chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 6 month old male (previously reported as 12 month old female) who on 21-AUG-2006 was inadvertently vaccinated with a dose of Prevnar. At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on an company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Prevnar. No product quality complaint was involved. Follow up information from the medical assistant indicated that, on unspecified dates, the patient was also concomitantly administered a third dose of hepatitis B vaccine, recomb (MSD) (lot# 651736/0672R), IM in the right thigh, a third dose of Tripedia, IM in the right thigh and a third dose of ACTHIB, IM in the left thigh. The medical assistant reported that there was no illness at the time of vaccination and no adverse event reported. No further information is expected.
Age: 1.3
Sex: M
Vaccine: PNC, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 15 month old male with no relevant medical history reported or illness at the time of vaccination who on 22-AUG-2006 was inadvertently vaccine (lot #650456/0974P), instead of a dose of Prevnar. The patient was vaccinated on unspecified dates with a fourth dose of DTaP (lot C2630AA) intramuscularly in the right thigh, a fourth dose of Hib conj vaccine (unspecified carrier) (lot UE876AC) intramuscularly in the right thigh, and a third dose of poliovirus vaccine inactivated (unspecified) (lot Y1067) intramuscularly in the left thigh. At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on a company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Pneumovax 23 (lot #650456/0974P), instead of a dose of Prevnar. No product quality complaint was involved. No additional information is expected.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, PPV
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 16 weeks old male who on 28-AUG-2006 was inadvertently vaccinated with a dose of Pneumovax 23 (lot #650456/0974P), instead of a dose of Prevnar. At the time of report, no symptoms had been reported. The medical assistant also reported that the Risk Management Department of her organization, which includes 30 clinics, was working on a company-wide program to develop a standardized protocol for vaccine administration. Some of the issues it was addressing included identifying the correct patient and rechecking the vaccine with another person. She noted that it was to protect both the patient and the health care professional who was administering the vaccine. Her office also sent a letter to the parents of the children who had received the Pneumovax 23 (lot #650456/0974P), instead of a dose of Prevnar. No product quality complaint was involved. Follow-up information was reported by an other reporter at the doctor's office which indicated that on 28-AUG-2006, the patient was concomitantly administered a first dose of Tripedia, IM in the right thigh, a first dose of ACTHIB, IM in the left thigh and a first dose of IPOL, IM in the right thigh. There was no illness at the time of vaccination. No adverse events were reported. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with Pneumovax 23. Subsequently the patient experienced dramatic local reaction. The patient was seen in the office. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with Pneumovax 23. Subsequently the patient experienced dramatic local reaction. The patient was not seen in the office. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Limb discomfort, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old female who, on 29-AUG2006, was vaccinated with a second dose of Pneumovax 23 (Lot# not reported). On 30-AUG-2006, the patient returned to the office with a large left upper arm swelling, redness, inflammation and discomfort. It was noted that she had no problems with her first dose of Pneumovax 23 (date unknown, it was given at a clinic). The nurse also reported that the patient recovered (date not reported). Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Inappropriate schedule of drug administration, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient with allergies to Penicillin ("ACETOPHIN"), and ("QUINOLONE") and on unspecified therapy for brain cancer, who was vaccinated with a dose of Pneumovax 23. Concomitant therapy included alendronate sodium, cough, cold, and flu therapies (unspecified), and antimicrobial (unspecified). The patient received two doses of the vaccine within 3 months time. Subsequently, the patient experienced flu-like symptoms of headache, chills, and fever. Unspecified medical attention was sought. No diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female with hypothyroidism, sulfa drug allergy and environmental allergies, who "two years ago" was vaccinated with a dose of Pneumovax 23. Concomitant therapy included an unspecified hormone replacement, unspecified thyroid medication, unspecified medication for environmental allergies. It was reported that "now" the patient "has titers for 4 of the covered pneumococcal strains that are below a protective level." The patient has not suffered any illness related to this event. Unspecified medical attention was sought. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated with a dose of Pneumovax 23 (lot # 654593/0358F). Subsequently, the patient developed redness and swelling at the injection site. Medical attention was sought. The patient's outcome was unknown. A review of the Laboratory Information Management System data revealed that the lot conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from a physician concerning the 54 year old white female teacher with allergies to sulfa and SUPRAX who on 05-SEP-2006 received a dose of Pneumovax 23 (lot # 654593/0358F) in the left arm. The patient presented 2 days later with increased redness, swelling and warmth in the left upper extremity. She was treated with AUGMENTIN 875 mg BID. On 08-SEP-2006 she developed fever and continued with present course of antibiotics. On 12-SEP-2006 her cellulitis was much improved. She continued with 10 days of antibiotics but was reported to be recovered on 12-SEP-2006. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a medical assistant concerning a male patient age 70 years or older who "about two weeks ago"was vaccinated with a dose of Pneumovax 23 (lot # 651319/1007P). Subsequently the patient experienced injection site rash. Unspecified medical attention was sought. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 76 year old female with novocain allergy who on 18-SEP-206 was vaccinated with a dose of Pneumovax 23 (lot # 651374/0485F) (0.5 ml), intramuscularly in the left deltoid. Concomitant therapy included ACTONEL, calcium, multivitamins and ACIPHEX). On 20-SEP-2006 the patient was seen in the office with redness and swelling around the whole injection site with fever. Her left arm was so swollen "as if it were to bust," similar to cellulitis. At the time of the report, the patient was considered to be not recovered. The office requested 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 complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: information has been received from a medical assistant concerning a 69 year old female with no allergies or medical history, who on 06-SEP-2006 was vaccinated IM into the left deltoid with 0.5 ml dose of Pneumovax 23 (lot# 651374/0485F). Concomitant therapy included simvastatin (manufacturer unknown), TOPROL XL TABLETS and lisinopril (manufacturer unknown). On 07-SEP-2006, the patient called the office to report her symptoms which included a sore left arm that was swollen and painful around the whole injection site. The physician's notes mentioned that cellulitis should be considered. The patient was treated with BENADRYL and AUGMENTIN as needed. No diagnostic laboratory studies were performed. At the time of this report, the patient's outcome was unknown. A lot check was requested by the reporter. 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 Standards of the Center for Evaluation and Research and was released. Sore, painful left arm and swollen around the whole injection site were considered to be other important medical events. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a male patient who was vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot # 651374/0485F). Subsequently, the patient experienced a severe reaction after the vaccination. The patient's injection site was "red, hot, and swollen" similar to cellulitis. The patient also experienced a high fever and was "sick." Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. A lot check was requested by the reporter. 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 Standards of the Center for Evaluation and Research and was released. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 83 year old female with allergies to penicillin, codeine, erythromycin, and CELEBREX who on the morning of 18-SEP-2006 was vaccinated IM into the deltoid with a second dose of Pneumovax 23. Later that same day, the patient developed redness, itching, swelling and a sensation of heat in the arm where she received the vaccine. The area of involvement progressed down the arm overnight. On 20-SEP-2006, the patient contacted her physician's office. She was told to treat her symptoms with BENADRYL, ice and an unspecified steroid cream. On 21-SEP-2006, the patient reported that her symptoms improved, but did not completely recover. In 1999, the patient received a first dose of pneumococcal 23 and did have a reaction. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning 4 elderly patients who on 29-AUG-2006 were vaccinated with a doe of Pneumococcal 23v (lot #651321/1036P). On 29-AUG-2006 the patients developed swelling, redness and heat in the injection site arms. The patient are being treated with BENADRYL and TYLENOL. It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experiences to be other important medical events. In follow up information the health professional confirmed that the patient had developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036P). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor had told her that all 4 patients (WAES # 0608USA06977, 0609USA05103, and 0609USA05104) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms after treatment with BENADRYL and TYLENOL. The health professional was aware that a lot check of concern had been initiated and she stated that she had no further information. 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 Office of Biological Research and Review and was released by the regulatory agency. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning 4 elderly patients who on 29-AUG-2006 were vaccinated with a dose of Pneumovax 23 (lot # 651321/1036P). On 29-AUG-2006 the patients developed swelling, redness and heat in their injection site arms. The patients are being treated with BENADRYL and TYLENOL. It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experiences to be other important medical events. In follow up information the health professional confirmed that the patient developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036P). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor told her that all 4 patient's (WAES #'s 0608USA06977, 0609USA05102, and 0609USA05104) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms after treatment with BENADRYL and TYLENOL. The health professional was aware that a lot check of concern had been initiated and she stated that she had no further information. 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 Office of Biologics Research and Review and was released by the regulatory agency. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning 4 elderly patients who on 29-AUG-2006 were vaccinated with a dose of Pneumovax (lot # 651321/1036P). On 29-AUG-2006 the patients developed swelling, redness and heat in their injection site arms. The patients are being treated with BENADRYL and TYLENOL. It was reported that the physician "is very concerned" about the lot number and therefore has requested a lot check. No further information was available. The reporter considered the patient's experiences to be other important medical events. In follow up information the health professional confirmed that the patient had developed swelling, redness and heat in the injection site arm after receiving a dose of Pneumovax 23 (lot # 651321/1036P). She stated that she had no information regarding each patient and stated she was not able to get that information. She said that the doctor had told her that all 4 patients (WAES #'s 0608USA06977, 0609USA05103, and 0609USA05102) had been seen in the office and have since recovered from the swelling, redness and heat in their injection site arms after treatment with BENADRYL and TYLENOL. The health professional was aware that a lot check of concern had been initiated and she stated that she had no further information. 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 Office of Biologics Research and Review and was released by the regulatory agency. Additional information is not expected.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning a 43 year old male with high blood pressure and diabetes and no drug allergies who on 08-SEP-2006 was vaccinated with a dose of Pneumovax 23 (lot # 651321/1036P) (0.5 ml), intramuscularly in the deltoid. Concomitant therapy included COREG, DIOVAN, felodipine, glimepiride and spironolactone. On 10-SEP-2006 the patient experienced pain in the injection arm and joint pain from the deltoid muscle to the rotator cuff that prevented the patient from lifting his arm above his head. There was no initial injection site rash or fever noted. The muscle/joint pain lasted for 2 weeks until the office was contacted. The patient was instructed to take ALEVE two tablets every 12 hours at that point. On 27-SEP-2006 the patient had recovered his full range of motion in the arm and was feeling fine. The nurse stated that the patient's symptoms were not serious. The patient's symptoms "resolved on their own." Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot #654593/0358F). Subsequently, the patient developed redness, swelling, and pain at the injection site. The patient's outcome was unknown. A review of the Laboratory Information Management System data revealed that the lot conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. 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 nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot # 654593/0358F). Subsequently, the patient developed redness, swelling, and pain at the injection site. The patient's outcome was unknown. A review of the Laboratory Information Management System data revealed that the lot conformed to all required testing at the time of product release. The lot complies with the standards of Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot # 654593/0358F). Subsequently, the patient developed redness, swelling, pain, and cellulitis. The patient's outcome was unknown. A review of the Laboratory Information Management System data revealed that the lot conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Lymphoedema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old male, with no illness at the time of vaccination, with no adverse events following prior vaccinations, whose reported weight was 197 pounds with hyperlipidaemia, hypertension, coronary artery disease, seasonal allergy, benign prostatic hypertrophy, glaucoma and myocardial infarction who on 27-SEP-2006 was vaccinated intramuscularly (IM) in the left deltoid with the second dose of Pneumovax 23 (Lot # 654981/0674F). On 27-SEP-2006 the patient developed cellulitis-like reaction at the injection site. The patient was seen in the Emergency Room (ER) and was released. At the time of the report it was unknown if the patient recovered. In follow-up it was reported that the patient's wife mentioned that her husband was in the ER for 6 hours. She would like a lot check performed immediately. She requested a response to her physician and herself as soon as possible. A lot check of concern has been requested. 