chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been recevied from a health professional concerning a 42 month old amish male with no medical HX and no allergies who on 07/23/2004 was vaccinated SQ in the LL with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. there were no concomitant medication. It was reported that the family was exposed to varicella on  11/25/2004. The pt broke out with about 8 vesicles in mid december there were no lab tests or relevant diagnostic date. Subsequently the pt recovered. Additional infomation is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old female patient who on an unknown date was vaccinated with varicella virus vaccine live.  It was noted that on 03/31/2004, the patient developed breakthrough varicella.  There was no product quality complaint reported.  No additional information was provided.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning an 8 year old male who was vaccinated subcutaneously with a dose of varicella virus vaccine live.  The physician reported that the patient subsequently developed breakthrough varicella.  Unspecified medical attention was sought and at the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Hypersensitivity, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 year old white male with a PCN allergy who on 02/02/1999 was vaccinated SC in the RA with a first dose of varicella virus vaccine live. There was no concomitant medication. On 08/02/2004, the pt developed a full blown case of chickenpox with more than 50 very red pustular lesions. It was not reported to be itchy. The pt was prescribed antibiotics including Duricef and Bactroban to treat the lesions. Follow up was scheduled for the next week. The physician believed that it was spurred by a daycare outbreak in the area. A product quality complaint was not involved. Follow up information was received from the physician who indicated that the pt developed a rash over the weekend of 07/30/2004. The pt was seen on 08/02/2004 with varicella and greater than 50 lesions. Some lesions were apparently becoming secondarily infected with surrounding erythema. Most lesions were pustular. The pt was treated with Duricef and Bactroban topically with supportive care. The pt was not febrile and there were no other symptoms of concern. It was noted that the pt was exposed at a child care center where at least five other cases were reported by the daycare and were all vaccinated per the care taker. No further information is exepected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old who was vaccinated with a dose of varicella virus vaccine live at one year of age. There were no concomitant medication. The reporter noted that the vaccination was received at another facility and no lot number or date of vaccination was available. On 08/01/04 the pt developed a relatively mild case of chickenpox. Unspecified medical attention was sought and no medication was given. The physicain noted that she did not refer to this breakthrough. It was also indicated that the pt was originally seen by a physician on 08/02/2004 and then for followup  on 08/04/2004 when the pt was reported to look much better. AT the time of the report, the pt was recovering. A product quality complaint was not involved. Follow up information information was recieved form the physician who indicated that on approximately 06/30/04 the pt had an outbreak of fairly classic varicella. On 08/02/2004, the pt  was seen with classic varicella and no evidence of secondary infection. There were noted to be greater than 50 lesions. The pt was seen again the following day with continued resoulution of the rash and drying . The pt was reported to be exposed at a daycare setting where at least five other children had chicken pox as well. The other children had also been vaccianted per the daycare report. No diagnostic or laboratory tests were performed. Subsequently, the pt recovered. No further information is expected. The physician also reported five other children who developed  chickenpox after therapy with varicella virus vaccine live.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Drug ineffective, Pyrexia, Urticaria, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old male (also reported as female) who on 07/31/2000 was vaccinated SQ in the LL with a first dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox. It was reported that the child had a fever of 101 degrees F and few pustules, no crusting as of yet. The physician reported that there were 4-5 lesions on the trunk, 2-3 lesions on both arms and 2-3 lesions on the head. The lesions began approximately 08/03/2004. It  was reported that no prescription medications were ordered but the mother was told to use diphenhydramine hcl ( Benadryl) for itch, acetaminophen (Tylenol) for fever and calamine + camphor+ pramoxine hydrochloride (Aveeno) bath if necessary. The mother was unaware of any contact with another affected person. The pt is recovering. At the time of the report, the pt's experience was considered to be an other important medical event. (OMIC) No additonal information was available. Follow up confirmation was receieved from the nurse who indicated that the pt experienced a very mild case of chicken pox that was definatedly not  serious. The pt has 15-20 spots. She did confirm that the parent was instructed to use Benadryl for itch, Tylenol for fever and calamine + camphor + pramoxine hydrochloride (Aveeno) bath if necessary. Additonal information has been requested. Another pt (WAES 0408USA00632) developed breakthrough chickenpox after vacciantion with varicella virus vaccine live.