chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a friend of his son who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on 06/01/2004, the patient developed chickenpox breakthrough.  Unspecified medical attention was sought.  A product quality complaint was not involved.  The physician mentioned his son also developed chickenpox post vaccination with varicella virus vaccine live.  The reporting physician also mentioned that he, himself, had negative titers post vaccination with varicella virus vaccine live.  Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 01/27/1998 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  Concomitant vaccination on the same day included a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 04/30/2004, the patient developed a full case of chickenpox approximately six years after the vaccination.  Subsequently, the patient recovered.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male patient who was vaccinated with a dose of varicella virus vaccine live.  On 06/10/2004, the patient developed a breakthrough case of chickenpox.  The patient had over 50 lesions on his trunk and bottom.  There was no fever.  Unspecified medical attention was sought, but treatment was not required.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Rash papular
Clinical narrative: Information has been received from a health professional concerning a white patient with a history of Eczema who on 07/11/2002 was vaccinated with a first dose of varicella virus vaccine live, in the left thigh.  Concomitant therapy on 07/11/2002 included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, in the right thigh.  On 05/13/2004 the patient developed symptoms.  On 05/20/2004 the patient presented to the doctor's office with scattered papules, one vesicle on back, check and neck present at one week.  The patient was diagnosed with varicella.  Subsequently, the patient recovered from varicella.  No further information is expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male fussy with decreased appetite and who on 05/24/2004 was vaccinated with a first dose of varicella virus vaccine live subcutaneously.  On 06/03/2004 the patient developed seven lesions, left cheek, right ankle, and left foot.  On 06/11/2004 the patient recovered.  Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received concerning a 5 year old female who on 08/13/1999 was vaccinated with a first dose of varicella virus vaccine live in the right arm.  Concomitant therapy that day included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, in the right arm.  There was no illness at the time of vaccination.  On 05/21/2004 at 13:30 the patient experienced varicella.  Subsequently, the patient recovered from varicella.  It was noted that the patient's father had shingles 2 weeks ago.  On 05/21/2004 the patient presented at an office visit with rash noted at 13:30 and increased spots by 16:00 - scalp, face, trunk, extremities less than 50 lesions.  The patient was diagnosed with varicella.  Subsequently the patient recovered.  Additional information has been requested.
Age: 1.19
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 34 month old healthy female with occasional otitis and no other pre-existing allergies, birth defects, or medical conditions who on 10/11/2002 in the AM was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  Concomitant therapy that day in the AM included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live administered subcutaneously in the right arm, and a fourth dose of pheumococcal administered intramuscularly in the left thigh.  On 06/10/2004 the patient presented to the physician's office with 50 plus blisters, papular and vesicular, on her trunk, face, and legs.  She was afebrile.  The physician recommended diphenhydramine hydrochloride and calamine lotion.  No other information was available.  There was no product quality complaint.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations of the patient or her siblings.  Follow up information indicated that the adverse event onset was 06/09/2004 at 11:25AM.  The patient presented to the clinic with papular weeping vesicles on her trunk, face, and legs (worse on legs).  She was afebrile.  The physician prescribed isolation, no aspirin, diphenhydramine hydrochloride, aveeno, and calamine.  The patient was instructed to return to the clinic in 7 days.  It was reported that the patient recovered on 06/18/2004.  No further information is expected. Follow up information received. The lot number for pneumococcal conj vaccine (CRM197) (PREVNAR) has been added.
Age: 5.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Developed a high fever 101 the first evening and continued for 2 days Temp continued to 103.4 when mother took child to Emergency Room.  Child placed on Zithromax and has recovered.
Age: 0.66
Sex: F
Vaccine: HEP, IPV
Symptoms: Pyrexia, Rash
Clinical narrative: CHILD RECORD REVIEWED. NEEDED IPV AND HEP B TO BRING UP TO DATE. 3RD. DOSE OF HEP B GIVEN 1/18/05 AT MD OFFICE INVALID-PT WAS LESS THEN 6 MO. OLD SO 4TH DOSE WAS GIVEN. FEVER OF 103 AND RASH WITHIN 24 HOURS. SEEN BY MD NEXT DAY (5/12/05). TEMP RETURNED TO NORMAL 5/13/05. RASH RESOLVED BY 5/16/05 WHEN SEEN BY SCHOOL HEALTH SUPERVISOR.
