chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
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: Pain, Pyrexia, Swelling
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: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Hypokinesia, Pain, Swelling
Clinical narrative: Information has been received from a 65 year old female public health registered nurse (115 pounds and 5'4") with allergies to phenobarbital, psyllium husk (METAMUCIL) and penicillin who on 10-NOV-2005, at 15:30 was vaccinated SC into the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 10-NOV-2005, the patient was vaccinated intramuscular into her left deltoid with a dose of influenza virus vaccine (unspecified).  On 11-NOV-2005, the patient developed swollen axillary glands, difficulty moving her arm, fever and chills for 48 hours, sore arm, pain across her left back and clavicle and down her breast and was extremely tired.  The patient was reported was reported as recovered.  There was no product quality complaint involved.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Back pain, Chest pain, Chills, Fatigue, Hypokinesia
Clinical narrative: Information has been received from a 65 year old female public health registered nurse (115 pounds and 5'4") with allergies to phenobarbital, psyllium husk (METAMUCIL) and penicillin who on 10-NOV-2005, at 15:30 was vaccinated SC into the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 10-NOV-2005, the patient was vaccinated intramuscular into her left deltoid with a dose of influenza virus vaccine (unspecified).  On 11-NOV-2005, the patient developed swollen axillary glands, difficulty moving her arm, fever and chills for 48 hours, sore arm, pain across her left back and clavicle and down her breast and was extremely tired.  The patient was reported was reported as recovered.  There was no product quality complaint involved.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Musculoskeletal pain, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 65 year old female public health registered nurse (115 pounds and 5'4") with allergies to phenobarbital, psyllium husk (METAMUCIL) and penicillin who on 10-NOV-2005, at 15:30 was vaccinated SC into the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 10-NOV-2005, the patient was vaccinated intramuscular into her left deltoid with a dose of influenza virus vaccine (unspecified).  On 11-NOV-2005, the patient developed swollen axillary glands, difficulty moving her arm, fever and chills for 48 hours, sore arm, pain across her left back and clavicle and down her breast and was extremely tired.  The patient was reported was reported as recovered.  There was no product quality complaint involved.  Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Feeling hot, Injection site induration, Injection site inflammation, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a healthcare professional concerning a 51 year old male with asthma, thyroid problems, allergic rhinitis, gout and tremor and no allergies who on 31-DEC-2005 in the am was vaccinated, with a second dose of pneumococcal 23v polysaccharide vaccine intramuscularly.  Concomitant therapy that day and time included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE), intramuscularly in the arm.  Other concomitant therapy included allopurinol, propranolol HCL (INDERAL), albuterol, fluticasone propionate (FLONASE) and loratadine (CLARTIN).  There was no illness at the time of vaccination.  On 31-dec-2005 the patient had neck stiffness.  On 01-JAN-2006 the patient experienced fever at 101 degrees, some achiness, arm became red, painful, hot hard and swollen (also described as arm inflamed).  The patient recovered on 02-JAN-2006.  There were to relevant diagnostic or laboratory tests.  Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a healthcare professional concerning a 51 year old male with asthma, thyroid problems, allergic rhinitis, gout and tremor and no allergies who on 31-DEC-2005 in the am was vaccinated, with a second dose of pneumococcal 23v polysaccharide vaccine intramuscularly.  Concomitant therapy that day and time included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE), intramuscularly in the arm.  Other concomitant therapy included allopurinol, propranolol HCL (INDERAL), albuterol, fluticasone propionate (FLONASE) and loratadine (CLARTIN).  There was no illness at the time of vaccination.  On 31-dec-2005 the patient had neck stiffness.  On 01-JAN-2006 the patient experienced fever at 101 degrees, some achiness, arm became red, painful, hot hard and swollen (also described as arm inflamed).  The patient recovered on 02-JAN-2006.  There were to relevant diagnostic or laboratory tests.  Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site inflammation, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Information has been received from a healthcare professional concerning a 51 year old male with asthma, thyroid problems, allergic rhinitis, gout and tremor and no allergies who on 31-DEC-2005 in the am was vaccinated, with a second dose of pneumococcal 23v polysaccharide vaccine intramuscularly.  Concomitant therapy that day and time included a first dose of influenza virus split virion 3v vaccine inactivated (FLUZONE), intramuscularly in the arm.  Other concomitant therapy included allopurinol, propranolol HCL (INDERAL), albuterol, fluticasone propionate (FLONASE) and loratadine (CLARTIN).  There was no illness at the time of vaccination.  On 31-dec-2005 the patient had neck stiffness.  