chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC, PPV
Symptoms: Medication error, No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose PREVNAR.  The physician stated that there was an error on the part of the office.  Specifically, 70 doses of Pneumovax 23 (MSD) were ordered instead of PREVNAR because both products were next to each other on the order form.  It was reported that 40 doses were administered with the belief that they were PREVNAR.  It was reported that there was no confusion in regards to product packaging.  The physician stated that the problem had been corrected at the office and did not foresee any future problems.  On an unspecified date, the patient was vaccinated with a fourth dose of PREVNAR.  There were no adverse experiences reported.  Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an adult male patient who in 2006 ("recently") was vaccinated IM with a 0.5 mL dose of Pneumovax 23 (possibly Lot# 655501/1035F). Subsequently, (2006) the patient developed an injection site reaction to include local pain, redness, general malaise and fever up to 102 F. At the time of the report, the reporter indicated that the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 58 year old female patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient developed severe redness and swelling in the arm around injection site.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional, physician and a 57 year old female who on 09-NOV-2006 at 4 pm was vaccinated IM, into the right upper arm, with a 0.5 ml first dose of Pneumovax 23 (lot 651437/0899F). Concomitant therapy included WELLBUTRIN and aspirin. On 09-NOV-2006, at approximately 10 p.m., the patient experienced cellulitis like reaction with redness, swelling and warmth at the injection site. The patient reported that "the whole upper part of my arm and underneath got swollen, red and itchy." The patient sought medical attention and was treated with elevation, ice and BENADRYL. There were no laboratory or diagnostic tests. At the time of the report, the patient was recovering. The licensed practical nurse expressed concern that three patients in the same week had these reaction and stated that they were no longer giving Pneumovax 23. She stated that she "will await the results of whatever investigations will be done." 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 government agency and was released by the regulatory agency. No further information is available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 73 year old female who on 09-NOV-2006, at 14:00, was vaccinated IM, into the right upper arm, with a first dose Pneumovax 23 (lot #651437/0899F). Concomitant therapy included NEXIUM, TOPROL XL and BENICAR. On 09-NOV-2006, at 22:00, the patient developed pain in shoulder radiating down to fingers of injection site arm. The patient sought medical attention and was treated with VICODIN. There were no laboratory or diagnostic tests performed. At the time of the report, the patient's pain in shoulder radiating down to fingers of injection site arm persisted. The licensed practical nurse expressed concern that three patients in the same week had these reactions and said that they were no longer giving Pneumovax 23. The nurse said that she will await results of whatever investigation will be done. 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 government and was released by the regulatory agency. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old male with no allergies and no medical history who on 07-NOV-2006 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #655500/1005F).  On 08-NOV-2006 the patient developed a swollen injection site arm that was painful and continual sweating. On 09-NOV-2006 the patient called the office to complain of these events.  He was directed to use cold compresses and take acetaminophen as needed.  No lab studies were performed.  As of 10-NOV-2006 the patient was recovering.  No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacy intern student concerning patient who on 10-NOV-2006 was vaccinated intramuscularly in the deltoid muscle with a 1 inch needle close to the elbow with a dose of Pneumovax 23. That same day the patient experienced a cellulitis-like reaction near the injection site that appeared red and swollen. Unspecified medical attention was sought and the patient was put on an unspecified antibiotic. At the time of report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old female with a sulfonamide allergy and an allergy to REMICADE and no medical history who on 07-NOV-2006 was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23 (lot #655500/1005F) in the right deltoid. Concomitant therapy included Fluvirin (manufacturer Novarits, lot #71926), PAXIL and "sodium chloride injection". On 08-NOV-2006, the patient called the office and reported that the injection site arm was swollen, red and painful. The patient complained of her arm hurting. The patient was directed to use cold compresses and take TYLENOL as needed. No lab studies were performed. On an unspecified date, the symptoms went away and the patient recovered from the events. No product quality complaint was involved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional and a licensed professional nurse concerning a 65 year old female with an allergy to codeine, hypertension and hyperlipidaemia who on 09-OCT-2006 at 1400 was vaccinated subcutaneously in the left upper arm with a first dose of Pneumovax 23 (lot #651330/1048P).  Concomitant therapy included ezetimibe (+) simvastatin (MSD), 10-20 tablet, total daily dose not reported, AVALIDE, SYNTHROID, CELEXA and COUMADIN.  There was no illness at the time of vaccination.  On 11-OCT-2006 at 1000 the patient experienced an injection site reaction with warmth, tenderness, and erythema, and a "cellulitis impression".  