chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective, Malaise, Pneumonia
Clinical narrative: Information has been received from a 80 year old female consumer with asthma who, 5 years ago, in 1999 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There were no concomitant medication. In 2002 the patient developed pneumonia and, again this spring. The patient indicated that she had not had pneumonia in 75 years and was surprised she developed it twice within 5 years of receiving the innoculation. She also reported that she was very sick, but not hospitalized because of this. Medical attention was sought, but no labs or diagnostic tests were done and no treatment was required. The patient recovered, but recovery date was not available. No product quality complaint was involved. The two episodes of pneumonia were considered to be life-threatening by the reporter. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Confusional state, Hyponatraemia, Laboratory test abnormal
Clinical narrative: He developed severe hyponatremia (114 meq/dl) approximately 6 hours after receiving an adult Td. Patient has recovered.  Nurse follow up on 05/25/04 states: "Altered Mental State (Confusion)."
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Feeling hot, Nausea
Clinical narrative: Approximately 8-12 hour following receipt of vaccine, felt nauseated, dizzy, feverish and experienced vomiting, diarrhea and abdominal cramping. After anthrax vaccine #3 on 8/7/03; experienced same symptoms within 8-12 hours, admitted on 8/8/03 for 1.5 days (no records available. ) See attached clinical study.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Approximately 8-12 hour following receipt of vaccine, felt nauseated, dizzy, feverish and experienced vomiting, diarrhea and abdominal cramping. After anthrax vaccine #3 on 8/7/03; experienced same symptoms within 8-12 hours, admitted on 8/8/03 for 1.5 days (no records available. ) See attached clinical study.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Injection site inflammation
Clinical narrative: Pt experienced knotting and inflammation of right tricep.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pt received Td on 5/14/04, then on 5/16/04 had increased leg pain, redness, warmth, swelling at site of injection in left deltoid.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Medication error
Clinical narrative: Used wrong diluent on HIB vaccine. Used MMR diluent instead of Hib Diluent.
Age: 2.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Medication error
Clinical narrative: Wrong diluent was used with Hib vaccine. The MMR diluent was used instead of Hib diluent.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dermatitis, Erythema, Eye swelling, Feeling hot, Ocular hyperaemia
Clinical narrative: 5/3/04 at 8:45 OV left upper arm deltoid red, warm to touch , slightly swollen. Dad stated noticed 5/1/04 left arm red and swollen; applied ice pack right upper arm some redness. None noted today at right arm. Dad denies fever but rash 5/1/04 after getting out of tub. rash noted left arm inside of elbow area. Dad said was dermatitis. Child no c/o's with when arm moved hurts. Child normal behavior per dad. Eyes red and swollen underneath. 5/5/04 pl arm better. Eyes slightly red underneath.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash, Swelling
Clinical narrative: 5/3/04 at 8:45 OV left upper arm deltoid red, warm to touch , slightly swollen. Dad stated noticed 5/1/04 left arm red and swollen; applied ice pack right upper arm some redness. None noted today at right arm. Dad denies fever but rash 5/1/04 after getting out of tub. rash noted left arm inside of elbow area. Dad said was dermatitis. Child no c/o's with when arm moved hurts. Child normal behavior per dad. Eyes red and swollen underneath. 5/5/04 pl arm better. Eyes slightly red underneath.
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Local reaction to immunization right arm. Treatment : warm compress, ibuprofen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local reaction left arm to DTaP. Arms red and swollen. Redness about size of large apple.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Increased swelling, itching and redness of left leg area to which injections were given, symptoms were 3x as bad on Sunday morning when grandma took pt to ER. Pt given Atarax Rx recheck on tues with improvement.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Erythema multiforme, Irritability, Pyrexia, Rash, Rash macular
Clinical narrative: Irritability, low grade fever, rash, erythema multiforme. Target lesions. Concentric macules trunk and extremities.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Skin ulcer
Clinical narrative: Irritability, low grade fever, rash, erythema multiforme. Target lesions. Concentric macules trunk and extremities.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Right leg at injection site swollen, red area approximately .5 inch around site, warm to touch, symptoms increased from 5/4 until morning of 5/5/04. Pt brought into office for appointment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling, Tenderness, Urticaria
Clinical narrative: Severe hives 45 minutes after shot given: arm was triple the size for 4-5 days, red, hot and very tender.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular
Clinical narrative: Low grade fever today and has broken out with 30+ chicken pox lesions on trunk and legs mostly.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling left upper arm beginning 4-9-04. Slightly bruised looking today 4-12, otherwise normal.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Rednes, marked swelling shoulder to elbow beginning 4-9-04. Resolved over several days.
