chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Agitation, Anorexia, Asthenia, Chills, Discomfort
Clinical narrative: Joint pain last week of December 2003. Fever, chills, loss of appetite, generalized weakness and discomfort. Syncope episode 1/12/04. Coughed up blood 1/13/04. Hospitalized 1/14 for respiratory failure. Vent   15th. Died on 1/18/04. Death certificate reads intractable pulmonary hemorrhage. Discharge Summary received on 6/14/2004 states agitation, restlessness, hypoxia, and tachycardia.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Haemoptysis, Hypoxia, Nervousness, Pulmonary haemorrhage, Pyrexia
Clinical narrative: Joint pain last week of December 2003. Fever, chills, loss of appetite, generalized weakness and discomfort. Syncope episode 1/12/04. Coughed up blood 1/13/04. Hospitalized 1/14 for respiratory failure. Vent   15th. Died on 1/18/04. Death certificate reads intractable pulmonary hemorrhage. Discharge Summary received on 6/14/2004 states agitation, restlessness, hypoxia, and tachycardia.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Respiratory failure, Syncope, Tachycardia
Clinical narrative: Joint pain last week of December 2003. Fever, chills, loss of appetite, generalized weakness and discomfort. Syncope episode 1/12/04. Coughed up blood 1/13/04. Hospitalized 1/14 for respiratory failure. Vent   15th. Died on 1/18/04. Death certificate reads intractable pulmonary hemorrhage. Discharge Summary received on 6/14/2004 states agitation, restlessness, hypoxia, and tachycardia.
Age: 15.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Anaphylactic reaction, Asthenia, Dyspnoea, Hyperhidrosis, Hyperventilation
Clinical narrative: 3.5 hours after immunizations, patient had anaphylactic reaction while picking berries at home. Received epi, steroids, antihistamines in ER. Admitted overnight.  Nurse follow up on 08/04/04 states: "Weak, Diff breathing, Pale, Diaphoretic, Hives, Tachypneic."
Age: 15.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Pallor
Clinical narrative: 3.5 hours after immunizations, patient had anaphylactic reaction while picking berries at home. Received epi, steroids, antihistamines in ER. Admitted overnight.  Nurse follow up on 08/04/04 states: "Weak, Diff breathing, Pale, Diaphoretic, Hives, Tachypneic."
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Arrhythmia, Eye movement disorder, Hypotonia, Infantile spasms
Clinical narrative: Patient began having brief spells of eyes rolling up and loss of tone in April, or possibly March. They happened every few days and perhaps 5-6 times a day. DTaP and IPV were given 5/5/04. Episodes increased so that family returned to office on 5/12/04. EEG showed hypsarrythmia. Baby has infantile spasms.  Nurse follow up on 05/27/04 states: completed.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Hypotonia, Pallor, Vomiting
Clinical narrative: 4 hours after vaccines, child went limp, pale, dusky. No tonic/clonic movement, nothing to suggest seizure. Did routine mouth to mouth. 911 called. Child vomited about 20 minutes later. By 1 hour later child was back to normal. Watch overnight in hospital. No etiology was found.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Musculoskeletal stiffness, Staring, Vomiting
Clinical narrative: Previously healthy 4 month old infant had generalized tonic seizure approximately 60 hours after receiving Pediarix, HIB, Prevnar. Lasted about 5 minutes; resolved spontaneously. Afebrile at the time. Hospitalized 1 day. CT head negative, EEG normal, Blood chemistry was normal. Second seizure occurred 11/20/03 (5 minutes - tonic). Patient started on Tegretol. Next seizure occurred 1/14/04. Two more seizures occurred 2/29/04. Patient re-admitted to hospital. EEG again normal. Blood chemistries normal, metabolic work up negative. Patient seizure free since 2/29/04. Remains on Tegretol. To date, no definite etiology for seizures has been determined.  Nurse follow up on 06/18/04 states: "ADD: Arm stiff, vomiting, staring."
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Convulsion, Cyanosis
Clinical narrative: DTaP given on 4/27/04. Patient's mother called 4/29/04 stating patient had a cyanotic episode with a possible seizure. Seizure work up done on patient. Patient placed on seizure medication and placed on apnea monitor.  Nurse follow up on 07/20/04 states: "Complete."
