chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a consumer concerning his wife who was vaccinated with Hepatitis A virus vaccine inactivated. The reporter stated, "that his wife experienced many adverse reactions similar to those listed in the PI (product Insert)". Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Eye disorder
Clinical narrative: Information has been received from a physician's assistant concerning a 20 year old male,  who was vaccinated with Hepatitis A virus vaccine inactivated 20 years ago. Subsequently, the patient started blinking the next day and continues to do so. The patient sought unspecified medical attention. Additional information has been requested. The reporter also reported on the patient's niece WEAS # 00120970.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 6 year old male patient who on 01/22/01 was vaccinated in the left arm with a 1st dose of Hepatitis A virus vaccine inactivated. There was no concomitant medications. On 01/22/01, the patient developed a 4 to 5 inch long and 2 to 3 inch wide area of redness at the site of the injection, the site was warm to touch, and the area was "pruritic". On 01/25/01, the patient returned to the physician's office. Additional details regarding the outcome of the patient's experiences were not reported. additional information is not expected.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Oral intake reduced, Pyrexia, Vomiting
Clinical narrative: Information has been received from an RN concerning a 4 year old white male with no known drug allergies who on 3/1/01 was vaccinated IM with Hep-A virus vaccine inactivated in his left thigh. There was no concomitant medication. On 3/5/01, the pt began vomiting. On 3/8/01, the pt ran a fever of 103F for 24 hours, with the highest fever reaching 104F. The pt had no fluid or food intake during this time period. On 3/8/01, the pt went to the ER and was given IV fluids only and sent home. The pt's symptoms resolved in 2 days and he recovered on 3/10/01. Upon internal review, the pt's fever of 103F was determined to be an "Other Medical Event". No further details were provided.
Age: 3.0
Sex: U
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Dermatitis contact, Rash
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Age: 3.0
Sex: U
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Hypotonia, Screaming, Stupor
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Age: 3.0
Sex: U
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Depressed level of consciousness, Hypotonia, Stupor
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Age: 3.0
Sex: U
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Hypotonia
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Age: 3.0
Sex: U
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypotonia, Hypoventilation, Screaming, Somnolence
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Age: 3.0
Sex: U
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Hypotonia, Stupor
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Age: 3.0
Sex: U
Vaccine: HEPA, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Coma
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who on approximately 03/19/01 was vaccinated with Hepatitis A vaccine inactivated. On approximately 03/20/01, the patient developed a fine (slight bumps) non-pruritic rash above and below the site of the injection. The rash appeared within 36 hours post injection and "now" lasted into day four post injection. The reporting physician did not feel that this was a hypersensitivity reaction to the vaccine, but she thought it was most likely a contact dermatitis to the alcohol swab. As of 03/23/01, the patient had no other symptoms. The patient sought unspecified medical attention. No further information is available.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 14 month old male child who was vaccinated with a 1st MMR live. Seven days post vaccination, the patient had a seizure. Upon internal review, seizure was considered to be an Other Medical Event. It was noted that the patient was "subsequently seizure free". The patient's sibling (WAES #99091863) had an adverse experience following exposure to MMR vaccine.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Laboratory test abnormal, Rheumatoid arthritis
Clinical narrative: Information has been received from a lawyer concerning a female who in 1991 was vaccinated with MMRII. The pt feels that the MMRII vaccine "gave her arthritis". No further information was provided. On 8/8/91, 21 days, post vax, she had hip pain, pain and swelling of the fingers that persisted and involved knees. On 8/23/91, RF test +40; ANA-neg. Over the next 2 years, polyarthritis was dx'd as rheumatoid arthritis by MD and treated extensively. On 1/10/84, her serum rubella antibody was positive and her RF was negative.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a professional representative concerning a pt who was vaccinate with varicella vax. Subsequently, the pt died. The cause of death is unknown. It was noted that the professional representative relayed this information, which was provided to her by a physicians office. The office did not have an adverse event or a particular pt. The office said they "just heard it somewhere". No further information is available. Follow up information was received on May 16,2001 from a professional representative who stated the name of the doctor involved with this report. this was the same doctor who reported the information for WAES98011537. It has been dtermined that WAES00071374 is a duplicate WAES98011537. Therefore WAES00071374 is being deleted from our files and the reports consolidated into WAES98011537.
