chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old male with no allergies or medical conditions who on 09/10/98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 626956/0837H).  Concomitant vaccine therapy that day included a third dose PO of poliovirus vaccine live oral (Lot # 0786F). There were no other medications. There was no illness at the time of vaccination.  On 10/18/03 the pt experienced a "vaccine failure", as he was diagnosed with chickenpox. The report indicated that the child still has them. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Eye disorder, Fatigue, Hypoaesthesia, Musculoskeletal stiffness, Pain
Clinical narrative: Shooting pains in arms and legs, stiffness, fatigue, rheumatoid arthritis.  Nurse follow up on 07/07/04 states: "Per review of medical records from vaccine provider-PCP, In 6/02, patient c/o tick bite followed by achiness (myalgia), fever (FEVER), & joint pain (ARTHRALGIA). Lyme disease was suspected, but lab tests were not done to confirm. Pt was treated with Doxycycline, but apparently did not return to the provider for follow up."  As per annual follow up: rheumatoid arthritis, unusual fatigue, Numbness in left eye.
Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Rheumatoid arthritis
Clinical narrative: Shooting pains in arms and legs, stiffness, fatigue, rheumatoid arthritis.  Nurse follow up on 07/07/04 states: "Per review of medical records from vaccine provider-PCP, In 6/02, patient c/o tick bite followed by achiness (myalgia), fever (FEVER), & joint pain (ARTHRALGIA). Lyme disease was suspected, but lab tests were not done to confirm. Pt was treated with Doxycycline, but apparently did not return to the provider for follow up."  As per annual follow up: rheumatoid arthritis, unusual fatigue, Numbness in left eye.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Dyspnoea, Oedema, Rash
Clinical narrative: 48 hours after immunization, developed rash on legs, neck, arms, ears. Denies edema, dyspnea, any other complaints. Referred to family MD.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Syncope vasovagal
Clinical narrative: From initial information received on 07/28/03 from a physician regarding an adverse event occurring in the USA, it was reported that a five and a half year old female pt received at DT ADS PSD USP vaccination, Lot # U0746AC, route and site of administration unknown, on an unspecified date. Five minutes after receiving the vaccination, the pt experienced a vasovagal response. The pt was placed on a bed with her bead in a downward position and was given oxygen. It was reported that the pt recovered nicely and was sent home. The reporter of this case is the same reporter of case  2003-01479.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Vomiting
Clinical narrative: From initial information received on 08/12/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four month old female pt received her second dose of DT ADS PED USF, Lot # U0746AE, administered in the left thigh and a dose of Pedvax (Lot # 0429N), administered in the right thigh on 08/11/03 at 11:15AM. The routes of administration were not reported. Tylenol was given prior to vaccination. Immediately following injection, the pt experienced excessive crying, which lasted for two hours. One day later, the pt vomited. There was no redness, swelling or warmth noted at the site. Reportedly, the pt has not recovered from these events.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, High-pitched crying
Clinical narrative: Inconsolable crying/high pitch cry about 3 hours.
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: 04/16/04: Received Hepatitis B, MMR and Chickenpox Vaccine. 04/24/04: Prior to this date had a runny nose for a couple days. This day started with a fever up to 102 deg and developed 6 marks on his chest and front area plus 2-3 marks on his back.  They were red and approximately 1cm in size with a clear white center mark.  Administered Tylenol.   04/25/04: Fever 98-99.5 deg and was cranky.  Marks faded. 04/26/04: To doctor. Temperature 97.4. Rash cleared, Appears OK. 04/28/04: During day developed rash on 1/3 of body. Rash appears raised. No fever. Behavior fine. Rash lasted 36-48 hours and dissapeared. OK since then.
Age: 1.1
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia, Rhinorrhoea
Clinical narrative: 6-8 pox, fever, runny nose for 1 week.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Had Varicella vaccine on 06/22/00.  Now diagnosed with chickenpox by MD.  # of pox=<50 mild case. Vaccine storage in freezer WNL's at 3 F consistently.  Follow up on 07/19/04 states: "Diagnosed with chickenpox 05/04/04."
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Pyrexia, Vomiting
Clinical narrative: (right arm) vomited after shot.  Had a fever, arm red, swollen (4x4 area).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Injection site induration
Clinical narrative: warm, red, indurated 2x2 cm ar4ea on LVE (left upper extremity).
