chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Thrombocytopenic purpura
Clinical narrative: Initial and follow up information has been received from a physician concerning a 12 month old male patient with no history of allergies, a trait of Mediterranean anemia, a platelet count of 481,000 on 4/30/99 and a platelet count of 517,000 on 6/8/99. ON 7/7/99 the patient was vaccinated with a first dose of MMR (lot # 630625/0353J). The physician reported that 3 weeks posts vaccination the child developed idiopathic thrombocytopenic purpura. On 7/28/99 the patient presented to the office with red dots on his neck and face. A CBC was done and laboratory evaluation revealed a white blood cell count of 9.1, hemoglobin of 11.1, hematocrit of 34 and a platelet count of 5,000. The patient was sent to a hematologist. The physician reported that he did not think that the child was hospitalized, but was treated with gamma globulins. On 8/6/99 laboratory evaluation revealed that the child's platelet count was back to normal at 508,000 and on 8/19/99 the platelet count was normal at 228,000. The patient fully recovered. He received his second dose of MMR and it was reported on 11/6/03 that he has not had any problems. Upon internal review, idiopathic thrombocytopenic purpura was determined to be an other important medical event (OMIC). No further information is available.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information ha been received from a health professional concerning an approximately 16 month old female patient who on 20OCT2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Subsequently, she experienced a rash, Unspecified medical attention was sought. Additional information is not expected.
Age: 1.28
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 15 month old male pt who on 19Sep03 was vaccinated with the first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot #641624/0126M), subcutaneously in the right arm. On 30Sep03, "9 days post vaccination", the pt developed urticaria over his entire body. The pt's urticaria responded to diphenhydramine (Benadryl). On 02Oct03, the pt recovered. It was reported that the pt had no illnesses at the time of vaccination. Additional information has been requested.
Age: 1.41
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 17 month old male who on 06-NOV-2003 was vaccinated with a dose of MMR II (lot# not reported). Subsequently the patient developed unilateral (left) parotitis. Unspecified medical attention was sough. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL, HBHEPB, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 4 year old male patient with an egg allergy who on 03APR2001 was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Secondary suspect therapy included varicella virus vaccine live which was administered on 03APR2001 and hepatitis B vaccine rHBsAg (yeast) + Hib conj vaccine which was administered on 13APR2001. In November 2003, the patient presented with a generalized rash over his body. There were no other symptoms present and no treatment was required. Subsequently, within one week time, the patient's generalized rash resolved. The nurse also stated that the patient was not vaccinated at their office. No product quality complaint involved. Upon follow up a nurse indicated that "we do not have records for original event. Only by mothers report. I have contacted family practice, pediatrics and public health, no one claims to have any documentation regarding reaction during primary series as reported." No further information is available.
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 who in September 1972, was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. The patient was administered another dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live 29Sep1989. On 01JUN2003 the patient failed to seroconvert and the patient's immunoglobin G index was negative. Additional follow up information from the registered nurse stated that the patient "failed to seroconvert after two doses". Additional information is not expected.
Age: 0.9
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a consumer concerning her daughter with no past medical history or allergies, who on an unspecified date, 5 days before her first birthday, at the age of 11 months, was vaccinated with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. she was vaccinated four months later, at the age of 15 months, with a second dose of measles virus vaccine live + mumps virus vaccine live +rubella virus vaccine live.  There were no concomitant medications. It was reported that the patient's "measles vaccination was low" when she was tested through a titer. It was determined that she was fine on mumps and rubella, but her measles was low. The physician did not give the mother a specific number to rate how low the titer was. Unspecified medical attention was sought. The patient's outcome was reported as not recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a female patient "in her 50s", with an unknown medical history, who was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Subsequently the patient experienced severe joint pain and fever. No other information is available. Unspecified medical attention was sought. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis
Clinical narrative: Information has been received from a 34 year old female who on approximately 05SEP2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. The patient reported that on approximately 12SEP2003, about a week after the vaccination, she experienced joint pain in her arms and legs. Medical attention was sought and the joint pain was treated as arthritis. The patient was taking naproxen sodium and cortisone for the joint pain which provided only moderate relief. At the time of this report, the patient's joint pain persisted. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 4 year old female with no known allergies who on 14NOV2003 was vaccinated with the second dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, subcutaneous administration in the left upper arm. On the same day, the patient was vaccinated with poliovirus inactivated in the left arm, influenza virus vaccine in the right arm, and diphtheria toxoid + pertussis vaccine + tetanus toxoid in the right arm all administered intramuscularly. Immediately after vaccination with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live, the patient developed a 3 to 4, 1-2 cm hives next to the injection vaccination site. The nurse reported that the poliovirus vaccine was administered on the left arm but at a different location. No treatment was required and the patient was monitored in the office. Within 15 minutes of the vaccination, the patient recovered from the hives. The nurse reported that the hives were self limited and not associated with any other therapies. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Skin reaction