Sex: F
Vaccine: MMR, TD
Symptoms: Myasthenic syndrome, Paraesthesia, Pyrexia, Tenosynovitis
Clinical narrative: Information has been received from a physician concerning a female who on 7/14/99, was vaccinated with MMRII. Concomitant therapy that same day, included a DT and a PPD skin test. On 7/14/99, the night of the vaccination, the pt experienced high fever and numbness in her right hand. The numbness had persisted "off and on" since the injection. The pt sought medical attention. In follow-up information received from the physician, it was noted that in 10/00, the pt's numbness and weakness had abated, however, a medical consultation was arranged. In 11/00, carpal tunnel syndrome was dx'd. The physician stated that the pt's experiences were "due to carpal tunnel syndrome and there was no connection to MMRII vaccine. "The pt's symptoms persisted." Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site reaction, Pain
Clinical narrative: On 2/25/01 the pt developed blisters on the front and upper left thigh, a possible herpes zoster breakout. It was also reported that a rash did not occur at the site of injection post vax. The child had no fever or complaints of itching, however, the child's mother reports that when changing the child's clothes or "pull-ups" the child appears to experienced discomfort. The pt was seen in the physician's office on 2/26/01 and also had a blistered back reported as lesions in groups of 10-15 vesicles distributed from the first, second, and third vertebrae region. A scraping was done and sent to a laboratory. On 2/27/01 the mother contacted the physician office to report that the affected area was getting larger. The child had no other symptoms.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Urticaria
Clinical narrative: The pt developed pos on his legs and abdomen with no fever. Treated with Benadryl before bed. By the next day, the pt had hives from the tip of is head to his toes. The pt experienced generalized urticaria. The pt subsequently recovered from the urticaria. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Haemolysis, Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 5 year old Asian Female patient with no known allergies or significant past medical history who on 03/16/00, was vaccinated with a 1st dose of Varicella virus vaccine live. Concomitant vaccinations on 03/16/00 included a 1st dose IM of Haemophilus B Conjugate vaccine (HibTiter). It was also noted that on 03/03/00, the patient received a 5th dose IM of Diphtheria Toxoid (+) Pertussis vaccine (+) Tetanus Toxoid (Acel-Imune) and a 4th dose SC of Poliovirus vaccine (IPOL). There were no illnesses at the time of vaccination. On 03/16/00, approximately 2-3 hours post Varicella virus vaccine live vaccination, the patient developed urticaria-like skin rashes and itching. It was reported that the skin rashes were "all over the patient's body surface which comes and goes". There was no respiratory difficulty or fever/cough. The patient was seen in the ER and administered IM diphenhydramine hydrochloride (Benadryl), followed by PRN doses q6 po. On 03/17/00, the patient was seen in the ER and given ranitidine (Zantac) to control the rash. Lab tests were performed on 03/18/00. The results are as follows: WBC 7600, Hemoglobin 13.6, Hematocrit 39%, Platelet Count 280,000, Bun 12, Creatinine 0.5, Neutrophil Count 80 %, Lymphocyte Count 18%, Monocyte Count 2%, and a urinalysis was negative. The physician considered the patient's experience to be an Other Medical Event as she required medical intervention. On 03/20/00, the patient recovered. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic reaction, Blood pressure decreased, Bradycardia, Diarrhoea, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 12 month old African American female pt with a history of osteomyelitis treated with clindamycin. It was noted that the pt has an allergy to clindamycin; she developed an allergic rash. On 4/1/00 at 12:30, the pt was vaccinated IM in the left thigh with a 1st dose of MMRII (lot 634038/1713J) and a 1st dose IM in the right thigh of varicella virus vaccine live (MSD) (lot 632384/1728J). Immediately, post vax, the pt developed anaphylaxis. She was swollen with vomiting and diarrhea and then went into shock. She was given epinephrine and sent immediately to the ER. The reporter felt that the pt's experience was life threatening. Follow-up information from a physician reported that approx. 10 minutes, post vax, the pt developed severe edema, vomiting, diarrhea and "lifelessness". It was noted that the pt's "pulse and respiratory rate remained strong but that she appeared to be in shock". The pt was rushed across the street to the ER after being administered epinephrine in the physician's office and treated with Solu-Medrol 20mg IV and Benadryl 12.5mg IV. The dx made by the ER physician was "acute allergic reaction". At 16:12, on 4/1/00, the pt was discharged to home with her mother. The pt's status is recovered. Additional follow-up information from the pt's physician reported that she experienced urticaria, vomiting, "decreased blood pressure" and "decreased pulses" with complete weakness occurring 5 minutes, post vax. The pt was administered 0.1cc of epinephrine (Adrenalin) and was taken to the ER where she was treated with steroids, Benadryl and IV fluids.