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Erythema, Feeling hot, Skin nodule
Clinical narrative: 3 1/4 x 4 3/4 inch area of redness, induration & heat on right thigh with small surrounding area of pinkness, non tender to touch.
Age: 10.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Anxiety, Injection site oedema, Injection site pain, Injection site reaction, Loss of consciousness
Clinical narrative: On 5/6/04 he was to receive two immunizations a Td was given first than about 10 minutes later Varicella was given. About 11:40 he had passed out. A couple of minutes later her woke up. Pt was taken to hospital to get checked out. Pt. was alert and oriented. Mom then took him in private vehicle to ER where the physician on duty had told mom that the pt had passed out due to anxiety. Then on 5/19/04 13 days later Pt had a swelling at injection site with 2 fluid filled pustules. Pt was complaining of pain and itching at injection site. Advised mom to take him to Primary Physician. Visited with mom on 5/24/04. Mom stated Physician had given him antibiotic to take and advised mom not to let him receive any more varicella vaccine. The injection site looked better. Swelling had resolved and pustules had scabbed.
Age: 10.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Pruritus, Rash pustular
Clinical narrative: On 5/6/04 he was to receive two immunizations a Td was given first than about 10 minutes later Varicella was given. About 11:40 he had passed out. A couple of minutes later her woke up. Pt was taken to hospital to get checked out. Pt. was alert and oriented. Mom then took him in private vehicle to ER where the physician on duty had told mom that the pt had passed out due to anxiety. Then on 5/19/04 13 days later Pt had a swelling at injection site with 2 fluid filled pustules. Pt was complaining of pain and itching at injection site. Advised mom to take him to Primary Physician. Visited with mom on 5/24/04. Mom stated Physician had given him antibiotic to take and advised mom not to let him receive any more varicella vaccine. The injection site looked better. Swelling had resolved and pustules had scabbed.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: Hep B #3 administered on 3/9/04 outdated. Hep B #3 re-administered on 5/4/04.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Medication error
Clinical narrative: 1/11/04 outdated Hepatitis B given on 3/1/04. Hep B readministered.
Age: 12.0
Sex: F
Vaccine: HEP, TD
Symptoms: Medication error
Clinical narrative: 2/27/04 outdated Hep B expired 1/11/04.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Expired Hep B given 2/3/04 outdated 1/11/04.
Age: 14.0
Sex: F
Vaccine: HEP, TD
Symptoms: Medication error
Clinical narrative: 3/10/04 outdated Hep B given expired 1/11/04.
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: 3/9/04 Hep B #3 administered- outdated. 5/4/04 Hep B #3 re-administered.
Age: 0.75
Sex: F
Vaccine: IPV
Symptoms: Medication error
Clinical narrative: 3/2/04 outdated Hep B #3 administered parents notified. Hep B #3 to be repeated at 12 months well child visit.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Expired Hep B given 1/13/04 outdated 1/11/04.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Medication error
Clinical narrative: 3/1/04 outdated Hep B expired 1/11/04.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Hep B #3 outdated on 1/11/04 given on 3/3/04 to be regiven.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Outdated Hep B, vaccine readministered.
Age: 16.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Medication error
Clinical narrative: Hep B #1 given 1/23/04- outdated 1/11/04.
Age: 14.0
Sex: F
Vaccine: HEP, TD
Symptoms: Medication error
Clinical narrative: 3/5/04 was given outdated Hep B expired 1/11/04.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: expired Hep B given 1/27/04 expired 1/11/04.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Hep B #3 outdated 1/11/04 given on 2/3/04.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: Hep B outdated 1/11/04, given on 3/3/04 vaccine to be readministered.
Age: 11.0
Sex: M
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: Hep B outdated on 1/11/04, given 1/22/04 to be readministered.
Age: 13.0
Sex: M
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: Hep B outdated 1/11/04, given on 3/3/04. Vaccine to be readministered.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Hep B was outdated- the hep B was readministered.
