chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Initial and follow up information has been received from a physician concerning a currently 22 year old male patient, with no allergies and no medical history, who in 1983 and in 1994 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There were no concomitant medications.  Subsequently the patient had a titer drawn that showed that he was not immune to mumps.  Laboratory evaluation on 05/24/2004 revealed:  IgG 0.91 and IgM 0.3.  The patient was given a prescription for mumps virus vaccine live, which was given at another facility.  Unspecified medical attention was sought.  It was noted that no symptoms manifested.  Additional information was not expected as the reporter had no knowledge of the patient's status since 07/28/2004.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Infection
Clinical narrative: Information has been received from a health professional concerning an 18 month old to 2 year old female with no past medical history and no allergies who was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no concomitant medication.  Subsequently, two weeks later she experienced measles.  Unspecified medical attention was sought.  No product quality complaint involved.  No further information is requested.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Hypokinesia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female patient who delivered a baby on 04/24/2004 and had been breast feeding who on 04/26/2004 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Two weeks later, on approximately 05/10/2004, the patient developed a rash, difficulty moving her finger, hand, left knee, and big toe and her milk dried up and she was not able to breast feed.  It was reported that the patient had successfully breast fed 2 infants previously for 11 months and 6 months.  It was reported that the patient was very upset.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old male with an egg allergy who as a child was vaccinated with a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Subsequently, the patient developed an anaphylactic reaction.  Unspecified medical attention was sought.
Age: 12.0
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Diarrhoea, Oral intake reduced, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 07/15/2004 was vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included HIB conj-hepatitis B vaccine.  On 07/22/2004 the patient developed a fever and was brought to the physician's office on 07/23/2004 with fever but no other symptoms.  On 07/24/2004 the patient refused to eat or drink, temperature was 99 degrees, and had loose stools but was not dehydrated.  On 07/25/2004 the physician spoke to the mother on the telephone and the patient had a spotted red rash on face and trunk.  The patient was drinking fluids and the temperature was 101 degrees.  The patient was instructed to increase fluids and take acetaminophen and use nystatin cream on rash.  On 07/26/2004 at 2:00AM the patient had a fever and was cranky.  The patient also had a loose stool and was sent to the emergency room and was diagnosed with probable roseola.  It was reported to be unknown if the patient was hospitalized.  No product complaint involved.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 06/04/2001 was vaccinated with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  On 06/05/2004 the patient developed 3-4 hives on her leg near the injection site.  On approximately the 6th or 7th of June the parent called the doctor's office and was advised to give the child Benadryl.  Subsequently, the patient recovered from the hives on her leg.  No further information is available.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Information has been received from a physician concerning a 5 year old white male patient with an allergy to amoxicillin who on 08/09/2004 at 11:00am was vaccinated subcutaneously in the left side with a second dose of measles virus vaccine, mumps virus vaccine live, rubella virus vaccine live.  There was no illness at the time of vaccination and no adverse events following prior vaccination.  On 08/09/2004 at 11:15am the patient developed an allergic reaction characterized by swelling of the face, erythema of the ears, itchy neck and rash on face.  There were no diagnostic laboratory tests performed.  The patient was treated with Benadryl 25mg by mouth in the office with decreased itching and was told to take Benadryl 22.5mg by mouth 4 times a day for 24 hours and call as needed.  it was noted that symptoms resolved.  Subsequently, the patient recovered on 08/09/2004.  No further information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse concerning a preschool aged male who was vaccinated when he was younger with a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Subsequently, the patient developed a seizure one week post vaccination.  It was unknown if the child was treated or hospitalized at the time.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Upon internal review seizure was considered to be another important medical event.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: titer showed lack of immunity to rubella
