chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 69-year-old male with asthma, hypercholesterolemia, and a penicillin allergy and a history of a "lung problem", asbestos exposure, questionable asbestosis, pneumonia in February 2005, and "reflux" who on 31-AUG-2005 was vaccinated intramuscular in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included simvastatin (manufacturer unknown) (20mg), thiothixene (1mg), Terazosin hydrochloride (4mg), pantoprazole sodium (PROTONIX) (40mg), albuterol sulfate (+) ipratropium bromide (COMBIVENT) inhaler, ascorbic acid, and vitamin E.  The nurse indicated that the patient received the first dose out of the vial.  On 02-SEPT-2005, the patient called the physician complaining of a very sore arm, sore shoulder and neck and upper back discomfort aching all over. no energy, flushed, and had a fever the day before, on 01-SEP-2005.  A complete blood count and blood cultures were performed, (results not provided).  The patient was seen as the physician office on 02-SEPT-2005 and was still not feeling well.  A product quality complain was not involved.  Follow-up information was received from the registered nurse who reported that on the evening of 31-AUG-2005, the patient developed a very sore arm, was achy all over, had a low grade temperature, and decreased energy.  He was seen in the office of 02-SEP-2005 and was very achy, had decreased energy, a sore arm, and was flushed.  Erythema was noted.  He was afebrile at this time. A complete blood count and blood cultures were obtained which were normal.  He recovered on 06-SEP-2005.  No further information is expected.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Heart rate increased, Hypertension
Clinical narrative: Information has been received from a 52 yr old female with no allergies and a splenectomy who on 23Sep05 at 15:00 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 23Sep05 between 18:00 and 19:00, the pt experienced extreme pain in her arm, nausea that resulted in vomiting, and flu like symptoms including body aches, headache, chills, and slight fever. The next day, on 24Sep05 the pt's arm was swollen from the elbow on up and she had red blotchy welts. Her pulse and blood pressure were also elevated. On an unspecified date, bloodwork was performed (results not provided). Unspecified medical attention was sought and the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: Information has been received from a 52 yr old female with no allergies and a splenectomy who on 23Sep05 at 15:00 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 23Sep05 between 18:00 and 19:00, the pt experienced extreme pain in her arm, nausea that resulted in vomiting, and flu like symptoms including body aches, headache, chills, and slight fever. The next day, on 24Sep05 the pt's arm was swollen from the elbow on up and she had red blotchy welts. Her pulse and blood pressure were also elevated. On an unspecified date, bloodwork was performed (results not provided). Unspecified medical attention was sought and the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Urticaria, Vomiting
Clinical narrative: Information has been received from a 52 yr old female with no allergies and a splenectomy who on 23Sep05 at 15:00 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 23Sep05 between 18:00 and 19:00, the pt experienced extreme pain in her arm, nausea that resulted in vomiting, and flu like symptoms including body aches, headache, chills, and slight fever. The next day, on 24Sep05 the pt's arm was swollen from the elbow on up and she had red blotchy welts. Her pulse and blood pressure were also elevated. On an unspecified date, bloodwork was performed (results not provided). Unspecified medical attention was sought and the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Eosinophilia, Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 66 yr old white male with a penicillin allergy who on 05OCT05 at 10:00AM was vaccinated IM in the right arm with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant vaccination in the other arm on 13Sep05, included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) with no adverse reaction. There was no illness at the time of vaccination. On 05Oct05, within 1.5 hrs of vaccination, the pt experienced a sore arm and had a fever later that day to 103 deg F. On 06Oct05, he was seen by a physician with a large area of his arm swollen with erythema and a temp of 101 deg F. The pt was taking acetaminophen (Tylenol) and he was also started on prednisone and cephalexin. The pt was sent for blood cultures, laboratory work with further blood test, and a urine culture (results not provided). It was also noted that the pt was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine over 10 years ago with no adverse reaction. A product quality complaint was not involved. Additional information has been received from the physician who reported that on 06Oct05, the pt had a severe local reaction with a temp elevation to 103 deg F orally approx 18 hrs after admin with the febrile condition lasting approx 48 hrs. Blood cultures showed no growth after five days.  See lab section for all other diagnostic results. Subsequently, the pt recovered. No further information is expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Lymphopenia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 66 yr old white male with a penicillin allergy who on 05OCT05 at 10:00AM was vaccinated IM in the right arm with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant vaccination in the other arm on 13Sep05, included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) with no adverse reaction. There was no illness at the time of vaccination. On 05Oct05, within 1.5 hrs of vaccination, the pt experienced a sore arm and had a fever later that day to 103 deg F. On 06Oct05, he was seen by a physician with a large area of his arm swollen with erythema and a temp of 101 deg F. The pt was taking acetaminophen (Tylenol) and he was also started on prednisone and cephalexin. The pt was sent for blood cultures, laboratory work with further blood test, and a urine culture (results not provided). It was also noted that the pt was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine over 10 years ago with no adverse reaction. A product quality complaint was not involved. Additional information has been received from the physician who reported that on 06Oct05, the pt had a severe local reaction with a temp elevation to 103 deg F orally approx 18 hrs after admin with the febrile condition lasting approx 48 hrs. Blood cultures showed no growth after five days.  