chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 69 yr old female with elevated triglycerides and depression who on 19May05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine in the left arm (route not reported). Concomitant therapy included cetirizine hydrochloride (Zyrtec), fenofibrate (Tricor) and amitriptyline hydrochloride. On 19May05 the pt developed injection site reaction with swelling down and under the upper arm. The pt reported "It looked like an octopus, swollen red, hot and sore". The pt sought medical attention and was treated in the ER but not admitted. 24 hrs later, the pt recovered. No further information is available.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 77 yr old female pt who on 07Jun05 was vaccinated IM with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). On 07Jun05 in the evening, the pt developed arm, redness, pain and warmth. On 08Jun05, the pt also experienced fever and chills. The pt was treated with ice, cephalexin (Keflex), and acetaminophen (Tylenol). The pt's outcome was unk. The physician indicated that he would like an investigation into that lot #. There was no product quality complaint involved. The records of testing prior to release of the lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical technologist concerning a male pt who on 08Jun05 or 09Jun05 was vaccinated with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). It was noted that the pt had injection site reactions. On approx 09Jun05, the pt called the doctor's office because he experienced temp to 103 deg F, chills, nausea, weakness, redness, swelling, and soreness of the arm to the elbow. It was noted that he was taking ibuprofen (Motrin) and or acetaminophen (Tylenol). Unspecified medical attention was sought. The pt's outcome was unk. The caller was concerned about further use of this lot number. 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 has been requested.
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Information has been received from a medical technologist concerning a male pt who on 08Jun05 or 09Jun05 was vaccinated with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). It was noted that the pt had injection site reactions. On approx 09Jun05, the pt called the doctor's office because he experienced temp to 103 deg F, chills, nausea, weakness, redness, swelling, and soreness of the arm to the elbow. It was noted that he was taking ibuprofen (Motrin) and or acetaminophen (Tylenol). Unspecified medical attention was sought. The pt's outcome was unk. The caller was concerned about further use of this lot number. 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 has been requested.
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a female who on 6/7/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (0.5 ml lot 650454/0751P), intramuscularly. On 6/7/05 the patients vaccinated arm became red and warm to touch. She developed a raised area on the arm 38 mm x 45mm. She experienced some discomfort. It was not known if this was her first dose or a booster dose. The symptoms resolved on their own in a few days. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with respiratory issues, immunodeficiency and an allergy to amoxicillin + clavulanate potassium Augmentin and Sulfamethoxazole + trimethoprim Bactrim who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Concomitant therapy included an unspecified respiratory medication. It was reported that the patient received a previous dose of Pneumococcal 23v polysaccharide vaccine in 2004. On 6/7/05 the patient developed an injection site reaction. The nurse reported that on 6/7/05 the patient developed a rash at the injection site with redness. The patient was treated with an unspecified antibiotic by the physician. The outcome of the patients injection site reaction was unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a  pharmacist concerning a 70 year old female patient with a sulfa allergy, who on 4/25/05 at 13:00 was vaccinated subcutaneously in the RUQ with a 0.5 ml first dose of Pneumococcal 23v polysaccharide vaccine. Illness at the time of vaccination included a urinary tract infection and dehydration. At 20:00, the patient developed injection site redness, erythema, swelling and soreness. Unspecified medical attention was sought. The patient was treated with warm compresses. No diagnostic lab test were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Thermal burn
