chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Medication error, Skin reaction
Clinical narrative: Information has been received from a physician concerning a female pt with a history of hospitalization, who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. It was noted that the pt went home from the hospital, three weeks later when she was seen in the clinic she was vaccinated again IM with another 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Recently after the second vaccination, the pt experienced a skin reaction. Unspecified medical attention was sought. The pts outcome was unknown. NO product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a health professional concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed hugh large welts at the injection site. No medical attention was sought. The pts outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site rash
Clinical narrative: Information has been received from a nurse concerning an elderly pt who was vaccinated SC with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). Subsequently, the pt developed a hugh rash and swelling at the injection site. Medical attention was sought. Subsequently, the pt recovered. The nurse requested that a lot check be preformed. 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. In addition, a review of the system revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site induration
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 46 year old female with allergies to corticosteroids Unspecified (steroids) who on 11/7/05 was vaccinated IM in the right deltoid muscle with Pneumococcal 23v polysaccharide vaccine, (lot 650541/1004P). On 11/8/05, reportedly at 2:04pm, the pt reported that she developed a large knot on area where she received the injection and she couldn't move her arm. The pt reported that she had to leave work and take pain medication. Subsequently, the pt reported that she was feeling better and wanted to advise the doctors office of the reaction. On 11/9/05, the pt recovered. In follow up it was reported, by the registered nurse that the pt had no further problems. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Dyspnoea, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a RN concerning a 34 year old female with no medical history who on 11/4/05 was vaccinated IM in the left arm with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 650541/1004P). There was no illness at the time of vaccination. On 11/4/05 the pts left arm became red, swollen, hot to touch and tender. On 11/5/05 the pt developed a fever to 103. On 11/6/05 the pt developed shortness of breath and a dry, hacky cough. She denied nasal congestion or chest pain. No medical attention was sought. On 11/14/05 the pt recovered. No further information is expected.
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Information has been received from a RN concerning a 34 year old female with no medical history who on 11/4/05 was vaccinated IM in the left arm with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 650541/1004P). There was no illness at the time of vaccination. On 11/4/05 the pts left arm became red, swollen, hot to touch and tender. On 11/5/05 the pt developed a fever to 103. On 11/6/05 the pt developed shortness of breath and a dry, hacky cough. She denied nasal congestion or chest pain. No medical attention was sought. On 11/14/05 the pt recovered. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician and a licensed Practical nurse concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed cellulitis. Unspecified medical attention was sought. After several days, the pt recovered. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a pt who was vaccianted in a different office with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed cellulitis. Unspecified medical attention was sought. After several days, the pt recovered. No product quality complaint was involved. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Discomfort, Ear pain, Hypokinesia, Injection site hypersensitivity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 49 year old female with an allergy to morphine and iodine. On 12/8/05, at 3:15pm, the pt was vaccinated IM in the left arm (also reported as the right arm) with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). The next day, on 12/9/05, the pt called to office complaining of a sore arm, nausea, and earache, chills and a fever. She called back a few days later and left a voice mail message stating that her right arm was red, feverish, and swollen to three inches past her elbow. The arm was stiff, she was unable to straighten it, and very painful. She was seen by the physician on 12/12/05 because she said that it was swollen and red from the shoulder to the wrist and that she could not straighten it and could not eat. The physician noted that it was atypical for a pt to complain of such severe problems and not find any lingering physical exam findings on examination except for subjective discomfort. The pt recovered on 12/12/05. A product quality complaint was in involved. IN follow up it was reported that on 12/9/05, at 8:23am, the pt developed a sore arm, area of shot red and feverish. swollen to 3 inches past elbow, stiff and can't straighten arm and was very painful. It was reported that when the pt came to the clinic on 12/12/05, there was nothing observed by the physician. On 12/12/05, the pt had recovered from the events. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Musculoskeletal stiffness, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 49 year old female with an allergy to morphine and iodine. On 12/8/05, at 3:15pm, the pt was vaccinated IM in the left arm (also reported as the right arm) with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). The next day, on 12/9/05, the pt called to office complaining of a sore arm, nausea, and earache, chills and a fever. She called back a few days later and left a voice mail message stating that her right arm was red, feverish, and swollen to three inches past her elbow. The arm was stiff, she was unable to straighten it, and very painful. She was seen by the physician on 12/12/05 because she said that it was swollen and red from the shoulder to the wrist and that she could not straighten it and could not eat. The physician noted that it was atypical for a pt to complain of such severe problems and not find any lingering physical exam findings on examination except for subjective discomfort. The pt recovered on 12/12/05. A product quality complaint was in involved. IN follow up it was reported that on 12/9/05, at 8:23am, the pt developed a sore arm, area of shot red and feverish. swollen to 3 inches past elbow, stiff and can't straighten arm and was very painful. It was reported that when the pt came to the clinic on 12/12/05, there was nothing observed by the physician. On 12/12/05, the pt had recovered from the events. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 49 year old female with an allergy to morphine and iodine. On 12/8/05, at 3:15pm, the pt was vaccinated IM in the left arm (also reported as the right arm) with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). The next day, on 12/9/05, the pt called to office complaining of a sore arm, nausea, and earache, chills and a fever. She called back a few days later and left a voice mail message stating that her right arm was red, feverish, and swollen to three inches past her elbow. The arm was stiff, she was unable to straighten it, and very painful. She was seen by the physician on 12/12/05 because she said that it was swollen and red from the shoulder to the wrist and that she could not straighten it and could not eat. The physician noted that it was atypical for a pt to complain of such severe problems and not find any lingering physical exam findings on examination except for subjective discomfort. The pt recovered on 12/12/05. A product quality complaint was in involved. IN follow up it was reported that on 12/9/05, at 8:23am, the pt developed a sore arm, area of shot red and feverish. swollen to 3 inches past elbow, stiff and can't straighten arm and was very painful. It was reported that when the pt came to the clinic on 12/12/05, there was nothing observed by the physician. On 12/12/05, the pt had recovered from the events. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Oedema
Clinical narrative: Information has been received from a nurse from a doctors office concerning a female of unknown age who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (date unknown). Subsequently, following vaccination the pt experienced swelling of her arm and face. Unspecified medical attention was sought. The nurse did not report any details but did say that the pt recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site nodule, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Information has been received from a health professional concerning an adult female with no reported previous medical history who on 12/12/05 at 11:00 am (also reported as 12/13/05, was vaccinated with a 0.5ml IM first dose in the deltoid area of Pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). On 12/13/05 th pt developed a red blotchy rash and there was itching at the injection site. There were no treatments for the conditions. The status of the pt was reported as unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been received from a registered nurse. The nurse reported that the deltoid area where the vaccine had been given to the pt became swollen to her elbow with a maculo papular rash and that her arm was very painful with a nodule. The pt went to the ER and was treated with oral prednisone. The pt recovered from the events on 12/19/05. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash macular, Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning an adult female with no reported previous medical history who on 12/12/05 at 11:00 am (also reported as 12/13/05, was vaccinated with a 0.5ml IM first dose in the deltoid area of Pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). On 12/13/05 th pt developed a red blotchy rash and there was itching at the injection site. There were no treatments for the conditions. The status of the pt was reported as unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been received from a registered nurse. The nurse reported that the deltoid area where the vaccine had been given to the pt became swollen to her elbow with a maculo papular rash and that her arm was very painful with a nodule. The pt went to the ER and was treated with oral prednisone. The pt recovered from the events on 12/19/05. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Difficulty in walking, Dizziness, Vertigo
