chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash pustular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old Caucasian male who on 13 JUL 1999 was vaccinated with the first dose of MMR in the right arm. On 13 JUL 1999, the patient was also vaccinated with the first dose of varicella virus vaccine live in the left arm. On 03 APR 2001, the patient developed fluid filled pustules (30) and a mild fever. The patient was treated with diphenhydramine HCl for itching. The patient was given acetaminophen for the fever. Subsequently, the patient recovered from the fluid filled pustules (30), mild fever and itching. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a consumer concerning her 12 month old son who on 04/16/01 was vaccinated with MMRII. It is unknown if other vaccines were administered on that day. On 04/21/01. the patient experienced a rash on his forehead and ears. It was describes as bumpy white dots that became red and then formed red dots. The rash later spread to his stomach. The child was seen by a doctor on 04/26/01 who thought it was vaccine related with slighty swollen glands. The child was seen by a dermatologist on 04/27/01 who thought it was a "morbilliform rash".  The dermatologist applied an unnamed corticosteroid" to the rash. On 04/29/01, the patient had a fever and, as of, 04/30/01, the fever continued and the glands were more swollen. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse practioner concerning a 12 month old Caucasian male with no known drug allergies who on 04/15/2001 was vaccinated with MMRII SC in the thigh that expired 02/28/2001. Concomitant vaccinations included Varivax, that was received SC in the thigh. The nurse practitioner reported "finding 2 occipital non-tender lymph nodes post vaccination". Unspecified medical attention was sought. In FOLLOW- UP, the nurse practioner reported that following the injection of the MMRII, she  realized that the vaccine was outdated, 2/01. She reported that at a subsequent clinic visit on 04/30/01, "two non-tender "shotty" occipitalm nodes were noted. The nurse practitioner reported that the patient did have a scalp injury from hitting head under coffee table about the same time that the mother noticed occipital nodes. The scalp area became somewhat inflamed and scabbed over and was healed by the 04/30/01 visit. Axillary and inguinal nodes were also "shotty". In FOLLOW-UP , the nurse practitioner reported that the patient had a scalp laceration at the time of vaccination. The nurse practitioner reported that the patient  had 2 non tender occipital nodes one week after vaccination with MMRII and Varivax. The patient recovered from his experience. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Pharyngitis, Pyrexia, Rash, Rhinitis
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old Hispanic male who on 03/15/01 was vaccinated with a first dose of MMRII. The patient was vaccinated SC in the left lateral thigh. No illness at time of vaccination was noted. The nurse noted the patient came to the doctor's office on 03/20/01 with cough and cold symptoms for a couple of days. The patient experienced rash, fever and cough (Other Medical Event). The patient was given antibiotics and cough medications. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Oedema, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old white male with no known allergies and no pertinent medical history who on 02/26/2001 was vaccinated SC in the right lateral thigh with a first dose of MMR II. There was no illness at the time of vaccination. On 03/27/2001, the pt experienced fever, cough, poor appetite, swollen tonsils and a slight rash. It was noted that the pt presented to the office with a several day history of the fever, cough and decreased appetite. No treatment was given. Subsequently, the pt recovered. No further info is available.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female with no known drug allergies who was vaccinated with MMR II IM instead of SC. This does not comply with the recommended route of administration. There was no concomitant medication. The pt remained at the clinic 20 minutes after the immunization and complained only of burning at the injection site. She had no other complaints. It is not known whether the pt sought medical attention. In follow up, the nurse reported that"this was not an adverse experience." The nurse further explained she called to inquire about the route of administration of MMR II. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Conjunctivitis, Cough, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old Asian male who on 04/03/01 was vaccinated with the first dose of MMR II SC in the left thigh. On 04/11/01, the pt experienced fever, cough x 2 days, rash to abdomen and conjunctivitis. The pt was treated with antibiotics, steroids and inhalers (not specified). Subsequently, the pt recovered. The registered nurse also reported on five other patients who had experiences following vaccination with MMR II (WAES01041191). Fever, cough x 2 days, rash to abdomen, and conjunctivitis were determined to be other important medical events. Additional info is not expected.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician's assistant concerning a 32 year old pregnant female who was vaccinated with MMR II "several years ago." Subsequently, the pt had a measles antibody titer in the last two weeks that was negative for measles antibodies. In follow-up, the physician's assistant reported that the pt informed her that her obstetrician found "no antibody response when screened for measles antibodies." The pt reported she has had "all the immunization." Unspecified medical attention was sought. No further info is expected.