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Pharyngolaryngeal pain, Throat tightness
Clinical narrative: 5/14/04:Vaccine received in 5/13/04. Received TC 5/14/04 at 10 am. Pt complained of sore throat, "felt like throat closing" evening of 5/13, pt did not contact anyone, took sleeping pill and went ot bed. This am, c/o sore throat on left, going up to left ear, weakness, denies fever. I pt to see MD today. This clinic contacted regional immunization report from  DOH.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Chicken pox.
Age: 6.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varicella
Age: 1.3
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen (2.5x2 inches) + redness at site of injection
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Contusion, Feeling hot, Injection site erythema, Pain
Clinical narrative: Left arm at injection site area redness, bruising, pain, warm to touch. Complained of pain left arm. Augmentin x10days per doctor. 8x2cm patchy area on arm.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site induration, Pruritus
Clinical narrative: Telephone call 5/5/01: rt arm red swollen 1"x3" slightly itchy and slightly warm to touch. Benadryl every 6 hours. Motrin every 6 hors and redness to be evaluated. 5-6-04: visit. rt arm redness, warm to touch, and hardness -98 degrees- 10x8 cm rash. --Augmentinx10days. F/U prn. Diagnosis: Vaccine reaction and cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Telephone call 5/5/04: left arm area from DTaP shot warm, red, itchy 1"x4". Denies pain. Ordered Benedryl, ice, Motrin to call if redness increases. 5/6/04 visit : on Benadryl every 6 hours, Motrin: left arm very, red, swollen, warm to touch. Afebrile. MD ordered augmentin 600mg TIDx10days and continue benadryl.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Diarrhoea, Headache, Irritability, Joint stiffness
Clinical narrative: Severe headache, nausea, vomiting, diarrhea, body rash, muscle soreness, joint stiffness and pain, malaise, fever, irritability. Went to local doctor and received Medrol dose pack.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Nausea, Pyrexia, Rash, Tenderness
Clinical narrative: Severe headache, nausea, vomiting, diarrhea, body rash, muscle soreness, joint stiffness and pain, malaise, fever, irritability. Went to local doctor and received Medrol dose pack.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Severe headache, nausea, vomiting, diarrhea, body rash, muscle soreness, joint stiffness and pain, malaise, fever, irritability. Went to local doctor and received Medrol dose pack.
Age: 15.0
Sex: M
Vaccine: TD
Symptoms: Convulsion, Dyskinesia, Musculoskeletal stiffness, Syncope
Clinical narrative: Td given IM in right deltoid. Student returned to class, then fainted. School nurse took BP and pulse and stated they were WNL. Nurse also reports that several minutes after fainting students exhibited seizure like activity (stiff neck, hand movements) 911 and parents were called. Parents refused ambulance. Will FU with MD.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Oedema
Clinical narrative: Left arm mild edema, erythema, local reaction probably to DTP vaccine. Sxtx: close observation.
Age: 2.08
Sex: F
Vaccine: DTAP, HBHEPB, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Pt has generalized rash all over body and has febrile episodes. Treatment with Tylenol and Benadryl. Rash lasted three days at time of report.
Age: 59.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Blister, Neck pain, Swelling
Clinical narrative: Patient states she took fourth capsule of one typhoid vaccine and noticed blisters on her tongue, neck pain and swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Pyrexia
Clinical narrative: 8x7 cm local induration left deltoid. T 99.7 degrees.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red and hot area, 3-4 cm medial to puncture site of DTaP.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Tenderness
Clinical narrative: erythema, warmth, tenderness to left deltoid area.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a RN concerning a female pt with a history of chickenpox who in approximately 2003 was vaccinated with a dose of varicella virus vaccine live (Lot # not provided). The pt subsequently developed shingles. It was not known what treatment was provided or if the pt recovered. Unspecified medical attention was sought.  There was no product quality complaint involved. The reporter indicated a similar experience with another pt (WAES # 0308USA01976). No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed "vaccine failure". "One child had more than 50 lesions" (WAES # 0308USA00716) "and the other child was covered." It was noted that the doctor did not provide any additional information at the time of this report. Unspecified medical attention was sought. There was no product quality complaint involved.  The reporter also mentioned a sibling that was vaccinated with varicella virus vaccine live and developed a similar experience (WAES # 0308USA00716).  Additional information has been requested.
