chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a 73 yr old female who was hospitalized for dehydration who on 18Aug05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On approx 18Aug05, the pt developed a localized skin reaction, fever, and cellulitis and was treated with ice packs. The pt was not treated with antibiotics for the cellulitis. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important event (OMIC). A product quality complaint was not involved. No further information was available.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a 78 yr old male who was hospitalized for a knee replacement who on 14Jul05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On approx 14Jul05, the pt developed a localized skin reaction, fever and cellulitis. The pt was treated with IV antibiotics for the cellulitis. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important medical event (OMIC). A product quality complaint was not involved. No further information was available.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia, Skin reaction
Clinical narrative: Information has been received from a registered pharmacist concerning an 86 yr old male who was hospitalized for a knee replacement who on 28Jul05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On approx 28Jul05, the pt developed a localized skin reaction, fever and cellulitis. The pt was treated with oral cephalexin (Keflex) for the cellulitis. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important medical event. A product quality complaint was not involved. No further information was available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia, Skin reaction
Clinical narrative: Information has been received from a registered pharmacist concerning an 73 yr old female who was hospitalized for a knee replacement who on 28Jul05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On approx 28Jul05, the pt developed a localized skin reaction, fever and cellulitis. The pt was not  treated with antibiotics for the cellulitis. Subsequently, the pt recovered. The pharmacist did not believe that the adverse events prolonged the pt's hospitalization and she did not feel this was an other important medical event. A product quality complaint was not involved. No further information was available.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning an adult pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (IM). Subsequently, the pt experienced injection site reaction with injection site redness, warmth and soreness within a day of vaccination. Unspecified medical attention was sought. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 61 yr old female with chronic obstructive pulmonary disease who on 27Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 28Aug05 the pt developed redness and swelling at the injection site. On 29Aug05 the pt was recovering from the redness and swelling at the injection site when she developed a fever of 103 deg F. Unspecified medical attention was sought. At the time of the report, the pt was recovering from the fever. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Difficulty in walking, Dizziness, Injection site erythema, Injection site pain, Rash macular
Clinical narrative: Information has been received from a 57 yr old female with hypertension and drug hypersensitivity to cephalexin (Keflex) who on 26Aug05 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol (Atenol), omeprazole (Prilosec) and nizatidine (Axid). Subsequently on 26Aug05 the pt experienced pain at injection site (left arm), dizziness, difficulty walking and red blotches in upper part of her left arm. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. The pt's adverse experiences had not improved since being vaccinated. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a pt in their mid 60's who was vaccinated IM into the deltoid muscle with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (649914/0578P). On approx 19Jul05 over this past week, the pt experienced localized redness and localized swelling that looked like cellulitis from the deltoid area down to the elbow and inner arm. The pt was seen in the clinic and was treated with cephalexin (Keflex). In about 4 days, the reaction resolved. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV, TTOX
Symptoms: Pain
Clinical narrative: Information has been received from a female consumer who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine administered at the same time included a dose of tetanus toxoid. Concomitant therapy included prednisone. Subsequently the pt experienced chronic pain. The pt's chronic pain persisted. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning an adult male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt experienced a severe reaction of his arm. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Information has been received from a 73 yr old male with hypertension who otherwise experienced good health and had no allergies who on 26Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included hydrochlorothiazide (+) telmisartan (Micardis HCT) and simvastatin. On 27Aug05 the pt developed red blotches near the injection site. Unspecified medical attention was sought. At the time of the report the pt's red blotches were still present. There was no product quality complaint involved. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a healthcare professional concerning a 63 yr old male who on 31Aug05 was vaccinated SC with a 0.5ml dose pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). On approx 31Aug05 the pt experienced erythema and soreness at the injection site. Unspecified medical attention was sought. The pt recovered without treatment within 48 hrs. The reporter would like to know if there have been any other problems with this lot number. 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 has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pyrexia, Tenderness