On 01-JAN-2006 the patient experienced fever at 101 degrees, some achiness, arm became red, painful, hot hard and swollen (also described as arm inflamed).  The patient recovered on 02-JAN-2006.  There were to relevant diagnostic or laboratory tests.  Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 77 year old male with no allergies with hypertension, elevated cholesterol, hyperlipidemia, spinal stenosis, arthritis, coronary artery disease and history of angioplasty who on 22-DEC-2005 was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine (0.5 ml), intramuscularly in the left arm.  Concomitant therapy included aspirin, celecoxib (CELEBREX), clopidogrel bisulfate (PLAVIX), simvastatin, hydrochlorothiazide (manufacturer unknown), Terazosin hydrochloride, metoprolol succinate (TOPROL XL tablets) and ezetimibe.  There was no illness at the time of vaccination.  On 22-DEC-2005 the patient experienced chills and left arm pain (also reported as "very sore left arm").  The patient recovered on 23-dec-2005.  There were no relevant diagnostic tests or laboratory data.  No further information is expected.
Age: 77.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 77 year old male with no allergies with hypertension, elevated cholesterol, hyperlipidemia, spinal stenosis, arthritis, coronary artery disease and history of angioplasty who on 22-DEC-2005 was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine (0.5 ml), intramuscularly in the left arm.  Concomitant therapy included aspirin, celecoxib (CELEBREX), clopidogrel bisulfate (PLAVIX), simvastatin, hydrochlorothiazide (manufacturer unknown), Terazosin hydrochloride, metoprolol succinate (TOPROL XL tablets) and ezetimibe.  There was no illness at the time of vaccination.  On 22-DEC-2005 the patient experienced chills and left arm pain (also reported as "very sore left arm").  The patient recovered on 23-dec-2005.  There were no relevant diagnostic tests or laboratory data.  No further information is expected.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: Injection site edema; dizziness; medication error; nausea; injection site erythema. Information has been received from a mother who is a licensed practical nurse concerning her 11 year old male son with asthma and allergy to ibuprofen, who on 16-JAN-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#0651254/0605R). Concomitant therapy included influenzae virus vaccine (unspecified) in the same arm. On 16-JAN-2006 several hours post vaccination the patient developed redness near injection site and swelling near injection site and experienced nausea and dizziness. Unspecified medical attention was sought. At the time of the report the symptoms remained. The patient's present status was reported as not recovered. No product quality complaint was involved. additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Dizziness, Erythema, Injection site oedema, Medication error, Nausea
Clinical narrative: Injection site edema; dizziness; medication error; nausea; injection site erythema. Information has been received from a mother who is a licensed practical nurse concerning her 11 year old male son with asthma and allergy to ibuprofen, who on 16-JAN-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#0651254/0605R). Concomitant therapy included influenzae virus vaccine (unspecified) in the same arm. On 16-JAN-2006 several hours post vaccination the patient developed redness near injection site and swelling near injection site and experienced nausea and dizziness. Unspecified medical attention was sought. At the time of the report the symptoms remained. The patient's present status was reported as not recovered. No product quality complaint was involved. additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Erythema, Feeling hot, Injection site induration, Injection site inflammation, Injection site reaction
Clinical narrative: Injection site edema; dizziness; medication error; nausea; injection site erythema. Information has been received from a mother who is a licensed practical nurse concerning her 11 year old male son with asthma and allergy to ibuprofen, who on 16-JAN-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#0651254/0605R). Concomitant therapy included influenzae virus vaccine (unspecified) in the same arm. On 16-JAN-2006 several hours post vaccination the patient developed redness near injection site and swelling near injection site and experienced nausea and dizziness. Unspecified medical attention was sought. At the time of the report the symptoms remained. The patient's present status was reported as not recovered. No product quality complaint was involved. additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ, PPV, FLUX, PPV, FLU3, MNQ, PPV
Symptoms: Oedema peripheral, Swelling
Clinical narrative: Injection site edema; dizziness; medication error; nausea; injection site erythema. Information has been received from a mother who is a licensed practical nurse concerning her 11 year old male son with asthma and allergy to ibuprofen, who on 16-JAN-2006 was vaccinated intramuscularly in the arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#0651254/0605R). Concomitant therapy included influenzae virus vaccine (unspecified) in the same arm. On 16-JAN-2006 several hours post vaccination the patient developed redness near injection site and swelling near injection site and experienced nausea and dizziness. Unspecified medical attention was sought. At the time of the report the symptoms remained. The patient's present status was reported as not recovered. No product quality complaint was involved. additional information has been requested.
