chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.84
Sex: M
Vaccine: PPV
Symptoms: Skin reaction, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 month old male with a history of immunization who on 02-MAY-2009 was vaccinated with a dose of PNEUMOVAX (lot # 661577/1161X) instead of PREVNAR due to human error (route and site not reported). No adverse event was reported. The patient had received the first and second dose of PREVNAR on 23-SEP-2008 and 03-FEB-2009. Follow-up information was received from the licensed practical nurse. The patient was 22 months old. The nurse indicated that the mistake was due to human error. She reported that both vaccines were stored next to each other on the same shelf and the nurse "inadvertently grabbed the wrong one". She said that the label was clear. Follow-up information was received from the physician who reported that the patient was given PNEUMOVAX instead of PREVNAR by mistake. The physician reported that on an unspecified date, the patient experienced a mild skin reaction. At the time of the report, the patient had recovered. No other untoward effects. It is unspecified if the patient sought medical attention. No further information is available.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a 21 year old male student who on 01-APR-2009 at 8:30 at a well visit was vaccinated with the second dose of PNEUMOVAX (lot # 659922/1667U), via subcutaneous in the right arm. On 01-APR-2009 1-2 hours after vaccination of PNEUMOVAX, the injection site became red, tender and swollen "area the size of a baseball" as per the patient. The patient was treated with ice packs and triamcinolone acetate 0.1% twice a day. The symptoms subsided after 3-4 days (approximately 05-APR-2009). The patient was reported as recovered. A signed informed consent form was not obtained. No further information is available.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX vaccine (lot number not provided). Subsequently the patient experienced fever of 101 Fahrenheit and swollen arm. The outcome was unknown. Follow up information was received from the physician by phone indicated that out of 12 patients who received PNEUMOVAX from the same lot, 3 of the patients experienced adverse events. Follow up information was received from a physician by phone on 06-MAY-2009 provided the identifier and date of birth for the patient. It was reported that the 58 year old female patient was vaccinated with a dose of PNEUMOVAX (lot # 662744/1085X) in 29-APR-2009. Concomitant therapy included BENADRYL and TYLENOL. On 30-APR-2009 the patient called the office with fever (102F) and swelling of the arm. On an unspecified date the patient recovered. This is one of several reports from the same source. No further information is available.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Erythema, Joint swelling, Mobility decreased
Clinical narrative: Information has been received from a physician assistant concerning a 74 year old male patient with diabetes and aspirin allergy who on 30-APR-2009 was vaccinated IM in his left deltoid with a 0.5 mL dose of PNEUMOVAX (662599/1076X). Concomitant therapy included lisinopril, metformin, LIPITOR, glucosamine and ZYRTEC. On 30-APR-2009 the patient developed a swollen left shoulder. He was unable to move his shoulder and it was red. There was also a peeling blister on his shoulder but it might have been caused from a heating pad that the patient was using. The patient returned to the office on 01-MAY-2009 because of his symptoms and he was given prednisone taper. The patient went again to the office on 4-MAY-2009 and he was 90 % better. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Mobility decreased, Pyrexia
Clinical narrative: Information has been received from a female nurse concerning herself who "recently" in approximately May 2009, was vaccinated with a dose of PNEUMOVAX (Lot # not reported) intramuscularly. "Recently" in approximately May 2009 after getting the vaccine she had cellulitis at the injection site. At the time on the report on 05-MAY-2009 the patient recovered from cellulitis. Follow-up information was received which reported that the 30 year old medical assistant with no pertinent medical history and no known allergies/drug reactions who on 30-APR-2009, was vaccinated with the first dose of PNEUMOVAX (Lot # 662599/1076X) intramuscularly into her right arm at 14:00 hours. It was reported that on 30-APR-2009 at 16:00, the medical assistant's arm began to be heavy and she was unable to raise it. On 01-MAY-2009, she had fever of 103 degrees and she began to have red marks going down the arm. On 03-MAY-2009 the medical assistant recovered. There was no illness at the time of vaccination and there were no relevant diagnostic/laboratory tests performed. The patient did not seek medical attention. No further information is available.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 54 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 15-DEC-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (Lot # 661065/1021X) intramuscularly.  There was no concomitant medication reported.  It was reported that "within 24 hours after the vaccination" the patient developed an injection site reaction.  It was reported that the patient's arm became red, swollen and tender.  The patient did not seek attention.  It was reported that the patient applied ice to the area.  There  were no laboratory diagnostic tests performed.  It was reported that the patient had recovered at the time of the report.  Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Alopecia
Clinical narrative: Information has been received from a nurse concerning a 33 year old female patient with rhinitis allergic, recurrent upper respiratory tract infection, dermatitis allergic, itching and allergy to ALLEGRA "spotting" and history of cough and nasal congestion itching who on 11-DEC-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX intramuscularly. Concomitant therapy included XYZAL. EPIPEN, phentermine and "CLUX-E" (unspecified). It was reported that the patient began to experienced rapid hair loss during the same time she got the vaccine. It was reported that the hair was coming back and she was getting some new growth. It was reported that the patient saw her primary care physician and an endocrinologist. It was reported that unspecified laboratory diagnostic tests were performed. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning an 18 week old male patient who on 27-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 0.6
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 7 month old female patient who on 22-JAN-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.  Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X).  There was no illness at the time of vaccination.  No reactions or adverse events were reported.  The patient did not seek medical attention.  This is one of several reports from the same source.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 12 month old male patient who on 19-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 9 week old male patient who on 03-APR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of (PREVNAR) by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reaction or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning an 8 week old female patient who on 19-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.