Age: 2.5
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a LPN concerning a 30 month old white male with no medical history and no known allergies who on 03/11/02 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 639901/1152L). There was no concomitant medication. On the evening of 08/05/03 the pt developed breakthrough chickenpox with approximately 15 vesicles, "bumps", a low grade fever, pruritis and fussiness. On 08/06/03 at 09:45 the pt "now" had more "bumps"; some with small blisters. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint was involved. It was also reported that a 27 month old female was vaccinated SC in the right arm with a dose of varicella virus vaccine live (Lot # 639901/1152L) and developed breakthrough chickenpox (WAES # 0308USA01109).  No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 36 month old black male with no past medical history and no concurrent conditions who in 2001 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. The child had an upper respiratory infection at the time of vaccination. Concomitant medications administered on 09/14/01 included a first dose in the right thigh of MMRII (Lot # 634222/0606L) and a fourth dose in the right thigh of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (Lot # 638581/21668K). On 02/28/03 the pt presented at the MD's office with a fever and a few lesions on both arms. The physician indicated that it was chickenpox breakthrough. The evening of 02/28/03 the child went to the ER and had "more lesions", but the pt was not treated and was released. The physician indicated that "she did not know why they took the child to ER since this was a chickenpox breakthrough". Unspecified medical attention was sought. There was no product quality complaint. No relevant diagnostic tests or lab data were reported. There were no adverse events following prior vaccinations. Follow up information indicated that on 02/27/03 the child developed a varicella rash. The reporter noted that the pt recovered. No further information is expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a RN concerning a 2 year old male who was vaccinated SC with a dose of varicella virus vaccine live. The reporter indicated that approximately two to three months ago the pt came into the office with chickenpox. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Infection, Laboratory test abnormal, Pyrexia, Rash
Clinical narrative: Information has been received concerning a 16 month old white female who on 07/22/03 in the PM was vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot # 643123/0550M).  Concomitant medications that day included a dose of MMRII, Prevnar.  On 07/29/03 the pt developed "bumps" on her trunk and a "varicella reaction". On 07/30/03 the pt had a positive "strep test". She was treated with Omnicef. On 08/01/03, she had a fever of 102.9 degrees and "bumps" with about 3-5 vesicles. Unspecified medical attention was sought. There were no adverse events following prior vaccinations. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a RN concerning a 12 month old female who on 01/27/99 was vaccinated with a dose of varicella virus vaccine live (Lot # 625470/0315H).  In approximately Feb 1999, "shortly after the immunization (with in a month perhaps)", the child developed a rash around the site of injection described as "bumpy varicella-like rash" that was confined in a 2x2 inch area on the child's thigh. The duration of the rash was one year and between ages 2 and 3 it was believed that she was "OK". It was noted that every year around the anniversary of her original immunization, the child developed a rash in the same confined area of her thigh "as when she was a baby". "The rash goes away after scabbing up". The child had not been seen by a physician for this condition. In 2000, "at age 3", the child developed a case of chickenpox. There was no prescription drug required for treatment. There was no product quality complaint involved. At the time of this report, the child was 5 years of age. The reporter also mentioned that inon 08/06/03, the child received MMRII and on 08/08/03, "presented with rash again" (WAES # 0308UA01150).  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, PNC, VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 30 month old male with no relevant medical history and no known allergies who on 05/01/03 (previously reported as 05/06/03) was vaccinated in the right arm with a SC first dose of varicella virus vaccine live (Lot # 643768/1063M). Concomitant therapy on 05/01/03, included an IM fourth dose in the left arm of Hib conj vaccine (crm197) (Batch # UA816AA), an IM fourth dose in the left arm of DTAP (Tripedia)(Batch # C1354BA) and an IM fourth dose of in the left arm of Prevnar (Batch # 493-187). There was no illness at the time of vaccination. Subsequently, the pt developed "12-15 varicella-like lesions", also described as "12-15 insect bite like lesions on back". There were no relevant lab or diagnostic studies performed. It was noted that no hospitalization or treatment was required. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint involved. No additional information was provided. No further information is expected.