Sex: F
Vaccine: TD
Symptoms: Abdominal pain, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Evaluated by PMD re: Fever, chills, nausea, vomiting, abdominal spasms, headache that begain 3 hours after receiving DT
Sex: F
Vaccine: TD
Symptoms: Vomiting
Clinical narrative: Evaluated by PMD re: Fever, chills, nausea, vomiting, abdominal spasms, headache that begain 3 hours after receiving DT
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Head discomfort, Nasal congestion, Pharyngolaryngeal pain
Clinical narrative: Evening after receiving MMR: onset of sore throat, nasal and head congestion, joint aches: total body, duration 3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, feverish area around injection site approximately 8cm in diameter. Non tender.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Pain, Pyrexia, Swelling
Clinical narrative: 48 hours after pneumovax injection, pt comes in with complaints left deltoid area pain, redness and swelling; recommended Benadryl and Tylenol. Continue Vioxx, began Biaxim xL 500mg qdx10 days on 12/18/03 with temperature 101.5 - 102.5 per pt report. Office temperature 97.3; 12/19/2004: began Prednisone 40mg qdx3 days. Then lost to follow up until 5/5/04: pt request.  "Knots under skin on left arm after pneumonia shot."
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Pyrexia, Tenderness
Clinical narrative: Vaccine given 5/10/04 to 4 year old with hemophilia A. Ice packed. Developed erythema, tenderness and fever to 102 degrees.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, raised, feverish area around injection site approxiamately 8cm in diameter.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Inconsolable crying >6 hours.
Age: 14.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Drug administration error
Clinical narrative: Varicella Vaccine given was expired for 3 days. Expiration date 04/16/04 and vaccination administered 04/19/04.  No adverse events noted.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness at site 3x3 inch, itchy left arm.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Immunizations given 05/12/2004 afternoon 05/13/04, mom noticed red lump at both injection sites. Child had been restless and irritable through the night. But does not seem bothered today. Areas are indurated and warm but not tender to touch.  No prescription needed.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Irritability, Restlessness
Clinical narrative: Immunizations given 05/12/2004 afternoon 05/13/04, mom noticed red lump at both injection sites. Child had been restless and irritable through the night. But does not seem bothered today. Areas are indurated and warm but not tender to touch.  No prescription needed.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema
Clinical narrative: Mild redness aterolateral right thigh.
Age: 1.21
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Macular rash on face, neck and trunk. No Koplik spot. Child had MMR 2 weeks ago.
Age: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Swelling
Clinical narrative: Swelling of deltoid right arm, warmth to touch, non tender, full range of motion.
Age: 2.5
Sex: M
Vaccine: HEPA, MMR
Symptoms: Convulsion, Coordination abnormal, Dysarthria, Febrile convulsion, Musculoskeletal stiffness
Clinical narrative: Child without chest pain had fever of 103 on 5-8-03, had tonic clonic movements of arms, stiffness, urinary incontinance, episode lasted 1 minute, 2 hour post istal. Evaluation in ER done. One prior febrile seizure 1 year ago. CT & MRI brain left in Dec 03. Child had slurred speech and poor coordination for 24 hours after event.
Age: 2.5
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Urinary incontinence
Clinical narrative: Child without chest pain had fever of 103 on 5-8-03, had tonic clonic movements of arms, stiffness, urinary incontinance, episode lasted 1 minute, 2 hour post istal. Evaluation in ER done. One prior febrile seizure 1 year ago. CT & MRI brain left in Dec 03. Child had slurred speech and poor coordination for 24 hours after event.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Local reaction-large at site DTAP #5
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever (102 F) 30 minutes after immunization.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: Local reaction-swelling/induration of 4.5x6cm on arm.  Swelling almost gone by 05/10/04.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Chest pain, Cough, Dyspnoea, Urinary tract infection
Clinical narrative: 05/05/04 @ 10AM: Vaccine given; 05/06/04 @ 02:00: Complained of shortness of breath, cough and chest pain, non-radiating; 05/06/04L 10AM: Dr. appointment;
Age: 1.2
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Developed low grade fever and maculo-papular rash on day 8 post vaccination.  Saw MD.  No treatment other than fever reduction and comfort measure.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Mild macular rash over face, trunk and extremities, onset 5/10/04. Low grade intermittent fever: not measured by mother; no treatment.
Age: 25.0
Sex: U
Vaccine: ANTH, TYP
Symptoms: Erythema, Injection site warmth, Pruritus, Swelling
Clinical narrative: Localized mild swelling. Redness, itching and hot to touch. Pt was given typhoid and anthrax IM in same arm.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site rash, Rash
Clinical narrative: Vaccines given at 9:00am and mother returned to office at 9:10 am stating patient had a rash on his face. Patient was seen by Dr. Flex and Benadryl was given. Patient also had rash to site where vaccines given.