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Shock, Swelling, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 month old African American female pt with a history of osteomyelitis treated with clindamycin. It was noted that the pt has an allergy to clindamycin; she developed an allergic rash. On 4/1/00 at 12:30, the pt was vaccinated IM in the left thigh with a 1st dose of MMRII (lot 634038/1713J) and a 1st dose IM in the right thigh of varicella virus vaccine live (MSD) (lot 632384/1728J). Immediately, post vax, the pt developed anaphylaxis. She was swollen with vomiting and diarrhea and then went into shock. She was given epinephrine and sent immediately to the ER. The reporter felt that the pt's experience was life threatening. Follow-up information from a physician reported that approx. 10 minutes, post vax, the pt developed severe edema, vomiting, diarrhea and "lifelessness". It was noted that the pt's "pulse and respiratory rate remained strong but that she appeared to be in shock". The pt was rushed across the street to the ER after being administered epinephrine in the physician's office and treated with Solu-Medrol 20mg IV and Benadryl 12.5mg IV. The dx made by the ER physician was "acute allergic reaction". At 16:12, on 4/1/00, the pt was discharged to home with her mother. The pt's status is recovered. Additional follow-up information from the pt's physician reported that she experienced urticaria, vomiting, "decreased blood pressure" and "decreased pulses" with complete weakness occurring 5 minutes, post vax. The pt was administered 0.1cc of epinephrine (Adrenalin) and was taken to the ER where she was treated with steroids, Benadryl and IV fluids.
Age: 5.0
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Arthralgia
Clinical narrative: Artharalgia -information has been received from a health care professional concerning a 5 yr old Caucasian male who 15-APR-2000 was vaccinated with the second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) (second generation). Concomitant vaccinations included injectable poliovirus vaccine and diphtheria (+) tetanus (+) acellular pertussis. On 24-APR-2000 the pt developed arthralgias.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Feeling hot, Injection site swelling, Pruritus, Sluggishness
Clinical narrative: Information has been received from an RN concerning a 22 year old female pt who on 3/28/00 was vaccinated SC in the left upper arm with a 2nd dose of MMRII (631046/0546J). There were no concomitant medications, past medical history or illnesses at time of vaccination reported. On 4/4/00, the pt experienced a 3cm-4cm circular raised pruritic area at the injection site. She also complained of feeling hot and sluggish. It was noted that the pt was afebrile. The pt's symptoms resolved with application of hydrocortisone cream by 4/5/00. No further information is available.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Flushing, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 33 year old female who on 3/15/00 was vaccinated SC with a 2nd doses of MMRII (lot 631046/0546J). There were no concomitant medications and no significant pas medical history. On 4/3/00, the pt developed an approx. 4-5cm circular nodule at the site of injection. The area was tender to even or light palpations, erythematous and warm to the touch that extended an additional 2-3cm beyond the nodule. The pt also complained about being flushed but was afebrile. The pt was treated with Augmentin and Motrin. The nodule was noted as decreasing in size on 4/10/00 down to 2cm. On an unspecified date, the pt recovered. No further information is available.
Age: 15.0
Sex: M
Vaccine: MMR, TD
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: Information has been received from an RN concerning a 15 year old Caucasian male student who on 4/5/00 was vaccinated SC, in the right arm, with a 2nd dose of MMRII (lot 633705/1660J). Concomitant therapy included 1 dose IM, in the left arm, of DT (lot U0010AA). The reporter stated that on 4/5/00, immediately, after receiving the MMRII, the pt experienced mild light-headedness, clamminess and nausea. The pt was instructed "to lie on back with cold compress applied to forehead". The reporter noted no injection site reactions. His pulse and BP were monitored. The pt sought unspecified medical attention. The symptoms lasted 5-10 minutes. On 4/5/00, the pt recovered from his experience. Also reported, was a female (WAES 00040978) and a 16 year old male (WAES 00052679) who were vaccinated and experienced similar events. No further information is available.