Sex: U
Vaccine: MMR
Symptoms: Infection
Clinical narrative: Information has been received froma public health registered nurse who received a call from a school nurse concerning a sixsth grader who during the week of 05/07/01 was vaccinated with MMRII. Subsequently, 2 days later, in 05/2001, the patient was diagnosed with varicella. It was unknown whether the child ever received Varivax. Additional information has been requested.
Sex: U
Vaccine: MMR, RUB
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning an adult female patient who was vaccinated with two doses of either MMRII or rubella virus vaccine live (second generation) and failed to seroconvert. No adverse reactions were noted. FOLLOW-UP information received indicated that the "young woman" thought she vaccinated with one dose of MMRII, as a child. Approximately two year ago, in approximately 1999, she was vaccinated with one dose of rubella virus vaccine live (second generation) A rubella titer obtained should receive a third "rubella vaccine". She stated that she did not have any further vaccination information, including lot members, as the vaccines were not administered there. In addition, she stated that the patient's  sister had "the same problem" with her rubella vaccinations (WAES01081730). No further is available.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Chest pain, Injection site abscess, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from PharmD concerning a 42 year old female patient who on 04/20/01 was vaccinated IM with MMRII. On 04/22/01, the patient developed a possible abscess at the injection site accompanied by erythema and swelling at the injection site. Unspecified medical attention was sought. FOLLOW UP information has been received from a health care professional who states the employee started to complain of pain above the shoulder, not at the injection site. It was reported that the physician thinks that there could be sterile abscess and he does not think that this is an adverse event from the vaccine. He feels it is a problem with the injection itself. The employee is reportedly receiving hydrotherapy and physical therapy and complains of discomfort at night. FOLLOW UP information has been received from a health care provider who reports the patient had right arm, chest and shoulder aching starting on 04/15/01, previously reported as 04/22/01 There were no diagnostic tests done, but the patient received hydrotherapy and physical therapy and took NSAIDS. The recovery status was reported as unknown. FOLLOW-Up information has been received from a health professional who reports the patients did, in fact, receive the MMRII on 04/20/01. The patient has fully recovered.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Pain
Clinical narrative: Information has been received from PharmD concerning a 42 year old female patient who on 04/20/01 was vaccinated IM with MMRII. On 04/22/01, the patient developed a possible abscess at the injection site accompanied by erythema and swelling at the injection site. Unspecified medical attention was sought. FOLLOW UP information has been received from a health care professional who states the employee started to complain of pain above the shoulder, not at the injection site. It was reported that the physician thinks that there could be sterile abscess and he does not think that this is an adverse event from the vaccine. He feels it is a problem with the injection itself. The employee is reportedly receiving hydrotherapy and physical therapy and complains of discomfort at night. FOLLOW UP information has been received from a health care provider who reports the patient had right arm, chest and shoulder aching starting on 04/15/01, previously reported as 04/22/01 There were no diagnostic tests done, but the patient received hydrotherapy and physical therapy and took NSAIDS. The recovery status was reported as unknown. FOLLOW-Up information has been received from a health professional who reports the patients did, in fact, receive the MMRII on 04/20/01. The patient has fully recovered.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 month old female who 05/04/01 was vaccinated with a first dose of MMRII in the left leg. There was no illness at the time of vaccination. The licensed practical nurse reported that on 05/18/01, the patient presented to the office with an erythematous maculo-papular rash on her face, back and legs, which "blanches with pressure, 1-4 mm diameter". The patient was treated with diphenhydramine hydrochloride, (Benadryl). The patient recovered from her experience. No further information is available.