Age: 1.75
Sex: M
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: 13x9 swelling in knee area.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous, Rash maculo-papular, Tonsillitis
Clinical narrative: Child vaccinated with MMR, Varivax on 3/20/04. Presented on 4/2/04 with fever to 100.7, irritability, poor po intake and rashx 3 days. Rash firm maculo-papular, erythematous, started on face, spread down and bilat. o. Medial tonsilitis. Rx: benadryl, Omnicef, Motrin.
Age: 1.6
Sex: F
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: 5-6-04 Mom said 15 min after shots started first raised welt on right arm. Then, kept getting more. She called ER. They said to use Benadryl. 4hours and watch for SOB. Called me in AM brought child. Had raised welts scaterred on body (back, chest, legs, arms, hands) . Told to take to Dr. Went to doctor. she said allergic reaction to MMR. Not to take dose 2 and to continue benadry. i told her to be careful with newomycin and gelatin use. Went to doctor  later 5-6-04.
Age: 10.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Pharyngolaryngeal pain, Pyrexia, Tenderness
Clinical narrative: Pt received tetanus- diptheria vaccine on 5-7-04. Parent called 3 days later to report fever, T101-104 for two days, arm was red on first day after vaccine given. Neck was sore and pt had slight sore throat. Neck was supple. Parent spoke with doctor on the telephone.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: 6 wk old with fever to 101.4 degrees. Child received a septic work-up, IM antibiotics. Evaluation was negative.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anorexia, Rash
Clinical narrative: Anorexia x 1 week. Rash this AM.
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Pain, Rash, Swelling
Clinical narrative: Developed rash and swelling to ears, face, neck, then trunk by the next day pt receiving Td took allegra x 2-3 days, took ibuprofen for pain.
Age: 1.2
Sex: F
Vaccine: IPV, MMR
Symptoms: Rash macular, Rash morbilliform, Skin ulcer
Clinical narrative: - Positive morbilliform- red blotchy coalescence of lesions > truncal/less on extremities 10 days after vaccine (MMR) given. No fever. No conjunctivitis, No pharyngitis. Observation/ no labs.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Elevated temp
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Erythema, Eye inflammation, Rash, Swelling
Clinical narrative: Skin rash whole and flare; lower eye lid: have some erythema and swelling.
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Many papules on red base. exposed to chicken pox at school.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB
Symptoms: Injection site rash
Clinical narrative: Rash on leg at injection site.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms, Paraesthesia
Clinical narrative: Pt came in today with symptoms of stands/sits bend neck feels tingling down back and ten has gradually gone down his thigh area and towards right shoulder pair tender to touch with charlie horses.
Age: 14.0
Sex: F
Vaccine: YF
Symptoms: Chest pain, Cough, Dyspnoea, Palpitations, Wheezing
Clinical narrative: Patient left 20 minutes after vaccination. Mother of patient said it started with pt trying to clear throat. soon as they left office while going down in elevator. Pt started wheezing which lead to coughing. Then SOB with heart palpitation Then some chest pain. Visited ER, where he was given O2, Benadryl and inhaler. She was released to her mom and stayed home tired today. Mom called at 9:00 AM 5-11-04.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypotension, Unintended pregnancy, Vomiting
Clinical narrative: Information has been received through the Merck pregnancy registry concerning a 30 year old black female with hypertension, a history of 2 pregnancies and 1 live birth (1 miscarriage at 10.5 weeks), and no known allergies, who on 10-JUN-2002 was vaccinated with a dose of varicella virus vaccine live. There was no local reaction at the vaccination site, and no symptoms of varicella or herpes zoster post vaccination. The patient was not tested for varicella antibodies before being vaccinatied with varicella virus vaccine live. Concomitant medication for hypertension included amlodipine besylate (NORVASC) 2.5 mgs dialy, (also reported as taking for 3 years) and metoprolol succinate (TOPROL XL TABLETS) 50mg BID. On 15-JUN-2002 the patient took an early home pregnancy test, and it came out positive. She reported that she was going to contact her physician to find out if she was really pregnant. She noted that her LMP was 17-MAY-2002. No medical attention was sought. Information was received on 02-JUL-2002 from her physician that noted her LMP was 13-MAY-2002. It was reported that there was no birth defects in any previous pregnancy. A screening ultrasound was scheduled for the first week in July 2002 and was reported as normal. On 12-Sep-2003, a screening maternal serum alpha fetal protein test was reported as normal. On 15-FEB-2003, at 39 weeks, the patient delivered a normal, 5lb., 14 oz. female. The infant had no congenital anomalies, complications or abnormalities, nor any features of congenital varicella zoster syndrome. The patient developed hyperemesis and hypotension during her pregnancy. There were no other reported complications, infections or illnesses during her pregnancy. No further information is expected.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Unintended pregnancy, Vomiting
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 22 year old female who during the week of 05-AUG-2002 was vaccinated with a dose of varicella virus vaccine live. On 12-AUG-2002. the patient presented to the physician's office due to vomiting and her urine pregnancy test was positive. Unspecified medical attention was sought.  Follow-up information indicated that the patient "never returned for follow up visits and we were not successful locating her." No further information is expected.