Clinical narrative: Information has been received from a physician concerning a 2 year old female with egg allergy who was allergy skin tested with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live and diluent. There was no concomitant medication. Subsequently, the patient experienced a local skin reactivity. Testing was being conducted to see if the patient could be vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. the local reaction occurred about 15 minutes after the start of testing. It was noted that the reaction was not dose related. No laboratory or diagnostic studies were performed. The local reaction resolved and there were no other symptoms. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old Asian male with HIV infected parents, a seroreverter and a history of no known adverse drug reactions or allergies and intermittent asthma with atopic dermatitis who on 16Dec1996 was vaccinated with the first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . On 16Dec96, immediately following vaccination, the pt developed hives. The pt sought unspecified medical attention. In follow up, the physician reported that the pt was treated with diphenhydramine (BENADRYL). Subsequently, on 16Dec96, the pt recovered from the hives. It was reported that the pt had shown no allergy to eggs. No additional information is expected.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Medication error, Nausea, Rash
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 62 year old white female pt who on 17Oct03 was vaccinated with a booster dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) , SC. Subsequently, the vaccine that was administered to the pt was expired (expiration date was 02Oct03). The nurse reported that the pt was called and offered a second dose. The pt stated that she has had a titer and the disease so opts not to repeat. After receiving the booster dose the pt developed a rash and became sick with nausea. The pt had an abscessed tooth at the time of vaccination which was eventually pulled. The nurse reported that the pt's husband was also vaccinated but did not have any side effects. Subsequently, the pt was recovering from the rash and nausea. Upon follow up the nurse reported that the pt had no side effects. Was given another MMR with no complications. Her sick nausea and rash was from abscess tooth. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 5 year old male pt with a history of ventricular septal defect repair who on 05Jun03 at 10:00AM was vaccinated with the second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) , SC administration in the right thigh. On 05Jun at 12:00PM, the pt developed scattered hives after MMR. It was unknown if the pt recovered from scattered hives. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Coma, Crying, Heart rate increased, Hypersensitivity
Clinical narrative: My son had his vaccines at 10:00am on May 15, 2004.  He immediatly went to sleep. When we got home, he woke up for a few minutes, crying.  He ate a few ounces of his bottle and went back to sleep.  At approximatly 5:00, I got concerned and went to check on him.  I was unable to wake him.  I called the doctor's office and was told to call 911, which I did.  When the firemen got there, they could not wake him at first.  He finally woke up after about 5 minutes.  His heart rate was elevated in the ambulance.  When we got to the hospital, they checked everything and said it was a reaction to the shots.  He was admitted and did not go home until the 17. There were 3 or 4 times after that date that I had trouble waking him and was told to return to the hospital or doctor's office.  They could not find anything wrong.  He has been seen by a neurologist who also could not find anything wrong. Follow up on 06/24/04 states: "Mom also described child as "limp" (hypotonia). He received Hep B at birth as well. Child did not receive MMR."  Nurse follow up on 08/19/04 states: "Per discharge summary, final diagnosis is "altered mental status secondary to vaccines". Admission diagnosis was lethargy. Slight irritability upon discharge."
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: hives, redness, swelling at site of ppd administration withe hives extending to entire anterior surface of lower left extremity-ppd received 6/21/04-required topical hydrocortisone and oral benadryl treatment
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: This is submitted to replace the incomplete form submitted on 6-21-04.  Client reports "bumps" at injection site after receiveing injection.  Now rash the size of a "50 cent" piece.  No pain, redness, swelling.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Abdominal pain, Blood pressure increased, Flushing, Neck pain
Clinical narrative: stomach cramps Feeling of compression of entire thorax pain at the back of the neck extream flushing elevated blood pressure
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Abdominal pain, Anaphylactic shock, Chest pain, Dyspnoea, Erythema
Clinical narrative: stomach cramps Feeling of compression of entire thorax pain at the back of the neck extream flushing elevated blood pressure
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Heart rate increased, Musculoskeletal stiffness
Clinical narrative: stomach cramps Feeling of compression of entire thorax pain at the back of the neck extream flushing elevated blood pressure
Age: 43.0
Sex: F
Vaccine: SMALL
Symptoms: Granuloma, Rash
Clinical narrative: Rash on palms of hands 01-2004, rash on face 04-2004-rash on face left scars like scar from smallpox vaccine received 03-04-03. Rash on hands biopsy report-granuloma annulare.