Medical attention at the doctor's office was sought.  The patient was treated with KEFLEX and warm compresses.  No lab studies were performed.  The patient did not return for further treatment.  On 13-OCT-2006 the patient recovered.  Follow-up information has been received from a nurse who expressed concern that three patients in the same week had these reactions and said that they were no longer giving Pneumovax 23 vaccinations.  The nurse said that she will await results of whatever investigation will be done.  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 by the regulatory agency.  No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning an adult patient (age and gender unknown) who was "recently" vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23. Subsequently the patient developed injection site redness, swelling, local heat, and "possible cellulitis". The patient sought unspecified medical attention. At the time of this report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) with no relevant medical history who on 06-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (lot 651400/0618F). There was no concomitant medication. On 06-NOV-2006, the patient developed soreness and pain at the injection site 3 hours after receiving the vaccination. The pain may have spread to her back. The patient returned to the clinic, and the injection site arm was described as sore and painful, but not red or hot. The patient received an unspecified injection for the pain on the return visit to the clinic on 06-NOV-2006. The patient recovered the next day on 07-NOV-2006. The reporter requested a lot check be performed on 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 complies with the government agency and was released. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 54 year old female patient (weight 140#, height 65") with allergy to aspirin, penicillin and clopidogrel bisulfate on 06-NOV-2006 at 11:00 am was vaccinated with the initial dose of Pneumovax 23 (lot #651400/0618F), 0.5 ml, IM. Concomitant medication was reported as none. On 06-NOV-2006 (previously reported as 08-NOV-2006 2 days later), the patient called back to report that she experienced painful, red, and hot injection site arm. It was unknown how soon after the vaccination that the reaction started. The nurse reported that the patient had recovered as of 07-NOV-2006 (previously reported as 10-NOV-2006). The nurse requested that a lot check be performed. Additional information has been received from a licensed practical nurse who reported that the patient complained of pain in the left arm, neck and shoulder where the patient had received injection earlier stated severe pain. The nurse reported there was no redness or local swelling, the pulse at the patient's wrist was intact and injection site could not be found. 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 is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on approximately 03-NOV-2006 ("last week") was vaccinated with Pneumovax 23.  Concomitant medication was not reported.  On approximately 03-NOV-2006 ("last week"), patient received the Pneumovax 23 vaccine.  The patient was fine when she left the physician's office but later that evening, the patient had a local reaction at the injection site.  The patient's skin was red, warm, swollen, puffy and itchy.  The area of redness was approximately the size of a baseball in circumference.  Subsequently on an unspecified date, the patient recovered from injection site skin was red, warm, swollen, puffy and itchy. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23.  On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23. On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23. On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm, nausea and diarrhea. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Diarrhoea, Nausea, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23.  On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm, nausea and diarrhea.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23.  On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm.  The patient went to the emergency room for the pain and was released.  The pharmacist stated that the patient is a "hypochondriac" and the nurse did not think her event warranted a visit to the hospital.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an "older" female patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient developed a round band of inflammation below the injection site. The area was warm to the touch. The vaccination was administered at the pharmacy. The pharmacist indicated she had never seen anything like it before. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an "older" female patient who was vaccinated with a dose of Pneumovax 23.  Subsequently the patient developed a round band of inflammation below the injection site.  The area was warm to the touch.  The vaccination was administered at the pharmacy.  The pharmacist indicated she had never seen anything like it before.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, 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.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender not reported) who on approximately 11-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.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 651357/0391F). Subsequently the patient experienced a reaction after receiving Pneumovax 23. At the time of this report, the outcome was unknown. 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 government agency and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23.  Concomitant medication was not reported.  Subsequently, the patient experienced swelling at injection site.  The outcome of the event was not reported.  No further information is available.