Sex: F
Vaccine: HEP, RUB, VARCEL
Symptoms: Neoplasm malignant, Unintended pregnancy
Clinical narrative: Information has been received from a certified nurse midwife through the Merck pregnancy registry concerning a white female with a history of 3 pregnancies and 1 live birth who on 29-JUL-2002 was vaccinated with varicella virus vaccine live (site unknown). Concomitant therapy that day included rubella virus vaccine live (MSD) and hepatitis B virus vaccine rHBsAg (yeast) (MSD). On 08-JUL-2002, the patient had been tested for antibodies and the results were negative. Subsequently, she became pregnant (LMP = 12-JUL-2002; EDD: 19-APR-2003) and on 27-APR-2003 delivered a normal, healthy male baby weighing 8 pounds  8 ounces. There were no complications or abnormalities during pregnancy or during labor/ delivery. The patient had a repeated, scheduled C-section. There were no reported medications used during the patient's pregnancy. On 18-NOV-2002 an ultrasound was performed for a fetal survey (18.2 weeks). Amniocentesis and MSAFP were reportedly declined. On an unspecified date, the patient had an abnormal pap smear with carcinoma in situ. There were no other reported diagnostic tests performed during pregnancy. it was noted that the patient did not have a local reaction at the injection site, varicella (chicken pox) symptoms post vaccination, or herpes zoster (shingles) symptoms post vaccination. The newborn infant did not feature any congenital varicella zoster syndrome (cutaneous scars, limb hypoplasia, eye or CNS malformation, or neurologic deficits.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Abscess, Hypersensitivity
Clinical narrative: Information has been received from a 31 year old female with a "sulfa minocin" allergy and a history of caesarean section (September, 2000) who on 26Jul2002 and 28Sep2002 was vaccinated with a dose of varicella virus vaccine live. There were no concomitant medications. On 01Oct2002, the patient discovered that she was pregnant. Unspecified medical attention was sought. On 07Oct2003, follow-up information from the physician revealed that the patient delivered a female patient with a birth weight of 7lb 3oz. via C-section on 27May2003. The apgars "were 9 and 9 and there were no complications with the baby". It was noted that the mother had an incision abscess post operatively and was seen in the office. The incision abscess was treated with "wound care". Additional information is expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Unintended pregnancy
Clinical narrative: Information has been received from a physician concerning a 28 year old female with no concurrent medical conditions and a history of 2 pregnancies and 1 live birth who on 03Jul2003 was vaccinated with a 0.5 ml dose of varicella virus vaccine. It was reported that the patient did not have any local reactions at the vaccination site, varicella or herpes zoster symptoms post vaccination. On 21Oct2000, laboratory evaluations revealed a negative titer for serum varicella antibodies. The pt's LMP was 06Jul2002 with an EDD of 12Apr2003 (reported as 2002). In July, 2002, the patient was started on prenatal vitamins. On 11Nov2002 a maternal serum alpha fetal protein test was reported as normal. On 15Nov2002, the patient had a routine ultrasound, the results of which are unknown. On 16Apr2003 at 40 4/7 weeks, the pt delivered a live born, normal, 8lb 4 oz male. Apgar score was 8 and 9. The infant had fetal bradycardia during labor/delivery and was delivered with forceps. There were no congenital anolmalies, complications, infections or illnesses during pregnancy. It was noted that there were no unusual diagnostic tests done during the pregnancy. On 25Apr2003 the infant was noted to have a possible tongue tie. He was to return to the clinic the next day for a frenotomy evaluation. On 20May2003 the infant was brought back to the clinic for a consult. It was noted that the infant had rested that morning and had much better tongue movement with go lateral movement and the tongue was protruding past the gums. The infant was seen by a physician. He nursed more effectively. The plan was to monitor the infant's progress and it was noted that the frenotomy would not be performed that day. It was also reported that the infant was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufactuer unknown) and developed a cough, sneezing, rhinnorhea, and wheezing at night. No further information is expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Premature labour
Clinical narrative: Information has been received from a physician concerning a 29 year old pregnant female with a medical history of "a heart condition" who on an unspecified date was vaccinated with varicella virus vaccine live. It was noted that the doctor stated that the "heart condition" was present before the pregnancy and it was a "long standing condition". The date of the patient's last menstrual period was reported to be approx. 13Sep2002 or 20Sep2002. The EDD was 20Jun2003, the exact due date was unknown. At the time of this report, the results of an ultrasound were pending. Unspecified medical attention was sought. Follow up information revealed that on 01Jun2003, the mother delivered a female baby with a birth weight of 5 lbs. 10 oz. It was noted that the patient was induced 5 weeks early due to her heart condition because they wanted her to deliver a smaller baby. It was also noted that the baby was "fine" and "all is going well with the baby". No further information was provided. No further information is expected.