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 5 year old white female with no known medical history who on 06/14/00 was vaccination with in the LUA with a first 0.5cc dose of varicella virus vaccine live. There was no concomitant medication. On 06/16/2004 the pt was exposed to chickenpox. On 06/21/04 the pt's mom noticed a couple of raised spots with a red base on her arms and one behind her neck. By 07/22/2004 a few more had appeared sporadically over her body. The pt complained of itching but feeling ok overall. On 07/22/2004 the pr was seen by the physician and varicella was confirmed. Symptomatic care was discussed. The pt recovered on 08/04/2004. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 or 9 year male pt who in 1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox. It was reported that the child was not seen in the office but the mother called and reported a fever of 100- 101 degrees F and about 10-12 lesions. The lesions began breaking out on 08/04/2004. The mother believed the child was exposed  to another child that had chicken pox about 12 days prior to breaking out. It was reported that no prescription medication was ordered, but the mother was told to use Benadryl for itch and acetaminophen (Tylenol) for the fever and calamine + camphor+ pramoxine Hcl ( Aveeno) bath if necessary. Th pt  was recovering. At the time of the report, the pt;s experience was considered to be another important event (OMIC). No additional information is available. Follow up clarification was received form the nurse who indicated that the pt experienced a very  mild case of chickenpox that was definitely not serious. The pt had 20-30 spots. She did confirm that the parent was instructed to use Benadryl for itch, Tylenol for fever and Aveeno Bath if necessary.  No additonal inoformation was available. Additional follow up indicated that the child was seen one time only for a mild case of breakthrough chicken pox. No work up was done and the chlid tolerated it well. He was not seen again in the office for any problems related to this DX. No additonal infomation was provided. Additional information is not expected. Another pt (WAES 0408USA00542) developed breakthrough chickenpox after vaccination with varicella virus vaccine live.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning an 11 year old female pt, who is a twin, with no allergies or pre existing medical conditions, who on 09/12/2000 was vaccinated SQ in the LA with a dose of varicella virus vaccine live. On 08/22/2004 the pt developed a  rash on her stomach which was described as 18-20 lesions. She was afebrile. The RN reported that the pt was treated with Benadryl and calamine as needed. Follow up information received from a RN reported that on 08/03/2004 the pt had  a varicella breakthrough and was described as 18-20 papular lesions on her chest, back and buttocks. There were no laboratory studies performed and she was not ill at the time of vaccination. On an unspecified date the pt recovered. The pt sought unspecified medical attention. The RN also reported that the pt's twin brother developed a varicella breakthrough rash of 18-20 lesions on his stomach following vaccination with varicella virus vaccine live. (WAES0408USA00321). No additonal information is expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 32 month old female who on 12/02/2002 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included amoxicillin for UTI prophylaxis. Subsequently  the pt  developed lesions. The pt's mother asked a resident to look at her daughters lesions. The resident reported lesions on her trunk and a few  on her face looked like a breakthrough varicella. A physicain then saw the pt and said that it maybe a breakthrough case and it may not be. The pt's lesions were crusty, dry and healing, and the pt was afebrile. It was reported that the nurse and the pediatrician never saw the pt. Subsequently, she recovered. There was no product quality complaint involved. Additonal information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 8 year old male  with NKDA who on 10/21/1996 was vaccinated with a dose of varicella virus vaccine live. On 08/10/2004 the pt experienced a breakthrough. Unspecified medical attention was sought and no lab diagnostic studies were performed. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 3 year old male who in approximately 2002, at the age of one year, was vaccinated with varicella virus vaccine live. The physician reported that two days after taking prednisolone Na phosphate (Orapred), on 08/08/04 the pt developed varicella. It was  noted that the pt had 50 lesions on his body. He was given acyclovir for the varicella. No other information regarding the adverse event was available.There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 6 year old female who on 11/03/1999 was vaccinated with a dose of varicella virus vaccine live. On 08/10/2004, the pt developed a severe case of chicken pox. The child was noted to have lesions all over her trunk and extremeties that were to numerous to count. ( probably over 200).The child is being treated with Benadryl, calamine lotion and Aveeno Bath. Unspecified medical attention was sought. It was noted that it  was tooo early to assess, but the child was expeted to make a full recovery. At the time of the report, the child was noted to be reocovering. There was no product quality complaint. Additoanal information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male who on 6/16/04 was vaccinated with a dose of varicella virus vaccine live (lot # 646141/0540N). Two weeks after vaccination on approximately 6/30/04, the patient experienced an injection site reaction. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also indicated that two other patients (WAES0409USA02212 and 0409USA02213) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash macular, Rash papular