Age: 2.3
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Dermatitis bullous, Infection, Irritability, Pruritus, Pyrexia
Clinical narrative: Information has been received from a LPN concerning a 27 month old white female with no medical history and no known allergies who on 04/11/02 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 639901/1152L).  There was no concomitant medication.  On 08/06/03 at 15:00 the pt developed breakthrough chickenpox described as a multiple erythema base; some with vesicles (approximately 50 vesicles) and some crusted. The pt also developed a low grade fever, pruritis and fussiness. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint as involved. It was also reported that this pt was vaccinated with a first dose of MMRII (manufacturer unknown) and at 12 months of age developed a fever and a rash (WAES # 0308USA02494).  It was also reported that an 18 month old male was vaccinated SC in the right arm with a dose of varicella virus vaccine live (Lot # 639901/1152L) and developed breakthrough chickenpox (WAES # 0308USA00828).  No further information is expected.
Age: 2.3
Sex: F
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a LPN concerning a 27 month old white female with no medical history and no known allergies who on 04/11/02 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (Lot # 639901/1152L).  There was no concomitant medication.  On 08/06/03 at 15:00 the pt developed breakthrough chickenpox described as a multiple erythema base; some with vesicles (approximately 50 vesicles) and some crusted. The pt also developed a low grade fever, pruritis and fussiness. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint as involved. It was also reported that this pt was vaccinated with a first dose of MMRII (manufacturer unknown) and at 12 months of age developed a fever and a rash (WAES # 0308USA02494).  It was also reported that an 18 month old male was vaccinated SC in the right arm with a dose of varicella virus vaccine live (Lot # 639901/1152L) and developed breakthrough chickenpox (WAES # 0308USA00828).  No further information is expected.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Malaise, Skin disorder, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 21 month-old white female who in October 2002, was vaccinate subcutaneously with a dose of varicella virus vaccine live. The mother of the patient reported that on 23-July-2003, the patient developed a "chicken pox lesion on her face, and the next day more lesions appeared". The lesions first appeared "on her face, and then moved to her chest, to her diaper area, then to her legs" and progressed to other parts of her body. It was noted that it "was severe in nature" and as of 07-Aug-2003 the "patient was still developing new lesions". It was also noted the child was "quite sick". The nurse did not treat the patient and did not know who the treated physician was. It was unknown if a prescription drug was required for treatment. It was also noted that the physician may not be contacted. Unspecified medical attention was sought. There was no product quality complaint involved. No additional information was provided. Follow-up information indicated that the nurse spoke with the patient's mother and "the child was misdiagnosed". The child had impetigo, not chicken pox. The child has been treated and is fine." No additional information is expected.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Eczema, Infection, Rash, Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a 14-month-old patient who on 27-May-2003 at 10:30 AM was vaccinated in the right arm with a first 0.5 mL dose of varicella virus vaccine live (Lot #641155/0793M) at "age one-year". At the time of vaccination, the patient had a upper respiratory tract infection, eczema, and candida diaper rash. Subsequently, when the child was seen at 14-months, she had herpes zoster. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a nurse practitioner indicated that on 06-Aug-2003 at 10:30 AM the patient developed zoster, described as less than or equal to 25 lesions on his right chest and right back for a two week duration. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. There were no other systematic symptoms. The patient did recover. There was no history of chickenpox. It is unknown if there was a recent exposure to chickenpox or herpes zoster. There was no direct flourescent antibody done. There was no specimen collected for PCR. No photo was taken. No further information is expected.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 14-month-old patient who on 27-May-2003 at 10:30 AM was vaccinated in the right arm with a first 0.5 mL dose of varicella virus vaccine live (Lot #641155/0793M) at "age one-year". At the time of vaccination, the patient had a upper respiratory tract infection, eczema, and candida diaper rash. Subsequently, when the child was seen at 14-months, she had herpes zoster. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a nurse practitioner indicated that on 06-Aug-2003 at 10:30 AM the patient developed zoster, described as less than or equal to 25 lesions on his right chest and right back for a two week duration. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. There were no other systematic symptoms. The patient did recover. There was no history of chickenpox. It is unknown if there was a recent exposure to chickenpox or herpes zoster. There was no direct flourescent antibody done. There was no specimen collected for PCR. No photo was taken. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been receive from a physician concerning a female patient who in approximately August 2003, was vaccinated with a dose of varicella virus vaccine live. On 13-Aug-2003 it was reported that the patient "recently" had a breakthrough with lesions that looked like mosquito bites. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient "developed a chicken pox break out". Unspecified medical attention was sought. There was no product quality complaint involved. "No further information was provided about the patient". Follow-up from the physician indicated "no further information necessary". No further information is expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye irritation, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female adult coworker with sulfamethoxazole (+) trimethoprim (Bactrim) and enverionmental allergies and a history of varicella who may have had varicella virus vaccine live splashed into her eye. Unspecified medical attention was sough. A product quality complaint was not involved. Follow-up information from the consumer who is a registered nurse indicated that on 12-Aug-2003 between 3:45 and 4:00 pm she was vaccinated a 10 year girl with the varicella virus vaccine live SC in the right deltoid. When the safety syringe was activated "spray" hit the nurse in the forehead. She then washed her forehead with soap and water. Approximately 30 minutes later, her eyes became irritated, the left greater that the right. She then flushed her eye with water for about 1 minute. Her eyes were somewhat itchy. Approximately 2 hours later she flushed her eyes again and the itchiness improved. On 13-Aug-2003, the patient was seen by a physician and an eye exam was done. The diagnosis was irritation to both eyes due to exposure to chemical. It was noted that her condition was stable. Her treatment included artificial tears supplement qid and polyehtylene glycol (+) propylene glycol (SUSTANE) 1 drop to both eyes qid for 2-3 days. Subsequently the patient recovered. No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician who is the mother of a 4 year old "normal, healthy" male patient with "no significant medical history" who in approximately 2000 (at ate 12-18 months of age) was vaccinated with a dose of varicella virus vaccine live and "has now developed breakthrough varicella". There was no concomitant medication . On "Sunday" 10-Aug-2003, the mother first noted that he had 2 lesions. On "Tuesday" 12-Aug-2003, "he had an obvious rash" and now had "approximately 100 lesions", most were papular and "approximately 10" were vesicular. It was noted that he did not have any fever or other complications, however, he had not complained of his "belly hurting" though he had "no obvious digestive problems." It was also noted that he has not had any "known, recent exposure to varicella", he attends daycare and the mother was not aware of any recent varicella outbreakes at the daycare center. Unspecified medical attention was sought. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7-year-old male who on 22-Sep-1998 was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 31-Jul-2003, the patient developed herpes zoster. The physician indicated that the patient was not hospitalized, but unspecified medical attention was sought. The patient was subsequently treated with acyclovir (Zovirax). In August 2003, the patient was considered to be recovered from the herpes zoster as the lesions were healed. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Infection, Pruritus
Clinical narrative: Information has been received from a physician concerning a 12 month old black female with asthma who on the morning of 14-Jul-2003 was vaccinated intramuscularly in the left arm with a first dose of varicella virus vaccine live (lot #0593U). On the morning of 14-Jul-2003 the patient was also vaccinated intramuscularly with a first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live (lot # 642182/0774M), and a third dose given intramuscularly of pneumococcal 4 6B 9V 14 18C 19F 23 F conj vaccine (CRM197) (lot #493899). There was no illness at the time of vaccination. There were no adverse events following previous vaccinations. On the afternoon of 31-Jul-2003 the patient "broke out" into a mild case of chicken pox (physician also reported this as "vaccinia"). It progresses over the next week with some itching. There was no fever. The physician did not know if it was due to the vaccine or from a wild virus. Unspecified medical attention was sought and no prescription drug was required. No diagnostic studies were performed. No product quality complaint was involved. On 10-Aug-2003, after 10 days, the patient recovered. No further information is expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning an 17-year-old non smoking white female who on 29-Nov-199 was vaccinated with a first dose of varicella virus vaccine live. The patient is going to college and on 05-Aug-2003 she was tested negative to a chicken pox titer. It was reported that there was no record or proof of this original vaccination, but the nurse believed the patient is a reliable historian. Because the school would not accept the student without proper evidence of vaccination, a second dose was given "recently". The report indicated that another dose will be administered at the appropriate level. There was not a product quality complaint involved. Unspecified medical attention was sought. Follow-up information indicated that the nurse did not consider the fact that the patient did not seroconvert with one vaccine an adverse event. Vaccination records were found which indicated that the vaccine was given on 29-Nov-1995. A titer drawn on 05-Aug-2003 was negative. A booster dose of varicella virus vaccine live (lot # 644565/1149M) was then given on 14-Aug-2003. Other vaccination history included a first, second, third, fourth and fifth doses of diptheria and tetanus on 07-Oct-1985, 05 Dec 1985, 06 Feb 1986, 15 Jun 1987 and 10 Feb-1997 respectively; a first, second, third and fourth dose of polio vaccine on 07-Oct-1985, 05-Dec-1985, 06-Fe-1986 and 15-Jun-1987 respectively, a dose of measles virus vaccine live (manufacturer unknown) on 03-Nov-1986, a dose of rubella virus vaccine live (manufacturer unknown) on 03-Nov-1986 and a dose of mumps virus vaccine live (manufacturer unknown) on 03-Nove-1986, a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) on 10-Feb-1997, a "tine" on 04-Aug-1986, a dose of Haemophilus B conjugate vaccine (manufacturer unknown) on 21-Nov-1987; a first, second and third dose of hepatitis B virus vaccine rHBsAg (yeast) manufacturer unknown) on 10-Feb-1997, 12-Mar-1997 and 11- Jul-1997 respectively. A TB was negative on 03-Aug-1998. Additional information is not expected.