Age: 2.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Feeling hot, Injection site mass, Injection site oedema, Livedo reticularis, Rash erythematous
Clinical narrative: Not reported to us by parent until 5-20-04. Dad states patient's leg was swollen and bumpy around vaccine site 3-4 days after shot. Brought to clinic 5-20-04 and looked at by RN and doctor- raised 3 x3 inch area on right thigh with mottled look. Warm and painful to touch.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Febrile convulsion, Grand mal convulsion, Pyrexia
Clinical narrative: Child developed fever of 100.3 (per mom) and had grand mal seizure. Paramedics were called in and child was taken to hospital and diagnosed febrile seizure. Temp at hospital ER was 104.5.
Sex: M
Vaccine: DTAP, MMR
Symptoms: Cellulitis, Erythema, Feeling hot
Clinical narrative: Cellulitis left arm. Left arm redness from deltoid to elbow, warm to touch. No fever.
Age: 70.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Swelling, redness extend around left arm, warm to touch. Started later in pm after shot.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pallor, Vomiting
Clinical narrative: Child very anxious about receiving vaccines- vomited immediately following vaccines. Color pale lips colorless. No history fever, allergies or recent illness cold cloth applied to forehead and laid pt. down. Left office 15 minutes later recovered.
Age: 33.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Pain, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: MMR given 02/06/04 fever, body aches, chills started 2/15/04. Fever broke 2/17/04. Rash began 2/18/04 (diffuse erythemic papular) over head & neck. Macular rash over trunk & arms. 2/21/04 rash gone.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema, Rash erythematous
Clinical narrative: DTaP/IPV in left leg & swollen- seen in office 5/17- 5 in area red, hot, swollen, tender- treated with Augmentin- much improved 24 hrs. 5/19- new raised red rash around original area of cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Tenderness
Clinical narrative: DTaP/IPV in left leg & swollen- seen in office 5/17- 5 in area red, hot, swollen, tender- treated with Augmentin- much improved 24 hrs. 5/19- new raised red rash around original area of cellulitis.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Left left swollen, red, warm to touch, no complains of pain.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Erythema, Oedema
Clinical narrative: Received immunizations Friday, Fri night pt. became inconsolable & leg was swollen & red per doctor to go to ER. By the time they got to ER, swelling went down. ER physician told mom to call us & report patient doing fine now.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash, Roseola
Clinical narrative: Rash began 5/19/2004, diagnosis Roseola 5/18/04.
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Convulsion, Oedema
Clinical narrative: 5-11 2 min seizure like activity. 5-12 2 further episodes (approx 2 mins each) of siezure like activity. Approx 5-18 left leg swollen entirely.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pyrexia, Vomiting
Clinical narrative: Temp increased 103 degrees Tues around 5 pm, vomited 1 time Wed 5 AM, left arm swelling began approx 4 pm Wed. Alterated Tylenol & Motrin (swelling extended down to elbow along with redness).
Age: 1.58
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection, Rash pustular, Skin ulcer
Clinical narrative: No fever. Scabby papules & on around scaling, red lesion along right back to chest-began about 3 wks ago- diagnosis Varicella Zoster- without history of disease. Is resolving now.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Oedema, Pain, Pruritus
Clinical narrative: Hot to touch, swollen, no itchy, no fever. Width 12 cm, long 14 cm. Treatment: Benadryl for itching swollen if pain continues give Tylenol.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Had redness and swelling about silver dollar size over right shoulder at site of DTaP/IPV injections. No systemic symptoms. Resolved in 48 hours.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Thrombocytopenic purpura
Clinical narrative: Thrombocytopenia and purpura. Diagnosis: idiopathic thrombocytopenic purpura 2 hours to MMR.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Feeling hot, Skin nodule
Clinical narrative: Right leg red, hot to touch, bump.
Age: 4.0
Sex: F
Vaccine: BCG, IPV, MER
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness, swelling, warmness at injection site. Keflex 250 mg 15 ml every 6 hours for 10 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain to left arm since vaccination. Has swelling left arm, erythema, tenderness. No other changes.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash macular
Clinical narrative: Macular 3mm rash on face, trunk, and extremities.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2"x2" area of erythema and warm to touch at vaccine site.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Rash macular, Swelling
Clinical narrative: 4cmx5cm redness/swollen area on left upper arm with multiple papular rash. Non-fluctuate. Happened one day after shot (DTaP, HIB, Prevnar). Treated with Keflex 250mg and Motrin1/2 teaspoon PO one time per day. Follow up tomorrow.