Age: 21.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Chills, Hyperhidrosis, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 5/11/05: Severe pain both legs, beginning about 7 hrs after vaccination. Pt is a runner. 5/12/05:Temp up to 102.5, chills, sweats, aches, severe leg pain, sore throat. Went to ER on 5/12/05. Treated for pain and fever and discharged. Was sick for about one week.
Age: 21.0
Sex: F
Vaccine: HEPA, YF, HEPA, YF
Symptoms: Chills, Fatigue, Injection site pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 5/11/05: Severe pain both legs, beginning about 7 hrs after vaccination. Pt is a runner. 5/12/05:Temp up to 102.5, chills, sweats, aches, severe leg pain, sore throat. Went to ER on 5/12/05. Treated for pain and fever and discharged. Was sick for about one week.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Patient states that after recieving the shot on Thursday, it continued to swell until Sunday but on Monday it was looking better.  When she came to the clinic on Monday I saw what looked like resolving cellulitis a little below the injection site on the left arm approximately 3 inches in diameter.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Chest pain, Injection site pain, Muscle spasms, Pain, Pyrexia
Clinical narrative: This 43 year old received routine TD vac to his lt deltoid on 18 May 2005 along w/his PPD (lt forearm).  He reports common adverse events of fever, body aches and pain at injection site w/deltoid swelling for 2 days.  Symptoms were treated with NSAID w/relief. Friday 5/20/05 he used a rear wheel drive lawnmower. 2 days later, he reports reoccurrence of left arm, chest wall spasm and pain with increased pain on deep breathing and lifting/pushing w/left arm. He is self treating with NSAID, Feldene w/some easing but spasms persist.  He is concerned about duration of discomfort, reason for and if he'll lose function of his left arm.  He denies paresthesia, cold-hot temp changes, no fevers, illness, trauma, bites, arm/hand swelling, or change in pulse.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Swelling
Clinical narrative: This 43 year old received routine TD vac to his lt deltoid on 18 May 2005 along w/his PPD (lt forearm).  He reports common adverse events of fever, body aches and pain at injection site w/deltoid swelling for 2 days.  Symptoms were treated with NSAID w/relief. Friday 5/20/05 he used a rear wheel drive lawnmower. 2 days later, he reports reoccurrence of left arm, chest wall spasm and pain with increased pain on deep breathing and lifting/pushing w/left arm. He is self treating with NSAID, Feldene w/some easing but spasms persist.  He is concerned about duration of discomfort, reason for and if he'll lose function of his left arm.  He denies paresthesia, cold-hot temp changes, no fevers, illness, trauma, bites, arm/hand swelling, or change in pulse.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Condition aggravated, Paralysis
Clinical narrative: Facility received letter from patient in March 2005 stating that he had developed an exacerbation of Gullian Barre Syndrome as a severe reaction most likely due to the flu vaccine. Patient's initial bout of Guillian Barre Syndrom occured about March 23, 2004. Pt experienced total body paralysis and was on a ventilator for 5 days at another hospital.  On about May 20, 2004 patient had a relapse with full body paralysis again.  Pt stated he had a relapse 2 days after "flu shot" with weakness throughout body. On November 15, 2004, pt saw private MD and was prescribed prednisone 60mg (pt had been of prednisone) one month.  Pt continued to experience weakness. November 19, 2004 pt was admitted to another hospital. Pt received 5 days of plasma exchange and continue with prednisone. Pt has returned to his baseline prior to influenza shot.  6/24/05 Received hospital medical records of 11/19-11/24/2004. FINAL DX: chronic inflammatory demyelinating polyneuritis exacerbation Records reveal patient experienced ascending weakness, numbness in all extremities, clumsiness, sensory changes, double vision.  Similar to previous episodes of same in March & April, 2004.  Had self d/c steroids & symptoms recurred 2 da s/p flu vaccine.  Seen by PCP, restarted steroids.  Initially improved then relapsed & admitted.  Neuro consult done, areflexic.  Tx w/plasmapheresis, improved & d/c to home on continued steroids.
Age: 81.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Medication error
Clinical narrative: Gave Menactra instead of Menomune.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Local reaction Lt deltoid region. Large area of redness and swelling.