Age: 1.92
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 23 month old male with pervasive development disorder and no known allergies who on 19-Sep-2000 was vaccinated with a first dose of varicella virus vaccine live (lot #635188/0761K). There was no concurrent medication. It was unknown if there was an illness present at the time of vaccination. Subsequently, the patient has had two episodes of herpes zoster both on the left shourlder in the C5 dermatome. On 20-Aug-2001 he was diagnosed in a hospital emergency department with herpes zoster. On 12-Aug-2003 he developed herpes zoster for the second time. On 14-Aug-2003 a specimen was obtained from one of his lesions. Fifteen lesions were noted and most were drying up. The PCR results, from an adequate specimen, were negative for VZV and HSV. The physician reported that the patient is a normal healthy child on no medications; however he is in foster care and was a high risk at birth for congenital HIV. The physician heard via "third-hand" information that the patient's HIV screening at birth was negative, however she has not been able to confirm this. The physician is planning on obtaining consent from the foster parents for HIV testing for the child. Follow-up information from the physician indicated that 12-Aug-2003, approximately 20 roughly similar vesiscles were noted. There was no recent exposure to chickenpox or shingles. on 14-Aug-2003 the physician reported that the child was happy and playful. Some lesions were dry and no acyclovir was given yet. His birth history was unknown "crack exposed" and his NBS was "WAL". His physican examination was otherwise notable for a large head and obvious delay. He was also diagnosed with PDD (date unspecified) by neurology and psychologists. On 11-Sep-2003 the physician reported that the chidl was recovering at the time the specimen was obtained and now has completely recovered. She reported that "he is otherwise healthy and does not look like and HIV infected child". No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Infection, Pyrexia, Rash papular
Clinical narrative: Information has been received from a physician concerning a 12-month-old "otherwise healthy" female with an ear infection who on 08-AUG-2003 was vaccinated with a dose of varicella virus vaccine live (Lot # 646137/0474N). Concomitant therapy included cefdinir (OMNICEF) for an ear infection. On 13-AUG-2003, one week post vaccination, the patient developed a fever of 101.5 degrees Fahrenheit and an unusual rash. The rash was described as pink and raised with papular marks  (rather than vesicular) 1/4 to 1/4 inches in size. The physician noted that the patient presented to the office on 15-AUG-2003, two days after the rash appeared. The patient was also noted to have a low grade fever (approximately 101.5 degrees Fahrenheit). Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: DTAP, HEP, PNC, VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a medical assistant concerning a 16 month old male with no known drug allergies or medical history who on 15-Aug-2002 was inadvertently vaccinated subcutaneously in the right thigh with a second dose of varicella virus vaccine live (lot # 640726/0211N). On 15-Aug-2003 the patient was also vaccinated intramuscularly in the right thigh with a fifth dose of diptheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) )(lot # U0856BA) a fourth dose given intramuscularly in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23 F conj vaccine (CRM 197) (Prevnar) (lot #491272) and a fourth dose given intramuscularly in the left thigh of hepatitis B virus vaccine rHBsAG (yeast) (lot # 64366/0054N). There was no other concomitant medication. There was no known illness at the time of vaccination. The patient had no adverse events following prior vaccinations. It was reported that the patient had already been immunized on 14-Apr-2003 with a first dose of varicella virus vaccine live. As of 20-Aug-2003 the patient "denies any side effect but was slightly irritable". There were no diagnostic tests performed. No medical attention was sought and no prescription drug was required. subsequently, the patient recovered. No product quality complaint was involved. It was also reported that on 08-Oct-2003 the patient was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast), and on 14-Jul-2003 the patient had received the following vaccinations: a fourth dose given intramuscularly in the left thigh of diptheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot #U0850DB1), a third dose given intramuscularly in the left thigh of pneumococcal 4 6 B 9V 14 18C 19F 23F conjugate vaccine (CRM 197) (lot # 491272), and a fourth dose given itnramuscularly in the right thigh of Haemophilus B conjugate vaccine (test toxoid) (ACTHIB) (lot # UA808AA).  