chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a healthcare worker is a pharmacy buyer and a registered pharmacist concerning a 75 year old female with "other issues on board" (not further specified), who on 28-FEB-2007 presented to the emergency room with cellulitis of the arm. The pateint was subsequently admitted to the hospital for the cellulitis and on the same day was vaccinated in the opposite arm(right arm) with the first dose of Pneumovax 23 (lot # 655668/1004F). On 01-MAR-2007 the patient reported to the emergency department with complaints of sharp pain (7-8/10) at the site of the injection (right upper arm). The patient was treated with acetaminophen (Vicodin) and asprin with relief obtained. The patient was discharged home. No further information is expected. This is one of several reports received from the same source.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a healthcare worker is a pharmacy buyer and a registered pharmacist concerning a 75 year old female with "other issues on board" (not further specified), who on 28-FEB-2007 presented to the emergency room with cellulitis of the arm. The pateint was subsequently admitted to the hospital for the cellulitis and on the same day was vaccinated in the opposite arm(right arm) with the first dose of Pneumovax 23 (lot # 655668/1004F). On 01-MAR-2007 the patient reported to the emergency department with complaints of sharp pain (7-8/10) at the site of the injection (right upper arm). The patient was treated with acetaminophen (Vicodin) and asprin with relief obtained. The patient was discharged home. No further information is expected. This is one of several reports received from the same source.
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 62 year old male with no medical history or drug reactions/allergies who in approximately 2001 (more than 5 years ago) may have been vaccinated with Pneumovax 23. On 14-OCT-2006, the patient was vaccinated with Pneumovax 23 (lot # 651399/0486F) 0.5 ml subcutaneously. Concomitant therapy included influenza virus vaccine (unspecified) also given on 14-OCT-2006. Several hours later on 14-OCT-2006, the patient experienced tenderness, warmth, swelling, and redness at the injection site with soreness of his whole arm with movement. The patient sought medical attention. The patient was treated with TYLENOL and BENADRYL. The events improved. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Swelling
Clinical narrative: Information has been received from a physician concerning a 64 year old female with hypertension and hyperlipidaemia who on 09-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651401/0619F) (0.5 ml), intramuscuarly. Concomitant therapy included LIPITOR and losartan potassium-HCTZ (MSD). Subsequently, "a few hours after teh vaccination," the patient experienced redness and swelling deltoid region of her right arm. The patient was examined by the physician on 11-OCT-2006. The patient was given an injection of ROCEPHIN, and started on an oral course of CEFZIL. The physician stated that the area of cellulitis measured 9 cm x 12 cm and extended to the right breast, oral temperature was 99.2 F. The patient was re-examined on 17-OCT-2006 and had responded well to the therapy. At the time of the report the patient was recovering. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received fro a pharmacist concerning a 24 year old female with an allergy to cephalosporins and no medical history, who on 14-OCT-2006 was vaccinated SC with a 0.5 mL dose of Pneumovax 23 (lot# 651399/0486F) and influenza virus vaccine (unspecified). Concomitant therapy included hormonal contraceptives (unspecified). Several hours later, the patient experienced tenderness, warmth, swelling, and redness at the injection site and soreness of the whole arm with movement. The patient was treated with BENADRYL and TYLENOL. ON 16-OCT-2006 the patient saw a doctor who ordered AUGMENTIN and VICODIN. It was noted that the patient was being referred to an Infectious Disease Specialist. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 29 year old female patient with no allergies or medical history reported who on 14-OCT-2006 at a pharmacy was vaccinated with a 0.5ml SC dose of Pneumovax 23 (lot # 651399/0486F). Secondary concomitant vaccination on 14-OCt-2006 included influenza virus vaccine (unspecified) (manufacturer unknown). Several hours later, on 14-OCT-2006 the patient experienced tenderness, warmth, swelling and redness at injection site and soreness of whole arm with movement. The patient was treated with TYLENOL and BENADRYL. She saw the doctor on 15-OCT-2006 when she also had a fever (103 degrees Fahrenheit) and chills. The doctor ordered prednisone and SEPTRA DS. The patient was referred to an infectious disease specialist. As of 17-OCT-2006 the patient had not yet recovered. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 29 year old female patient with no allergies or medical history reported who on 14-OCT-2006 at a pharmacy was vaccinated with a 0.5ml SC dose of Pneumovax 23 (lot # 651399/0486F). Secondary concomitant vaccination on 14-OCt-2006 included influenza virus vaccine (unspecified) (manufacturer unknown). Several hours later, on 14-OCT-2006 the patient experienced tenderness, warmth, swelling and redness at injection site and soreness of whole arm with movement. The patient was treated with TYLENOL and BENADRYL. She saw the doctor on 15-OCT-2006 when she also had a fever (103 degrees Fahrenheit) and chills. The doctor ordered prednisone and SEPTRA DS. The patient was referred to an infectious disease specialist. As of 17-OCT-2006 the patient had not yet recovered. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Dizziness, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 45 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 vaccine was administered that ranged from redness to blotchiness to pain; and visited the hospital for flu like symptoms (diarrhea and dizziness), but was not admitted. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. The reporter indicated there were 4 other patients who developed similar reactions after receiving Pneumovax 23 vaccine (lot #651319/1007P). Follow up information has been received from the Certified Medical Assistant concerning the black patient with hypertension, high cholesterol, asthma, and an allergy to codeine who at 4:15 p.m. on 12-OCT-2006 was vaccinated IM in left deltoid with a dose of Pneumovax 23 vaccine (lot #651319/1007P). At 4:17 p.m. she was vaccinated in the right deltoid with a dose of Fluvirin. At 7:00 p.m. the patient went to the ER approximately 3 hours after the injection. She was dizzy, sick, reaction in arm, flu-like symptoms, did not feel well. She recovered from the above symptoms on 16-OCT-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Rash macular
Clinical narrative: Information has been received from a medical assistant concerning a 45 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 vaccine was administered that ranged from redness to blotchiness to pain; and visited the hospital for flu like symptoms (diarrhea and dizziness), but was not admitted. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. The reporter indicated there were 4 other patients who developed similar reactions after receiving Pneumovax 23 vaccine (lot #651319/1007P). Follow up information has been received from the Certified Medical Assistant concerning the black patient with hypertension, high cholesterol, asthma, and an allergy to codeine who at 4:15 p.m. on 12-OCT-2006 was vaccinated IM in left deltoid with a dose of Pneumovax 23 vaccine (lot #651319/1007P). At 4:17 p.m. she was vaccinated in the right deltoid with a dose of Fluvirin. At 7:00 p.m. the patient went to the ER approximately 3 hours after the injection. She was dizzy, sick, reaction in arm, flu-like symptoms, did not feel well. She recovered from the above symptoms on 16-OCT-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Haematoma
Clinical narrative: Information has been received from a physician's office manager concerning a female patient who on an unspecified date was vaccinated SQ with a dose of Pneumovax 23 vaccine. Subsequently, the patient developed a large hematoma. Medical attention was sought. She was treated with topical cortisone. Her outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from an office staff member concerning an adult male who on 10-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651400/0618F). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced edema, redness and warmth at the injection site. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) who on 16-OCT-2006 was vaccinated in the upper arm with a 0.5 mL dose of Pneumovax 23 (lot 651374/0485F). Subsequently, the patient developed localized swelling, redness and tenderness. The patient sought medical attention and was told to take an antihistamine and apply warm compresses to the affected area. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a male in his 40's who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 651572/0741R). Subsequently the patient developed redness at the injection site. Also, the patient's whole arm turned red. The physician gave the patient antibiotics to help with the redness. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a female patient in her 40's who on an unspecified date was vaccinated with a 0.5 ml dose of Pneumovax 23 vaccine (lot 651272/0741R). Subsequently, the patient's arm turned red at the injection site. The physician gave the patient antibiotics to help with the redness. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot #651373/0320F). Subsequently the patient experienced a local reaction including redness, soreness and swelling. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient experienced pain at the injection site. Unspecified medical attention was sought. The patient was put on VICODIN because the pain was so severe. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot # 651572/0741R). Subsequently the patient experienced redness, swelling and tenderness at the injection site. The patient was given an unknown cream for treatment. Unspecified medical attention was sought. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Hyperhidrosis, Pain in extremity, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 43 year old male (weight 172, height 71") with a history of exercise induced asthma who on 16-OCT-2006 was vaccinated with the first dose of Pneumovax 23 (lot #651404/0325F), 0.5 ml, IM. Concomitant therapy included FLOMAX and finasteride (MSD). On 17-OCT-2006, the patient experienced soreness in arm, red quarter sized spots on arm, chills and sweats. The patient sought unspecified medical attention but did not come in to the physicians office. The physician reported that the patient did not have a fever, no shortness of breath and did not experience wheezing. On 20-OCT-2006, the patient recovered from the soreness in arm, red quarter sized spots on arm, chills and sweats. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female with no medical history and no drug allergies who on 17-OCT-2006 at 2:00 PM was vaccinated with second dose of Pneumovax 23 (lot # 651400/0618F) (0.5 ml), intramuscularly in the right deltoid. Concomitant therapy included multi-vitamin supplements, low dose aspirin, alendronate sodium, folic acid, glucosamine and quinine. It was noted that the patient was "healthy at the time of vaccination." On 18-OCT-2006 "within 24 hours" the patient experienced redness, swelling and tenderness at the injection site. It was also reported that on 18-OCT-2006 the patient had chills, tenderness right biceps at injection site with left axillary and left anterior cervical adenopathy. It was also reported on 18-OCT-2006 that the patient had "increased arm swelling, red, tender around entire upper arm also axillary tenderness on same side." On 19-OCT-2006 the patient was examined in the office with redness, swelling and tenderness at the injection site involving the whole upper arm. The tenderness extended to the triceps and biceps of the injection area. Lymph node swelling in the neck and axilla area of the injection site was noted on 19-OCT-2006. The patient was given KEFLEX an antibiotic to prevent infection. It was also reported that the patient was treated with cephalosporin for possible cellulitis. The patient had received an earlier vaccination in October 1999 without any problems. The patient recovered on approximately 21-OCT-2006. It was noted that the patient did not have any adverse events following previous vaccinations. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female with no medical history and no drug allergies who on 17-OCT-2006 at 2:00 PM was vaccinated with second dose of Pneumovax 23 (lot # 651400/0618F) (0.5 ml), intramuscularly in the right deltoid. Concomitant therapy included multi-vitamin supplements, low dose aspirin, alendronate sodium, folic acid, glucosamine and quinine. It was noted that the patient was "healthy at the time of vaccination." On 18-OCT-2006 "within 24 hours" the patient experienced redness, swelling and tenderness at the injection site. It was also reported that on 18-OCT-2006 the patient had chills, tenderness right biceps at injection site with left axillary and left anterior cervical adenopathy. It was also reported on 18-OCT-2006 that the patient had "increased arm swelling, red, tender around entire upper arm also axillary tenderness on same side." On 19-OCT-2006 the patient was examined in the office with redness, swelling and tenderness at the injection site involving the whole upper arm. The tenderness extended to the triceps and biceps of the injection area. Lymph node swelling in the neck and axilla area of the injection site was noted on 19-OCT-2006. The patient was given KEFLEX an antibiotic to prevent infection. It was also reported that the patient was treated with cephalosporin for possible cellulitis. The patient had received an earlier vaccination in October 1999 without any problems. The patient recovered on approximately 21-OCT-2006. It was noted that the patient did not have any adverse events following previous vaccinations. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Rash macular
