chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Bilirubinuria, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: 5/30/08, Headache, sore throat, fever, emesis, fatigue, bilirubinuria, lasted 5 days.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blood bilirubin normal, Fatigue, Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 5/30/08, Headache, sore throat, fever, emesis, fatigue, bilirubinuria, lasted 5 days.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Urine analysis abnormal, Vomiting, White blood cell count increased
Clinical narrative: 5/30/08, Headache, sore throat, fever, emesis, fatigue, bilirubinuria, lasted 5 days.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Pruritus
Clinical narrative: Mother states developed nickle-sized area at site - red, warm to touch, plus itch.  Evaluation on 5/16/08 - right arm cellulitis after immunization reaction.  Area marked; Keflex BID for 10 days.  Mother to monitor, advised to call for continued or increased symptoms.  No call received (area 2 in x 1.5 in).
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swollen and redness of left deltoid.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash erythematous
Clinical narrative: 6/11/08 VARIVAX given right arm SQ.  Child had 4" x 4" red erythematous area - 48 hours after shot on 6/9/08.  Seen by us and advised to use compress and Advil for comfort.  A dose of Benadryl one teaspoon to be given if itching.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On 6/10/08 - caregiver reported S/S and RN verified approx 5 cm red area at injection site on (R) upper arm - area warm to touch. Patient c/o painful to touch - observed at 1700 on 6/10/08.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash
Clinical narrative: Patient developed rash consistent with varicella 6/10/08. Treated symptomatically with Benadryl.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Urticaria
Clinical narrative: After receiving DTaP; Hep A in the thigh, within a hour, child presented with body hives/upper and lower extremities and torso. Was seen by same doctor in PM. Gave Rx for Benadryl Elixir and Orapred.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Local reaction, Oedema, Skin warm
Clinical narrative: Localized reaction with erythema, edema, induration & warmth.  No edema at lips/tongue/throat.  No mental status changes.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Hives developed 48 hrs after PNEUMOVAX immunization.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pyrexia, Urticaria
Clinical narrative: Patient developed hives 6-6-08, and took BENADRYL Q 6 hours.  On 6-7-08, pt still had hives, then developed fever, and joint pain.  Dr. recommended pt. go to ER, where she received prednisone, ZANTAC, and DECADRON inj.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Clinical shingle after immunization.  No known history of natural varicella.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash papular, Rash pustular, Viral infection
Clinical narrative: 5/27/08 Per mom developed (1) lesion on shoulder area, some itchiness noted. New lesions < 12 developed papular, pustular rash on trunk and extremities; some areas crusted on exam 6/2/08. Diagnosed with varicella infection; comfort measures reviewed.
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Erythema left deltoid approximately 3cm below injection site.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: Information has been received from a Hair Dresser concerning her 13 year old niece who in approximately January 2008, was vaccinated with a first dose of GARDASIL. There were no concomitant medications. She reported that a "couple of days ago" while doing her niece's hair (giving her highlights) she noticed the color bubbled up and got hot really quickly. The hair turned from brown to blond within a minute and she had to wash it off. She reported the hair was not permanently damaged. The patient did not seek medical attention. The patient's outcome was reported as recovered. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Drug exposure during pregnancy, Placental disorder, Wrong drug administered
Clinical narrative: Initial report received on 08/Sep/2006 from a health care professional. A 28-year-old female patient with a past medical history of one spontaneous abortion, hypertension, and depression had inadvertently received a 0.5 mL intra-muscular dose of ADACEL, lot number 2557AA, in the left deltoid, on 08/Sep/2006 instead of a DTaP vaccine. The patient's physician did not want the patient to receive the pertussis portion of ADACEL, he only wanted her to receive a Tetanus Diptheria vaccine since she was at 17 weeks gestation. The dates of the patient's last menstrual period was 08/May/2006, and her expected date of delivery is 12/Feb/2007. Per the reporter, the patient has not experienced any adverse events since the vaccination with ADACEL on 08/Sep/2006. Follow-up information received on 27 October 2006. Request for authorization for release of reporter name and contact information to the center specialists was also received. The subject had no concurrent illnesses at the time of the vaccination with ADACEL on 08 September 2006. The ADACEL vaccination was received at 10:00 am on 08 September 2006. It was previously reported that the patient had a history of one spontaneous abortion. Per the reporter, this is not the case. The patient has not had any previous obstetrical history. The date of the subject's last menstrual period was on 06 May 2006, not 08 May 2006 as previously reported. The expected date of delivery remains the same. The subject had an ultrasound on 19 September 2006 that showed a low lying placenta. Per the reporter, the subject has not experienced any other adverse events since the vaccination with ADACEL on 08 September 2006. A Corrective version was created to ammend the outcome/seriousness criteria from Category I to Category II. No new medical information was received.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Antepartum haemorrhage, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Initial report received on 07/Sep/2006 from a nurse.  A 24-year-old female patient with a past medical history of three pregnancies that resulted in the delivery of three, live, full-term babies, and who currently takes ranitidine for nausea had received a 0.5 mL intra-muscular dose of ADACEL, lot number C2457AA, in the left deltoid on 07/Jul/2006.  The patient had a negative pregnancy test at the time of the vaccination.  The date of the patient's last menstrual period was 15/Jul/2006, and her expected date of delivery is 03/Jul2007.  On 31/Aug/2006, the patient had an ultrasound to determine the expected date of delivery, and a small subchorionic hemorrhage was noted.  According to the reporter, the patient had not experienced any adverse events since the vaccination on 07/Jul/2006.  A corrective version was created for the sole purpose of adding the adverse event previously reported of sub-chorionic hemorrhage that was noted on ultrasound on 31/Aug/2006.  No new information was received.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Chest X-ray normal, Cough, Fatigue, Full blood count normal, Headache