Age: 54.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood pressure decreased, Erythema, Pruritus, Rash
Clinical narrative: Patient reports itching, rash to trunk of body several hours after receiving Twinrix on 5/5/04 which progressed quickly to cover entire body. Per family doctors instruction, patient presented to ER for evaluation. States her BP was low (90/70). Per patient report, she was given 50mg Benadryl, 60mg Prednisone and discharged home with prescription for Prednisone dose pack. Rash resolved but recurred during the last few days of dose pack. On 5/12/04 seen by doctor and given shot of Prednisone. Rash resolved with exception of redness to hands (palms). No follow up schedule with doctor.
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Moderate swelling with redness shoulder to elbow. Tender to touch. No complaints of hives or trouble breathing.
Age: 1.25
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Abscess, Convulsion
Clinical narrative: Abscess left thigh with persistent seizures.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: On 5/18/04, swelling and redness to right arm, complaints of itching at injection site. Swelling 3.75"x2.5". DTaP and MMR given at site. Keflex given.
Age: 6.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: 2 days after 5th DTaP/Varivax given, temperature to 103, vomiting, rash on back of neck.
Age: 54.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Had redness and swelling about silver dollar size over right shoulder at site of DTaP/IPV injections. No systemic symptoms. Resolved over 48 hours.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Lethargy, Pyrexia
Clinical narrative: Patient became lethargic several hours after shot administered. Then developed a fever of 104. Taken to ER by parents and treated with ibuprofen. Fever coming down now after 24 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large red area to right thigh approximately 5 inch in diameter; warm to touch. Benadryl 1-2 teaspoons ever 6 hours. Pediapred 5/5 1 teaspoon PO TID for 4 days.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction, Pain
Clinical narrative: Cellulitis at site, severe arm pain for 1 week.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Pain, Pyrexia
Clinical narrative: Severe arm pain with cellulitis at site. Fever. All symptoms lasted 2 days.
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: Gave patient shot, DTaP in the right upper thigh on 5/20/04.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling 2 cm distal to injection site 2 days later. Redness and swelling fully resolved within a few days.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Rash, itching, fever.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever to 100.5 2 times on 5/13/04.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever to 100.5 2 times on 3/9/04.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure less than 24 hours after immunization. Immunization 5/6. Temp 102 that night. Early 5/7 AM, febrile seizure.
Age: 35.0
Sex: F
Vaccine: RAB, TD
Symptoms: Hypersensitivity, Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: 10 being worst pain ever experienced. Left shoulder pain (8+) started morning after injections. Pain continued that day and next day. Shoulder and arm weakness persist x 7 day. Improving slowly. Started having "shock like" feeling down down both arms on May 16th with sensitivity especially to cold. Improving slowly. Taking ibuprofen with some relief.
