chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Anaemia, Aspiration, Brain oedema, Cardio-respiratory arrest, Convulsion
Clinical narrative: Vomiting, low grade fever, anemia, electrolyte imbalance, seizure like activity, and cardiopulmonary arrest. Received autopsy report which revealed COD as hemolytic uremic syndrome w/glomrulo microthrombi & bilateral acute interstitial nephritis.  Other findings at autopsy: cerebral edema, hemolytic anemia, acute renal failure, pulmonary congestion c/w aspiration pneumonia.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Electrolyte imbalance, Haemolytic anaemia, Haemolytic uraemic syndrome, Nephritis, Pulmonary congestion
Clinical narrative: Vomiting, low grade fever, anemia, electrolyte imbalance, seizure like activity, and cardiopulmonary arrest. Received autopsy report which revealed COD as hemolytic uremic syndrome w/glomrulo microthrombi & bilateral acute interstitial nephritis.  Other findings at autopsy: cerebral edema, hemolytic anemia, acute renal failure, pulmonary congestion c/w aspiration pneumonia.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Renal failure, Thrombosis, Vomiting
Clinical narrative: Vomiting, low grade fever, anemia, electrolyte imbalance, seizure like activity, and cardiopulmonary arrest. Received autopsy report which revealed COD as hemolytic uremic syndrome w/glomrulo microthrombi & bilateral acute interstitial nephritis.  Other findings at autopsy: cerebral edema, hemolytic anemia, acute renal failure, pulmonary congestion c/w aspiration pneumonia.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis 48 hrs after varicella vaccine. Requiring Hospitalization at med center, plus 5 days of rehab after discharge.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site reaction, Pruritus
Clinical narrative: Increasing redness around injection site and into axilla. Pruritis at site.
Age: 1.45
Sex: M
Vaccine: DTAP, FLUX, HIBV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Injection site, thigh is warm, red, hard, and swollen.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Contusion, Platelet count decreased, Thrombocytopenia
Clinical narrative: 1 week history of increased bruising; discovered thrombocytopenia (Platelet 2000/cmm). Treated with IVIG and platelets increased to 96,000/cmm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Right arm swollen and red. Warm to touch. To do cool compresses, elevate and anti inflammatory meds.
Age: 39.0
Sex: F
Vaccine: HEP, TD
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Gave Td IM on Friday 04/29/05, No reaction until 6 days later 05/04/05 with hard knot (size of marble) and pain.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Angioneurotic oedema, Decreased appetite, Eyelid oedema, Face oedema, Lethargy
Clinical narrative: One hour after vaccination, infant developed angioedema of eyelids and lips which resolved with treatment with in 24 hours. After 24 hours, infant developed a rash and became labile with poor feeding.
Age: 0.23
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: One hour after vaccination, infant developed angioedema of eyelids and lips which resolved with treatment with in 24 hours. After 24 hours, infant developed a rash and became labile with poor feeding.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dyspnoea, Hyperhidrosis, Tachycardia
Clinical narrative: 30 minutes after receiving a Hep B vaccine this pt developed tachycardia (112-128/min) elevated BP (130/90) diaphoresis and felt SOB. Lungs were clear to ascultation.
Age: 1.23
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Mom called 05/16/05 and reported child had fever of 101 F rectally. 05/13-05/16/05. 05/16/05 had 20-30 Chicken Pox lesions over body- mostly arms and face. Pox starting to dry up 05/17/05. Child seems to be recovering nicely 05/18/05..
Age: 1.02
Sex: F
Vaccine: HEP, MER, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Developed full blown chicken pox with high fever (103.3)
Age: 69.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Erythema, Injection site erythema, Oedema peripheral, Pruritus, Rash pruritic
Clinical narrative: The day following each vaccine the pt got red, itchy patches of skin on lower legs and after Hep B #3 he also got these patches on arms and waistband with swelling of lower legs after day 3.