Clinical narrative: Information had been received from a certified medical assistant concerning a 79 year old female with chronic obstructive pulmonary disease and chronic respiratory acidosis, who on 8/1/05 at 15:00 was vaccinated IM into the left arm with a second dose of Pneumococcal 23v polysaccharide vaccine lot 649694/0386P. On 8/2/05, the patient experienced a local site reaction of redness, tenderness and edema. The pt stated that her arm was sore, she had some swelling and had a low grade fever. That day the pt was brought in for a follow up appt. The Dr noted erythema in the left arm that measured 16cm in length and 16 cm in width. The DR also noted that it looked like skin cellulitis. Subsequently the pt recovered. The medical assistant requested a lot check. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Thermal burn
Clinical narrative: Information has been received from a medical assistant concerning an 80 year old male with hypertension and hypercholesterolemia, and with no known drug allergies, who on 9/6/05 at 15:00pm was vaccinated IM in the left arm with a third dose of Pneumococcal 23v polysaccharide vaccine lot 647661/0055R. There was no illness at the time of vaccination. The pt was noted to have been administered the first and second doses of Pneumococcal 23v polysaccharide vaccine in Nov 1997 and Dec 2001. Subsequently, on 9/6/05 at approximately 22:00pm, the pt experienced burning at site of injection and pain at site of injection. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a medical assistant indicated that on 9/6/05 the pt left upper arm had edema, was swollen, was warm to touch and had pain. The pt was advised to use two Benadryl every 4 hours PRN and Tylenol. He was also told to use cold compresses. There were no adverse events following prior vaccinations. The patient recovered on 9/9/05. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Lymphadenopathy
Clinical narrative: Information has been received from a female who, in Sept 2005 was vaccianted with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently within a day of vaccine administration, she had a local reaction that included 2 red bands around her arm at the injection site. She also had lymph node involvement on the arm the injection was given. It was reported that the injection was given high on the arm, possible at the joint. The duration of symptoms was about 2-3 days. At the time of the report the patient had recovered. Medical attention was not sought. There was no product quality complaint involved. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a healthcare professional concerning a 73 year old female who on 8/31/05 was vaccinated subcutaneously with a 0.5ml dose Pneumococcal 23v polysaccharide vaccine lot 649914/0578P. On approximately 8/31/05 the pt experienced erythema and soreness at the inject site. Unspecified medical attention was sought. The pt recovered without treatment within 48 hours. The reporter would like to know if there have been any other problems with this lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards an was released. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a healthcare professional concerning a 45 year old female who on 8/30/05 was vaccinated subcutaneously with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine lot 649914/0578P. On approximately 8/31/05 the patient experienced erythema and soreness at the injection site. Unspecified medical attention was sought. The patient recovered without treatment within 48 hours. The reporter would like to know if there have been any other problems with this lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Thermal burn
Clinical narrative: Information has been received from a medical assistant concerning a 78 year old retired female with hypertension, hypercholesterolemia, COPD, and a sulfa allergy who on 8/3/05 at 9:30am was vaccianted IM in the left arm with a first 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). There was no illness at the time of vaccination. Subsequently the pt experienced burning at site of injection and pain at site of injection. Follow up information received from a medical assistant indicated that on 8/3/05 at approx 6:00PM, the pt developed pain, edema and warm to touch in the left upper arm. She was advised to use Benadryl every l4 hours PRN, Tylenol every 4 hours PRN, and cold compresses. Additional follow up information received from a medical assistant indicated that the pt recovered. No additional information is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Information has been received from a physician concerning a 73 year old female with an allergy to sulfa drugs and a history of hip replacement who on 9/6/05 was vaccinated with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included gabapentin (Neurontin) and alendronate sodium MSD. It was reported that on 9/6/05, shortly after being vaccinated, the patients arm began itching. She also experienced redness, swelling, and extreme pain in her arm from her elbow to her shoulder, She could barely move her arm. Unspecified medical attention was sought. No lab diagnostic test were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Oedema, Throat tightness