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from an 84 year old female consumer with high blood pressure and drug reactions/allergies reported as none who on 08-NOV-2006 was vaccinated with Pneumovax 23. Concomitant therapy included unspecified blood pressure medication. On 09-NOV-2006, the patient experienced a "severe reaction" of a low grade fever, a very red arm and swelled arm after being vaccinated with Pneumovax 23. The patient "heard of the batch being bad" and the office was not charging her for the vaccination. The physician treated the patient with acetaminophen and will see the physician for follow-up today. The patient stated that "this was a booster dose of Pneumovax 23". At the time of the report, the patient was feeling better. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with no known allergies who was hospitalized for cardiac reasons with a medical history of pericardial effusion who on 12-NOV-2006 was vaccinated intramuscularly with 0.5 mL dose of Pneumovax 23 (Lot number not specified).  Concomitant therapy included TENORMIN, aspirin, ascorbic acid, glimepride, LOVENOX, iron (unspecified), folic acid, LASIX, SYNTHROID, simvastatin (MSD), ALDACTONE and DIOVAN.  On 12-NOV-2006 the patient developed a swollen arm at the injection site.  The patient was treated with warm compresses.  The patient had not received the Pneumovax 23 vaccine in the past 5 years.  The patient's swollen arm at the injection site did not prolong the patient's hospital stay.  At the time of the report, it was not reported if the patient recovered.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician via a pharmacist concerning an adult patient who in October 2006, was vaccinated with a dose of Pneumovax 23 (lot #651437/0899F).  The pharmacist reported that the vaccination may have been a revaccination.  In October 2006, the patient developed injection site swelling and fever of 102 F.  Unspecified medical attention was sought and the treatment was symptomatic.  Subsequently, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a female patient between the age of 19 and 39 years who between 23-OCT-2006 and 27-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (lot #654981/0674F).  Subsequently, in October 2006, the patient developed swelling and warmth in the vaccinated arm.  Unspecified medical attention was sought and the patient was treated with unspecified antibiotics.  At the time of report, the patient was recovering.  The nurse requested a lot lot check for lot number 0674F.  No product quality complaint was involved.  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.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a female patient between the age of 19 and 39 years who between 23-OCT-2006 and 27-OCT-2006 was vaccinated subcutaneously with a dose of Pneumovax 23 (lot #654981/0674F).  Subsequently, in October 2006, the patient developed swelling and warmth in the vaccinated arm.  Unspecified medical attention was sought and the patient was treated with unspecified antibiotics.  At the time of report, the patient was recovering.  The nurse requested a lot check for lot number 0674F.  No product quality complaint was involved.  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.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning an adult male who "recently" was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (lot 651319/ 1007P).  Subsequently the patient developed injection site pain, redness and swelling. The patient sought medical attention and was treated with ADVIL.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 79 year old female who on 30-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml subcutaneously.  On 31-OCT-2006, the patient experienced redness and raised area the size of silver dollar at the injection site.  The patient sought medical attention.  The outcome of the event was not reported.  Additional information has been received from an other unspecified.  No diagnostic tests were performed.  On an unspecified date, the patient recovered.  No further information is expected.
Age: 41.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Information has been received from a nurse concerning a 41 year old patient (sex not reported) with unspecified pertinent medical history and drug reactions/allergies who on approximately 13-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F, 651374/0485F, or 651321/1036P). Concomitant therapy included influenza virus vaccine (unspecified) given at the same time. On approximately 13-NOV-2006, the patient experienced swelling, redness, rash on the lower arm and pain. The patient sought medical attention. The outcome was not reported. All vaccines from these lot numbers had been discarded. 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. 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 agency and was released by the regulatory agency. Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Influenza like illness, Pain, Rash
Clinical narrative: Information has been received from a nurse concerning a 61 year old patient (sex not reported) who on 06-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) IM in the left deltoid.  Concomitant therapy included influenza virus vaccine (unspecified) given at the same time.  On 06-NOV-2006, the patient experienced chills, achy and felt flu-like for 2 days.  It was also reported that the patient experienced swelling, redness, rash on the lower arm, and pain.  The patient sought medical attention.  On 07-NOV-2006, the patient recovered from the chills, achy, and flu-like feeling.  The outcome of the swelling, redness, rash and pain 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 agency and was released by the regulatory agency.  This is a consolidation of WAES 0611USA04692 and 0701USA00012.  No additional information is available.