Age: 33.0
Sex: F
Vaccine: HIBV, MEN
Symptoms: Dizziness, Influenza like illness, Paraesthesia, Pyrexia
Clinical narrative: I received two vaccines in right upper arm on the same day. I felt fine until a few hours later. I became dizzy and light headed. The next morning I woke up with flu-like symptoms and remained dizzy. I called the Health Department and I was informed that the side effects were normal. Today is the fourth day after receiving the vaccines. I remain with dizzy light headedness, flu-like symptoms and now have a low grade fever of 99.4 that I did not have on the previous days. The dizziness has increased each day and now feels like tingling in my fingers and arms. I spoke to a nurse today and was told that the side effects are normal. It does not feel right or normal, and it frightens me. I believe I am having adverse side effects, especially with the dizziness. I thought that the side effects were important enough to report.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Petit mal epilepsy, Staring
Clinical narrative: This case was reported by a consumer and described the occurrence of petit mal seizure in a 4 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The reporter is the mother of the patient. A physician or other health care professional has not verified this report. Medical history included egg allergy. Concurrent medications included Ibuprofen for an unspecified medical condition. On an unspecified date in October 2002, the subject received the fifth dose of Infanrix in the left arm. On an unspecified date in October 2002, less than one month after vaccination with Infanrix, the subject experienced an injection site reaction characterized as swelling and and redness. The patient was seen at the doctor's office. The injection site reaction resolved on an unspecified date in October 2002. On an unspecified date on or after the fifth dose of Infanrix in October 2002 and before 5/24/05, the subject experienced staring episodes and was also noted to make clicking sounds. The consumer reported that the subject, "had a 72 hour electroencephalogram at the 4 year checkup," however, results of the EEG were not provided. The consumer stated that she, "believes that the staring episodes are a sign of petit mal seizure, though no formal diagnosis of seizure has been made." The staring spells and clicking noises were ongoing at the time of initial reporting, 5/24/05. Comment: Petit mal seizure was assessed as medically serious (OMIC).
Sex: M
Vaccine: PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, the mother of a male patient, who received a fourth dose of Prevnar on an unspecified date. Also, on an unspecified date, the child developed autism. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified ate, the child received a fourth dose of Prevnar. Also, on an unspecified date, the child developed autism. The patient's outcome is unknown. The reporter declined to provide any further information in order to conduct follow up.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Cough, Erythema, Generalised oedema, Pruritus
Clinical narrative: -Low grade fever- severe swelling (cellulitis with redness and itching) and cough.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: -Low grade fever- severe swelling (cellulitis with redness and itching) and cough.
Age: 1.51
Sex: F
Vaccine: DTAP
Symptoms: Urticaria
Clinical narrative: Urticaria 1 day after DTaP.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site hypersensitivity, Injection site pain, Pyrexia
Clinical narrative: Right arm red and sore. Redness down to elbow. Pt felt feverish and chilled. Reported to office on 05/09/05. Pt states symptoms cleared by 05/11/05. No TX given.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Cerebral haematoma, Crying, Fracture, Gastrooesophageal reflux disease, Injury
Clinical narrative: Baby began to suffer of acid reflux, he would shake, throw up through nose. On 02/24/05- was crying more than usual, couldn't move legs at the hospital they discovered that the baby had broken leg and ribs were fractured. State took baby from mother. Will send medical records as follow up.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Movement disorder, Screaming, Tremor, Vomiting
Clinical narrative: Baby began to suffer of acid reflux, he would shake, throw up through nose. On 02/24/05- was crying more than usual, couldn't move legs at the hospital they discovered that the baby had broken leg and ribs were fractured. State took baby from mother. Will send medical records as follow up.
Age: 0.08
Sex: M
Vaccine: HEP, HEP
Symptoms: Child maltreatment syndrome, Hydrocephalus, Subdural haematoma, Tremor, Vomiting
Clinical narrative: Baby began to suffer of acid reflux, he would shake, throw up through nose. On 02/24/05- was crying more than usual, couldn't move legs at the hospital they discovered that the baby had broken leg and ribs were fractured. State took baby from mother. Will send medical records as follow up.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Oedema
Clinical narrative: Pt reports after receiving vaccine (HBV #1). Pt had swelling of right arm and side of face right side. She felt right leg also swollen but not sure. She went to ER.
