chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Rash, Rash morbilliform
Clinical narrative: Information has been received from a pharmacist concerning her 18 month old daughter who in approximately 1991 was vaccinated with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). In approximately 1991, when the pt received the vaccine, she developed a measles like rash on the trunk of her body. The rash was limited to the upper portion of her body. Unspecified medical attention was sought. Subsequently, the pt recovered. At the time of the report, on 06MAY2003, the pt was 13 years old and noted to be otherwise healthy. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anaphylactic reaction, Cough, Cyanosis, Face oedema, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an 18 month old male patient, who uses albuterol nebulizer PRN for asthma and with a possible milk sensitivity, who on 4/13/03 was vaccinated with a dose of MMR. Concomitant therapy on 4/13/03 included a dose of varicella virus vaccine live. On 4/13/03, shortly after the patient received the vaccines, he experienced an anaphylactic reaction. The patient developed sneezing, coughing, vomiting, hives, facial edema and turned purple. The patient was taken to the emergency room and was admitted overnight and then discharged. Therapy included IV diphenhydramine and dexamethasone sodium phosphate. The patient was seen by an allergist, who was consulted while the patient was in the hospital, on 4/24/03 and was OK. The reporter indicated that the physician is planning on doing allergy testing on both vaccines in order to determine which vaccine the child is allergic to in the near future. The reporter did not have vaccination records for the lots of the vaccines. It was noted that the patient was first seen by the allergist on 5/6/02 due to a rash that developed around his mouth after drinking Enfamil. The child's prick test was positive and the child was switched to a soy formula at that time. Subsequently, the patient recovered from anaphylactic reaction. It was reported that the patient's experiences were considered to be immediately life-threatening and disabling. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Medication error, Sneezing, Urticaria, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 month old male patient, who uses albuterol nebulizer PRN for asthma and with a possible milk sensitivity, who on 4/13/03 was vaccinated with a dose of MMR. Concomitant therapy on 4/13/03 included a dose of varicella virus vaccine live. On 4/13/03, shortly after the patient received the vaccines, he experienced an anaphylactic reaction. The patient developed sneezing, coughing, vomiting, hives, facial edema and turned purple. The patient was taken to the emergency room and was admitted overnight and then discharged. Therapy included IV diphenhydramine and dexamethasone sodium phosphate. The patient was seen by an allergist, who was consulted while the patient was in the hospital, on 4/24/03 and was OK. The reporter indicated that the physician is planning on doing allergy testing on both vaccines in order to determine which vaccine the child is allergic to in the near future. The reporter did not have vaccination records for the lots of the vaccines. It was noted that the patient was first seen by the allergist on 5/6/02 due to a rash that developed around his mouth after drinking Enfamil. The child's prick test was positive and the child was switched to a soy formula at that time. Subsequently, the patient recovered from anaphylactic reaction. It was reported that the patient's experiences were considered to be immediately life-threatening and disabling. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a NP concerning a pt (age and gender not reported) who had an "MMRII titer drawn which was reported as low". The pt was vaccinated with a booster dose of MMRII (Lot # not reported). Subsequently, the pt had the "MMRII titer redrawn and it was still low".  The NP also reported that another pt had an adverse event following vaccination with MMRII (WAES # 0305USA00049) and another pt had a low titer after receiving the MMRII (WAES # 0305USA00716).  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a NP concerning a female pt who had an "MMRII IgG antibody titer drawn on 02/04/03 which was 0.84." On 02/26/03 the pt was vaccinated with a booster dose of MMRII (Lot # 641881/0772M).  On 04/29/03 the "pt's MMRII IgG antibody titer was redrawn and it was only 0.90."  The NP reported that she planned on giving the pt another booster. The NP also reported that another pt had a low titer after receiving the MMRII (WAES # 0305USA00715).  She also reported that another pt had an adverse experience after receiving the MMRII vaccine (WAES # 0305USA00049).  Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Pharyngolaryngeal pain, Pyrexia, Rhinitis, Viral infection
Clinical narrative: Information has been received from a RN concerning a 17 year old male who was vaccinated with two doses of MMRII (manufacturer unknown).  The pt was exposed to an imported case of measles from a classmate while at school. Subsequently, the pt developed measles. He developed a sore throat, cough, coryza, and fever on 04/03/03.  On 04/05/03, the pt developed a rash and was seen at the pediatrician's office. The pt was again seen at the pediatrician's office on 04/06/03 and then at the local hospital ER. The pt tested positive for measles IgM and IgG on 04/11/03.  Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Screaming