Clinical narrative: Initial report received on 06/Sep/2006 from the patient's parent who is also a physician.  A 17-year-old male patient had received a left deltoid, first dose injection of ADACEL, lot number unknown, on 21/Jul/2006.  Twenty-three days later, on 13/Aug/2006, he developed a sore throat, was evaluated by a nurse practitioner and treated with Zythromycin.  He was re-evaluated 24-48 hours later for persistent sore throat and the development of a cough.  No cultures were obtained at that time.  He was examined by a physician again on 24/Aug/2006 in an urgent care center for persistent cough, headache and fatigue.  On that day, he had a CBC, chemistry panel and thyroid function tests which were "all normal".  He was given a second pack of Zythromycin.  On 30/Aug/2006, he was examined by his regular physician.  A chest x-ray and pulmonary function test were performed and were normal.  The patient was evaluated for exercise induced asthma because "when he was at football practice the week before the onset of symptoms, the symptoms were exacerbated by physical activity".  The diagnosis of exercise induced asthma was ruled out.  The patient was prescribed Prednisone (start date not reported), and the parent reported that the patient's cough had improved after being on Prednisone.  The parent had contacted the company, on 06/Sep/2006 and reported that within three weeks after receiving ADACEL her son became ill with a fulminant pertussis like illness from which "he is still ill now on 06/Sep/2006".  The parent also reported that she had contacted the patient's physician and was told that her son did not have pertussis or a pertussis like illness and that his illness was not related to the vaccine.  At the time of this report, the patient had not recovered.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Laboratory test normal, Pharyngolaryngeal pain, Pulmonary function test normal, Thyroid function test normal
Clinical narrative: Initial report received on 06/Sep/2006 from the patient's parent who is also a physician.  A 17-year-old male patient had received a left deltoid, first dose injection of ADACEL, lot number unknown, on 21/Jul/2006.  Twenty-three days later, on 13/Aug/2006, he developed a sore throat, was evaluated by a nurse practitioner and treated with Zythromycin.  He was re-evaluated 24-48 hours later for persistent sore throat and the development of a cough.  No cultures were obtained at that time.  He was examined by a physician again on 24/Aug/2006 in an urgent care center for persistent cough, headache and fatigue.  On that day, he had a CBC, chemistry panel and thyroid function tests which were "all normal".  He was given a second pack of Zythromycin.  On 30/Aug/2006, he was examined by his regular physician.  A chest x-ray and pulmonary function test were performed and were normal.  The patient was evaluated for exercise induced asthma because "when he was at football practice the week before the onset of symptoms, the symptoms were exacerbated by physical activity".  The diagnosis of exercise induced asthma was ruled out.  The patient was prescribed Prednisone (start date not reported), and the parent reported that the patient's cough had improved after being on Prednisone.  The parent had contacted the company, on 06/Sep/2006 and reported that within three weeks after receiving ADACEL her son became ill with a fulminant pertussis like illness from which "he is still ill now on 06/Sep/2006".  The parent also reported that she had contacted the patient's physician and was told that her son did not have pertussis or a pertussis like illness and that his illness was not related to the vaccine.  At the time of this report, the patient had not recovered.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Laboratory test
Clinical narrative: Case received from a healthcare professional through MIS/VIS on 22/Aug/2006 under the local reference number 06-381.  A 60-year-old female patient with medical history of asthma and GERD and who had fatigue at time of vaccination, had received an intramuscular dose of ADACEL, batch number C2556AA, in the left arm on 16/Aug/2006.  5 days later, i.e on 21/Aug/2006, she experienced 6 cm redness and swelling at injection site leading to doctor visit.  The diagnosis was "cellulitis" however no cultures were done.  She received KEFLEX.  It was worth noting that she had concomitant treatments with NASONEX, LEVOXYL, "PRIEDCID" and SINGULAIR.  The patient was not recovered at the time of the report.  Follow-up information received on 18/Sep/2006.  Per the reporter, the patient had the flu at the time of the vaccination, and laboratory work was performed.  The results of the laboratory work were not reported.  The ADACEL was administered on 16/Aug/2006, not 26/Aug/2006 as previously reported.  The ADACEL was a booster dose for the patient.  The patient's recovery status was not reported.  Follow-up information received on 29/Sep/2006 from a health care provider.  The patient recovered completely by 31/Aug/2006.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Migraine, Musculoskeletal stiffness, Pain
Clinical narrative: Initial report received on 25/Aug/2006 from the patient. A 44-year-old female patient with no acute illnesses, and medical history of celiac disease had received a dose of ADACEL (lot number unknown), in the right deltoid, on 17/Aug/2006. The route of administration of ADACEL was not reported. The patient's last Tetanus Diphtheria vaccination was 10 years ago. The evening of 17/Aug/2006, the patient experienced arm stiffness, and generalized aches that have lasted eight days. 24 hours post-immunization, the patient developed a severe migraine headache, generalized arthritic pain in the joints, and extreme fatigue/exhaustion. The patient required medical evaluation, but treatment and diagnostic testing/laboratory data were not reported. The severity of the headache lessened seven days after onset, but was continuing at the time of this report. The events of generalized arthritic pain in the joints and extreme fatigue/exhaustion resolved seven days after onset.