Age: 1.03
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician's assistant concerning a 16 month old male with no medical history and no allergies who on 02/04/2004 was vaccinated subcutaneously in the right arm with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy given intramuscularly in the left arm included a fourth dose of an unspecified vaccine.  There was no illness at the time of vaccination.  On 06/10/2004, the patient developed a breakthrough varicella rash.  No medical attention was sought.  Subsequently, the patient recovered.  No further information is expected.
Age: 1.02
Sex: M
Vaccine: IPV, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a pharmacist concerning a 15 month old while male who on 02/16/2004, at 09:30, was vaccinated subcutaneously in the right arm with the first dose of varicella virus vaccine live.  Concomitant vaccinations on that same day included the third subcutaneous dose in the left arm of poliovirus vaccine inactivated and the fourth IM dose in the right thigh of pneumococcal vaccine.  The physician reported that on 06/02/2004, the patient developed chickenpox.  It was noted that the patient's father had resolving shingles.  Medical attention was not sought  and no prescription drug treatment was required.  In June 2004, 5-7 days after developing the chickenpox, the patient recovered.  Additional information is not expected.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Retching, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 36 month old female with no medical history who on 7/23/02 was vaccinated SC in the right arm with the first dose of varicella virus vaccine live (lot # 642635/0270M). Illness at the time of vaccination included otitis media (diagnosed in ER on 7/20/03). The LPN reported that, on the morning of 6/19/04, the patient developed an itchy rash and gagging when swallowing. Medical attention was not sought and no laboratory/diagnostic tests were performed. At the time of this report, the outcomes were unknown. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old caucasian male patient with a history of iron deficiency anemia who on 03/26/2004 at 14:30 was vaccinated intramuscularly in the thigh with a first dose of varicella virus vaccine live.  Concomitant vaccination on 03/26/2004 at 14:30 included a first intramuscular dose in the thigh of measles virus vaccine, mumps virus vaccine live, rubella virus vaccine live.  There was no illness at the time of vaccination.  On 07/15/2004 in the AM, the patient woke up with a rash.  The patient was seen at a doctor visit.  The patient was diagnosed with chickenpox and vaccine failure was noted.  It was unknown if the patient recovered.  Follow up information from the nurse indicated that the patient recovered on an unknown date.  Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: JEV, JEV
Symptoms: Angioneurotic oedema, Oedema, Urticaria
Clinical narrative: From initial information received on 5/16/05 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 16 year old female patient received her second dose of JE-VAX, lot number EJN216B, administered SC in the left arm on 5/11/05 at 9:45 AM. Two days later, on the evening of 5/13/04, the patient developed hives on her wrist and shoulder. Her mother treated her with Benadryl. By the third day, the patient had developed swelling of her toes and wrists. The patient was seen by a physician on 5/16/05 with angioedema. She did not have any respiratory symptoms. She was treated with oral prednisone. It was not reported whether the patient recovered from these events. (OMIC)
Age: 16.0
Sex: F
Vaccine: JEV, JEV
Symptoms: Angioneurotic oedema, Oedema peripheral, Urticaria
Clinical narrative: From initial information received on 5/16/05 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 16 year old female patient received her second dose of JE-VAX, lot number EJN216B, administered SC in the left arm on 5/11/05 at 9:45 AM. Two days later, on the evening of 5/13/04, the patient developed hives on her wrist and shoulder. Her mother treated her with Benadryl. By the third day, the patient had developed swelling of her toes and wrists. The patient was seen by a physician on 5/16/05 with angioedema. She did not have any respiratory symptoms. She was treated with oral prednisone. It was not reported whether the patient recovered from these events. (OMIC)
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a school aged patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed a mild case of breakthrough chicken pox. Unspecified medical attention was sought, but laboratory tests were not performed and treatment was not required. A product quality complaint was not involved. The reporter also mentioned a second patient who developed chicken pox post vaccination with varicella virus vaccine live (WAES0405USA01135). Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 year old female who in approximately June 2001, was vaccinated with a dose of varicella virus vaccine live. On 6/7/04, the patient presented to the physician's office over 200 lesions and a fever. Acyclovir and acetaminophen were prescribed for the patient/ The patient was reported as recovering with sequelae. The final diagnosis was breakthrough/vaccine failure. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 6/4/04 in the PM the patient presented with a fever of 100.3 degrees and numerous papular lesions on her chest, groin, arms, and legs. A doctor visit was required. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning his wife who in 1996 was vaccinated with 2 doses of varicella virus vaccine live.  Subsequently, the patient failed to seroconvert.  The patient was re-vaccinated with 2 more doses of varicella virus vaccine live and again showed no immunity.  A product quality complaint was not involved.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old white female with no allergies and no pertinent medical history who on 10/30/1998 was vaccinated with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy included a first dose of influenza virus split virion 3v vaccine inactivated.  The patient had impetigo and a questionable allergy to milk at the time of vaccination.  It was noted that the patient was exposed to chickenpox at the end of May 2004.  The patient's mother called the physician's office to report that on 06/05/2004 the patient broke out in chickenpox with multiple lesions on her body.  On 06/12/2004 the patient's mother called the physician to report that it looked like bug bites and itchy lesions on her neck.  There was no fever.  On 06/14/2004 the patient's mother noted that there were over 100 lesions and that they were severe.  Unspecified medical attention was sought and no treatment was required.  No lab tests were performed.  Subsequently, the patient recovered.  No product quality complaint was involved.  No further information is expected.