Age: 15.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Lymphadenopathy, Malaise, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female who in March 2001, was vaccinated with the first dose of MMR II.  Concomitant vaccination the same day included the first dose of hepatitis b vaccine, recombinant (Engerix B). Four days after the first vaccinations, the pt was inadvertently vaccinated with a second dose of MMR II and a second dose of hepatitis b vaccine, recombinant (Engerix B). This does not comply with the recommended dosage schedule. Within a week of the second doses, the pt developed a measles-like rash, fever and swollen glands. "Two months later" on 05/23/2001, it was reported that the pt still had swollen glands and did not feel well. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received on 05/23/2001 from a registered nurse concerning four patients between the ages of 15 and 18 months of age who about three weeks ago on approximately 05/01/2001 were vaccinated with one dose of MMR II (lot 637431/0026L). Seven to eighteen days later, the four patients reported to the emergency room, one with a high fever and the four also developed a generalized rash. It was also reported that one other pt, vaccinated from the same lot developed a low grade fever (WAES01072621). It was reported that all of the children are "doing fine now" and were recovered. The records of testing prior to release of this lot have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a mother regarding her 17 year old male, with an allergy to eggs, who on 03/03/98 was vaccinated with a second dose of MMR II. In approximately June 1998, the pt experienced seizures. In follow-up, the primary care physician's office assistant reported that the pt was vaccinated at another physician's office. The child was seen on 01/30/98 and 05/11/98 according to the office records. Additional info has been requested. Upon internal review, seizures are considered as other important medical event.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Angioneurotic oedema, Contusion, Pyrexia, Rash, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 12 month old female pt with no known allergies and no past vaccination who on 05/16/2001 was vaccinated with MMR II. Concomitant vaccine therapy included varicella virus vaccine live and poliovirus vaccine (IPOL). There as no other concomitant medication. On 05/24/2001 the pt's mother called the office because of a mild rash and a fever in the child. On 05/25/2001, the pt was seen in the office. Her temperature at the time of the visit was 99.3 and the rash was described as an extensive urticaria type rash on face and trunk. The pt's mother reported that the rash began around the umbilicus and spread across the torso then the extremities as scattered maculopapular erythematous areas which became confluent. On her legs, the urticaria was described more as angioedema. None of the rash blistered, it did not resemble measles and it was not chicken pox. It was noted that over the 6-8 hrs before the appointment, the rash continued to extend and bruising developed in some areas. Her temperature was 102.1 and she was irritable. The physician recommended cool compresses and ibuprofen and the pt was sent to the ER. A urine culture by catheterization came back negative for any infection and the CBC showed a slightly elevated white count of 11.9 with a normal hemoglobin and platelet count. The chest x-ray was suggestive of bronchial wall thickening, but there was no pulmonary complaints or involvement. On 05/26/2001 the pt was seen again in the physician's office. Her temperature was 100 and her mother remained concerned about the swelling of the lower extremities. It was noted that the pt had a probable angioedema of the lower extremities as well as some bruising around the buttocks and back. The physician prescribed Atarax about 5mg every 6 hrs. On 05/27/01 she had another follow-up appointment. The pt's mother was concerned about a temperature of 103 on the previous night. At the office visit it was 101. It was reported that the rash on the legs had started to improve but new lesions formed on the scalp and around the nose and mouth. Some bruising was still evident. A quick strep test was done and was negative. The pt's dose of Atarax was increased to 7.5mg QID. As of 05/29/2001, the pt's temperature had settled back to baseline and her urticaria also responded nicely. Skin bruising was still noted. The pt was instructed to continue the Atarax as prescribed for the following 48 hours. It was noted that the pt had "almost completely recovered." Follow-up info received from a physician reported that the rash had completely resolved. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a health professional concerning a 12 month old female pt with no known allergies and no past vaccination who on 05/16/2001 was vaccinated with MMR II. Concomitant vaccine therapy included varicella virus vaccine live and poliovirus vaccine (IPOL). There as no other concomitant medication. On 05/24/2001 the pt's mother called the office because of a mild rash and a fever in the child. On 05/25/2001, the pt was seen in the office. Her temperature at the time of the visit was 99.3 and the rash was described as an extensive urticaria type rash on face and trunk. The pt's mother reported that the rash began around the umbilicus and spread across the torso then the extremities as scattered maculopapular erythematous areas which became confluent. On her legs, the urticaria was described more as angioedema. None of the rash blistered, it did not resemble measles and it was not chicken pox. It was noted that over the 6-8 hrs before the appointment, the rash continued to extend and bruising developed in some areas. Her temperature was 102.1 and she was irritable. The physician recommended cool compresses and ibuprofen and the pt was sent to the ER. A urine culture by catheterization came back negative for any infection and the CBC showed a slightly elevated white count of 11.9 with a normal hemoglobin and platelet count. The chest x-ray was suggestive of bronchial wall