See lab section for all other diagnostic results. Subsequently, the pt recovered. No further information is expected.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 52 year old male, who was hospitalized due to an accident, who was vaccinated with a 0.5 ml subcutaneous dose of pneumococcal 23 v polysaccharide vaccine (Lot# 651523/0604R). It was reported that the patient developed an erythema at the injection site, which developed into cellulitis requiring antibiotics. Subsequently the patient recovered. The event resulted in prolonged hospitalization and was considered to be an other important medical event (OMIC) by reporter. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a 34 yr old female with a depressed immune system and no drug reactions/allergies reported, who on 04Oct05 was vaccinated IM into the left deltoid at 3:00PM with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (Lot 650331/0749P) and at the same time vaccinated IM into the right deltoid with a dose of influenzae virus split virion 3v vaccine inactivated (Fluzone). Four hours after the vaccination (7:00PM) on 04Oct05, the pt developed a soreness and swelling in the left arm from the elbow to the shoulder. The pt was seen at the doctor's office. At the time of the report the pt's present status was unk. No product quality complaint was involved. The pharmacist requested a lot check. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 79 yr old white female who on 07Sep05 in the am was vaccinated IM in the left arm with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Four to seven hours post vaccination the pt experienced pain, redness and swelling at the injection site. Unspecified medical attention was sought. At the time of the report the pt had recovered. There was no product quality complaint involved. Follow up information indicated that on 08Sep05 at 1:00PM the pt developed swelling and redness of the left arm, 6x10 cm rectangle. No further information was available.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 73 yr old white female who on 06Oct05 at 9:30AM was vaccinated IM in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant vaccination that day included a dose of influenza virus split virion 3v vaccine inactivated (Fluvax) (lot AFLUA1318A) given in the left arm. Four to seven hours post vaccination the pt experienced pain, redness and swelling at the injection site. Unspecified medical attention was sought. At the time of the report the pt had recovered. There was no product quality complaint involved. Follow up information indicated that on 06Oct05 at 19:00 the pt experienced redness, swelling and pain in her left arm. No further information is expected.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 48 yr old white female registered nurse with chronic obstructive pulmonary disease. It was reported that the pt and her sibling had no other adverse events following prior vaccination. On 06Oct05, at 2PM, the pt was vaccinated SC in the left arm with the second dose of pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). It was reported that on 05Oct05, at 10AM, the pt had been vaccinated with the first dose of influenza virus split virion 3v vaccine inactivated (Fluzone (influenza virus split virion 3v vaccine inactivated) ) (Lot number U1810AA) administered IM into the right deltoid. The pt did not have any illness at the time of vaccination. On 06Oct05, at 8PM, the pt developed from the shoulder to forearm pain, swelling and erythema which became progressively worse overnight. The pt was reported to have limited range of motion, nausea, vomiting, a fever 103F and chills. The pt was treated with methylprednisolone acetate (Depo Medrol), 80mg IM, ketorolac tromethamine (Toradol), 60mg, IM and rest. The pt sought unspecified medical attention. At the time of this report, the pt had recovered from the events (date unk). No further information is available.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a RN concerning a 48 yr old white female registered nurse with chronic obstructive pulmonary disease. It was reported that the pt and her sibling had no other adverse events following prior vaccination. On 06Oct05, at 2PM, the pt was vaccinated SC in the left arm with the second dose of pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). It was reported that on 05Oct05, at 10AM, the pt had been vaccinated with the first dose of influenza virus split virion 3v vaccine inactivated (Fluzone (influenza virus split virion 3v vaccine inactivated) ) (Lot number U1810AA) administered IM into the right deltoid. The pt did not have any illness at the time of vaccination. On 06Oct05, at 8PM, the pt developed from the shoulder to forearm pain, swelling and erythema which became progressively worse overnight. The pt was reported to have limited range of motion, nausea, vomiting, a fever 103F and chills. The pt was treated with methylprednisolone acetate (Depo Medrol), 80mg IM, ketorolac tromethamine (Toradol), 60mg, IM and rest. The pt sought unspecified medical attention. At the time of this report, the pt had recovered from the events (date unk). No further information is available.