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 44 month old male with a history of anemia who on 12/10/2001 was vaccinated with a first dose of MMR SQ in the arm. There are no  concomitant medication or illness at time of vaccination. Subsequently the pt's mother reported that the pt developed swollen eyes in 07/04. It was reported tht the pt was referred to a nephrologist who obtained mumps titers. It was reported that on 07/02/04 the pt did not have protective antibodies to mumps. It was also reported that the pt was positive for mumps antibody. On 07/29/04 the pt did not have protective antibodies to rubella. It was reported that the pt recovered. No further information is expected.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Medication error
Clinical narrative: Information has been received from a consumer concerning her daughter with asthma, reflux, allergy to famotidine, and ranitidine hydrochloride who at age 5 in approximately 1996, was vaccinated with a third dose of MMR. The pt has received the first dose of MMR at 18 months of age and the second dose at 4 years of age. Concomitant therapy included fluticasone propionate and salmeterol xinafoate. The consumer reported that her daughter had been given and extra dose of MMR by mistake. ON 08/16/04 the pt developed the mumps. It was reported that it was on her left side only and she had swelling and tenderness below her left ear and left side of her jaw. Unspecified medical attention was sought. On 08/18/04 it was reported that the pt was recovering. Follow up information from the office indicated that the MD was not here to examine the pt on 08/18/04. It was reported that this office never gave pt any MMR vaccine. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received form a RN concerning an adult pt who as a child was vaccinated with a series of doses of MMR. On 08/19/04 it was reported that the pt is now failing to show seroconversion on his titers drawn recently for employment. It was noted that two years ago the pt had proof of seroconversion. The pt did not have any adverse reaction. No medical attention was sought. No product quality complaint was involved. No further information is expected.
Age: 21.0
Sex: M
Vaccine: HEP, MMR, TTOX, HEP, MMR, TD
Symptoms: Drug ineffective
Clinical narrative: information has been received from a manufacturer concerning a 21 year old male who was vaccinated with a does of MMR. Concomitant therapy included a first dose of Hep B in the RA and a dose of tetanus toxoid on 06/17/04 the pt
Age: 21.0
Sex: M
Vaccine: HEP, MMR, TTOX, HEP, MMR, TD
Symptoms: Rash
Clinical narrative: information has been received from a manufacturer concerning a 21 year old male who was vaccinated with a does of MMR. Concomitant therapy included a first dose of Hep B in the RA and a dose of tetanus toxoid on 06/17/04 the pt
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a RN concerning a 4 year old male with a food allergy to mango and no illness at the time of vaccination who on 07/07/04 was vaccinated SQ in the RA with a 2nd dose of MMR live. . On 07/07/04 immediately post vaccination the pt developed hives above the injection site. Unspecified medical attnetion was sought. The pt was treated with oral Benadryl. The pt was observed fro 60 minuted and then dismissed. Subsequently, the pt recovered. It was reported that no immunization was given within 4 weeks prior to vaccination with MMR vaccine. A pediatric allergy consult was performed and the pt will need skin testing prior to immunizations. No additonal information is expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Medication error
Clinical narrative: Information has been requested from a PA concerning her 5 year old healthy son who on 08/12/04 was vaccinated with a dose of MMR vaccine. The PA reported that she tried to vaccinate her son with the MMR in her home. She had difficulty witht the vaccination process and sprayed the vaccine over the sink in her home. The vaccine was then refrigerated in a syringe for 3 days, the PA then transported the MMR vaccine in her car for 2.5 hours at temps possibly above 77 F. Her son was then vaccinated by another health care professional in the office where she works. The pt developed GI problems which began on 08/23/2004. Unspecified medical attention was sought. The PA also reported that she develped GI problems after exposure to the MMR vaccine live. ( WAES0501USA01399) Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Infection, Laboratory test abnormal
Clinical narrative: Information has been received from a RN concerning a 4 yr old male who on 13Jun04 was vaccinated at an unk time with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . On 13Jun04 at an unspecified time the pt experienced an anaphylactic reaction. The child was referred to an allergist for follow up. Serum test were performed for porcine and bovine. The test was positive for porcine. The pt had received his first dose of the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 635920/0826K) on 19Feb01 and did not experienced an adverse event at that time. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 21 month old male who on 08/23/2003 was vaccinated with MMR vaccine live. On 06/10/2004 a titer was taken and the pt was found to be negative for mumps. No other symptoms noted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.37
Sex: M
Vaccine: MMR, PNC
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 16 month old male pt who on 10/30/2000 was vaccinated with a dose of MMR live vaccine. Concomitant therapy on 10/30/2000 included a dose of pneumococcal 4 6N 9v 14 18C 19F 23F conjugate vaccine (crm197 protein) (Prevnar). Subsequently 9 days after vaccination, on 11/08/2000 the pt developed a  fever of 104.4. Subsequently, the pt recovered from fever of 104.4 on an unknown date. Additional information has been requested.