Age: 8.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pyrexia, Swelling, Vaccination complication
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with sickle cell disease who on 11/7/05 was vaccinated IM with a dose of Pneumococcal 23v polysaccharide vaccine (lot 647635/0864N). It was reported that the vaccine had expired in June of 2005. Following the vaccination (on an unspecified date) the pt developed a severe local site reaction of redness and swelling. The child was taken to see a physician and was treated with oral diphenhydramine hydrochloride Benadryl. The RN reported that the child has since recovered. No product quality complaint was involved. Follow up information has been received from the registered nurse indication that no additional information is available regarding this pts experience.  Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with sickle cell disease who on 11/7/05 was vaccinated IM with a dose of Pneumococcal 23v polysaccharide vaccine (lot 647635/0864N). It was reported that the vaccine had expired in June of 2005. Following the vaccination (on an unspecified date) the pt developed a severe local site reaction of redness and swelling. The child was taken to see a physician and was treated with oral diphenhydramine hydrochloride Benadryl. The RN reported that the child has since recovered. No product quality complaint was involved. Follow up information has been received from the registered nurse indication that no additional information is available regarding this pts experience.  Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Nausea, Oedema
Clinical narrative: Injection site pain; pain; injection site pruritus; injection site warmth; nausea; malaise; injection site swelling; injection site erythema. Information has been received from a registered nurse concerning a 46 year old white male with penicillin allergy and hypertension who on 02-NOV-2005 at 10:00 AM was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (IM) (Lot # 649912/529P) in the left deltoid. Concomitant therapy at the same time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (IM) (Lot #U1761AA), in the right deltoid. There was no illness at the time of vaccination. On 02-NOV-2006 at 6:00 PM the patient experienced injection site red, itchy, warm to touch, swollen and soreness in the left deltoid. There was a distinct "dime where redness and edema stopped." The patient used ice to site. The patient also stated that he had nausea/aching that lasted approximately 12 hours. The patient recovered. There was no adverse experienced following prior vaccinations. Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Injection site pain; pain; injection site pruritus; injection site warmth; nausea; malaise; injection site swelling; injection site erythema. Information has been received from a registered nurse concerning a 46 year old white male with penicillin allergy and hypertension who on 02-NOV-2005 at 10:00 AM was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (IM) (Lot # 649912/529P) in the left deltoid. Concomitant therapy at the same time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (IM) (Lot #U1761AA), in the right deltoid. There was no illness at the time of vaccination. On 02-NOV-2006 at 6:00 PM the patient experienced injection site red, itchy, warm to touch, swollen and soreness in the left deltoid. There was a distinct "dime where redness and edema stopped." The patient used ice to site. The patient also stated that he had nausea/aching that lasted approximately 12 hours. The patient recovered. There was no adverse experienced following prior vaccinations. Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Injection site pain; pain; injection site pruritus; injection site warmth; nausea; malaise; injection site swelling; injection site erythema. Information has been received from a registered nurse concerning a 46 year old white male with penicillin allergy and hypertension who on 02-NOV-2005 at 10:00 AM was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (IM) (Lot # 649912/529P) in the left deltoid. Concomitant therapy at the same time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (IM) (Lot #U1761AA), in the right deltoid. There was no illness at the time of vaccination. On 02-NOV-2006 at 6:00 PM the patient experienced injection site red, itchy, warm to touch, swollen and soreness in the left deltoid. There was a distinct "dime where redness and edema stopped." The patient used ice to site. The patient also stated that he had nausea/aching that lasted approximately 12 hours. The patient recovered. There was no adverse experienced following prior vaccinations. Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nausea, Pain, Pruritus