Age: 49.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Arthritis
Clinical narrative: Have had joint pains in differing parts of my body since I have had the Lymerix vacine shots. At first it was diagnosed as possible Arthritis starting. Now every time I mention a pain it gets attributed to Arthritis.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: received immunizations on 5/14/2004. On 5/17/2004 child awakened covered in hives according to mother.  On 5/19/2004 mother called this staff who referred her to her private physician.  Treated with benadryl.
Age: 14.0
Sex: M
Vaccine: HEPA, TD, YF
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Per parent phone call: anaphylaxis reaction after receiving travel shots en route home when he had trouble breathing. Stopped at emergency room - released to home after 2 hrs with tagament and steroid
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: received twinrix 3/22/04 - late 3/23/04 client developed stomach pains, nausea, diarrhea - continued thru the night and into next day. Pt taking OTC medications for diarrhea, by 3/26/04 had recovered
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 12 month old female with no illness at the time of vaccination who on 19Nov2003 at 3:40PM was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) , SC injection in the right thigh and was vaccinated with suspect concomitant therapy varicella virus vaccine live, SC injection in the left thigh at 3:40PM. ON 19Nov2003, 2 minutes later, both thighs at the injection site broke out into urticarial welts. On 19Nov2003, the pt was administered diphenhydramine hydrochloride liquid (BENADRYL) and the welts went away. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old male birth triplet born at 34 weeks gestation (triplets not genetically similar) who on 17Dec2003 at approximately 2:00PM was vaccinated SC into the left arm with first a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . Concomitant medication on 17Dec2003 included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR), IM into the left thigh. The pt developed hives (also reported as a rash) within five minutes of vaccination at approximately 2:10PM. The hives were noted to be on the face, neck, trunk, and extremities. Oral diphenhydramine hydrochloride (Benadryl) was prescribed. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information was received from a physician, the pt's father, who indicated that his son developed and IgE mediated reaction of hives post vaccination. Within one hour post vaccination, the hives were resolving. In follow up information from the physician's office, it was reported that the pt recovered. The reporter indicated that on 13Dec03 the pt received a dose of influenza virus vaccine administered at home by the pt's father who is a physician. The reporter also indicated similar reactions in the pt's two male siblings after therapy with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old male birth triplet (triplets not genetically similar), birth weight 4 lb 4 oz, and who sometimes breaks out in minor eczema, who on 17Dec2003 at 2:00PM was vaccinated SC into the left arm with first 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 pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR) and influenza virus vaccine.  The pt developed hives within five minutes of vaccination. The hives were noted to be on the face, neck and arms. Oral diphenhydramine hydrochloride (Benadryl) was prescribed. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information was received from a physician, the pt's father, who indicated that his son developed and IgE mediated reaction of hives post vaccination. Within one hour post vaccination, the hives were resolving. The reporter also indicated that he wondered if gramicidin (+) neomycin sulfate (+) polymyxin B sulfate (NEOSPORIN) that he occasionally uses when his son's skin cracks around the base of the penis could have triggered the neomycin allergy.  Further information has been received from an employee of the pt's physician, who reported that on 17Dec03, at 2:10PM, the pt developed a rash on his face, neck, trunk and extremities. The pt was treated with diphenhydramine hydrochloride (BENADRYL) within 5 minutes. Subsequently, the pt recovered from the rash.  The reporter also indicated similar reactions in the pt's two male siblings after therapy with measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). No further information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old male birth triplet born at 34 weeks gestation (triplets not genetically similar) who on 12/17/03 at approximately 14:00 was vaccinated SC in the left arm with a first dose of MMRII (Lot # 639512/0471N).  