Clinical narrative: Information has been received from a health care worker concerning a 26 year old female with no medical history or allergies reported. On 1/13/05 the patient was vaccianted with the first dose of Pneumococcal 23v polysaccharide vaccine. There were no concomitant medication reported. On 1/14/05 the patient developed redness, swelling and burning of injection site. The patient sought unspecified medical attention. The events subsided in a few days and no treatment was required. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician concerning a 52 year old male (previously reported as 51 years old) with no adverse events following prior vaccinations reported. On 6/14/05 at 4pm, the patient was vaccinated intramuscularly with Pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). The patient had asthma at the time of vaccination. On 6/15/2005 in the PM, within 24 hours, the patient developed swelling and erythema of the left arm (previously reported that on 6/17/05 the patient developed an injection site reaction that included the following, redness, swelling, local heat and pain. The patient sought unspecified medical attention. On 6/20/05, the patient had recovered from the swelling and erythema of the left arm. No further information is available.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Oedema
Clinical narrative: Information has been received from a 41 year old female registered nurse with asthma and unspecified allergies. In June 2004, the nurse was vaccinated with Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified therapy Naacort fexofenadine hydrochloride + pseudoephedrine hydrochloride Allergra D, Fluticasone propionate Flovent, and lansoprazole Prevacid. In June 04, the nurse developed arm swelling when she received the Pneumococcal 23v polysaccharide vaccine. The nurse reported that the entire arm was swollen. The swelling was relieved by ice and diphenhydramine hydrochloride Benadryl. The nurse sought unspecified medical attention. At the time of this report, the patient had recovered from the event date unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site warmth
Clinical narrative: Information has been received from a medical technologist concerning a female patient who on 4/1/05 was vaccinated with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/005R). It was noted that the patient had injection site reaction. On 6/6/05, the patient was seen in the doctors office with a red and hot arm. It was noted that she was taking Ibuprofen Motrin and or acetaminophen Tylenol. Unspecified medical attention was sought. The patients outcome was unknown. It was noted that the patient received this vaccine in the past. The caller was concerned about further use of this lot number. 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. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthropathy, Cellulitis, Erythema, Hypersensitivity, Injection site hypersensitivity
Clinical narrative: Initial and follow up information has been received from a  medical assistant and a physician concerning a 65 year old female violin teacher who is well nourished, well developed, and well groomed and has a good build, with allergies to erythromycin (rash), penicillin (swelling), and sulfa drugs (rash), non smoker, and a history of De Quevain's tenosynovitis, Dupuytren's  contracture (right fifth digit), a mammogram 6/10/05, colonoscopy 8/2003 not complete, and a core biopsy 9/04 and non contributory family history, who on 6/22/05 at 11:14 was vaccianted intramuscularly into the left deltoid muscle with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). Concomitant therapy included calcium carbonate, vitamins unspecified, amitriptyline HCL and estradiol Estrace. On 6/22/05, the patient went home and started noticing redness and swelling around the site that had continued to extend. on 6/23/05, the patient stated that she had an allergic reaction to the vaccine given yesterday. She complained of skin problems which included significant erythema, swelling and pain covering a large portion of her upper arm. Her body temperature measurement was 99.2 deg F and her pulse was 102 and regular. It was also noted that new lesions and skin color charges were present. The patient was diagnosed with cellulitis of the arm specifically the axilla. The patient was advised to use cool packs periodically and do her best to keep her arm elevated. She was treated with Azithromycin Zithromax 250 mg tablet QD, 1 tablet a day, 2 tablets to be taken on day 1 and methylprednisolone Medrol, 4mg tablet QD. The patient will return to the office on 6/24/05 for follow up. It was noted that the risk of complications was moderate. AT the time of this report, the patient had not recovered from cellulitis. On 7/5/05, the patient stated that she has pain on her left thumb, possibly tendonitis. The patient had taken Ibuprofen Advil and diphenhydramine hydrochloride Benadryl. It was noted that NSAID not specified dose of 600mg. She did this and her symptoms improved. The patient was concerned because she had swelling around the proximal thumb and was afraid of osteomyelitis. It was noted that the patient felt well in general but she had wrist and hand pain and joint redness, swelling and tenderness over the left metacarpal bone. She was diagnosed with tendonitis. The patient was advised to continue with NSAIDS and if there was no improvement then she should see a hand surgeon. Lab test included a blood platelet count, a serum C reactive protein test, a serum rheumatoid factor test, a complete blood cell count, and erythrocyte sedimentation rate (results not reported). The risk of complication were moderate. It was noted that the patient used to have a egg allergy but has received influenza vaccines without problems as an adult. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Oedema, Osteomyelitis, Pain