Clinical narrative: Information has been received from a mother of a male child, with no prior medical history, who in approximately 2000, almost 4 years ago as reported on 05/07/03, was vaccinated with a dose of MMRII. There was no concomitant medication. Immediately post vaccination, the pt developed a fever of 103F and was screaming/crying uncontrollably. The pt was taken to the ER and given Demerol to calm him down. It was noted that the pt was never admitted to the hospital. The pt was taken to the MD the following day for follow up. At that time of the report, on 05/07/03, the pt was 4 years old. No outcome was reported. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received form a MA concerning a 13 month old female who on 05/07/03 was vaccinated with a dose of MMRII (Lot # 640790/1378L). Concomitant vaccination on 05/07/03 included a dose of varicella virus vaccine live. On 05/07/03, within minutes after vaccination, the pt developed a red area approximately 2 inches in diameter at injection site on the right thigh. Unspecified medical attention was sought. No treatment was required. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health RN concerning a female pt who in 1003 was vaccinated with 2 doses of MMRII. It was noted that the pt received a MMRII "series" in 1978.  It was also reported that the pt never had a record of the MMRII being given. In 11/02, the pt had titers drawn. It was reported that the pt seroconverted for measles and rubella, the results were "high" and the pt had immunity. It was also reported that the pt had immunity to chickenpox. The pt did not have immunity to mumps; the result was 0.67, which is low according to the reporter (anything less and .9).  Unspecified medical attention was sought. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: MMR, PNC
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from a LPN concerning a 15 month old male pt with no medical history, no illness at time of vaccine and no adverse events following prior vaccination. On 05/06/03 the pt was vaccinated with a dose of MMRII (Lot # 644507/1038M). Secondary suspect medication included vaccination on the same day, 05/06/03 with a dose of Prevnar. Subsequently the pt developed a red rash and itching. Unspecified medical attention was sought. The pt was treated with comfort measures including anti itch medication and Tylenol. It was reported that the pt was scheduled to be seen in the office on 05/09/03.  Follow up information reported that the nurse stated that as of 05/14/03 the pt had not been seen in the office for follow up. The nurse noted that she assumed that the pt had recovered from the events, as she had not heard back from the parents. The nurse asked if this lot # has had similar adverse reactions reported. Follow up information received from the LPN reported that "Upon further investigation, this was a reaction to the Prevnar vaccine." It was also reported that the pt had recovered. Further follow up information was obtained from the nurse. She reported that the pt had received MMRII and Prevnar on the same day. She reported that the child had been seen in the office and the rash that the child had on his leg (also reported as red rash) was "definitely a reaction to Prevnar and not MMRII".  The records of testing prior to release of this lot have been check by compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that two other children had developed a red rash and itching and one of those children had also developed a fever (WAES # 0305USA01564 & 0305USA01563).  No further information is available.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Injection site swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a LPN concerning a 5 year old male pt with no medical history, no illness at time of vaccination and no adverse events following prior vaccinations, who on 05/06/03 at 3:45PM was vaccinated with a second dose of MMRII (Lot # 644507/1038M) (Lot # also reported as not documented). It was initially reported that subsequently the pt developed a red rash, itching and a fever. Follow up information reported that on 05/07/03 the pt developed a "red rash with itching and bumps at injection site." Unspecified medical attention was sought. The pt was treated with comfort measures included anti itch medication and Tylenol.  There were no relevant diagnostic tests or lab data reported. It was reported that the pt was scheduled to be seen in the office on 05/09/03. Follow up information reported that the nurse stated that as of 05/14/03 the pt had not been seen in the office for follow up. The nurse reported that she assumed that the pt had recovered from the events, as she had not heard back from the parents. The nurse asked if this lot # has had similar adverse reactions reported. Further follow up information noted that the pt had recovered.  The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that two other children had developed a red rash and itching (WAES @ 0305USA01205 & 0305USA01564).  