Clinical narrative: Information has been received from a physician and a nurse practitioner concerning a 12 month old white male patient with no known allergies and no pertinent medical history who on 8/2/04was vaccinated SC with a dose of varicella virus vaccine live (lot # 647715/0190P). There was no concomitant medication. On 8/12/04 at 07:30, the patient presented to the physician's office with two dozen chicken pox, described as a rash of scattered macules and fluid filled papules on his trunk and spreading to the legs for 12-24 hours. He also had a low grade fever for three days. The rest of the patient's physical examination was negative. There was no recent family illness. No laboratory tests performed. The patient's recovery status is unknown. There was no product quality complaint reported. Follow up information indicated that the patient recovered on 8/12/04. Unspecified medical attention was sought. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a male who was under 2 years old who in approximately January 2004, late last year or early this year was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed chicken pox. There were no complications from the chicken pox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rhinorrhoea, Skin ulcer, Viral infection
Clinical narrative: Information and additional follow up have been received from a physician concerning a mixed race five year old female patient with cerebral palsy, developmental delay and a history of recurrent herpes simplex, who on 9/11/00 was vaccinated with a dose of varicella virus vaccine live (lot # 634514/0539K). There were no concomitant medications. At the time of vaccination, the patient had otitis media. On 8/10/04, the patient developed a breakthrough case of chicken pox described as less than 50 lesions. The experience was further described as a rash consisting of small red bumps on the patient's abdomen, arms, legs, and she had itching. It was noted that she also had mild rhinorrhea. The patient was treated with oral diphenhydramine to control the itching. It was noted that no laboratory tests were performed and the patient had no adverse events following prior vaccination. The patient recovered on an unspecified date. There was no product quality complaint involved. Unspecified medical attention was sought. No additional information is expected.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received fro a physician concerning a 3 year old child who in approximately August 2004 was vaccinated with a dose of varicella virus vaccine live. The physician reported that in approximately August 2004, one week after being vaccinated, the patient developed a mild case of breakthrough chicken pox. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning an 18 month old female patient with no allergies and no pertinent medical history, who on 1/6/04 was vaccinated with a dose of varicella virus vaccine live (lot # 646360/0571N). There was no concomitant medication. On 7/20/04, the patient was diagnosed with a mild non-dramatic case of varicella. She had 10-15 pox and no fever. Treatment was not required. The patient has recovered from mild non-dramatic varicella. There was no product quality complaint reported. The physician also reported that the patient's mother was not immune so she was given varicella-zoster immune globulin and she also had a minor breakout of chicken pox. Additional information has been requested. The physician also mentioned another female patient who experienced a similar reaction following vaccination with varicella virus vaccine live (lot #620630/1345D) (WAES0408USA01536).
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 16 year old white female student with irritable bowel syndrome and asthma who on 8/11/04, at 16:50, was vaccinated SC in the upper arm with the first dose of varicella virus vaccine live (lot # 647093/0886N). There was no illness at the time of vaccination. The NP reported that on 8/13/04 the patient developed several small, itchy, red vesicular lesions on both arms (patient called clinic on 8/16/04 to reported event). The NP indicated that no other symptoms were noted. At the time of this report, the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: information has been received from a registered nurse concerning an adult make housekeeper who was in contact with an individual that was vaccinated with a dose of varicella virus vaccine live. The patient subsequently developed shingles. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information was received from the registered nurse who indicated that the adverse experience was reported by an employee who came in contact with a client/patient who received the varicella virus vaccine live. The employee was determined by the reporter's medical director to be not related. No further information is expected.