Clinical narrative: Information has been received from a medical assistant concerning a 84 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 was administered, that ranged from redness to blotchiness to pain. Medical attention was sought. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. There were 4 other patients who experienced similar reactions after vaccination with Pneumovax 23. Follow up information has been received from the Certified Medical Assistant concerning the patient with hypertension and high cholesterol who on 11-OCT-2006 was vaccinated IM in left deltoid with a dose of Pneumovax 23 (lot #651319/1007P). On the same day she received Fluvirin in the right deltoid. The same day, she complained of "splotchy left arm and redness from shoulder to elbow. It was sore per patient for 3-4 days after the shot was administered." The patient was reported as recovered on 14-OCT-2006. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site discolouration, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Information has been received from a medical assistant concerning a 54 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 was administered, that ranged from redness to blothiness to pain. Medical attention was sought. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. Follow up information has been received from the Certified Medical Assistant concerning the patient with hypertension, type II diabetes mellitus, "cholesterol", and allergies to KEFLEX, BIAXIN, and amoxicillin who on 8:15 a.m. on 11-OCT-2006 was vaccinated IM in right deltoid with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Flurivin, administered in the left deltoid at 8:10 a.m. the same day. It was reported that on the same day the patient's right arm got swollen and red with pain. She also stated that she wasn't feeling that well for several days after the vaccination. Her outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity, Rash macular
Clinical narrative: Information has been received from a medical assistant concerning a 54 year old female patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Fluvirin (unspecified), administered at the same visit in separate arms (separate sites). On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 was administered, that ranged from redness to blothiness to pain. Medical attention was sought. Subsequently, the patient was feeling better. The medical assistant requested a lot check. No product quality complaint was involved. Follow up information has been received from the Certified Medical Assistant concerning the patient with hypertension, type II diabetes mellitus, "cholesterol", and allergies to KEFLEX, BIAXIN, and amoxicillin who on 8:15 a.m. on 11-OCT-2006 was vaccinated IM in right deltoid with a dose of Pneumovax 23 (lot #651319/1007P). Concomitant therapy included Flurivin, administered in the left deltoid at 8:10 a.m. the same day. It was reported that on the same day the patient's right arm got swollen and red with pain. She also stated that she wasn't feeling that well for several days after the vaccination. Her outcome was not reported. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 82 year old male patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P).  Concomitant therapy included influenza virus vaccine (unspecified), administered at the same visit in separate arms (separate sites).  On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 vaccine was administered, that ranged from redness to blotchiness to pain.  Medical attention was sought.  Subsequently, the patient was feeling better.  The medical assistant requested a lot check.  No product quality complaint was involved.  The reporter indicated there were other patients who developed similar reactions after Pneumovax 23 vaccine was administered.  Follow up information has been received from the Certified Medical Assistant concerning the retired patient with an allergy to an unspecified "numbing medication" who on the morning of 11-OCT-2006 was vaccinated IM in right deltoid with a dose of Pneumovax 23 (lot #651319/1007P).  He received a dose of FLUVIRIN on the same morning in the left deltoid.  On the same day, the patient developed pain and redness in the right arm for several days.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 82.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash macular
Clinical narrative: Information has been received from a medical assistant concerning a 82 year old male patient who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651319/1007P).  Concomitant therapy included influenza virus vaccine (unspecified), administered at the same visit in separate arms (separate sites).  On approximately 11-OCT-2006 the patient developed a reaction in arm where the Pneumovax 23 vaccine was administered, that ranged from redness to blotchiness to pain.  Medical attention was sought.  Subsequently, the patient was feeling better.  The medical assistant requested a lot check.  No product quality complaint was involved.  The reporter indicated there were other patients who developed similar reactions after Pneumovax 23 vaccine was administered.  Follow up information has been received from the Certified Medical Assistant concerning the retired patient with an allergy to an unspecified "numbing medication" who on the morning of 11-OCT-2006 was vaccinated IM in right deltoid with a dose of Pneumovax 23 (lot #651319/1007P).  He received a dose of FLUVIRIN on the same morning in the left deltoid.  On the same day, the patient developed pain and redness in the right arm for several days.