No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pain, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a LPN concerning a 5 year old male pt with no medical history or allergies, who on 05/06/03 at 10:00AM was vaccinated SC in the right arm with a second dose of MMRII (Lot # 644507/1038M). Concomitant therapy that same day, at that same time, included a fifth dose of DTAP (Infanrix, Lot # 586A9) given IM in the left arm and a fourth dose of IPV (Lot # W0704) given SC in the left arm. There was no illness at the time of vaccination.  Subsequently the pt developed a red rash and itching.  Unspecified medical attention was sought. No diagnostic or lab tests were performed.  The pt was treated with comfort measures included anti itch medication and Tylenol.  It was reported that the pt was scheduled to be seen in the office on 05/14/03. Follow up information reported that the nurse stated that as of 05/14/03 the pt had not been seen in the office for follow up. The nurse reported that she assumed that the pt had recovered from the events, as she had not heard back from the parents. The nurse asked if this lot # has had similar adverse reactions reported.  The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that two other children had developed a red rash and itching (WAES @ 0305USA01205 & 0305USA01564). Follow up information from the nurse indicated that on 05/09/03 the pt developed "soreness" red rash with itching at injection site." It was reported that there were no known adverse events for the pt or a sibling following prior vaccinations. It was reported that the pt recovered, date not provided. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Drug ineffective, Lymphadenopathy, Otitis media, Parathyroid disorder, Parotid gland enlargement
Clinical narrative: Information has been received from a consumer and a physician concerning a 4 year old white female patient with a history of a severe febrile reaction to Haemophilus B conjugate vaccine (ActHIB) on 23SEP1998 (also reported as 28SEP2003) and who was well at the time of vaccination. On 06MAY2003 (reported as 03MAY2003 by consumer) the patient was vaccinated with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). The patient received the first dose on 18NOV1999. Secondary suspect therapy included vaccination in the other arm on the same day with a dose of diphtheria toxoid + pertussis vaccine + tetanus toxoid (manufacturer unknown). There were no other concomitant medications. On 16MAY2003 the consumer reported that her daughter was just diagnosed with mumps. Follow up information from the physician noted that the child was seen in the office on 16MAY2003 for massive swelling of her left parathyroid and submandibular glands which the physician stated looked like mumps. He reported that the child was not treated with anything and that he did not draw titers. Additional follow up information from the physician from the physician noted that the patient developed classical parotid and submandibular mumps and the onset date was reported as 16MAY2003 (also reported as 12 days after immunization). Follow up information from the consumer reported that the child did not have a fever, which the consumer stated was "after effects from the DPT shot." The consumer reported that her daughter had lost 8 pounds and had just started to get out of bed on 27MAY2003. On 29MAY2003 the child was seen in the physician's office for bilateral cervical adenopathy which the physician thought was related to a mild ear infection. On 29MAY2003 the physician reported that the patient had recovered from the mumps. The outcomes of the ear infection, weight decreased and fever were unknown. The consumer questioned if the measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) was somehow contaminated. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTP, MMR
Symptoms: Pyrexia, Viral infection, Weight decreased
Clinical narrative: Information has been received from a consumer and a physician concerning a 4 year old white female patient with a history of a severe febrile reaction to Haemophilus B conjugate vaccine (ActHIB) on 23SEP1998 (also reported as 28SEP2003) and who was well at the time of vaccination. On 06MAY2003 (reported as 03MAY2003 by consumer) the patient was vaccinated with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). The patient received the first dose on 18NOV1999. Secondary suspect therapy included vaccination in the other arm on the same day with a dose of diphtheria toxoid + pertussis vaccine + tetanus toxoid (manufacturer unknown). There were no other concomitant medications. On 16MAY2003 the consumer reported that her daughter was just diagnosed with mumps. Follow up information from the physician noted that the child was seen in the office on 16MAY2003 for massive swelling of her left parathyroid and submandibular glands which the physician stated looked like mumps. He reported that the child was not treated with anything and that he did not draw titers. Additional follow up information from the physician from the physician noted that the patient developed classical parotid and submandibular mumps and the onset date was reported as 16MAY2003 (also reported as 12 days after immunization). Follow up information from the consumer reported that the child did not have a fever, which the consumer stated was "after effects from the DPT shot." The consumer reported that her daughter had lost 8 pounds and had just started to get out of bed on 27MAY2003. On 29MAY2003 the child was seen in the physician's office for bilateral cervical adenopathy which the physician thought was related to a mild ear infection. On 29MAY2003 the physician reported that the patient had recovered from the mumps. The outcomes of the ear infection, weight decreased and fever were unknown. The consumer questioned if the measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) was somehow contaminated. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Measles, Mumps antibody test negative, Rash erythematous, Rubella, Viral test
Clinical narrative: Information has been received from a licensed practical nurse concerning a currently 21 year old female patient with no medical history and no allergies who on 11-AUG-1983, at 15 months of age, was vaccinated with a first dose of MMR II (lot # not reported - unavailable). On 15-DEC-1993 the patient was vaccinated witha  second dose of MMR II (second generation) (lot# not reported-unavailable) and it was reported that the patient had a cold at the time of that vaccination. Concomitant therapy reported be birth control. It was initially reported that the patient experienced a 'fine red rash after the vaccination." Follow up information reported that as a child the patient had a rash after receiving the first dose of MMR II (second generation). The patient's mother felt the rash was from a viral illness. It was reported that the rash resolved. laboratory evaulation on 27-AUG-2001 revealed a titer that was positive for Rubella and Rubeola. Mumps was not checked. Laboratory evaluation on 21-APR-2003 revealed that 'mumps antibodies Igg-negative." Treatment for the negative mumps titer was vaccination subcutaneously on 08-MAY-2003 with a dose of MMR II (second generation) (lot# 644708/1125B). It was reported that the patient tolerated the vaccination on 08-MAY-2003 without any difficulties. Follow-up information reported that the patient was recovered.
Age: 1.3
Sex: F
Vaccine: HIBV, MMR
Symptoms: Drug ineffective, Pruritus, Rash maculo-papular, Viral infection
Clinical narrative: Information has been received from a physician concerning an adopted 16 month old female patient, with no known drug allergies or past medical history, who on 15MAY2003 was vaccinated SC into the right thigh with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant medication on 15MAY2003 included a fourth dose of Haemophilus B conjugate vaccine (ACTHIB) IM into the right thigh. The patient had "no known disease" at the time of vaccination. On 16MAY2003 (previously reported as 12-24 hours post vaccination) the patient developed a rash on torso, arms and face with itching (previously reported as a generalized rubelliform and maculopapular rash) and a decrease in appetite. The pt was treated with cetirizine hydrochloride (ZYRTEC) syrup 2.5 mg/ml 1/2 teaspoon every day and prednisolone (Prelone syrup) 5 mg/tsp. 1 teaspoon twice a day (BID) for 5 days. No other symptoms were noted. The patient was referred to an allergist. It was noted that the patient had no adverse events following prior vaccinations. It was reported that the patient recovered from her experience. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Anger, Coordination abnormal, Mental disorder
Clinical narrative: Information has been received from a consumer concerning a 16 month old female who on 13MAR2003 was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). On 16MAR2003 the patient experienced ataxia, psychotic reaction and paroxysm of rage for the duration of one hours. There as no suspicion of epileptic reaction. Subsequently, the patient recovered from ataxia, psychotic reaction and paroxysm of rage for the duration of one hour rage. No further information is available.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash maculo-papular
Clinical narrative: Information has been received from a nurse practitioner concerning a 28 year old Hispanic male employee (aide) with hypertension due to neurogenic bladder (diagnosed 10 years ago) and no known drug allergies, who on 07MAY2003 (also reported as 18MAY2003) at 11:00 was vaccinated SC with a second dose (dose number questionable) of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy included "Motrin" acetaminophen and enalapril maleate 20mg for hypertension. It was reported that there was no illness at the time of vaccination. On 18MAY2003 the patient developed some tonsillar swelling. On 19MAY2003 the patient presented with a macular papular rash on his arms and chest. The reporter stated that the patient did not have a fever, his temperature was 97.5. Unspecified medical attention was sought and no treatment was required. No laboratory or diagnostic testing was performed. Follow up information indicated that the patient had a discrete macular papular rash on his arms and trunk and "tonsillar nodes palpable." The patient recovered on 21MAY2003. Additional information is not expected.