Concomitant medication on 12/17/03 included a fourth dose of Prevnar (Lot # 494-384) IM into the left thigh. The pt developed hives (also reported as a rash) within 5 minutes of vaccination at approximately 2:10pm. The hives were noted to be on the face, neck, trunk and extremities. Oral Benadryl was prescribed. Unspecified medical attention was sought. No diagnostic lab tests were performed. A product quality complaint was not involved. Additional information was received from a physician, the pt's father, who indicated that his son developed and IgE mediated reaction of hives post vaccination. Within one hour post vaccination, the hives were resolving.  In follow up information from the physician's office, it was reported that the pt recovered. The reporter indicated that on 12/13/03 the pt received a dose of influenza virus vaccine (unspecified)(manufacturer unknown) administered at home by the pt's father who is a physician.  The reporter also indicated similar reactions in the pt's two male siblings after therapy with MMRII (WAES # 0312USA02137 & 0312USA02362).  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a RN concerning a 4 year old male with asthma and seasonal allergy who on 09Mar2004 at 11:30 was vaccinated IM in the left arm with a second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy, that same day and at the same time, included a fifth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) given IM in the right arm and a fourth dose of poliovirus vaccine inactivated given IM in the right arm. There was no illness at the time of vaccination. On 09Mar04, within thirty minutes post vaccination, at 12:00, the pt developed urticarial hives over his entire body. He was treated with diphenhydramine hydrochloride (BENADRYL) in the physician's office. Subsequently, the pt recovered from urticarial hives. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Cough, Pruritus, Urticaria, Wheezing
Clinical narrative: Initial information was received from a health professional and a nurse and follow up information from the nurse and nursing supervisor concerning a 4 year old male pt with no illness at the time of vaccination, no history of allergies (also reported as allergy to morphine) and no history of any problems or reactions to any of his previous vaccinations and with a history of a congenital heart problem that had been corrected, noted on follow up to be transposition of great arteries.  On 03/05/04 at 13:00 the pt was vaccinated SC with a first dose of MMRII (Lot # 646898/0950N). Concomitant therapy included aspirin, digoxin and vaccination at 13:00 on 03/05/04 with a first dose of Hepatitis A vaccine (Lot # 647340/1123N) given IM, with a fourth dose of DTP (Daptacel, Lot # C1679AA), given IM and with a third dose of IPV (Lot # X0707) given SC. Subsequently the pt experienced itching, wheezing and hives (also reported as itchy rash and cough developed within one minute of vaccine and wheezing developed soon after). Follow up information reported that the child's reaction was considered to be an anaphylactic reaction with an immediate onset after vaccination. The child's oxygen saturation went down on the pulse oximetry (value not reported) and then went back up, so oxygen was not required. The pt was not hospitalized. Unspecified medical attention was sought. There was no diagnostic or lab testing done. The pt was treated with two doses of epinephrine, oral Benadryl and an oral steroid prenisolone and was monitored in the office. The pt recovered on 03/05/04.  Follow up information reported that the physician thought that the MMRII vaccine was the primary suspect drug. The nurse reported that they were not sure if any of the other vaccinations were suspect because the reaction occurred immediately after the MMRII was given. Upon internal review, anaphylactic reaction was determined to be an other important medical event (OMIC).  The nurse also reported that a male pt experienced an anaphylactic reaction following vaccination with MMRII (WAES # 0403USA02121).  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Pruritus, Urticaria, Wheezing
Clinical narrative: Initial information was received from a health professional and a nurse and follow up information from the nurse and nursing supervisor concerning a 4 year old male pt with no illness at the time of vaccination, no history of allergies (also reported as allergy to morphine) and no history of any problems or reactions to any of his previous vaccinations and with a history of a congenital heart problem that had been corrected, noted on follow up to be transposition of great arteries.  