Age: 0.99
Sex: F
Vaccine: VARCEL
Symptoms: Eczema, Infection, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old white female patient with a history of occasional Eczema who in the AM on 05/21/2004 was vaccinated in the right thigh with a first dose of varicella virus vaccine live.  Other vaccines administered in the AM on 05/21/2004 included a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live administered in the left thigh.  The patient was not ill at the time of vaccination.  On 12 or 06/13/2004 in the afternoon the patient developed a chickenpox rash.  The pox appeared in the diaper area and down her legs.  The parent reported that the patient also had cold symptoms.  The patient also developed a diaper rash which was treated with over the counter options.  It was noted that otherwise the patient received over the counter and palliative care.  There were no laboratory or diagnostic tests performed.  It was noted that the patient and sibling had no adverse events following prior vaccinations.  The patient was reported recovered on 06/22/2004.  No product quality complaint was involved.  Unspecified medical attention was sought.  No additional information is expected.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, the patient developed a varicella like rash.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Dermatitis bullous, Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female twin with Asthma who on 07/26/1999 was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live.  The RN reported that the patient subsequently developed about 10-20 varicella lesions.  The lesions were reported to be all different, some were crusted, some were vesicular and some looked like bug bites.  Unspecified medical attention was sought.  The patient was noted to be afebrile.  The patient also developed a cough, but the physician thought it was due to her Asthma.  The patient was treated with pain medicine and an unspecified Asthma medication.  No product quality complaint involved.  The physician also reported that the patient's twin sister also developed varicella after being vaccinated with varicella virus vaccine live.  Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old female who on 08/22/2002 was vaccinated with varicella virus vaccine live subcutaneously.  There was no concomitant medication.  On 01/11/2004 the patient developed a breakthrough case of varicella.  The patient broke out with lesions all over her body and had a temperature of 101 degrees.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 38 year old healthy female who was vaccinated with 2 doses of varicella virus vaccine live, four weeks apart.  One month after the second dose the patient had a negative titer.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.59
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cough, Pyrexia, Rash, Respiratory disorder, Rhinitis
Clinical narrative: Information has been received from a consumer concerning her 19 month old daughter and follow up from a physician concerning the 19 month old white female patient with sinusitis, otitis media, allergies, and penicillin allergy with no other pre-existing medical conditions, who on 06/07/2004 was vaccinated subcutaneously in the right thigh with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy on 06/07/2004 included a fourth dose of diphtheria toxoid, pertussis acellular Biken vaccine, tetanus toxoid, administered intramuscularly in the left thigh.  Other concomitant therapy included azithromycin started on 05/07/2004 for sinusitis and cetirizine hydrochloride for allergies.  On 06/10/2004, the patient developed respiratory symptoms, a runny nose, sneezing, a rash on her back and front torso, and coryza and cough.  On 06/13/2004, the patient also developed a low grade/tactile fever and ibuprofen was given.  The duration of the symptoms was reported unknown.  The physician reported that no medications were prescribed.  On 06/14/2004, the patient was seen by a physician.  The evaluating physician felt that the patient had a viral infection versus a reaction to varicella virus vaccine live.  Also reported as a diagnosis of adverse reaction to varicella virus vaccine live.  Also on 06/15/2004, there was slight improvement.  It was noted that the patient also had a diaper rash, which appeared to be a yeast infection from the antibiotic.  It was also noted that the patient did not have adverse events following prior vaccination.  A product quality complaint was not involved.  Follow up information reported that at an office visit on 07/12/2004, the patient had no further signs or symptoms of a reaction to varicella virus vaccine live.  It was noted that the patient recovered.  No additional information is expected.