Age: 1.08
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Swelling, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse on behalf of a mother who works for the physician's office concerning her 13 month old daughter who on 19MAY2003 was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy given on the same day 19MAY2003, included varicella virus vaccine live (MSD) and poliovirus vaccine inactivated. On 19MAY2003 the nurse reported that the child was administered MMR II in what appeared to be an intradermal method as opposed to subcutaneously. It was reported that the injection was given like a TB test and created a wheal. The wheal was still very large and swollen two days later on 05/21/2003. At the time of this report the patient had sought medical attention and the outcome was unknown. No additional information is expected.
Age: 27.0
Sex: M
Vaccine: HEPA, IPV, MMR, MNQ, TYP
Symptoms: Ear pain, Parotitis, Swelling face
Clinical narrative: Information has been received from a nurse concerning a 27 year old male with no drug allergies who on 16MAY2003 was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) 0.5 ml subcutaneously. Concomitant therapy included hepatitis A vaccine, meningitis vaccine, poliovirus vaccine inactivated and yellow fever virus vaccine live. The health care provider reported that the patient was vaccinated with numerous vaccines on the same day. The vaccines were administered at different anatomical sites. On 18MAY2003 the patient experienced left side parotiditis, ear pain and swelling of the mouth. The patient did seek medical attention and was using Tylenol and Aleve for relief, but the nurse said that no treatment was recommended at this time. At the time of this report the outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Deafness
Clinical narrative: Information has been received from a consumer concerning his 4 year old son, with no medical history, who was vaccinated on an unspecified date with a dose of MMR (lot # not reported). There were no concomitant medications. A month later the patient experienced deafness. The patient has been deaf since that time. Unspecified medical attention was sought. It was reported that there were no diagnostic studies performed. Deafness was reported to be disabling. No further information is available.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia
Clinical narrative: Information has been received form a nurse practitioner concerning a 28 year old female patient who on 15MAY2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). About 6 days later, on approximately 21MAY2003, the patient developed joint pain in her knees and ankles. No additional information was provided.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a mother concerning her 4 year old daughter who on 5/16/103 was vaccinated with MMR (lot # 640790/1378L). On 5/24/03 the patient experienced a seizure that lasted for 1/2 hour. Subsequently, the patient was hospitalized overnight and was given valium to treat her seizure. She had a spinal tap done and a Cat Scan while hospitalized. The patient was scheduled to be given an MRI and EEG later that week. Subsequently, the patient recovered. Upon internal review, seizure was considered an other important medical event (OMIC). Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 44 year old male patient with a history of seizures and whom the physician initially reported had symptoms of Bell's palsy and subsequently the physician reported had Bell's pals beginning a few days prior to vaccination. On 22MAY2003 the patient was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy included phenytoin. Subsequently the physician reported that the patient had Bell's palsy and it was unknown if the Bell's palsy worsened after vaccination with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. The physician saw the patient on 27MAY2003 and treatment was acyclovir. The physician reported that she wanted to prescribe steroids. The physician reported that she did not consider the Bell's palsy related to the measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning a 12 month old male who in approximately 2000 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) as well as a dose of varicella virus vaccine live. Concomitant therapy included unspecified microfungals. The patient had a severe diaper rash at the time of vaccination. Within 24 hours after receiving the vaccines the patient developed a rash all over his body. Medical attention was sought and the patient was treated with unspecified "hand creams" On 28MAY2003, the patient was "given a titer and it was reported that he was not immune to the mumps virus vaccine live at this time". No product quality complaint was involved. On 15JUL2003 the patient's mother reported that she did not call about an "adverse reaction" to the vaccine. She called with questions. No further information is expected.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a health professional concerning a 19 year old female patient who is an employee in the office. It was reported that the patient was practicing the administration of PPD's utilizing "Merck Sterile Water Diluent for Live Virus vaccine" as a placebo. Subsequently the pt developed "an allergic reaction at the injection site." According to the reporter that patient experienced burning, pain and faintness. The pt did not require hospitalization or treatment. The pt pulse oximetry and vitals were normal according to the reporter. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: This report was received from GSK for Infanrix and was assigned manufacturer report number A0408220A. This was originally reported by a health professional concerning a 5 year old male pt who on 15MAY2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy on 15MAY2003 included a fifth dose of diphtheria toxoid/pertussis vaccine/teta (INFANRIX) and a dose of poliovirus vaccine. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 15MAY2003 2-3 hours post vaccination the pt developed hives on the ears and face. The parents telephoned the physician and were instructed to administer diphenhydramine hydrochloride and to keep the area cool. The reporter considered the hives to probably be related to the Infanrix administration. It was unknown if the patient recovered. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Cough, Dysphonia, Pruritus, Rash erythematous
Clinical narrative: Information has been received initially from a licensed practical nurse then in follow up from the female pt (age not reported), a licensed social worker, with allergies, asthma, kidney disorder, borderline diabetes and arthritis who on 19MAY2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). It was noted than an unspecified TB test was performed on the same day, 19MAY2003. Concomitant therapy included cetirizine hydrochloride taken from around 19MAY2003 for allergies, albuterol inhaler taken prn for asthma and lisinopril taken for her kidneys, pt is a borderline diabetic. About one week after vaccination, on approximately 26MAY2003, the pt developed wheezing, dry cough and hoarseness. Her primary care physician prescribed azithromycin which was started on 28MAY2003. On 02JUN2003 the pt awoke with itchy red spots like little bumps on face, chest and arms, not al of same size. It was noted that the pt was not able to see her primary care physician since then, but her rash was seen in passing by a registered nurse and physician that the pt works with. The pt noted that she has arthritis, but she has not had any pain for a while. Over the last week,from approximately 02JUN2003, the patient's knees have been very painful as well as other joints that are not usually affected, and she has had aches in all joints. At the time of this report, it was noted that the wheezing, aches in all joints and hoarseness were still continuing. The rash was still present, although it was noted to be getting lighter and was not as pronounced. The outcome for dry cough was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rash pruritic, Wheezing
Clinical narrative: Information has been received initially from a licensed practical nurse then in follow up from the female pt (age not reported), a licensed social worker, with allergies, asthma, kidney disorder, borderline diabetes and arthritis who on 19MAY2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). It was noted than an unspecified TB test was performed on the same day, 19MAY2003. Concomitant therapy included cetirizine hydrochloride taken from around 19MAY2003 for allergies, albuterol inhaler taken prn for asthma and lisinopril taken for her kidneys, pt is a borderline diabetic. About one week after vaccination, on approximately 26MAY2003, the pt developed wheezing, dry cough and hoarseness. Her primary care physician prescribed azithromycin which was started on 28MAY2003. On 02JUN2003 the pt awoke with itchy red spots like little bumps on face, chest and arms, not al of same size. It was noted that the pt was not able to see her primary care physician since then, but her rash was seen in passing by a registered nurse and physician that the pt works with. The pt noted that she has arthritis, but she has not had any pain for a while. Over the last week,from approximately 02JUN2003, the patient's knees have been very painful as well as other joints that are not usually affected, and she has had aches in all joints. At the time of this report, it was noted that the wheezing, aches in all joints and hoarseness were still continuing. The rash was still present, although it was noted to be getting lighter and was not as pronounced. The outcome for dry cough was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a physician's office staff concerning a 4 year old female with no past medical history who on 30MAY2003 was vaccinated IM with a second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) and SC with a first dose of varicella virus vaccine live. There were no further concomitant medications. The following day, on 31MaY2003, the pt had a "systemic hypersensitivity reaction that resulted in hives all over her body." Unspecified medical attention was sought and the physician determined that this was not a varicella breakthrough but an allergic reaction. No diagnostic studies were performed. The pt was treated with Benadryl and Hydroxyzine for the symptoms. At the time of this report, the patients condition had improved, but she still was showing hives on her skin. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old female pt who at a younger age was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). The pt was vaccinated post partum one year ago with a dose of rubella virus vaccine live (second generation). Subsequently on 05FEB2003 the pt had an antibody titer drawn that revealed that the pt failed to seroconvert to MUMPSVAX. Unspecified medical attention was sought. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a physician assistant concerning a 27 year old female patient with Crohn's disease and an allergy to sulfa who several years ago was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). Concomitant therapy included mercaptopurine, mesalamine, Nefazodone HCl and ethinyl estradiol/norethindrone acetate. It was reported on 06JUN2003 that laboratory evaluation revealed that the patient's titer drawn in the past month is low. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a currently 12 year old child with no known allergies with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Subsequently, the patient experienced a "severe reaction" as an infant to the vaccine. Unspecified medical attention was sought. It was unknown if treatment was required. Follow up information reported that no further information was available regarding the "severe reaction" and it was noted that the child was presently healthy and had no current medical conditions. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning an 18 year old male student, who as a child, was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). It was reported that on 05JUNE2003 laboratory tests showed that the patient tested positive for rubella (50, positive for rubeola (1.23), and negative for mumps. It was noted that the patient would be revaccinated. No further information was available. Unspecified medical attention was sought. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a RN concerning a 38 year old male pt, with no reported medical history, who on 02Jun2003 was vaccinated SC into the left deltoid with a dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The pt denied any illness at the time of vaccination. ON 15Jun03 (previously reported as 14Jun03) the pt developed a "rash" on his face, abdomen (stomach), right arm and right leg with itching and came to employee health on 16Jun03 at 14:45. There was no drainage or vesicles noted. It was reported that the pt did not develop a fever and he did not require hospitalization or treatment. It was noted that the pt recovered. The pt stated that his mother told him that he did have an adverse reaction to the vaccine when he was a child. Additional information is not expected.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 16 month old male pt with no past medical history or allergies who on 02Jun03 was vaccinated SC into the left arm with a first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was noted that the pt had diaper dermatitis at the time of vaccination. On 13Jun03 the mother brought the pt to the office and the pt was seen by the nurse practitioner because of a rash mainly on his trunk which started on 12Jun03. The pt was diagnosed with an MMR related rash. The pt was treated with diphenhydramine hydrochloride elixir (Benadryl). It was noted that the pt did not have a fever and the mother was told to call back in 72 hrs if no improvement. As of 16Jun03, it was reported that the mother had not called back and the pt recovered. It was noted that the pt did not have an adverse event following prior vaccination. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DPP, MMR
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Periorbital oedema, Pruritus
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no pertinent medical history and being treated for an ear infection who on 17Jun03 was vaccinated SC with a 0.5ml second dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant medication on 17Jun03 included diphtheria toxoid/ pertussis vaccine/tetanus (manufacturer UNK). The pt had been on clarithromycin (BIAXIN) for one week prior to vaccination for an ear infection, but was considered otherwise  well at the time of vaccination. On 17Jun03 the pt developed a rash, site of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) was very red and puffy, and his face appeared puffy. The clarithromycin (BIAXIN) was stopped. The pt was seen in the physician's office on 20Jun03 at which time the pt had itching, periorbital edema, puffiness around his face, and a slightly raised red area on his shoulder where the vaccine was administered. The pt was given one dose of diphenhydramine hydrochloride (BENADRYL) at home and the physician administered a second dose of diphenhydramine hydrochloride (BENADRYL) in the office. Subsequently, the pt recovered. It was noted that the pt had no problems following first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was also noted that the physician felt this reaction may have been a hypersensitivity reaction but she could not really say what it was. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DPP, MMR
Symptoms: Swelling face