Clinical narrative: Information has been received from a registered nurse concerning an 82 year old female with no medical history or no known allergies who on the morning of 9/7/05 was vaccinated IM in the right deltoid with the first dose of Pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). There was no concomitant therapy or illness at the time of vaccination. The RN reported that on 9/7/05, the pt developed what was described as a possible allergic reaction. The pt was noted to have developed a red swollen arm. On 9/8/05, the patient went to the ER because her throat felt tight. The patient denied any allergies to the vaccine components. While in the ER, the pt was treated with two oral Benadryl tablets, was not admitted and was sent home. On 9/14/05 the pts events resolved. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: MEN, PPV
Symptoms: Headache, Hyperhidrosis, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 58 year old female with asthma and cardiac arrhythmia who the morning of 9/7/05 was vaccinated in the left deltoid with an IM 0.5ml first dose of Pneumococcal 23v polysaccharide vaccine (lot 650457/0973P). Concomitant vaccination that morning included a SC first dose of meningococcal ACYW polysaccharide vaccine (Menomune AlClYlW-135) (lot UE4804A) in the left arm. There was no illness at the time of vaccination. On 9/14/05 the patient called the office complaining of a headache and tingling in her fingers. Unspecified medical attention was sought. No lab test were performed. There was no product quality complaint involved. Follow up information indicated that the patient complained of a headache several hours after vaccination which persisted for three days. On 9/13/05 profuse sweating began which lasted three days. The patient stated that she had to get up during the night several times to change gowns. The patients temp was not taken. It was reported that all complaints ended by 9/17/05, the pt was considered to be recovered. Neither the pt nor her sibling had an adverse event following prior vaccination. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Oedema, Tenderness
Clinical narrative: Information has been received from a registered pharmacist concerning a 70 year old male who on 9/14/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine 0.5ml (lot 651523/0604R), IM. On 9/14/05 the pt experienced immediate local reaction with redness, swelling, and tenderness. The swelling progressed the length of the left arm (where the injection was given) and down the lateral chest wall on the left side. The pt did not have any itching but said the area ached. It was noted that the pt received Pneumococcal 23v polysaccharide vaccine injection 5 years earlier without incident. The pt was considered to be not recovered. The facility requested an investigation into lot 651523/0604R. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a pt who on 15Sep05 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml) (lot 649981/0704P or 650451/0750P), IM. Subsequently, on 16Sep05, the pt called the office complaining of local reaction described as large swollen, reddened, hot area in left arm from deltoid down to elbow. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a pt who on 06Sep05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml), IM (lot 649981/0704P or 650451/0750P). On 07Sep05 the pt complained of hard firm area at site with swelling and more swelling at the elbow than the vaccination site. Ice was prescribed to area and acetaminophen (Tylenol). The nurse stated that the pt had improved. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Rash macular, Rash papular, Urticaria
Clinical narrative: Information has been received from a physician concerning a 58 yr old male with many health problems who on 22Aug05 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included multiple mediations. In Aug 2005, the pt experienced urticaria and a papular rash that became more macular. The rash persisted for 3 weeks. It started at the injection site and spread over the trunk and other arm with no facial involvement. There were no respiratory problems or other symptoms. Unspecified medical attention was sought. The pt was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a pt (age and gender not reported) with unk medical history and unk allergies who in approx Dec 2004 (winter 2004) was vaccinated IM in the arm with pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed severe local injection site reactions in the same arm the injection was given but below the actual site of injection. It was reported that the pt recovered on an unk date. The pt sought unspecified medical attention. There was no product quality complaint involved. No additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 48yr old female who on 07Sep05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (IM) (lot 550453/0791P). Subsequently, within two days, the pt experienced injection site redness, mild swelling and arthralgia. The pt was treated with ice, ibuprofen (Tylenol) and ibuprofen, as needed. No product quality complaint involved. It was also reported that another pt had an adverse reaction following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0509USA02437). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 65 yr old white female with an unk medical history and unk allergies who on 19Sep05 at 17:00 was vaccinated IM, left deltoid with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On the night of 19Sep05 (previously reported as within 48 hrs of being vaccinated), the pt developed redness and swelling at the injection. The pt had a mild pain and she took ibuprofen (Advil). She also felt low grade fever. The CMA reported that the pt developed cellulitis near injection site and tenderness from shoulder to elbow. The pt was treated with dicloxacillin. On 23Sep05, the pt recovered. There was no product quality complaint involved. The CMA also reported another pt who was vaccinated with the same lot number (WAES0509USA03585). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site nodule, Nausea, Pallor
Clinical narrative: Initial and follow up information has been received from a medical assistant concerning a 65 yr old white female with a resolving vesicular rash, cardiac disorder, and an allergy to Tolech who on 21Sep05, at approx 9:30AM, was vaccinated IM in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). It was reported that the pt was vaccinated with a prior dose of pneumococcal 23v polysaccharide vaccine on 10Sep68 (approved for market 07Jul83). Concomitant therapy included atenolol, aspirin, alendronate sodium and rabeprazole sodium (Aciphex). On the pt's drive home after vaccination, on 21Sep05, the pt felt nauseous, pale, sweaty and developed a lump at the injection site. In follow up, it was reported that at approx 9:45AM on 21Sep05, the pt got pale, sweats, and nauseous, with redness at injection site and a definite lump. The pt did not develop any itching. On 22Sep05, the pt reported the event to the physician's office, and also reported that she was feeling better, although, the lump and redness were still present. By the afternoon of 22Sep05, the pt was recovered. A concern regarding the lot was expressed by the reporter. No further information is expected. 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.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Movement disorder
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 72 yr old white male (198lb, 74") with coronary artery disease, increased blood pressure and no illness at time of vaccination and a history of pneumonia (May 20050 and unk allergies who on 11Jul05 was vaccinated IM, left deltoid, with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On 12Jul05 (previously reported as within 48 hrs of being vaccinated), the pt developed pain and redness over the vaccination site, severe left arm swelling and swelling down to elbow and distally to wrist. He was unable to raise his arm. The pt was treated with dicloxacillin, ibuprofen (Advil) and moist heat was applied. The certified medical assistant reported that around 20Jul05, the pt recovered. There was no product quality complaint involved. The CMA also reported another pt who was vaccinated with the same lot number (WAES0509USA03153). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a physician concerning a male pt who in 1999 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in 1999, the pt developed an injection site reaction with redness and induration after vaccination. Unspecified medical attention was sought. Subsequently, the pt recovered. No other information was provided. There was no product quality complaint. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 68 yr old Hispanic female with diabetes mellitus and dizziness who on 23Sep05 was vaccinated IM in the right arm with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 650087/0815P, also reported as 650083/0746P). Concomitant therapy included atorvastatin calcium (Lipitor), trandolapril (Mavik), meclizine, estrogens, esterified (+) methyltestosterone (Estratest), vitamins (Centrum), aspirin, and rabeprazole NA (Aciphex). On 24Sep05, the day after her vaccination, the pt developed a very swollen, hot and red arm. The pt was so swollen she could not even see her elbow. The pt contacted the nurse practitioner for advice, and the nurse recommended that the pt to come into the office or to the ER to be examined. The pt chose not to go and instead treated herself with diphenhydramine HC1 (Benadryl). The nurse stated that the pt was never seen by medical personnel, and that the pt only received diphenhydramine HC1 for the experience. The swelling came down slowly, and she subsequently recovered. It was reported that the arm was swollen, hot and red for one day. No additional information is expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from health professional concerning a 71 yr old male, with atrial fibrillation, diabetes, hypertension and cholesterolemia, and no known allergies, who on 21Sep05 was vaccinated with a SC dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant therapy included warfarin sodium (Coumadin). It was reported that on 23Sep05 the pt's entire arm, that had received the injection, had redness, swelling, pain, and was warm to the touch. The swelling was past the elbow into the forearm. The pt was seen in the ER and given diphenhydramine hydrochloride (Benadryl). He was then rechecked in the physician's office on 27Sep05. It was reported that the pt recovered. No other information was provided. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning an 81 year old female who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650331/0749P). On approx 9/27/05 the pt experienced swelling, tenderness, and redness at the injection site. The pt was treated warm compresses and antihistamines. The symptoms resolved. The outcome was reported as recovered. No further information was available. There was no product quality complaint. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a healthcare professional concerning a 62 year old female with diabetes, and allergies to sulfonamides and codeine who at the end of Sept 2005 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included metformin HCL (Glucophage), Levothyroxine NA (Synthroid), venlafaxine HCL (Efferxor), atorvastatin CA (Lipitor), Benazepril HCL (Lotensin), estrogens, conjugated (Premarin) and medroxyprogesterone acetate (Provera). The healthcare professional reported that at the end of Sept 2005, one day after being vaccinated, the pt developed a fever and some swelling near injection site. Unspecified medical attention was sought, but no lab/diag test were performed. At the time of this report, the pt was recovering from her fever and injection site swelling. No further information is available.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning an 85 year old female with atrial fibrillation, hypertension and osteoporosis who on 9/28/05 was vaccinated with an IM dose in the deltoid of Pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant therapy included warfarin sodium Coumadin for the treatment of atrial fibrillation. It was reported that the patient was seen in the physicians office on 9/29/05 since her shoulder to elbow, of the arm that received the injection, was red, swollen, warm to the touch, and painful. It was noted that the pt was not hospitalized and the event was not life threatening. No other information was provided. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Urticaria
Clinical narrative: Information has been received from a health professional concerning an approx 64 year old male with an allergy to penicillin and no other past medical history who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650331/0749P). Concomitant therapy included dexamethasone and prochlorperazine maleate Compazine. Subsequently, the pt developed painful welts at the injection site. He went to the ER, but was not admitted. He was given moxifloxacin hydrochloride Avelox as treatment. No lab diag studies were performed. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a license practical nurse concerning an 66-year-old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P).  On approximately 27-SEP-2005 the patient experienced swelling, tenderness, and redness at the injection site.  The patient was treated warm compress and antihistamines.  The symptoms resolved.  The outcome was reported as recovered.  No further information was available.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an older female who on 17-AUG-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P).  On 17-AUG-2005 the patient developed pain and swelling at the injection site. Unspecified medical attention was sought.  The patient's pain and swelling at injection site persisted.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness
Clinical narrative: Information has been received from a pharmacist concerning a female in her 50"s who on approximately 03-SEP-2005 began self administrating pneumococcal 23v polysaccharide vaccine daily (duration not reported).  Subsequently, the patient experienced dizziness.  The patient was seen in the clinic and was asked to bring the bottle of medication to the clinic.  On 03-OCT-2005 the patient returned to the clinic and brought 9 empty vials of pneumococcal 23v polysaccharide vaccine.  The pharmacist indicated that the patient was clinically stable with no dizziness.  No product quality complaint involved.  Follow up information was received.  On 05-OCT-2005, the pharmacist reported that the pharmacy had given the patient a box of pneumococcal 23v polysaccharide vaccine vials instead of insulin.  The pharmacy had mistakenly labeled a box of pneumococcal 23v polysaccharide vaccine as insulin.  There was no confusion on the part of the pharmacy regarding the label of the products themselves.  It was described by the pharmacist as a mistake on the part of the pharmacy labeling the box incorrectly.  As of 05-OCT-2005 the patient had not developed any other problems.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 27 year old female who on 27-SEP-2005 was vaccinated with pneumococcal23v polysaccharide vaccine (lot 650648/0967P), 0.5 ml, one dose.  On 29-SEP-2005 the patient reported pain, swelling, redness and warmth at the injection site.  As of 03-OCT-2005 the patient was recovering from her experiences.  Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Injection site swelling, Joint range of motion decreased
