chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female age not specified who on approx 10/26/05, the past 48 hrs was vaccinated with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649981/0704P). On approx 10/26/05, the past 48 hrs, the pt developed significant injection site reaction, fever, chills, swelling and redness from elbow to deltoid at injection site. It was also reported that symptoms started within 12 to 24 hours of receiving the vaccine. The pt sought unspecified medical attention. There were no lab diag studies performed. The pt had been taking acetaminophen Tylenol every four hours for the events. At the time of this report, the pt had not recovered from the events. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site hypersensitivity, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a nurse concerning an 8 year old female who on 10/24/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. On 10/24/05, the pt was concomitantly vaccinated with a dose of hepatitis A vaccine inactive. Subsequently, the pt developed injection site redness, a rash, fever, and vomiting. unspecified medical attention was sought. Subsequently, the pt recovered. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician's assistant concerning a 55 year old female who on 10/26/05 was attending a clinic and was vaccinated IM with a 0.5ml second dose of Pneumococcal 23v polysaccharide vaccine. The pt reported that she had received the Pneumococcal 23v polysaccharide vaccine six years ago and was requesting another. The reporter noted that she had heard from another health care professional that on 10/7/05 the pt developed a cellulitis like reaction. Unspecified medical attention was sought. the pts outcome was unknown. The physicians assistant was going to call the pt to follow up with her. No product quality complaint was involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Erythema, Injection site inflammation, Musculoskeletal stiffness
Clinical narrative: Information has been received from a healthcare worker concerning a 52-year-old female with a history of organ transplant and no known drug reactions or allergies who on 31-OCT-2005 at 13:30 pm. was vaccinated intramuscular with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  It was reported that the patient had the flu on 26-OCT-2005, however, there was no illness at the time of vaccination.  On 01-NOV-2005, the patient developed swelling, stiffness, and a rash on the upper arm.  The patient was treated with steroids.  The patient's outcome was reported as recovered.  A product quality complaint was not involved.  Follow up information was received from the healthcare worker who reported that on 31-OCT-2005 at 17:00 pm., the patient had difficulty breathing, a body rash, the upper shoulder was inflamed, red, and swollen, and she was lightheaded.  The patient had a medical visit with her family doctor and an exam.  She was treated with 20 mg of oral PREDNISONE and a topical steroid cream.  The patient recovered on 01-NOV-2005.  It was noted that the patient had no adverse events following prior vaccination.  No further information is expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 52-year-old female with a history of organ transplant and no known drug reactions or allergies who on 31-OCT-2005 at 13:30 pm. was vaccinated intramuscular with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  It was reported that the patient had the flu on 26-OCT-2005, however, there was no illness at the time of vaccination.  On 01-NOV-2005, the patient developed swelling, stiffness, and a rash on the upper arm.  The patient was treated with steroids.  The patient's outcome was reported as recovered.  A product quality complaint was not involved.  Follow up information was received from the healthcare worker who reported that on 31-OCT-2005 at 17:00 pm., the patient had difficulty breathing, a body rash, the upper shoulder was inflamed, red, and swollen, and she was lightheaded.  The patient had a medical visit with her family doctor and an exam.  She was treated with 20 mg of oral PREDNISONE and a topical steroid cream.  The patient recovered on 01-NOV-2005.  It was noted that the patient had no adverse events following prior vaccination.  No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning an adult patient with unknown medical history and unknown drug reactions or allergies, who "over the last ten days" in October 2005, was vaccinated intramuscularly with a 0.5 ml dose pneumococcal 23v polysaccharide vaccine (Lot# unknown).  Subsequently, in October 2005 the patient developed a local reaction at the injection site including soreness, warmth, erythema and swelling.  Unspecified medical attention was sought.  The patient was reported to be recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a pt over 40 yrs old who on approx 10/24/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651523/0604R). ON approx 10/24/05, the pt experienced a more extreme reaction than usual which included extreme soreness, redness, pain and swelling at the injection site and limb and site tenderness. Unspecified medical attention was sought. Subsequently, the pt recovered. It was noted that the pt did not have a reaction to the initial vaccination of Pneumococcal 23v polysaccharide vaccine. A investigation into the lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a physician in the office who on approx 10/31/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651523/0604R. On approx 10/31/05, the physician experienced a more severe reaction than usual to the vaccine. The reaction included pain and swelling at the injection site. Unspecified medical attention was sought. Subsequently, the physician recovered. A investigation into the lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Erythema, Feeling hot, Hypoaesthesia, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a male pt who on 10/26/05 was vaccinated in the arm with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). On approx 10/26/05 the pt experienced numbness in arm, tightness in the chest, low grade fever, and hot red spots on his body. As of 10/28/05 th pt was improving. Additional information has been requested