Clinical narrative: Injection site pain; pain; injection site pruritus; injection site warmth; nausea; malaise; injection site swelling; injection site erythema. Information has been received from a registered nurse concerning a 46 year old white male with penicillin allergy and hypertension who on 02-NOV-2005 at 10:00 AM was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (IM) (Lot # 649912/529P) in the left deltoid. Concomitant therapy at the same time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (IM) (Lot #U1761AA), in the right deltoid. There was no illness at the time of vaccination. On 02-NOV-2006 at 6:00 PM the patient experienced injection site red, itchy, warm to touch, swollen and soreness in the left deltoid. There was a distinct "dime where redness and edema stopped." The patient used ice to site. The patient also stated that he had nausea/aching that lasted approximately 12 hours. The patient recovered. There was no adverse experienced following prior vaccinations. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Cellulitis; Nausea Initial and follow up information has been received from a physician concerning a 69 year old white menopausal female with hypertension, arrhythmia, hypothyroidism and a history of pneumonia and thyroid surgery, who on 20-JAN-2006 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown). On 21-JAN-2006 the day after the injection in the evening, the patient developed circumferential swelling, pain and redness of the upper arm. She also had chills with no fever. There was no illness at the time of vaccination. Two days after having the pneumococcal 23v polysaccharide vaccination injection on 22-JAN-2006 the patient presented herself to the emergency room. The hospital reported that the patient presented with cellulitis, now has pain to left arm with redness and had a fever and chills at home. The onset of the symptoms occurred 1 day prior to arrival on 21-JAN-2006. The degree of pain was reported as moderate. No pre-arrival treatment occurred. It was reported that the patient had a gastrointestinal symptom (nausea), onset approximately 22-JAN-2006. The hospital reported that the physical examination showed a general appearance of moderate distress; skin warm, dry, and erythema to left mid upper arm/circumferential. The problem area examination was reported as erythema and swelling. The patient was alert and oriented times 3.  On 22-JAN-2006 her vital signs were as follows: temperature 98.2 deg F (normal), pulse 65 bpm (normal.), respiratory rate 16 brpm (normal), systolic blood pressure 130 mm Hg, diastolic 68mm Hg, and mean blood pressure 89 mm Hg. It was noted that the vital signs were reviewed. no update. Clinical work up on 22-JAN-2006 was as follows: WBC 8.4x1Ce3/microL, RBC 4.18x10e5/microL, (low), Hgb 13.8g/dL, Hct 39.7%, MCV 95.0fl, MCH 32.9pg (HI), MCHC 34.6gm/dL, Platelet 332 10e3/microL, RDW 13.1%, EOS % 2.0%. Neut % 69.5% (HI), Neut #5.8x10e3/microL, Lymph #1.8x10e3/microL, Mono #0.6x10e3/microL, Lymph % 21.4%, Mono % 6.6%, Baso % 0.5%, EOS # 0.2x10e3microL, and Baso # 0.0x10e3/microL. The patient was diagnosed with cellulitis. She was treated with Morphine (Morhpina), cefazolin sodium (Ancef 1gm IV) and ofloxacin(Floxin). Upon re-examination it was reported that the patient was improving. Still had pain, but did not want additional pain medication. The patient was considered stable and discharged with acetaminophen (+) hydrocodone bitartrate (Vicodin) 5mg every 4-6 hours as needed and and oral antibiotic, cefadroxil (Duricef) 500mg orally 2 times a day for 7 days from the emergency room. In about one week the patient has fully recovered. No product quality was involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Nausea, Pain
Clinical narrative: Cellulitis; Nausea Initial and follow up information has been received from a physician concerning a 69 year old white menopausal female with hypertension, arrhythmia, hypothyroidism and a history of pneumonia and thyroid surgery, who on 20-JAN-2006 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown). On 21-JAN-2006 the day after the injection in the evening, the patient developed circumferential swelling, pain and redness of the upper arm. She also had chills with no fever. There was no illness at the time of vaccination. Two days after having the pneumococcal 23v polysaccharide vaccination injection on 22-JAN-2006 the patient presented herself to the emergency room. The hospital reported that the patient presented with cellulitis, now has pain to left arm with redness and had a fever and chills at home. The onset of the symptoms occurred 1 day prior to arrival on 21-JAN-2006. The degree of pain was reported as moderate. No pre-arrival treatment occurred. It was reported that the patient had a gastrointestinal symptom (nausea), onset approximately 22-JAN-2006. The hospital reported that the physical examination showed a general appearance of moderate distress; skin warm, dry, and erythema to left mid upper arm/circumferential. The problem area examination was reported as erythema and swelling. The patient was alert and oriented times 3.  