Age: 60.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Initial report received from a physician on 02/Mar/2006.  A 60-year-old female patient with a history of drug allergies developed local injection site itching followed by a pinkish rash, warmth and "indurated (well demarcated)" area 5 x 8cm seven days following the injection of DECAVAC, lot number U1620AA in the right deltoid on 22/Feb/2006.  Per reporter there was no nodule present.  A one inch needle was used to administer DECAVAC.  The patient had no illness at the time of vaccination.  She was seen by a physician on 02/Mar/2006.  Her last Td booster is unknown.  It was reported she had the same local reaction following the flu vaccine in 1996.
Age: 60.0
Sex: F
Vaccine: DT
Symptoms: Local reaction
Clinical narrative: Initial report received from a physician on 02/Mar/2006.  A 60-year-old female patient with a history of drug allergies developed local injection site itching followed by a pinkish rash, warmth and "indurated (well demarcated)" area 5 x 8cm seven days following the injection of DECAVAC, lot number U1620AA in the right deltoid on 22/Feb/2006.  Per reporter there was no nodule present.  A one inch needle was used to administer DECAVAC.  The patient had no illness at the time of vaccination.  She was seen by a physician on 02/Mar/2006.  Her last Td booster is unknown.  It was reported she had the same local reaction following the flu vaccine in 1996.
Age: 73.0
Sex: F
Vaccine: DT
Symptoms: Cellulitis, Injection site oedema, Local reaction
Clinical narrative: Initial report received on 22/Feb/2006 from a health care professional.  A 73-year-old female patient who no reported past medical history, had received an administration (route not reported) of DECAVAC, lot number U1703CA, in the left deltoid on 24/Jan/2006.  Two day later, the patient developed increased local edema at the injection site and was diagnosed with cellulitis.  Per the reporter, the patient was treated with antibiotics and no further office visits were completed.  At the time of this report, it is unknown if the patient recovered from these events.
Age: 29.0
Sex: F
Vaccine: DT
Symptoms: Oedema peripheral
Clinical narrative: Initial report received from a licensed Practical Nurse on 06/Feb/2006. A 29-year-old female patient developed a "large swollen left arm" two days after receiving the intramuscular injection of DECAVAN, lot number U1636CA (expiry date 08/Jun/2007) on 01/Feb/2006. The patient received immunization at her routine physical and had no illness at the time. Treatment and recovery status was not reported.
Age: 24.0
Sex: F
Vaccine: DT
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Initial report received from the vaccine provider on 26/Jan/2006.  A 24-year-old female patient, with a history of an allergy to AUGMENTIN, received an intramuscular, right deltoid injection of DECAVAC, manufacturer sanofi pasteur, lot number U1637BA, on 19/Jan/2006.  The next day she experienced redness and pain at the injection site.  One day after that, she was examined in an emergency room and diagnosed with cellulitis and treated with intravenous ROCEPHIN.  She was also administered KEFLEX per os.  The patient had no illness at the time of vaccination, and other medications included ORTHO TRI-CYCLEN LO and LEXAPRO.  At the time of this report, the patient had recovered.
Sex: M
Vaccine: DT
Symptoms: Confusional state
Clinical narrative: Initial report received on 29/Dec/2005 from a health care professional. A male patient of unknown age and date of birth had received an administration (route and site not reported) of DECAVAC (lot number not reported) on an unspecified date for a wound. Two to three weeks later, the patient received another administration of DECAVAC in the physicians office. At an unspecified time later, the facility where the patient resides reported an increase in the patient's confusion. It is unknown if the patient recovered from this adverse event at the time of this report. Follow-up information received on 27/Jan/2006. Per the reporter, when the adverse events were reported to the physician, the physician felt all changes in the patient' condition were related to his chronic disease state (disease state not reported). The physician did not feel the application of the DECAVAC had anything to do with the patient's decline.
Age: 11.0
Sex: M
Vaccine: DT
Symptoms: Chills, Lymphadenitis, Lymphadenopathy, Pain in extremity
Clinical narrative: Initial report received from a physician on 18/Nov/2005.  An 11-year-old male patient developed left axillary swelling, adenopathy extending upper part of the chest wall, subjective chills and his arm was painful upon movement within 24 hours of receiving the intramuscular injection of DECAVAC, lot number U1620AA in the left deltoid on 16/Nov/2005.  There was no fever or rash.  The patient denies any illness at the time of vaccination.  Treatment and recovery status was not reported.  Follow-up information received on 13/Feb/2006 from a health care provider.  The patient recovered, and there is no additional information at this time.
