chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal, Lymphopenia
Clinical narrative: Initial information (via a company rep) and follow up information has been received from a physician, concerning a 45 yr old white female, with no known medical history and no known drug reactions/allergies reported, who on 05May06 was vaccinated SC in the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (650644/0004F). Concomitant therapy included vancomycin. It was previously reported that on 05May06 after receiving the immunization the pt developed cellulitis. It was reported that the pt experienced redness, swelling and pain to her arm. Follow up information from the physician indicated that on 06May06 the pt contacted the doctor about fever and red painful arm at the injection site. The doctor notified infusion center and they met with the pt. The pt was given vancomycin, IV. The pt was seen in the doctor's office and reported that the right arm upper area was red and hot to touch. The area was approx 20cm x 10 cm and marked. The pt returned on 07May06 for more vancomycin and it was noted that the pt had slightly decreased red area. The doctor saw the pt again on 08May06. On 08May06 the pt had a complete blood count, urinalysis, and chemistry performed. The results are as follows: Complete Blood count (WBC 10.9 K/mm3 high, SEGS 83.2% high, Lymphocytes 9.5% low); Hematology (ESR 45 mm/hr high); Urinalysis (occult blood 10/microL high; RBC 10-20/HPF abnormal, other findings few budding yeast); chemistry (potassium 3.4 mEq/L low). All other results were within normal expected range. The pt received daptomycin 4mg/kg IV. On 09May06 the pt was seen and it was noted that the arm greatly improved. It was reported that the pt had a fever of unk origin at the time of vaccination. The pt recovered on an unspecified date. No product quality complaint was involved. The pt's experiences were considered to be an other important medical event (OMIC). Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Red blood cells urine, White blood cell count increased
Clinical narrative: Initial information (via a company rep) and follow up information has been received from a physician, concerning a 45 yr old white female, with no known medical history and no known drug reactions/allergies reported, who on 05May06 was vaccinated SC in the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (650644/0004F). Concomitant therapy included vancomycin. It was previously reported that on 05May06 after receiving the immunization the pt developed cellulitis. It was reported that the pt experienced redness, swelling and pain to her arm. Follow up information from the physician indicated that on 06May06 the pt contacted the doctor about fever and red painful arm at the injection site. The doctor notified infusion center and they met with the pt. The pt was given vancomycin, IV. The pt was seen in the doctor's office and reported that the right arm upper area was red and hot to touch. The area was approx 20cm x 10 cm and marked. The pt returned on 07May06 for more vancomycin and it was noted that the pt had slightly decreased red area. The doctor saw the pt again on 08May06. On 08May06 the pt had a complete blood count, urinalysis, and chemistry performed. The results are as follows: Complete Blood count (WBC 10.9 K/mm3 high, SEGS 83.2% high, Lymphocytes 9.5% low); Hematology (ESR 45 mm/hr high); Urinalysis (occult blood 10/microL high; RBC 10-20/HPF abnormal, other findings few budding yeast); chemistry (potassium 3.4 mEq/L low). All other results were within normal expected range. The pt received daptomycin 4mg/kg IV. On 09May06 the pt was seen and it was noted that the arm greatly improved. It was reported that the pt had a fever of unk origin at the time of vaccination. The pt recovered on an unspecified date. No product quality complaint was involved. The pt's experiences were considered to be an other important medical event (OMIC). Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 69 yr old white female who on 17Apr06, was vaccinated IM with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P). Several hours post vaccination, the pt developed pain at the injection site. The pt's arm was very sore to the point of having trouble lifting the arm. The pt might have also developed redness and swelling at the injection site. The pt was treated with a triamcinolone acetonide (Kenalog) injection to get relief. Subsequently, the pt recovered in 4 to 5 days. The pt's injection site pain, redness and swelling were considered other medical events by the reporter (OMIC). No additional information is expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypokinesia, Injection site pain, Swelling