Age: 18.0
Sex: F
Vaccine: MMR, TD
Symptoms: Dizziness, Nausea
Clinical narrative: Info has been received from a woman in a Dr's office concerning an 18 year old white female student who was vaccinated with one dose of measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) (lot #1660J). 10 to 15 minutes post vaccination, the pt experienced light-headedness and nausea. The reporter noted no injection site reactions. The pt sought unspecified medical attention. Follow up info received on 25-MAY-2000 from a physician indicated that on 04-APR-2000 the pt was vaccinated with a second dose of measles virus vaccine live and mumps virus vaccine live and rubella virus vaccine live (second generation) (lot #1660J) SC in the right arm. On the same day she received one dose of diphtheria toxoid and tetanus toxoid IM in the left arm. Immediately post vaccination the pt experienced lightheadedness and nausea times 10-15 minutes. The pt was instructed to lie on her back with feet elevated and cold compress was applied to forehead. The report noted that the pt's pulse and blood pressure were monitored. On 04-Apr-2000, the pt recovered.
Age: 16.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: Info has been received from a Dr concerning a 16 yr old white male student who on 04/04/2000 was vaccinated with the second dose of MMRII SC in the right arm. Other vaccinations that day included the first dose of hepatitis B IM in the left arm, and other vaccinations, date unspecified included one dose of DT IM in the left arm. Immediately post vaccination with the MMRII the pt became lightheaded. The reporter noted that the pt was cold and skin was clammy. It was also reported the pt experienced nausea. The pt was instructed to lie on back and cold compress was applied to neck and face. The reporter noted no injection site reactions. The pt's pulse and blood pressure was monitored. Sx lasted 10 minutes. ON 04/04/2000, the pt recovered. The pt sought unspecified medical attention. No further info is expected.
Age: 22.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Erythema, Feeling hot, Infection, Urticaria
Clinical narrative: Uritcaria, warm sensation, rain, skin erythema - Information has been received from a registered nurse concerning a 32 year old male patient with allergies to bee stings and penicillin who on 04 Apr 2000 at 11:30 was vaccinated sc with one dose of varicella virus vaccine live. There were no concomitant medications. On 04 Apr 2000 by 22:00 the patient developed a nickel size welt. it was reported that as of 07 Apr 2000 the patient has a 6 inch wide hand going around the arm. It was noted the the band is hot, red and sore. The patient is febrile. Unspecified medical attention was sought.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Headache, Herpes zoster, Infection, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 44 month old son who on 1/29/98 was vaccinated in the right arm with a 1st dose of varicella virus vaccine live (lot 622970/0538E). On 4/12/00, the pt developed shingles. On 4/15/00, the pt sought unspecified medical attention and was dx'd with shingles. The pt was treated with Tylenol. Follow-up information from a physician reported that there were no illnesses at the time of vaccination or any medical conditions. The pt was seen in the office on 4/15/00 and treated "conservatively". It was noted that the pt also developed a headache, stomach ache and fever for 2-3 days and then improvement. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from an RN concerning a 12 month old male pt who on 3/29/00 was vaccinated SC in the left arm with a 1st dose of MMRII (lot 634036/1711J). Concomitant therapy included a 1st dose SC in the right arm of varicella virus vaccine (MSD) (lot 632616/1688J) and a 4th dose IM in the right leg of Haemophilus B conjugate vaccine (HIBTITTER) (lot 469386). It was noted that there was no past medical history and no illnesses at the time of vaccination. On 4/6/00, the pt experienced fever, rhinorrhea and fussiness. He was seen in the physician's office on 4/7/00 for his symptoms. On 4/8/00, the pt was examined in the ER for a temperature of 104.9F. Upon internal review, temperature of 104.9F was determined to be an "Other Medical Event". On an unspecified date, the pt recovered.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform, Rhinorrhoea, Tonsillitis, White blood cell count increased
Clinical narrative: Information has been received from an RN concerning a 12 month old male pt with right otitis media who on 3/30/00 was vaccinated SC in the left arm with a 1st dose of MMRII (lot 634036/1711J). Concomitant therapy included a 1st dose SC in the right arm of varicella virus vaccine live (MSD) (lot 632626/1688J), a 4th dose IM in the right leg of Haemophilus B conjugate vaccine (HIBTITTER) (lot 469356) and amoxicillin. On 4/6/00, the pt developed a fever of 105.9F (rectal), systemic morbilliform rash and rhinorrhea. Upon internal review, fever of 105.9F was determined to be an "Other Medical Event". On 4/7/00, it was noted that the pt also had mild tonsillar exudate. The pt was seen in ER on 4/7/00. The amoxicillin was discontinued and the pt was administered 1 dose of Rocephin and sent home. He was followed up in the physician's office on 4/8/00 and 4/12/00. It was noted that the otitis media as well as the "vaccine reaction" are resolving. The reported expressed a concern with the lot. It was reported that another pt (WAES00040817) had a similar experience following exposure to MMRII. Follow-up information from an RN reported that on an unspecified date, the pt recovered from his experiences.