Clinical narrative: Information has been received from a health professional concerning an 85 year old female also reported as male with no relevant medical history or illness at time of vaccination who at 2:00pm on 10/10/2005 was vaccinated in the left deltoid with a second dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). AT 1:00 am on 10/11/05 the pt experienced dizziness. The dizziness progressed throughout the day on 10/11/05 to the point that the pt felt that she could not ambulate without assistance. The physician advised the pt to come to the office for an exam. The pt was unable to come to th office because of the vertigo. The physician advised the patient to take one teaspoonful of diphenhydramine HCL liquid four times daily. The pt was instructed to contact the office if symptoms worsened. The office did not receive a call from the pt. On 10/12/05, the pt recovered from dizziness. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site rash
Clinical narrative: Information has been received from a nurse concerning a elderly pt who was vaccinated SC with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). Subsequently, the pt developed a hugh rash and swelling at the injection site. The pt was seen in the ER and released. Subsequently, the pt recovered. The nurse requested that a lot check be performed. 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.  In addition, a review of the system revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who in approximately December 2005, was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#649697/1038P).  In approximately December 2005, the patient experienced a reaction that extended from his/her shoulder to his/her hand.  It was noted to be extremely painful, and severe erythema was noted.  The reporter indicated that the patient had a cellulitis-like reaction.  The patient was treated with antibiotics, and the condition resolved.  There was no product quality complaint.  It was noted that the physician was concerned about this 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.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a nurse from a physician's office concerning a woman in her 40's who on 14-DEC-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  On 15-DEC-2005 the patient developed a local reaction characterized by a red, swollen arm.  The patient developed a local reaction characterized by a red, swollen arm.  The swelling was 3-4 inches in diameter around the injection site.  Unspecified medical attention was sought and at that the time of the report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site reaction, Injection site warmth, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65-year-old female patient with an allergy to Penicillin, who on 09-SEP-2005 at 09:15 am, was vaccinated subcutaneously with a second dose of pneumococcal 23v polysaccharide vaccine (649694/0386P).  It was noted that at the time of vaccination the patient had weight loss and abdominal pain.  The licensed practical nurse reported that on 09-SEP-2005, the patient developed an injection site reaction which included redness, pain, local heat and swelling and was reported as a cellulitis.  She sought medical attention and the cellulitis was treated with antibiotics.  The patient fully recovered.  There was no product quality complaint reported.  Additional information been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65-year-old female patient with an allergy to Penicillin, who on 09-SEP-2005 at 09:15 am, was vaccinated subcutaneously with a second dose of pneumococcal 23v polysaccharide vaccine (649694/0386P).  It was noted that at the time of vaccination the patient had weight loss and abdominal pain.  The licensed practical nurse reported that on 09-SEP-2005, the patient developed an injection site reaction which included redness, pain, local heat and swelling and was reported as a cellulitis.  She sought medical attention and the cellulitis was treated with antibiotics.  The patient fully recovered.  There was no product quality complaint reported.  Additional information been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 71 year old female with a history of osteoporosis and no allergies, who on 30-NOV-2005 was vaccinated with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine (Lot#651318/1006P).  Concomitant therapy included alendronate sodium (MSD), calcium (unspecified), vitamin D (unspecified), simvastin (MSD), and folic acid.  On 01-DEC-2005 the patient's arm, at the injection site, became red, warm, painful, and swollen.  She also had a fever to 101 degrees F.  The patient called the physician who recommended rest.  It was reported that the patient was improving.  Follow up information has been received from a physician concerning the 71 year old retired white female patient.  It was reported that on 30-NOV-2005 she had a severe local reaction with arm swelling and 100 degree oral temperature, and that she requires 1 and a half days bed rest before recovering on 02-DEC-2005. No product quality complaint was involved.  No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician's assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#650453/0791P).  Subsequently the patient developed a fever, and injection site swelling, pain and redness.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  The reporter expressed a concern about the lot number.  