Age: 1.24
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a RN nurse concerning a 15 month old female who on 28Feb1985 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The nurse reported that the pt may have had an allergic reaction to measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  that was administered earlier. Unspecified medical attention was sought. There was no product quality complaint involved. At the time of the report the pt was 20 years of age. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: MMR
Symptoms: Blister, Drug ineffective, Malaise, Rash erythematous
Clinical narrative: Information has been received from a physician's assistant concerning a 26 yr old white male student with no known allergies and a history of asthma as a child who on 27Aug04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 644981/1235M). Concomitant therapy included guaifenesin (Bidex) and albuterol). On approx 28Aug04, within a day or two post vaccination, the pt developed reddened bumps on chest, some with vesicles that were fading at the time of this report. The pt also felt bad and had no fever. Unspecified medical attention was sought. No treatment was required. It was reported that the pt was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  in the past (no specific details could be provided). On 25May04, the pt had a negative titer to mumps. Additional information was received from RN who reported that on 31Aug04, the pt notified the office that during the weekend prior to 31Aug04, he had red bumps from the chest upward. Some of the bumps had vesicles, and some areas were fading. The pt was referred to a physician. The pt subsequently reported that the physician's diagnosis was a coincidental rash that had nothing to do with the vaccine. The pt subsequently recovered from the rash. The nurse also reported that on 23Aug04, the pt had finished therapy with methyl prednisolone (Medrol Dosepak), clarithromycin (Biaxin), and montelukast sodium. No additional information is expected.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a 33 yr old white female licensed practical nurse with a relevant medical history of past pneumothorax who on 11Nov02 at 0930 was vaccinated with a fourth 0.5ml dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 642497/0344M). It was noted that she received the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child at 15 months of age, then received another dose at approx 5 yrs of age and another dose as a teenager. On 25Aug04 an antibody test was negative for rubeola. She stated she had no untoward effects from the vaccinations. Unspecified medical attention was sought. It was also reported that on 14Oct02 at 1000 the pt was vaccinated with a dose of measles virus vaccine (lot638832/1722K). There was no product quality complaint complaint involved. No further information is expected.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion
Clinical narrative: Information has been received from a RN concerning a female child who was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy that day included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. Subsequently, two days later, the pt experienced a seizure and was hospitalized. The pt was
Age: 28.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Erythema, Lymphadenopathy, Pruritus, Pyrexia, Rash papular
Clinical narrative: Initial and follow up information has been received from a health professional and a physician concerning a 27 year old male student with no past medical history, who on 11Aug04 at 2:15PM was vaccinated IM in the left deltoid with the first dose of the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 646124/0615N). Concomitant therapy included hep B virus vaccine rHBsAg (yeast) in the right deltoid. On 23Aug04 (previously reported as 26Aug04) the pt developed a widespread rash which was itchy. The red papular rash was reported to be all over, including the face and right postauricular LAP. The pt also reported experiencing a mild fever and swollen lymph nodes. The pt was diagnosed with German measles. The pt was seen by a dermatologist and subsequently recovered in Sept 2004. The German measles was considered to be an other important medical event (OMIC). No further information is expected.
Age: 28.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Viral infection
Clinical narrative: Initial and follow up information has been received from a health professional and a physician concerning a 27 year old male student with no past medical history, who on 11Aug04 at 2:15PM was vaccinated IM in the left deltoid with the first dose of the measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 646124/0615N). Concomitant therapy included hep B virus vaccine rHBsAg (yeast) in the right deltoid. On 23Aug04 (previously reported as 26Aug04) the pt developed a widespread rash which was itchy. The red papular rash was reported to be all over, including the face and right postauricular LAP. The pt also reported experiencing a mild fever and swollen lymph nodes. The pt was diagnosed with German measles. The pt was seen by a dermatologist and subsequently recovered in Sept 2004. The German measles was considered to be an other important medical event (OMIC). No further information is expected.