Age: 0.75
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a mother concerning her 9 1/2 month old son who on 20March1998, 3 months prior to his first birthday, was vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. On 22May2003, the mother reported the she had had her son's serum tested "recently" and he is not immune to the chicken pox. No product quality complaint was involved. No further information is expected.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Migraine, Prolonged labour
Clinical narrative: Information has been received from a physician concerning a 34 year old female patient with migraines and no previous pregnancies who on 16Aug2000 was vaccinated with a second 0.5cc dose of varicella virus vaccine live (Pl: 11Jul2000, 0.5cc dose). Prior to vaccination on 22Jun2000, the patient tested negative for varicella antibodies. The patient was not vaccinated for immigration purposes. The patient did not develop a local reaction at the vaccination site, varicella symptoms or herpes zoster symptoms post vaccination. Subsequent to vaccination, the patient became pregnant with a LMP of 15Oct2000. During the entire pregnancy, the patient was treated with prenatal vitamin tablet daily for pregnancy supplementation. On 13Feb2001, an ultrasound for dating was normal and an amniocentesis was normal (46X4). In approximately June 2001 at 32 wees. The patient developed pre-term contractions. From 02Jul2001 to 02Aug2001. The patient was treated with "Surtak" one tablet twice a day as needed for constipation. The reporter indicated that there were no infections or illnesses during pregnancy. On 02Aug2001 at 41 weeks, the patient underwent induction and artificial rupture of membranes secondary to "post dates". Oxytocin (pitocin) augmentation was used secondary to a prolonged labor. On 02Aug2001 at the time of delivery, AMA was 354. On 02Aug2001, the patient delivered a normal, healthy male child weighing 7 pounds, 8 ounces. The reporter indicated that there were no complications during labor or delivery. There were no congenital anomalies and no features of congenital varicella zoster syndrome. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: This is in follow-up to report (s) previously submitted on 5/14/2004. Information has been received through the manufacturer pregnancy registry from a physician concerning a 30 year old  female, G2, P1 with no known drug allergies and no concurrent medical conditions who in Feb 02 and on 07/11/02 was vaccinated with a first and second dose of varicella virus vaccine live, respectively.  It was unknown if the pt was tested for varicella antibodies before vaccination.  It was unknown if there was a local reaction at the vaccination site, or if there were varicella or herpes zoster symptoms post vaccination. Concomitant therapy included prenatal vitamins.  The pt had her last menstrual period on 08/03/02.  Medical attention was sought and on 12/10/02 it was reported that the pt was currently pregnant and was exhibiting no untoward signs or symptoms.  On 12/03/02 a materal serum alpha fetal protein was normal. On 01/07/03, an ultrasound was performed for size and dates and was normal. No product quality complaint was involved.  On 05/02/03 the pt spontaneously delivered vaginally a normal, liveborn 7lbs, 3oz male. Apgar scores were 8 and 9.  The infant had no congenital anomalies or features of congenital varicella zoster syndrome. The mother developed gestational diabetes. There were no other reported complications, infections or illnesses during her pregnancy or labor/delivery. Medication used during the mother's pregnancy included supplemental prenatal vitamins and docusate calcium as a stool softener. On 03-May-2003 the infant had a circumcision per the parents desire. No further information is available.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Thrombocytopenia
Clinical narrative: Information has been received through the manufacturer registry from a physician and the spouse of a 27 year old Indian with no concurrent medical conditions, no known drug allergies and a history of having had a therapeutic abortion in her first trimester who on 10/02/02 was vaccinated with a dose of varicella virus vaccine live. There were no concomitant medications. The pt's spouse reported that the pt was pregnant around 10/29/02.  The pt's LMP was on 09/30/02.  Subsequently, the pt developed gestational thrombocytopenia during her pregnancy. There were no local reactions at the vaccination site nor any varicella or herpes zoster symptoms post vaccination.  On 05/10/02 the pt had been tested for varicella antibodies before vaccination and the results were negative.  On 12/20/02 the pt had an ultrasound performed for dating purposes with an EDC of 08/04/03.  On 03/05/03, 04/02/03 and 07/07/03 the pt had an ultrasound performed which were reported as normal.  On 07/30/03, 39+ weeks from her LMP, the pt delivered a liveborn, normal, 7lb, 12 oz. female.  