On 03/05/04 at 13:00 the pt was vaccinated SC with a first dose of MMRII (Lot # 646898/0950N). Concomitant therapy included aspirin, digoxin and vaccination at 13:00 on 03/05/04 with a first dose of Hepatitis A vaccine (Lot # 647340/1123N) given IM, with a fourth dose of DTP (Daptacel, Lot # C1679AA), given IM and with a third dose of IPV (Lot # X0707) given SC. Subsequently the pt experienced itching, wheezing and hives (also reported as itchy rash and cough developed within one minute of vaccine and wheezing developed soon after). Follow up information reported that the child's reaction was considered to be an anaphylactic reaction with an immediate onset after vaccination. The child's oxygen saturation went down on the pulse oximetry (value not reported) and then went back up, so oxygen was not required. The pt was not hospitalized. Unspecified medical attention was sought. There was no diagnostic or lab testing done. The pt was treated with two doses of epinephrine, oral Benadryl and an oral steroid prenisolone and was monitored in the office. The pt recovered on 03/05/04.  Follow up information reported that the physician thought that the MMRII vaccine was the primary suspect drug. The nurse reported that they were not sure if any of the other vaccinations were suspect because the reaction occurred immediately after the MMRII was given. Upon internal review, anaphylactic reaction was determined to be an other important medical event (OMIC).  The nurse also reported that a male pt experienced an anaphylactic reaction following vaccination with MMRII (WAES # 0403USA02121).  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR, DTAP, HEPA, IPV, MMR
Symptoms: Anaphylactic reaction, Cough, Pruritus, Urticaria, Wheezing
Clinical narrative: Initial information was received from a health professional and a nurse and follow up information from the nurse and nursing supervisor concerning a 4 year old male pt with no illness at the time of vaccination, no history of allergies (also reported as allergy to morphine) and no history of any problems or reactions to any of his previous vaccinations and with a history of a congenital heart problem that had been corrected, noted on follow up to be transposition of great arteries.  On 03/05/04 at 13:00 the pt was vaccinated SC with a first dose of MMRII (Lot # 646898/0950N). Concomitant therapy included aspirin, digoxin and vaccination at 13:00 on 03/05/04 with a first dose of Hepatitis A vaccine (Lot # 647340/1123N) given IM, with a fourth dose of DTP (Daptacel, Lot # C1679AA), given IM and with a third dose of IPV (Lot # X0707) given SC. Subsequently the pt experienced itching, wheezing and hives (also reported as itchy rash and cough developed within one minute of vaccine and wheezing developed soon after). Follow up information reported that the child's reaction was considered to be an anaphylactic reaction with an immediate onset after vaccination. The child's oxygen saturation went down on the pulse oximetry (value not reported) and then went back up, so oxygen was not required. The pt was not hospitalized. Unspecified medical attention was sought. There was no diagnostic or lab testing done. The pt was treated with two doses of epinephrine, oral Benadryl and an oral steroid prenisolone and was monitored in the office. The pt recovered on 03/05/04.  Follow up information reported that the physician thought that the MMRII vaccine was the primary suspect drug. The nurse reported that they were not sure if any of the other vaccinations were suspect because the reaction occurred immediately after the MMRII was given. Upon internal review, anaphylactic reaction was determined to be an other important medical event (OMIC).  The nurse also reported that a male pt experienced an anaphylactic reaction following vaccination with MMRII (WAES # 0403USA02121).  Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia, Tremor, Viral infection
Clinical narrative: Information has been received concerning a 12 month old female who on 12/22/03 was vaccinated with a dose of MMR. On 12/22/03, the patient was concomitantly vaccinated with varicella virus vaccine live and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 12/25/03, 3 days post vaccination, the patient developed a fever ranging from 99.7 to 102.6. At 10:00 PM on 12/25/03, the patient developed tremors and generalized seizure. She was transported to the emergency room. The patient was diagnosed with febrile seizure, viral illness versus reaction to MMR, varicella virus vaccine live and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. Upon internal review, the patient's febrile convulsion was considered an other medical event (OMIC). Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Tremor