Age: 0.4
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 19 week old female patient who on 17-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of (PREVNAR) by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female of chronic cougher who on 04-MAY-2009 was vaccinated with the first dose of PNEUMOVAX. Concomitant therapy included Z-PAK. Subsequently the patient had an injection site reaction after her first vaccination. The patient had a fever of 103 Fahrenheit and extreme swelling of her arm. The patient sought medical attention and was seen in the physician's office. At the time of reporting the patient was not recovered. Follow up information was received from a physician via telephone on 06-MAY-2009. It was reported that the 54 year old female patient was vaccinated with a dose of PNEUMOVAX (lot# 662744/1085X) on 04-MAY-2009. Concomitant therapy included BENADRYL and TYLENOL. It was reported that the patient was seen in the physician's office on 06-MAY-2009 with fever (103F) and extreme swelling of the arm. On an unspecified date the patient recovered. This is one of several reports form the same source. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 6 month old female patient who on 12-MAR-2009, was vaccinated with PNEUMOVAX instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.  Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X).  There was no illness at the time of vaccination.  No reactions or adverse events were reported.  The patient did not seek medical attention.  This is one of several reports from the same source.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a female who on 05-MAY-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX (it was not know if this was the patient's first or second dose). Within one hour of receiving the dose the patient's arm began to swell. It had progressed with redness and warmth to touch. The patient's arm's swell and redness and warmth to touch persisted. The patient went to hospital to  be evaluated (not reported if the patient was admitted). Additional information has been requested. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 12 month old male patient who on 01-APR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning an approximately 82 year old patient who was vaccinated with a dose of PNEUMOVAX (lot# 661831/0310Y). Subsequently the patient experienced cellulitis at the injection site. At the time of reporting, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning an 8 month old male patient who on 30-MAR-2009, was vaccinated with PNEUMOVAX instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.  Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot 661934/1441X).  There was no illness at the time of vaccination.  No reactions or adverse events were reported.  The patient did not seek medical attention. This is one of several reports from the same source.  Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 12 month old female patient who on 12-MAR-2009 was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of (PREVNAR) by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PMEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several; reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a female patient with latex allergy who "three years ago" was vaccinated with a dose of PNEUMOVAX. It was reported that the same day as the PNEUMOVAX the patient experienced a local injection site reaction. The patient sought medical attention at the office. It was reported that the patient had recovered at the time of the report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning an approximately 58 year old patient who was vaccinated with a dose of PNEUMOVAX (lot# 661831/0310Y). Subsequently the patient experienced cellulitis at the injection site. At the time of reporting, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 78 year old female patient with no known drug allergies/drug reactions who on 11-MAY-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 657143/0380U) subcutaneously into her left arm. It was reported that on 11-MAY-2009 the patient experienced soreness, redness and swelling of her arm at the injection site after receiving PNEUMOVAX. The patient sought medical attention with an office visit. There were no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of report. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 58 day old female patient who on 24-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a 64 year old female who was vaccinated IM with a dose of PNEUMOVAX. Subsequently the patient experienced a severe cellulitis of the upper arm that included her arm pit. There was no medical intervention, hospitalization or further intervention. The patient did not die, the patient has not recovered but is recovering. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist intern concerning a 24 hours old male who on 14-MAY-2009, was vaccinated with PNEUMOVAX (dose, route and lot unspecified). The pharmacist intern mentioned that a patient received a dose of the vaccine instead of PREVNAR. It was unspecified if the patient sought medical attention. No adverse effects reported. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Chills, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her father-in-law who on 18-MAY-2009 was vaccinated with PNEUMOVAX. It was reported that the patient developed sore arm that was very painful and her had chills all evening long. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 61 day old female patient who on 27-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 64 year old female with sulfa, penicillin and food allergies who on 26-MAY-2009 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX (lot # 663012/1163X). There was no concomitant medication. On 28-May-2009 the patient developed cellulitis near the injections site after receiving the vaccine. It was reported that the patient had the 3 by 6 inches swollen red area which extended from deltoid to the elbow. The area was very painful and itchy. The patient sought medical attention and came to the physician's office. As of 28-MAY-2009 the patient did not recovered. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 71 year old male patient with a history of an "unspecified cardiology-related surgery recently" who on 28-MAY-2009 was vaccinated with a dose of PNEUMOVAX (dose, route and lot number not reported). Concomitant therapy included "unspecified pain medication". The patient reported that he received the vaccine from a nurse while being discharged from the hospital. The next day, on 29-MAY-2009, the patient experienced pain and swelling at the injection site. The patient stated that "he may had a dose of PNEUMOVAX three to four years ago but he was not sure". The patient reported that he had not yet contacted his physician but he was planning to do so on 29-MAY-2009. No lab tests were performed. The patient did not seek medical attention. No further information is available.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Limb discomfort, Musculoskeletal pain, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 49 years old female with asthma and colitis who on 01-Apr-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 via intramuscular administered at the left deltoid. Concomitant therapy included ADVAIR. There as no history drug reactions and allergies. On 02-Apr-2009, one day after receiving PNEUMOVAX 23 vaccine, the patient developed pain at the injection site of left upper arm. The patient was examined in the office on 22-Apr-2009 and was found to have pain on movement of the left arm but no edema, no swelling and no redness at the injection site. The patient was recommended to take Ibuprofen. The patient returned to the office on 29-May-2009 stating that the pain had persisted and radiated up to the left shoulder. The examination on revealed that the patient had full range of motion of the left arm but movement caused discomfort. An X-ray of the left arm was performed on 29-May-2009, and the result was negative. At time of reporting, the patient did not recover. Additional information has been requested.
Age: 0.6
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 6 month old male patient who on 10-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Underdose
Clinical narrative: Information has been received from a female who was vaccinated with PNEUMOVAX. The patient reported that when the pharmacist was taking air out of the syringe, he was "very sloppy" and he squirted out some of the medication in the process and gave her less than the required amount (0.5ml). The patient had slight pain at the injection site but this was minimal. It was unknown if the patient sought medical attention. No further information is available.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 9 week old female patient who on 25-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is on of several reports from the same source. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 12 month old female patient who on 05-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error.  It is unknown if the patient sought medical attention.  Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X).  There was no illness at the time of vaccination.  No reactions or adverse events were reported. The patient did not seek medical attention.  This is one of several reports from the same source.  Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning an 18 weeks old female patient who on 10-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 6 month old male patient who on 02-APR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning a 61 day old male patient who on 01-APR-2009, was vaccination with PNEUMOVAX 23 (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX 23 (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 4 month old female patient who on 25-NOV-2008 was vaccinated with a dose of PNEUMOVAX (Lot # 662661/0978X). It was reported that the patient received PNEUMOVAX instead of PREVNAR due to human error. It was reported that the patient had received her first dose of PREVNAR on 26-SEP-2008 and a second dose on 29-JAN-2009. No adverse reaction reported. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site exfoliation, Skin exfoliation
Clinical narrative: Information has been received from a nursing supervisor concerning a male in his middle 50's who on approximately 15-APR-2009, two to three weeks ago, was vaccinated with a "standard dose" of PNEUMOVAX. Subsequently, a few days after receiving PNEUMOVAX, the patient noticed that his skin around the injection site was peeling off. The patient sought unspecified medical attention from a physician. It was unspecified if lab studies were performed. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: 17 x 8 cm area of redness with 2 x 1.5 blistering lesion on (R) thigh, occurring about 24 hours after vaccinations at health department (see progress note).
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: C-reactive protein, Full blood count, Injection site erythema, Injection site vesicles, Red blood cell sedimentation rate
Clinical narrative: 17 x 8 cm area of redness with 2 x 1.5 blistering lesion on (R) thigh, occurring about 24 hours after vaccinations at health department (see progress note).