Clinical narrative: Initial and follow up information has been received from a  medical assistant and a physician concerning a 65 year old female violin teacher who is well nourished, well developed, and well groomed and has a good build, with allergies to erythromycin (rash), penicillin (swelling), and sulfa drugs (rash), non smoker, and a history of De Quevain's tenosynovitis, Dupuytren's  contracture (right fifth digit), a mammogram 6/10/05, colonoscopy 8/2003 not complete, and a core biopsy 9/04 and non contributory family history, who on 6/22/05 at 11:14 was vaccianted intramuscularly into the left deltoid muscle with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). Concomitant therapy included calcium carbonate, vitamins unspecified, amitriptyline HCL and estradiol Estrace. On 6/22/05, the patient went home and started noticing redness and swelling around the site that had continued to extend. on 6/23/05, the patient stated that she had an allergic reaction to the vaccine given yesterday. She complained of skin problems which included significant erythema, swelling and pain covering a large portion of her upper arm. Her body temperature measurement was 99.2 deg F and her pulse was 102 and regular. It was also noted that new lesions and skin color charges were present. The patient was diagnosed with cellulitis of the arm specifically the axilla. The patient was advised to use cool packs periodically and do her best to keep her arm elevated. She was treated with Azithromycin Zithromax 250 mg tablet QD, 1 tablet a day, 2 tablets to be taken on day 1 and methylprednisolone Medrol, 4mg tablet QD. The patient will return to the office on 6/24/05 for follow up. It was noted that the risk of complications was moderate. AT the time of this report, the patient had not recovered from cellulitis. On 7/5/05, the patient stated that she has pain on her left thumb, possibly tendonitis. The patient had taken Ibuprofen Advil and diphenhydramine hydrochloride Benadryl. It was noted that NSAID not specified dose of 600mg. She did this and her symptoms improved. The patient was concerned because she had swelling around the proximal thumb and was afraid of osteomyelitis. It was noted that the patient felt well in general but she had wrist and hand pain and joint redness, swelling and tenderness over the left metacarpal bone. She was diagnosed with tendonitis. The patient was advised to continue with NSAIDS and if there was no improvement then she should see a hand surgeon. Lab test included a blood platelet count, a serum C reactive protein test, a serum rheumatoid factor test, a complete blood cell count, and erythrocyte sedimentation rate (results not reported). The risk of complication were moderate. It was noted that the patient used to have a egg allergy but has received influenza vaccines without problems as an adult. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin discolouration, Skin disorder, Skin ulcer, Tenderness
Clinical narrative: Initial and follow up information has been received from a  medical assistant and a physician concerning a 65 year old female violin teacher who is well nourished, well developed, and well groomed and has a good build, with allergies to erythromycin (rash), penicillin (swelling), and sulfa drugs (rash), non smoker, and a history of De Quevain's tenosynovitis, Dupuytren's  contracture (right fifth digit), a mammogram 6/10/05, colonoscopy 8/2003 not complete, and a core biopsy 9/04 and non contributory family history, who on 6/22/05 at 11:14 was vaccianted intramuscularly into the left deltoid muscle with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). Concomitant therapy included calcium carbonate, vitamins unspecified, amitriptyline HCL and estradiol Estrace. On 6/22/05, the patient went home and started noticing redness and swelling around the site that had continued to extend. on 6/23/05, the patient stated that she had an allergic reaction to the vaccine given yesterday. She complained of skin problems which included significant erythema, swelling and pain covering a large portion of her upper arm. Her body temperature measurement was 99.2 deg F and her pulse was 102 and regular. It was also noted that new lesions and skin color charges were present. The patient was diagnosed with cellulitis of the arm specifically the axilla. The patient was advised to use cool packs periodically and do her best to keep her arm elevated. She was treated with Azithromycin Zithromax 250 mg tablet QD, 1 tablet a day, 2 tablets to be taken on day 1 and methylprednisolone Medrol, 4mg tablet QD. The patient will return to the office on 6/24/05 for follow up. It was noted that