Age: 12.0
Sex: M
Vaccine: DT, HEP, MMR
Symptoms: Pharyngeal oedema, Urticaria
Clinical narrative: Information has been received from a RN concerning an 11 yr old white male no known allergies who on 16Jun04, at 1500, was vaccinated SC with the second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot645434/0276N). Concomitant vaccine therapy included a first dose of hep B virus vaccine rHBsAg (yeast) and a dose of diphtheria toxoid (+) tetanus toxoid. There was no illness at the time of vaccination. The RN reported that on 17Jun04, at 1800, the pt developed hives over his entire body. On that same day, the pt was taken to the ER and was prescribed diphenhydramine HC1 (Benadryl), every six hours. The pt's hives persisted and he also developed a swollen throat. On 19Jun04 the pt was again taken to the ER where he was prescribed methylprednisolone (Medrol Dosepak). No laboratory/diagnostic testing was performed. On 30Jun2004, the pt recovered from the hives and swollen throat. No further information is expected.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Pyrexia, Rash
Clinical narrative: Information was received on 14 SEP 2004 from a registered pharmacist concerning a 16 month old female who "about week ago" was vaccinated with MMR.  Subsequently the patient developed a temperature of 100 deg F, a rash on her chest, and a large red spot at the injection site.  Hospitalization was not required.  Topical hydrocortisone and oral tylenol were prescribed. No product quality complain involved.  Additional information was requested.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a LPN concerning a 30 year old male who, as a child, was vaccinated with a series of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Subsequently, the pt was found to have negative titer levels for measles and rubella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEPAB, MMR, TTOX, HEPAB, MMR, TTOX
Symptoms: Alopecia, Pruritus
Clinical narrative: This report was received from manf and was assigned manf report number A0524880A. Information has been received by the consumer who is a 30 year old female who on 21Jun04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included a first dose of hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix) and tetanus toxoid adsorbed. On 28Jun04, approx seven days following the first administration of hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix), the pt developed hair loss and itching. The pt was seen at a physician's office and was treated with corticosteroids and desloratadine (Clarinex). The hair loss continued. The itching improved. On 23Jul04, the pt received the second dose of hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix). The pt reported that the hair loss continued following the second dose of hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAG (yeast) (Twinrix). The outcome was not recovered. The pt declined to grant authority to contact her physician; therefore, no further information will be available. No further information was provided.
Age: 1.79
Sex: F
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Cough, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 22 month old white female with no allergies and no medical history who on 09/02/2004 was inadvertently vaccinated intramuscularly with a second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included a dose of pneumococcal (prevnar), a dose of varicella virus vaccine live and a dose of Hepatitis B vaccine, recomb.  There was no other concomitant medication.  There was no illness at the time of vaccination.  On 09/04/2004, 48 hours post-vaccination, the patient developed a fever of 100.6 to 101 degrees, a red, itchy raised rash over her chest, and a cough.  The fever lasted for 2 days.  The rash lasted 5-6 days and was treated with hydrocortisone 1% ointment on day 4.  The cough was gone by day 6.  Unspecified medical attention was sought.  No diagnostic lab tests were performed.  No product quality complaint was involved.  It was also noted that neither the patient nor her sibling developed adverse events following prior vaccinations.  No further information is expected.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Speech disorder
Clinical narrative: Information has been received from a physician who is the parent of a 12 month old male patient who on 06/26/200 was vaccinated subcutaneously with a 0.5ml dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no concomitant medication.  Within 3 months of receiving measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, in approximately September 2000, the patient developed significant speech delays.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner and from a healthcare worker concerning a 39 year old white female physician employee, with allergies to penicillin and sulfa and no other pertinent medical history, who on 08/12/2004 at 10:15AM was vaccinated subcutaneously in the left upper arm with a second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  There was no concomitant medication.  It was noted that the patient was not ill at the time of vaccination.  On 08/12/2004, the patient complained of pain and injection site tenderness and fatigue.  The patient was afebrile and there was no redness, swelling, tenderness or lymphadenopathy.  There was no treatment required.  On 09/21/2004, the patient reported that she felt the pain had increased and she felt more tired.  It was noted that the events occurred from 08/12/2004 through 09/23/2004.  The patient was reported to have recovered in September or October 2004.  On 11/15/2004 the nurse practitioner reported that the patient had informed her that the fatigue and injection site tenderness had resolved 1-2 months ago.  It was also mentioned that the patient tested negative for rubeola immunity, and positive for rubella immunity on 07/13/2004.  No product quality complaint involved.  No additional information is expected.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a healthcare worker concerning a 12 year old male with seasonal allergies and no other medical history who in March 1993 and October 1995, was vaccinated with a first and second dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included loratadine.  In 2004, the patient had a titer which showed no mumps seroconversion.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.  The healthcare worker also reported that the patient had a varicella titer of 0.03 after therapy with a varicella virus vaccine live.