Age: 1.59
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Rhinorrhoea, Sneezing, Viral infection
Clinical narrative: Information has been received from a consumer concerning her 19 month old daughter and follow up from a physician concerning the 19 month old white female patient with sinusitis, otitis media, allergies, and penicillin allergy with no other pre-existing medical conditions, who on 06/07/2004 was vaccinated subcutaneously in the right thigh with a first dose of varicella virus vaccine live.  Concomitant vaccine therapy on 06/07/2004 included a fourth dose of diphtheria toxoid, pertussis acellular Biken vaccine, tetanus toxoid, administered intramuscularly in the left thigh.  Other concomitant therapy included azithromycin started on 05/07/2004 for sinusitis and cetirizine hydrochloride for allergies.  On 06/10/2004, the patient developed respiratory symptoms, a runny nose, sneezing, a rash on her back and front torso, and coryza and cough.  On 06/13/2004, the patient also developed a low grade/tactile fever and ibuprofen was given.  The duration of the symptoms was reported unknown.  The physician reported that no medications were prescribed.  On 06/14/2004, the patient was seen by a physician.  The evaluating physician felt that the patient had a viral infection versus a reaction to varicella virus vaccine live.  Also reported as a diagnosis of adverse reaction to varicella virus vaccine live.  Also on 06/15/2004, there was slight improvement.  It was noted that the patient also had a diaper rash, which appeared to be a yeast infection from the antibiotic.  It was also noted that the patient did not have adverse events following prior vaccination.  A product quality complaint was not involved.  Follow up information reported that at an office visit on 07/12/2004, the patient had no further signs or symptoms of a reaction to varicella virus vaccine live.  It was noted that the patient recovered.  No additional information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a pharmacist concerning a 5 year old male who in June 2004, was vaccinated with a dose of varicella virus vaccine live.  Subsequently, on an unspecified date in June 2004, the patient experienced a varicella like rash.  Unspecified medical attention was sought and no treatment was required.  A product quality complaint was not involved.  Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: Information has been received from a health professional concerning an 8 year old white male with no medical history or allergies who was vaccinated with a dose of varicella virus vaccine live.  On 05/30/2004 the patient experienced an itchy papular rash.  It was reported that it presented 48 hours before office visit.  Medical attention was sought.  Recovery status was unknown.  No additional information is expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Mouth ulceration, Pruritus, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 11 year old male with Asthma, Gastro-esophagael Reflux, Pectus Excavatum, and seasonal allergy, who on 06/12/2005 was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included ranitidine, fluticasone propionate, albuterol and fluticasone propionate.  On 06/02/2004 the patient experienced fever, and few itchy papules.  It was noted that over the course of the next 4 days he had a total body break out with vesicular lesions and oral mucosal ulcers.  No labs were done and no medications were prescribed.  The patient was treated with hydroxyzine hydrochloride, acetaminophen, calamine, camphor, pramoxine hydrochloride baths, and calamine lotion.  It was noted that the patient recovered by 06/11/2004 without incident.  Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female healthcare worker who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, the patient developed 19 pox-like lesions approximately 10 days to 2 weeks after vaccination.  The patient reported the lesions to be pruirtic with heads.  It was noted that she missed work and had a fever for approximately 10 days post-development.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning an 11 year old male who was vaccinated with a dose of varicella virus vaccine live.  The physician reported that the patient subsequently developed 50 pox-like lesions after exposure to varicella.  Unspecified medical attentions was sought.  It was also noted that the patient's sibling was also exposed to varicella, but did not contract varicella.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old white female who on 08/11/1999 was vaccinated with a dose of varicella virus vaccine live.  In November 2003, the patient developed shingles on her face.  On 11/30/2003, the patient was diagnosed at a hospital urgent care facility.  Subsequently, the patient recovered with no problems.