Age: 76.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 76 year old male who on 12-OCT-2005 was vaccinated intramuscularly, with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 651539/0607R). It was reported that this was the first dose of pneumococcal 23v polysaccharide vaccine that the patient had received. On 12-OCT-2005, the patient was also vaccinated intramuscularly in the left arm with 0.5 ml dose of influenza virus vaccine (unspecified). On 13-OCT-2005, the patient went to the doctor's office and was diagnosed with right arm cellulitis. The physician treated the patient with levofloxacin (Levaquin), 750 mg. The patient sought unspecified medical attention. On 19-OCT-2005, the patient had recovered. Upon internal review, the reporter felt that the patient's right arm cellulitis was an other important medical event (OMIC). Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia, Pain, Pyrexia, Tachycardia
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old female patient with cardiomyopathy, mitral valve prolapse, and allergies to penicillin and ace inhibitors (unspecified) who at 3:00 pm on 27-OCT-2005 was vaccinated in the deltoid with a first dose of with a dose of pneumococcal 23v polysaccharide vaccine.  On 28-OCT-2005, the patient developed a fever of 102 F, myalgia, chills, pain in the left arm and neck, and an increased heart rate.  The patient went to the emergency room and received unspecified treatment.  The patient was not admitted to the hospital.  The patient subsequently recovered.  No additional information is expected.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old white female patient with asthma, hypercholesteremia and allergies to codeine, cefaclor (CEFLOR), propoxyphene HCL (DARVON), erythromycin, and hyoscyamine/atropine/scopolomine phenobarbital (DONNATAL) who at 2:00 pm on 24-OCT-2005 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine.  On 27-OCT-2005, the patient developed redness of the arm was hot to the touch and painful.  The patient received no treatment.  The patient was seen by the physician for follow up and had subsequently recovered.  No additional information is expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female patient with cardiomyopathy, acid reflux, and an iodine allergy who at 10:00 am on 24-OCT-2005 was vaccinated in the left deltoid with a first dose pneumococcal 23v polysaccharide vaccine.  On 25-OCT-2005, the patient developed pain in the left arm and swelling down to the elbow.  The patient also developed discoloration at the injection site which extended down to the elbow and to the left breast area.  The patient want to the emergency room and received unspecified treatment.  The patient was not admitted to the hospital.  The patient subsequently recovered.  No additional information is expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 65 yr old male registered nurse who on 25Oct05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). The nurse reported that he developed pain in the left arm where the injection was given. The pt and soreness were so bad that he woke up several times at night. He was treated with ibuprofen for the pain. The pain lasted for 3 days and then subsequently subsided. The nurse reported that he subsequently recovered. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Swelling
Clinical narrative: Information has been received from a physician concerning a 71 year old male patient who on 25-OCT-2005 was vaccinated into right deltoid muscle with a dose of pneumococcal 23v polysaccharide vaccine (lot#650331/0749P).  Concomitantly the patient was vaccinated into left deltoid muscle with a dose of influenza virus vaccine (unspecified).  On 26-OCT-2005, the patient developed severe upper arm swelling, erythema and edema.  The patient was reported as recovered.  There was no product quality complaint involved.  A lot checked has been requested.  The records of testing prior to release of this lot have  been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Pruritus
Clinical narrative: Information has been received from a physician concerning a 67 yr old female who on 25Oct05 in the AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650331/0749P), in the right deltoid. Concomitant therapy that day included influenza virus split virion 3v vaccine inactivated (Fluzone (influenza virus split virion 3v vaccine inactivated) ) (lot U1810AA), in the left deltoid. On 26Oct05 the pt experienced severe upper arm edema, erythema, vesicles and itching. Subsequently, the pt recovered. There were no relevant diagnostic tests or lab data. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Discomfort, Erythema, Oedema peripheral, Skin burning sensation, Swelling