On 22-JAN-2006 her vital signs were as follows: temperature 98.2 deg F (normal), pulse 65 bpm (normal.), respiratory rate 16 brpm (normal), systolic blood pressure 130 mm Hg, diastolic 68mm Hg, and mean blood pressure 89 mm Hg. It was noted that the vital signs were reviewed. no update. Clinical work up on 22-JAN-2006 was as follows: WBC 8.4x1Ce3/microL, RBC 4.18x10e5/microL, (low), Hgb 13.8g/dL, Hct 39.7%, MCV 95.0fl, MCH 32.9pg (HI), MCHC 34.6gm/dL, Platelet 332 10e3/microL, RDW 13.1%, EOS % 2.0%. Neut % 69.5% (HI), Neut #5.8x10e3/microL, Lymph #1.8x10e3/microL, Mono #0.6x10e3/microL, Lymph % 21.4%, Mono % 6.6%, Baso % 0.5%, EOS # 0.2x10e3microL, and Baso # 0.0x10e3/microL. The patient was diagnosed with cellulitis. She was treated with Morphine (Morhpina), cefazolin sodium (Ancef 1gm IV) and ofloxacin(Floxin). Upon re-examination it was reported that the patient was improving. Still had pain, but did not want additional pain medication. The patient was considered stable and discharged with acetaminophen (+) hydrocodone bitartrate (Vicodin) 5mg every 4-6 hours as needed and and oral antibiotic, cefadroxil (Duricef) 500mg orally 2 times a day for 7 days from the emergency room. In about one week the patient has fully recovered. No product quality was involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Cellulitis; Nausea Initial and follow up information has been received from a physician concerning a 69 year old white menopausal female with hypertension, arrhythmia, hypothyroidism and a history of pneumonia and thyroid surgery, who on 20-JAN-2006 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown). On 21-JAN-2006 the day after the injection in the evening, the patient developed circumferential swelling, pain and redness of the upper arm. She also had chills with no fever. There was no illness at the time of vaccination. Two days after having the pneumococcal 23v polysaccharide vaccination injection on 22-JAN-2006 the patient presented herself to the emergency room. The hospital reported that the patient presented with cellulitis, now has pain to left arm with redness and had a fever and chills at home. The onset of the symptoms occurred 1 day prior to arrival on 21-JAN-2006. The degree of pain was reported as moderate. No pre-arrival treatment occurred. It was reported that the patient had a gastrointestinal symptom (nausea), onset approximately 22-JAN-2006. The hospital reported that the physical examination showed a general appearance of moderate distress; skin warm, dry, and erythema to left mid upper arm/circumferential. The problem area examination was reported as erythema and swelling. The patient was alert and oriented times 3.  On 22-JAN-2006 her vital signs were as follows: temperature 98.2 deg F (normal), pulse 65 bpm (normal.), respiratory rate 16 brpm (normal), systolic blood pressure 130 mm Hg, diastolic 68mm Hg, and mean blood pressure 89 mm Hg. It was noted that the vital signs were reviewed. no update. Clinical work up on 22-JAN-2006 was as follows: WBC 8.4x1Ce3/microL, RBC 4.18x10e5/microL, (low), Hgb 13.8g/dL, Hct 39.7%, MCV 95.0fl, MCH 32.9pg (HI), MCHC 34.6gm/dL, Platelet 332 10e3/microL, RDW 13.1%, EOS % 2.0%. Neut % 69.5% (HI), Neut #5.8x10e3/microL, Lymph #1.8x10e3/microL, Mono #0.6x10e3/microL, Lymph % 21.4%, Mono % 6.6%, Baso % 0.5%, EOS # 0.2x10e3microL, and Baso # 0.0x10e3/microL. The patient was diagnosed with cellulitis. She was treated with Morphine (Morhpina), cefazolin sodium (Ancef 1gm IV) and ofloxacin(Floxin). Upon re-examination it was reported that the patient was improving. Still had pain, but did not want additional pain medication. The patient was considered stable and discharged with acetaminophen (+) hydrocodone bitartrate (Vicodin) 5mg every 4-6 hours as needed and and oral antibiotic, cefadroxil (Duricef) 500mg orally 2 times a day for 7 days from the emergency room. In about one week the patient has fully recovered. No product quality was involved. Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: PPV, TD, PPV