Age: 56.0
Sex: M
Vaccine: HEPAB, IPV, TD
Symptoms: Fatigue, Malaise
Clinical narrative: Fatigue and malaise since 5-6-04, almost 3 weeks. No temp. No n/v. Taking ASA, switched from IBU.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Headache, Pyrexia, Swelling
Clinical narrative: Redness, fever, HA, left buttocks swollen
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia, Screaming
Clinical narrative: Pt received pediarix no. 1, HIB no. 1 and prevnar in AM of 3-26-04 and pt developed temp.101 degrees with very fussy, screaming episodes that afternoon until approximately non the following day.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Unintended pregnancy
Clinical narrative: Information has been received through the manufacturer pregnancy registry from a health professional concerning a 34-year old female who on 13-Feb-2004 was vaccinated with a dose of varicella virus vaccine live (lot number not available). The patient's last menstrual period was 11-Jan-2004. The patient was pregnant at the time of vaccination. No additional information was available unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.91
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Blister, Drug ineffective, Erythema, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician and a medical assistant concerning an 8 year old female who on 19-Nov-1996 was vaccinated with a dose of varicella virus vaccine live. On 13-Feb-2004, the patient was seen in the office for shingles that had been present for 5 days. It was reported that the skin lesions involved the entire 6th thoracic dermatome from her spine around to the middle of her sternum. The physician reported that the rash was asymmetric spreading from the left lateral spine to the left of the sternum and it went all the way around her back. The rash was red and some oozing vesicular blisters were noted. The patient indicated that some of the lesions were itchy and painful. No cultures of the vesicles were done and the child had no known exposure to wild chicken pox. The patient was still being treated with acetaminophen (Tylenol) with codeine for pain. No other information was provided. Upon internal review the patient's experience was considered another important medical event. Additional information has been requested (OMIC).  Follow up information, this is in follow up to report previously submitted on 05/14/2004. information has been received from a physician and a medical assistant concerning a 9 year old female student with no known allergies and no known past medical history who on 11/07/1996 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on 11/07/1996 included a dose of live hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine OMPC MSD and a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The shingles lasted approximately two weeks. On Feb 28 2004, the shingles disappeared, but substantial residual redness remained. It was noted that the patient recovered. Additional information is not expected.
Age: 1.91
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Pruritus, Rash, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician and a medical assistant concerning an 8 year old female who on 19-Nov-1996 was vaccinated with a dose of varicella virus vaccine live. On 13-Feb-2004, the patient was seen in the office for shingles that had been present for 5 days. It was reported that the skin lesions involved the entire 6th thoracic dermatome from her spine around to the middle of her sternum. The physician reported that the rash was asymmetric spreading from the left lateral spine to the left of the sternum and it went all the way around her back. The rash was red and some oozing vesicular blisters were noted. The patient indicated that some of the lesions were itchy and painful. No cultures of the vesicles were done and the child had no known exposure to wild chicken pox. The patient was still being treated with acetaminophen (Tylenol) with codeine for pain. No other information was provided. Upon internal review the patient's experience was considered another important medical event. Additional information has been requested (OMIC).  Follow up information, this is in follow up to report previously submitted on 05/14/2004. information has been received from a physician and a medical assistant concerning a 9 year old female student with no known allergies and no known past medical history who on 11/07/1996 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on 11/07/1996 included a dose of live hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine OMPC MSD and a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The shingles lasted approximately two weeks. On Feb 28 2004, the shingles disappeared, but substantial residual redness remained. It was noted that the patient recovered. Additional information is not expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Pain, Rash maculo-papular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 35-month-old female who on 27-Nov-2001 was vaccinated with a dose of varicella virus vaccine live. On 08-Nov-2003 the patient developed herpes zoster. The patient was diagnosed with the herpes zoster since she had spots on her back and belly. The child's father had active herpes zoster at the time of the patient's diagnosis. The patient was treated with acyclovir (Zovirax). The patient fully recovered and no hospitalization was required. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.  Follow up information (Lot number 640311/0794L). There was no illness at the time of vaccination. No concomitant medications. Follow up information indicated that the child contracted varicella. It was also noted that she got herpes zoster from father after a recent herpes zoster exposure in Nov 2003. No lab or diagnostic data was reported. There was no rash that occurred at the site of injection or elsewhere within 42 days of the vaccination. The date of the herpes zoster was 11/08/2003. it was noted to be questionable zoster. The patients maximum temperature was 98.5 F. The pain was quantified as a 3 with 0 being the least and 10 being the most. There were no other symtemic symptoms. The patient did recover. There was no historyy of chickenpox. There was no direct flourescent antibody done. No specimen was collected for PCR. No photo was taken. No further information is expected.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Acne, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old patient who "about two weeks ago" on approximately 10-Feb-2004 was vaccinated SC in the right upper arm with a first dose of varicella virus vaccine live (lot "0805N"). "Today" on 24-Feb-2004 the patient's mother reported that the child has 24 pox around around arms and back of knees. The child did not have a fever. Unspecified medical attention was sought, but prescription drug treatment was not required. No product quality complaint was involved. No additional information was given at this time. Additional information has been requested.   Follow up report, Concomitant vaccinations the same day included a fifth dose IM in the left deltoid of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (manufacturer unknown), a fourth dose IM  in the right deltoid of inactivated poliovirus vaccine (manufacturer unknown)  and a second dose SQ in the left upper arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. Follow up information indicated that the child broke out on 02/22/2004 with approximately 2 dozen pimple like pox. Only a few of them were vesicle filled. The report indicated that they were located on the trunk. 1 on back and in the armpit and knees and elbows. There were no labs or diagnostic test done. It was reported that by 02/25/2004 they had dried up and by 02/27/2004 They were mostly gone. It was also reported that the patient recovered. No additional information is expected.