the risk of complications was moderate. AT the time of this report, the patient had not recovered from cellulitis. On 7/5/05, the patient stated that she has pain on her left thumb, possibly tendonitis. The patient had taken Ibuprofen Advil and diphenhydramine hydrochloride Benadryl. It was noted that NSAID not specified dose of 600mg. She did this and her symptoms improved. The patient was concerned because she had swelling around the proximal thumb and was afraid of osteomyelitis. It was noted that the patient felt well in general but she had wrist and hand pain and joint redness, swelling and tenderness over the left metacarpal bone. She was diagnosed with tendonitis. The patient was advised to continue with NSAIDS and if there was no improvement then she should see a hand surgeon. Lab test included a blood platelet count, a serum C reactive protein test, a serum rheumatoid factor test, a complete blood cell count, and erythrocyte sedimentation rate (results not reported). The risk of complication were moderate. It was noted that the patient used to have a egg allergy but has received influenza vaccines without problems as an adult. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Tendonitis
Clinical narrative: Initial and follow up information has been received from a  medical assistant and a physician concerning a 65 year old female violin teacher who is well nourished, well developed, and well groomed and has a good build, with allergies to erythromycin (rash), penicillin (swelling), and sulfa drugs (rash), non smoker, and a history of De Quevain's tenosynovitis, Dupuytren's  contracture (right fifth digit), a mammogram 6/10/05, colonoscopy 8/2003 not complete, and a core biopsy 9/04 and non contributory family history, who on 6/22/05 at 11:14 was vaccianted intramuscularly into the left deltoid muscle with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). Concomitant therapy included calcium carbonate, vitamins unspecified, amitriptyline HCL and estradiol Estrace. On 6/22/05, the patient went home and started noticing redness and swelling around the site that had continued to extend. on 6/23/05, the patient stated that she had an allergic reaction to the vaccine given yesterday. She complained of skin problems which included significant erythema, swelling and pain covering a large portion of her upper arm. Her body temperature measurement was 99.2 deg F and her pulse was 102 and regular. It was also noted that new lesions and skin color charges were present. The patient was diagnosed with cellulitis of the arm specifically the axilla. The patient was advised to use cool packs periodically and do her best to keep her arm elevated. She was treated with Azithromycin Zithromax 250 mg tablet QD, 1 tablet a day, 2 tablets to be taken on day 1 and methylprednisolone Medrol, 4mg tablet QD. The patient will return to the office on 6/24/05 for follow up. It was noted that the risk of complications was moderate. AT the time of this report, the patient had not recovered from cellulitis. On 7/5/05, the patient stated that she has pain on her left thumb, possibly tendonitis. The patient had taken Ibuprofen Advil and diphenhydramine hydrochloride Benadryl. It was noted that NSAID not specified dose of 600mg. She did this and her symptoms improved. The patient was concerned because she had swelling around the proximal thumb and was afraid of osteomyelitis. It was noted that the patient felt well in general but she had wrist and hand pain and joint redness, swelling and tenderness over the left metacarpal bone. She was diagnosed with tendonitis. The patient was advised to continue with NSAIDS and if there was no improvement then she should see a hand surgeon. Lab test included a blood platelet count, a serum C reactive protein test, a serum rheumatoid factor test, a complete blood cell count, and erythrocyte sedimentation rate (results not reported). The risk of complication were moderate. It was noted that the patient used to have a egg allergy but has received influenza vaccines without problems as an adult. No product quality complaint was involved. Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician and a company representative concerning an 88 year old female patient with a history of hypertension and no reported allergies who on 6/23/05 with vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine lot 647661/0055R. There was no concomitant medication. Subsequently, on an unspecified date, the patient developed redness, soreness, swelling and then hardness at the injection sight that caused a great deal of pain. The company representative also reported that the physician told him that the patient's arm got red and it turned hard about 4-6 hours after receiving the injection. The physician reported that he treated the patient with NASAIDS and compresses and that the patient was recovering. The company representative subsequently reported that the patient recovered with anti inflammatory medication treatment. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning an adult female patient (age not reported) who several weeks ago, on an unspecified date, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). The patient reported to the nurse by phone that she developed an injection site reaction that included redness and local pain lasting about 2 weeks. It was reported that the patient sought unspecified medical attention. At the time of the report he patient outcome was unknown. The was no product quality complaint involved. No other information was available.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site rash, Pyrexia, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with respiratory issues who on 6/9/05 was vaccinated wit a dose of Pneumococcal 23v polysaccharide vaccine lot 650082/0691P. Concomitant therapy included an unspecified respiratory medication. On 6/10/05 the patient developed an injection site reaction. The nurse reported that on 6/10/05 the patient developed fever (measurement not reported), hives, rash and redness at the injection site. The patient was treated with cefdinir (Omnicef), acetaminophen Tylenol. and Ibuprofen Motrin. The patient's outcome was unknown. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a 50 year old male registered nurse, who in 10/04, was vaccinated with the first dose of Pneumococcal 23v polysaccharide vaccine. Twenty four hours after the injection, he developed flu like symptoms, soreness and a fever. The nurse reported that the fever lasted about a day. The nurse did not seek medical attention. At the time of this report, the nurse had recovered from the events. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site pain, Injection site warmth
Clinical narrative: Initial and follow up information has been received from an office manager for the physician and a physician concerning a 70 year old female with no known adverse drug reactions, no known allergies and no pertinent medical history reported. On 7/18/05 the patient was vaccianted with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine lot 650327/0792P. There were no concomitant medications reported. The same day, following vaccination, the patient developed pain and redness at the injection site, was warm to touch at injection site and had difficulty moving her arm. The patient sought unspecified medical attention. The office manager reported that she believed the patient had recovered from the events date unknown. The physician reported a concern regarding the lot. 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 follow up information has been received concerning the retired female patient, who on the morning of 7/18/05 received her second dose of Pneumococcal 23v polysaccharide vaccine into her left arm. It was reported that on the same day she developed pain and redness at injection site, warm to touch hurts to move up an down. The patient recovered on an unknown date. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site hypersensitivity, Injection site oedema, Injection site pain, Medication error
Clinical narrative: Initial and follow up information has been received from a registered nurse via a company representative concerning a 54 year old female patient with an unknown medical history how on 7/6/05 at 8:30am was vaccinated in the left deltoid with a dose of Pneumococcal 23v polysaccharide vaccine lot 650457/0973P. On 7/6/05 previously reported as 7/7/05, at 9:00pm, the patient developed a bad pain in the shoulder/arm and chills. It was reported that the reaction was red and swollen and was pronounced in the arm where the injection was given (from the elbow to the shoulder). Follow up information from the nurse confirmed that the patient had a large local reaction to the injection that was painful at the site with chills. The patient was directed to put ice on the arm and take ibuprofen by the nurse who saw her on the follow up visit. It was also reported that the patient recovered on an unspecified date in July 2005. Follow up information from the nurse also indicated that the pt had a previous vaccination with Pneumococcal 23v polysaccharide vaccine on 3/7/05 and noted that the one given on 7/6/05 was given in error, thus the reaction. There was no product quality complaint involved. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Medication error, Pyrexia, Tenderness