Age: 69.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: The day following each vaccine the pt got red, itchy patches of skin on lower legs and after Hep B #3 he also got these patches on arms and waistband with swelling of lower legs after day 3.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Muscle spasms, Neck pain, Pain
Clinical narrative: Severe L upper arm pain with L trapezius and neck spasm/ pain. L lower back spasm/pain. Low grade fever.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Rash papular
Clinical narrative: Papular rash anterior chest wall.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: OV 05/18/05, noted 312 lesions over body. Chest is tender. Acyclovir 800mg QID x 5 days ordered. Advised to call office with follow up.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Office visit on 05/18/05. Started on legs 3 days ago. Lesions spreading to face, abdomen and back. Fever 3 days ago, none since.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dizziness, Fatigue, Nausea, Syncope
Clinical narrative: Directly after receiving immunizations, became dizzy, faint. Recovered before leaving, nausea continued. For next four days nausea and dizziness continued. No fever noted per mom. Had fatigue for 1 week.
Age: 0.55
Sex: F
Vaccine: HBHEPB, IPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt had violent vomiting and temp of 102 F.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Oedema
Clinical narrative: Red, swollen and warm to the touch.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site oedema, Oedema peripheral
Clinical narrative: R thigh completely swollen indurated and red. No fever or other systemic problems.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Rash 20 lesions- buttocks, stomach and face.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Blister, Rash papular, Skin ulcer
Clinical narrative: Papular lesions on face, neck, arms, abd and sparingly beginning on left arm, vesicles.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site abscess, Injection site erythema, Injection site infection, Injection site mass, Injection site oedema
Clinical narrative: Red swollen leg area at site of injection, Rt thigh hardness felt at site, question of abscess, mother to apply warm compresses, antibiotic given. 2 1/2 x 2 1/2 cm septic looking at site area, appt scheduled for follow up with MD.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt received Varivax and was dx with chicken pox 5/11/05.
Age: 1.11
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Red, itchy rash on face, arms and abdomen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Feeling hot, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: T102-T103.4 after injection was given on 05/12/2005. Still had fever on 5/16/05. Bruising at injection site and warm to touch and hurting on 5/13/05. Injection site got to size of tennis ball by 5/16/05.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Medication error
Clinical narrative: Injection administered by med assistant (Hib ordered). MA noted "no vaccine" in syringe when gave injection (air likely injected IM), MA gave HIB vaccine after drawing up/mixing HIB vaccine. Mom question air injection IM vs repeat dose of Hib. Reassurance given re air injected IM (and even primarily of IV). I spoke with Dr, reassurance given re side effect of local erythema if Hib given x 2.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Varivax given 12/19/2003, Atypical varicella 5/18/2005
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Viral infection
Clinical narrative: Vaccine associated chickenpox started d 10.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site oedema
Clinical narrative: L arm (upper) pair and swelling after shot.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Rash both anterior thighs, red raised no vesicles.
Age: 0.99
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Asthenia, Gait disturbance
Clinical narrative: On return to clinic for follow up vaccines, 5/19/05, parent reported child demonstrates weakness in left leg since January immies, child observed limping. Follow up vaccines not given. Child referred to provider at a primary care clinic for evaluation.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient who on 3/17/04 was vaccinated with a dose of varicella virus vaccine live. On 3/30/04, the patient's mother brought her to the physician's office with a case of the chicken pox. The physician recorded that the patient's body was covered with 75 to 85 lesions, particularly in the extremities and cheeks area. The patient had some scabbing over parts of her body. There was no fever. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female with no pertinent medical history who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, the patient developed 39-45 chicken pox lesions 21 days later. She was treated with diphenhydramine hydrochloride and calamine lotion. The patient recovered. Unspecified medical attention was sought. There was no product quality complaint. There were no laboratory diagnostic studies performed. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 year old female patient with no past medical history who on 3/19/04 was vaccinated with a dose of varicella virus vaccine live (lot # 644788/0328N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. There was no concomitant therapy. On approximately 3/27/04, the patient was exposed to chicken pox. On 3/30/04, the patient developed a vesicular rash all over her body including on the face, trunk and a few on the extremities. There was also associated itching. There was no fever and no other symptoms. Unspecified medical attention was sought. Treatment for the rash was topical. The patient received calamine lotion and hydroxyzine hydrochloride. Laboratory tests were not performed. On 4/5/04, the patient's experience resolved with no complications. A product quality complaint was not involved. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Gait disturbance, Herpes zoster, Infection