Clinical narrative: Edema peripheral; burning sensation; discomfort; urticaria; erythema Information has been received from a registered nurse concerning a 71 year old white male with a penicillin allergy who on 25-OCT-2005 was vaccinated in the right deltoid muscle pneumococcal 23v polysaccharide vaccine (lot #549989/0579P). Concomitant therapy that same day included a vaccination in the left deltoid muscle with influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated). On 26-OCT-2005 the patient presented at the medical center with a "red, swollen hive looking area on the right upper inner arm with complaints of burning and discomfort." The patient's primary care physician prescribed diphenhydramine hydrochloride (Benadryl) which the patient refused. The patient was advised to apply cold packs to the affected area and return for a re-check if the site worsened. The patient's primary care physician also recommended that the patient no longer receive the pneumococcal 23v polysaccharide vaccine. Subsequently, the patient recovered from the red, swollen, hive looking area on the right upper inner arm as well as from the burning and discomfort. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Urticaria
Clinical narrative: Edema peripheral; burning sensation; discomfort; urticaria; erythema Information has been received from a registered nurse concerning a 71 year old white male with a penicillin allergy who on 25-OCT-2005 was vaccinated in the right deltoid muscle pneumococcal 23v polysaccharide vaccine (lot #549989/0579P). Concomitant therapy that same day included a vaccination in the left deltoid muscle with influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated). On 26-OCT-2005 the patient presented at the medical center with a "red, swollen hive looking area on the right upper inner arm with complaints of burning and discomfort." The patient's primary care physician prescribed diphenhydramine hydrochloride (Benadryl) which the patient refused. The patient was advised to apply cold packs to the affected area and return for a re-check if the site worsened. The patient's primary care physician also recommended that the patient no longer receive the pneumococcal 23v polysaccharide vaccine. Subsequently, the patient recovered from the red, swollen, hive looking area on the right upper inner arm as well as from the burning and discomfort. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Skin burning sensation, Urticaria
Clinical narrative: Edema peripheral; burning sensation; discomfort; urticaria; erythema Information has been received from a registered nurse concerning a 71 year old white male with a penicillin allergy who on 25-OCT-2005 was vaccinated in the right deltoid muscle pneumococcal 23v polysaccharide vaccine (lot #549989/0579P). Concomitant therapy that same day included a vaccination in the left deltoid muscle with influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated). On 26-OCT-2005 the patient presented at the medical center with a "red, swollen hive looking area on the right upper inner arm with complaints of burning and discomfort." The patient's primary care physician prescribed diphenhydramine hydrochloride (Benadryl) which the patient refused. The patient was advised to apply cold packs to the affected area and return for a re-check if the site worsened. The patient's primary care physician also recommended that the patient no longer receive the pneumococcal 23v polysaccharide vaccine. Subsequently, the patient recovered from the red, swollen, hive looking area on the right upper inner arm as well as from the burning and discomfort. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Discomfort, Erythema, Oedema peripheral, Skin burning sensation, Swelling
Clinical narrative: Information has been received from a RN concerning a 71 yr old Caucasian male pt with hypertension and benign prostatic hyperplasia (BPH) who on 25Oct05 at 1:30PM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot649989/0579P), IM in the right deltoid. There was no illness at the time of vaccination. On 26Oct05 in the PM the pt developed swelling/redness right upper arm, and slight burning sensation began. The pt was seen in the physician's office on 27Oct05. It was also reported that the pt experienced hives and swelling all around injection site. The pt was advised diphenhydramine HC1 (Benadryl) and ice pack. There were no relevant diagnostic tests or laboratory date. The pt recovered on 27Oct05. No further information is expected.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a RN concerning a 71 yr old Caucasian male pt with hypertension and benign prostatic hyperplasia (BPH) who on 25Oct05 at 1:30PM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot649989/0579P), IM in the right deltoid. There was no illness at the time of vaccination. On 26Oct05 in the PM the pt developed swelling/redness right upper arm, and slight burning sensation began. The pt was seen in the physician's office on 27Oct05. It was also reported that the pt experienced hives and swelling all around injection site. The pt was advised diphenhydramine HC1 (Benadryl) and ice pack. There were no relevant diagnostic tests or laboratory date. The pt recovered on 27Oct05. No further information is expected.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Skin burning sensation, Urticaria