thickening, but there was no pulmonary complaints or involvement. On 05/26/2001 the pt was seen again in the physician's office. Her temperature was 100 and her mother remained concerned about the swelling of the lower extremities. It was noted that the pt had a probable angioedema of the lower extremities as well as some bruising around the buttocks and back. The physician prescribed Atarax about 5mg every 6 hrs. On 05/27/01 she had another follow-up appointment. The pt's mother was concerned about a temperature of 103 on the previous night. At the office visit it was 101. It was reported that the rash on the legs had started to improve but new lesions formed on the scalp and around the nose and mouth. Some bruising was still evident. A quick strep test was done and was negative. The pt's dose of Atarax was increased to 7.5mg QID. As of 05/29/2001, the pt's temperature had settled back to baseline and her urticaria also responded nicely. Skin bruising was still noted. The pt was instructed to continue the Atarax as prescribed for the following 48 hours. It was noted that the pt had "almost completely recovered." Follow-up info received from a physician reported that the rash had completely resolved. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no past medical history who on 05/23/2001 was vaccinated on the right with a first dose of MMR II (lot 633822/1168K). Concomitant vaccinations on 05/23/01 included a third dose on the left of Haemophilus B conjugate vaccine (lot 474701). There were no illnesses at the time of vaccination. On 05/26/2001 the pt experienced a rash and fever lasting 10 days. The pt was seen by a physician who felt the fever and rash were consistent with a measles-like reaction. The pt is recovered. No further info is available.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Blood amylase increased, Face oedema, Parotitis
Clinical narrative: Information has been received from a physician concerning a 15 month old Caucasian female who on 05/15/2001 was vaccinated with the first dose of MMR II (lot 637431/0026L) IM. At the time of vaccination the child was status post resection of peripheral nerve "sweat" tumor in the abdomen. On 05/31/01, the pt presented to the physician with facial swelling over the parotid area, but no fever. The physician had the pt follow-up with a gastrointestinal physician. The pt was found to have acute amylase elevation, with amylase level of 490. With the facial swelling and amylase elevation, the physician "is diagnosing this as parotitis, possibly associated with MMR II." the pt was treated with Augmentin. On 06/06/01, the "facial swelling was going down." On follow-up, the physician reported that on 06/06/01 the pt recovered from the parotitis and the increased amylase level. Additional info has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning an 18 year old female who on 11/02/83 and 09/14/94 was vaccinated with the first and second dose of MMR II, respectively (lot not available) A Rubella IgM test, done on 06/06/01 was 0.22. This was considered to be a negative titer. The pt sought unspecified medical attention. Upon follow-up, it was reported that the pt was "not exposed to disease." The physical exam for nursing school required a rubella titer. Because the titer "came back non-immune," despite having had two doses of MMR II, it was reported that the physician advised "another rubella vaccine, which was given on 07/12/01." No further info is expected.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 40 year old female with systemic lupus erythematosus, goiter, and no known allergies. The reporter stated that she "thinks" the pt was vaccinated with one dose of MMR II, on an unspecified date. Concomitant medications include Plaquenil, Celebrex, Acetaminophen and Codeine phosphate, and Ferrous Sulfate. Titer drawn was positive for Rubeola antibodies, but negative for mumps or rubella. The pt sought unspecified medical attention. Office manager states the vaccine was not given at that location, and that further vaccination info is not known. Upon follow-up, it was reported that the reporter originally called to ask a question about this pt with lupus erythematosus and that she did not administer the vaccine. No further info is available.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male with no known allergies who in 1992 was vaccinated with MMR II (dosage and lot number not provided). In 1991, 10-14 days post-vaccination, the pt developed a rash all over his body and fever. At that time, the pt had sought medical attention. Subsequently, the pt recovered from his symptoms. In June 2001, the 12 yea old male pediatric pt needs a second MMR II vaccination and the registered nurse inquired as to whether the child will experience the same events. Additional info has been requested.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26 year old male pt who was vaccinated with MMR II in the past. Subsequently, the pt is not immune to mumps. Unspecified medical attention was sought. In follow-up the nurse reported, "there was no adverse reaction." The nurse reported the pt had the MMR II as a child. She reported the titer revealed that he was " immune to measles, rubella but not mumps and the pt needed to be re-immunized." No further info is available.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Injection site rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 month old male, with past medical history of 10 week premature birth/"delayed milestones" and constipation at the time of vaccination, who on 06/01/01 was vaccinated with a first dose of MMR II (lot 635598/1659J), administered SC, in the left arm. Immediately, at 11:50 AM on 06/01/01, the pt developed a "dime-sized" hive at the injection site. The pt was medicated with 1 teaspoon of Benadryl, at that time. At 12:00noon that same day, 2 hives were noted on his face. The pt was medicated with epinephrine (manuf unknown) and dexamethosone. By 12:30 PM, that same day, the hive on his arm was still present, but the "rash on his face was gone." It was reported that the pt recovered on 06/01/01. No further info is available.