Clinical narrative: Initial and follow up information has been received from a physician concerning a 63 year old female admissions representative with no known drug allergies who on the morning of 7/28/05 wad inadvertently vaccinated IM in the left deltoid with a second 0.5ml dose of Pneumococcal 23v polysaccharide vaccine 650452/0753P. Concomitant therapy included simvastatin, lisinopril, aspirin, acebutolol, Brompheniramine maleate pseudoephedrine Lorane, hydrochlorothiazide manufacturer unknown, and glucosamine. Subsequently the office realized that she already received a dose of Pneumococcal 23v polysaccharide vaccine in Jan 2005 date note specified. Upon follow up received from the physician it was reported that on 7/28/2005 at approximately 9:30pm, the patient developed a fever up to 101 deg F and was swollen and tender to touch. There was no illness at the time of vaccination. The patient was reported to have recovered on 7/29/05. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a female who on 7/25/05 was vaccinated in the left deltoid with a second dose of Pneumococcal 23v polysaccharide vaccine. On 7/25/05, the patient developed soreness at the injection site. The pt subsequently developed swelling and erythema 7cm by 3cm on the inner aspect of the left bicep. The pt did not seek medical attention for the experience. At the time of this report, the patients soreness at the injection site and swelling and erythema on the inner aspect of the left bicep persisted. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Swelling
Clinical narrative: Information has been received from a physician concerning a 67 year old who on 06-Jun-2005 was vaccinated intramuscularly with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). On 06-JUN-2005, the patient's arm was swollen and warmth.  The patient was treated with ice packs and elevation.  The physician requested an investigation into the lot number.  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: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 70 year old female who on 06-JUN-2005 was vaccinated intramuscularly with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  On 07-JUN-2005, the patient's arm was swollen with cellulitis.  The patient was treated with amoxicillin (+) clavolanate potassium (AUGMENTIN).  On 09-JUN-2005, the patient developed a fever and pain in the right hip when walking.  The physician requested an investigation into the lot number.  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: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Myalgia
Clinical narrative: Information has been received from a health professional concerning a 78 year old male on 02-JUN-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  Subsequently, the patient experienced a sore and red arm.  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  The physician requested an investigation into the lot number.  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 is not expected.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site pain, Injection site warmth
Clinical narrative: Initial and follow up information has been received from an office manager for the physician and a physician concerning an 86 year old male with no known adverse drug reactions, no know allergies and no pertinent medical history reported. On 7/19/05, in th Am the pt was vaccinated in the left arm with the first 0.5ml dose of Pneumococcal 23v polysaccharide vaccine lot 650327/0792P. There were no concomitant medications reported. That same day, following vaccination in the AM, the pt developed pain and redness at the inj site, pain and was warm to touch at inject site and was reported to hurt to move his arm up and down (previously reported had difficulty moving his arm). The patient sought unspecified medical attention. On 7/21/05 the patient had recovered from the events. The physician reported a concern regarding the lot. 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. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: Initial and follow up information has been received from an office manager for the physician and a physician concerning a 65 year old retired female with no known adverse drug reactions, no known allergies and no pertinent medical history reported.  On 20-Jul-2005, in the morning, the patient was vaccinated in the left arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  There were no no concomitant medications reported.  That same day, following vaccination in the morning, the patient developed pain and redness at the injection site, was warm to touch at injection site and had difficulty moving her arm.  The patient sought unspecified medical attention.  The office manager reported that she believed the patient had recovered from the events(date unknown).  The physician reported a concern regarding the lot.  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.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: Initial and follow up information has been received from an office manager for the physician and a physician concerning a 65 year old retired female with no known adverse drug reactions, no known allergies and no pertinent medical history reported.  On the morning of 27-JUL-2005, the patient was vaccinated into the right arm with a 0.5 ml, first dose of pneumococcal 23v polysaccharide vaccine (lot650453-0791P).  There were no concomitant medications reported.  That same day, following vaccination, the patient developed pain and redness at the injection site was warm to touch at injection site and had difficulty moving her arm.  The patient sought unspecified medical attention.  The office manager reported that she believed the patient had recovered from the events (date unknown).  The physician reported a concern regarding the lot.  The records of testing prior to release of this lot have been checked by the Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Thermal burn