Clinical narrative: Information has been received from a physician concerning a 23 month old healthy caucasian female patient with no known drug allergies who on 04/28/2003 was vaccinated subcutaneously in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot#643122/0549M).  There was no concomitant medication.  There was no illness at the time of vaccination and there were no adverse events following prior vaccination.  On 04/03/2004 the patient's parent noticed lesions on the patient's right lower leg.  On 04/05/2004, the patient was seen by the physician.  The lesions were vesicular, starting to crust and followed the dermatome over the right inner leg and ankle.  There were several clusters of lesions and each cluster contained approximately 5 to 10 lesions.  The patient was afebrile.  The reporter stated the patient had developed classic shingles and an onset date of 04/03/2004 was noted.  No treatment was prescribed and laboratory tests were not performed.  The patient had a mild limp for 2 days, but no itching.  There was no residual pain.  On 04/26/2004, the patient was recovered with only minimum redness still at the site.  A product quality complaint was not involved. The reporter also mentioned another patient who developed shingles post vaccination with varicella virus vaccine live (Oka/Merck) (WAES 0404USA01172).  Additional information is not expected. This is in follow-up report(s) previously submitted on 5/16/2005. Information has been received from a physician and an other health care professional concerning a 23-month-old healthy female patient with no past medical history and no known drug allergies who on 28-APR-2003 was vaccinated subcutaneously in the right thigh with a first dose of VARIVAX (Merck) (Lot # 643122/0549M). There was no concomitant medication. There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 03-APR-2004, the patient's parent noticed lesions on the patient's right lower leg. On 05-APR-2004, the patient was seen by the physician. The lesions were vesicular, starting to crust and followed the dermatome over the right inner leg and ankle. There were several clusters of lesions and each cluster contained approximately five to ten lesions. The patient was afebrile. The reporter states the patient had developed classic shingles and an onset date of 03-APR-2004 was noted. No treatment was prescribed and laboratory test were not performed. The shingles lasted until approximately 12-APR-2004, at which time all the lesions were crusted and the scabs were off. Flat redness lasted a few more weeks. The patient had a mild limp for two days, but "no itchy". There was no residual pain. On 16-APR-2004, the patient was recovered with only minimum redness still at the site. A product quality complaint was not involved. The reporter also mentioned another patient who developed shingles post vaccinationwith VARIVAX (Merck) (WAES # 0404USA01172). Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 23 month old healthy caucasian female patient with no known drug allergies who on 04/28/2003 was vaccinated subcutaneously in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot#643122/0549M).  There was no concomitant medication.  There was no illness at the time of vaccination and there were no adverse events following prior vaccination.  On 04/03/2004 the patient's parent noticed lesions on the patient's right lower leg.  On 04/05/2004, the patient was seen by the physician.  The lesions were vesicular, starting to crust and followed the dermatome over the right inner leg and ankle.  There were several clusters of lesions and each cluster contained approximately 5 to 10 lesions.  The patient was afebrile.  The reporter stated the patient had developed classic shingles and an onset date of 04/03/2004 was noted.  No treatment was prescribed and laboratory tests were not performed.  The patient had a mild limp for 2 days, but no itching.  There was no residual pain.  On 04/26/2004, the patient was recovered with only minimum redness still at the site.  A product quality complaint was not involved. The reporter also mentioned another patient who developed shingles post vaccination with varicella virus vaccine live (Oka/Merck) (WAES 0404USA01172).  Additional information is not expected. This is in follow-up report(s) previously submitted on 5/16/2005. Information has been received from a physician and an other health care professional concerning a 23-month-old healthy female patient with no past medical history and no known drug allergies who on 28-APR-2003 was vaccinated subcutaneously in the right thigh with a first dose of VARIVAX (Merck) (Lot # 643122/0549M). There was no concomitant medication. There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 03-APR-2004, the patient's parent noticed lesions on the patient's right lower leg. On 05-APR-2004, the patient was seen by the physician. The lesions were vesicular, starting to crust and followed the dermatome over the right inner leg and ankle. There were several clusters of lesions and each cluster contained approximately five to ten lesions. The patient was afebrile. The reporter states the patient had developed classic shingles and an onset date of 03-APR-2004 was noted. No treatment was prescribed and laboratory test were not performed. The shingles lasted until approximately 12-APR-2004, at which time all the lesions were crusted and the scabs were off. Flat redness lasted a few more weeks. The patient had a mild limp for two days, but "no itchy". There was no residual pain. On 16-APR-2004, the patient was recovered with only minimum redness still at the site. A product quality complaint was not involved. The reporter also mentioned another patient who developed shingles post vaccinationwith VARIVAX (Merck) (WAES # 0404USA01172). Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Information has been received from a woman in a medical office concerning a 12 month old male patient who on 03/22/2004 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot#646358/0569N).  Concomitant vaccination in the right arm on 03/22/2004 included a first dose of measles virus vaccine live (Moraten) mumps virus vaccine live, rubella virus vaccine live (lot#645434/0276N).  The patient was well at the time of vaccination.  On 04/02/2004, the patient developed a rash breaking out on several areas of the body and a runny nose.  Symptomatic treatment was noted, but medical attention was not sought.  Subsequently, the patient recovered.  Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, Varicella
Clinical narrative: 05.