Clinical narrative: Information has been received from a RN concerning a 71 yr old Caucasian male pt with hypertension and benign prostatic hyperplasia (BPH) who on 25Oct05 at 1:30PM was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot649989/0579P), IM in the right deltoid. There was no illness at the time of vaccination. On 26Oct05 in the PM the pt developed swelling/redness right upper arm, and slight burning sensation began. The pt was seen in the physician's office on 27Oct05. It was also reported that the pt experienced hives and swelling all around injection site. The pt was advised diphenhydramine HC1 (Benadryl) and ice pack. There were no relevant diagnostic tests or laboratory date. The pt recovered on 27Oct05. No further information is expected.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Contusion, Ecchymosis, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 64 yr old Caucasian female with hypothyroid who on 22Oct05 at 11:30AM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P), in the right arm IM. Concomitant therapy that day included an influenza virus vaccine (unspecified) in the other arm. There was no illness at the time of vaccination. The pt reported that by evening on 22Oct05 at 8:00PM my hand on that arm was puffed out on top and arm was aching. Next day swelling on hand gone down some and knuckles were black and blue. Pain in arm and elbows lasted 4 days. On 6th day the hand (was) still discolored. Information was also received from the responsible physician's office which reported that on 22Oct05 the pt developed edematous to right hand, pain to right arm described as aching. Following day knuckles to right arm ecchymotic, pain lasted 4 days ecchymosis lasted 6 days. The pt recovered one week after immunization. The pt had health dept visit on 26Oct05. No lab tests were performed. It was also reported that other pt's experienced an adverse event following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0510USA09350, 0511USA01105 and 0511USA01106). Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Arthralgia, Dysphonia, Fatigue, Listless
Clinical narrative: Initial and follow up information has been received from a RN and a health professional concerning a 68 yr old retired white female with diabetes who on 21Oct05 at 13:30 was vaccinated IM in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant vaccine therapy given on 20Oct05 included an annual dose of influenza virus vaccine (unspecified) given in the left arm. There was no illness at the time of vaccination. On the evening of 21Oct05 the pt developed excruciating pain from the shoulder and neck down to the arm, was listless, had a loss of appetite (x4-5days), post nasal drip, hoarseness (lost his voice) and had a head and chest cold. The pt did not resolve despite hot and cold packs and rest. The pt slept when he could and had no energy. On 18Nov05 the pt had a family doctor appt. Unspecified blood work was performed which was within normal limits. The physician noted that the pt had no severe reaction. The physician prescribed unspecified antibiotics for sinus congestion. Subsequently, the pt recovered from pain from shoulder down to arm, listless, loss of appetite, post nasal drip and head and chest cold, and hoarseness. The pt's sinus congestion (also reported as some upper respiratory congestion) persisted. No further information is expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Rhinitis, Rhinorrhoea
Clinical narrative: Initial and follow up information has been received from a RN and a health professional concerning a 68 yr old retired white female with diabetes who on 21Oct05 at 13:30 was vaccinated IM in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant vaccine therapy given on 20Oct05 included an annual dose of influenza virus vaccine (unspecified) given in the left arm. There was no illness at the time of vaccination. On the evening of 21Oct05 the pt developed excruciating pain from the shoulder and neck down to the arm, was listless, had a loss of appetite (x4-5days), post nasal drip, hoarseness (lost his voice) and had a head and chest cold. The pt did not resolve despite hot and cold packs and rest. The pt slept when