No product quality complaint was involved.  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. In addition, a review of Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Inflammation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information was received from a physician and a registered nurse concerning a 71 year old retired white female with no known allergies, diabetes mellitus non-insulin dependent and a thyroid disorder who on 18-NOV-2005 was vaccinated intramuscularly with a 0.5 ml dose pneumococcal 23v polysaccharide vaccine (lot#651318/1006P).  Concomitant therapy included levothyroxine Na fluoxetine, metformin, trazodone HCL, "dislosenant", gabapentin, atorvastatin calcium (LIPITOR) and "prophylthiuracil".  On 18-NOV-2005 at 11:00 the patient developed a severe local inflammatory reaction with redness, swelling, warmth, and pain at the injection site.  The patient called the physician who recommended rest.  No lab tests were performed.  There was no other treatment.  On 21-NOV-2005 the patient recovered.  No product quality complaint was involved.  No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered technician concerning a pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot651330/1048P;exp: 4/26/07). Subsequently, the pt experienced red, hot sore arm at injection site within 48 hrs post vaccination. Treatment is unk. The registered tech had no other available information and placed a nurse practitioner on the phone. The nurse practitioner stated that she is not comfortable using this lot 1048P until a lot check is performed. 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. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 68 yr old (also reported as 86 yr old) female with no known allergies with sickle cell disease, asthma and arthritis who on 14Dec05 was vaccinated with pneumococcal 23v polysaccharide vaccine, .5ml. There was no concomitant medication. On 16Dec05 the pt experienced urticaria and rash. Unspecified medical attention was sought. The pt's urticaria and rash persisted. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a medical assistant concerning a 55 yr old male who on an unspecified date was vaccinated IM with pneumococcal 23v polysaccharide vaccine. It was unk if the pt received the vaccination in the leg. On an unspecified date, the pt developed a red, painful, local unspecified date, the pt developed a red, painful, local reaction after receiving pneumococcal 23v polysaccharide vaccine. The pt sought unspecified medical attention. It was reported that as a result of these reactions the office was going to give all future pneumococcal 23v polysaccharide vaccines SC. At the time of this report, the pt had recovered from the events (date unk). Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Back pain, Dyspnoea, Intestinal obstruction, Nausea
Clinical narrative: Information has been received from a physician's office concerning a 46 yr old white male with a sulfonamide allergy, drug hypersensitivity to naproxen (Naprosyn) and doxycycline, gastrooesophageal reflux disease, chronic obstructive pulmonary disease and depression. On 23Oct05, in the AM, the pt was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine. At the time of vaccination, the pt was noted to have abdominal pain, nausea, vomiting and a small bowel obstruction. On 23Oct05, at 1:20PM, the pt experienced shortness of breath and back pain. The pt was given methylprednisolone sodium succinate (Solumedrol) 125mg and hydromorphone hydrochloride (Dilaudid) for back pain. The shortness of breath resolved with disipation of back pain. On 24Oct05 the pt recovered from the events. Additional information is not expected.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician's office concerning a 46 yr old white male with a sulfonamide allergy, drug hypersensitivity to naproxen (Naprosyn) and doxycycline, gastrooesophageal reflux disease, chronic obstructive pulmonary disease and depression. On 23Oct05, in the AM, the pt was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine. At the time of vaccination, the pt was noted to have abdominal pain, nausea, vomiting and a small bowel obstruction. On 23Oct05, at 1:20PM, the pt experienced shortness of breath and back pain. The pt was given methylprednisolone sodium succinate (Solumedrol) 125mg and hydromorphone hydrochloride (Dilaudid) for back pain. The shortness of breath resolved with disipation of back pain. On 24Oct05 the pt recovered from the events. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who is over 65 yrs old who was vaccinated with pneumococcal 23v polysaccharide vaccine IM several years ago. The physician reported that the pt was given two doses of pneumococcal 23v polysaccharide vaccine within a three year time frame. The pt experienced severe illness, fever and malaise. This occurred several years ago. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Pruritus, Rash macular
Clinical narrative: Information has been received from a health professional concerning a female who on 13Dec05 was vaccinated with a 0.5ml IM dose of pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). On 13Dec05 the pt developed a red blotchy rash and there was itching at the injection site. There were no treatments for the condition. The status of the pt was reported as unk. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 51.0
Sex: M