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 by the regulatory agency. In follow-up it was reported by a license professional nurse that the patient developed cellulitis and lymphedema to the left upper extremity and severe pain after receiving Pneumovax in the left upper extremity about 11:00 or 11:15 a.m. on 27-SEP-2006. The patient was seen in the ER on 27-SEP-2006 at 8:00 p.m. and then at the clinic on 29-SEP-2006 and 02-OCT-2006. The patient was treated with ZYRTEC, ice and elevation and AUGMENTIN, 875 mg # 20. It was reported by the patient's wife on 24-OCT-2006, that the patient had started to recover, but his arm was still affected by the Pneumovax 23 and he still had pain in his arm. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old female patient who on 27-SEP-2006 was vaccinated with a dose of Pneumovax 23 (route not reported; Lot# 654981/0674F). The nurse reported that on 27-SEP-2006, the patient developed a cellulitis-like reaction at the injection site. The patient was seen in the emergency room and released. At the time of the report the outcome of the patient's cellulitis-like reaction at the injection site was not reported. Follow-up information has been received from the consumer. The consumer was concerned and requests that a lot check be performed immediately and response be sent to the physician and consumer. Follow-up information has been received from a licensed practical nurse concerning this female patient (weight 156 #) who was a housewife with a history of hypertension, hyperlipidemia, osteopenia, colonic polyps, chronic obstructive pulmonary disease, peripheral neuropathy, monoclonal gammopathy and hyperglycemia. Concomitant therapy included cyanocobalamin. The nurse reported that the patient had severe pain and was unable to move left arm for 2 days following Pneumovax 23 injection into the left deltoid. The patient had a local reaction with redness and swelling which was treated with ice and elevation. The patient recovered from the events on 29-SEP-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 by the regulatory authority. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Fatigue, Influenza like illness, Oedema peripheral
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 70 year old, white, female patient, occupation, unknown, whose reported weight was 146 pounds with osteoporosis, hypercholesterolaemia and hypertension who on 27-SEP-2006 was vaccinated, intramuscularly into the left deltoid muscle with her first dose of Pneumovax 23 (Lot # 651373/0320F). It was reported, that the patient had flu-like symptoms at the time of vaccination. Concomitant therapy included ACTONEL, LIPITOR and enalapril maleate (manufacturer unknown). It was reported that within 24 hours of vaccination, approximately 27-SEP-2006 the patient developed severe cellulitis. It was reported that the patient had flu-like symptoms and fatigue. The patient's arm was red, huge and hot to the touch. The patient came to the office on 28-SEP-2006 and sought medical treatment. The patient was given a prescription for antibiotics. The physician requested a lot check. At the time of the report, the patient had recovered. A lot check of concern has been requested. 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 by the regulatory agency. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 70 year old, white, female patient, occupation, unknown, whose reported weight was 146 pounds with osteoporosis, hypercholesterolaemia and hypertension who on 27-SEP-2006 was vaccinated, intramuscularly into the left deltoid muscle with her first dose of Pneumovax 23 (Lot # 651373/0320F). It was reported, that the patient had flu-like symptoms at the time of vaccination. Concomitant therapy included ACTONEL, LIPITOR and enalapril maleate (manufacturer unknown). It was reported that within 24 hours of vaccination, approximately 27-SEP-2006 the patient developed severe cellulitis. It was reported that the patient had flu-like symptoms and fatigue. The patient's arm was red, huge and hot to the touch. The patient came to the office on 28-SEP-2006 and sought medical treatment. The patient was given a prescription for antibiotics. The physician requested a lot check. At the time of the report, the patient had recovered. A lot check of concern has been requested. 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 by the regulatory agency. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 49 year old, white, female, occupation unknown, whose reported weight was 177.2 pounds (lbs.) and whose reported height was 62 inches (in.) who on 21-SEP-2006 was vaccinated intramuscularly into the right deltoid muscle with the first dose of Pneumovax 23 (Lot # 651373/0320F). It was reported that the patient had flu-like symptoms at the time of vaccination. There was no concomitant medication. It was reported that "within 24 hours of vaccination" approximately, 21-SEP-2006 the patient developed severe cellulitis in the arm she was vaccinated. The patient went to the Emergency Room (ER) where she was treated with antibiotics and was released. The patient was treated with antibiotics for 10 days. Subsequently on an unknown date, the patient recovered from severe cellulitis in the arm she was vaccinated. The physician requested a lot check. A lot check of concern has been requested. The records 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 by the regulatory agency. Additional information ahs been requested.