Symptoms: Decreased appetite, Feeling hot, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an 81 year old male with dementia, hypertension, anemia, depression and penicillin allergy who on 3/14/06 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 651320/1008P), IM. Concomitant therapy included furosemide sodium, potassium, citalopram hydrobromide, donepezil hydrochloride, docusate, morniflumate, and loratadine. On 3/15/06, the patient developed a red, warm, raised area at injection site and a temperature of 102. The patient was given acetaminophen for elevated temperature. It was noted that the patient had a slightly elevated BUN. The patient was considered to be not recovered. The reporter considered red, warm, raised area of injection site and temperature of 102 were considered to be disabling and other medical events (OMIC). Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV, TD, PPV
Symptoms: Injection site pain, Nausea, Pyrexia, Wheezing
Clinical narrative: Information has been received from a physician concerning an 81 year old male with dementia, hypertension, anemia, depression and penicillin allergy who on 3/14/06 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 651320/1008P), IM. Concomitant therapy included furosemide sodium, potassium, citalopram hydrobromide, donepezil hydrochloride, docusate, morniflumate, and loratadine. On 3/15/06, the patient developed a red, warm, raised area at injection site and a temperature of 102. The patient was given acetaminophen for elevated temperature. It was noted that the patient had a slightly elevated BUN. The patient was considered to be not recovered. The reporter considered red, warm, raised area of injection site and temperature of 102 were considered to be disabling and other medical events (OMIC). Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV, TD, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site inflammation, Injection site swelling, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an 81 year old male with dementia, hypertension, anemia, depression and penicillin allergy who on 3/14/06 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 651320/1008P), IM. Concomitant therapy included furosemide sodium, potassium, citalopram hydrobromide, donepezil hydrochloride, docusate, morniflumate, and loratadine. On 3/15/06, the patient developed a red, warm, raised area at injection site and a temperature of 102. The patient was given acetaminophen for elevated temperature. It was noted that the patient had a slightly elevated BUN. The patient was considered to be not recovered. The reporter considered red, warm, raised area of injection site and temperature of 102 were considered to be disabling and other medical events (OMIC). Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV, TD, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an 81 year old male with dementia, hypertension, anemia, depression and penicillin allergy who on 3/14/06 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 651320/1008P), IM. Concomitant therapy included furosemide sodium, potassium, citalopram hydrobromide, donepezil hydrochloride, docusate, morniflumate, and loratadine. On 3/15/06, the patient developed a red, warm, raised area at injection site and a temperature of 102. The patient was given acetaminophen for elevated temperature. It was noted that the patient had a slightly elevated BUN. The patient was considered to be not recovered. The reporter considered red, warm, raised area of injection site and temperature of 102 were considered to be disabling and other medical events (OMIC). Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Hypokinesia, Nausea, Neck pain, Pain
Clinical narrative: Injection site pain Information has been received from a pharmacist concerning a 93 year old female with unknown medical history and unknown drug reactions/allergies who on 21-APR-2006 was vaccinated (route unknown) with a dose of pneumococcal 232v polysaccharide vaccine (Lot #651321/1036P). The pharmacist reported that the patient came into the clinic on 24-APR-2006 with severe pain at the injection site. At the time of the report treatment was unknown. No product quality complaint was involved. Outcome was not reported. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Vomiting