The infant had no congenital anomalies, complications, abnormalities, or features of congenital varicella zoster syndrome. There were no complications during labor or delivery. The pt had no infections or other illnesses during her pregnancy. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received through the manufacturer's registry from a certified nurse midwife concerning an "otherwise healthy" 30 year old white female smoker with depression, marijuana use, and a history of eight previous pregnancies, one full term birth, one pre-term birth at 36 weeks, four sponteneous abortions all at less than six weeks, and no history of birth defects in any previous pregnancy who on 09/14/02 was vaccinated with a dose of varicella virus vaccine live.  It was noted that prior to vaccination, on 09/13/01, the pt was tested for varicella antibodies and was negative. The reported indicated that the pt received the vaccination "right at the time of conception".  It was indicated that the pt did not have a local reaction at the vaccination site. There were no varicella or herpes zoster symptoms post vaccination.  Unspecified medical attention was sought. Her LMP was 10/14/02 and expected date of delivery was 07/21/03.  Prenatal testing for screening on 02/06/03 included a "quad" and was negative. Other diagnostic tests during pregnancy included "quad" on 02/16/03 which was negative and a sonogram on 02/20/03 which was normal and appropriate for gestational age. Complications during pregnancy included preterm labor and hyperemesis. There were no infections or illnesses during pregnancy. There were no complications during labor and delivery. Medications used during pregnancy included promethazine hydrochloride (Phenergan, 25mg) starting on 12/04/02 for nausea and vomiting, folic acid (400mcg) starting on 12/04/02, ranitidine hydrochloride (Zantac, 150mg) starting on 12/16/02 for gastroesophageal reflux disease, "emetrex" (spelling unclear) starting on 12/16/03 for a prenatal vitamin, clonazepam (klonopin, 1mg, 1/4 to 1/2 tab) starting on 02/06/03 for insomnia, and IM betamethasone (12mg) on 05/22/03 and 05/23/03 for preterm labor. On 07/07/03, 38 weeks from her LMP, the pt delivered a normal male baby weighing six pounds, 14 ounces. It was noted that there were no features of congenital varicella zoster syndrome. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received through the manufacturer pregnancy registry from a 29 year old Caucasian female pt with no allergies and no past medical history, who on 09/19/02 and 10/25/02 was vaccinated with a first and second dose of varicella virus vaccine live, respectively. There was no concomitant medication. The pt reported that she was "14 weeks" pregnant with a LMP of 08/17/02 and had conceived between receiving doses of varicella virus vaccine live.  Unspecified medical attention was sought.  Follow-up information was received from a physician. It was reported that the pt had one previous pregnancy, no full-term births, no pre-term births, no stillbirths or miscarriages and no birth defects with previous pregnancies. The pt was not tested for varicella antibodies prior to vaccination with varicella virus vaccine live. There was no local reaction at the vaccination site.  There were no varicella or herpes zoster symptoms post vaccination.   On 02/11/03, an ultrasound for a fetal anatomic survey and cervical length was normal. Two other ultrasounds were also normal. In Jan 2003, MSAPP was normal (part of a study).  On 06/07/03, a "biophysical" for decreased fetal movement was normal (8/8). During the third trimester in 2003, the pt experienced excessive weight gain. There were no concurrent conditions, no infections or illnesses during pregnancy and no complications during labor or delivery.  On 06/16/03, the pt gave birth to a normal, male infant weighing 6lbs, 11 oz.  The reporter indicated that the birth was "36+1" weeks from the LMP. There were no features of congenital varicella zoster syndrome.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 14 month old male with allergies to eggs, milk and peanuts, severe eczema and asthma who on 10-FEB-2003 was vaccinated in the right leg with 0.5cc of varicella virus vaccine live (lot 640554/0800M). Concomitant therapy included albuterol and budesonide (PULMICORT). The RN reported that on 26-FEB-2003, the patient developed a maculopapular rash characterized by 10 lesions on his left arm and chest. The patient's maximum temperature was noted to be 97. On that same day, a scab speciment was obtained form the patient. On 03-MAR-2003, the scab specimen was sent to a laboratory for PCR analysis. It was noted that the patient did not have a recent exposure to chickenpox or shingles. Unspecified medical attention was sought. Subsequently, the patient recovered from the maculopapular rash. Results from PCR analysis are as followed: A scab specimen was observed. Varicella zoster virus (VZV) DNA was not amplified. B-globuin DNA was amplified. Interpretation: Adequate specimen, no VZV wild-type strain or vaccine strain virus identified: negative. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abscess, Unintended pregnancy