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a healthcare worker concerning a male pt who on 10/26/05 was vaccinated in the arm with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). On approx 10/26/05 the pt experienced numbness in arm, tightness in the chest, low grade fever, and hot red spots on his body. As of 10/28/05 th pt was improving. Additional information has been requested
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female who on 10/26/05 was vaccinated with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). She called the following day to complain of pain, redness, and swelling at site of injection. The nurse practitioner advised acetaminophen Tylenol for pain and ice packs. She was advised to call the next day if not better. At the time of the report, she had not called. The pt was considered to be recovering. It was also reported that two other pts had an adverse experience following vaccination with Pneumococcal 23v polysaccharide vaccine WAES0511USA00025 and WAES0511USA00420. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Joint range of motion decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female who on 28-OCT-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R).  On 31-OCT-2005 the patient called with entire arm sore, stiff, difficulty sleeping on and moving the arm.  Unspecified medical attention was sought.  The patient was considered to be recovering.  It was also reported that two other patient's had an adverse experience following vaccination with pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient who was vaccinated intramuscularly in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 631319/1007P).  Subsequently she developed a red, warm, swollen arm at the injection site.  It was also reported that she developed a "cellulitis type reaction" and fever.  The patient sought medical assistance and was recovering at the time of the report.
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia, Rash macular
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a male patient who was vaccinated intramuscularly in left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 651319/1007P).  Subsequently the patient developed a red , blotchy arm and fever.  The CMA also stated that he developed a red, warm, swollen arm at injection site.  The patient sought medical attention and was recovering at the time of this report.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Rash, Swelling
Clinical narrative: Information has been received from a 75 year old female with no allergies and unremarkable medical history who on 30-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine, in her left arm.  Concomitant medication included phenytoin (DILANTIN) and atorvastatin calcium (LIPITOR).  On 30-OCT-2005 the patient experienced swelling of elbow, rash 3 inches below and 6 inches above elbow, redness, and warm to touch in area of injection.  At the time of the report she was still experiencing most of the events.  The patient "felt rash had improved slightly today".  There were no relevant diagnostic tests or laboratory data.  The patient was considered to be recovered.  No additional information is expected.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Hyperhidrosis, Muscle spasms, Myalgia
Clinical narrative: Information has been received from a 30 year old female patient with asthma and" post partum" thyroiditis, who on 28-OCT-2005 was vaccinated intramuscularly into the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 650648/0967P).  There was no concomitant medication.  On 28-OCT-2005, about five hours after vaccination, the patient experienced sleepiness.  On 29-OCT-2005 the patient experienced soreness at injection site, queezy stomach, chills, sweating, headache, muscle cramping and developing a ever of 100.8 degree.  On 30-oct-2005 the patient's fever was 101.5 degree, and as high as 101.9.  On 30-OCT-2005 the patient's fever was 100.9 and that the patient was feeling "better".  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Somnolence
Clinical narrative: Information has been received from a 30 year old female patient with asthma and" post partum" thyroiditis, who on 28-OCT-2005 was vaccinated intramuscularly into the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 650648/0967P).  There was no concomitant medication.  On 28-OCT-2005, about five hours after vaccination, the patient experienced sleepiness.  On 29-OCT-2005 the patient experienced soreness at injection site, queezy stomach, chills, sweating, headache, muscle cramping and developing a ever of 100.8 degree.  On 30-oct-2005 the patient's fever was 101.5 degree, and as high as 101.9.  On 30-OCT-2005 the patient's fever was 100.9 and that the patient was feeling "better".  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a patient with a history of pneumococcal 23v polysaccharide vaccination and unknown allergies who on approximately 26-OCT-2005 ("within the last week") was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot unknown).  Subsequently, on an unknown date in 2005, the patient developed redness and swelling at the injection site.  The patient sought unspecified medical attention.  It was unknown if the patient recovered.  There was no product quality complaint involved.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an adult female who on approximately 27-OCT-2005 was vaccinated in the deltoid with an 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650302/1039P).  Within an hour of vaccination, the patient called the physician complaining of painful, red, swollen arm at the site of injection.  The physician prescribed diphenhydramine HCL (BENADRYL) and told her to call back if no improvement.  The patient called back the next day and reported that she was "fine".  Subsequently, the patient recovered.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Myalgia