Age: 5.0
Sex: M
Vaccine: DPP, IPV, MMR
Symptoms: Erythema, Premature labour, Pruritus, Rash, Swelling
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no allergies to eggs, gelatin or neomycin and a history of prematurity and CP who on 09/28/2004 at 12:40PM was vaccinated subcutaneously with a dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live in the right thigh.  It was reported that the patient had previously been vaccinated with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Concomitant therapy included diphtheria toxoid, pertussis vaccine, tetanus toxoid and inactivated poliovirus vaccine.  The reporter indicated that within minutes after the patient received the vaccination he developed swelling in the right leg, and that he developed rash and itching in right leg.  It was reported that the patient had been given DPT IPV in opposite leg the same day and there was no swelling.  Ice was given for treatment for the right leg.  The patient's outcome was unknown.  Follow up information has been received from a health professional concerning the patient's hive at site.  Upon vaccination with measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, the patient immediately started developing swelling right below the injection site with redness.  The patient was kept in the office for observation.  He complained of itching, but there was no pain or breathing problems.  The physician evaluated the injection site, and diphenhydramine hydrochloride was ordered.  On 09/29/2004, the patient recovered.  No further information is available.
Age: 1.01
Sex: F
Vaccine: MMR
Symptoms: Crying, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12 month old white female patient with no known drug allergies who on 10/13/2004 at 10:00AM was vaccinated was vaccinated with a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live, in the arm.  There was no concomitant medication or illness at the time of vaccination.  On 10/13/2004 at 10:05AM the patient inconsolable crying with local rash over site of injection which lasted 30-45 minutes.  The patient's experience was also described as cried uncontrollably for 30 minutes, and developed a red swelling and rash around injection site.  There was observation but no treatment.  It was reported that the patient calmed down and was doing well.  The patient recovered on 10/13/2004.  It was reported that the office manager said that this must be a bad batch of MMR and should be removed.  The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory.  The lot complies with the standards of the center for biologics evaluation and research and was released.  It was also reported that another patient had an adverse event.  No additional information is expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information was received from a nurse concerning a one year old female with no known allergies who on 07 OCT 2004 was vaccinated with MMR.  Concomitant therapy that day included Varicella virus vaccine.  On 07 OCT 2004 the patient was placed on a 10 day course of AMOXIL.  On 17 OCT 2004 the patient broke out in a rash.  It was reported that "it does not sound like Varicella virus vaccine live".  No fever was present.  It was reported that the child to be seem by a dermatologist as soon as possible.  Unspecified medical attention was sought.  No product quality complaint involved.