No further information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 5  year old white male with no known allergies who on 11/03/98 was vaccinated at another facility with a first 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 07/05/03 the pt started breaking out with small red spots on his trunk. Within 24 hours, as the day and weekend progressed, the rash spread and the spots got a little bigger and vesicular looking. On 07/07/03 the pt was seen in the office by a physician and diagnosed with varicella. The pt was treated symptomatically. No prescription drug was required. Subsequently, the pt recovered. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a 36 month old male who on 01/11/01 was vaccinated with a dose of varicella virus vaccine live. The pt developed "breakthrough varicella". There was no concomitant therapy. There was no prescription drug treatment required. Subsequently, the pt recovered. Additional information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 5 year old white male with no medical history and no allergies who on 07/22/00 was vaccinated in the right arm with a dose of varicella virus vaccine live (Lot # 631165/0712J).  There were no adverse events following prior vaccinations. In April 2003, the pt developed breakthrough varicella with less than 60 lesions. No medical attention was sought. Subsequently, the pt recovered.  No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a NP concerning a 36 month old male with "no allergies" who on 06/07/01 was vaccinated SC in the left thigh with a first dose of 0.5mL (Lot # 637672/1610K) and "had break through chickenpox". There was no concomitant medication. The pt presented to the nurse practitioner with a "rash", described as a mild case of varicella. There were no lab studies performed. It was noted that no treatment or hospitalization was needed. It was also noted that the child was exposed to chickenpox at day care. Unspecified medical attention was sought. It was also noted that symptoms resolved and the pt had recovered. The reporter also mentioned another pt who experienced a similar reaction with varicella virus vaccine live (Lot # 624781/0056H) (WAES # 0308USA01465).  No further information is expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Infection
Clinical narrative: Information has been received from a consumer concerning her 12 year old grandson who in 1994 was vaccinated with a dose of varicella virus vaccine live. On approximately 08/10/03, the pt broke out in shingles. His grandmother thinks that "he received a weakened dose of chickenpox vaccine". She also thinks "he was exposed to chickenpox, but broke out in shingles". The pt sought medical attention and was seen at the MD's office.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a RN concerning a female pt with a history of chickenpox who in approximately 2003 was vaccinated with a dose of varicella virus vaccine live (Lot # not provided). The pt subsequently developed shingles. It was not known what treatment was provided or if the pt recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated a similar experience with another pt (WAES # 0308USA00822).  No further information is available.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 15 month old male who at 15 months of age was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live. Subsequently, 21 days later, the patient developed 10-15 lesions all over the body. No further specifics were provided. Unspecified medical attention was sought. No product quality complaint was involved. on 03-Sep-2003 a registered nurse reported that the patient may have been a case study that was discussed by several physicians during a meeting. The event could have occurred years ago and there was no way to trace the original case and it was most likely already reported when it originally took place. No further information is expected.