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, Asperger's disorder, Speech disorder developmental
Clinical narrative: Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient developed delayed speech and ASPERGER's syndrome. The consumer stated her child was now recovered. It was also reported that her son still had negative titers to MMR II. It was unspecified if the patient sought medical attention or not. Upon internal review, ASPERGER's syndrome was considered to be other important medical events. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Aura, Blindness, Catatonia, Convulsion, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a physician concerning a female with a history of experiencing aura of blindness and prevaccination anxiety after previous vaccines (unspecified which ones) and no known drug allergies, who on an unspecified date was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number 659054/0315Y). Concomitant therapy included MENACTRA. "After receiving the vaccine", the patient started experiencing an aura of blindness and proceeded to have a catatonic movement that went into a seizure. The patient recovered shortly after. No lab tests were performed. The patient did not seek medical attention. Upon internal review seizure was determined to be other important medical events. Follow up information was received from a registered nurse. It was reported that the 16 year old female patient has an allergy to Amoxicillin (hives) and a history of the aura of blindness and feeling strange after her vaccination with ADACEL, 3 summers ago (date not provided). The patient's mother reported that her daughter "last time" (3 summers ago) after she got a vaccine, she experienced the aura of blindness after they got out to the car. She did not loose consciousness, but felt really strange. The patient was administered GARDASIL (lot number 659054/0315Y, Expiration date 13-JUL-2010) on 06-JUL-2009. Concomitant medications included ibuprofen PRN and MENACTRA, also given on 06-JUL-2009. The patient was observed in the physician's office saying she was having an aura of blindness, she could not see and then proceeded to become catatonic and the went into a seizure. The registered nurse reported that she recovered shortly after, and was able to go home with no problems. The registered nurse reported that as far as she knows, the patient had not experienced any more seizure activity since 06-JUL-2009. She further noted that as far as she knows, the patient has completely recovered and that she has not called into the office and has not been in to the office since 06-JUL-2009. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Abasia, Allergy to vaccine, Contusion, Erythema, Injection site erythema
Clinical narrative: Vaccine on the 10th, Left thigh into knee swollen and sore on 11th, Right knee down to mid  top foot swollen, red and feverish on the 12th (pt. could not walk). Admitted to hospital. Variety of test (all neg). Pt given steroids, antihistamines during visit was sent home on steroids. 7/14/09 x 5 days (Sunday) 7/19/09. Patient received vaccination on July 10, 2009. On July 11, 2009 his left thigh all the way down into the middle part of his left knee was swollen and sore. By the afternoon of Sunday, July 12, 2009, Patient's right knee all the way down to his right mid foot was swollen, red, and hot to the touch and was unable to walk. He was admitted to the hospital, all the test came back negative. He was put on Steroids and antihistamines during his hospital stay. He was sent home on Steroids for five days which ended on Sunday, July 19, 2009. On Thursday, July 23, 2009 my son started having hives on his legs, I gave him BENADRYL and 1 1/2 later, they had spread all over his body which resulted in me taking him to Pediatrics, for the forth time in less than 2 weeks. There he was put back on steroids for two days and I took him to his pediatrician on Friday, July 24, 2009, where she, put him on ATARAX, and gave me a prescription for an epi-penJr., Sunday the 26th was his last day of steroids and today is Tuesday July 28, 2009 and he still has the hives and itching, his skin in now blotchy and bruised, and red in some spots from his head down to his ankles. He had no problems like this before immunization (Hepatitis A) was given, in which he was diagnosed at hospital as being allergic to, but he has had that one before, but Polio/DTaP (KINREX) he has never had, so I am assuming that he had an allergic reaction to that one.  8/12/09 Hospital records received DOS 7/12/09 to 7/14/09. Assessment: Lower extremity rash - resolving. Pain - resolved. Swelling - resolved. Lymphadenopathy - resolving. Limp - resolved. Contact dermatitis.  Patient c/o right calf and ankle pain/swelling with concurrent decreased activity. Limping. Nodules posterior aspect of thighs. On admission new onset ecchymosis on right lower extremity. Large nodule on posterior of right thigh. Posterior cervical lymphadenopathy. Dry erythematous papules bilateral lower extremities. Unable to walk. Thighs tender and warm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth, Pruritus