Age: 1.06
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Pneumonia, Rash, Viral infection
Clinical narrative: Information has been received from a physician's office concerning a 4 year old white female who on 11/30/00 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of MMR. There was no illness at the time of vaccination. In the morning of 4/21/04, the patient developed chicken pox after having been exposed two weeks prior at a babysitter's. The patient had a cough and developed pneumonia after chicken pox. Subsequently, the patient recovered. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a nine year old female patient with no pertinent medical history who on 1/23/97 was vaccinated with a dose of varicella virus vaccine live (lot # 620630/1345D). There was no concomitant medication. On 5/3/04, the patient was diagnosed with a mild case of chicken pox. She had no fever and no treatment was required. The patient has recovered. There was no product quality complaint reported. Additional information has been requested. The physician also mentioned another female patient who experienced a similar reaction following vaccination with varicella virus vaccine live (lot # 646360/0571N) (WAES0408USA01180).
Age: 1.09
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse and a physician concerning a 7 year old white female patient with juvenile rheumatoid arthritis who on 8/17/98 was vaccinated with a first dose of varicella virus vaccine live (lot # unknown). It was noted that the patient had been vaccinated by another health care provider. On 8/15/04 the patient presented with over 100 vesicular lesions and a moderate fever. She was diagnosed with severe varicella. The patient recovered on 8/22/04. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Medication error, Rash
Clinical narrative: Information has been received from a registered nurse concerning an anonymous young female patient, who on 6/21/04 was vaccinated IM with a first dose of varicella virus vaccine live. It was reported that about six weeks (approximately August 2004), after receiving the first dose of varicella virus vaccine live, she developed a rash on her injection site arm. It was noted that the patient was traveling abroad and she also had a rash on her legs and under the opposite arm. The patient treated the rash with witch hazel and it subsided within a week. The patient said the rash did not look like varicella. No further information was available. The patient recovered on an unknown date. It was noted that the patient did not seek medical attention. There was no product quality complaint reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash, Rash papular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female with no pre-existing allergies, birth defects, or medical conditions who on 10/14/99 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 631524/1012J). There was no illness at the time of  vaccination. On 8/13/04 the patient developed a chicken pox rash that was noted to be a break out of several bumps on her abdomen which were itchy. The bumps were described as scattered, erythemataous, papules that were few in number but spread to her face. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 8/11/04 she noted bumps on her abdomen. She was seen in the office on 8/13/04 and was diagnosed with varicella. She was prescribed supportive care of acetaminophen, diphenhydramine hydrochloride, and calamine lotion. It was also noted that the patient's sister was vaccinated with varicella virus vaccine live and developed chicken pox (WAES0408USA01673). No additional information is expected. Follow up information indicated that on 11-AUG-2004 she noted "bumps" on her abdomen. She was seen in the office on 13-AUG-2004 and was diagnosed with varicella. She was prescribed supportive care of TYLENOL, BENADRYL, and calamine lotion. No additional information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Nasal congestion, Pruritus, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old white female with no known medical history or allergies who on 7/20/99 was vaccinated in the right arm with a dose of varicella virus vaccine live (lot # 630678/0427J). There was no illness at the time of vaccination. On 8/14/04, the patient developed a rash. The rash consisted of more than 50 lesions but less than 200 lesions. Unspecified medical attention was sought. The patient was given Acyclovir for the rash if needed and it was unknown if the patient did take the Acyclovir. Subsequently, the patient recovered. A product quality complaint was not involved. Follow up information from the physician indicated that there were no adverse events, but noted that the patient also had itching, slight cough and congestion. The patient was treated with diphenhydramine hydrochloride after the rash started. A visual exam was performed by the physician. It was reported that the recovery for the patient's itching, slight cough and congestion was ongoing. The patient had no adverse events following prior vaccination. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 11 year old female who on 3/20/96 was vaccinated with a dose of varicella virus vaccine live. On 8/19/04 the patient seen in the doctor's office and scarring was noted on her upper torso. When questioned the mother reported that the patient had varicella in January 2004 after the child was exposed to shingles. Over 200 lesions from the waist up were noted. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 7/14/03 was vaccinated with a dose of varicella virus vaccine live. On 8/18/03, the patient came down with chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash, Rash papular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 10/14/99 was vaccinated with a dose of varicella virus vaccine live (lot # 631524/1012J). On 8/13/04 the patient developed a chicken pox rash that was noted to be on her abdomen and spread to her armpits. Her rash was also described as erythematous, papules, and some vesicles. At the time of the report, there was no specific treatment necessary. Unspecified medical attention was sought. There was no product quality complaint. It was also noted that the patient's sister was vaccinated with varicella virus vaccine live and developed chicken pox (WAES0408USA01569). Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a healthy 41 year old adult white female patient with environmental allergies, who on 12/29/97 and 2/11/98 was vaccinated with a first and second dose of varicella virus vaccine live (lot # not available). The registered nurse reported that a recent titer on 7/27/04 was negative (<1:4), non-immune status for varicella. On 8/20/04, the patient was administered a third dose of varicella virus vaccine live (lot # 647088/0852N) in the left deltoid. Concomitant medication included birth control pills. A repeat titer was done on 9/24/04 and was <1:4 again, a non-immune status for varicella. There was no other information available. There was no product quality complaint involved. Unspecified medical attention was sought. No additional information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old female with Down's syndrome and congenital heart disease who on 8/10/04 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 647707/1245N). There was no illness at the time of vaccination. On 8/19/04 the patient broke out with a few lesions, but more lesions are expected. The patient also developed a fever of 103. The patient had a CBC done to check her immune system. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that on 8/17/04 at 11:00AM the patient developed a rash and had lesions which were red in color. The lesions were all over and the next day more showed up. The rash was consistent with atypical varicella. The patient recovered in approximately three days. The reporter also indicated that another patient (WAES0408USA01856) had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who on 8/13/04 was vaccinated SC with a dose of varicella virus vaccine live. On 8/18/04, five days later, the patient developed vesicles on the hand. Two days later, 50 to 100 atypical vesicles appeared on various dermatomes. No fever was present. The child was being observed with no treatment. Unspecified medical attention was sought. The patient was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varicella  Information has been received from a physician concerning a 5 year old female who on 12-Oct-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 20-Aug-2004 the patient was diagnosed with chickenpox, 7 lesions were noted. The child was well otherwise. Unspecified medical attention was sought. there was no product quality complaint involved
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 42 year-old white female patient with an allergy to amoxicillin and no other pertinent medical history, who on 26-Mar-2004 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#644570/1159M) and a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 648051/1350N) was administered on 14-May-2004. It was noted that an antibody titer drawn on 14-Jul-2004 had a negative result. The patient failed to seroconvert. It was also mentioned that the patient stated that she was exposed to chicken pox several times as a child and never got them. There was no product quality complaint reported.  Unspecified medical attention was sought.  No additional information is expected.
Age: 3.17
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash
Clinical narrative: Information has been received from a licensed practical nurse and additional information was received from a registered nurse concerning a 38 month old female patient with no known allergies and no pertinent medical history who on 28-May-2002 was vaccinated with varicella virus vaccine live (Oka/Merck) at another medical facility. On 26-Jul-2004 the patient's mother called the physician's office and reported that the patient had rash on her chest and under her arms. It was noted that the patient started with viral symptoms one week prior (approximately 16-Aug-2004) to presentation in the physician office on 23-Aug-2004. Today, 23-Aug-2004, the patient presented to the physician office with a similar rash. There are 10-15 non-itchy lesions on the trunk of her body; fluid filled, ruptured, and scabbed. The patient will be sent to a dermatologist for follow-up. No other treatment was reported and it is unknown whether lab studies were preformed. In additional information, the registered nurse reported that the patient recovered on 01-Sep-2004. There was no product quality complaint reported.  Unspecified medical attention was sought.  No additional information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no know medical history or allergies who on 09-Aug-2004 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 647707/1245N). There was no illness at the time of vaccination. Subsequently the patient broke out with blisters and a few lesions and developed a fever of 103. No tests were done. Unspecified medical attention was sought.  There was no produce quality complaint involved.  follow-up information indicated that on 17-Aug-2004 the patient came in with a 102 fever, rash and red lesions all over her body. Her rash was consistent with atypical varicella. On approximately 20-Aug-2004 the patient recovered. There was no laboratory or diagnostic tests performed.  The reporter also indicated that another patient (WAES # 0408USA01717) has similar experiences following exposure to varicella virus vaccine live (Oka/Merck).  No further information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash papular