he could and had no energy. On 18Nov05 the pt had a family doctor appt. Unspecified blood work was performed which was within normal limits. The physician noted that the pt had no severe reaction. The physician prescribed unspecified antibiotics for sinus congestion. Subsequently, the pt recovered from pain from shoulder down to arm, listless, loss of appetite, post nasal drip and head and chest cold, and hoarseness. The pt's sinus congestion (also reported as some upper respiratory congestion) persisted. No further information is expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning a 50 year old female with allergy to codeine and moxifloxacin who on 01-NOV-2005 at 9:30 am was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine, in the right deltoid.  Concomitant therapy included esomeprazole magnesium (NEXIUM) and metformin HCL (GLUCOPHAGE).  There was no illness at the time of vaccination.  On 01-NOV-2005 at 7:30 pm the patient experienced erythema (5 x 4 centimeter), slight induration at the site of injection and sore at the site of injection.  It was reported to be unknown if the patient recovered.  Additional information has been request.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female with allergy to cefaclor who on 10/25/2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 651318/1006P) (0.5 ml), SC, in the right arm. There was no illness at the time of vaccination. The next day, on 10/26/05, the patient presented to the office with cellulitis of the left arm. That same night, the patient went to the hospital, and was hospitalized for four days. The patient had cellulitis and a fever of 104. It was also reported that the patient, "two days post immunization," developed erythema and swelling " size of golf ball" to right arm. Temperature 101.7F. On 10/28/05, the patient admitted to hospital for IV antibiotics and blood culture for diagnosis of cellulitis. Subsequently, the patient recovered on 11/29/05. The nurse requested a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the system revealed that there were no open Quarantines registered against this lot/fill. The patient's experience was considered to be disabling and an other important medical event by the reporter (OMIC). Additional information is not expected. Other business partner numbers included E200505521.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Pain
Clinical narrative: Information has been received from a physician concerning a 64 year old male with asparaginase and sulfonamide allergy, hypertension, peptic ulcer disease, gastroesophageal reflux disease, and arteriosclerotic vessel disease who on 11-NOV-2005 AT 8:00 am was vaccinated with pneumococcal 23v polysaccharide vaccine, in the left deltoid.  Concomitant therapy that day included influenza virus split virion 3v vaccine inactivated, in the right deltoid.  Other therapy included amlodipine besylate (NORVASC), alginic acid (+) aluminum hydroxide (+) magnesium carbonate (TOPROL), finasteride(PROSCAR), clopidogrel bisulfate (PLAVIX) and ramipril (ALTACE).  There was no illness at the time vaccination.  On 12-NOV-2005 at 10:45 am the patient experienced external pain in deltoid, trouble abducting arm and redness.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Erythema, Lethargy, Oedema, Pain
Clinical narrative: Information has been received from a healthcare professional concerning a 79 year old female who on 17-AUG-2005 at 10:00 am was vaccinated with pneumococcal 23v polysaccharide vaccine, subcutaneously in the left deltoid.  Concomitant therapy included alendronate sodium.  On 19-AUG-2005 the patient experienced redness, edema, left deltoid pain, area felt hot, loss of appetite, was lethargic and some sweats.  However, there were no chills.  The arm was elevated.  The patient required a doctor's visit.  There were no relevant diagnostic tests or laboratory data.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a license practical nurse concerning a 70 year old female who on 16-AUG-2005 was vaccinated SC into left left deltoid muscle with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included HYDROCHLOROTHIAZIDE/triamterene (MAXZIDE), candesartan cilexetil (ATACAND), amlodipine besylate (NORCASC), sertraline HCL (ZOLOFT), levothyroxine Na (SYNTHROID), omeprazole (PRILOSEC), risedronate sodium (ACTONEL), pilocarpine HCL (SALAGEN TABLETS), acetaminophen (+) propoxyphene napsylate (DARVOCET) and digoxin.  on 18-AUG-2005, the patient's left arm was red, hot, painful and she couldn't move her arm, elbow and shoulder easily (previously reported as injection site redness, pain, local warmth and swelling).  The patient was reported as recovered.  There was no product quality complaint involved.  Additional information is not expected.