Age: 3.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from an LPN concerning a 7 year old female with allergies to penicillin and Ceclor who on 3/8/96 was vaccinated with 1 dose of varicella virus vaccine live. There was no concomitant medication. On 5/5/00, the pt experienced breakthrough chickenpox with many itchy lesions that "lasted the full 7 days". She experienced fever the first 3-4 days. Medical attention was sought. The pt's bother also experienced chickenpox following vaccination with varicella virus vaccine live. (WAES 00051748). No further information is available.
Age: 2.7
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 6 year old male pt who on 10/3/96 was vaccinated with varicella virus vaccine live. On 5/2/00, the pt developed chickenpox "upon exposure". Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from an RN concerning a 22 year old female pt who on 4/12/00 was vaccinated in the left arm with a 1st dose of varicella virus vaccine live (lot 632057/1450J). There were no illnesses at the time of vaccination and no past medical history. On 4/23/00, the pt developed "5 hive-like rash". On 4/26/00, the pt presented with 5 large red itchy hives resembling mosquito bites. Follow-up information reported that on an unspecified date the pt recovered.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 7 year old female pt who on 6/1/98 was vaccinated with varicella virus vaccine live. On 5/15/00, the pt was seen by a physician and dx'd with chickenpox described as "several (6) small vesicles on her face and trunk. There was no treatment." Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Otitis media, Pityriasis rosea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old Black female with no past medical history who on 5/12/00 was vaccinated in the right thigh with a 1st dose of MMRII (lot 633598/1659J). Concomitant therapy on 5/12/00 included a 1st dose, in the left thigh, of varicella virus vaccine live (MSD) (lot 632612/1851J). It was noted that there were no illnesses at the time of vaccination. On 5/15/00, the pt developed a non-vesicular, papular rash at the MMRII injection site that spread all over her body, sparing her face, palms and soles. She also experienced a fever of 102F. It reportedly progressed into pityriasis rosea. As the rash was progressing, the pt was being treated for a suspected otitis media with Augmentin. It was reported that the pt "seems to have improved". No treatment was prescribed for the rosea. Follow-up information from a physician reported that on 5/15/00, the pt was dx'd as having acute otitis media. Additionally, it was noted that on an unspecified date, the pt recovered.
Age: 1.25
Sex: F
Vaccine: IPV, MMR, VARCEL, IPV, MMR, VARCEL
Symptoms: Cough, Dyspnoea, Laryngitis, Vaccine positive rechallenge, Wheezing
Clinical narrative: Information has been received from a physician concerning a 14 month old female who on 5/11/00 was vaccinated in the right thigh with the 1st dose of varicella virus vaccine live (lot 632614/1687J). Concomitant therapy included the 1st dose of MMRII (lot 633011/1275J) in the left thigh and a 3rd dose of injectable poliovirus vaccine in the left deltoid. On 5/11/00, the pt developed wheezing and a "croup-like" illness. The pt was treated with prednisolone (Prelone) and the condition resolved within 3 days. Additionally, it was noted that the pt had previously, on 10/28/99, experienced a similar reaction after vaccination with Hep-B virus vaccine, recombinant (MSD) (WAES00063265). No further information is expected.
Age: 1.25
Sex: F
Vaccine: IPV, MMR, VARCEL, IPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Information has been received from a physician concerning a 14 month old female who on 5/11/00 was vaccinated in the right thigh with the 1st dose of varicella virus vaccine live (lot 632614/1687J). Concomitant therapy included the 1st dose of MMRII (lot 633011/1275J) in the left thigh and a 3rd dose of injectable poliovirus vaccine in the left deltoid. On 5/11/00, the pt developed wheezing and a "croup-like" illness. The pt was treated with prednisolone (Prelone) and the condition resolved within 3 days. Additionally, it was noted that the pt had previously, on 10/28/99, experienced a similar reaction after vaccination with Hep-B virus vaccine, recombinant (MSD) (WAES00063265). No further information is expected.