Clinical narrative: Information has been received concerning a 5 year old male who on 14-aug-2000 was vaccinated in the right leg with a dose of varicella virus vaccine live (Oka/Merck) (Lot #634838/1863J). On 09-Aug-2004 the patient experienced papules and vesicles on the abdomen and buttocks. It was reported that he was itchy and afebrile and that he recovered on an unknown date.  Additional information has been requested.  OMIC
Age: 1.01
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Drug ineffective, Rash, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 3 year old white male with no allergies or medical history who on 30-Jan-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine that day included a dose of poliovirus vaccine. There was no illness at the time of vaccination. On 23-Aug-2004 the patient awoke from his nap with red spots. On 24-Aug-2004 the patient was seen in the office with red vesicles on his trunk. A few of the vesicles had begun to open. At this time there are less than 25 lesions, however new lesions are still emerging. It was noted that the patient's mother currently has a case of shingles. No treatment was given at this time. No product quality complaint was involved.  Follow-up information from a physician indicated that the child developed "varicella disease (chicken pox)" on 22-Aug-2004. The child had a doctor appointment on 23-Aug-2004 when the clinical diagnosis was made. The patient recovered  Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 31 year old female who in 2002 was vaccinated with first and second doses of varicella virus vaccine live (Oka/Merck) which were given one month apart. Subsequently the patient's IGG antibody test was negative. Unspecified medical attention was sought. There was no product quality complaint involved.  Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a LVN concerning a 39 month old white female with NKDA or medical Hx who on 04/30/02 was vaccinated SQ in the RAT with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 08/24/04, the pt developed a breakthrough case of chicken pox. The pt had too many lesions to count which covered the trunk, back, and arms. She was noted to be afebrile. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the LVN who indicated that on 08/24/04 the pt has "too many to count macular rash on trunk, arms, and legs." The DX was varicella. The pt recovered on 08/30/04. No diagnostic lab tests were performed. Neither the pt nor her sibling had any adverse event following prior vaccinations. No further information is expected. The nurse also reported that the pt's brother developed chickenpox after therapy with varicella virus vaccine live (WAES 0409USA02169).
Age: 1.31
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male with no known medical history or allergies who on 06-Aug-2004 at 11:00 a.m. was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 645575/0436N). There was no concomitant medication. There was no illness at the time of vaccination. On 11-Aug-2004 the patient developed a few "blister-like" lesions at the injection site. On 18-Aug-2004 the patient's mom reported apparent mild onset varicella. On 21-Aug-2004 no further lesions were noted; all have dried and the patient recovered.  No further information is available.  OMIC
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse and a physician concerning a female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced breakthrough chickenpox. On 24-Aug-2004 the physician saw the patient who had about 15 lesions and no fever. The patient was not treated with any medication. There was not product quality complaint involved. OMIC
Age: 1.46
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis atopic, Rash maculo-papular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who was vaccinated with a dose of varicella virus vaccine live in another country in November 2000. On 8/23/04, the patient presented with varicella. Symptoms included multiple vesicular lesions over her entire body including three in her mouth. Many of the lesions have already started to crust. A product quality complaint was not involved. Follow up information was received from the registered nurse who reported that on 8/21/04, the patient had multi-generational maculopapal vesicles on the trunk, extremities, and scalp. Subsequently the patient recovered. No diagnostic laboratory tests were performed. The patient had no adverse events following prior vaccination. It was also reported that the patient had atopic dermatitis on 8/17/01 No further information is expected.
Age: 0.12
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Abnormal sleep-related event, Sudden infant death syndrome
Clinical narrative: Patient found lifeless in bed; was not resuscitated successfully. Received Autopsy Report which revealed COD as SIDS w/cosleeping as contributing factor.  Manner of death was undetermined.