Age: 4.0
Sex: M
Vaccine: FLUX, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a 4 yr old male who on 18Oct04 was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 644981/1235M) in his left arm. Concomitant therapy included influenza virus vaccine (unspecified) (manf unk). On 18Oct04 the pt experienced erythema and swelling around the injection site. The erythematous area was 12cm by 10cm in size. The report indicates that the pt sought medical attention. At the time of the report, the outcome was unk. No further information is available. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information was received from a nurse concerning the father of patient reported that his son was vaccinated in 1990 with MMR.  In 1990 after vaccination the patient developed hives.  Subsequently the patient recovered from hives.  Additional ifnromation was received from the physician who rpeorted that he did not give the first dose of MMR.  The physician reportted on an unspecifued date the patient receibed second dose of MMR and there was no reaction.  Additional information was expected.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Activated partial thromboplastin time normal, Contusion, Full blood count, Measles antibody negative, Mumps antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 17 month old male with no past medical history and no allergies who on 6/9/04 at 10:30 AM was vaccinated in the left arm with a first dose of MMR (lot # 646405/0616N). There was no concomitant medication or illness at the time of vaccination. On 8/18/04, the patient was seen in the office for bruising during past 2 month. CBC, differential, platelets count, protime and PTT were done and the platelets were 30 k/ul, protime and PTT was normal. The patient saw a hematologist on 8/19/04. He had a platelet count repeated and it was to 17 k/ul. The diagnosis was thrombocytopenia related to MMR injection. The patient was to wear a helmet to protect head and continue monitoring lab work. The patient was seen again on 9/9/04, platelets to 34 k/ul (also reported as 24 k/ul), normal range 152-406, still wearing helmet for protection. Platelet count on 12/2/03 was 291 k/ul. Unspecified medical attention was sought. No product quality complaint involved. It was noted that the patient had no adverse events following prior vaccinations. The patient's recovery status was reported to be still monitoring. Upon internal review, thrombocytopenia (with a platelet count of 17) was considered to be an other medical event (OMIC). Additional information has been requested. Follow up information received from a licensed visiting nurse indicated that on 09-FEB-2007, antibody titers for measles, mumps, and rubella were negative
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Platelet disorder, Rubella antibody negative, Thrombocytopenia, White blood cell count
Clinical narrative: Information has been received from a registered nurse concerning a 17 month old male with no past medical history and no allergies who on 6/9/04 at 10:30 AM was vaccinated in the left arm with a first dose of MMR (lot # 646405/0616N). There was no concomitant medication or illness at the time of vaccination. On 8/18/04, the patient was seen in the office for bruising during past 2 month. CBC, differential, platelets count, protime and PTT were done and the platelets were 30 k/ul, protime and PTT was normal. The patient saw a hematologist on 8/19/04. He had a platelet count repeated and it was to 17 k/ul. The diagnosis was thrombocytopenia related to MMR injection. The patient was to wear a helmet to protect head and continue monitoring lab work. The patient was seen again on 9/9/04, platelets to 34 k/ul (also reported as 24 k/ul), normal range 152-406, still wearing helmet for protection. Platelet count on 12/2/03 was 291 k/ul. Unspecified medical attention was sought. No product quality complaint involved. It was noted that the patient had no adverse events following prior vaccinations. The patient's recovery status was reported to be still monitoring. Upon internal review, thrombocytopenia (with a platelet count of 17) was considered to be an other medical event (OMIC). Additional information has been requested. Follow up information received from a licensed visiting nurse indicated that on 09-FEB-2007, antibody titers for measles, mumps, and rubella were negative
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Irritability
Clinical narrative: Information was received from a nurse concerning a 5 year old female who in 2000 was vaccinated with a first dose of MMR.  Subsequently the patient developed irritability for two weks.  Unspecified medical attention was sought.  No product quality complaint was involved.
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective
Clinical narrative: Information has been received from an epidemiologist concerning a female pediatric patient who was vaccinated with MMR. Subsequently, the patient developed mumps. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: FLU3, HIBV, MMR, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Information has been received from a physician concerning a 15 month old male, with no medical history and no allergies, who on 10/27/04 was vaccinated with a dose of MMR (lot # 0515P). Concomitant vaccines administered on the same day included varicella virus vaccine live, influenza virus split virion 3v vaccine inactivated, and HIB conjugate vaccine. On 11/1/04, the patient experienced a rash, erythema multiforme. It was reported that the rash was well appearing, not peeling, was extensive all over, and that the patient was afebrile. The patient was treated with cetirizine hydrochloride and hydroxyzine. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Malaise
Clinical narrative: Information was received from a nurse concerning a male who "many year ago, as a child" was vaccinated with a dose of MMR.  It was reported that subsequently the patient had a reaction and became "very sick".  Unspecified medical attention was sought.  The patient;s outcome was not reported.  It was also reported that the patient's son had a similar experience following vaccination with MMR.  Additional information has been sought.