Clinical narrative: Information has been received from a health care worker concerning a 77 year old female with cholesterol, acid reflux, an unspecified "heart condition" and no allergies reported.  On 13-JUN-2005 the patient was vaccinated with the first dose of pneumococcal 23v vaccine (lot 647661-0055R).  Concomitant therapy included esomeprazole magnesium (NEXIUM), atorvastin calcium (LIPITOR) clopidogrel bisulfate (PLAVIX) and aspirin.  On 14-JUN-2005 the patient developed redness, swelling an burning of injection site area.  The patient sought unspecified medical attention.  The events subsided in a few days with no treatment required.  The patient was noted to be recovering.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a 70 year old female with  high cholesterol,  seasonal allergies, no food or drug allergies and a history of a prior immunization with pneumococcal 23v vaccine in 2000. On 01-NOV-2004 the patient was vaccinated with the second dose of pneumococcal 23v vaccine.  Concomitant therapy included risedronate sodium (ACTONEL), aspirin, unspecified vitamins, atorvastatin calcium (LIPITOR) and triamcinolone acetomise (NASOCORT).  On 02-NOV-2004 the patient developed redness, swelling and burning of injection site area.  The patient sought unspecified medical attention.  The events subsided in a few days with no treatment requires.  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Oedema, Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning a 63 year old white male with gastroesophageal reflux disease, chronic obstructive pulmonary disease and chronic bronchitis who on 01-AUG-2005 at 16:38 was vaccinated intramuscularly into the left arm with a second dose of pneumococcal 23v vaccine (lot 649694/0386P).  On 02-AUG-2005, the patient's left arm was sore,"felt hard" and was not warm to the touch.  The patient stated that he just doesn't fell well.  The patient experienced a local site reaction of redness, tenderness and edema.  He stated that he felt better when he took ibuprofen (ADVIL).  On 03-AUG-2005, the patient stated that his arm was better and he felt better.  He also stated that he really felt had he took ibuprofen (ADVIL) all day, but he did not need a follow up appointment.  Unspecified medical attention was sought.  The patient's outcome was unknown.  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 by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 73 year old white female with penicillin allergy and hospitalized for a minor unspecified GYN procedure and a history of splenectomy (due to lymphoma)and knee replacement who on 29-JUL-2005 (before discharge from hospital) was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included estradiol (ESTRACE) and medroxyprogesterone acetate (PROVERA).  On 30-JUL-2005 the patient developed a fever of over 102 F for three days.  The patient was prescribed ibuprofen (MOTRIN), acetamiphen (TYLENOL) and levofloxacin (LEVAQUIN).  A cat scan was negative.  The patient recovered.  No product quality complaint involved.  Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from e registered nurse concerning a female in her 50's clinically compromised with no drug allergies who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (intramuscularly).  There was no concomitant medication.  Subsequently the patient experienced puffy swelling from under ears to and including hands.  Ibuprofen (ADVIL) was given for the redness and swelling.  The patient recovered.  It was noted that the patient had no history of reactions to any other vaccines and was not diabetic.  It was also noted that the patient was clinically compromised but that pneumococcal 23v polysaccharide vaccine was given because the benefits outweighed the risks.  It was also reported that another patient had the same experienced.  Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 71-year-old white male who on 23-OCT-2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  Concomitant therapy included aspirin, atorvastatin calcium (LIPITOR), glimepiride (AMARYL) and amlodipine besylate (NORVASC).  Subsequently, the patient developed a high fever, body aches and flu like symptoms.  It was later discovered that the patient had received pneumococcal 23v polysaccharide vaccine one year prior.  Unspecified medical attention was sought and the patient subsequently recovered.  A product quality complaint was not involved.  Follow up information was received from the physician who reported that on 20-OCT-2003, the patient developed a flu like illness, myalgias and localized pain and swelling.  The patient recovered on 26-OCT-2003.  No diagnostic laboratory tests were performed.  No further information is expected.