Age: 37.0
Sex: F
Vaccine: DT, HEPA
Symptoms: Dysgeusia
Clinical narrative: Initial report received from a nurse on 02/Nov/2005.  A 37-year-old female complained of a metallic, bitter taste in her mouth 10-14 days after receiving the injection of DECAVAC, lot number U1576BA.  Route and site of administration was not reported.  Vaccine was received "approximately 02/Sep/2005.  The patient received in concomitant HAVRIX, lot number not reported.  The patient had no other complaints.  The patient also received the flu shot after the symptoms started.  She was seen by an ENT specialist on 02/Nov/2005.  A mirror exam was within normal limits.  A scope was not performed.  The patient denies any medications or injections in the month prior to receiving the immunization, nor has she experienced these symptoms previously.  As per the reporter the patient has not recovered.
Age: 63.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received on 31/Oct/2005 from a health care professional. A 53-year-old patient had received an intra-muscular injection of DECAVAC, lot number U1597CA in the left deltoid on 12/oct/2005. At an unspecified time later, the patient developed redness, swelling, itching, nodule and pain at the injection site. Per the reporter, it is unknown if the patient recovered from these events. The reporter of this case is the same as for cases 2005-02253, 2005-02254, 2005-02255, 2005-02256.
Age: 13.0
Sex: M
Vaccine: DT, HEPA, MNQ
Symptoms: Abdominal discomfort, Abdominal pain upper, Bacteria urine identified, Blood creatinine decreased, Blood urine present
Clinical narrative: Post-licensure Safety Surveillance Study of Routine Use of MENACTRA, trial code MTA30. Initial report received on 04/Oct/2005 from a investigator participating in the above-mentioned trial under the reference number MTA30. A 13- year-old male subject developed febrile illness with nausea, vomiting and fever one day after he received an injection of MENACTRA, lot number U1589AA. The subject received in concomitant an injection of DECAVAC, lot number U1565CA and Hepatitis A vaccine lot number 0202R. The subject took 2 Advil at 0430. He had vomited three times since 0300. The subject was seen in the emergency department on 06/Aug/2005. He has had a moderate fever and headache as well as complaints of nausea, vomiting and fever since receiving immunization the day prior. Right now he feels much better. His mother brought him to ER because his heart was beating (illegible). At 0820 an IV was started, with Ziofran. At 0915 - Mom was at her son's bedside and he was resting comfortably although was complaining of stomach pain. The subject still thinks he is hungry and it is causing abdominal discomfort. No PHM. Review of systems notable for fever, nausea/vomiting/diarrhea. Heart rate was regular rhythm and rate. A urinalysis on 06/Aug/2006 showed appearance-cloudy, blood-small, ketones - 40mg%, protein 100mg%, Bacteria - occasional, mucus - 2+, Blood tests showed creatinine low - 0.6 (normal 0.8 - 1.5), neutrophils high - 85% (normal 50 -70), Lymphocytes low - 5% 9 normal 20 - 70). The subject was discharged at 0950 with a diagnosis of fever, vomiting and diarrhea with instructions to follow-up with the pediatrician. The patient recovered. Documents held by sender: Laboratory Results (urinalysis, chemistry, CBC), 12-18 year old Adolescent visit Report. Pediatric and adult injection/treatment slip, Consent form x2, Emergency Department Physician Record, Medical Screening Exam, Medication Administration Record, Emergency Department nurse's notes, Emergency Department Triage form.
Age: 13.0
Sex: M
Vaccine: DT, HEPA, MNQ
Symptoms: Diarrhoea, Headache, Heart rate normal, Lymphocyte percentage decreased, Nausea
Clinical narrative: Post-licensure Safety Surveillance Study of Routine Use of MENACTRA, trial code MTA30. Initial report received on 04/Oct/2005 from a investigator participating in the above-mentioned trial under the reference number MTA30. A 13- year-old male subject developed febrile illness with nausea, vomiting and fever one day after he received an injection of MENACTRA, lot number U1589AA. The subject received in concomitant an injection of DECAVAC, lot number U1565CA and Hepatitis A vaccine lot number 0202R. The subject took 2 Advil at 0430. He had vomited three times since 0300. The subject was seen in the emergency department on 06/Aug/2005. He has had a moderate fever and headache as well as complaints of nausea, vomiting and fever since receiving immunization the day prior. Right now he feels much better. His mother brought him to ER because his heart was beating (illegible). At 0820 an IV was started, with Ziofran. At 0915 - Mom was at her son's bedside and he was resting comfortably although was complaining of stomach pain. The subject still thinks he is hungry and it is causing abdominal discomfort. No PHM. Review of systems notable for fever, nausea/vomiting/diarrhea. Heart rate was regular rhythm and rate. A urinalysis on 06/Aug/2006 showed appearance-cloudy, blood-small, ketones - 40mg%, protein 100mg%, Bacteria - occasional, mucus - 2+, Blood tests showed creatinine low - 0.6 (normal 0.8 - 1.5), neutrophils high - 85% (normal 50 -70), Lymphocytes low - 5% 9 normal 20 - 70). The subject was discharged at 0950 with a diagnosis of fever, vomiting and diarrhea with instructions to follow-up with the pediatrician. The patient recovered. Documents held by sender: Laboratory Results (urinalysis, chemistry, CBC), 12-18 year old Adolescent visit Report. Pediatric and adult injection/treatment slip, Consent form x2, Emergency Department Physician Record, Medical Screening Exam, Medication Administration Record, Emergency Department nurse's notes, Emergency Department Triage form.