Age: 1.1
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Face oedema, Lymphadenopathy, Parotitis
Clinical narrative: Initial and follow up information has been received from a physician concerning a 13 month old white female with developmental delay who on 10/12/04 was vaccinated SC in the left arm with her first dose of MMR (lot # 648473/0313P). Concomitant therapy included varicella virus vaccine live, influenza virus split virion 3v vaccine inactivated, and polymyxin B sulfate (+) trimethoprim. On 11/3/04, the patient developed acute parotitis with swelling in the left gland. The physician reported that approximately 12 days ago the patient received MMR, and that she presented with sudden onset of swelling of left cheek. It was also reported that the whole left side of her face was swollen, and that there was a firm induration and a soft, puffy area. There was no fever or change in level of consciousness. At the time of the report, the patient had not yet recovered. The physician felt that acute parotitis was related to MMR. There was no product quality complaint involved. No further information is available.
Age: 1.3
Sex: F
Vaccine: FLUX, MMR, PNC
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Informaiton was received from an emergency medical technician (patient's mother) concerning her 15 month old daughter who on 01 NOV 2004 was vaccinated with MMR.  Concomitant therapy included a dose of PREVNAR and a dose of influenza virus vaccine.  On 01 NOV 2004 the patient developed a severe erythematous generlized rash, and fever.  It was also reported that the patient had a TB test on 01 NOV 2004.  The child was examined at the hospital but not admitted.  It was also reported that she was being treated symptomatically was recovering.  There was no product quality complaint involved.  Additional information is not expected
Sex: U
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with MMR. Subsequently, the patient experienced rash and fever 4-5 days post vaccination. The patient sought unspecified medical attention. No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Haematuria, Rash, Urticaria
Clinical narrative: Information has been received for diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid and was assigned manufacturer report number A0534190A. This was originally reported by a registered nurse concerning a 4 year old male patient with no known allergies, who on 2/10/04 at 14:00 was vaccinated SC with a second dose of MMR (lot # 644763/1231M). Concomitant vaccine therapy included a fifth dose in the left arm of diphtheria (+) pertussis acellular 3-component vaccine (+) tetanus toxoid and a dose of poliovirus vaccine inactivated. There were no illnesses at the time of vaccination. In February 2004, the patient experienced hives at the injection site of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid. The patient complained of hives on and off to the present day. The hives were described as a darker rash at times and clearly hives at others. It was reported that the patient had 3 doctors appointments to the allergist and to infectious disease. It was reported that laboratory tests were performed at another office and noted a very slight hematuria. The hives resolved after several months. It was reported that the patient recovered from all his adverse events. It was also reported that the patient had no adverse events following receipt of previous administration of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Information has been received for diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid and was assigned manufacturer report number A0534190A. This was originally reported by a registered nurse concerning a 4 year old male patient with no known allergies, who on 2/10/04 at 14:00 was vaccinated SC with a second dose of MMR (lot # 644763/1231M). Concomitant vaccine therapy included a fifth dose in the left arm of diphtheria (+) pertussis acellular 3-component vaccine (+) tetanus toxoid and a dose of poliovirus vaccine inactivated. There were no illnesses at the time of vaccination. In February 2004, the patient experienced hives at the injection site of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid. The patient complained of hives on and off to the present day. The hives were described as a darker rash at times and clearly hives at others. It was reported that the patient had 3 doctors appointments to the allergist and to infectious disease. It was reported that laboratory tests were performed at another office and noted a very slight hematuria. The hives resolved after several months. It was reported that the patient recovered from all his adverse events. It was also reported that the patient had no adverse events following receipt of previous administration of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy
Clinical narrative: Information was received from a physician concerning a 15 month old male with no medical history who on 24 NOV was vaccinated into the thigh with a first dose of MMR.  Concomitant vaccine therapy included a dose of varicella vaccine.  There was no illnesses at the time of vaccination.  There was no other concomitant medication.  On the morning of 26 NOV 2004 the patient experienced right parotid gland swelling.  He was afebrile.  Unspecified medical attention was sought.  No treatment was required. One week later the patient recovered.  No product quality complain was involved.  Additional information was not requested.