Clinical narrative: Information has been received from a health professional concerning an adult male patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P).  Subsequently, the patient complained of redness, warmth and soreness at the injection site.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Pain, Vomiting
Clinical narrative: Information has been received from a licensed nurse practitioner concerning an adult female patient, with unknown medical history and unknown drug reactions/allergies, who on 24-OCT-2005 was vaccinated in the left deltoid intramuscularly with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P).  The patient called the office the same day complaining of vomiting, body aches, redness and heat in the deltoid about 10 centimeters in diameter.  She was seen in the office, given promethazine hydrochloride (PHENERGAN) intramuscularly for vomiting, and an ice pack was applied to the arm.  Subsequently, it was reported that as of 27-oct-2005 the patient was doing "well".  No further information is available.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 50 year old female with a drug hypersensitivity to codeine, high cholesterol, high blood pressure and diabetes who on 03-NOV-2005 was vaccinated subcutaneously with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650302/1039P).  Concomitant therapy included "Meglazine" (NOS), valsartan (DIOVAN), ezetimibe (+) simvastin, amlodipine besylate (NORVASC), calcium (unspecified) and chondroitin sulfate sodium (+) dimethyl sufone (+) glucosamine.  On 03-Nov-2005 the patient experienced injection site swelling and injection site redness.  The patient sought unspecified medical attention.  At the time of this report the patient's injection site swelling and redness persisted.  Additional informational has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site hypersensitivity, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a pt who, on 11/1/05, was vaccinated with a first IM dose in the right deltoid of Pneumococcal 23v polysaccharide vaccine (lot 650457/0937P). It was reported that the pt had a pretty significant allergic reaction and would be coming into the physicians office the week of 11/7/05. Follow up information from a woman working in a physicians office indicated that on 11/3/05 the pt called reporting a a local reaction to Pneumococcal 23v polysaccharide vaccine, described as a reddened, 6in circular area. The physician ordered Ibuprofen. On 11/4/05 the pt came to the office with localized cellulitis of the right upper arm. The pt was treated with Ibuprofen, Fexofenadine hydrochloride Allergra, heat to the area, and antibiotics. The pt was to return if there was no improvement. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a consumer concerning his 74 year old wife, with no medical history and no allergies, who on 10/27/05 was vaccianted once with a 0.5ml IM dose of Pneumococcal 23v polysaccharide vaccine. Concomitant vaccine included a dose of Influenza virus vaccine unspecified. It was reported that, on 10/27/05, the pt had an injection site reaction with a large red mark, sensation of warmth, an inability to lift her arm for two days post dose, and with a transient lump that had moved slightly down the arm. It was noted that the pts reactions were resolving. there were no lab or diag test performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult pt who on 6/30/04w as vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. IN Oct 2005, the pt was inadvertently vaccianted IM with an 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. In Oct 2005, the pt developed injection site reaction to include redness, swelling, pain and warmth. Unspecified medical attention was sought. The pts outcome was unknown. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site hypersensitivity, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 59 year old female with chronic obstructive pulmonary disease who on 11/4/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). Subsequently, on 11/05/05, the pt experienced a severe local reaction. The pt then experienced chills, a fever of 102 deg F, pain and redness at the injection site, and presented to the ER on 11/6/05. the pt was released and treated with antibiotic. On 11/7/05, it was noted that the symptoms persisted. The outcome was reported as not recovered. It was also noted that the pt received a previous dose of Pneumococcal 23V polysaccharide vaccine in approximately 1995. There was no product quality complaint. It was noted that the physician did not feel comfortable using the remaining doses in the vial and would like an investigation in to Pneumococcal 23v polysaccharide vaccine (lot 650648/0957P). 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: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a male who in Oct 2005, was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed a severe local site reaction described as arm pain. Unspecified medical attention was sought. It was also reported that other pts experienced an adverse event Following vaccination with Pneumococcal 23v polysaccharide vaccine WAES0510USA09350 WAES0511USA01104 and WAES0511USA01106. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Chromatopsia, Erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female who on 10/22/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed a severe local site reaction described as sore arm, pain, chills and vision changes (she saw the color red). Unspecified medical attention was sought. It was also reported that other pts experienced an adverse event following vaccination with Pneumococcal 23v polysaccharide vaccine WAES0510USA09350, WAES0511USA01104 and WAES0511USA01105. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a physician concerning a pt who was over 50 years old who was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt experienced local swelling at the injection site. No additional information was available. Additional information had been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Breast pain, Erythema, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female, who on 10/24/05 at 11:30 was vaccinated into the left deltoid with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). There was no illness at the time of vaccination. ON 10/24/05, the pt developed itching and half moon sized redness. By the evening, the pt experienced pain at the site. On 10/25/05, the pts pain was radiating into her left breast, and she complained of swelling and pain in her entire upper left arm down to her left elbow. She also experienced a fever of 101 deg F and said that she felt bad. the pt was going to use ice packs and Ibuprofen Advil. The pts was advised to call the office if there was no improvement. At the time of this report, the pts outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female, who on 10/24/05 at 11:30 was vaccinated into the left deltoid with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). There was no illness at the time of vaccination. ON 10/24/05, the pt developed itching and half moon sized redness. By the evening, the pt experienced pain at the site. On 10/25/05, the pts pain was radiating into her left breast, and she complained of swelling and pain in her entire upper left arm down to her left elbow. She also experienced a fever of 101 deg F and said that she felt bad. the pt was going to use ice packs and Ibuprofen Advil. The pts was advised to call the office if there was no improvement. At the time of this report, the pts outcome was unknown. Additional information has been requested.
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 adult female who on 11/1/05 was vaccinated in the deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). ON 11/1/05, post vaccination, the pt called the office complaining of arm soreness, redness, swelling, and arm was warm to tough. The physician ordered diphenhydramine HCL Benadryl and told the pt to call back. She subsequently called back and said she was fine. At the time of this report, the pts outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a female pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). Subsequently the pt experienced a severe local reaction. It was noted that the physician did not feel comfortable using the remaining doses in the vial and would like an investigation into Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). 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: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). Subsequently the pt experienced a severe local reaction. It was noted that the physician did not feel comfortable using the remaining doses in the vial and would like an investigation into Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). 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: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a licensed professional nurse concerning an 84 year old male who on 10/20/05 was vaccinated IM in the deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). On approx 10/20/05 the Pt experienced swelling, redness and pain of the injection site. The pt was treated in the ER and was released. No diagnostic or laboratory studies were performed. Subsequently, the LPN reported that the pt recovered. The LPN requested a check of the 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. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an adult female who in Nov 2005, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. The physician reported that in Nov 2005, the pt developed injection site swelling and redness that extended onto her chest. The pt was seen in the ER, but was not admitted. In Nov 2005, the pts injection site swelling and redness resolved. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a physician concerning a male who on 10/12/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine (0.5ml), in the arm. Concomitant therapy that day included influenza virus vaccine (unspecified), in the opposite arm. On 10/14/05 the pts arm was swollen (arm vaccinated with Pneumococcal 23v polysaccharide vaccine). The physician did not think that the Pneumococcal 23v polysaccharide vaccine caused the swelling. The pt was prescribed an antibiotic and swelling was gone. Subsequently, the pt recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician, via a company representative, concerning a male pt age unknown, with unknown medical history and unknown drug reactions/allergies, who on an unspecified date was vaccinated route unknown, with a dose of Pneumococcal 23v polysaccharide vaccine (lot known). The physician reported that the day after the injection the pt experienced a case of breakthrough. The physician also reported that there has been about two other cases that are nearly identical. Unspecified medical attention was sought. No product quality complaint was involved. The outcome was reported as unknown. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site mass, Pain
Clinical narrative: Information has been received from a health professional concerning a 46 year old female who on 11/7/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650541/1004P). On 11/8/08 the pt experienced a large knot at the area of the injection site. She also had pain in her arm and trouble moving her arm. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a 52 yr old female diabetic, who on 26Sep05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On 28Sep05 about two days post vaccination, the pt experienced generalized arthralgia. Unspecified medical attention was sought. The pt was placed on naproxen. No diagnostic lab studies were performed. At the time of this report, the pt had not recovered. No product quality complaint was involved. Generalized arthralgia was considered to be disabling.  