Clinical narrative: Injection site pain Information has been received from a pharmacist concerning a 93 year old female with unknown medical history and unknown drug reactions/allergies who on 21-APR-2006 was vaccinated (route unknown) with a dose of pneumococcal 232v polysaccharide vaccine (Lot #651321/1036P). The pharmacist reported that the patient came into the clinic on 24-APR-2006 with severe pain at the injection site. At the time of the report treatment was unknown. No product quality complaint was involved. Outcome was not reported. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: Injection site pain Information has been received from a pharmacist concerning a 93 year old female with unknown medical history and unknown drug reactions/allergies who on 21-APR-2006 was vaccinated (route unknown) with a dose of pneumococcal 232v polysaccharide vaccine (Lot #651321/1036P). The pharmacist reported that the patient came into the clinic on 24-APR-2006 with severe pain at the injection site. At the time of the report treatment was unknown. No product quality complaint was involved. Outcome was not reported. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Diarrhoea, Hypokinesia, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 32 yr old male with HIV, acute pharyngitis, asthenia, and renal impairment, who on 28Apr06 was vaccinated (route unk) in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651173/1211R). Suspect concomitant therapy included tuberculin purified protein derivative (PPD) in the left forearm. Other concomitant therapy included unnamed medications. On 29Apr05 the pt developed a fever, diarrhea, and his left deltoid became red and painful. He was unable to lift his left arm. The pt was seen in the ER with a temp of 103F. A lumbar puncture was done, no results were provided. The pt was treated with cephalexin (Keflex) 500mg, orally 4 times a day for 10 days, and ibuprofen (Motrin). It was reported that the pt was seen in the clinic on 01May06 and had recovered. No product quality complaint was involved. A lot check has been requested. The records of testing prior to release of this lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site swelling, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female with a penicillin allergy hives who on 11/7/2005 at 1630 was vaccinated intramuscularly with her first dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). Concomitant vaccine therapy included a dose of influenza virus split virion 3v vaccine inactivated Fluzone given intramuscularly in the other arm lot U1912AA. At the time of vaccination the patient had a left leg contusion with a probable hematoma (work related). At 2200 that night her left upper arm developed erythema with mild to moderate warmth, was tender and swelled from the shoulder down with a beefy rash. Unspecified medical attention was sought. The patient was diagnosed with questionable cellulitis and was treated with acetaminophen Tylenol ES, antibiotics Keter, 400 two QD x 7 days, and prednisone 20mg, two QD x 5 days, Subsequently, the patient recovered. Cellulitis was considered to be other important medical event (OMIC). No further information is expected.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female with a penicillin allergy hives who on 11/7/2005 at 1630 was vaccinated intramuscularly with her first dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). Concomitant vaccine therapy included a dose of influenza virus split virion 3v vaccine inactivated Fluzone given intramuscularly in the other arm lot U1912AA. At the time of vaccination the patient had a left leg contusion with a probable hematoma (work related). At 2200 that night her left upper arm developed erythema with mild to moderate warmth, was tender and swelled from the shoulder down with a beefy rash. Unspecified medical attention was sought. The patient was diagnosed with questionable cellulitis and was treated with acetaminophen Tylenol ES, antibiotics Keter, 400 two QD x 7 days, and prednisone 20mg, two QD x 5 days, Subsequently, the patient recovered. Cellulitis was considered to be other important medical event (OMIC). No further information is expected.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female with a penicillin allergy hives who on 11/7/2005 at 1630 was vaccinated intramuscularly with her first dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). Concomitant vaccine therapy included a dose of influenza virus split virion 3v vaccine inactivated Fluzone given intramuscularly in the other arm lot U1912AA. At the time of vaccination the patient had a left leg contusion with a probable hematoma (work related). At 2200 that night her left upper arm developed erythema with mild to moderate warmth, was tender and swelled from the shoulder down with a beefy rash. Unspecified medical attention was sought. The patient was diagnosed with questionable cellulitis and was treated with acetaminophen Tylenol ES, antibiotics Keter, 400 two QD x 7 days, and prednisone 20mg, two QD x 5 days, Subsequently, the patient recovered. Cellulitis was considered to be other important medical event (OMIC). No further information is expected.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site rash, Injection site warmth