Age: 1.19
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pharyngolaryngeal pain, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 09/12/1996 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot#617223/562D) subcutaneously.  Concomitant therapy that day included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (616454/0382D) subcutaneously.  Subsequently on 03/24/2004, the patient developed chickenpox breakthrough.  The patient was seen with lesions and a sore throat.  The patient sought unspecified medication.  No medications were prescribed.  There was no product quality complaint involved.  The patient recovered. It was also reported by the physician that the practice had seen at least 10 cases of chickenpox breakthrough, all in children who were vaccinated in 1996 (WAES #0404USA00981).  Additional information has been requested.
Age: 1.36
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female patient with no allergies and no past medical history who on 08/25/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  There was no illness at the time of vaccination.  On 04/07/2004, the patient developed breakthrough chickenpox (also reported as varicella) with multiple lesions on her face, extremities and trunk.  Unspecified medical attention was sought, but treatment was not required and laboratory tests were not performed.  Subsequently, the patient recovered.  A product quality complaint was not involved.  Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 2 year old patient who "about one year ago at one year of age" was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  The registered nurse reported that the mother of the patient stated that "this week" (April 2004), her child developed 10 red bumps on its back that were diagnosed as Chickenpox.  It was noted that no lot number was available and no treatment was required for the adverse event.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a medical assistant concerning a 46 month old male with no medical history and no allergies who on 05/25/2001 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 638568/1888K).  Concomitant vaccination the same day included a first dose of measles-mumps-rubella vaccine (MSD) (lot3 636776/0021L) given subcutaneously, a third dose of HIB conj-hepatitis B vaccine (MSD) (lot#638841/1762K) given intramuscular, a second dose of pneumococcal 4 6b 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (lot # 479-240) given intramuscularly and a third dose of diphtheria toxoid pertussis acellular 3-component vaccine, tetanus toxoid (Infanrix) (lot# DTPa982A2) given intramuscularly.  The mother of the patient reported that on 04/05/2004 the patient developed lesions all over his body and had a fever for the last 2 days.  The medical assistant reported the AE as chickenpox breakthrough.  Unspecified medical attention was sought and the patient was prescribed cetirizine hydrochloride (Zyrtec) and pimecrolimus (Elidel) but the mother never filled the pimecrolimus (elidel).  No product quality complaint was involved.  Follow up information from the licensed practical nurse indicated that the patient was seen on 04/05/2004 with a raised rash that progressed in the next 24 hours into a widespread varicella rash.  It was noted that the rash started on 04/04/2004.  Subsequently the patient recovered.  It was also reported that the patient's brother had a similar experience following exposure to varicella virus vaccine live (Oka/Merck).  No further information is expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Injection site vesicles
Clinical narrative: Information has been received from a healthcare professional concerning a 31 year old female with no past medical history and no known allergies who on 06Mar04, also reported as 19Mar04, at 9:30AM was vaccinated in the deltoid with a first dose of varicella virus vaccine live (lot 645288/0689). On 29Mar04, ten days later, the pt experienced an area on her upper arm that was a half dollar size with a blister. The area was sore and itchy, and the pt was afebrile. The pt was treated with diphenhydramine hydrochloride (Benadryl) and cool compresses. No further information was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the pt experienced erythema and tenderness at the site. The outcome was reported as unk. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Tenderness
Clinical narrative: Information has been received from a healthcare professional concerning a 31 year old female with no past medical history and no known allergies who on 06Mar04, also reported as 19Mar04, at 9:30AM was vaccinated in the deltoid with a first dose of varicella virus vaccine live (lot 645288/0689). On 29Mar04, ten days later, the pt experienced an area on her upper arm that was a half dollar size with a blister. The area was sore and itchy, and the pt was afebrile. The pt was treated with diphenhydramine hydrochloride (Benadryl) and cool compresses. No further information was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that the pt experienced erythema and tenderness at the site. The outcome was reported as unk. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Lymphadenopathy, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 10 year old white female student with no pre-existing medical conditions who on 06/20/1997 was vaccinated once subcutaneously in the left arm with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck) (lot#617355/0567D).  