Age: 1.34
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal, Medication error
Clinical narrative: Information has been received from a nurse practitioner and a 27 year old female with a Naprosyn allergy and no medical history who on 6/26/78 at 1 year old, and February 1997, was vaccinated IM with the first and second dose of MMR, respectively. Concomitant medication included birth control tablets. On 11/23/04, the patient's titer was low for rubella. The patient reported she was not protected against rubella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is expected.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female who in 1990 was vaccinated with a dose of MMR. It was also reported that in 1972, the patient received rubella vaccination. A current (approximately November 2004) titer shows low antibodies to rubella. Unspecified medical attention was sought. No product quality complaint was involved. No other information is available. No further information is expected.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Platelet disorder, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old female who in approximately 2001 was vaccinated with a first dose of MMR. Subsequently, the patient developed rash as measles and low platelets (value not reported). The patient's outcome was unknown. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: Information was received from a physician concerning a "healthy" 15 month old male with asthma who in Feb 2002 was vaccinated with a dose of MMR.  Shortly after vaccination the child developed facial swelling and was taken to the ER.  The child was diagnosed with mild mumps.  The child was treated with medication but the child's father could not recall what it was.  It was reported after 4-5 days that condition was resolved.  No product quality complaint was involved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Laboratory test abnormal, Parotid gland enlargement, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white male with asthma (well controlled) who on 11/15/04 was vaccinated SC in the right thigh with a second dose of MMR (lot # 648465/0320P). There was no illness at the time of vaccination. Concomitant vaccinations included a fourth dose of poliovirus vaccine inactivated (batch # X1189) administered SC in the left thigh and a fifth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (batch # DTPa614A9) administered IM in the left thigh. On 11/22/04 at3:30 AM the patient developed right parotid swelling, then the swelling developed on his left side. It was reported that the physicians believe this is not true mumps, but a side effect of the vaccine. Unspecified medical attention was sought. Laboratory tests performed included serum mumps immunoglobulin G antibody test and serum mumps immunoglobulin M antibody test, on 11/30/04 and 12/6/04 (results not reported. At the time of the report, the patient had recovered. There was no product quality complaint involved. Follow up information indicated that the patient developed right ear pain on 11/22/04 at 3:30 AM. On 11/23/04, a PS virus IgG AB was 4.56 (positive). It was noted that a measurable antibody titer may also reflect a positive response to vaccination. A mumps virus IgG AB was 4.56 (positive). It was noted that a measurable antibody titer may also reflect a positive response to vaccination. A mumps virus IgM AB showed 11 U/ml (equivocal). On 12/6/04, a mumps virus IgG AB showed 3.64 (negative) and a mumps virus IgM AB showed <8 (none detected). The outcome was reported as recovered. No additional information is expected.
Sex: M
Vaccine: MMR
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a male child who was vaccinated with a dose of MMR. Subsequently, the patient experienced an unknown reaction described as possibly a rash. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 1.36
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Pyrexia
Clinical narrative: Initial and follow up information has been received from a epidemiologist and a registered nurse concerning a 16 month old female patient who on 11/15/04, was vaccinated with a dose of MMR (lot # 646552/0961N). Subsequently, on 11/23/04, the patient developed a high fever of 104 and a seizure. Unspecified medical attention was sought. It was also reported that the patient was not hospitalized and she was feeling much better and feeling normal. The patient was considered to be recovered (date unspecified). Upon internal review, the patient's seizures were considered an other medical event (OMIC). The epidemiologist wanted to know if the high fever was related to the lot of MMR. Lot check has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. This is a consolidation of two reports concerning the same patient. It was reported that 3 other patients developed high fevers post vaccination with MMR (WAES0412USA01748, 0501USA00211, 0501USA00212). Additional information is not expected.