Clinical narrative: Injected limb mobility decreased; injection site erythema; injection site pain; injection site swelling. Information has been received from a registered nurse concerning a 66 year old white female who on 12-DEC-2005 was vaccinated intramuscularly with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650660/0748P). Several hours post vaccination the patient developed pain at the injection site. The patient's arm was very sore to the point of having trouble lifting the arm. The patient might have also developed redness and swelling at the injection site. The patient was treated with hydrocodone. Subsequently, the patient recovered in 4 to 5 days. The patient's injection site pain, redness and swelling were considered other medical events by the reporter. No additional information is expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 71 yr old white male who on 08Apr06 was vaccinated IM with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P). Several hours post vaccination, the pt developed pain at the injection site. The pt's arm was very sore to the point of having trouble lifting the arm. The pt might have also developed redness and swelling at the injection site. On 09Apr06, the pt was treated with a triamcinolone acetonide (Kenalog) injection to get relief. Subsequently, the pt recovered in 4 to 5 days. The pt's injection site pain, redness, and swelling were considered other medical events by the reporter (OMIC). No additional information is expected.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 63 yr old male physician, with unk medical history, who on 13Apr06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). There was no concomitant medication. On 13Apr06 the pt developed cellulitis. The pt was treated with antibiotics (unspecified). No product quality complaint was involved. The reporting physician requested a lot check. Cellulitis was considered to be disabling and other important medical event (OMIC). 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. In addition, a review revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Tenderness
Clinical narrative: Initial and follow up information has been received from a medical assistant, via a company rep, concerning an 80 yr old white retired male, with glucose intolerance, hyperlipidemia, herpes zoster virus, and a history of abdominal aortic aneurysm, AAA, who on 01Aug05, was vaccinated SC with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). Initially the nurse reported that, on an unspecified date, the pt developed cellulitis of the arm after having been vaccinated with pneumococcal 23v polysaccharide vaccine. Follow up information from the nurse further described that on 02Aug05, the pt developed erythema, warmth, and tenderness at the site. On an unspecified date the pt recovered. No product quality complaint was involved. It was reported that there was no illness at the time of vaccination. Clearance for dental procedure was noted. The reporter considered the pt's experience to be an other important medical event (OMIC). Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist, via a company rep, concerning a female (age unk) who in Apr 2006, was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). It was reported that after receiving a dose of pneumococcal 23v polysaccharide vaccine the pt had to be admitted to the hospital because of a fever. The fever developed within 23 hrs of receiving the vaccine. It was reported that the pt had a low grade fever before vaccination and she was being observed in a hospital setting for an upper respiratory condition and during this observation was when the pneumococcal 23v polysaccharide vaccine was administered. It is not clear if the fever was from the vaccination of the pre-existing respiratory condition. No product quality complaint was involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a RN concerning a 59 yr old female pt (198 pounds) with a sulfa allergy, who on 03Mar06, was vaccinated IM into the right deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (651320/1008P). Subsequently, the pt's right deltoid was swollen, red and warm to touch at the injection site. The pt also experienced injection site pain. The pt was treated with cephalexin (Keflex) 500mg BID for 7 days. Subsequently, the pt recovered. No product quality complaint was involved. Injection site pain was considered to be an other important medical event (OMIC). Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a RN concerning a 71 yr old white male pt who on 09Mar06 was vaccinated IM into the right deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (651320/1008P). On 09Mar06 in the evening, the pt experienced swelling, redness and pain in the right arm at the injection site. The pt also developed cellulitis and injection site local heat. The pt was treated with cephalexin (Keflex) 500mg every four hours for 10 days and diphenhydramine hydrochloride (Benadryl) 25 mg every 6 hrs PRN. Subsequently, the pt recovered. No product quality complaint was involved. Injection site local heat and cellulitis were considered to be other important medical events (OMIC). Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning an 66 yr old white male painter, with an allergy to aspirin, hypertension, back pain, and non insulin dependent diabetes, who on 22Mar06 was vaccinated IM in the right arm with a first 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). There was no concomitant medication. In the evening of the injection, on 22Mar06, the pt's right arm became painful and swollen. It became worse the next day. It was reported that the pt's right arm became painful and swollen. It became worse the next day. It was reported that there was warmth at the site, no open wounds or drainage. The pt was diagnosed with cellulitis and treated with warm compresses and cefdinir (Omnicef), 300mg, twice daily for 10 days. The pt recovered on an unk date. No product quality complaint was involved. The pt's experience was considered to be an other important medical event (OMIC) by the reporter. Additional information is not expected.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning an 87 yr old Caucasian male with diabetes neuropathy, non insulin dependent diabetes mellitus, aspirin allergy and hypertension who on 20Mar06 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot651320/1008P), IM, in the right arm. There was no concomitant medication. There was no illness at the time of vaccination. One day after injection the pt developed soreness at the site of injection. An exam revealed erythema and induration and tenderness consistent with cellulitis. The pt was treated with cefdinir (Omnicef), 300mg, BID x 10 days. The pt was also given an IV. It was noted that the pt had no adverse reaction following his first dose of pneumococcal 23v polysaccharide in 1999. The reporter considered the pt's experience to be other medical event (OMIC). Additional information is not expected.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a health professional concerning an 87 yr old Caucasian male with diabetes neuropathy, non insulin dependent diabetes mellitus, aspirin allergy and hypertension who on 20Mar06 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot651320/1008P), IM, in the right arm. There was no concomitant medication. There was no illness at the time of vaccination. One day after injection the pt developed soreness at the site of injection. An exam revealed erythema and induration and tenderness consistent with cellulitis. The pt was treated with cefdinir (Omnicef), 300mg, BID x 10 days. The pt was also given an IV. It was noted that the pt had no adverse reaction following his first dose of pneumococcal 23v polysaccharide in 1999. The reporter considered the pt's experience to be other medical event (OMIC). Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information have been received from a RN concerning a 72 yr old white male pt who on 10Feb06 was vaccinated IM into the left deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). On 11Feb06, the pt developed left upper arm redness to the elbow. Within the last 6 weeks, the pt experienced an injection site reaction to include swelling, local heat and pain. The pt was treated with cephalexin (Keflex) 500mg, four times daily for 10 days, acetaminophen (Tylenol) and diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered. No product quality complaint was involved. Injection site reaction to include swelling, local heat and pain were considered to be other important medical events (OMIC). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an adult (age and gender unknown) patient who within the last six months, on an unknown date, was vaccinated (route unknown) with a 0.5mL dose pneumococcal 23v polysaccharide vaccine (lot # 650329/0747P). Subsequently, within the last six months on an unspecified date, the patient developed an injection site reaction which included pain, redness, swelling, and local heat. The patient also developed cellulitis and was treated with antibiotics. Subsequently, on an unspecified date the patient recovered. No product quality complaint was involved. A lot check has been requested. 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. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an adult (age and gender unknown) patient who within the last six months, on an unknown date, was vaccinated (route unknown) with a 0.5mL dose pneumococcal 23v polysaccharide vaccine (lot # 650329/0747P). Subsequently, within the last six months on an unspecified date, the patient developed an injection site reaction which included pain, redness, swelling, and local heat. The patient also developed cellulitis and was treated with antibiotics. Subsequently, on an unspecified date the patient recovered. No product quality complaint was involved. A lot check has been requested. 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. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female with no known allergies who on 9/14/2005 at 3:30 pm was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine 0.5ml IM lot 647661/0055R, in the right deltoid. Concomitant therapy that day included influenza virus split virion 3v vaccine inactivated lot U1772AA, in the left deltoid. Subsequently within 24 hours, the patient developed an adverse reaction on right arm. The patient experienced redness at injection site, mild swelling and achiness arthralgia. The patient was treated with acetaminophen Tylenol and Ibuprofen. The patient recovered on 9/17/2005. No product quality complaint involved. It was also reported that another patient had an adverse reaction following vaccination with Pneumococcal 23v polysaccharide vaccine (WAES0509USA03027). No further information is expected.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 58 yr old female who on 03Oct05 was vaccinated IM with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant vaccination on the same day in the other arm included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone). On 03Oct05, within 1.5 hrs of vaccination, the pt experienced a very sore arm. Unspecified medical attention was sought. No treatment was required. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Malaise, Pain