Clinical narrative: Information has been received concerning a 12 month old female who on 12/22/03 was vaccinated with a dose of MMR. On 12/22/03, the patient was concomitantly vaccinated with varicella virus vaccine live and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. On 12/25/03, 3 days post vaccination, the patient developed a fever ranging from 99.7 to 102.6. At 10:00 PM on 12/25/03, the patient developed tremors and generalized seizure. She was transported to the emergency room. The patient was diagnosed with febrile seizure, viral illness versus reaction to MMR, varicella virus vaccine live and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine. Upon internal review, the patient's febrile convulsion was considered an other medical event (OMIC). Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Feeling hot, Rash, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a RN concerning a 4 year old male with no allergies who on 03Nov2003 was vaccinated with a first dose of measles-mumps-rubella vaccine administered SC in the left. Concomitant therapy that day included a fourth dose of poliovirus vaccine inactivated. On approximately 04Nov03 the pt developed 5 generalized small raised bumps which were 1/2 inch diameter and felt warm. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a RN indicated that on 04Nov2003 the pt developed a rash with small red bumps (two on his chin, one on his neck, one on his arm, and one on his thumb). Each bump was 1/2 inch in diameter and raised. The pt "felt warm". No temperature was taken. The outcome was reported as not recovered, yet the date of recovery was reported as 10Nov03. The nurse also reported that the pt was vaccinated on 04Sep2003 with a dose of hepatitis A virus vaccine inactivated and the pt had a similar reaction that resolved within a few days. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Feeling hot, Rash maculo-papular
Clinical narrative: Information has been received from a RN concerning a 4 year old male with no allergies who on 03Nov2003 was vaccinated with a first dose of measles-mumps-rubella vaccine administered SC in the left. Concomitant therapy that day included a fourth dose of poliovirus vaccine inactivated. On approximately 04Nov03 the pt developed 5 generalized small raised bumps which were 1/2 inch diameter and felt warm. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a RN indicated that on 04Nov2003 the pt developed a rash with small red bumps (two on his chin, one on his neck, one on his arm, and one on his thumb). Each bump was 1/2 inch in diameter and raised. The pt "felt warm". No temperature was taken. The outcome was reported as not recovered, yet the date of recovery was reported as 10Nov03. The nurse also reported that the pt was vaccinated on 04Sep2003 with a dose of hepatitis A virus vaccine inactivated and the pt had a similar reaction that resolved within a few days. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Child maltreatment syndrome, Coma, Diarrhoea, Injury, Lethargy
Clinical narrative: Lethargic. Developed an upper respiratory infection, diarrhea, vomiting.  Nurse follow up on 06/30/04 states: "ADD: shaken baby syndrome, retinal hemorrhage, tachycardia, unresponsive."  Nurse follow up on 07/27/04 states: "manner of death was Homicide."  Nurse follow up on 07/30/04 states: "Complete."
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Retinal haemorrhage, Tachycardia, Upper respiratory tract infection, Vomiting
Clinical narrative: Lethargic. Developed an upper respiratory infection, diarrhea, vomiting.  Nurse follow up on 06/30/04 states: "ADD: shaken baby syndrome, retinal hemorrhage, tachycardia, unresponsive."  Nurse follow up on 07/27/04 states: "manner of death was Homicide."  Nurse follow up on 07/30/04 states: "Complete."
Sex: F
Vaccine: RAB
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Hypersensitivity, Oedema peripheral
Clinical narrative: A 43 year old female with exposure to dog saliva with rabies developed an allergic reaction and dizziness after immunization of RabAvert for post exposure treatment. The patient received her second dose of RabAvert (IM injection into the deltoid) on 5/25/04. Her past medical history was non-contributory, and she was not on any concomitant medication. Her past vaccination history included pre-exposure prophylaxis rabies vaccine. On 6/1/04, one week after the immunization, she developed hives which she self-treated with Benadryl 50mg three times daily. On 6/2/04, the hives continued and she began to develop swelling in throat, lips, tongue, and extremities. The patient reported to the emergency room at this time where she received treatment with epinephrine, prednisone 20mg three times daily, and Atarax 25mg twice daily. In addition to the above symptoms, she also reported dizziness. On 6/3/04, the patient was evaluated by her primary care physician who felt that these events were secondary to an allergic reaction to RabAvert. She was also evaluated by an allergist on 6/4/04 who discontinued her prednisone and started her on Medrol and hydrochlorothiazide. At this time, the patient reported to have an episode of elevated blood pressure (170/100) which was attributed to the treatment with corticosteroids. Currently, all symptoms were noted to improve with the exception of the swelling of extremities, which remained. Follow up information received 6/11/04: On 6/4/04, the patient developed recurrence of hives, and