Age: 0.58
Sex: F
Vaccine: DT, IPV, PNC
Symptoms: Fatigue, Irritability, Vomiting
Clinical narrative: Info first reported in county health department on November 14, 2005: Has been acting fussy and tired since 11/10/2005.  Moves head back and forth everytime she starts to eat since 11/11/05.  Vomited 4 hours after taking formula (Lactose-Free Similac) on 11/13/05 and spit up a couple of times after feeding on 11/14/05.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 66 yr old white female, with a history of immunization and no known pertinent medical history reported, who on 17Nov05 was vaccinated IM with a second dose (0.5mL) of pneumococcal 23v polysaccharide vaccine (lot651318/1006P). It was reported that the pt was vaccinated with influenza virus vaccine (unspecified) on 25Oct05 and was previously vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manf unk) on 05Nov99. On 18Nov05 the pt developed redness and swelling to right arm for 48 hrs. On 19Nov05, the pt was seen in the office and received Medrol dose pack. Subsequently, on 21Nov05 the pt recovered. No further information is available.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Information has been received from a 75 year old female consumer who on 15-NOV-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, that afternoon her left arm became very red, hot swollen and painful.  There was about 14-15 (inches of redness.  She also developed a red, hot rash.  The patient noted that "It wasn't where I got the needle but the opposite side of my arm"  On 18-NOV-2005 she called her physician and went back to his office.  The physician put her on prednisone tablet, 20mg twice a day and desloratadine (CLARINEX) tablet 5 mg daily.  On 18-NOV-2005 and 21-NOV-2005 she had to go back to the office.  The patient's outcome was unknown.  The also patient noted that she had never had a bad reaction to any vaccine before.  No product quality complaint was involved.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Injection site pain, Injection site reaction
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 73 year old white female with diabetes and hypertension who on 11/29/05, at 13:00, was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 650329/0747P). On 11/29/05, the patient developed an injection site reaction that included soreness, erythema, warmth, swelling and pain. In follow up, it was reported that on 11/29/05, at 22:00, the patient developed fever, chills, and pain at the injection site. On 11/30/05, the patient presented to the office with cellulitis at the injection site, and was given unspecified antibiotics. On 12/05/05, the patient recovered from the injection site cellulitis. The reporter considered the injection site cellulitis to be an other important medical event (OMIC). No further information is expected. Other business partner numbers included E200505260.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Pyrexia, Swelling
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 73 year old white female with diabetes and hypertension who on 11/29/05, at 13:00, was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 650329/0747P). On 11/29/05, the patient developed an injection site reaction that included soreness, erythema, warmth, swelling and pain. In follow up, it was reported that on 11/29/05, at 22:00, the patient developed fever, chills, and pain at the injection site. On 11/30/05, the patient presented to the office with cellulitis at the injection site, and was given unspecified antibiotics. On 12/05/05, the patient recovered from the injection site cellulitis. The reporter considered the injection site cellulitis to be an other important medical event (OMIC). No further information is expected. Other business partner numbers included E200505260.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Cough, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician and a healthcare worker concerning a 73 year old retired male patient with no known allergies, hypertension, giant cell arteritis, and polymyalgia rheumatica who on 28-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included prednisone, methotrexate, valsartan (DIOVAN), folic acid and "ISOTOL". On 07-NOV-2005 the patient developed a cough, phlegm, and a few days later developed a fever.  He had an elevated white count and an infiltrate in the left lung, his blood cultures at that time showed staphylococcal hominis but the physician noted that he was certain if this was a contaminant or not.  He was treated with intravenous high dose levofloxacin (LEVAQUIN) for several weeks and the infiltrate improved.  He became asymptomatic and the process resolved.  He was seen by a pulmonary specialist who agreed that the problem was resolved.  It was reported that the patient was not hospitalized.  There was no product quality complaint involved.  The physician noted that he could not attest to the fact that there was a cause and effect relationship to the pneumococcal 23v polysaccharide vaccine, as this was a staphylococcal coagulase negative,  He did not think that clinically, it was staphylococcal lung pneumonia, but a contaminant.  Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Rash