Sex: M
Vaccine: MMR
Symptoms: Thrombocytopenic purpura
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with MMRII..Subsequently 7-10 days after immunization, the patient experienced idoipathic thrombocytopenic purpura. It was noted that he never went for his second dose. Upon internal review, the patient's thrombocytopenic purpura was considered to be an Other Important Medical Event. FOLLOW-UP Information was received and indicated that the patient had recovered from the experience. No further information is available.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on an unspecified date "thought she was vaccinated" with MMRII. The patient reported this in an employee screening. Labs for rubella and rubeola show "equivocal and negative titers". No adverse symptoms were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 18 year old Caucasian female who on 9/17/92 and 8/12/97 was vaccinated with the first and second dose of MMR II, respectively. On 6/2/00 a rubella IgG tet was performed and results showed that the "antibody levels were in the quivocal range for this assay may be insufficient to protect against clinical illness upon exposure to rubella virus." The pt sought unspecified medical attention. It was noted that on 7/11/01 the pt received a third dose  (lot 634420/0012L), subcutaneously. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old Caucasian female patient who on 07/10/01 was vaccinated with the first dose of MMRII, administered in the right leg. Concomitant therapy, that day, included the first dose of Varivax, administered in the left leg,and the  fourth dose of IPV administered in the left leg. It was reported that the MMRII and Varivax were reconstituted with Hemophilus B conjugate vaccine (+) Hepatitis B Vaccine recombinant (yeast), instead of the saline diluent. The physician stated that the error occurred as a result of "human error"on the part of the nurse. The vaccinations were administered at two different sites. On 07/10/01, it was reported that the patient "now has a temperature of 100.4 deg F". The patient sought unspecified medical attention. On an unspecified date, the fever resolved, with no further problems. Measles, Mumps and Rubella titers were all reported to be positive. It was noted that the patient is "immune". No further information is available.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 month old male with asthma, eczema, and eggs allergy with anaphylactic reactions and a history of allergic rashes who on 07/12/01 was  vaccinated with the first dose  of MMRII, SC in the right arm. this does not comply with the recommended dosage. concomitant therapy included albuterol. there was no illness at the time of vaccination. It was reported that within 10 minutes (also reported as 30 minutes) of vaccination the child developed hives "everywhere"but no wheezing. There was no reaction at the site of injection. it was noted that the patient had a history of asthma and many allergic reactions. The patient responded to diphenhydramine HC(Benadryl). It was also reported that on 05/05/01, the patient received the first dose of Varivax  SC in the left arm and had no adverse reactions. FOLLOW-UP information, reported that the physician "administered 0.1 cc of the vaccine because the mother thought the child might be allergic to MMRII, although the child received a previous dose of Varivax without complications". No further information is expected.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 5 year old Caucasian patient who in approximately 1997 was vaccinated with the first dose of MMRII. Immediately following the vaccination, the patient developed a fever which lasted for seven days. The patient sought medical attention. It was reported that the patient recovered. FOLLOW-UP information noted that the physician did not have any details about the episode since the physician did not have the patient at the time. It was also noted that the patient did receive a second dose of MMRII and that there were no adverse events reported. No further information is available.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Polyarthritis
Clinical narrative: Information has been received from an RN and a 35 year old white female RN with no known drug allergies and a history of a miscarriage at 10 weeks on 5/25/01 who on 5/31/01 was vaccinated with MMRII. An RN in a physician's office reported that the pt was vaccinated with either lot 633092/0175K (expiration 1/02) or lot 636975/1281K (expiration 8/02); she was not sure which the pt received. Concomitant therapy included vitamins (unspecified). Prior therapy included globulin, immune (RHOGAM) on 5/25/01. The pt reported that on 6/22/01, she began to experience arthralgia of her wrists, hands, feet, ankles and knees, for which she sought medical attention. On 7/6/01, the pt's physician prescribed methylprednisolone (Medrol Dosepak), which was followed by therapy with decreasing doses of prednisone. Follow-up information has been received and indicated that the pt suffered from severe symmetrical polyarthritis. The symptoms resolved within 2 to 3 weeks of treatment with prednisone. No further information is available.