Age: 13.0
Sex: M
Vaccine: DT, HEPA, MNQ
Symptoms: Neutrophil percentage increased, Protein urine, Pyrexia, Urine analysis abnormal, Urine colour abnormal
Clinical narrative: Post-licensure Safety Surveillance Study of Routine Use of MENACTRA, trial code MTA30. Initial report received on 04/Oct/2005 from a investigator participating in the above-mentioned trial under the reference number MTA30. A 13- year-old male subject developed febrile illness with nausea, vomiting and fever one day after he received an injection of MENACTRA, lot number U1589AA. The subject received in concomitant an injection of DECAVAC, lot number U1565CA and Hepatitis A vaccine lot number 0202R. The subject took 2 Advil at 0430. He had vomited three times since 0300. The subject was seen in the emergency department on 06/Aug/2005. He has had a moderate fever and headache as well as complaints of nausea, vomiting and fever since receiving immunization the day prior. Right now he feels much better. His mother brought him to ER because his heart was beating (illegible). At 0820 an IV was started, with Ziofran. At 0915 - Mom was at her son's bedside and he was resting comfortably although was complaining of stomach pain. The subject still thinks he is hungry and it is causing abdominal discomfort. No PHM. Review of systems notable for fever, nausea/vomiting/diarrhea. Heart rate was regular rhythm and rate. A urinalysis on 06/Aug/2006 showed appearance-cloudy, blood-small, ketones - 40mg%, protein 100mg%, Bacteria - occasional, mucus - 2+, Blood tests showed creatinine low - 0.6 (normal 0.8 - 1.5), neutrophils high - 85% (normal 50 -70), Lymphocytes low - 5% 9 normal 20 - 70). The subject was discharged at 0950 with a diagnosis of fever, vomiting and diarrhea with instructions to follow-up with the pediatrician. The patient recovered. Documents held by sender: Laboratory Results (urinalysis, chemistry, CBC), 12-18 year old Adolescent visit Report. Pediatric and adult injection/treatment slip, Consent form x2, Emergency Department Physician Record, Medical Screening Exam, Medication Administration Record, Emergency Department nurse's notes, Emergency Department Triage form.
Age: 13.0
Sex: M
Vaccine: DT, HEPA, MNQ
Symptoms: Urine ketone body present, Vomiting
Clinical narrative: Post-licensure Safety Surveillance Study of Routine Use of MENACTRA, trial code MTA30. Initial report received on 04/Oct/2005 from a investigator participating in the above-mentioned trial under the reference number MTA30. A 13- year-old male subject developed febrile illness with nausea, vomiting and fever one day after he received an injection of MENACTRA, lot number U1589AA. The subject received in concomitant an injection of DECAVAC, lot number U1565CA and Hepatitis A vaccine lot number 0202R. The subject took 2 Advil at 0430. He had vomited three times since 0300. The subject was seen in the emergency department on 06/Aug/2005. He has had a moderate fever and headache as well as complaints of nausea, vomiting and fever since receiving immunization the day prior. Right now he feels much better. His mother brought him to ER because his heart was beating (illegible). At 0820 an IV was started, with Ziofran. At 0915 - Mom was at her son's bedside and he was resting comfortably although was complaining of stomach pain. The subject still thinks he is hungry and it is causing abdominal discomfort. No PHM. Review of systems notable for fever, nausea/vomiting/diarrhea. Heart rate was regular rhythm and rate. A urinalysis on 06/Aug/2006 showed appearance-cloudy, blood-small, ketones - 40mg%, protein 100mg%, Bacteria - occasional, mucus - 2+, Blood tests showed creatinine low - 0.6 (normal 0.8 - 1.5), neutrophils high - 85% (normal 50 -70), Lymphocytes low - 5% 9 normal 20 - 70). The subject was discharged at 0950 with a diagnosis of fever, vomiting and diarrhea with instructions to follow-up with the pediatrician. The patient recovered. Documents held by sender: Laboratory Results (urinalysis, chemistry, CBC), 12-18 year old Adolescent visit Report. Pediatric and adult injection/treatment slip, Consent form x2, Emergency Department Physician Record, Medical Screening Exam, Medication Administration Record, Emergency Department nurse's notes, Emergency Department Triage form.
