pt was diagnosed with "a mile case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 4 year old male who on 02/02/98 was vaccinated with one dose of varicella virus vaccine live (site unknown). Subsequently, it was reported that on 05/30/01, the patient was diagnosed with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccines was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases. Subsequently the patient recovered. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old male who on 3/4/97 was vaccinated with 1 dose of varicella virus vaccine live (site unknown) (lot 619272/1339D). Subsequently, it was reported that on 6/1/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 2.9
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 35 month old male who on 7/13/99 was vaccinated with 1 dose of varicella virus vaccine live (site unknown) (lot 629899/0113J). Subsequently, it was reported that on 6/1/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 9/25/96 was vaccinated with 1 dose of varicella virus vaccine live (site unknown) (lot 617312/0768D). Subsequently, it was reported that on 6/12/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Chills, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Medical history, concurrent conditions and concurrent medications were not specified. The pt reportedly, had no known allergies. On an unspecified date, the pt received his 1st injection of Hep-A vaccine. The pt believed that he experienced a fever, post vax. Within the period of 4/27/02 and 5/2/02, the pt reportedly received his 2nd injection of Hep-A vaccine. Reportedly, within 12 hours post vax, the pt experienced chills and felt "bad"; this progressed to being unable to talk or get out of bed. He also vomited. It was reported that "when he felt better, the next day", he saw the ship's medic, who examined him and gave him light duty for the day. As of 5/6/02, the mother reported that adverse events had "improved"; however, she also stated that all events ended within 24 hours of onset. **Follow-up report on 9/12/02: On 9/5/02, a MD reported that the subject received an injection of Havrix on 4/19/02 and 12 hrs later developed a fever which lasted the next 24 hrs. The subject also vomited 3 times. He was seen by the MD at a military hospital. When the subject was seen by the reporting MD on 5/14/02, "he had been well since 4/19/02." The MD did not confirm the inability to talk, chills, and malaise reported by the vaccinee's mother. The inability to talk in this report, is considered "Medically Serious".
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Speech disorder, Vomiting
Clinical narrative: Medical history, concurrent conditions and concurrent medications were not specified. The pt reportedly, had no known allergies. On an unspecified date, the pt received his 1st injection of Hep-A vaccine. The pt believed that he experienced a fever, post vax. Within the period of 4/27/02 and 5/2/02, the pt reportedly received his 2nd injection of Hep-A vaccine. Reportedly, within 12 hours post vax, the pt experienced chills and felt "bad"; this progressed to being unable to talk or get out of bed. He also vomited. It was reported that "when he felt better, the next day", he saw the ship's medic, who examined him and gave him light duty for the day. As of 5/6/02, the mother reported that adverse events had "improved"; however, she also stated that all events ended within 24 hours of onset. **Follow-up report on 9/12/02: On 9/5/02, a MD reported that the subject received an injection of Havrix on 4/19/02 and 12 hrs later developed a fever which lasted the next 24 hrs. The subject also vomited 3 times. He was seen by the MD at a military hospital. When the subject was seen by the reporting MD on 5/14/02, "he had been well since 4/19/02." The MD did not confirm the inability to talk, chills, and malaise reported by the vaccinee's mother. The inability to talk in this report, is considered "Medically Serious".
Age: 36.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Lymphopenia, Monocytosis, Pain, Pyrexia
Clinical narrative: The pt received his 1st injection of Twinrix on 1/4/02. On 1/7/02, 3 days post vax, he began to experience muscle aches, body aches, joint pain and rash. On 1/9/02, 5 days post vax, he began to experience fever that ranged from 101F to 103F. He presented for medical attention on 1/12/02. In the physician's office, his temperature was 102.1F.
Age: 36.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Rash, Red blood cell sedimentation rate increased, Viral infection, White blood cell count increased
Clinical narrative: The pt received his 1st injection of Twinrix on 1/4/02. On 1/7/02, 3 days post vax, he began to experience muscle aches, body aches, joint pain and rash. On 1/9/02, 5 days post vax, he began to experience fever that ranged from 101F to 103F. He presented for medical attention on 1/12/02. In the physician's office, his temperature was 102.1F.
Age: 36.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Arthralgia, Myalgia, Pyrexia, Rash
Clinical narrative: The pt received his 1st injection of Twinrix on 1/4/02. On 1/7/02, 3 days post vax, he began to experience muscle aches, body aches, joint pain and rash. On 1/9/02, 5 days post vax, he began to experience fever that ranged from 101F to 103F. He presented for medical attention on 1/12/02. In the physician's office, his temperature was 102.1F.