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Information has been received from an RN concerning a 16 month old white female with a history of premature birth at 34 4/7 weeks and no known drug allergies who on 7/20/01, in the morning, was vaccinated, IM, in the right thigh, with a 2nd dose of MMRII (lot 633597/1657J). There was no concomitant medication. It was reported that on 4/13/01, at 13 months of age, the pt was vaccinated with the 1st dose. This does not comply with the recommended administration schedule. There was no adverse event reported. Follow-up information from an RN indicated that the pt was seen on 7/23/01 with a low-grade fever, a rash on her trunk and occasional loose stool. On 7/27/01, it was reported that "the rash left in a few days as well as the loose stool". The nurse stated that there was "no untoward effect from the 16 month injection noted". She also indicated that the child had a well baby visit at 18 months and "received appropriate 18 month immunizations". No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an RN regarding a pt who was vaccinated with MMRII. The nurse reported that a consumer told her that the pt, a friend's child, subsequently, had "problems". Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning 2, 15 month old pts, who on 4/3/01 were vaccinated with MMRII (lot 639491/0600L). The RN reported that shortly after the vaccination, the pts experienced a fever of 104F. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received on 5/23/01 from an RN concerning a pt between the age of 15 and 18 months of age who about 3 weeks ago, on approx. 5/1/01, was vaccinated with 1 dose of MMRII (lot 637431/0026L) and in the early part of 5/01 received 1 dose of varicella virus vaccine live (lot 636368/1341K). Seven to eighteen days later, the pt reported to the ER with a low-grade fever (previously reported as high fever). It was also reported that 4 other children, vaccinated from the same lot of MMRII, and developed similar symptoms (WAES01072621). It was reported that all of the children are "doing fine now" and were recovered. The records of testing prior to release of this lot (637431/0026L) have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 1.7
Sex: U
Vaccine: DTAP, MMR
Symptoms: Blister, Hypersensitivity, Pyrexia
Clinical narrative: Information has been received concerning a 20 month old pt who on 5/24/01 was vaccinated, SC, in the right thigh with a 1st dose of MMRII (lot D024L-invalid lot). Concomitant therapy included a 4th dose, IM, in the left thigh of (Acel-Imune). There was no other concomitant medication. There was no illnesses at the time of vaccination. On 5/24/01, the pt experienced fever of 101F and 2 "nickel-sized" blisters at both injection sites. The outcome status is unknown. Follow-up information has been received from a health professional who reports the reaction was from the band aid applied after the injection, not from the vaccine. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information was received on 7/10/01 from an RN concerning a child (demographics unknown) who was recently vaccinated with a dose of MMRII. Subsequently, the child developed a "post vaccine fever and rash". There was no further information provided. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from an NP concerning a 26 year old female pt with no known allergies who on 7/9/01 was vaccinated with MMRII, SC (lot 637433/0149L). Concomitant therapy included Hep-B, IM (lot 637981/0283L). On 7/12/01, the pt developed a low-grade temperature (99.5F) and swelling and heat at the site of injection. On approx. 7/14/01, 2-3 days, the low-grade temperature, swelling and heat at the injection site resolved. No additional information is expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 5 year old male child who in approx. 1998 was vaccinated with a 0.5ml 1st dose of MMRII. Immediately, post vax, the pt experienced a histamine reaction. No other information was available. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Initial and follow-up information has been received from an LPN concerning a 5 year old Caucasian female pt who on 7/16/01, at 14:45, was vaccinated, IM, in the right thigh (also reported as the left thigh) with the 2nd dose of MMRII (lot 636662/0019L). On 7/18/01, the pt was seen by a physician for an injection site erythema (11 X 7cm) and injection site pain (symptoms began sometime in the evening on 7/17/01). It was reported that the pt was treated with amoxicillin trihydrate (+) clavulanate potassium (Augmentin) (400/5ml bid for 10 days) and that on 7/20/01, the symptoms improved. The pt subsequently recovered. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a male (demographics unknown) who on 8/2/01 was vaccinated with 1 dose of MMRII, in the left thigh (lot 637834/0696L). On 8/6/01, the pt experienced injection site reaction and was reported to be seeing the doctor, at the time of report. Reporter stated she would call with additional information. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a male (demographics unknown) who on 7/30/01 was vaccinated with 1 dose of MMRII, in the right thigh (lot 637834/0696L). On 8/2/01, the pt was seen in the physician's office for injection site swelling 5" X 4" and injection site erythema 2 1/2" in diameter. It was reported that the pt was treated with cephalexin (Keflex) 250mg/5 ml tid. On 8/4/01, he was seen by the physician again, for increased redness. The regimen of Keflex was continued. Additional information has been requested.