Age: 4.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Erythema multiforme, Oedema peripheral, Swelling face, Urticaria
Clinical narrative: Approximately 36 hours post vax, in the evening of 06/11/2000, the patient experienced an urticarial rash including some right ankle swelling that progressed to include an erythema multiforme rash on his trunk. He also had lip, hand and foot swelling. By the 9th day, he was much improved with a dose of Prelone syrup. Subsequently, the patient recovered. The physician also reported 4 other patients who developed hives after being vaccinated with varicella virus vaccine live. Additional information is not expected.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Oral intake reduced, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 month old Philippine male with no past medical history who on 5/4/00 was vaccinated SC with the 1st dose of varicella virus vaccine live, in the left upper arm (lot 632612/1851J). There was no concomitant therapy. On 5/26/00 or 5/30/00, the pt developed generalized varicella lesions and fever of 102F. It was noted that on 5/30/00, the pt developed a decreased appetite for several days. Medical attention was sought. On 6/5/00, the pt was fully recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a company representative concerning a patient who was vaccinated with one dose of Varicella virus vaccine live. Subsequently, the patient died. The cause of death was unknown. No further information is expected.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Injection site rash, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from an RN concerning a 12 month old Caucasian male pt with no known medical history who on 5/30/00 at 10:30AM was vaccinated SC, via the right vastus lateralis, with a 1st dose of varicella virus vaccine live (632620/1619J). Concomitant vaccinations that same day included a 1st dose of MMRII, SC, via the left vastus lateralis and a 3rd dose of Hib conj-Hep-B vaccine (MSD) (633692/0526K) given IM, via the right vastus lateralis. Approx. 1 week, post vax, the pt experienced on intermittent rash and fever. "The rash started at the injection site on right right thigh, then went to the other thigh and has been reappearing on other parts of the body since. The rash is mostly on the front park of the body, including the face and arms. At this point, the rash is abating. Mother is an RN and is concerned about the reappearance of this rash." Follow-up information from the RN indicated that "the rash appeared first around the site of injection (right thigh), on approx. 6/6/00, 1 week after giving the varicella virus vaccine live. It appeared to be that of  a red raised bump, the appearance of varicella. It did not crust over or have any pustules. The rash seemed to disappear or lessen and then reappear at a different site or location on the body. The rash occurred over a 3 week period of time. The rash spread from the right leg to the left leg which was raised bumps too numerous to count. Later, the rash went to the arms, face and trunk areas. This rash was of a few red bumps only, it was of a countable number. The child's temperature for the 3 week period of time was between 99F and 100F. On 6/11/00, when the pt was assessed at the clinic, a fine rash was noted to touch on both legs. The rash had no redness and was not scabbed over. It was stated by the pt's father that the pt appeared to be better. No treatment was given." Follow-up information from the RN indicated that the child's rash resolved on approx. 7/25/00. It was reported that the child has not had any reoccurrence with a rash since. No further information is expected.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Erythema, Oedema peripheral, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on April 17, 2000 was vaccinated with varicella virus vaccine live intramuscular in the right thigh (lot # 632610/1654J). On April 17, 2000 the patient was also vaccinated with streptococcus pneumonia vaccine (Prevnar) intramuscularly in the left thigh (lot# 471-207). On April 18, 2000 (also reported as April 19, 2000) the patient developed a red, papular rash over her entire body with increased lesions noted around both vaccine sites. She also developed red and swollen feet. The events were treated with diohenhydramine (Benadryl). Subsequently the patien recovered from the events. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEP, MMR, OPV
Symptoms: Infection, Pyrexia, Tremor