Sex: F
Vaccine: DT
Symptoms: Erythema, Swelling
Clinical narrative: Case received from a healthcare professional on 23-Sep-05. A female patient (age not reported) with unknown medical history, had received injection of DECAVAC (lot, route and site not reported) and later, she complained of redness and swelling (unspecified). The patient received corrective treatment with BENADRYL and IBUPROFEN. The patient's recovery status was unknown. Additional information provided at a later date.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0447 and 05-0453).  A 43-year-old female patient, with history of diverticulitis, had received an injection of DECAVAC (lot # U1215AA, on right deltoid) on 22-Jul-05 and 1 day later, she complained of fever, rash confined to arm, headache, nausea, fatigue, body aches and sore arm.  It was reported that the vaccine was given with a 1" needle.  The patient recovered on 28-Jul-05.  Follow up information received on 17/Nov/2005.  As per responsible physician there is no further information for this case.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Rash
Clinical narrative: Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0447 and 05-0453).  A 43-year-old female patient, with history of diverticulitis, had received an injection of DECAVAC (lot # U1215AA, on right deltoid) on 22-Jul-05 and 1 day later, she complained of fever, rash confined to arm, headache, nausea, fatigue, body aches and sore arm.  It was reported that the vaccine was given with a 1" needle.  The patient recovered on 28-Jul-05.  Follow up information received on 17/Nov/2005.  As per responsible physician there is no further information for this case.
Age: 78.0
Sex: F
Vaccine: DT
Symptoms: Injection site pain, Pruritus, Rash generalised
Clinical narrative: Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0448 and 05-0452).  A 78-year-old female patient, with history of hypertension, polymyalgia and gastroesophageal reflux disease, had received an injection of DECAVAC (lot # U1586BA, on right gluteal region) on 24-Aug-05 and 2 days later, she presented with rash on whole body, uncontrolled itching and injection site tenderness.  She was seen in emergency room.  There was no fever.  It was reported that the vaccine was given with a 23 ga - 1" needle.  The patient did not recover.  Follow up information received on 17/Nov/2005.  As per responsible physician there is no additional information for this case.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Feeling hot, Headache, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0449 and 05-0451).  A 37-year-old female patient, with no relevant medical history, had received an injection of DECAVAC (lot # U1596AA, on left deltoid) on 06-Sept-05 and 1 day later, she complained of fever, headache, arm edema, warmth, arm pain and injection site pain.  There is no rash.  It was reported that the vaccine was given with a 1" needle.  The patient did not receive any treatment.  The patient recovered on 12-Sep-05.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Pyrexia
Clinical narrative: Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0449 and 05-0451).  A 37-year-old female patient, with no relevant medical history, had received an injection of DECAVAC (lot # U1596AA, on left deltoid) on 06-Sept-05 and 1 day later, she complained of fever, headache, arm edema, warmth, arm pain and injection site pain.  There is no rash.  It was reported that the vaccine was given with a 1" needle.  The patient did not receive any treatment.  The patient recovered on 12-Sep-05.
Age: 39.0
Sex: F
Vaccine: DT
Symptoms: Headache, Pain in extremity, Pyrexia, Rash
Clinical narrative: Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0447 and 05-0450). A 39-year-old female patient, with no relevant medical history, had received and injection an injection of DECAVAC (lot # U1215AA, on left deltoid) on 26 Jul 05 and later on the same day, she complained of headache, arm edema, sore arm, rash on arm (no description) and low grade fever. It was reported that the vaccine was given with a 5/8" needle. She required a doctor visit. The patient did not received any corrective treatment. The patient recovered on 29-Jul-05. Follow up information received on 17/Nov/2005. As per responsible physician there is no further information for this case.
Age: 17.0
Sex: F
Vaccine: DT, MNQ
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Initial report received on 09/Sep/2005 from a health care professional.  A 17-year-old female received an intra-muscular injection of MENACTRA, lot number U1675AA in the left deltoid and an intra-muscular injection of DECAVAC, lot number U1219BA in the right deltoid on 15/Aug/2005 at 3:00pm.  Twelve hours post injection the patient experienced generalized aches, chills and a fever of 103 degrees Fahrenheit.  The duration of her symptoms lasted 36 hours with intermittent fever that fluctuated lower than 103 degrees Fahrenheit at times.  At the time of the injection it was reported that the patient had no history of illness, pre-existing conditions or use of other medications.  The patient recovered from these events.  Follow-up information received on 19/Oct/2005 from a health care professional.  The adverse events started on 16/Aug/2005 at 03:00.  No further information is expected.