Age: 1.75
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Irritability
Clinical narrative: Information has been received from an MT concerning a 21 month old male with no known allergies, who had not received vaccinations at the recommended times and/or interval. The child is frequently sick at the scheduled times of vaccination. The 3rd Hib-Titer was given in 3/01, the 1st Hep-B (Engerix) was given at 16 months, the 4th DPT (Infanrix) was 2 months late and the 3rd poliovirus (IPOL) was 2 months late. The MT plans to administer the MMRII on 8/9/01, if the child keeps the appointment. Follow-up information from the MT noted that on 8/24/01, the child was vaccinated with the 1st dose of MMRII (lot 637834/0696L), 0.5ml, SC, in the left arm. Concomitant therapy that same day included a dose of varicella virus vaccine live, 0.5ml, SC, in the right arm (lot 638246/0494L), the 1st dose of HIB, 0.5ml IM, in the left vastus lateralis (lot 638434/1639K) (it was reported that the pt had previously had 3 doses of HIB and 2 doses of Hep-B), the 5th dose (also reported as 4th dose) DPT (Infanrix), 0.5ml, IM, in the vastus lateralis (lot DTPa505A2) and the 4th dose of poliovirus vaccine (IPOL), 0.5ml, IM, in the left vastus lateralis (lot T12732). The MT reported that the child was "a little fussy" the next day. The child's mother reported that the child was "a little fussy" but that it was nothing that she was concerned about. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a pharmacist concerning an adult male who was vaccinated with MMRII. Subsequently, the pt failed to sero-convert for rubella. No other information was provided. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Pain
Clinical narrative: Information has been received from a pharmacy employee concerning a 45 year old Caucasian female pt with no known drug allergies, environmental allergies and a peanut allergy who in approx. 5/01 was vaccinated in the left arm with MMRII (lot 634420/0012L). There was no concomitant medication. A pharmacy employee reported that 3 weeks, post vax, the pt developed swollen hands. Subsequently, her hands became painful to the extent she couldn't life a gallon of milk and her pain was sporadic. She was treated with nabumetone (Relafen) without relief. The pharmacy employee noted that the pt was to see a rheumatologist in the near future. At the time of this report, the pt was starting therapy with celecoxib (Celebrex). Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Rash
Clinical narrative: Information has been received from a company representative concerning her 15 month old son with a history "significant for ear infections" who on 8/9/01 was vaccinated with the 1st dose of MMRII (lot 637834/0696L), administered in the left thigh. On 8/15/01, the pt developed a rash on his abdomen and legs. It was also reported that he "seemed to be tired and much quieter at school today". In addition, it was reported that the pt's vaccinations "are all current". Follow-up information, from the physician, was received on 9/7/01. It was noted that "the only side effect to my knowledge was a rash". Subsequently, the pt recovered. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 17 to 18 year old female with no known drug allergies who on 6/28/85 was vaccinated with the 1st dose of MMRII. There was no concomitant medication. On 8/20/01, it was reported that a recent titer did not detect sero-conversion to rubella. The pt sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from an RPh concerning a pt (demographics unknown) with asthma and some antibiotic allergies who was vaccinated with a dose of MMRII. Concomitant therapy included an unspecified "inhaled steroid". Subsequently, the pt had an unspecified reaction to MMRII. The pt sought unspecified medical attention. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from an RN concerning a 26 year old Caucasian female with no past medical history who "many years ago probably as a child" was vaccinated with a dose of MMRII. On 8/16/01, the pt had a negative rubella titer IgG AB. The pt sought unspecified medical attention. Follow-up information reported that the pt on 8/27/01, received a 3rd dose of MMR (638832/1874K) in the right arm. No further information is expected.