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 a 51 yr old white male with no preexisting allergies, birth defects, or medical conditions reported. On 08Dec05, at 3:10 PM (also reported as 3:20PM), the pt was vaccinated IM in the right arm (also reported as left arm) with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). On 09Dec05, the pt complained of soreness of the right arm, but was not seen by the physician. The pt recovered on 12Dec05. A product quality complaint was not involved. In a follow up it was reported that on 09Dec05 the pt developed a shot area has fever and was red (also reported as shot area red and feverish) and was swollen down past elbow. It was reported that the pt was feeling bad and experienced an arm sore. At the time of this report, the pt had recovered from the events (date unk). No further information is available.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 60 yr old male with no known history or allergies who was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650329/0747P). Subsequently, the pt experienced a large local site reaction. Unspecified medical attention was sought and the client has since recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a medical assistant concerning a patient (age not specified) who on unspecified date was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine.  It was unknown if the patient received the vaccination in the leg.  On an unspecified date, the patient developed a "red, painful, local reaction after receiving pneumococcal 23v polysaccharide vaccine".  The patient sought unspecified medical attention.  It was reported that "as a result of those reactions the office was going to give all future pneumococcal 23v polysaccharide vaccine subcutaneously".  At the time of this report, the patient had recovered from the events (date unknown).  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: Information has been received from a medical assistant concerning a 68 year old white female who on 25-OCT-2005 was vaccinated in the left deltoid with a second dose pneumococcal 23v polysaccharide vaccine, intramuscular (lot#"06072").  In the evening of 25-OCT-2005, the same day as the vaccination, the patient's arm was warm to the touch and red.  The patient was instructed to apply ice and take Ibuprofen (ADVIL).  The on 27-OCT-2005, it became worse and the patient went to the emergency room where she was treated with epinephrine 0.5 cc and methylprednisone (MEDROL DOSEPAK).  On 31-OCT-2005, the patient returned to the office and was recovered.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a health professional concerning a 71 year old female with gastroesophageal reflux disease, an allergic to ciprofloxacin hydrochloride (CIPRO) and pneumococcal 23v polysaccharide vaccine and a history of mastectomy with reconstruction for cancer who on 05-JUL-2005 was vaccinated subcutaneously in the right deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#649694/0386P).  Concomitant therapy included alendronate sodium (FOSAMAX), rabeprazole sodium (ACIPHEX) and "acebutolol".  On 07-JUL-2005 the patient called and complained her right arm was red, hot and swollen between the elbow and shoulder.  She denied shortness of breath or any problems breathing.  She was told to come in for an appointment but she declined.  The patient recovered on an unknown date.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (Lot#650087/0815P).  Subsequently the patient developed a generalized rash.  Subsequently, the patient recovered.  There was no product complaint.  It was noted that the reporter a lot check to be done on 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.  In addition, a review of the Quality Control Quarantines/Rejection System revealed that there was no open Quarantines registered against this lot/fill.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (Lot3650087/0815P).  On 14-OCT-2005 the patient developed severe itching and injection site pain, heat and puffiness.  Unspecified medical attention was sought.  She took aspirin for two days, and used ice packs.  Subsequently, the patient recovered.  No other information was available.  There was no product quality complaint.  The nurse requested a lot check be done on 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.  In addition, a review of the Quality Control Quarantines/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Eye swelling, Rash, Swelling face, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 14-OCT-2005 was vaccinated with at least a second dose of pneumococcal 23v polysaccharide vaccine (Lot#650087/0815P).  After the vaccination with pneumococcal 23v polysaccharide vaccine, on approximately 14-OCT-2005, the patient experienced rash, hives, swelling of lips and swelling of eyes.  She sought medical attention and was treated with Ibuprofen (ADVIL), diphenhydramine (BENADRYL), and Ibuprofen (MOTRIN).  The patient recovered on an unspecified date.  No further information was provided was provided regarding the adverse event.  There was no product quality complaint reported.  It was noted that the reporter requested a lot checked be done on 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.