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female with steroid and codeine allergy who on 16-OCT-2006 was vaccinated with Pneumovax 23 vaccine (lot #651401/0619F), 0.5 ml, IM in the left deltoid.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently on 17-OCT-2006, the patient experienced warmth, swelling, pain at injection and induration at injection (arm).  On an unspecified date, the patient experienced swelling that extended from the injection site to under the patient's arm pit.  On an unspecified date, the patient sought unspecified medical attention.  Subsequently on 19-OCT-2006, the patient recovered from warmth, swelling, pain, induration at injection (arm) and arm swelling.  Follow-up information has been received.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 45 year old female with asthma, rhinitis allergic, sulfonamide allergy, penicillin allergy and drug hypersensitivity to CEFZIL and aspirin, and a history of pneumonia 2 years ago who on 11-AUG-2006 was vaccinated with Pneumovax 23 (lot number 651328/1046P) in the left arm.  Concomitant therapy included CLARITIN and FLONASE.  Between 11-AUG-2006 and 13-AUG-2006, the patient experienced cellulitis at injection site, with erythema and pain that extended to the entire upper arm.  The patient was treated with oral CIPRO and subsequently, the patient improved rapidly (also reported as recovered) from cellulitis at injection site, with erythema and pain that extended to the entire upper arm.  Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus, Rash generalised
Clinical narrative: Information has been received from a health professional concerning an 86 year old female with diabetes mellitus, hypertension and hyperlipidemia who on 19-OCT-2006 at "12 noon" was vaccinated with a dose of Pneumovax 23 (lot # 651357/0391F also reported as 651400/0618F), intramuscularly in the right deltoid.  Concomitant therapy that day at 10:35 AM included FLUZONE (lot # U2202AA), intramuscularly in the left deltoid.  On 19-OCT-2006, "during night" the patient experienced rash all over her body, arm was red and arm was itching.  The patient's daughter called in AM of 20-OCT-2006 and asked if she could give her BENADRYL because arm was red/itching.  The doctor "OK'd" BENADRYL.  The patient recovered.  There were no relevant diagnostic tests or laboratory tests.  The reporter stated physician requested a lot check for lot# 651400/0618F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin irritation
Clinical narrative: Information has been received from a health care worker concerning a 66 year old female with allergy to sulfa and DARVON who on 12-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651357/0391F), intramuscularly.  Concomitant therapy included ZANTAC, ALLEGRA and TIAZAC.  The patient developed redness of the arm in which she was vaccinated.  She also developed swelling and irritation in the area almost to her elbow.  The patient was last vaccinated with Pneumovax 23 in 2001.  The patient was reportedly "almost recovered."  The reporter stated that the physician would like a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a 66 year old female with allergy to sulfa and DARVON who on 12-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651357/0391F), intramuscularly.  Concomitant therapy included ZANTAC, ALLEGRA and TIAZAC.  The patient developed redness of the arm in which she was vaccinated.  She also developed swelling and irritation in the area almost to her elbow.  The patient was last vaccinated with Pneumovax 23 in 2001.  The patient was reportedly "almost recovered."  The reporter stated that the physician would like a lot check.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin irritation
Clinical narrative: Information has been received from a health professional concerning a 66 year old female with drug hypersensitivity to DARVON and DEMEROL and a history of edema after vaccination with DECAVAC who on 12-OCT-2006, at 2:45 p.m., was vaccinated IM, into the right deltoid, with a dose of Pneumovax 23 (lot #651357/0391F).  Concomitant therapy included FLUZONE in the left deltoid.  On 14-OCT-2006 the patient's right arm became red and swollen down to the elbow.  The patient was seen in the clinic on 16-OCT-2006.  Subsequently, the patient recovered.  Additional information is not available.
Age: 66.0
Sex: F
Vaccine: PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 66 year old female with drug hypersensitivity to DARVON and DEMEROL and a history of edema after vaccination with DECAVAC who on 12-OCT-2006, at 2:45 p.m., was vaccinated IM, into the right deltoid, with a dose of Pneumovax 23 (lot #651357/0391F).  Concomitant therapy included FLUZONE in the left deltoid.  On 14-OCT-2006 the patient's right arm became red and swollen down to the elbow.  The patient was seen in the clinic on 16-OCT-2006.  Subsequently, the patient recovered.  Additional information is not available.