Age: 1.78
Sex: F
Vaccine: VARCEL
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a RN concerning a 10- year old white female who on 03/14/1996 was vaccinated with a dose of varicella virus vaccine, live. On 06/09/2004 in the PM, the pt experienced a "breakout", and on 06/10/2004, the "breakout" continued. The outcome was reported as not recovered. Additional inoformation has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 14 year old female pt, who was vaccinated with varicella virus vaccine, live . The physician reported that out of 10 children vaccinated with varicella virus vaccine, live one female failed to seroconvert after a titer was drawn. The physician mentioned the lot numbers were different, but he had no information as to whether TX was required. No other additional information wa available. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested. The physician also mentioned that 3 male children out of 10 children vaccianted with varicella virus vaccine, live failed to seroconvert after a titer was drawn (WAES# 0406USA00335). Additionally, the physician mentioned that some clients vaccinated with measles virus vaccine live + mumps virus vaccine, live + rubella virus vaccine live are not immune to either mumps or rubella when older (WAES# 0406USA1779).
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received form a health professional concerning a 5 year old white female with a peanut allergy and an egg allergy, but otherwise healthy who on 12/01/1999 was vaccinated SC in the LL with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06/16/04, the pt presented to the office with a scattered vesicular rash on his right leg and thigh, left thigh and trunk.  There were 40-50 lesions. The rash started on 06/14/04. Medical attention was sought, but no tx was required. No product quality complaint was involved. Follow up information indicated that the pt was seen in the office on 06/16/04 with a rash for 2-3 days. It was described as scattered vesicular lesions on the right leg and thigh, left leg and thigh and right upper extremity: "trunk". There were 40-50 lesions without fever. There were no labs or diagnostic tests performed. It was reported that the pt recovered.  Follow up information indicated that the pt was diagnosed with varicella. Additonal information is not expected.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site pain, Laboratory test abnormal
Clinical narrative: Information has been received from a consumer concerning his 56 year old wife with "no pertinant medical history" who, six months ago, was vaccinated with a 0.5ml dose of varicella virus vaccine, live. Concomitant therapy included estradiol and celecoxib (Celebrex). Her arm became red and sore, which lasted  for a week or two. It was reported that she recently discovered that she has a high value single strand DNA. Medical attention was sought and the outcome was reported as not recovered. No product quality  complaint was involved. Additonal information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Drug ineffective, Pruritus, Rash, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 12 month old male with milk allergies who on 06/08/2004 was vaccinated  in the RL with a first dose of varicella virus vaccine live. On 06/16/04 the pt developed a rash of 20-25 lesions that looked like bug bites and itching. Medical attention was sought. No Tx was recommended. No product quality complaint involved. Follow up information from a LPN indicated that the pt had a papular, non pruritic rash on his arms, legs, and back. His temperature was 99.8 degrees at times. He was seen by the doctor on 06/17/04 for probable viral exanthema. It was noted to last one week and the pt recovered 06/23/04. No additional information is expected.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been requested from a nurse concerning a female physician with no pertinent  medical history or allergies who in 2000 was vaccianted with a first and second dose of varicella virus vaccine, live. Subsequently in 2004, the pt's antibody titer was 0.8 which is less than recommended. There was no product quality complaint involved. Additional information has been requested. Additional information received. The patient's age and date of birth has been added.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Pharyngolaryngeal pain, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a health care professional concerning a 10 year old male who in 1995 was vaccinated with a dose of varicella virus vaccine, live. On 06/16/04 the pt presented with chickenpox. The Sx included 50-75 vesicular lesions, a fever of 101.2 F, and a sore throat. Tx included oral and ocular antibiotics. Follow up information from the nurse indicated that the pt did not have chicken pox. The child had adenovirus. No product quality complaint was involved. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Pityriasis rosea, Rash erythematous, Rash papular, Urticaria, Viral infection