There was no concomitant medication.  It was noted the patient had no illness at the time of the vaccination.  On 03/26/2004 the patient developed chickenpox described as a varicella eruption of the skin and mucous membranes with 150-200 lesions (also reported as 50-100 lesions at time patient seen in the office).  It was also noted that she had fever and cervical adenopathy.  The physician reported that no treatment was required for the adverse event and no laboratory tests were performed.  It was noted the therapy was discontinued.  It was also reported that the patient's chickenpox abated and she recovered.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a patient at an elementary school of kindergarten to fourth grade, who on 06/03/1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had more than 50 pox, but was afebrile.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
Age: 1.25
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 6 year old male recovering from croup who on 01/22/1999 at 4:00PM was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck)(Lot#625383?031OH) subcutaneously, 0.5ml.  Concomitant therapy that day and time included a first dose of hepatitis B virus vaccine rHBsAg (yeast) Hib conj vaccine (OMPC) (MSD) (IM) and a first dose of measles virus vaccine line (Moraten) mumps virus vaccine live rubella virus vaccine live (MSD) (lot#628551/1184H) (SQ).  On 11/20/1999 the patient received dexamethasone 6mg, IM.  On 04/06/2004 the patient developed a breakthrough case of chickenpox with about 100 lesions.  It was reported that "one on left arm secondarily infected.:  Subsequently, the patient recovered from breakthrough case of chickenpox.  No product quality complaint involved.  No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash papular
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old male who on 04/19/1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  The patient's mother reported that on the night of 04/07/2004 the patient developed 20 lesions.  There was no fever.  No further information is available.   Follow up information from the licensed practical nurse indicated that the patient was seen on 03/04/2003 and was diagnosed with varicella.  It was noted that he had numerous papules in different stages, widespread which started on 03/03/2003.  On 04/08/2004, the patient broke out again with approximately 20 lesions.  Subsequently the patient recovered.  It was also reported that the patient's brother was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed breakthrough chickenpox. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently, the patient developed shingles.  The reporter also mentioned another patient who developed shingles post vaccination with varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Chills, Cough, Pain, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning a 47 year old female patient with a history of Asthma and recurrent Sinusitis, who just recovered from Sinusitis, was vaccinated subcutaneously in the right upper extremity with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck)(644031/1058M) on 04/06/2004.  Subsequently the patient's Sinusitis recurred.  Unspecified medical attention was sought.  It was noted that prior to vaccination the patient had a varicella titer drawn which was very low.  There was no product quality complaint involved.  Follow up information indicated that at the time of vaccination, the patient had a sinus infection that was almost resolved.  On 04/07/2004 she developed a runny nose, aching and chills which appear to be related to an upper respiratory infection (URI).  Subsequently the patient developed a cough.  The physician questioned if this was related to "VARIVAX" versus coincidence with the onset of URI.  On 04/16/2004 the patient recovered.  No further information is expected.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Sinusitis, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 47 year old female patient with a history of Asthma and recurrent Sinusitis, who just recovered from Sinusitis, was vaccinated subcutaneously in the right upper extremity with a 0.5ml first dose of varicella virus vaccine live (Oka/Merck)(644031/1058M) on 04/06/2004.  Subsequently the patient's Sinusitis recurred.  Unspecified medical attention was sought.  It was noted that prior to vaccination the patient had a varicella titer drawn which was very low.  There was no product quality complaint involved.  Follow up information indicated that at the time of vaccination, the patient had a sinus infection that was almost resolved.  On 04/07/2004 she developed a runny nose, aching and chills which appear to be related to an upper respiratory infection (URI).  Subsequently the patient developed a cough.  The physician questioned if this was related to "VARIVAX" versus coincidence with the onset of URI.  On 04/16/2004 the patient recovered.  No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a patient at an elementary school of kindergarten to fourth grade, who on 11/06/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#627337/1057H).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had less than 50 pox and was afebrile.