Age: 1.58
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pyrexia, Rash papular
Clinical narrative: Information has been received from a nurse practitioner concerning a 19-month-old Hispanic male with no known drug allergies and with otitis media who on 29-Dec-2003, at 18-months-old, was vaccinated in the right deltoid and with a first dose of varicella virus vaccine live (lot3 646360/0571N). Concomitant therapy from 23-Dec-2003 included ceftriaxone sodium (Rocephin) for otitis media. On 13-Jan-2004 the patient presented to the physician's office with a full blown case of chickenpox, described as a papular rash, a few vesicles, and some scabs on his face and trunk. It was also noted that there was left ear drainage, and that the patient had a slight fever. The outcome was reported as not recovered. It was noted that the non-vaccinated, 4-year-old sibling of the patient had a case of chickenpox toward the end of December 2003. No other information was given. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a nurse practitioner indicated that the patient recovered. No further information is expected.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 7-year old white male with no allergies or medical history who on 08-Jan-1998 was vaccinated in the left thigh with a 0.5 mL first dose of varicella virus vaccine live (lot #624648/1323E). Concomitant therapy on the same day included a first dose in the right thigh of measles-mumps-rubella vaccine (lot #624115/1019E). There was no illness at the time of vaccination. On 14-Feb-2004 at 10:00 am, the patient started with a blistery rash. He also had a low-grade fever and sore throat. The rash was all over the body but was worse on the trunk and groin area. On 16-Feb-2004 a rapid strep test was done which was negative. A prescription drug was not required to treat the experience. Additional information has been requested. Follow up report: the patient recovered. No further inforrmation is expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lymphopenia, Platelet count increased
Clinical narrative: Information has been received from a physician concerning a 12 month old female (also reported as male) with a history of anemia who on approximately 09Feb2004 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination included a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On approximately 20Feb04, a complete blood cell count was dose as a follow up to the child's prior history of anemia. The laboratory results showed a platelet count of only 700/microliter and 6 atypical lymphocytes. Unspecified medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. Additional information was received from the physician who indicated that the vaccination seemed to cause an increase in platelets and atypical lymphocytopenia. He stated that her platelet count was 700,000. The physician noted that the pt was doing fine post vaccination and the laboratory tests were performed to follow up due to the anemia and to test for lead. Since she had no other viral symptoms he felt that it was from the live virus vaccines. The reporter was looking more at varicella virus vaccine live since the laboratory test was two weeks post vaccination, and the natural cycle of chickenpox falls within that time frame. He also noted that the pt was completely asymptomatic and was doing great. He planned to repeat the labs in a couple months. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain, Pyrexia, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 12Mar98 was vaccinated with a dose of varicella virus vaccine live. On 23Feb2004 the pt presented to the physician and was diagnosed with shingles. No product quality complaint was involved. Two other pts were vaccinated with varicella virus vaccine live and developed chickenpox. Additional information has been requested.  Follow up information previously submitted on 05/14/2005 information has been received from a health professional concerning a 7 year old female with no allergies or medical conditions who on 03/12/1998 was vaccinated SC in the right leg with a first dose of varicella virus vaccine live Lot 624724/1127E. There was no illness at the time of vaccination. Follow up information from a health professional indicated that the patient was diagnosed with shingles which bagan on 02/24/2004. The patient complained of pain and an elevated temperature and had exposure to chicken pox 2-3 weeks prior to the illness. Diagnosis was made by clinical signs and symptoms. No diagnostic test were performed. The patient fully recovered approximately 2 weeks after the illness began. Two other patients (WAES0403USA00668 and WAES0403USA00669) were vaccinated with varicella virus vaccine live (lot 24724/1327E) and developed chicken pox. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Fatigue, Headache, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 14 yr old female pt who on 06Jun1995 was vaccinated with a dose of varicella virus vaccine live C508580/0406B). Concomitant medication included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (ADDERALL) daily. Over the past week, on approximately 13Feb04, the pt developed chickenpox. She developed only 7-8 lesions but reports a headache and tiredness. She was treated with diphenhydramine hcl  (BENADRYL) over the counter orally and topically. Unspecified medical attention was sought. No product quality complaint was involved. The pt's brother had a similar experience after vaccination with varicella virus vaccine live. Additional information has been requested.  Follow up information indicated that approximately 9 years after receiving varicella virus vaccine live, on 2/13/2004, the child developed chicken pox. It was reported at 12:05pm that she had approximately 50 lesions. Her brother had chicken pox about 9 days earlier. No lobs or diagnostic studies were done. The child recovered on 02/18/2004. The patients brother (WAES0402USA01150) had a similar experience after vaccination with varicella virus vaccine live Lot 608580/0408B. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Drug ineffective, Headache, Infection