swelling of throat and extremities. She also noted some chest tightness and felt edematous. Her blood pressure remained elevated. She proceeded to the emergency room where she received treatment with Solu Cortef IV and Tagamet IV. She was cleared from the ER after four hours. She was re-evaluated by her allergist following the events. Her allergist felt that her symptoms were a continuation of the allergic reaction, which was thought to be a serum sickness like reaction from RabAvert. In addition, the edema and elevated blood pressure were believed to be a consequence of the steroid treatment. She was instructed to continue with Medrol, Atarax, and Zyrtec. On 6/11/04, she completed her treatment with Medrol. Her hives had completely resolved by this time. Her other symptoms continued to improve. (OMIC)
Sex: F
Vaccine: RAB
Symptoms: Pharyngeal oedema, Serum sickness, Swelling face, Tongue oedema, Urticaria
Clinical narrative: A 43 year old female with exposure to dog saliva with rabies developed an allergic reaction and dizziness after immunization of RabAvert for post exposure treatment. The patient received her second dose of RabAvert (IM injection into the deltoid) on 5/25/04. Her past medical history was non-contributory, and she was not on any concomitant medication. Her past vaccination history included pre-exposure prophylaxis rabies vaccine. On 6/1/04, one week after the immunization, she developed hives which she self-treated with Benadryl 50mg three times daily. On 6/2/04, the hives continued and she began to develop swelling in throat, lips, tongue, and extremities. The patient reported to the emergency room at this time where she received treatment with epinephrine, prednisone 20mg three times daily, and Atarax 25mg twice daily. In addition to the above symptoms, she also reported dizziness. On 6/3/04, the patient was evaluated by her primary care physician who felt that these events were secondary to an allergic reaction to RabAvert. She was also evaluated by an allergist on 6/4/04 who discontinued her prednisone and started her on Medrol and hydrochlorothiazide. At this time, the patient reported to have an episode of elevated blood pressure (170/100) which was attributed to the treatment with corticosteroids. Currently, all symptoms were noted to improve with the exception of the swelling of extremities, which remained. Follow up information received 6/11/04: On 6/4/04, the patient developed recurrence of hives, and swelling of throat and extremities. She also noted some chest tightness and felt edematous. Her blood pressure remained elevated. She proceeded to the emergency room where she received treatment with Solu Cortef IV and Tagamet IV. She was cleared from the ER after four hours. She was re-evaluated by her allergist following the events. Her allergist felt that her symptoms were a continuation of the allergic reaction, which was thought to be a serum sickness like reaction from RabAvert. In addition, the edema and elevated blood pressure were believed to be a consequence of the steroid treatment. She was instructed to continue with Medrol, Atarax, and Zyrtec. On 6/11/04, she completed her treatment with Medrol. Her hives had completely resolved by this time. Her other symptoms continued to improve. (OMIC)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Coordination abnormal, Diarrhoea, Guillain-Barre syndrome, Hyporeflexia, Laboratory test abnormal
Clinical narrative: Patient complained of pain of extremities and presented with ataxia and absent reflexes. Diagnosed with Guillian-Barre Syndrome. Received IVIG and physical therapy. No lumbar tap (parents refused).  Nurse follow up on 07/27/04 states: "diarrhea."  Per annual report- have not seen patient in the office since 4-15-04.  Have not spoken to family since 4-19-04.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pain
Clinical narrative: Patient complained of pain of extremities and presented with ataxia and absent reflexes. Diagnosed with Guillian-Barre Syndrome. Received IVIG and physical therapy. No lumbar tap (parents refused).  Nurse follow up on 07/27/04 states: "diarrhea."  Per annual report- have not seen patient in the office since 4-15-04.  Have not spoken to family since 4-19-04.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Face oedema, Pyrexia, Sepsis
Clinical narrative: Possible vaccine failure. Patient developed invasive bacteremia (streptococcus pneumoniae). Patient has a history of hypogammaglobulemia.  Nurse follow up for 06/25/04 states: "No new information."  Nurse follow up on 08/26/04 states: "swelling (L) cheek; fever."
Age: 35.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Arthralgia, Body temperature increased, Chromaturia, Fatigue, Jaundice
Clinical narrative: Increased temperature, arthralgia, fatigue. Ruddy rash, arms and thighs. Jaundice, nausea, vomiting. Mild renal damage-resolved, dark urine.