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a male patient at an elementary school of kindergarten to fourth grade, who on 12/11/1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had more than 50 pox and a temperature of 103.5 for 3 days.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female patient at an elementary school of kindergarten to fourth grade, who on 06/10/1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had less than 50 pox and a low grade fever.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male patient at an elementary school of kindergarten to fourth grade, who on 09/22/1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Between 03/01/2004 and 04/05/2004, the patient developed breakthrough varicella.  The patient had less than fifty pox and was afebrile.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The reporter also mentioned other cases of breakthrough varicella at the same elementary school.  Additional information is not available.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received form a registered nurse concerning a female patient at an elementary school of kindergarten to fourth grade, who on 8/31/98 was vaccinated with a dose of varicella virus vaccine live (lot # 626767/0668H). Between 3/1/04 and 4/5/04, the patient developed breakthrough varicella. The patient had lass than fifty pox and was afebrile. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned other cases of breakthrough varicella at the same elementary school (WAES0404USA01117, 0404USA01259 through 0404USA01262, 0404USA01264 and 0404USA01265). Additional information is not available.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a female patient at an elementary school of kindergarten to fourth grade, who was vaccinated with a dose of varicella virus vaccine live . Subsequently, between 3/1/04 and 4/5/04, the patient developed breakthrough varicella. The patient had less than fifty pox and was afebrile. The Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned other cases of breakthrough varicella at the same elementary school (WAES0404USA01117, 0404USA01259 through 0404USA01263 and 0404USA01265). Additional information is not available.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a female patient at an elementary school of kindergarten to fourth grade, who on 10/25/96 was vaccinated with a dose of varicella virus vaccine live (lot #616997/1656B). Between 03/01/04 and 4/05/04, the patient developed breakthrough varicella. The patient had less than fifty pox and was afebrile. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned other cases of breakthrough varicella at the same elementary school (WAES040401117 and 0404USA01259 through 0404USA01264). Additional information is not available.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a nurse concerning a female child who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced a normal case of chicken pox. It was reported that the child recovered and had no complications. There was no hospitalization. Unspecified medical attention was sought and no product quality complaint was involved. No other information is available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a patient who 5 or 6 years ago, in approximately 1998, was vaccinated with a dose of varicella virus vaccine live. Recently, the patient developed a mild case of varicella. Unspecified medical attention was sought. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Age: 1.12
Sex: M
Vaccine: VARCEL
Symptoms: Rash macular, Rash pustular
Clinical narrative: Information has been received from a health professional concerning an 8 year old male with no known medical history or allergies who on 2/12/97 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot # 620614/1106D). There was no concomitant medication or illness at the time of vaccination. On 4/5/04 the patient developed macules and pustules on his face, chest, and extremities. Twenty lesions were noted and some were scabbed. Unspecified medical attention was sought and he was treated with calamine (+) camphor (+) praxomine hydrochloride and calamine lotion. There were no laboratory tests performed. Subsequently, the patient recovered. It was reported that there were no adverse events following prior vaccination. No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no past medical history and no known drug allergies who in October 1998, was vaccinated SC with a 0.5ml dose of varicella virus vaccine (lot # 625382/0309H). Concomitant therapy included famotidine. On 4/13/04 the patient developed breakthrough varicella. She presented to the office on 4/14/04 with breakthrough varicella which was scattered and less than 50 lesions. She had no fever. The physician gave her diphenhydramine hydrochloride and acetaminophen for the itching and discomfort. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9-10 year old patient who was vaccinated with varicella virus vaccine live (SC). Subsequently, the patient's mother called the doctor's office and reported that her child had a pretty bad case of chicken pox. The patient's parent also reported that a few other children at the school also had chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 1/25/99 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot number not given). On 4/7/04 the patient developed a breakthrough case of chicken pox. It was noted that the girl was exposed to someone at school with the chicken pox. The child had lesions on her back; the number of lesions was not given. It was noted that the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a registered nurse indicated that the office does not remember the patient's name. No further information is expected.