Age: 1.5
Sex: M
Vaccine: HEP
Symptoms: Apathy, Aphasia, Drug toxicity, Emotional disorder, Neurodevelopmental disorder
Clinical narrative: Medical history, concurrent conditions and concurrent medications were not specified. The pt reportedly received an injection on Engerix-B (lot ENG2390A2) on 11/25/97, at the age of 8 months. The pt also received DTP vaccine (lot 6F81445) on 4/30/97, (lot 7A81601) on 7/7/97 and (lot 7L81673) on 9/16/97. According to the pt's attorney, he "was born a perfectly normal, healthy boy whose APGAR score at birth was well within the normal range. Developmentally, neurologically and socially, (he) achieved every developmental milestone anticipated of all normally developing children, including the following: a. By 3 months of age, (he) was alert, cooing, responding to sounds, responding to others and beginning to recognize and interact with his parents; b. At 6 months of age, (he) had achieved milestones including speech sounds that form parts of words and was behaviorally responsive to his environment, his parents, other children and toys. c. At 18 months of age, (he) achieved speech milestones, including 3 words strung together in a sentence-type form and had vocabulary of approx. 25 words. At approx. 18 months of age, (he) was neurologically devastated by the accumulation of Mercury in his body, having been exposed via intramuscular vaccinations and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to, the following: a. He became withdrawn, unable to speak, unresponsive to his environment; and b. His injuries include the loss of language skills, motor skills and affect." The attorney alleged that these represent "severe devastating permanent neurological injuries". This report of developmental regression is considered "Medically Serious".
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Atrial septal defect, Cardiac disorder
Clinical narrative: Pt's "lips turned blue"-parents took baby to hospital where a work up was done. Doctor told parents initially that it could be a vaccine reaction. Later, pt was examined by a cardiologist who told parents, baby has a heart murmur and is to follow up w/ both the MD and cardiologist. Per follow-up information: Pulmonic valve stenosis, Atrial septal defect.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness, swelling and a nodule. Gave .4 Tylenol and warm compresses for 2 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swelling; treated with Keflex 250k.
Age: 9.0
Sex: F
Vaccine: DTAP, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Breakthrough chickenpox, 4 years after immunization.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large red and swollen area that was warm and non-tender.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: The pt received Hep-B vaccine (1.0cc) at 10:05. He was kept in the room under observation for 20 minutes. At 10:45, he fainted. Vital signs were normal. He was discharged home to mother.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, tenderness and swelling.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swelling from shoulder to elbow. Area is red and warm to touch. No temp.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Balance disorder, Difficulty in walking, Fatigue, Hypoaesthesia
Clinical narrative: Paralysis of left hand, little finger and numbness that spread to other hand, legs and toes. Fatigue, stiffness and inability to hold on to small objects. Difficulty climbing stairs and loss of balance. Treatment provided by MD.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Paralysis
Clinical narrative: Paralysis of left hand, little finger and numbness that spread to other hand, legs and toes. Fatigue, stiffness and inability to hold on to small objects. Difficulty climbing stairs and loss of balance. Treatment provided by MD.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On 5/9/02, mom called and reported redness and swelling the size of a golf-ball, warm to touch and a fever of 100F-101F. On 5/10/02, seen in office with a fever of 100F, increased redness and some swelling. Still able to move in all motions and still warm to touch.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Erythema, Pruritus, Rash macular
Clinical narrative: Within 6 hours of receiving the vaccine for Hep-B (1st in series), the pt started to develop a rash on her arm. By morning, the rash covered most of her body, except her face. Had some joint aches especially in left shoulder and left arm. Rash was erythematous, macular and pruritic.
Age: 4.5
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Local reaction at injection site with red, hot, swollen and very tender left deltoid. About 3cm swelling. Lasted about 1 week.
Age: 4.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Hypokinesia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On 5/17/02, parent returned to the clinic with the pt to report hot, red, swollen and indurated injection site on right arm (deltoid). The swelling involved most of the upper arm from the elbow to the shoulder with limited activity and some secondary pain.
Age: 4.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site warmth
Clinical narrative: On 5/17/02, parent returned to the clinic with the pt to report hot, red, swollen and indurated injection site on right arm (deltoid). The swelling involved most of the upper arm from the elbow to the shoulder with limited activity and some secondary pain.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Cerebellar ataxia
Clinical narrative: Acute cerebellar ataxia-severe. No yet recovered. An annual follow up report received 6/9/2003 adds: Ataxia continued.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Anorexia, Aphasia, Balance disorder, Cerebellar ataxia, Cough
Clinical narrative: Acute cerebellar ataxia-severe. No yet recovered. An annual follow up report received 6/9/2003 adds: Ataxia continued.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Croup infectious, Diarrhoea, Difficulty in walking, Ear pain, Gait disturbance
Clinical narrative: Acute cerebellar ataxia-severe. No yet recovered. An annual follow up report received 6/9/2003 adds: Ataxia continued.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Laboratory test abnormal, Nausea, Nervous system disorder, Psychomotor hyperactivity, Pyrexia
Clinical narrative: Acute cerebellar ataxia-severe. No yet recovered. An annual follow up report received 6/9/2003 adds: Ataxia continued.