Clinical narrative: Information has been received from a registered nurse through the Merck pregnancy registry concerning a 38 year old female patient with no concurrent conditions who on 12-NOV-2002, was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy included a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(MSD) and tuberculin  purified protein derivatives (TB). The patient was "pregnant at the time of vaccination" and as of 11-MAR-2003, the patient was at least 4 months pregnant. The reporter noted that the patient had not received any pre-natal care, so her exact due date was unknown. Unspecified medical attention was sought. Follow up information was received from a registered nurse. The reporter indicated that the patient had nine previous pregnancies including a 7 full term births and 1 pre term birth at 28 gestational weeks. There was no still birth , miscarriage or birth defect in any previous pregnancy. The patient's last menstrual period was approximately 14-NOV-2002 and her estimated due date was 21-AUG-2003. The patient was administered varicella virus vaccine live for immigration purposes. The patient was an Albanian refugee. It was unknown if the patient was tested for varicella antibodies before vaccination with varicella virus vaccine live. It was unknown if the patient developed a local reaction at the vaccination site. It was unknown if the patient developed varicella or herpes zoster symptoms post vaccination. On 17-APR-2003 at 22 weeks gestation, an ultrasound revealed normal findings including BPD 5.4 cm and placenta anterior. Complications during pregnancy included gestational diabetes The gestational diabetes was treated with daily insulin 75/25 form 18/JUN/2003 to 11/Aug/2003 (18-JUN-2003 to 20/JUN/2003: 10 units BID; 20-JUN-2003 to 11-AUG-2003: 15/10 units). Infections during pregnancy included a left molar abscess. The left molar abscess was treated with "PEN U-K" 500 mg four times a day for seven days from 30-JUN-2003 to 07-JUL-2003 (28 doses taken). Starting in mid July 2003, bi weekly non stress tests were within normal limits. On 05-AUG-2003, a non-stress test was normal. On 11-AUG-2003, at 38 weeks and 5 days gestation, the patient gave birth a normal 8 pound , 0.5 ounce female infant. There were no complications during labor or delivery. There were no congenital anomalies, complications or abnormalities. There were no features of congenital varicella zoster syndrome.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received form a licensed visiting nurse concerning a 10 year old male with von  Willbrand's disease and a history of shingles (August 2002) who was vaccinated with a dose of varicella virus vaccine live. The LVN reported that in 2003 the patient developed chickenpox. It was unknown if medical attention was sought.  It was also reported that the patient's sister (WAES 0303USA01321) and three other children (WAES 0304USA01539, 0303USA01670 AND 0304USA01540) also developed chickenpox after being vaccinated with varicella virus vaccine live. Additional information has been requested.
Age: 3.75
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 45 month old female with no known drug allergies and no medical history who on 20FEB2001 was vaccinated in the thigh with a first dose of varicella virus vaccine live (lot 634479/0767K). There was no concomitant medication. There was no illness at the time of vaccination.  The registered nurse reported that on 17-MAR-2003 the patient was seen in the physician's office for a "mild case" of varicella. The reporter noted there were " a few lesions present" and the patient was afebrile. The reporter indicated that no diagnosti or laboratory tests had been ordered for the patient. The reporter stated the patient was exposed to several cases of varicella at school. Follow up information was received form the registered nurse which indicated that on 17-MAR-2003 the patient had a "mild case of possible chickenpox." It was noted that the patient recovered. Follow up information received form the registered nurse indicated that in March 2003 the patient had a mild case of chickenpox. No further information is expected. The reporter mentioned that "5 to 6" other children also had varicella following vaccination with varicella vaccine live (WAES 0304USA01500).
Age: 5.0
Sex: M
Vaccine: DPP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 5 year old male with allergies to amoxicillin, potatoes and okra who on 04/02/02, was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccinations on that same day included diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, MMRII, inactivated poliovirus vaccine. The RN reported that, on the morning of 03/18/03, the pt developed chickenpox. The pt visited the physician's office and the RN indicated that the case was mild characterized by two lesions on the pt's head and a couple lesions on his shoulders. The pt was also noted to be afebrile. The pt was treated with hydroxyzine HC1 (Atarax), 3/4 teaspoon three times daily. On 03/24/03, the pt recovered from the chickenpox. Additional information is not expected.