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with an IM dose of pneumococcal 23v polysaccharide vaccine (Lot # 650087/0815P). The RN reported that the patient subsequently experienced injection site soreness, low grade fever and chills. Unspecified medical attention was sought. Subsequently, the patient recovered from the injection site soreness, low grade fever and chills. The reported requested a lot check. 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 of the Center for Biologics and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Injection site pain; injection site erythema; injection site induration Information has been received from a registered nurse (RN) concerning a female who on 14-OCT-2005 was vaccinated with IM with a dose of pneumococcal 23v polysaccharide vaccine (lot #650087/0815P). The RN reported that on 14-OCT-2005 the patient developed injection site pain/throbbing, redness and hardness. Unspecified medical attention was sought. Subsequently the patient recovered from the injection site pain/throbbing, redness and hardness. The reported requested a lot check. 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 of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain
Clinical narrative: Pain, Myalgia Information has been received from a health professional concerning her husband who on 22-DEC-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #651330/1048P). On 22-DEC-2005, the patient developed achy deep muscle soreness. Unspecified medical attention was sought and the patient was treated with acetaminophen (Tylenol) and ice. At the time of the report the patient had not recovered. A product quality complaint was no involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Injection site pain Information has been received from a health professional concerning a female patient who on 22-DEC 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #651330/1048P). On 22-DEC-2005 the patient experienced an achy deep soreness in the injection arm. It was noted that this may have been her second vaccination with pneumococcal 23v polysaccharide vaccine. At the time of this report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia
Clinical narrative: Information has been received from a registered technician concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651330/1048P).  Subsequently the patient experienced red, hot sore arm at injection site within 48 hours post vaccination.  Treatment is unknown.  The registered technician had no other available information and placed a nurse practitioner on the phone.  The nurse practitioner stated that "she is not comfortable using this lot 1048P until a lot check is performed".  The records of testing prior to release of this lot have been checked by Quality Assurance an found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality control Quarantine/Rejection System revealed that there was no open Quarantines registered against this lot/fill.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia
Clinical narrative: Information has been received from a registered technician concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot#651330/1048P).  Subsequently the patient experienced red, hot sore arm at injection site within 48 hours post vaccination.  Treatment is unknown.  The registered technician had no other available information and placed a nurse practitioner stated that "she is not comfortable using this lot 1048P until a lot check is performed".  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.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 15-DEC-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (LOT#651330/1048P).  The reporter mentioned that it may have been the patient's second dose.  On an unspecified date in December 2005, the patient developed joint soreness that felt like bursitis after vaccination.  The patient sought medical attention and was treated with acteminophen (TYLENOL) and ice.  The joint soreness did not improve and the patient was reported as not recovered.  There was no product quality complaint reported.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a 29 year old white female with stomach pain, juvenile diabetes and allergy to erythromycin who on 12-DEC-2005 was vaccinated into right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot#650583/0746P).  On 12-DEC-2005 the patient developed severe pain in the right shoulder, collar bone, into neck and down arm.  The patient was advised treatment with ice and ibuprofen.  It was reported on 15-DEC-2005, that the patient's neck pain resolved.  The pain in right shoulder, collar bone and arm persisted.  No further information is available.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a registered nurse (RN) concerning an approximately 80 year old female with diabetes who in November 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  The RN reported that in November 2005, after vaccination, the patient's arm "swelled up like a softball".  Unspecified medical attention was sought.  Subsequently, the patient's arm swelling fully resolved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site reaction
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who in approximately December 2005 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#649697/1038P).  In approximately December 2005, the patient developed a local injection site reaction which was hot to the touch.  Severe erythema was also noted.  Subsequently, the patient recovered.  The physician indicated he was concerned about this 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.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site reaction, Pain, Swelling