Sex: U
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a manager of a pharmaceutical wholesaler from a sales representative concerning a patient who was "recently" vaccinated with a dose of Pneumovax 23 (lot # 651319/1007P).  Subsequently the patient experienced "swelling that turned purple" and was also itchy, at the injection site.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure, Erythema, Hypotension, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a health care worker concerning a 72 year old female patient with diabetes and hyperlipidemia and no drug reactions or allergies who on 16-OCT-2006 at 14:05 was vaccinated intramuscularly in the right deltoid with a dose of Pneumovax 23 (lot #651357/0391F).  The patient was also vaccinated intramuscularly with a dose of Fluzone (Lot # U2202AA) in the left deltoid on 16-OCT-2006.  Concomitant therapy included simvastatin (MSD), lisinopril (manufacturer unknown), verapamil and hydrochlorothiazide (manufacturer unknown).  On 17-OCT-2006 in the morning, the patient's proximal basilic vein area on her right arm became sore and very swollen and she developed redness in the vaccinated arm and irritation almost down to the elbow.  Unspecified medical attention was sought on 19-OCT-2006.  On 19-OCT-2006 the patient's blood pressure was 94/59 RUE (sitting).  It was noted that the right arm was mildly, minimally erythematous and did not hurt.  At the time of report the patient recovered but the outcome of the low blood pressure was unknown.  It was noted that the patient was last vaccinated with a dose of Pneumovax 23 in 1998.  No product quality complaint was noted.  The physician requested a lot check for lot number 0391F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin irritation, Vein disorder
Clinical narrative: Information has been received from a health care worker concerning a 72 year old female patient with diabetes and hyperlipidemia and no drug reactions or allergies who on 16-OCT-2006 at 14:05 was vaccinated intramuscularly in the right deltoid with a dose of Pneumovax 23 (lot #651357/0391F).  The patient was also vaccinated intramuscularly with a dose of Fluzone (Lot # U2202AA) in the left deltoid on 16-OCT-2006.  Concomitant therapy included simvastatin (MSD), lisinopril (manufacturer unknown), verapamil and hydrochlorothiazide (manufacturer unknown).  On 17-OCT-2006 in the morning, the patient's proximal basilic vein area on her right arm became sore and very swollen and she developed redness in the vaccinated arm and irritation almost down to the elbow.  Unspecified medical attention was sought on 19-OCT-2006.  On 19-OCT-2006 the patient's blood pressure was 94/59 RUE (sitting).  It was noted that the right arm was mildly, minimally erythematous and did not hurt.  At the time of report the patient recovered but the outcome of the low blood pressure was unknown.  It was noted that the patient was last vaccinated with a dose of Pneumovax 23 in 1998.  No product quality complaint was noted.  The physician requested a lot check for lot number 0391F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacy technician concerning a female patient, "in her mid-50's", who was vaccinated at a pharmacy, with a dose of Pneumovax 23 (lot #651322/1044P).  Three days later she returned to the pharmacy with a swollen and red injection site reaction.  The area below the injection site was red and "lifted" but not sore.  Unspecified medical attention was sought.  It was unknown if this was a revaccination.  At the time of report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Injection site reaction, Local reaction, Urticaria
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot # 654982/0675F).  Subsequently the patient experienced severe localized reactions which included welts and a rash on the extremity that was vaccinated, but not necessarily at the injection site.  The reaction was reported "from the shoulder to the elbow."  The patient sought unspecified medical attention.  It was reported that the lot # would not be used and there was concern expressed regarding the lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
Age: 63.0
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 a female patient with a history of pneumonia who on 11-AUG-2006 was vaccinated with a dose of Pneumovax 23 (lot # 650644/0004F).  Concomitant suspect therapy included lisinopril (manufacturer unknown) and simvastatin (MSD).  Concomitant therapy included SYNTHROID.  Subsequently, on an unspecified date, the patient developed redness, swelling and pain at the injection site.  The patient recovered from redness, swelling and pain at the injection site.  Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician concerning an 89 year old female with drug allergies to "non-steroidal anti-inflammatory drugs, STADOL, and DURAGESIC patch and a history of arthritis and strial fibrillation who on 19-OCT-2006 was vaccinated into th right arm with a dose of Pneumovax 23.  Concomitant therapy included digoxin, BUMEX, K-DUR and TYLENOL WITH CODEINE.  On 19-OCT-2006 the patient experienced redness, swelling and soreness to her right arm after an immunization with Pneumovax 23 in that arm.  The area involved "is hot" to the touch and extends down to the mid-forearm.  The patient sought unspecified medical attention.  As of 20-OCT-2006 the patient had not yet recovered.