Age: 68.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Abdominal pain upper, Arterial thrombosis, Blood calcium decreased, Blood creatinine increased, Blood glucose increased
Clinical narrative: Additional information received on 3/18/05. A 67 year old male received RSV vaccine or placebo and Influenza vaccine on 11/7/02 and 102 days later was admitted to the hospital for chest pain. A chest x-ray revealed bronchitis and infection of the lungs per patient. ECG and catheterization was done to rule out cardiac condition. The patient was treated with Prednisone 40mg QD from 2/17/03 to 3/3/03 and Tequin 400mg from 2/17/03 to 2/29/03. The patient recovered and was discharged on 2/22/03. The investigator assessed the events as possibly related to the study products. Follow up information received 2/28/03: Patient is a pleasant 67 year old, white male with a history of chronic intermittent upper epigastric/musculoskeletal chest pain, history of emphysema/COPD, hypothyroidism, with a recent negative Cardiolite stress test and negative GI work up, who presents with upper epigastric substernal chest pressure with shortness of breath on exertion. Patient has received negative GI work up recently with negative ultrasound of the bladder and questionable ROD for esophagitis. On admission, the patient was placed on rule out myocardial infarction. Cardiology evaluation with a recommendation of cardiac catheterization  on 2/21/03 with normal coronary arteries with 60% right common iliac lesions. The cardiac cause of pain was then ruled out. During this admission, the patient was placed on Prevacid 30mg twice a day with improvement of his upper epigastric/lower sternal chest pain. Patient is waiting for an outpatient follow up with Gastroenterology for further evaluation of his atypical chest pain which could be gastrointestinal or musculoskeletal in origin. Discharge diet is cardiac diet. Activities as tolerated. Condition is stable. Follow up in 7 to 10 days. Also follow up in gastroenterology in 7 to 10 days. Additional information received on 3/18/05. Investigator reported that discharge diagnoses were considered pre-existing conditions. Also confirmed the causality as possible. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
Age: 68.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Bronchitis, Chest pain, Condition aggravated, Dyspnoea, Infection
Clinical narrative: Additional information received on 3/18/05. A 67 year old male received RSV vaccine or placebo and Influenza vaccine on 11/7/02 and 102 days later was admitted to the hospital for chest pain. A chest x-ray revealed bronchitis and infection of the lungs per patient. ECG and catheterization was done to rule out cardiac condition. The patient was treated with Prednisone 40mg QD from 2/17/03 to 3/3/03 and Tequin 400mg from 2/17/03 to 2/29/03. The patient recovered and was discharged on 2/22/03. The investigator assessed the events as possibly related to the study products. Follow up information received 2/28/03: Patient is a pleasant 67 year old, white male with a history of chronic intermittent upper epigastric/musculoskeletal chest pain, history of emphysema/COPD, hypothyroidism, with a recent negative Cardiolite stress test and negative GI work up, who presents with upper epigastric substernal chest pressure with shortness of breath on exertion. Patient has received negative GI work up recently with negative ultrasound of the bladder and questionable ROD for esophagitis. On admission, the patient was placed on rule out myocardial infarction. Cardiology evaluation with a recommendation of cardiac catheterization  on 2/21/03 with normal coronary arteries with 60% right common iliac lesions. The cardiac cause of pain was then ruled out. During this admission, the patient was placed on Prevacid 30mg twice a day with improvement of his upper epigastric/lower sternal chest pain. Patient is waiting for an outpatient follow up with Gastroenterology for further evaluation of his atypical chest pain which could be gastrointestinal or musculoskeletal in origin. Discharge diet is cardiac diet. Activities as tolerated. Condition is stable. Follow up in 7 to 10 days. Also follow up in gastroenterology in 7 to 10 days. Additional information received on 3/18/05. Investigator reported that discharge diagnoses were considered pre-existing conditions. Also confirmed the causality as possible. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
Age: 68.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Laboratory test abnormal, Oesophagitis, Platelet disorder, Skin ulcer, White blood cell disorder