Clinical narrative: Information has been received from a health professional concerning a 86 year old female with asthma, chronic obstructive pulmonary disease, dust allergy, pollen allergy and mold allergy who on 10/11/2005, between 11:00 and 16:00, was vaccinated IM in the right deltoid with a 0.5ml second dose of Pneumococcal 23v polysaccharide vaccine (lot 646501/0497N). Concomitant therapy included a dose in the left arm of influenza vaccine unspecified. On 10/12/2005 the patient presented to the doctor office. She had a knot on the right arm, was feeling funny and had pain in her right arm up to her neck. She was treated with cetirizine hydrochloride Zyrtec and no lab were done. At the time of this report she had not recovered. Follow up information indicated that the patients right arm was swollen down to the elbow, she had pain that ran down her arm and had a strange or funny feeling. There was a knot on her arm where the injection was given. It was reported that the patient recovered on an unknown date. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Depression, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a 70 year old female with depression, acid reflux, a broken left arm and no allergies who on 10/13/2005, was vaccinated SC in the right arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650331/0749P) last dose reportedly received 10 years prior. Concomitant vaccinations on that same day included a dose in the right arm of influenza virus vaccine (unspecified). Other concomitant therapy included esomeprazole magnesium (Nexium), tolterodine tartrate (Detrol) and sertraline HCL Zoloft. The patient reported that on 10/13/2005, she developed chills and swelling and redness around the injection site. No lab diagnostic test were performed as medical attention was not sought. At the time of this report, the patient's events persisted. No further information is available.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cardiac failure congestive, Feeling hot, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 82 yr old white female hospital inpt with a penicillin allergy who on 20Oct05 at 14:30pm was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). Concomitant vaccination at the same time included an IM dose in the right deltoid of influenza virus split virion 3v vaccine inactivated (Fluarix) (lotAFLUA123BC). Concomitant therapy included levothyroxine Na (Synthroid), Mg oxide (Mag ox 400 tablets), excitalopram oxalate (Lexapro). Salcatonin (Miacalcin), sucralfate (Carafate), colestipol HC1 (Colestid), ranitidine hc1 (Zantac), zolpidem tartrate (Ambien), iron (unspecified),  pantoprazole sodium (Protonix), loperamide HC1 (Loperamid), Fluticasone propionate (+) salmeterol xinafoate (Advair diskus), potassium chloride (Klor-con), furosemide (Lasix), ondansetron hydrochloride (Zofran), nitroglycerin (Nitrostat), aluminum hydroxide (+) magnesium hydroxide (Maalox), acetaminophen (Tylenol extra strength), escitalopram oxalate (Lexapro), ferrous sulfate, magnesium hydroxide (Phillips Milk of Magnesia) and lorazepam (Ativan). Illness at the time of vaccination included a rectal bleed, low hemoglobin and hermatocrit, and congestive heart failure. On 21Oct05, the pt developed a local reaction at the injection site on her left arm. She experienced warmth, redness, and a raised area at the injection site. She also had a fever of 102.5 deg F. A chest x-ray and urinalysis were performed (results not provided). Unspecified medical attention was sought. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Follow up information was received from the pharmacist who reported that on 21Oct05 at 8:00AM, the pt had a fever of 102.5 deg, swelling, hardness, redness, tenderness, and warmth at the injection site. The area was noted to be the size of a baseball. The reaction improved daily up until discharge on 25Oct05. The reaction was treated with acetaminophen (Tylenol) 650 mg PO and warm compresses. It was unk if the pt recovered. See lab section for all diagnostic results including a chest x-ray and urinalysis. No further information is expected.