Age: 61.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a nurse concerning a 61 year old patient (sex not reported) who on 06-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) IM in the left deltoid.  Concomitant therapy included influenza virus vaccine (unspecified) given at the same time.  On 06-NOV-2006, the patient experienced chills, achy and felt flu-like for 2 days.  It was also reported that the patient experienced swelling, redness, rash on the lower arm, and pain.  The patient sought medical attention.  On 07-NOV-2006, the patient recovered from the chills, achy, and flu-like feeling.  The outcome of the swelling, redness, rash and pain 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 agency and was released by the regulatory agency.  This is a consolidation of WAES 0611USA04692 and 0701USA00012.  No additional information is available.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F). Concomitantly, the patient was vaccinated with influenza virus vaccine (unspecified). On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site. The patient sought unspecified medical attention. At the time of this report, the patient had fully recovered from the events (date unknown). Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning an 87 year old female who in August 2001 was vaccinated with the first dose of Pneumovax 23. On 14-NOV-2006, the patient was vaccinated with the second dose of Pneumovax 23 (Lot# 651399/0486F. On an unspecified date, the patient developed an injection arm erythema which extended to the elbow and also to the axillary and the chest area. The patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. The registered nurse was requesting a lot check for Pneumovax 23 (Lot #651399/0486F). 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.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from an office manager concerning a male patient who during the time period of 11-OCT-2006 through 17-OCT-2006 was vaccinated with Pneumovax 23 (lot #s 651437/0899F, 651404/0352F, 651401/0619F and 651328/1046P), intramuscularly.  Subsequently, "within the last 7 to 10 days" the patient experienced swelling and pain in the injected arm.  The patient had swelling down to his wrist and he was being treated with antibiotics.  The physician requested a lot check.  The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory.  The lot met the requirements of agency and was released.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Information has been received from an office manager concerning a female patient who during the time period of 11-OCT-2006 through 17-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #s 6514370/899F, 651404/0352F, 651404/0619F and 651328/1046P), intramuscularly. Subsequently, "within the past 7 to 10 days" the patient experienced swelling and pain in the injected arm. The patient was treated with an unspecified cream for the pain. The physician requested a lot check. The records of testing prior to release of the lots in question have been rechecked and found to be satisfactory. The lot met the agency requirements and was released. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Initial and follow-up information has been received from a health professional and a consumer who reported that her 12 year old son, whose reported weight was 100 pounds and whose reported height was 67 inches with no drug reactions or allergies and no known illness at the time of vaccination who on 14-NOV-2006, at 2:30 P.M., was vaccinated subcutaneously into the right arm with Pneumovax 23, (Lot # 655588/0883F).  Concomitant medication included influenza virus vaccine (unspecified).  The reporter stated that her son was experiencing a local injection site reaction from Pneumovax 23.  The reaction consisted of quarter-size induration of redness on the arm accompanied by chills and fever.  The patient stated that the pain in his arm was so severe that on a pain scale of 1 to 10, it was 10.  The patient did not seek medical attention.  At the time of the report, the patient had not recovered.  In follow-up it was reported that the patient on 14-NOV-2006 at 5:00 P.M. developed a large, red, warm reaction at the injection site and later had chills.  The patient was treated with MOTRIN and used an ice pack.  The patient's temperature went to 102 degrees at 24 hours.  The patient also vomited.  No swelling of throat, wheezing, shortness of breath (SOB) or hives.  The reaction was up to 6 inches in size and lasted 4-5 days before resolution.  At the time of the patient's office visit the size was about 2 inches.  It was reported that the patient recovered on an unknown date.  Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Initial and follow-up information has been received from a health professional and a consumer who reported that her 12 year old son, whose reported weight was 100 pounds and whose reported height was 67 inches with no drug reactions or allergies and no known illness at the time of vaccination who on 14-NOV-2006, at 2:30 P.M., was vaccinated subcutaneously into the right arm with Pneumovax 23, (Lot # 655588/0883F).  Concomitant medication included influenza virus vaccine (unspecified).  The reporter stated that her son was experiencing a local injection site reaction from Pneumovax 23.  The reaction consisted of quarter-size induration of redness on the arm accompanied by chills and fever.  