Age: 3.17
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 38 month old male patient who on 21-Jul-2001 was vaccinated with a dose of varicella virus vaccine live. On approximately 19-Aug-2003, the patient developed a "severe" case of chickenpox with lesions on his trunk, groin area, in his mouth and ears. The patient had not been seen by a physician and the information was based on the patient's father diagnosis of the condition. Medical attention was not sought and treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 38 month old male patient who on 7/21/01 was vaccinated with a dose of varicella virus vaccine live. On approximately 8/19/03, the patient developed a severe case of chicken pox with lesions on his trunk, groin area, in his mouth and ears. The patient had not been seen by a physician and the information was based on the patient's father's diagnosis of the condition. Medical attention was not sought and treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pain, Pruritus, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant concerning a 7 year old Greek male with no known allergies who on 10MAR1999 was vaccinated SC with a first 0.5ml dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter noted that the child had a family member with leukemia going through chemotherapy. On 14AUG2003 the patient presented to the doctor's office with a rash, itching, some leg pain(unknown which leg), and a stomach ache. An antibody test was taken and the titer came back negative result for chickenpox. No other information is available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received a physician indicated that there was questionable exposure to varicella zoster 3 weeks prior to vesiculopapular rash, which is continuous with VZV. On 14AUG2003 the patient was tested for VZV IgM and VZV IgG because his sister had been on chemotherapy since May 2003 for leukemia and "she did not get VZIG when he presented with this rash". The results of the tests were negative. It was all noted that all titers were negative. The reporter indicated that the results indicate a different virus. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Erythema, Infection, Pain, Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 month old white male with no medical history, no history of chicken pox and no allergies who on 06-Mar-2003 was vaccinated in the right thigh with a 0.5 ml dose of varicella virus vaccine live (lot # 43824/0870M). On 06-Mar-2003 the patient was also vaccinated in the left deltoid with a first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #43715/0838M). There was no other concomitant medication. At the time of vaccination the patient was ill with atopic dermatitis. On 15-Aug-2003 the patient developed clustered, painful vesicular lesions on a red base. There were three patches located on the right dermatome lesion, the right leg and the right lumbar spin (?L4). On 20- Aug-2003 the patient was seen in the office. The patient was diagnosed with herpes zoster and treated with acyclovir (Zovirax) ointment. No prescription drug was required. It was also reported that no rash occurred at the site of the injection or elsewhere within 42 days of the vaccination. No direct flourescent antibody was done and no specimen was collected for PCR. A photo was taken. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.42
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a certified medical assistant concerning a 17 month old white male with no medical history, no history of chicken pox and no allergies who on 06-Mar-2003 was vaccinated in the right thigh with a 0.5 ml dose of varicella virus vaccine live (lot # 43824/0870M). On 06-Mar-2003 the patient was also vaccinated in the left deltoid with a first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #43715/0838M). There was no other concomitant medication. At the time of vaccination the patient was ill with atopic dermatitis. On 15-Aug-2003 the patient developed clustered, painful vesicular lesions on a red base. There were three patches located on the right dermatome lesion, the right leg and the right lumbar spin (?L4). On 20- Aug-2003 the patient was seen in the office. The patient was diagnosed with herpes zoster and treated with acyclovir (Zovirax) ointment. No prescription drug was required. It was also reported that no rash occurred at the site of the injection or elsewhere within 42 days of the vaccination. No direct flourescent antibody was done and no specimen was collected for PCR. A photo was taken. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 44 month-old female with an allergy to amoxicillin who on 08-Aug-2003 was vaccinated with a dose of varicella virus vaccine live, "1 vial" . There was no concomitant medication. On 19-Aug-2003, the patient developed a varicella like rash throughout her body and a fever. It was noted that the patient visited the physician on 19-Aug-2003 and "no therapy administered". No prescription drug was required. It was also noted not to contact the physician. Unspecified medical attention was sought. It was noted that the patient had not recovered. No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Injection site reaction, Petechiae, Rash papular
Clinical narrative: Information has been received from a physician and a reporter from the physician's office concerning a 12 month old Hispanic male with no known drug allergies and no medical history who on 18-Aug-2003 was vaccinated in the left arm with a first does of varicella virus vaccine live (l;ot 3644573/0014N). On 18-Aug-2003 the patient was also vaccinated with a dose of measles virus vaccine live (+) rubella virus vaccine live (second generation). On 20-Aug-2003 the patient developed a papular rash on the left arm. It was also reported that the patient developed a rash which looked like an allergic reaction from the injection site to the elbow and petechiae. It was not a varicella-like rash. Medical attention was sought and the patient was treated with diphenhydramine (Bendaryl). The patient did not have a fever, wheezing nor itching. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.