Clinical narrative: Additional information received on 3/18/05. A 67 year old male received RSV vaccine or placebo and Influenza vaccine on 11/7/02 and 102 days later was admitted to the hospital for chest pain. A chest x-ray revealed bronchitis and infection of the lungs per patient. ECG and catheterization was done to rule out cardiac condition. The patient was treated with Prednisone 40mg QD from 2/17/03 to 3/3/03 and Tequin 400mg from 2/17/03 to 2/29/03. The patient recovered and was discharged on 2/22/03. The investigator assessed the events as possibly related to the study products. Follow up information received 2/28/03: Patient is a pleasant 67 year old, white male with a history of chronic intermittent upper epigastric/musculoskeletal chest pain, history of emphysema/COPD, hypothyroidism, with a recent negative Cardiolite stress test and negative GI work up, who presents with upper epigastric substernal chest pressure with shortness of breath on exertion. Patient has received negative GI work up recently with negative ultrasound of the bladder and questionable ROD for esophagitis. On admission, the patient was placed on rule out myocardial infarction. Cardiology evaluation with a recommendation of cardiac catheterization  on 2/21/03 with normal coronary arteries with 60% right common iliac lesions. The cardiac cause of pain was then ruled out. During this admission, the patient was placed on Prevacid 30mg twice a day with improvement of his upper epigastric/lower sternal chest pain. Patient is waiting for an outpatient follow up with Gastroenterology for further evaluation of his atypical chest pain which could be gastrointestinal or musculoskeletal in origin. Discharge diet is cardiac diet. Activities as tolerated. Condition is stable. Follow up in 7 to 10 days. Also follow up in gastroenterology in 7 to 10 days. Additional information received on 3/18/05. Investigator reported that discharge diagnoses were considered pre-existing conditions. Also confirmed the causality as possible. Unblinding information received on 5/16/05. The subject received Non-Adjuvanted RSV vaccine.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Developmental delay, Electroencephalogram abnormal, Gene mutation identification test negative, Hypotonia
Clinical narrative: Seemed hypotonic after 2 month visit (has not recovered), developed seizure disorder with one week of 9 month visit. I will list vaccines from first visit on 13 and second (9 month) on 14.  As Per follow up report: Hypotonia, developmental delay.
Age: 0.16
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Metabolic function test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Seemed hypotonic after 2 month visit (has not recovered), developed seizure disorder with one week of 9 month visit. I will list vaccines from first visit on 13 and second (9 month) on 14.  As Per follow up report: Hypotonia, developmental delay.
Age: 1.45
Sex: M
Vaccine: DTAPH, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Patient was seen 48 hours after vaccine given. His right thigh had a severe local reaction with induration and erythema 9cmx12cm. Leg circumference 3cm bigger than left leg. Patient admitted to hospital for IV antibiotics and for cellulitis for 24 hours. Oxacillin for 9 days and PO Keflex.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Acne, Dermatitis bullous, Skin ulcer
Clinical narrative: On 05/25/2005, noted pimple like lesion on chin, scabbed within 24 hours. Developed 6 other lesions within 5 days, all scabbed. No fever, unable to confirm cause of lesions.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction, Vaccination complication
Clinical narrative: Cellulitis like localized event to area around injection site. TX: Keflex 500mg PO, TID, x 10
Age: 43.0
Sex: M
Vaccine: HEP, TYP
Symptoms: Hypoaesthesia, Nervous system disorder, Neurological examination abnormal, Paraesthesia, Shoulder pain
Clinical narrative: Received vaccine on 01/25/05. On 02/22/05, reported to health unit with 5 day HX of shoulder pain (right) with finger tingling and numbness x 1 day. Went to PMD, heat advised without relief/ Received TX from a chiropractor x 3 weeks later for an unspecified length of time. Numbness to this site remained. He was referred to a neurologist and was DX with Brachial Plexitis; resulted after EMG and nerve conduction studies. Ongoing recovery.
Age: 1.06
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Fever on Tuesday (no temp taken, felt hot), Per MD. Stated forhead and also a rash on diaper line. Fever, Rash, on body, face, trunk and extremeties. No SOB, HA, NV.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash erythematous, Rash macular
Clinical narrative: 3.5" diameter red, raised macular rash with no clear center.