Clinical narrative: Initial and follow up information has been received from a pharmacist and physician's assistant concerning a 47 year old unemployed black female with an allergy to penicillin noted as rash.  On 29-SEP-2005, at 9:00 am, the patient was vaccinated intramuscularly in the left deltoid arm with the first dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P).  There were no illness at the time of vaccination.  Subsequently the patient experienced an injection site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  On 30-SEP-2005, at 8:00 am "after 24 hours", the patient developed left arm lateral area pain, edema, limited range of motion, and erythema, encircled injection site 2 inch radius.  The patient was treated with ibuprofen (MOTRIN) 800 two tablets, oral, every 6-8 hours as needed, and cephalexin (KEFLEX) 500 mg, oral twice a day times 5 days.  At the time of this report, the patient had recovered from the events (date unknown).  No product quality complaint involved.  The pharmacist and physician assistant also mentioned another patient's experience following vaccination with pneumococcal 23v polysaccharide vaccine.  Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema, Pain, Pyrexia
Clinical narrative: Initial and follow up information has been received from a pharmacist and physician's assistant concerning a 47 year old unemployed black female with an allergy to penicillin noted as rash.  On 29-SEP-2005, at 9:00 am, the patient was vaccinated intramuscularly in the left deltoid arm with the first dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P).  There were no illness at the time of vaccination.  Subsequently the patient experienced an injection site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  On 30-SEP-2005, at 8:00 am "after 24 hours", the patient developed left arm lateral area pain, edema, limited range of motion, and erythema, encircled injection site 2 inch radius.  The patient was treated with ibuprofen (MOTRIN) 800 two tablets, oral, every 6-8 hours as needed, and cephalexin (KEFLEX) 500 mg, oral twice a day times 5 days.  At the time of this report, the patient had recovered from the events (date unknown).  No product quality complaint involved.  The pharmacist and physician assistant also mentioned another patient's experience following vaccination with pneumococcal 23v polysaccharide vaccine.  Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a medial assistant concerning a 58 year old white male with benign prostatic hyperplasia (BPH), elevated cholesterol, "onychotic" toe nails, sciatica and an allergy to sulfa, rosuvastatin calcium (CRESTOR), cefuroxime axetil (CEFTIN), trees, grass, mold and dust who on 20-SEP-2005, AT APPROXIAMTELY 10:30 am was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P).  Concomitant therapy included terbinafine (LAMISIL) ans saw palmetto.  On 22-Sep-2005 the patient called the physician's office and reported that he had developed a swollen, red spot, the size of a fist, at the injection site.  In follow up, it was reported that on 20-SEP-2005, the patient developed huge red spot, the size of a fist, where the shot was given and the patient had experienced very bad headaches.  On 21-SEP-2005, the injection site swelling was smaller.  Subsequently, the patient had recovered.  The reporter expressed concern regarding the lot.  No further information is expected.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site reaction, Malaise, Petechiae
Clinical narrative: Information has been received from a nurse practitioner concerning a 60-year-old male who in the last 10 days (approximately September 2005) was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P).  It was reported that within one day of the vaccination ( approximately September 2005), the patient developed an injection site reaction.  He also developed a whole body rash, red pettichiae on both arms and chest, malaise, fever, and the injection site was hard and tender.  He was treated with diphenhydramine (BENADRYL).  It was noted that the patient did receive the pneumococcal 23v polysaccharide vaccine in the past.  There was no product quality complaint reported.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a 60-year-old male who in the last 10 days (approximately September 2005) was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P).  It was reported that within one day of the vaccination ( approximately September 2005), the patient developed an injection site reaction.  He also developed a whole body rash, red pettichiae on both arms and chest, malaise, fever, and the injection site was hard and tender.  He was treated with diphenhydramine (BENADRYL).  It was noted that the patient did receive the pneumococcal 23v polysaccharide vaccine in the past.  There was no product quality complaint reported.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling, Nausea
Clinical narrative: Information has been received from a pharmacist and physician's assistant concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649979/0531P).  Subsequently the patient experienced an injection site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  The patient was treated with ibuprofen (MOTRIN).  As OF 04-oct-2005, the patient was recovering from injection site reaction site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  No product quality complaint involved.  The pharmacist and physician's assistant also mentioned another patient's experience following vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist and physician's assistant concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649979/0531P).  Subsequently the patient experienced an injection site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  The patient was treated with ibuprofen (MOTRIN).  As OF 04-oct-2005, the patient was recovering from injection site reaction site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  No product quality complaint involved.  The pharmacist and physician's assistant also mentioned another patient's experience following vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Drug ineffective, Unevaluable event