Age: 35.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Nausea, Rash, Renal disorder, Vomiting
Clinical narrative: Increased temperature, arthralgia, fatigue. Ruddy rash, arms and thighs. Jaundice, nausea, vomiting. Mild renal damage-resolved, dark urine.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Chest pain, Urticaria
Clinical narrative: 1) Crushing chest pain @ 4 hours later for 4 hours. 2) Welts developing @ 24 hours later. 3) More welts @ 36 hours later, seen at ER, received antibiotics and was told of possible embolism. 4) Additional welts @ 72 hours, seen by MD, chest x-ray and increased antibiotics.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema
Clinical narrative: Swollen tricep;
Age: 37.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Hypoaesthesia, Oedema, Pain, Pruritus, Skin burning sensation
Clinical narrative: 06/12/04: Burning itching (use ice to soothe). 06/13/04: Swelling, burning, itching, numbness, pain when breathing, entire arm especially hand. 06/14/04: Same as on 06/13/04 and arm joints aching, intensity increased when lying down at night-breathing ok. 06/15/04: Same as on 06/14/04 but less intensity. Saw physician on 06/16/04-no treatment pt recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Anorexia, Headache, Lethargy, Oedema
Clinical narrative: Pt was given MMRI on 06/17/04.  2 hours later, fever, 2pm-lethargy, anorexia, around 4pm. Headache, on 06/18/04 vomiting, rash. Stomach pain for 2 days, on Sunday testicular swelling spent day at ER.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Pt was given MMRI on 06/17/04.  2 hours later, fever, 2pm-lethargy, anorexia, around 4pm. Headache, on 06/18/04 vomiting, rash. Stomach pain for 2 days, on Sunday testicular swelling spent day at ER.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Blister, Erythema, Injection site induration, Oedema
Clinical narrative: Erythema, induration and swelling of left arm developed within 24 hours of vaccination in left arm with DTAP and IPV. Clear blisters also developed around injection site. Symptoms and signs resolving with oral Benadryl and Ibuprofen.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: DTAP given 06/15/04.  Injection site how with 10x10cm erythematous, hard, warm, tender area. Augmentin prescribed for cellulitis.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: No treatment needed. Vaccine administered at 15:00 on 06/17/04.  Awoke in AM with spots mostly on back and abdomen on 06/18/04.  Itching client self prescribed hydrocortisone. Client reporter this to Health Department, when ask if it looked like a rash, client stated more like spots.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site oedema
Clinical narrative: Pt developed huge swelling of the left arm from shoulder to elbow. No pain, full range of motion present.
Age: 1.3
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site infection
Clinical narrative: Localized infection at site of Comvax. Omnicef 200 twice a day for 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site warmth, Pain
Clinical narrative: Left injection site swollen (thigh); warm to touch and very sore. Swollen from 5cm below left inguinal area to lower part of left knee (left thigh 31cm circumference, right thigh 29cm)
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Face oedema, Urticaria
Clinical narrative: Swelling of left face and lid-resolved. Mild urticaria. No treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Tenderness
Clinical narrative: Today (2 day after vaccine) mom noted erythema, warmth, induration and tenderness at site. No fever or other systemic symptoms. On PE there is an area of approximately 9cm in max diameter of edema, induration, erythema and warmth with injection site at center. No vesicles, excoration or break in skin noted. No axillary nodes; Treatment symptomatic (+) cephalexin (abx) prescribed for 10 days.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right thigh: red, swelling at the 2 shots on right thigh.
Age: 1.0
Sex: F
Vaccine: HBHEPB, IPV, MMR
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Temperature of 103.7 on 06/16/04 at 10:00PM. Fever decreased to 101.8 on 06/17/04 AM. MD notified. Left leg have a knot. Advised to see MD today 06/17/04.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red, swollen arm from shoulder to elbow. No fever, no pain.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Chickenpox clinically 05/24/04.  Vaccine x2 seems to have been ineffective.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Rash
Clinical narrative: Rash locally;
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Rash vesicular
Clinical narrative: See attached dictation - 04/30/04 - Local reaction.  05/20/04: Vesicular rash at injection site, viral studies done: negative.  The pt is a 5 year old white male with history as above. Basically, he has had some erythema and swelling at the injection site from a recent immunization done 3 days ago. Prescribed: Empiric therapy with Keflex 250mg per mouth three times a day for 7 days. Atarax 10-20 mg per mouth twice daily as needed. Return or call back if symptoms worsen or persist and this was discussed.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left forearm became edematous, red and warm after vaccination. No fever. Given Benadryl and Tylenol in clinic. Called family 06/17/04: Child better, on Keflex for 10 days.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Feeling hot, Swelling
Clinical narrative: Pt states when got up this AM Left arm red and swollen, hot to touch. Tylenol taken. Instructed to apply ice
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Localized redness, edema, warmth at site-left forearm. No treatment necessary.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Feeling hot, Injection site mass
Clinical narrative: Feverish knot that is elongated to approx 7 in.
Age: 1.33
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Feeling hot, Injection site mass
Clinical narrative: Large, feverish knot that continued to enlarge to approx 4 in. in diameter. The knot tended to be above the skin, more than under.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Pyrexia, Rash
Clinical narrative: febrile rash, face bright red, fine red rash, T 100 AA P120 R20, Tx-Atarax and Tylenol. Observed x1 hr, released.
Age: 17.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Approximately 24 hrs after administration developed soreness and swelling at injection site with fever 101. 6/17 still with swelling. Fever resolved.