Clinical narrative: Information has been received from a RN concerning a 6 year old female with no pertinent medical history and no allergies who on 07/22/98 was vaccinated SQ in the RL with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06/16/2004 the pt developed red bumps on her hands and face. It was reported that they started as tiny bumps and they got bigger over a course of a few hours. On 06/17/2004 she presented to the doctors office with red, itchy, slightly raised tiny papules to vesicles approximately 1/2 - 1 cm., located on her face, hands, and one on her leg. There were about 15 lesions in total. There was no fever. No Tx or lab studies were required. The pt was Dx with breakthrough chickenpox. At the time of report the pt had not recovered. The report indicated that the pt was sent home to isolate and told to follow up as needed. No product quality complaint was inovlved. Follow up information indicated that the pt returned to the office 6 days later, on 06/23/2004. The pt was thought to have chicken pox. Some lesions had crusted over and some faded away. Now lesions were still coming out. They started as small 1/2 cm barely raised papules and progress ot 1/2-2cm  red papules in a few hours. In about 1-2 days, they crust over or just fade. They are a little itchy. Everything else feels well, she is afebrile and eating well. On exam  she had some old lesions that were now large (2-3cm) and irregularly shaped and scaly. Now 1/2-1cm red papules are on legs, smaller on buttocks. She still has lesions on arms and face, but not on palms, soles, or in the throat. It was noted that there were no vesicles. The Dx was pityriasis rosea vs. papular urticaria. Tx included diphenhydramine hydrochloride ( Benadryl) and calamine lotion. Outcome was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 15 year old female pt who on 05/04/2001 was vaccianted with varicella virus vaccine live. On 06/11/04 the pt had a titer done which was reported as "too low". The titer was ".40". No other information was available at the time of this report. There was no product quality complaint reported. Unspecific medical attention was sought. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Contusion, Immune system disorder, Petechiae, Platelet count decreased, Rash
Clinical narrative: Information has been received from a physician, a LPN and medical records concerning a 15 month old white/asian male pt with no allergies, no concurrent conditions and a Hx of fever who on 05/18/2004 was vaccinated SQ in the right thigh with a 1st dose of varicella virus vaccine live. Concomitant vaccination on 05/18/04 included; 1st SQ dose in LL of MMR vaccine, and a 3rd dose in the LL of Hep B virus vaccine + Hib conjugate vaccine. Other concomitant therapy included . There were no adverse events following prior vaccination. On 06/10/04, the pt presented to the medical office with thrombocytopenia. The pt had a petechial rash on the arms, legs, trunk, and buttocks. There were no signs or symptoms of illness or fever. Lab work revealed the following platelet counts: 06/10/04- 8, 06/11/04-11, 06/13/04-10, 06/17/04-19, 06/27/04-62 (reference range: 250-600). The physician confirmed the pt's platelets were extremely low. A probable Dx of ITP was made and an onset date on 06/10/04 was noted. The physician consulted with a hematologist and the recommendation was to just medically manage. The pt was not hospitalized and no Tx was initiated. The pt wore a helmet. Aside from his bruising, there was no obvious bleeding. The physician stated the pt experienced some type of immune thrombocytopenia, "presumably temporarily associated to the vaccine. however there was no way to assess this. Subsequently in approximately 07/2004 the pt completely recovered on his own and was clinically normal with platelets up to the 200's. The physician did not feel the pt's experience me the definition of other medical event, however felt this was a "major" adverse response. A product quality complaint was not involved, additional information has been requested.
Age: 1.27
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Thrombocytopenia
Clinical narrative: Information has been received from a physician, a LPN and medical records concerning a 15 month old white/asian male pt with no allergies, no concurrent conditions and a Hx of fever who on 05/18/2004 was vaccinated SQ in the right thigh with a 1st dose of varicella virus vaccine live. Concomitant vaccination on 05/18/04 included; 1st SQ dose in LL of MMR vaccine, and a 3rd dose in the LL of Hep B virus vaccine + Hib conjugate vaccine. Other concomitant therapy included . There were no adverse events following prior vaccination. On 06/10/04, the pt presented to the medical office with thrombocytopenia. The pt had a petechial rash on the arms, legs, trunk, and buttocks. There were no signs or symptoms of illness or fever. Lab work revealed the following platelet counts: 06/10/04- 8, 06/11/04-11, 06/13/04-10, 06/17/04-19, 06/27/04-62 (reference range: 250-600). The physician confirmed the pt's platelets were extremely low. A probable Dx of ITP was made and an onset date on 06/10/04 was noted. The physician consulted with a hematologist and the recommendation was to just medically manage. The pt was not hospitalized and no Tx was initiated. The pt wore a helmet. Aside from his bruising, there was no obvious bleeding. The physician stated the pt experienced some type of immune thrombocytopenia, "presumably temporarily associated to the vaccine. however there was no way to assess this. Subsequently in approximately 07/2004 the pt completely recovered on his own and was clinically normal with platelets up to the 200's. The physician did not feel the pt's experience me the definition of other medical event, however felt this was a "major" adverse response. A product quality complaint was not involved, additional information has been requested.