Clinical narrative: Information ahs been received from a healthcare pharmacy student concerning an approx 87 year old male with no know allergies and history of cold agglutination disease who within the year approx 2005 was vaccianted with a dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included prednisone. On 8/16/05 the pt had a titer which showed a response to only 6 serotypes. There was no other information available regarding the pts adverse event. The adverse event did not improve and the pt is not recovered. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: Information has been received from a pharmacist concerning adult female who on 04-OCT-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R).  It was noted that the patient received her first dose prior to age 65.  On 04-OCT-2005, immediately after vaccination, the patient's entire upper arm was red and warm to touch.  It covered the entire upper arm with no defined border.  Unspecified medical attention was sought and the patient was instructed to use ice packs for comport.  The patient was recovering.  A product quality compliant was not involved.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a health professional concerning an approximately 64-year-old female with no known allergies who on 28-SEP-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650331-0749P).  Subsequently, in September 2005 the patient developed swelling from her shoulder to her elbow.  She was given antibiotics.  It was unknown if the patient was on other medications, and the patient's status at the time of the report was unknown as well.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin discolouration
Clinical narrative: Information has been received from a 79 year old female consumer with emphysema who on 06-OCT-2005 was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (lot number unknown).  On 06-OCT-2005 the patient experienced rash after getting injection.  The patient mention that the rash started below the injection site and spread down the arm.  The caller indicated that by the next day, 07-OCT-2005, the rash was gone and only some discoloration was left.  At the time of the report it is unknown if the patient recovered from discoloration.  No product quality compliant was involved.  No further information is available.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with seizure disorder, chronic anemia, gastroesophageal reflux disease , aguegenic myeloid metaplasia and seasonal allergy who on 05-OCT-2005 was vaccinated intramuscularly in her left arm with a first dose of pneumococcal 23v polysaccharide vaccine.  There was no concomitant medication.  On 06-OCT-2005 the patient developed cellulitis at an area other than injection site.  The cellulitis developed in her left arm but in the axilla area.  The patient sought medical attention and was prescribed antibiotics and ibuprofen (ADVIL).  Patient's outcome reported as not recovered.  There was no product quality complaint involved.  Follow up information received on 25-OCT-2005 from the physician's office indicated that the patient's complaint was not related to the vaccine.  No further information is available.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning an 88 year old female who on 06-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650456/0974P).  Subsequently, the patient developed large raised welts at the site.  No prescription drug treatment was required.  The patient's outcome was unknown.  No further information is available.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female who on 08-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine  (lot 650456/0974P).  On 08-OCT-2005, the patient developed large raised welts at the site of injection.  It was noted that hydrocortisone cream was ordered to reduce the welt in this patient.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a 64-year-old female with asthma and no drug allergies who on 07-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  Concomitant therapy included fluticasone propionate (FLOVENT), ALBUTEROL, montelukast Na, and thyroid.  On 07-OCT-2005, after vaccination, the patient's right arm swelled up to three times the normal size at the injection site area.  The patient also developed pain and redness in the right arm.  Medical attention was not sought and the patient took acetaminophen (TYLENOL) to relieve the pain.  No laboratory/diagnostic tests were performed.  On 10-OCT-2005, the patient's events resolved.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist technician concerning a patient (age and sex not specified) who on 06-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650456/0974P).  On 06-OCT-2005 , within 24 hours, the patient developed an injection site reaction of swelling and redness.  The patient sought unspecified medical attention.  It was reported they have requested a check of lot 650456/0974p.  At the time of this report, the outcome of the events were unknown.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information has been requested.