The patient stated that the pain in his arm was so severe that on a pain scale of 1 to 10, it was 10.  The patient did not seek medical attention.  At the time of the report, the patient had not recovered.  In follow-up it was reported that the patient on 14-NOV-2006 at 5:00 P.M. developed a large, red, warm reaction at the injection site and later had chills.  The patient was treated with MOTRIN and used an ice pack.  The patient's temperature went to 102 degrees at 24 hours.  The patient also vomited.  No swelling of throat, wheezing, shortness of breath (SOB) or hives.  The reaction was up to 6 inches in size and lasted 4-5 days before resolution.  At the time of the patient's office visit the size was about 2 inches.  It was reported that the patient recovered on an unknown date.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered pharmacist concerning a 65 year old female who on 13-NOV-2006 was inadvertently vaccinated in the arm with a second dose of Pneumovax 23. It was noted that it had been only 9 months after the patient had received her first dose of the vaccine. On 15-NOV-2006 the patient experienced a cellulitis-like reaction in her injection site arm. She was treated in the emergency room with an antibiotic and then released. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 70 year old male who on 05-NOV-2006 was vaccinated with Pneumovax 23. Concomitant therapy included NORVASC and LEXAPRO. Subsequently the nurse reported that the patient developed redness, swelling and tenderness from shoulder to elbow. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old female who on 07-NOV-2006 was vaccinated with Pneumovax 23 (lot #651406/0620F), 0.5 ml, SQ. Concomitant therapy included influenza virus vaccine (unspecified) which was given during the same visit but the vaccine was given at a different site. In November 2006, the patient was hospitalized for treatment with IV antibiotics because she developed a cellulitis shortly after her recent Pneumovax 23. The cellulitis was not responsive to oral antibiotics. On 16-NOV-2006, the nurse reported that the patient was discharged from the hospital. The outcome of the event was not reported. Cellulitis was considered to be serious due to hospitalization and other important medical event. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old male who on 07-NOV-2006 was vaccinated with Pneumovax 23, 0.5 ml, SQ.  Concomitant therapy included influenza virus vaccine (unspecified) which was received at the same visit but the vaccine was given at a different site.  It was reported that the patient developed a cellulitis "shortly after" his recent Pneumovax 23 and was treated with oral antibiotics.  The outcome of the cellulitis was not reported.  Cellulitis was considered to be an other important medical event.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from an office manager concerning a 20 year old female who on 09-NOV-2006 was vaccinated with a dose of Pneumovax 23.  On 09-NOV-2006 the patient experienced swollen arm and redness.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician via a center (case #2006023-2357329) concerning a 72 year old female who on 16-NOV-2006 was vaccinated with Pneumovax 23 (lot #651406/0620F), 0.5 ml in the deltoid.  Concomitant medication was not reported.  On 16-NOV-2006, later the same day, the patient developed pain and swelling at injection site, fever of 100.4 and an area of redness was 14 cm in size at the injection site.  The outcome of the events was unknown.  Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old female who in December 1998 was vaccinated with the first dose of Pneumovax 23. On 07-NOV-2006, the patient was vaccinated with the second dose of Pneumovax 23 (Lot# 651399/0486F). On an unspecified date, the patient developed injection arm erythema which extended to the elbow and also to the axillary and the chest area. At the time of this report, the outcome of the event was unknown. The registered nurse was requesting a lot check for Pneumovax 23 (Lot# 651399/0486F). 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 and was released by the regulatory authority. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Malaise
Clinical narrative: Information has been received from a physician concerning a male (age not reported) who on an unspecified date was vaccinated with Pneumovax 23. Concomitant suspect therapy included influenza virus vaccine (unspecified). The physician reported that the patient had received a combination of Pneumovax 23 and influenza virus vaccine (unspecified) and had been "sick for a few days" and "had a pretty good reaction" (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning his partner's patient (age and gender not reported) who on an unspecified date was vaccinated with Pneumovax 23 (unspecified). Subsequently, the patient developed a "reaction" after receiving a combination of Pneumovax 23 and influenza virus vaccine (unspecified). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 50 year old male with no allergies who on 14-NOV-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (655289/0958F).  Concomitant therapy included METAMUCIL, simethicone, albuterol inhaler, ADVAIR, fosinopril sodium, SPIRIVA, NORVASC and ISORBID.  That evening, the patient developed a temperature and when she came in for follow-up she had redness, swelling and warmth from the inner portion of the arm to the elbow.  The patient was treated with KEFLEX.  