Clinical narrative: Fever; Tremor - Information has been received from the parent of a 5 year old male who on 02 Sep 1999 was vaccinated with the second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot# 671370/0371J.  On 02 Sep 1999 the patient was also vaccinated with the third dose of hepatitis b vaccine recombinant yeast manufacturer unknown.  the third dose of poliovirus vaccine orimune given orally and the first dose of diphtheria toxoid (+) tetanus toxoid given IM.  In the early morning of 03 Sep 1999, the patient developed a fever of 103 degrees f. and trembling all over his body.  the symptoms lasted all day until the evening.  subsequently, the patient recovered, no further details were provided.  Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Crying, Infection, Irritability, Pyrexia
Clinical narrative: Fever, Crying - Information has been received from wyath-ayerst for diphtheria toxoid/pertussia vaccine / tetanus acel-imune and was assigned manufacturer report number h01058214Feb2000.  On 09 Fed 2000 a 15 month old female was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rebella virus vaccine live second generation lot 531771/1030J Im in the right thigh.  Conromitant therapy included fourth dose of diphtheria toxoid pertussis vaccine tetanus acel-imune Im in the left thigh.  On 10 Feb 2000 the patient experienced fever and fussiness.  Subsequently, the patient recovered.  This information was originally reported by a medical assistant.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, UNK
Symptoms: Pyrexia
Clinical narrative: Fever - Information has been received for Wyeth Ayerst for Prevnar and assigned manufacturer control number HQ1898320Apr 2000.  The report concerned a 12 month old patient who on 11 Apr 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation Im in right thigh lot 634132/1739J.  Concomitant therapy included streptococcus pneumonies vaccine Im in right thing administrered on 11 Apr 2000.   Other concomitant therapy included hib conjugate vaccine Hibtiter Im in left thigh and poliovirus vaccine IPOL SQ in left thigh.  On 17 Apr 2000 the patient developed a fever of 102 to 103 degree F.  The patient was treated with ibuprofen Motrin and acetaminophen Tylenol.  Sebsequently, the patient recovered from fever,  the reproter felt the fever was related to streptococcus vaciine.  This information was originally reported by a physician.  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HIBV, IPV, MMR, PNC, HIBV, IPV, MMR, UNK
Symptoms: Infection, Pyrexia
Clinical narrative: Fever - Information has been received for Wyeth Ayerst for Prevnar and assigned manufacturer control number HQ1898320Apr 2000.  The report concerned a 12 month old patient who on 11 Apr 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation Im in right thigh lot 634132/1739J.  Concomitant therapy included streptococcus pneumonies vaccine Im in right thing administrered on 11 Apr 2000.   Other concomitant therapy included hib conjugate vaccine Hibtiter Im in left thigh and poliovirus vaccine IPOL SQ in left thigh.  On 17 Apr 2000 the patient developed a fever of 102 to 103 degree F.  The patient was treated with ibuprofen Motrin and acetaminophen Tylenol.  Sebsequently, the patient recovered from fever,  the reproter felt the fever was related to streptococcus vaciine.  This information was originally reported by a physician.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: On 08/02/2000 the patient experienced cellulitis in the left thigh. The patient was seen by a physician. The patient recovered on 08/05/2000. No further information is available.
Age: 1.2
Sex: M
Vaccine: HIBV, MMR
Symptoms: Crying, Pyrexia, Rash
Clinical narrative: Information has been received from an RN concerning a 14 month old Caucasian male pt with no medical history or allergies who on 8/3/00 was vaccinated SC, in the right thigh, with a 1st dose of MMRII (lot 630102/0125J). Concomitant vaccinations that same day included a 4th dose of Haemophilus B conjugate vaccine (lot 450253A) given IM, via the left thigh. There was no illness at the time of vaccination. On 8/6/00, at 23:30, the pt woke up crying with a fever of 103F. The pt's mother gave Motrin. It was reported that the cried until 06:00. The next morning, the child went to the doctor and he gave the pt Motrin and indicated that there was nothing wrong. The pt's fever resolved on 8/8/00. Follow-up information from the RN indicated that on 8/7/00, the pt was seen by the physician and he reported that the fever was a reaction to MMRII and prescribed Motrin prn for an elevated temperature. The pt's mother reported the pt's temperature to be normal on 8/8/00. On 8/13/00, the pt developed a generalized fine red rash. The pt was seen by the physician who indicated that the rash was a typical adverse reaction to the MMRII. Subsequently, on 8/17/00, it was reported that the rash was gone and the pt recovered. No further problems were noted. It was also reported that the pt's sibling (WAES 00091389) had a similar reaction to Haemophilus B conjugate vaccine. No further information is expected.