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no pertinent medical history and being treated for an ear infection who on 17Jun03 was vaccinated SC with a 0.5ml second dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant medication on 17Jun03 included diphtheria toxoid/ pertussis vaccine/tetanus (manufacturer UNK). The pt had been on clarithromycin (BIAXIN) for one week prior to vaccination for an ear infection, but was considered otherwise  well at the time of vaccination. On 17Jun03 the pt developed a rash, site of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) was very red and puffy, and his face appeared puffy. The clarithromycin (BIAXIN) was stopped. The pt was seen in the physician's office on 20Jun03 at which time the pt had itching, periorbital edema, puffiness around his face, and a slightly raised red area on his shoulder where the vaccine was administered. The pt was given one dose of diphenhydramine hydrochloride (BENADRYL) at home and the physician administered a second dose of diphenhydramine hydrochloride (BENADRYL) in the office. Subsequently, the pt recovered. It was noted that the pt had no problems following first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). It was also noted that the physician felt this reaction may have been a hypersensitivity reaction but she could not really say what it was. Additional information is not expected.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Hypersensitivity, Injection site erythema, Injection site rash, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 month old male pt, with no allergies and no medical history, who on 29APR2003 at 9:30AM was vaccinated SC in the right leg with a first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included vaccination IM  in the left leg on 29Apr03 at 9:30AM with a fourth dose of HIB conjugate vaccine (ACTHIB) and vaccination IM in the left leg on 29Apr03 at 9:30AM with a fourth dose of Streptococcus pneumoniae vaccine (PREVNAR). On 06May2003 the pt experienced a red itching rash at site of injection. No medical attention was sought. It was reported that there were no diagnostic tests or laboratory data. The pt recovered on an unspecified date. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning her 1 year old male some who on 28Mar03 was vaccinated with  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation), IM administration. There was no concomitant medication. On approximately 04Apr03, one week after receiving the vaccination, the pt developed a fever which lasted for 2 weeks off and on. The pt was treated with acetaminophen (Tylenol) and ibuprofen (Motrin). Subsequently, the pt recovered from fever. The pt sought unspecified medical attention. No product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Initial and follow up information has been received from a RN concerning a 12 month old male pt with no medical history, no allergies and who had no illness at the time of vaccination. On 13Jun03 the pt was vaccinated SC in the left leg with a first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The vaccine was given at 12 months of age. There were no concomitant medications. Initially the RN reported on 26Jun03 that the pt presented to the doctor's office yesterday with a head to toe rash. No treatment was required. On follow up information the nurse described the rash as a full body rash and the onset date was 24Jun03. The pt recovered from the full body rash. No further information is available.
Sex: F
Vaccine: MMR
Symptoms: Malaise, Parotitis, Pyrexia, Thyroiditis
Clinical narrative: Information has been received from a physician concerning an adult female (age not reported) who on 29May03 was vaccinated with a dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). On 26Jun03 the pt presented to the doctor with parotitis and thyroiditis. The pt's temp was 99.9. The reporter stated that the pt began to feel ill in mid June. It was unknown if this was the pt's first vaccination with  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) because the past medical history was reportedly unclear, but since the pt was traveling to a foreign country she was vaccinated. No further information was available at the time of this report. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female (age not given) who was vaccinated on unknown dates with a first and second dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The first dose was given when the pt was a child and the second was administered following delivery of her baby. According to the reporter, the pt was tested six weeks after the second dose and she has a low titer of rubella antibodies. Unspecified medical attention was sought. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Headache, Loss of consciousness, Pyrexia
Clinical narrative: Information has been received regarding a case in litigation concerning a 12 year old female pt who had received a  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) vaccine in 1992 with no complications. On  09Jun03 the pt was vaccinated with a dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The consumer reported that this particular immunization caused a terrible reaction. The consumer reported that approximately 15 minutes after the shot was administered, the pt passed out or fainted, and had a seizure type episode. It was reported that this happened in the doctors office. The pt had a terrible fever and a headache for the remainder of that day. Upon internal review, passed out or fainted and had a seizure type episode were determined to be other important medical events (OMIC). No further information is available.