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning an 82 yr old white female hospital inpt with a penicillin allergy who on 20Oct05 at 14:30pm was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). Concomitant vaccination at the same time included an IM dose in the right deltoid of influenza virus split virion 3v vaccine inactivated (Fluarix) (lotAFLUA123BC). Concomitant therapy included levothyroxine Na (Synthroid), Mg oxide (Mag ox 400 tablets), excitalopram oxalate (Lexapro). Salcatonin (Miacalcin), sucralfate (Carafate), colestipol HC1 (Colestid), ranitidine hc1 (Zantac), zolpidem tartrate (Ambien), iron (unspecified),  pantoprazole sodium (Protonix), loperamide HC1 (Loperamid), Fluticasone propionate (+) salmeterol xinafoate (Advair diskus), potassium chloride (Klor-con), furosemide (Lasix), ondansetron hydrochloride (Zofran), nitroglycerin (Nitrostat), aluminum hydroxide (+) magnesium hydroxide (Maalox), acetaminophen (Tylenol extra strength), escitalopram oxalate (Lexapro), ferrous sulfate, magnesium hydroxide (Phillips Milk of Magnesia) and lorazepam (Ativan). Illness at the time of vaccination included a rectal bleed, low hemoglobin and hermatocrit, and congestive heart failure. On 21Oct05, the pt developed a local reaction at the injection site on her left arm. She experienced warmth, redness, and a raised area at the injection site. She also had a fever of 102.5 deg F. A chest x-ray and urinalysis were performed (results not provided). Unspecified medical attention was sought. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Follow up information was received from the pharmacist who reported that on 21Oct05 at 8:00AM, the pt had a fever of 102.5 deg, swelling, hardness, redness, tenderness, and warmth at the injection site. The area was noted to be the size of a baseball. The reaction improved daily up until discharge on 25Oct05. The reaction was treated with acetaminophen (Tylenol) 650 mg PO and warm compresses. It was unk if the pt recovered. See lab section for all diagnostic results including a chest x-ray and urinalysis. No further information is expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female pt who on 21Oct05 was vaccinated IM in the right deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy at the same site in the right deltoid included a dose of influenza virus vaccine (unspecified). On 22Oct05 the pt complained redness and soreness at the site. Unspecified medical attention was sought. The pt is recovering. Follow up information indicated that the pt has recovered. No additional information is available. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Condition aggravated, Dysuria, Prostatic disorder
Clinical narrative: Information has been received from a pharmacist concerning a 65 yr old male with an enlarged prostate and a history of benign prostatic hyperplasia who on 17Oct05 was vaccinated with a 0.5mL IM dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Suspect vaccination that day included a dose of influenza virus vaccine (unspecified). Concomitant therapy included morniflumate (Flomax). The pt complained the same evening that he difficulty voiding. It was reported that the pt had enlargement of the prostate the day after vaccination. Medical attention was not sought. No laboratory diagnostic tests were performed. Subsequently the pt recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Neck pain
Clinical narrative: Information has been received from a physician concerning a female adult who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine (unspecified). Subsequently, the pt experienced neck pain. Unspecified medical attention was sought. There was no additional information regarding the pt's present status. No product quality complaint was involved. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Contusion, Dyspnoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 36 yr old male who on 10Oct05 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant therapy included a dose of influenza virus vaccine (unspecified). On 10Oct05 later that day, the pt experienced a severe localized reaction with soreness, redness, and bruising from the deltoid to the elbow, headache and a fever to 101 deg F. It was noted that the pt also experienced 5 minute episodes of nausea, dyspnea and vertigo a few times that evening. Unspecified medical attention was sought. On 12Oct05, the pt recovered. It was also noted that the pt also had a dose of pneumococcal 23v polysaccharide vaccine the year before. No product quality complaint was involved. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: Information has been received from a RN concerning a 36 yr old male who on 10Oct05 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant therapy included a dose of influenza virus vaccine (unspecified). On 10Oct05 later that day, the pt experienced a severe localized reaction with soreness, redness, and bruising from the deltoid to the elbow, headache and a fever to 101 deg F. It was noted that the pt also experienced 5 minute episodes of nausea, dyspnea and vertigo a few times that evening. Unspecified medical attention was sought. On 12Oct05, the pt recovered. It was also noted that the pt also had a dose of pneumococcal 23v polysaccharide vaccine the year before. No product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 yr old female pt with allergies to meperidine hydrochloride (Demerol), codeine, and procaine hydrochloride (Novocain), degenerative joint disease, hormone deficiency and dyspepsia who on 25Oct05 was vaccinated IM into the upper left deltoid with a second dose pneumococcal 23v polysaccharide vaccine (lot 651523/0604R). Concomitant therapy given IM into the left deltoid included a third dose of influenza virus whole virion 3v vaccine inactivated (Fluzone (influenza virus whole virion 3v vaccine inactivated)) (lot U1777AA), Iansoprazole (Prevacid) and omeprazole. There was no illness at the time of vaccination. On 25Oct05, the pt returned to the office because she experienced a more extreme reaction than usual to the vaccine which included possible cellulitis with redness, warmth, swelling at the site and severe site pain and tenderness. Unspecified medical attention was sought. The pt used ice packs and ibuprofen for two days for muscle aches and redness. On 29Oct05 after 4 days, the pt recovered. It was noted that the pt did not have a reaction to the initial vaccination of pneumococcal 23v polysaccharide vaccine. A investigation into the lot number was requested. No product quality complaint was involved. 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 in not expected.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 yr old female pt with allergies to meperidine hydrochloride (Demerol), codeine, and procaine hydrochloride (Novocain), degenerative joint disease, hormone deficiency and dyspepsia who on 25Oct05 was vaccinated IM into the upper left deltoid with a second dose pneumococcal 23v polysaccharide vaccine (lot 651523/0604R). Concomitant therapy given IM into the left deltoid included a third dose of influenza virus whole virion 3v vaccine inactivated (Fluzone (influenza virus whole virion 3v vaccine inactivated)) (lot U1777AA), Iansoprazole (Prevacid) and omeprazole. There was no illness at the time of vaccination. On 25Oct05, the pt returned to the office because she experienced a more extreme reaction than usual to the vaccine which included possible cellulitis with redness, warmth, swelling at the site and severe site pain and tenderness. Unspecified medical attention was sought. The pt used ice packs and ibuprofen for two days for muscle aches and redness. On 29Oct05 after 4 days, the pt recovered. It was noted that the pt did not have a reaction to the initial vaccination of pneumococcal 23v polysaccharide vaccine. A investigation into the lot number was requested. No product quality complaint was involved. 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 in not expected.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a RN concerning a 63 yr old male with a history of pneumonia last year. On an unspecified date, the pt was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). Concomitant suspect therapy included an unspecified influenza virus vaccine administered into the opposite arm. On an unspecified date, the pt developed redness, swelling, and tenderness up to the shoulder for several days. The pt sought unspecified medical attention. It was reported that the events resolved itself without treatment. At the time of the report, the pt had recovered from the events (date unk). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cough, Pharyngolaryngeal pain, Wheezing
Clinical narrative: Information has been received from a RN concerning a 59 yr old male with neck squamous cell carcinoma, metastases to lung and a history of left upper lobe lobectomy. On 11Oct05 the pt was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). Concomitant suspect therapy included an unspecified influenza virus vaccine. On an unspecified date, the pt complained of a scratchy throat and cough after vaccination. On 14Oct05 the pt was treated for wheezing and a worsening of cough. The pt was ordered sulfamethoxazole (-) trimethoprim (Bactrim), codeine phosphate (+) promethazine hydrochloride (Phenergan with codeine) and an albuterol inhaler. It was reported that the pt was normally dyspneic. Several days later, the physician added fluticasone propionate (+) salmeterol xinafoate (Advair) inhaler. The pt was not getting better and he was started on oral prednisone. On 25Oct05, the nurse contacted the pt and it was reported that he was feeling better. At the time of this report, the pt was recovering from the events. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a healthcare worker concerning a 44 yr old female pt with asthma and environmental allergies who on 25Oct05 was vaccinated IM with her first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), tiotropium bromide (Spiriva), montelukast sodium, and albuterol. On 26Oct05 the pt developed redness at injection site (not specified). On 27Oct05 she was seen in the office with blisters around the injection site, with a large red swollen area around that and pain. The pt was treated with diphenhydramine hydrochloride (Benadryl) and another unspecified medication. Her symptoms persisted. No product quality complaint was involved. Follow up information has been received from a physician concerning the female administrative assistant with environmental allergies to trees, grass, dust and ragweed, who on 25Oct05 at 6:00PM was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). On the same day the pt was also vaccinated with influenzae virus split virion 3v vaccine inactivated (Fluzone) in the left deltoid below the pneumococcal 23v polysaccharide vaccination. The physician reported that on the morning of 26Oct05 the pt developed lymphadenitis of the left arm extended to axilla with induration and redness. A complete blood cell count was within normal limits (wnl). The pt recovered from lymphadenitis, induration, and redness. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphadenitis
Clinical narrative: Information has been received from a healthcare worker concerning a 44 yr old female pt with asthma and environmental allergies who on 25Oct05 was vaccinated IM with her first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair), tiotropium bromide (Spiriva), montelukast sodium, and albuterol. On 26Oct05 the pt developed redness at injection site (not specified). On 27Oct05 she was seen in the office with blisters around the injection site, with a large red swollen area around that and pain. The pt was treated with diphenhydramine hydrochloride (Benadryl) and another unspecified medication. Her symptoms persisted. No product quality complaint was involved. Follow up information has been received from a physician concerning the female administrative assistant with environmental allergies to trees, grass, dust and ragweed, who on 25Oct05 at 6:00PM was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). On the same day the pt was also vaccinated with influenzae virus split virion 3v vaccine inactivated (Fluzone) in the left deltoid below the pneumococcal 23v polysaccharide vaccination. The physician reported that on the morning of 26Oct05 the pt developed lymphadenitis of the left arm extended to axilla with induration and redness. A complete blood cell count was within normal limits (wnl). The pt recovered from lymphadenitis, induration, and redness. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Fatigue, Feeling hot, Pain, Pyrexia
Clinical narrative: Cellulitis; Fatigue Information has been received from a physician concerning a 37 year old female with sulfa allergy and a history of migraine who on 24-OCT-2005 at 5:00 PM was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #651318/1006P), in the left arm upper arm. On 24-OCT-2005 the patient's left arm became swollen with pain, heat and fever (40 C). The patient took diphenhydramine HCL (Benadryl), "which helped a little." On 27-OCT-2005 she was seen by the doctor and she was given an antibiotic. Subsequently it was reported that the patient developed cellulitis of the left side arm 30x30cm red, hot, temperature 101.4, very tired. The patient was treated with cephalexin (Keflex) and antihistamine. The patient had "not yet" recovered. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Cellulitis; Fatigue Information has been received from a physician concerning a 37 year old female with sulfa allergy and a history of migraine who on 24-OCT-2005 at 5:00 PM was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #651318/1006P), in the left arm upper arm. On 24-OCT-2005 the patient's left arm became swollen with pain, heat and fever (40 C). The patient took diphenhydramine HCL (Benadryl), "which helped a little." On 27-OCT-2005 she was seen by the doctor and she was given an antibiotic. Subsequently it was reported that the patient developed cellulitis of the left side arm 30x30cm red, hot, temperature 101.4, very tired. The patient was treated with cephalexin (Keflex) and antihistamine. The patient had "not yet" recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Swelling; Pain; Erythema; Skin warm Information has been received from a Certified Medical Assistant (CMA) concerning a 63 year old female with allergy to tetanus vaccine, depress and acid reflux (esophageal) and a history of hysterectomy, sinus operation and kidney stone who on 19-OCT-1-2005 was vaccination with 0.5ml pneumococcal 23v polysaccharide vaccine (lot #650454/0751P) subcutaneously. Concomitant therapy included lansoprazole (Prevacid), venlafaxine HCL (Effexor) and imatinibmesylate (Gleevec). On 19-OCT-2005 the patient experienced swelling, pain and hot skin to touch. The patient was treated with cephalexin (Keflex). The symptoms persisted and on 21-OCT-2005 she went to the emergency room for treatment with unspecified IV antibiotics. The patient was not hospitalized. It was reported that the patient was recovering. Follow up information has been received from a CMA concerning the 63 year old white female vet tech with high blood pressure and gastroesophageal reflux disease who on 19-OCT-2005 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine, lot # 651524/0605R (lot number confirmed, the CMA state when she pulled the patient's chart to fill out the follow up form she saw that the lot number was different than originally reported). On the same day, the patient was vaccinated in the left arm with a dose of influenza virus vaccine (unspecified). It was reported that subsequently on 20-OCT-2005 the patient developed "red, hot swelling" that radiated down her right arm and that required an office visit for an oral antibiotic and an ER visit for IV antibiotic. The patient recovered.