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a male student who in 2003 was vaccinated with a dose of varicella virus vaccine live (lot # 644572/0013N). It was noted that titers did not show seroconversion post vaccination. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning her 14 year old female family friend who at approximately 7 years old, in approximately 1997, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Over Christmas 2003, the patient had an outbreak of zoster on the face which spread to an eye. The nurse was unsure which eye. The patient went to an urgent care physician to report this and she was diagnosed with zoster and told to follow up with a primary care physician. The report indicated that the patient had made a full recovery. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a school aged male child who several years ago was vaccinated with varicella virus vaccine live. The child gets a rash every time he is exposed to chicken pox in the community. It appeared that the child had numerous episodes. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning her physician colleague's son who was previously vaccinated with a 0.5ml single dose of varicella virus vaccine live. The physician noted that in February 2004, her colleague's son developed a breakthrough case of zoster. It was noted that he recovered completely from the breakthrough case of zoster. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no known drug allergies who on 3/29/04 was vaccinated SC with a first dose in the left thigh of varicella virus vaccine live (lot #646241/0548N). There was no illness at the time of vaccination. On 4/2/04, 3-4 days after injection, redness and firmness occurred on the left thigh. On 4/14/04, the patient came back to the office with a knot in her thigh at the injection site, which was very red and the size was somewhere between a quarter and a fifty cent piece (also described as redness increased to size of quarter with firmness 1.2 dollar size). There ere no laboratory diagnostic tests performed. It was noted that the redness had resolved on 5/5/04 but the firmness was still present, however, decreased in size. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 0.97
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning an approximately 7 year old female patient who at twelve months of age in approximately April 1998, was vaccinated with a dose of varicella virus vaccine live. The reporter noted that recently, the patient developed a breakthrough case of chicken pox. There were approximately 30 to 40 lesions. The patient did not have any fever. The physician treated the patient with Acyclovir. A product quality complaint was not 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 registered nurse concerning an 11 year old female student with no allergies and no past medical history who on 8/30/96 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 617260/0563D). There was no known illness at the time of vaccination. On 4/16/04, the patient developed a mild/moderate case of varicella. Unspecified medical attention was sought. The patient was diagnosed with a chicken pox rash with fifty plus lesions. Laboratory tests were not performed. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 5 year old male with no past medical history who on 3/1/01 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 4/13/04 the patient broke out in head to toe lesions and was diagnosed as having chicken pox by physician. The patient was advised to soak in colloidal oatmeal and apply calamine lotion. No other treatment was prescribed. The patient was recovering with sequelae. No lab diagnostic tests performed. No product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 year old pt who approx 7 years ago in approx 1997 was vaccinated with a dose of varicella virus vaccine live. On approx 16Apr04 the pt experienced a mild case of chicken pox. It was noted that the pt only had a few lesions and is recovering without treatment. No lab diagnostic studies were performed. Medical attention was sought. It was also reported that the event abated and that the pt was recovering with sequelae. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning his 37 month old white grand daughter student who on 21Feb02 at twelve months of age was vaccinated SC in the right arm with a dose of varicella virus vaccine live (lot 639488/0572L). Concomitant vaccination on 21Feb02 included a SC dose in the left arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (639527/1083L). On 04Apr04, the pt developed breakthrough pox. Six varicella lesions appeared on the body. The pt saw a pediatrician while on vacation. No treatment was given. There was no increase in the number of lesions and they disappeared in a few days. It was noted that the pt recovered. A product quality complaint was not involved. Additional information is not expected.