Clinical narrative: Information has been received from a physician concerning a 48 year old female with hay fever, no egg allergies and no other pertinent medical history had been hospitalized for a possible vascular occlusion of the third finger on her right hand. An angiogram was negative. While in the hospital, on 10/5/05, she was vaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination therapy included a dose of influenza virus split virion 3v vaccine inactivated given in an unspecified but different arm. There were no other concomitant medications. There was no illness at the time of vaccination and the patient was discharged from the hospital on that same day. On 10/10/05, the patient developed a diffused pinpoint rash on her torso that became generalized over her entire body. She went to the hospital emergency room twice on the same day, was treated and released. The first visit, she was treated with oral prednisone and diphenhydramine hydrochloride. The second visit at the ER, she was treated with IV steroids and diphenhydramine hydrochloride, at that time she was placed on prednisone PO. It was noted that the patient experienced a local site reaction of the arm but was unsure if it was site vaccinated with influenza virus vaccine or pneumococcal 23v polysaccharide vaccine. The patient was examined during an office visit on 10/12/05 and the symptoms had resolved. The reporter noted that the patient was not hospitalized for these events. At the time of this report, the patient had recovered. The reporting physician considered the diffuse rash and local site reaction of the arm to be disabling and other important medical events (OMIC). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old white female (157 lb) teacher, with no known drug allergies and no medical history, who on 11/09/05 at 3:30 PM was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 651318/1006P). Concomitantly the patient was vaccinated IM into the left deltoid muscle with a fourth dose of influenza split virion 3v vaccine inactivated (lot # U1825EA). Concomitant therapy included rosumvastatin calcium. There was no illness at the time of vaccination. On 11/10/05 the patient developed cellulitis. The patient's right arm was red, warm, painful, and swollen. She had a fever of 102F. The patient was treated with telithromycin 400mg for 9 days and fexofenadine hydrochloride (+) pseudoephedrine hydrochloride 180mg for 10 days. The patient was reported recovered. There was no product quality complaint involved. Follow up information from a health professional indicated that the patient contacted the physician on 11/10/05 and was seen in the office. The patient complained of redness that was raised and demarcated on the leading margin, and tenderness of the right upper arm. The diagnosis was cellulitis of the upper arm. It was noted that the patient was unable to work. The event was considered to be disabling and to be an other important medical event by the reporter (OMIC). The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. A review of the system revealed that there were no open quarantines registered against this lot/fill. Additional information is not expected. This is a consolidation of two reports concerning the same patient.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old white female (157 lb) teacher, with no known drug allergies and no medical history, who on 11/09/05 at 3:30 PM was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 651318/1006P). Concomitantly the patient was vaccinated IM into the left deltoid muscle with a fourth dose of influenza split virion 3v vaccine inactivated (lot # U1825EA). Concomitant therapy included rosumvastatin calcium. There was no illness at the time of vaccination. On 11/10/05 the patient developed cellulitis. The patient's right arm was red, warm, painful, and swollen. She had a fever of 102F. The patient was treated with telithromycin 400mg for 9 days and fexofenadine hydrochloride (+) pseudoephedrine hydrochloride 180mg for 10 days. The patient was reported recovered. There was no product quality complaint involved. Follow up information from a health professional indicated that the patient contacted the physician on 11/10/05 and was seen in the office. The patient complained of redness that was raised and demarcated on the leading margin, and tenderness of the right upper arm. The diagnosis was cellulitis of the upper arm. It was noted that the patient was unable to work. The event was considered to be disabling and to be an other important medical event by the reporter (OMIC). The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. A review of the system revealed that there were no open quarantines registered against this lot/fill. Additional information is not expected. This is a consolidation of two reports concerning the same patient.