Clinical narrative: Vaccine on the 10th, Left thigh into knee swollen and sore on 11th, Right knee down to mid  top foot swollen, red and feverish on the 12th (pt. could not walk). Admitted to hospital. Variety of test (all neg). Pt given steroids, antihistamines during visit was sent home on steroids. 7/14/09 x 5 days (Sunday) 7/19/09. Patient received vaccination on July 10, 2009. On July 11, 2009 his left thigh all the way down into the middle part of his left knee was swollen and sore. By the afternoon of Sunday, July 12, 2009, Patient's right knee all the way down to his right mid foot was swollen, red, and hot to the touch and was unable to walk. He was admitted to the hospital, all the test came back negative. He was put on Steroids and antihistamines during his hospital stay. He was sent home on Steroids for five days which ended on Sunday, July 19, 2009. On Thursday, July 23, 2009 my son started having hives on his legs, I gave him BENADRYL and 1 1/2 later, they had spread all over his body which resulted in me taking him to Pediatrics, for the forth time in less than 2 weeks. There he was put back on steroids for two days and I took him to his pediatrician on Friday, July 24, 2009, where she, put him on ATARAX, and gave me a prescription for an epi-penJr., Sunday the 26th was his last day of steroids and today is Tuesday July 28, 2009 and he still has the hives and itching, his skin in now blotchy and bruised, and red in some spots from his head down to his ankles. He had no problems like this before immunization (Hepatitis A) was given, in which he was diagnosed at hospital as being allergic to, but he has had that one before, but Polio/DTaP (KINREX) he has never had, so I am assuming that he had an allergic reaction to that one.  8/12/09 Hospital records received DOS 7/12/09 to 7/14/09. Assessment: Lower extremity rash - resolving. Pain - resolved. Swelling - resolved. Lymphadenopathy - resolving. Limp - resolved. Contact dermatitis.  Patient c/o right calf and ankle pain/swelling with concurrent decreased activity. Limping. Nodules posterior aspect of thighs. On admission new onset ecchymosis on right lower extremity. Large nodule on posterior of right thigh. Posterior cervical lymphadenopathy. Dry erythematous papules bilateral lower extremities. Unable to walk. Thighs tender and warm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Rash macular, Urticaria
Clinical narrative: Vaccine on the 10th, Left thigh into knee swollen and sore on 11th, Right knee down to mid  top foot swollen, red and feverish on the 12th (pt. could not walk). Admitted to hospital. Variety of test (all neg). Pt given steroids, antihistamines during visit was sent home on steroids. 7/14/09 x 5 days (Sunday) 7/19/09. Patient received vaccination on July 10, 2009. On July 11, 2009 his left thigh all the way down into the middle part of his left knee was swollen and sore. By the afternoon of Sunday, July 12, 2009, Patient's right knee all the way down to his right mid foot was swollen, red, and hot to the touch and was unable to walk. He was admitted to the hospital, all the test came back negative. He was put on Steroids and antihistamines during his hospital stay. He was sent home on Steroids for five days which ended on Sunday, July 19, 2009. On Thursday, July 23, 2009 my son started having hives on his legs, I gave him BENADRYL and 1 1/2 later, they had spread all over his body which resulted in me taking him to Pediatrics, for the forth time in less than 2 weeks. There he was put back on steroids for two days and I took him to his pediatrician on Friday, July 24, 2009, where she, put him on ATARAX, and gave me a prescription for an epi-penJr., Sunday the 26th was his last day of steroids and today is Tuesday July 28, 2009 and he still has the hives and itching, his skin in now blotchy and bruised, and red in some spots from his head down to his ankles. He had no problems like this before immunization (Hepatitis A) was given, in which he was diagnosed at hospital as being allergic to, but he has had that one before, but Polio/DTaP (KINREX) he has never had, so I am assuming that he had an allergic reaction to that one.  8/12/09 Hospital records received DOS 7/12/09 to 7/14/09. Assessment: Lower extremity rash - resolving. Pain - resolved. Swelling - resolved. Lymphadenopathy - resolving. Limp - resolved. Contact dermatitis.  Patient c/o right calf and ankle pain/swelling with concurrent decreased activity. Limping. Nodules posterior aspect of thighs. On admission new onset ecchymosis on right lower extremity. Large nodule on posterior of right thigh. Posterior cervical lymphadenopathy. Dry erythematous papules bilateral lower extremities. Unable to walk. Thighs tender and warm.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: ZOSTAVAX administered 2/18/08. Hearing loss in Rt ear approximately 10 days later.   8/11/09 Otolaryngology consult records received DOS 2/05/02 to 7/21/08. Patient presents with sudden hearing loss. Concerned that hearing loss occurred because she "exercises too much". She washed out the ear with Murine which made things worse. Cerumen impactions.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Disorientation, Speech disorder
Clinical narrative: Suspected seizure. Disoriented. Difficulty talking ~5 minutes.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Viral DNA test negative