Follow up information indicated that in further evaluation this pt did not have the adverse reaction to pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male pt who sometime this week was vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed swelling, redness and cellulitis. It was not known if this was the first dose of vaccine. The physician gave him cortisone injection and was doing fine now. The pt recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 69 yr old female who in 1999 and on approx 01Nov05 was vaccinated with a first and second dose (lot 649693/0496P) of pneumococcal 23v polysaccharide vaccine (0.5ml) (IM), respectively. On 08Nov05 the pt experienced significant swelling from her elbow to her shoulder. It was also reported that the pt developed painful, swollen, red arm. The pt was reportedly recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning an adult pt who on 24Oct05 was vaccinated with an IM 0.5mL first dose pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). On 25Oct05 the pt was diagnosed with cellulitis. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a female who on 24Oct05 was vaccinated with IM with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (650302/1039P). It was reported that the pt's first dose of pneumococcal 23 polysaccharide vaccine was administered 5-10 yrs ago. On 25Oct05 the pt was diagnosed with cellulitis in her arm. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an adult female who on 25Oct05 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). On 24Oct05 the pt experienced a fever, swelling and arm pain at the injection site. She was seen by the physician and was ordered acetaminophen (Tylenol). At the time of this report, the pt was recovering from swelling and arm pain at the injection site but her fever persisted. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Injection site pain, Malaise
Clinical narrative: Information has been received from a nurse practitioner concerning an 80 yr old female pt with a history of three previous vaccinations with pneumococcal 23v polysaccharide vaccine, who in the last 10 days (approx Sep 2005) was vaccinated with a fourth dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). It was reported that within one day of the vaccination (approx Sep 2005), the pt developed an injection site reaction. Her arm was sore and weak, and she also developed malaise, fatigue. There was no treatment at this time. There was no other information available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 59 yr old male pt who in the last 10 days (approx Sep 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 (approx Sep 2005), the pt developed a severe injection site reaction. He also developed a cellulitis, fever and chills. He was treated with an antibiotic. It was noted that the pt did receive the pneumococcal 23v polysaccharide vaccine in the past. There was no other information available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning an adult pt (age and gender not reported) with an unk medical history and unk allergies who on 27Oct05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651524/0605R). Subsequently, the pt developed an injection site reaction which included swelling, redness, pain and local heat. The pt was treated with antibiotics (unspecified). The pt was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a physician concerning an adult pt (gender and age not provided) who on 11Nov05 was vaccinated ID with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot not provided). On 11Nov05 the pt developed an inflammatory reaction at the injection site. The pt was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Bronchitis, Cellulitis
Clinical narrative: Information has been received from a physician via a company rep concerning an 83 yr old male a history of previous vaccination with a first dose of pneumococcal 23v polysaccharide vaccine who three weeks ago, on approx 21Oct05 was vaccinated with a dose of pneumococcal 23 polysaccharide vaccine (lot not provided). Three weeks ago, on approx 21Oct05 the pt developed a local injection site cellulitis reaction. The pt was treated with antibiotics for 10 days. In Nov 2005, the pt developed bronchitis. The pt was reported as recovered in late Oct 05. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an adult female who in August 2005, was vaccinated IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 647661/0055R). In Aug 2005, the pt developed injection site reactions to include pain, local warmth, redness and swelling. The pt's were reported as recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed professional nurse (LPN) concerning a 33 yr old female who on 18Oct05 was vaccinated IM in the deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 7091P). Concomitant therapy included hormonal contraceptives (unspecified). On approx 18Oct05 the pt experienced injection site swelling, redness and pain. Unspecified medical attention was sought. Subsequently, the pt recovered. The LPN requested a check of the lot number. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed professional nurse (LPN) concerning a 76 yr old female who on 18Oct05 was vaccinated IM in the deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot reported as 7091P). The LPN reported that the pt was on multiple drugs concomitantly. On approx 18Oct05 the pt experienced injection site swelling, redness and pain. Unspecified medical attention was sought, no diagnostic or laboratory studies were performed. Subsequently, the pt recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a nurse practitioner concerning a pt (age and gender not reported) with an unk medical history and unk allergies who on an unspecified date was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed cellulitis as a result of the vaccination. It was reported that the pt recovered from cellulitis on an unspecified date. The reporter felt that the pt's cellulitis was related to therapy with pneumococcal 23v polysaccharide vaccine. There was no product quality complaint involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from licensed practical nurse (LPN) and a healthcare provider concerning a 58 yr old white female pt, with hypertension, diabetes and gastrooesophageal reflux disease and unk drug reactions/allergies, who on 08Nov05 was vaccinated IM in the left deltoid with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot651329/1047P). On 08Nov05, follow up information from the healthcare provider indicated that the pt's left deltoid area became red, swollen, warm to touch, and sore. It was reported that the pt presented to the office and was instructed to use diphenhydramine hydrochloride (Benadryl) over the counter, cool compresses, amoxicillin (+) clavulanate potassium (Augmentin), and follow up if no better. On an unk date the pt recovered. No product quality complaint was involved. No additional information is expected.