Clinical narrative: swollen, reddened, hot rash over site.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old white female with no relevant medical history reported who at 06:10 on 28-APR-2005 was vaccinated subcutaneously in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient had pneumonia at the time of vaccination. At 12:00 on 28-APR-2005, the patient developed redness, warmth and swelling at the injection site. Subsequently, the patient recovered. The reporter felt that the patient's injection site redness, warmth, and swelling were other medical events (OMIC). No further information is available.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a physician concerning a 57 year old white female patient with chronic obstructive pulmonary disease, reactive airway disease, hypertension, hyperlipidemia, pneumoconiosis and allergies to penicillin, erythromycin, prochlorperazine, and oxycodone (+) aspirin who at 03:50 on 29-JUN-2005 was vaccinated IM in the right deltoid with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 649692/0371P). Concomitant therapy included antimicrobial (unspecified) aspirin, rosuvastatin calcium (Crestor), hydrochlorothiazide (manufacturer unknown), amlodipine besylate (+) benazepril hydrochloride (Lotrel), flunisolide (Nasarel) and tiotropim bromide (Spiriva). Subsequently, on 29-JUN-2005 the patient developed cellulitis around the injection site (right arm). The patient sought unspecified medical attention and was treated with unspecified oral antibiotics. The patient recovered on an unspecified date. There was no product quality complaint. Injection site cellulitis was considered to be an other important medical event (OMIC). Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 69 year old patient with high blood pressure, GERD, IBS, and lots of allergies, who on 5/3/00 and on 8/22/05 was vaccinated with a first and second dose (lot # 647661/0055R) of pneumococcal 23v polysaccharide vaccine, respectively. After the first dose, on 5/3/00, the patient developed a 4x6cm red area on left arm and was diagnosed with cellulitis. After the second dose the patient developed a swollen red area at site of injection. The patient was seen in the doctor's office on 8/24/05. The patient was given ceftriaxone sodium. No product quality complaint was involved. The patient reportedly recovered from both adverse experiences. The reporter considered swollen red area at injection site to be an other important medical event (OMIC). The reporter also provided information on two other patients who had an adverse experience following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0508USA04558 and 0508USA04672). No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a patient who on 13-SEP-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649981/0704P or 650451/0750P). On 15-SEP-2005 the patient was seen by a physician, after developing a local reaction described as a large swollen painful area in left arm at site of injection down to forearm. The patient was placed on Keflex and Domboro soaks. At the time of the report the patient was in the process of treatment. No product quality complaint involved. The reporter considered the patient's local reaction, "larger swollen painful are in left arm at site of injection down to forearm" to be an other important medical event (OMIC). Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old male who on 30-SEP-2005 was vaccinated IM with 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 650649/0790P). On approximately 30-SEP-2005, the patient reported that he went to an urgent care facility due to a severe localized reaction. He was diagnosed with cellulitis and placed on cephalexin (Keflex). A product quality complaint was not involved. Cellulitis was determined to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female who on 20-SEP-2005 was vaccinated SC with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 650649/0790P). On an unspecified date in approximately September 2005, the patient went back to her physician and was diagnosed with localized allergic urticaria and was placed on methylprednisolone (Medrol) dose pack. A product quality complaint was not involved. Localized allergic urticaria was determined to be an other important medical event (OMIC) by the reporter. Additional information has been requested.