Age: 11.0
Sex: F
Vaccine: DT
Symptoms: Eye oedema, Eye pruritus, Lacrimation increased, Ocular hyperaemia, Sneezing
Clinical narrative: Initial report received from a health care provider on 06/Sep/2005.  An eleven-year-old patient with a medical history of bronchitis and upper respiratory infection at time of vaccination received an injection of DECAVAC, lot number U1563CA, in the left deltoid on 06/Sep/2005.  Twenty minutes later, she developed red, watery, itchy eyes and slight edema around her eyes.  She also experienced sneezing.  The patient experienced no difficulty breathing or shortness of breath per the reporter.  She was treated with BENADRYL 25 mg.  At the time of this report, it was unknown if the patient had recovered.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Full blood count normal, Laboratory test normal, Local reaction, Lymphadenopathy
Clinical narrative: Initial report received from a healthcare professional on 02/Sep/2005; A 43-year-old female patient received DECAVAC, lot number U1370CA, intramuscularly in the left deltoid on 29/Aug/2005. Two days later, she developed a local reaction of redness, as well as regional lymphadenopathy. She also felt a "pulling sensation" around the abdomen and back. The patient was examined in an emergency department on 01/Sep/2005 and was diagnosed with post-vaccination viremia. She was treated with Motrin and Duracef. The patient was reevaluated by a physician on 02/Sep/2005. CBC and chemistry results from the emergency department were reported as normal. At the time of this report, the patient had not recovered from the events.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Viraemia
Clinical narrative: Initial report received from a healthcare professional on 02/Sep/2005; A 43-year-old female patient received DECAVAC, lot number U1370CA, intramuscularly in the left deltoid on 29/Aug/2005. Two days later, she developed a local reaction of redness, as well as regional lymphadenopathy. She also felt a "pulling sensation" around the abdomen and back. The patient was examined in an emergency department on 01/Sep/2005 and was diagnosed with post-vaccination viremia. She was treated with Motrin and Duracef. The patient was reevaluated by a physician on 02/Sep/2005. CBC and chemistry results from the emergency department were reported as normal. At the time of this report, the patient had not recovered from the events.
Age: 52.0
Sex: M
Vaccine: DT
Symptoms: Bradyphrenia, Fatigue, Memory impairment
Clinical narrative: Initial report received from the patient's wife on 31-Aug-05.  A 52-year-old male patient had received for wound an injection of DECAVAC (lot unknown) on 28-Aug-05.  1 day later, he had "slow thinking", fatigue and memory problems.  As per the reporter, the patient has history of "gluten ataxia", allergies to codeine and emycin, diabetes and TBD.  The patient received many other medications (unspecified).  The patient's recovery status was not reported.  Follow-up information received on 17/Nov/2005.  This case is now medically confirmed.  As per responsible physician the patient was not seen in her office.  The patient has gluten ataxia-neuro symptoms which worsens by exposure to gluten.  His symptoms were worse for three days post immunization.  Lot number for DECAVAC was U1584BA and was administered in the left deltoid.  As per reporter the patient recovered.
Age: 39.0
Sex: M
Vaccine: DT
Symptoms: Chills, Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a physician on 26-August-2005. A male patient, who is also a physician (age not reported), experienced severe pain in the arm where the vaccine was administered and slight fever (exact temperature not reported) 12-24 hours after he received DECAVAC (lot number not reported) on 23-August-2005. The patient stated possibly lymph node involvement. The symptoms persisted and the patient was unable to life his arm. At the time of report, the patient had not received. Follow-up information received on 31-August-2005. The patient is a 39 year old male physician. On 23-August-2005, the eve of vaccination, the patient experienced pain at the injection site, subjective fever, chills and "felt warm to touch". 48 hours later, the patient developed axillary lymph node swelling, severe pain and arm weakness. On the seventh day post injection, the patient had a 10 x 6 cm area of redness, warmth and swelling at the injection site that covered 70% of the upper arm. The patient was treated for infection. Follow-up information received on 06-September-2005. The patient stated that the swelling of the deltoid had decreased however he still had significant swelling in the axillary area. He complained that when his arm was not elevated, he experienced tingling, pain and swelling in the arm.
Age: 39.0
Sex: M
Vaccine: DT
Symptoms: Injection site warmth, Muscular weakness, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Initial report received from a physician on 26-August-2005. A male patient, who is also a physician (age not reported), experienced severe pain in the arm where the vaccine was administered and slight fever (exact temperature not reported) 12-24 hours after he received DECAVAC (lot number not reported) on 23-August-2005. The patient stated possibly lymph node involvement. The symptoms persisted and the patient was unable to life his arm. At the time of report, the patient had not received. Follow-up information received on 31-August-2005. The patient is a 39 year old male physician. On 23-August-2005, the eve of vaccination, the patient experienced pain at the injection site, subjective fever, chills and "felt warm to touch". 48 hours later, the patient developed axillary lymph node swelling, severe pain and arm weakness. On the seventh day post injection, the patient had a 10 x 6 cm area of redness, warmth and swelling at the injection site that covered 70% of the upper arm. The patient was treated for infection. Follow-up information received on 06-September-2005. The patient stated that the swelling of the deltoid had decreased however he still had significant swelling in the axillary area. He complained that when his arm was not elevated, he experienced tingling, pain and swelling in the arm.
Age: 39.0
Sex: M
Vaccine: DT
Symptoms: Pyrexia
Clinical narrative: Initial report received from a physician on 26-August-2005. A male patient, who is also a physician (age not reported), experienced severe pain in the arm where the vaccine was administered and slight fever (exact temperature not reported) 12-24 hours after he received DECAVAC (lot number not reported) on 23-August-2005. The patient stated possibly lymph node involvement. The symptoms persisted and the patient was unable to life his arm. At the time of report, the patient had not received. Follow-up information received on 31-August-2005. The patient is a 39 year old male physician. On 23-August-2005, the eve of vaccination, the patient experienced pain at the injection site, subjective fever, chills and "felt warm to touch". 48 hours later, the patient developed axillary lymph node swelling, severe pain and arm weakness. On the seventh day post injection, the patient had a 10 x 6 cm area of redness, warmth and swelling at the injection site that covered 70% of the upper arm. The patient was treated for infection. Follow-up information received on 06-September-2005. The patient stated that the swelling of the deltoid had decreased however he still had significant swelling in the axillary area. He complained that when his arm was not elevated, he experienced tingling, pain and swelling in the arm.