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician a pt who in Oct/Nov05, who along with 6 other pt's was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650331/0749P and 649989/0579P). Some pt's were first time vaccinated while others received a previous injection at least 5 yrs ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine (unspecified). Subsequently, the pt developed severe local reactions. The pt was reported as recovered. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a female patient (age and gender not provided) who on unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 650331/0749P). Subsequently, the patient developed injection site reaction which was uncomfortable and very painful. The patient required treatment with an antibiotic PO (unspecified) and methylprednisolone. The patient was reported as recovered. Injection site reaction was considered to be an other important medical event by the registered nurse. There was no product quality complaint involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 59 yr old female with no medical history and no known allergies who on 10Nov05 was vaccinated IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). There was no concomitant medication. Subsequently, the pt developed red, hot, painful and grapefruit size areas at the injection site. On 14Nov05, the pt was seen in the office and was treated with compresses. The pt was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a medical assistant concerning a male pt greater than 65 yrs of age who was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine. It was reported that no other vaccinations were given with the pneumococcal 23v polysaccharide vaccine. The pt was reported as generally healthy with no major health problems. Subsequently, the pt developed injection site cellulitis which lasted at the most for 3 days. The pt recovered from the injection site cellulitis. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a RN concerning a male (age not provided) who in early Oct 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P). Subsequently, the pt developed injection site reaction. The pt was reported as recovered. There was no product quality complaint involved. The registered nurse also provided information regarding another pt's experiences with pneumococcal 23v polysaccharide vaccine (WAES0511USA02165, 0511USA03746). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Information has been received from a 71 yr old female with high cholesterol who on 10Nov05 was vaccinated IM in the right deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant therapy included simvastatin, latanoprost (Xalatan), antihistamine, acetaminophen/oxycodone hydrochloride (Percocet) and naproxen. On 10Nov05 the pt experienced transient pain on the medial aspect of the injection arm from arm pit to elbow with erythema, warmth, nausea, and difficulty sleeping. The pt was seen in the ER. At the time of the report the pt had not yet recovered. There was no product quality complaint involved. Information received the same day from the RN indicated that the pt was vaccinated at another location on 10Nov05. The RN reported that on 13Nov05 the pt experienced swelling, redness and pain in the right deltoid. The pt told the nurse that she was given an antihistamine after being examined at a clinic. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Information has been received from a 71 yr old female with high cholesterol who on 10Nov05 was vaccinated IM in the right deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant therapy included simvastatin, latanoprost (Xalatan), antihistamine, acetaminophen/oxycodone hydrochloride (Percocet) and naproxen. On 10Nov05 the pt experienced transient pain on the medial aspect of the injection arm from arm pit to elbow with erythema, warmth, nausea, and difficulty sleeping. The pt was seen in the ER. At the time of the report the pt had not yet recovered. There was no product quality complaint involved. Information received the same day from the RN indicated that the pt was vaccinated at another location on 10Nov05. The RN reported that on 13Nov05 the pt experienced swelling, redness and pain in the right deltoid. The pt told the nurse that she was given an antihistamine after being examined at a clinic. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old sister who on approx 10/15/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. The RN reported that on approximately 10/15/05, immediately after being vaccinated, her sister developed edema like a softball and redness at the injection site. Unspecified medical attention was sought. At the time of this report, the pts edema and redness at the injection site persisted. The follow up it was reported that the reaction to the Pneumococcal 23v polysaccharide vaccine happened to a relative and the details of the facility, physician and vaccine were unknown. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a female pt who in March 2005, was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. IN March 2005, the pt experienced redness, swelling and tenderness from the elbow to the shoulder. Unspecified medical attention was sought. It was noted that the pharmacist was unsure of how long the pts symptoms lasted. Subsequently, the pt recovered. No product quality complaint was involved. Additional information has been requested.