Clinical narrative: Pt. was given zoster vaccine 7/10/09. She presented 7/23 w/ bilateral blisters on 1st & 2nd digit of hand. She was referred to derm. Will be seeing 8/14/09.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash, small dots on neck
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Varicella
Clinical narrative: 7/14/09 Shingle shot - 4 days later broke out with chicken pox - all over body - arms - legs - vagina.  Back corner of eye.  I was a mess - headache - fever etc - 7/31/09 - seemed to go away - almost gone.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) upper arm red warm to touch. BENADRYL, HC ointment
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Induration, Injection site pain, Injection site pruritus, Oedema peripheral
Clinical narrative: Pt had TDAP vaccination in the (L) arm 7/29/09. Following morning she had swelling and a hard lump in the (L) upper arm. The site was itchy and painful.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Dev a rash 6d after ZOSTAVAX injection - arm, abd, leg-Rt.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pain, Restlessness, Swelling, Weight increased
Clinical narrative: Pt received immunizations at 0800 at 2100 developed restlessness and extreme aching pain from head to toe. Took 2 ASA and 3 hr later took 2 ibuprofen. Felt good enough to sleep woke up feeling fine at 0900 7/30/09. Skin was extremely sensitive at night as well. This week-body puffy all over and weight gain of 8 lbs.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Nausea, Pyrexia
Clinical narrative: 103.0 fever the night of injection, headache, nausea, slight redness at injection site.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Death
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of death nos in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July 2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July 2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July 2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The healthcare professional considered the event was possibly related to vaccination with ROTARIX. The subject died on 19 July 2009; cause of death was not specified. It was unknown whether an autopsy was performed. No further details were reported.  8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty.  Dx viral URI.  Sick family member.  RTC 7/9/09 w/vomiting, cough, decreased appetite x 3 days.  Dx viral gastroenteritis.  RTC 7/15, well child visit w/shots.  Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min.   ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9 hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor.  10/5/09 ER records received for 7/18/09 which had been previously received.
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via a GSK representative, and described the occurrence of cellulitis in a child female subject of appropriate age who was vaccinated with KINRIX (GlaxoSmithKline). Concomitant vaccines, medications and relevant medical history were unknown. It was not known whether the subject had experienced adverse events following previous vaccinations. On 17 July 2009 the subject received unspecified dose of KINRIX (details unknown). On 17 July 2009, less than one day after vaccination with KINRIX, the subject experienced injection site redness and swelling at injection site. The subject was seen at the Emergency Room and diagnosed with cellulitis. The physician reported that it was the "largest local reaction he has ever seen". This case was assessed as medically serious by GSK. The subject was treated with antibiotics (Antibiotic) from the Emergency Room. Upon return to the physician office for follow up, the physician added another antibiotic, but noted that the subject did not have a fever and was "acting normal". At the time of reporting the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with KINRIX.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Surrounding erythema and swelling upper L delt R arm 39cm L arm 42.5   19x16cm L deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: VARIVAX given 8/5/09 - 48hrs later, seen in office with 3-4cm circular cellulitic rash at injection site.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper thigh dime size red swollen warm area noted. Approx 2 1/2 cm x 2 cm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis chronic, Injection site induration, Injection site rash, Rash, Wheezing
Clinical narrative: Received ZOSTAVAX on Friday, July 31. When she removed bandage later that day she noted a hard lump about 2" by 1" at the injection site over next 2 days, a rash developed and spread down her arm to the elbow. She saw her family doctor who prescribed a Medrol dose pack. Two days later (8/5/09) saw another doctor who noted increased wheezing.(this is patient's account of symptoms) rash improving.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Malaise, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Fever developed day of immunisation- Monday 8-3-09. Felt ill on Tuesday. Swelling deltoid, redness and warmth decreased on Fri. Here in office Friday 8-7-09 redness and warmth 1 1/2 inch in diameter. Patient states improved.
Age: 11.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema
Clinical narrative: Redness at the site of injection. Antihistamine and Hydrocortisone ointment.