Age: 10.0
Sex: F
Vaccine: DT
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Initial report received from a physician on 10-August-2005.  A ten year old female patient developed a fever and an abscess at the injection site the day after receiving the injection of DECAVAC, lot number U1219BA in the left deltoid on 20-June-2005.  Route of administration not reported.  The day after vaccination in the left deltoid at the injection site was red, tender, painful and 3cm x 4cm in size.  The patient had a fever under 101 degrees Fahrenheit which lasted 1-2 days.  The injection site still has some symptoms.  The patient received corrective treatment with KEFLEX which was started on 10-August-2005 for a 10 day duration.  The patient is to follow up with a surgeon.  Recovery status of the patient was not reported.
Age: 82.0
Sex: M
Vaccine: DT
Symptoms: Epistaxis, International normalised ratio increased
Clinical narrative: Initial report received from a health care professional on 22-Jul-2005.  A 82 year old male patient, with medical history of deep vein thrombosis, benign prostatic hypertrophy, spinal/aortic stenosis and drug allergy, presented with INR levels rising approximately 3 weeks after receiving DECAVAC (lot number unknown) on unknown date.  The patient was on coumadin controlled for years.  Patient went to ER on 19/Jul/05 due to uncontrolled nose bleed.  INR level was 4.1 (patient norm was 2-3).  At the time of reporting, the patient's recovery status was unknown.
Age: 27.0
Sex: F
Vaccine: DT
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site cellulitis, Injection site erythema, Injection site irritation
Clinical narrative: Initial report received from a health care professional on 18/Jul/2005.  A 27-year-old female patient had received a subcutaneous injection of DECAVAC, lot number U1219DA, in error on 28/Jun/2005.  Immediately after injection, the patient had irritation at the site of administration.  Two days later there was a 6 cm area of redness, pain, warmth and a palpable knot at the injection site.  At the time of this report, the patient had not recovered from these events.  Follow-up information received on 07/Nov/2005 from a health care professional.  Per the reporter, the route of administration of the DECAVAC was administered in error intradermally instead of subcutaneously as previously reported.  It was also reported that the patient experienced right forearm cellulitis and a six centimeter erythema area around the site that was warm to the touch and painful.  The patient completely recovered from these events at the time of this report.
Age: 27.0
Sex: F
Vaccine: DT
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 18/Jul/2005.  A 27-year-old female patient had received a subcutaneous injection of DECAVAC, lot number U1219DA, in error on 28/Jun/2005.  Immediately after injection, the patient had irritation at the site of administration.  Two days later there was a 6 cm area of redness, pain, warmth and a palpable knot at the injection site.  At the time of this report, the patient had not recovered from these events.  Follow-up information received on 07/Nov/2005 from a health care professional.  Per the reporter, the route of administration of the DECAVAC was administered in error intradermally instead of subcutaneously as previously reported.  It was also reported that the patient experienced right forearm cellulitis and a six centimeter erythema area around the site that was warm to the touch and painful.  The patient completely recovered from these events at the time of this report.
Age: 10.0
Sex: M
Vaccine: DT, MNQ
Symptoms: Headache, Oedema peripheral, Pyrexia
Clinical narrative: An initial report was received from a health care professional on 18/Jul/2005.  An 11-year-old male patient complained of a headache, right arm swelling and a fever of 102 degrees Fahrenheit in the evening after receiving an intra-muscular injection of MENACTRA, lot number U165BAA in the right deltoid and DECAVAC, lot number U1215DA intra-muscular in the left deltoid.  His fever lasted three days.  He was not seen by a physician.  As per the patient's mother he recovered.  Follow-up information received on 08-August-2005.  The patient did not have any laboratory/diagnostic tests performed.  He did not have any other vaccinations within 4 weeks; he did not have any illness at the time of vaccination and was not on any medications.
Age: 21.0
Sex: M
Vaccine: DT
Symptoms: Abdominal pain, Abdominal rigidity, Arthralgia, Feeling jittery, Hot flush
Clinical narrative: From initial information received on 17/Jun/2005 from a physician, it was reported that a 22-year-old male patient received a dose DECAVAC, lot number U1563BA, administered intra-muscular in the left deltoid on 15/Jun/2005. The next day at 12:00pm, the patient developed injection site pain, joint pain, tight muscles, the jitters, warm flushes, cold hands, cramping and muscle twitching in his abdomen. The patient was seen by a physician who prescribed Valium. The patient's recovery status is listed as unknown. Follow-up information received on 11-July-2005. The patient was fully vaccinated as a child (last dose at age 4). The patient experienced cramping of the finger and hand flexors. He experienced muscle twitching - especially of the abdominal flexors. He had spontaneous remission of symptoms within approximately 18 hours. The case is closed.