Age: 2.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Rhinorrhoea, Upper respiratory tract infection, Vomiting
Clinical narrative: Acute cerebellar ataxia-severe. No yet recovered. An annual follow up report received 6/9/2003 adds: Ataxia continued.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cyanosis, Pyrexia, Respiratory rate increased, Skin ulcer
Clinical narrative: Fever of 104.2F; hands/feet purple; rapid breath and lesion in right temporal area.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 9/24/98 was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot number unk). Subsequently, it was reported that on 6/11/01, the pt was dx'd with a "mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 12/20/95 was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot 609296/C441B). Subsequently, it was reported that in 6/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old male who on an unspecified date was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot unk). Subsequently, it was reported that on 6/15/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on an unspecified date was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot unk). Subsequently, it was reported that in 6/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 9 year old female who on 8/31/95 was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot 608665/0425B). Subsequently, it was reported that in 6/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning an 11 year old male who on 10/27/95 was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot 609293/0436B). Subsequently, it was reported that in 6/01, the pt was dx'd with "a mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 6/13/97 was vaccinated with 1 dose of varicella virus vaccine live (site unk). Subsequently, it was reported that on 6/20/01, the pt was dx'd with "a very mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity
Clinical narrative: Information has been received from a consumer concerning a 2 year old female who on 7/18/01 was vaccinated with varicella virus vaccine live. On 7/20/01, the pt developed injection site irritation. Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a pt's mother and a physician concerning a 13 month old male with no past medical history and no known allergies who on 7/3/01 was vaccinated with varicella virus vaccine live (lot 638247/0495L). Concomitant vaccination included mumps virus vaccine live (636958/1042K, invalid lot this corresponds with measles virus vaccine live. She said yesterday, she noticed he had "2 pustules on his back and one on his arm". In follow-up, the pt's physician reported he was seen on 7/14/01 because of a rash. The pt ha a few flesh-colored papules but no ill symptoms. The dx at this time was atopic dermatitis versus "measles" immunization reaction versus varicella immunization reaction. On 7/20/01, the pt was seen again with 2 lesions on his back. One lesion was papular and the other vesicular. The pt also had vesicular lesions on his right arm. The dx at this time was probable mild atypical varicella following varicella immunization. No lab diagnostic tests were performed. The pt's final dx was probable atypical varicella following varicella immunization. On 8/23/01, the pt was vaccinated with measles virus live (lot 630227/0455K invalid lot this corresponds with mumps virus vaccine live). On 10/4/01, the pt was vaccinated with rubella virus vaccine live (second generation) (lot 638553/1873K). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Feeling hot, Herpes zoster, Injection site mass, Pyrexia, Rash
Clinical narrative: Information has been received from an RN concerning her 1 year old granddaughter who on 7/6/01 was vaccinated in her thigh with a dose of varicella virus vaccine live. Concomitant vaccination the same day included MMR vaccine, Hib conj-Hep-B vaccine and Prevnar. On approx. 7/8/01, 2-3 days post vax, the pt developed a "knot" at the injection site on 1 of her thighs and a generalized body warmth; a fever. It was reported that the specific sites of injection for each vaccine (right or left thigh) was not known. The fever and the injection site knot on her thigh had resolved on the following day. It was noted that the child had been teething prior to her vaccination. On approx. 7/17/01, the pt developed fine red rash, little dots, on her chest which had resolved within a day. It was also reported by the RN that her father who had asbestosis. emphysema, long term steroid therapy (inhaled and oral) for treatment of his emphysema and a history of being "susceptible to pneumonia", chicken pox and shingles around his chest "several years ago" also had experienced symptoms. On 7/16/01, the child's grandfather had developed blistering around the corner of his eye and forehead, which was initially dx'd as conjunctivitis. The blistering continued to worsen and the pt returned to his physician who dx'd shingles. The pt was treated for shingles with an unspecified medication. It was reported that the pt had scabbed lesions around the corner of his eye, forehead and scalp. On follow-up, it was reported by the nurse that he was "feeling better" today. This episode was reported in (WAES010724661 as secondary transmission of herpes zoster). In follow-up, the RN was interested in information on secondary transmission. The VZV ID Program was discussed with her. The reporting nurse stated that the pt had a number of scabs and there were several in the pt's scalp area, which could be uproofed without risk of scarring. She stated that she would speak with her father to see if he would like to participate in the VZV ID Program. Additional information has been requested.