Age: 0.7
Sex: M
Vaccine: PNC, PPV
Symptoms: Eye swelling
Clinical narrative: Information has been received from a registered nurse concerning an eight month old "healthy" male patient who on 08-AUG-2005 was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (0.5 ml) (intramuscularly) (lot 647363/0944N), in the left vastus lateralis, instead pneumococcal 4 6B 9v 14 18C 19F conj vaccine.  There was no concomitant medication.  The nurse reported that a follow up call was placed to mother of the child who stated child seemed fine and no adverse event.  However, two days post vaccination a phone conversation with father of the child says there was a mark on the child's leg and child's eyes were swollen.  Father of child told nurse he may take him to the emergency room.  No product quality complaint involved.  Additional follow up information from the registered nurse reported that " no adverse event, client not seen by physician".  No relevant diagnostic laboratory tests performed.  The patient had no prior adverse following vaccination.  No further information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Rash erythematous
Clinical narrative: Initial and follow up information has been received from a physician concerning a 72 yr old white, retired, female who on 17Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650370/0740P) into the left deltoid. On 17Aug05 the pt developed pain and swelling at the injection site. Follow up information reported that the pt also developed  and erythematous rash at the injection site. Unspecified medical attention was sought. At the time of the follow up report, the pt had recovered. Additional information is not available.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a RN concerning a 58 yr old female physician who on 16Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 6499989/0579P), IM in the left deltoid. On 16Aug05 the pt developed severe pain, redness and swelling in left arm. There was severe swelling, redness and a large blister noted at the injection site the following AM. The symptoms began a few hrs after receiving the injection. The physician recovered. It was also reported that another adult pt had an adverse experience after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0508USA03733). No further information is expected.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Information has been received from a RN concerning her daughter a 24 yr old female with Crohn's disease and asthma who on 18Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included polypharmacy. On 18Aug05 the pt developed intense swelling at the injection site and her entire body was aching. It was unk if medical attention was sought or if laboratory diagnostic tests were performed. She was treated with acetaminophen (Tylenol) and was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Blood alkaline phosphatase increased, Injection site pain, Injection site swelling, Pyrexia, White blood cell count decreased
Clinical narrative: Information has been received from a RN concerning a 21 yr old female pt who on 09Aug05 at 10:15AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 6499989/0579P), IM in the left arm. On 09Aug05 the pt developed severe pain and swelling in left arm, then developed febrile illness with decreased WBC and increased alk phosphate. The pt recovered. It was also reported that another adult pt had an adverse experience after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0508USA03390). No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a female nurse who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, she experienced a local injection site reaction and achiness. It was noted that she was not able to go to work the day following her immunization. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a 75 yr old female with cancer and a history of urinary tract bacteria, splenectomy and no allergies, who on approx 18Aug05 last week was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included (Leboxyl), esomeprazole magnesium (Nexium), (Prevachol) and pancreatic enzymes. Last week, the pt developed vomiting and diarrhea. Unspecified medical attention was sought. No lab diagnostic studies were performed. The consumer reported that she was feeling better but she had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Angioneurotic oedema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 70 yr old female family friend who on 22Aug05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 23Aug03, the pt's arm was swollen almost to her elbow. The physician said, it looked like angioedema. No treatment was needed. At the time of this report, the pt was recovering. It was noted that the reporting physician was a family friend and the pt was vaccinated at another doctor's office. No product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia, Skin reaction
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 yr old male who was hospitalized for cholecystitis and was post op cholecystectomy who on 25Jun05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On approx 25Jun05, the pt developed a localized skin reaction, fever, and cellulitis. The pt was treated with IV antibiotics for the cellulitis. It was noted that the pt has a previous unspecified reaction to a tetanus toxoid vaccination. 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 additional information was available.