Clinical narrative: Information has been received from a license practical nurse concerning a 50-year-old white adult female with an allergy to codeine who on 21-NOV-2005 at 9:30 am was vaccinated subcutaneous with a 0.5 ml second dose of pneumococcal 23v polysaccharide vaccine (Lot#649694/0386P).  The patient was noted to be suffering from anxiety and depression at the time of vaccination.  On 21-NOV-2005, the patient developed an injection site reaction to include redness, pain, local heat and swelling, noted to be a cellulitis.  The patient was treated with antibiotics and subsequently, fully recovered.  No product quality complaint was involved.  No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia oral, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a medical assistant concerning a female patient who was vaccinated with a pneumococcal 23v polysaccharide vaccine (lot#651859/0877R).  Subsequently, the patient experienced swelling at the site of injection, numbing of the lips, and itching eyes.  No product quality compliant was involved.  No other  information was provided.  The patient recovered.  It was also reported that another patient had a similar reaction.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Information has been received from a nurse via company representative concerning her 64 year old husband who in the middle of December ("2nd or 3rd Friday of December"), on approximately 09-DEC-2005 was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot# not provided).  The night after receiving vaccination, on approximately 10-DEC-2005 the patient experienced chills, feeling of malaise and developed fever.  The patient was given acetaminophen (TYLENOL) to take care of the symptoms.  The patient was reported as recovered.  There was no product quality complaint involved.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician via company representative concerning a elderly female (age not provided) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# not provided).  Subsequently the patient developed reaction (not further specified).  The patient's outcome was not reported.  There was no product quality complaint involved.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Swelling, Tenderness
Clinical narrative: Injection site pain; Injection site reaction; Injection site swelling Information has been received from a health professional concerning a 50 year old white female registered nurse with sarcoidosis who on 04-JAN-2006 at 09:30 was vaccinated SC into the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot #651322/1044P). On 06-JAN-2006 at 08:30 the patient experienced tenderness, soreness, swelling at the injection site and a "ring" around the injection site )1-1 1/2 inches). Unspecified medical attention was sought. The patient was treated with (Keflex) 500 mg 4 times a day for 5 days. Subsequently the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Dyspnea; injection site erythema; injection site swelling; mass Information has been received from a 45 year old female with hypertension and borderline diabetes who in October 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included pioglitazone hydrochloride )Actos) and "antihypertensive medications". The patient had previously been vaccinated with pneumococcal 23v polysaccharide vaccine between 4 and 8 years prior to October 2004. upon vaccination, the patient experienced redness and swelling at the injection site. She also developed a large lump on her arm and shortness of breath less than 24 hours after vaccination. She was seen by her physician and treated with prednisone, diphenhydramine (Benadryl) and ibuprofen. Subsequently the patient recovered from redness and swelling at the injection site, shortness of breath and large lump on arm. No further information is available.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain, Swelling
Clinical narrative: Erythema; Pain in extremity; Skin warm; Edema peripheral Information has been received from a health care professional and a 54 year old female white consumer with hypertension, hyperlipidemia, allergic rhinitis and no allergies who on 17-NOV-2005 at 1)30 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot #650329/0747P). Concomitant therapy included HCTZ/triamterene and simvastatin (MSD). Subsequently on 17-NOV-2005 the patient's right arm was swollen ("size of baseball"), hot, red, and also created a great deal of pain. There were no relevant diagnostic tests or laboratory data. Unspecified medical attention was sought. The patient recovered after several days over 2 days. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site swelling; pyrexia; injection site erythema; injection site pain Information has been received from a physician's assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650453/0791P). Subsequently the patient developed a fever and injection site swelling, pain and redness. Unspecified medical attention was sought. Subsequently the patient recovered. The reporter expressed a concern about the lot number. 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 of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejeciton System revealed that there was no open Quarantine registered against this lot/fill. Additional information has been requested.