Clinical narrative: Information has been received from a RN concerning a 5 year old female with no past medical history and no known drug allergies who on 01Sep99 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 20Feb2004 the pt developed breakthrough chickenpox. The pt was described as having 20-30 blisters and a headache on the first two days of therapy. The pt was reported to have been slowed down the first two days after onset but has been fine since. The reporter indicated that she is unaware of the rash status. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a RN concerning a 12 month old male with no medical history and no allergies who on 13Feb2004 was vaccinated with varicella virus vaccine live. On 25Feb2004 the pt presented to the doctors office with chickenpox. The pt had about 14 small vesicles on lips, arms, groin, no fever. There was no treatment required. There was no product quality complaint involved. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning a 15 month old male who on 23Feb2004 was vaccinated in the right thigh with a dose of varicella virus vaccine live. Concomitant vaccination the same day included a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) in the left thigh and poliovirus vaccine in the right thigh. On 26Feb2004 the pt experienced breakthrough chickenpox. The pt's mother reported that he had 10 vesicles near the injection site of the right thigh. No fever was noted. No treatment and no lab diagnostic studies were required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a mother, also a RN, concerning her son who at one year of age on an unknown date in 1997 was vaccinated with varicella virus vaccine live. The mother reported that she got the chickenpox when her son was three years old and two weeks after the start of her clinical symptoms, her son developed six Varicella like lesions. The mother reported that no treatment was needed and his lesions healed on their own. It was noted that the adverse event abated. At the time of this report her son is eight years old. There was no product quality complaint reported. No other information was provided at the time of this report. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning her child who was vaccinated with varicella virus vaccine live. The physician reported that her child developed a chickenpox breakthrough. She described the child's case as severe with several hundred lesions on the body and in the mouth. The reporter indicated the pt may have been treated with acyclovir. No other information was available at the time of this report. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested. The physician also mentioned that there have been a large number of chickenpox breakthrough cases in children who have been vaccinated with varicella virus vaccine live.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a female pt in her forties who in the past was vaccinated with a dose of varicella virus vaccine live. On 27Feb2004, it was reported that the pt was recently exposed to varicella and her titer is now 0.85. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is available at this time. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a woman in a physician's office concerning a female pt with no allergies and no medical history who on 01Aug2002 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication. Subsequently, the pt developed a skin rash. Unspecified medical attention was sought and no treatment or prescription drug was required. It was reported that the condition had resolved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a child pt with no history of having  chickenpox, who on an unspecified date in the past was vaccinated with varicella virus vaccine live. The physician reported that the pt developed shingles and recovered. No additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 year old male with no known drug allergies or medical history who on 16Dec1999 was vaccinated with a dose of varicella virus vaccine live. On 20Feb2004 the pt presented to a school nurse with a mild case of chickenpox. Unspecified medical attention was sought. It was noted that the school in this county had an outbreak of chickenpox. No product quality complaint was involved. It was also reported that 2 additional children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox. No additional information was available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 year old male with no known drug allergies or medical history who on 25Jun98 was vaccinated with a dose of varicella virus vaccine live. On 20Feb2004 the pt presented to a school nurse with a mild case of chicken pox. Unspecified medical attention was sought. It was noted that the school in this county had an outbreak of chickenpox. No product quality complaint was involved. It was also reported that 2 additional children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox. No additional information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 9 year old female with no known drug allergies or medical history who on 30Sep1996 was vaccinated with a dose of varicella virus vaccine live. On 20Feb2004 the pt presented to a school nurse with a mild case of chicken pox. Unspecified medical attention was sought. It was noted that the school in this county had an outbreak of chickenpox. No product quality complaint was involved. It was also reported that 2 additional children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. The physician reported that the pt completed the varicella virus vaccine live series and still had a negative titer. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 11 year old female who eight to nine years ago, in approximately 1995 was vaccinated with a dose of varicella virus vaccine live. The physician reported that he saw the pt on 01Mar2004 with 500 plus varicella lesions break through. Unspecified medical attention was sought and it was unknown if treatment was required. A product quality complaint was not involved. Additional information was received which indicated that the pt's sister developed breakthrough chickenpox after therapy with varicella virus vaccine live. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning her 4 year old granddaughter who on 21Feb04 was vaccinated with a dose of varicella virus vaccine live. On 01Mar04 the reporter noticed a small red, raised area about the size of a quarter near the site of the injection. The child had not been seen by a physician. There was no product quality complaint. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 29 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. A titer was drawn on 24Feb2004 and the pt failed to seroconvert. Unspecified medical treatment was sought. There was no product quality complaint involved.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Dermatitis bullous, Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a RN concerning a 7 year old female with a history of strep on 06Feb2004 and ear infections recently who on 06Sep00 was vaccinated with a dose of varicella virus vaccine live. There were no concomitant vaccinations. On 02Mar04 the pt develop a breakthrough described as 20-25 lesions, both vesicular and maculopapular, itching, had a decrease in appetite and low grade fever. There were no diagnostic laboratory tests performed. It was noted that the treatment was nonspecific symptomatic. Medical attention was sought. There was no product quality complaint involved. No other information was provided. Information was received which pertained to the events which occurred approximately 4 years after vaccination with varicella virus vaccine live. This information contained the following adverse events: strep and ear infections recently (in approximately 2004). No additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 year old female employee who on 27Jan04 was vaccinated with a dose a varicella virus vaccine live. The nurse practitioner reported the pt developed four lesions on her trunk and arm one week post vaccination. She also experienced pruritus. The nurse practitioner reported the pt did not require treatment for the adverse event. It was noted the lesions lasted 2 weeks then resolved and the pt recovered. There was no product quality complaint involved. No other information was available. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15 month old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced rash. A specimen was collected, sent to a lab and it was not wild type or vaccine varicella. The rash resolved and was recurrent over 3 months. It was reported that the patient is a twin and the sibling did not have any reaction to "VARIVAX". No additional information is available at this time. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a female who on 29DEC2003 was vaccinated with varicella virus vaccine live. Concomitant therapy that day included measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, Hib conj vaccine (tet toxoid), pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine, diphtheria toxoid + pertussis acellular 5-component vaccine + tetanus toxoid. There was no other concomitant medication. On 07JAN2004 the patient developed chicken pox like lesions on the trunk. The patient developed approximately 200 lesions but did not develop blisters. The lesions were described as "just red." The patient sought unspecified medical attention. There was no treatment provided. The patient recovered. There was no product complaint involved. Additional information has been requested.
Age: 1.88
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pruritus, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female patient wit no past medical history who on 03MAY1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 03MAR2004, the patient presented with a mild case of chickenpox with lesions scattered over her upper body. Diphenhydramine hydrochloride was ordered to control pruritus. A product quality complaint was not involved. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 28 month old female who on 31OCT2002 was vaccinated with a dose of varicella virus vaccine live. On 04MAR2004 it was reported that the pt "now" has atypical chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. No further information has been requested.