No diagnostic laboratory studies were performed.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a 50 year old female who on 14-NOV-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot# 655291/0985F). Concomitant therapy included albuterol, "L-Tab", MOTRIN, "Norontin", PREVACID and ROBAXIN. After vaccination on 14-NOV-2006, that evening the patient had a temperature and redness towards outer portion of the arm approximately 3 centimeters in diameter below the injection site. The patient outcome was not reported. The patient sought unspecified medical attention. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female with a penicillin allergy who on 15-NOV-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot# 655289/0958F). Concomitant therapy included Atenolol, clonazepam ("klonazpam"), losartan potassium (manufacturer unknown), LODINE, MEVACOR, PREVACID, "PREVACOL", lactulose and REGLAN. On the evening of 15-NOV-2006 the patient experienced a temperature of 101F degrees and the injection site was warm to the touch. There was no redness. She was seen in the emergency room and sent home. The patient was reported as recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacy student concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of Pneumovax 23.  Subsequently the patient experienced an allergic reaction.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a physician concerning a male (age unknown) who was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot #651356/0089F).  On approximately 13-NOV-2006 ("within the last week") the patient developed redness and a rash from the shoulder to the elbow.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a patient (age and gender unknown) who was vaccinated on an unspecified date with a dose of Pneumovax 23 (655289/0958F).  Subsequently, on an unspecified date, the patient developed injection site redness and swelling and experienced a decreased range of motion of the arm.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  No product quality complaint involved.  A lot check was requested.  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.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on an unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23.  Subsequently, on an unspecified date, the patient complained of injection site reactions.  The patient sought unspecified medical attention.  At the time of this report, the patient was recovering.  No product quality complaint involved.  Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site swelling
Clinical narrative: Information has been received from a license practical nurse concerning a 65 year old patient (gender unknown) who on 10-NOV-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL dose of Pneumovax 23 (Lot # 651406/0620F).  On 11-NOV-2006 the patient developed an injection site reaction of a swollen arm which was very hard to move.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  No product quality complaint was involved.  Follow-up information indicated that no reaction occurred.  Additional information is not expected.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chest X-ray, Local reaction, White blood cell count increased, X-ray limb
Clinical narrative: Information has been received from a registered nurse from the infectious control department concerning a 57 year old male with hypertension and arthritis and a history of a coronary artery bypass, cardiac catheterization, and renal failure that required dialysis caused by a "combination of Toradol and contrast dye, who on 15-NOV-2006, in a physician's office was vaccinated subcutaneously with a dose of Pneumovax 23 (lot #651437/0899F). On 16-NOV-2006 the patient developed a localized reaction and was started on Keflex. On 18-NOV-2006 the patient was hospitalized with cellulitis. The area affected was initially approximately 3 inches in diameter and then the entire upper arm and several inches below the elbow became involved. The patient was treated with vancomycin 15 gm every 12 hours and rifampin 300 mg BID. A chest x-ray and arm x-rays were performed. A white blood cell count was 15, 000. On 20-NOV-2006 he was discharged home and was reported to be recovering. No product quality complaint was involved. The reporter considered that cellulitis was an other important medical event because the patient required antibiotics. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a healthcare worker concerning a female (age unknown) with no allergies who, on an unspecified date, was vaccinated intramuscularly with a 0.5mL dose of Pneumovax 23 (651401/0619F).  Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow.  At the time of this report, the patient recovered.  No product quality complaint involved.  A lot check was requested by the reporter.  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: 87.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a nurse concerning an 87 year old male with no past medical history who was vaccinated with an IM dose of Pneumovax 23 (lot #655289/0958F).  There was no concomitant medication.  On 15-NOV-2006 the patient developed a very red dermatologic area covering most of his arm including forearm.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  The reporting nurse has requested a lot check of this vaccine due to patients having adverse experience.  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.