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a female who on 29-SEP-2006 was vaccinated with a dose of Pneumovax 23 (lot# 650644/0004F).  Concomitant therapy included ARIMIDEX, FLONASE, LORTAB, MS CONTIN, SYNTHROID and trazodone HCl.  On approximately 30-SEP-2006, the patient developed redness, swelling and pain at the injection site vaccination.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female (age not reported) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient "contracted a reaction in her arm".  She was administered the vaccine by a nurse.  The patient "complained of her arm being red and swollen."  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist who reported that a female patient had an allergic reaction from Pneumovax 23 vaccine as a child or young adult. The reporter did not know how much. No further information was provided. No further information is available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager of a physician's office concerning a 68 year old male with no relevant medical history reported who on 18-AUG-2006 was vaccinated with a dose of Pneumovax 23 (lot 650644/0004P). Concomitant therapy included vitamins (unspecified). Within 24 hours of vaccination, the patient developed redness, swelling, and pain at injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Local reaction, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning one "geriatric female" with "cardiac condition" who on 10-OCT-2006 (also reported as 11-OCT-2006) was vaccinated with Pneumovax 23 (lot number 650541/1004F). On 11-OCT-2006 the patient experienced local adverse reactions, including pain, redness, "fever" in the arm, tenderness and swelling near the injection site. The patient sought unspecified medical attention. The patient's local adverse reaction, pain, redness, "fever" in the arm, tenderness and swelling near the injection site persisted. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a registered nurse concerning one "geriatric female" with "cardiac condition" who on 10-OCT-2006 (also reported as 11-OCT-2006) was vaccinated with Pneumovax 23 (lot number 650541/1004F). On 11-OCT-2006 the patient experienced local adverse reactions, including pain, redness, "fever" in the arm, tenderness and swelling near the injection site. The patient sought unspecified medical attention. The patient's local adverse reaction, pain, redness, "fever" in the arm, tenderness and swelling near the injection site persisted. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Malaise, Stomach discomfort
Clinical narrative: Information has been received from a 65 year old male consumer with asthma who on 20-OCT-2006 was vaccinated with Pneumovax 23 and influenza virus vaccine (unspecified). Concomitant therapy included SINGULAIR.  On 20-OCT-2006 the patient experienced "arm got red and swollen" at injection site, and also had an upset stomach, diarrhea and just "wasn't feeling good".  The patient sought unspecified medical attention.  Subsequently, the patient is recovering from "arm got red and swollen" at injection site, upset stomach, diarrhea and just "wasn't feeling good".  No further information is available.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 60 year old female who on 21-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 Lot # 651399/0486F).  Concomitant therapy included influenza virus vaccine (unspecified).  On 21-OCT-2006, post vaccination, the patient experienced nausea, chills, shivering, weakness and developed soreness, swelling and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient's nausea, chills, shivering, weakness and soreness, swelling and redness at the injection site persisted.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea
Clinical narrative: Information has been received from a nurse concerning a 60 year old female who on 21-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 Lot # 651399/0486F).  Concomitant therapy included influenza virus vaccine (unspecified).  On 21-OCT-2006, post vaccination, the patient experienced nausea, chills, shivering, weakness and developed soreness, swelling and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient's nausea, chills, shivering, weakness and soreness, swelling and redness at the injection site persisted.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 69 year old female with a penicillin, codeine and DARVOCET allergy who on 21-OCT-2006 was vaccinated with one dose of Pneumovax 23 (Lot # 651401/0619F).  Concomitant therapy included MAXZIDE.  "Within 24 hours  of vaccination", the patient experienced swelling of the arm which was vaccinated.  The patient sought unspecified medical attention.  The patient was treated with ATARAX.  At the time of this report, the patient was recovering.  The physician requested a lot check of Pneumovax 23 (Lot # 651401/0619F).  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 70 year old female who on 21-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot # 651404/0352F).  On 21-OCT-2006, a few hours later, the patient developed redness, swelling and soreness at injection site of right arm.  The patient sought medical attention.  The physician recommended ice compresses and BENADRYL.  The patient was re-examined on 23-OCT-2006 which revealed redness and swelling resolved but continuing mild soreness.  The physician added that the patient has had Pneumovax 23 "multiple times" in the past without difficulty.  Additional information has been requested.