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction Information has been received from a registered nurse concerning a patient who on 29-OCT-2005 was vaccinated intramuscularly with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot #651329/1047P). Concomitant therapy included influenza virus vaccine (unspecified). Eight to twelve hours later the patient developed a local injection site reaction. Unspecified medical attention was sought. It was reported that the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Pain, Vomiting
Clinical narrative: Incision site cellulitis; pain; vomiting Information has been received from a registered nurse concerning a patient in their 60's who in approximately October 2005 was vaccinated intramuscularly with a 0.5ml of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time included influenza virus vaccine (unspecified) (both vaccines were administered at separate sites and via separate syringes). Subsequently the patient developed a site reaction of cellulitis, vomiting and described their body as "hurting". Unspecified medical attention was sought. The patient was treated and subsequently recovered. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Amnesia, Dizziness, Fatigue, Medication error
Clinical narrative: Dizziness;Fatigue;Inappropriate Schedule of drug administration; amnesia Information has been received from a registered nurse concerning her friend an 82 year old female patient with memory loss who on approximately 25-OCT-2005 ("about a week ago") was vaccinated (route unknown) with a second dose pneumococcal 23v polysaccharide vaccine (Lot # and Batch # unknown). It was reported that the patient also received the influenza virus vaccine (unspecified). The patient was complaining of exhaustion, dizziness, memory loss. Reporter also indicated that the patient memory loss was present previously. When the patient called her physician he told her she had pneumococcal 23v polysaccharide vaccine last year. He also told her to take acetaminophen. If was reported that the patient has an appointment with a neurologist. No product quality complaint was involved. Outcome was not recovered. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a male who on 02-NOV-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy that day in the sane arm included influenza virus vaccine (unspecified).  The first vaccination was given three months ago and second was given by mistake. On 02-NOV-2005 the patient experienced pain at the injection site.  Follow up reported that the patient "did not have reaction"  Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received from a physician concerning an adult patient who within the lst week (approximately November 2005) was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine therapy administered on the same day included a dose of influenza virus vaccine (unspecified). The physician reported that within the last week (approximately November 2005) the patient developed redness only, at the injection site. It was mentioned that the patient may have been given a steroid. It was also mentioned that the nurse gave both shots in the same arm but no record could be found. There were no laboratory studies performed. The adverse event improved and the patient is recovering. There was no product quality event reported. No further information was available regarding the adverse event. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a female consumer who on 23-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot reported as "1406P".  Concomitant therapy that day in the same arm included influenza virus vaccine (unspecified).  She reported that she became quite ill beginning the day after receiving the shots, on 24-OCT-2005.  The patient's physician confirmed that she experienced a severe reaction to the vaccination.  The patient ended up missing a full week of work and at the time of the report was still feeling the effects.  No further information was provided.  No product quality complaint was involved.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Myalgia, Swelling
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 68 year old white female, with hypertension, hypercholesterolemia, penicillin allergy, venous insufficiency and peripheral vascular disorder who on 08-NOV-2005 was vaccinated intramuscularly in the left deltoid with a second dose  (0.5 ml) of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P) and at the same time was vaccinated intramuscularly in the right deltoid with a second dose of influenza virus SAg 3v vaccine inactivated (CHIRON). On 08-NOV-2005 the patient's left deltoid area became red, swollen, warm to touch and sore.  The patient was notified to use warm compresses and call back if no better.  Subsequently, on an unknown date, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.