Age: 1.11
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 23 month old female pt with a history of "imperforated anus s/p reconstruction, 8/01" who on 04/09/02 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (Lot # 640823/1154L).  There was no illness at the time of vaccination.  Concomitant therapy on 04/09/02 included a SC first dose in the left thigh of MMRII (Lot # 640963/1379L) and an IM second dose in the right thigh of Haemophilus B conjugate vaccine + hepatitis B recombinant (yeast) vaccine (Lot # 639126/0348L).  On 03/12/2003, the pt developed a chickenpox rash, described as a papular-vesicular rash with 12 lesions total that were crusted over within 48 hours.  It was noted that the child was mildly pruritic, there was no fever and no other symptoms were noted.  There was no relevant diagnostic lab data.  It was also noted that she was not ill at the time, but was in the office with another sibling that was ill. Unspecified medical attention was sought. Subsequently, the pt recovered on 03/14/03.  There was no product quality complaint involved. The physician also reported on two other siblings that developed chickenpox (WAES # 0303USA02487 & WAES # 0303USA02488).  No further information is expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 25 month old female pt who on 01/25/02 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live (Lot # 640119/0965L). The health professional reported the pt "now has chickenpox". The reporter indicated the time of onset is questionable, but reports that sometime between 03/14/03 and 03/16/03 small raised areas were first noticed, and were thought to be insect bites. At an office visit on 03/19/03 the pt had 25 lesions on her trunk and face in various stages. The reporter indicated no other symptoms were noted. The health professional reported the chickenpox resolved, and no further information is available.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a RN concerning a 30 year old female pt who was vaccinated with a first dose of varicella virus vaccine live. The pt developed chickenpox within 16 days of receiving the varicella virus vaccine. It was noted that the severity of the outbreak and details were not available at the time of this report.  Unspecified medical attention was sought. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a RN concerning a 7 year old caucasian female pt who on 12/17/96 was vaccinated with a first dose of varicella virus vaccine live. Concomitant vaccination included a first dose of MMRII.  On 03/16/03, the pt developed a "breakthrough of chickenpox" that was also described as a generalized varicellular eruption. The pt had between 30 and 50 lesions scattered over her body including the scalp and genital area. The lesions were described as vesicles that were very itchy. A doctor visit was required and the pt was treated with acyclovir and hydroxyzine hydrochloride. The pt was seen on a follow up visit and all lesions were crusted over. It was noted that the pt would finish acyclovir and that she had recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a pt who in 1990 was vaccinated with a dose of varicella virus vaccine live and six months later developed "full blown varicella".  On approximately 03/18/03 (this past week) the pt developed "full blown varicella again".  It was unknown if medical attention was sought.  The physician also reported on another pt with a similar experience (WAES # 0303USA02378).  Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 14 year old "N" male student with a history of asthma but non since 1999 who on 02/27/03 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 644086/0974M).  It was reported that the pt received the vaccine because of a negative antibody titer. There was no illness at the time of the vaccination.  On 02/10/03 the pt was vaccinated with a dose of hepatitis B vaccine recombinant (manufacturer unknown) that was "given elsewhere" and on 02/19/03 the pt was vaccinated in the left arm with an adult dose of TD toxoid (Lot # 90820AA).  There were no other concomitant medications. The pt had no adverse events following prior vaccinations.  On 03/12/03 the pt was seen at a medical center ER with a "few/several" generalized varicella-like, vesicular lesions of his arms, face and trunk. It was reported that he was treated and released.  On 04/01/03, the pt was seen in follow up by a pediatrician. A varicella antibody titer was ordered and the reported noted that he had seen the report and that it "must be IgG (no IgM identified)-- the titer was positive (0.99)".  On 04/04/03 the pt recovered. No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Rash erythematous
Clinical narrative: Information has been received from a LPN concerning a 36 month old white male with an unknown medical history (previously reported as no medical history and no known drug allergies) and an unknown history of chickenpox who on 02/01/01 was vaccinated SC in the right lower thigh witha  first dose of varicella virus vaccine live (Lot # 9043905, invalid for this product). There was no concomitant medication. It was unknown if the pt was ill at the time of vaccination, had any adverse events following prior vaccinations, pt was ill at the time of vaccination, had any adverse events following prior vaccinations, or had a recent exposure to chickenpox or herpes zoster. It was unknown if the pt developed a rash at the injection site or elsewhere within 42 days after vaccination because the pt was not given the vaccination at the reporters' office. On 02/03/03 the pt was seen in the office for shingles. The date he started with symptoms was not available. The affected area was described as a fine, red rash with raised bumps under the right arm, right back and side and up to the right shoulder. Clear vesicles on an erythematous base were noted on the right upper back, right chest and right upper arm per dermatology. The pt had a temperature of 98.2 at the time of the office visit. The maximum temperature was unknown. It was noted that a direct fluorescent antibody and PCR was not done at the reporter's office. The pt's pain was rated an 9 on a scale of 1 to 10. That same day the pt was seen by a dermatolgoist who confirmed shingles and treated him with acyclovir and aceptaminophen prn. It was also reported that the pt had "probable" shingles. On 02/07/03 the pt was seen in the office for a non-related left ear infection with no mention on his chart of the shingles. On 03/24/03 it was reported that there had been no further contact from the pt's parent and it was unknown if he had been seen again by the dermatologist. On 05/06/03 information was received from a LPN that the pt had recovered on an unknown date. No further information is expected.