Age: 0.9
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 12-month-0ld Caucasian male with a history of tear duct problems (one is very small) status post eye surgery, eustachian tubes, sinus wash, allergies to zithromax (sever abdominal pain) and amoxicillin (Amoxil) (Severe diarrhea with hospitalization one time).  The patient also has a past medical history of Lactose and Fructose intolerance until he was 9 months old and "lots of diarrhea" from which he was noted to be doing better.  He has seen an allergist and had no allergies documented.  On 30-Jun-2000, the patient was seen in the physician's office and was noted to be a well child.  On 30-Jun-2000 the patient was vaccinated with the first dose of varicella virus vaccine live SC in the right thigh (Lot # 632617/0083K).  Concomitant therapy on 30-Jun-2000 included the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD) SC in the left thigh (lot #629269/15023).  Hemoglobin was 12.2 on 30-Jun-2000.  On 09-Jul-2000 the patient developed a low grade fever.  On 10-Jul-2000 the patient developed approximately ten typical chicken pox spots which was described as blister type pox shots.  Later, 4-5 additional spots were noted.  The patient ran a fever for about three days.  The spots healed after two weeks.  On the 27-Jul-2000, it was noted that the patient had 10 spots and some of the spots were scabbed over.  The patient is considered recovered.  Medical attention was sought.  On 10-Jul-2000 the patient's mother had called the physician to report the symptoms and to get advice because on 10-Jul-2000, while having lesions, the patient came in contact with a patient (WAES# 00072611) who was reported to have experienced similar events.  Also reported was a patient (WAES# 00100930) who was exposed to the patient (WAES# 00072611) and developed similar events.  No further information is expected.
Age: 3.9
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received form a RN concerning a 6 year male pt who on 23-JAN-1998 was vaccinated SC with a first dose of varicella virus vaccine live (lot #0802E). On 24-JUL-2000 the pt developed a moderate case of chicken pox with a moderate number of lesions. The pt was seen in emergency room. The pt's brother (WAES #00081753) has a similar experience following exposure to varicella virus vaccine live. The pt was seen 09-Aug-2000, and that the pt recovered.
Age: 5.0
Sex: M
Vaccine: DTP, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male patient who on 20- Jan-1998 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 623647 / 0802E). Concomitant vaccinations that same day included a second dose of measles-mumps-rubella vaccine (MSD) (lot number unknown) given SC, a fourth dose of poliovirus vaccine, oral (Lederle lot# 0767H) and a first dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # 827A2) given IM.  Subsequently on 06- Aug - 2000 the patient developed a moderate case of chicken pox and was seen in an emergency room.  It was reported that the patient presented to the doctor's office on 09-Aug-2000 with a moderate case of chicken pox day three or rash.  The patient's brother (WAES #00081647) has a similar experience following exposure to varicella virus vaccine live.  Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash erythematous
Clinical narrative: The pt experienced red raised lesions on arms, legs, trunk and face. No fever was noted. The pt was treated with camphor, diphenhydramine hydrochloride, zinc oxide. The pt was given Benadryl twice but did not continue because it made the pt drowsy. The pt recovered.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Injection site erythema, Injection site swelling
Clinical narrative: On 09-SEP-2000 the pt developed a varicella-like rash at the injection site (one lesion) and one lesion on her back.  There was some redness and mild swelling at the injection site. The pt took po Benadryl for itching and the symptoms resolved after 4 days.
Age: 2.25
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 27 month old male with a history of febrile seizure in conjunction with otitis media several months previously who on 17-AUG-2000 was vaccinated with one dose of varicella virus vaccine live (Lot #1863J). On 17-AUG-2000 the pt was vaccinated with streptococcus pneumoniae vaccine (Prevnar) (Lot #471-203). On 18-AUG-2000 the pt experienced hives over lower extremities which progressed to generalized hives over the entire body by 19-AUG-2000. It was noted not sick in the past several months. On no meds. No recent change in diet, no new pets. There was no mucous membrane involvement at the time of the report.  Medical attention was sought. Follow up info from the Dr indicated that the pt developed generalized welts on 18-AUG-2000. The pt recovered within 4 days. The Dr indicated a possible relationship between this event and varicella virus vaccine live.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash, Rash papular, Urticaria, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old Caucasian female with a penicillin allergy who on 7/11/00 was vaccinated in the right anterior left thigh with the 1st dose of varicella virus vaccine live (lot 635205/0073K). Concomitant therapy included injection in the left anterior left thigh with the 2nd dose of Prevnar (lot 471228). On 7/11/0, at the time of the immunization, she had a papular rash (site unspecified), which the vaccine provider considered to represent "possible early Coxsackle". On 7/25/00, the pt developed hives on her hands, arms, forehead, legs and around her ears. The outcome of the pt's hives was unknown. Additional information has been received from a health care provider who reports the pt got hives transiently for 2 to 3 weeks that was thought to be post viral exanthema. The report indicated that, when treated with Benadryl, the hives cleared. No further information is available.