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a male who on the week of 08/20/01 was vaccinated with MMR II. On 08/24/01, it was reported that the vaccinee's wife developed a tiny red rash on her abdomen and chest and that she is pregnant. The pt sought unspecified medical attention.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Dyskinesia
Clinical narrative: Information has been received from an RN concerning a 15 month old Caucasian female child with no known drug allergies and no past medical history who on 8/16/01 was vaccinated SC in the left arm with the 1st dose (lot 639617/0739L) of MMRII. Concomitant therapy on 8/16/01 included the 3rd dose (lot 639122/0484L), IM in the right thigh of HIB. There were no other concomitant therapies or illnesses at the time of vaccination. On 8/24/01, the pt's mother called the physician's office and reported that on 8/22/01, the child "began to have head jerking episodes" as though she was nodding her head "no". It was noted that the episodes lasted just a few seconds but occurred every few hours. The episodes decreased in number and the child had only 1 episode on 8/24/01. No other symptoms were reported. It was noted that the pt had no other reactions to other immunizations. No medical attention was sought. It was reported that the pt recovered. No further information is available.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from an RN concerning a 22 year old male with no past medical history and no known drug allergies who on 7/30/80 and 7/90 was vaccinated with the 1st and 2nd dose of MMRII. There was no concomitant medication. On 8/27/01, it was reported that recent titers done for work were found to have no antibodies for mumps and measles. The pt sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no known drug allergies who on 5/16/97 was vaccinated with a dose of MMRII. There was no concomitant medication. On approx. 5/26/97, 10 days post vax, the pt developed a fever of 105F and a rash. The pt sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Injection site reaction, Urticaria
Clinical narrative: Information has been received from an RN from an allergy practice concerning a young female child with a severe egg white allergy, who had a history of an ER admission in the past and a less severe episode with an epinephrine therapy who was vaccinated with a 1:100 dose of MMRII, intradermally. There was no reaction in a scratch test, however, there was a very large immediate reaction (about a 50 cent piece side wheal) at intradermal injection. The pt sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from an RN concerning a 5 year old female with no known allergies and who recently has a physical for special education on 8/28/01 was vaccinated with a dose of MMRII. Concomitant therapy included multi-vitamins and supplements. On 8/29/01, the pt's mother reported that her "child broke out in rash on her chest". There were no other symptoms reported (no fever, no cough, no lethargy and no swelling). The pt sought unspecified medical attention. Follow-up information from the reporter stated that the adverse event was unlikely vaccine related. The reporter spoke with the mother again and the child was improving. It was reported that the pt recovered. No further information in expected.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from an NP concerning a 44 year old female pt with no known allergies and no significant past medical history who on 8/21/01 was vaccinated with a dose of MMRII (lot 638599/0598L). Concomitant therapy included calcium (unspecified) and multivitamins (unspecified). On 8/26/01, between 04:00 and 06:00, the pt developed a rash characterized by welts and hives from the neck down. It was noted that there were no welts on her face. The pt took Benadryl and reported that the welts went away. During the nights of 9/3/01 and 9/4/01, the rash appeared again. Once again, the pt took Benadryl and the rash remitted. It was noted that the pt was experiencing fewer patches with each reaction and that the rash was decreasing in severity each time it appeared and that the welts were getting smaller. The pt reported that she had changed nothing in her habits. Unspecified medical attention was sought. No further information was available. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an 8 year old female with no known drug allergies who in approx. 8/01 was vaccinated with a dose of MMRII. Concomitant therapy included fluticasone propionate (Flovent). A day after vaccination, the pt presented to the physician's office with an injection site reaction that was red and swollen. It was noted that the pt was afebrile. No other symptoms were reported. No further information was available. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 38 year old white female with no past medical history or allergies who on 8/27/01 was vaccinated with the 1st dose of MMRII, IM left arm (lot 632765/1308K). There was no known illness at the time of vaccination. On 8/29/01, (previously reported as starting on 9/8/01), the pt experienced hard, red and sore lump 1/2" diameter, at the injection site. It was noted that the pain radiated from the injection site down to elbow and was painful anytime the arm was flexed. The pt was evaluated by a physician on 9/12/01. The pt recovered on 9/30/01. Additional information is not expected.