Age: 75.0
Sex: F
Vaccine: DT, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a white, retired female whose reported weight was 90.6 Kilograms (kg) and whose reported height was 62 inches (in) who on 25-SEP-2006 was subcutaneously, vaccinated into the right deltoid muscle with a dose of PNEUMOVAX (Lot # 651400/0618F).  At 4:00 P.M. on 25-SEP-2006, the patient was concomitantly, vaccinated, intramuscularly into the left deltoid muscle with the second dose of DT Absorbed (Lot # U1847BA) (manufacturer Aventis Pasteur).  The patient experienced pain in the arm she received the PNEUMOVAX, and "a welt" at the injection site.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  In follow-up it was reported that the pharmacist requested a lot check for the PNEUMOVAX vaccine, (Lot # 651400/0618F).  The pharmacist wanted to know if there have been other adverse event reports with this vaccine.  The pharmacist will await the results of the lot check before vaccinating any more clients with the PNEUMOVAX vaccine that was left over from this lot.  A lot check of concern has been requested.  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 agency.  In follow-up it was reported from physician office notes the following:  The patient was vaccinated on 25-SEP-2006 subcutaneously into the right deltoid muscle with a dose of PNEUMOVAX (lot # 651400/0618F).  The patient presented to the physician's office on 26-SEP-2006, with a 10 centimeter (cm) reddened, raised area on her right upper arm, below where the injection site was.  She stated that it was very tender and felt tight inside.  The physician looked at the area and wanted her to try diphenhydramine hydrochloride (BENADRYL) and apply a cold pack to the affected site several times a day.  The patient verbalized that she understood the plan of care.  It was reported that on 02-OCT-2006, the patient recovered.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: DT, PPV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a white, retired female whose reported weight was 90.6 Kilograms (kg) and whose reported height was 62 inches (in) who on 25-SEP-2006 was subcutaneously, vaccinated into the right deltoid muscle with a dose of PNEUMOVAX (Lot # 651400/0618F).  At 4:00 P.M. on 25-SEP-2006, the patient was concomitantly, vaccinated, intramuscularly into the left deltoid muscle with the second dose of DT Absorbed (Lot # U1847BA) (manufacturer Aventis Pasteur).  The patient experienced pain in the arm she received the PNEUMOVAX, and "a welt" at the injection site.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  In follow-up it was reported that the pharmacist requested a lot check for the PNEUMOVAX vaccine, (Lot # 651400/0618F).  The pharmacist wanted to know if there have been other adverse event reports with this vaccine.  The pharmacist will await the results of the lot check before vaccinating any more clients with the PNEUMOVAX vaccine that was left over from this lot.  A lot check of concern has been requested.  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 agency.  In follow-up it was reported from physician office notes the following:  The patient was vaccinated on 25-SEP-2006 subcutaneously into the right deltoid muscle with a dose of PNEUMOVAX (lot # 651400/0618F).  The patient presented to the physician's office on 26-SEP-2006, with a 10 centimeter (cm) reddened, raised area on her right upper arm, below where the injection site was.  She stated that it was very tender and felt tight inside.  The physician looked at the area and wanted her to try diphenhydramine hydrochloride (BENADRYL) and apply a cold pack to the affected site several times a day.  The patient verbalized that she understood the plan of care.  It was reported that on 02-OCT-2006, the patient recovered.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Cold sweat, Pain in extremity, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with hypertension and hypothyroidism who on 29-SEP-2006 was vaccinated with a first dose of Pnemovax 23 (Lot# not reported). Concomitant therapy included LEXAPRO. The nurse reported that on 29-SEP-2006, after receiving the vaccination, the patient developed  severe pain in the arm persisting for 2 days. The patient also reporting having "cold sweats" with her chills. The patient was reported to be recovering but her arm was still tender today. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female who was vaccinated on 28-SEP-2006 with a dose of Pneumovax 23. On 28-SEP-2006, within 3-4 hours post-vaccination, the patient experienced severe pain in the injection arm, from the shoulder to the forearm, and chills. The nurse reported that the patient's chattering teeth caused her to bite the inside of her mouth. The patient sought unspecified medical treatment. The patient's severe arm pain lasted approximately 24 hours. Subsequently, the patient improved "on therapy," and was reported as recovering. It was also reported that in 1995 the patient was vaccinated with a dose of Pneumovax 23 "with no problem." Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 74 year old, female whose reported weight was 136 pounds and whose reported height was 66 inches with steroid allergy and penicillin allergy, who more than 5 years ago was vaccinated with a first dose of Pneumovax 23 and had no reaction to the first dose who on 28-SEP-2006 was vaccinated intramuscularly, in the left arm with a second dose of 0.5 ml of Pneumovax 23 (Lot # 651356/0089F). On approximately 28-SEP-2006 the patient developed redness and swelling at the injection site and no treatment was needed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. In follow-up it was reported by a health care worker on 08-NOV-2006, concerning a 74 year old, female whose reported weight was 136 pounds and whose reported height was 66 inches with steroid allergy and penicillin allergy, who on 28-SEP-2006, at 9:00 a.m., was vaccinated intramuscularly, in the left deltoid muscle with a second dose of 0.5 ml of Pneumovax 23 (Lot # 651356/0089F). It was reported that on 28-SEP-2006, at 5:00 (a.m. and p.m. not specified) the patient had swelling and warmness to the upper arm with a little pain. On 30-SEP-2006, the patient recovered. Medical records were received on 08-NOV-2006, from a physician's office visit, which indicated that the patient had developed asthma in her 20's and had an extreme sensitivity to a wide range of medications. The patient could not take most medications because of a variety of side effects, the patient had a hysterectomy 2001 (ovaries left in), cataract surgery 2001, high cholesterol and the patient could not tolerate anti cholesterol medication in the past secondary to extreme body aches, osteopenia, last flu shot (2005), mammogram (2005), DEXA scan (2005), non-smoker, and drinks alcohol. Concomitant therapy included montelukast sodium (MSD), "asthacord" and FLONASE. The patient reported that on 10-SEP-2006, the patient had a syncopal episode. She was brought to the hospital and diagnosed with dehydration. She was given fluids and sent home. It was reported that she has been fine since. She believed her syncope was related to a 2-pack prescription for upper respiratory infection. Follow-up information received on 08-NOV-2006, contained the following adverse experiences: Syncope (28-SEP-2006), hypercholelsterolemia (28-SEP-2006), asthma (28-SEP-2006), and osteopenia (28-SEP-2006). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Myalgia, Nausea, Sinus congestion, Sneezing
Clinical narrative: Information has been received from a 71 year old female with cancer, a reaction to dronabinol (MARINOL), and a history of epstein-barr virus infection who on 21-AUG-2006 was vaccinated with a dose of PNEUMOVAX 23.  Concomitant therapy included levofloxacin (LEVAQUIN) and an unspecified antineoplastic.  On approximately 30-AUG-2006, the patient experienced vomiting, nausea, weakness, muscle ache, clogged sinuses and sneezing.  The patient did not seek medical attention for her experience.  At the time of this report, the patient had not recovered.  No further information is available.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a 71 year old female with cancer, a reaction to dronabinol (MARINOL), and a history of epstein-barr virus infection who on 21-AUG-2006 was vaccinated with a dose of PNEUMOVAX 23.  Concomitant therapy included levofloxacin (LEVAQUIN) and an unspecified antineoplastic.  On approximately 30-AUG-2006, the patient experienced vomiting, nausea, weakness, muscle ache, clogged sinuses and sneezing.  The patient did not seek medical attention for her experience.  At the time of this report, the patient had not recovered.  No further information is available.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Inappropriate schedule of drug administration, Local reaction, Nausea, Oedema
Clinical narrative: Information has been received from a 69 year old male physician with a sulfonamide allergy and no other relevant medical history who in 2005 was vaccinated subcutaneously with a 0.5 mL first dose of Pneumovax 23. On 02-OCT-2006, the physician was vaccinated subcutaneously with a 0.5 mL second dose of Pneumovax 23 (lot 651399/0486F). There was no concomitant medication. On 02-OCT-2006, soon after the second vaccination, the physician developed a localized reaction on his right upper deltoid arm where he received the vaccination. The reaction consisted of painful swelling with edema. He also felt some nausea and arthralgia. The physician sought unspecified medical attention. At the time of this report, the physician was recovering. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a 69 year old male physician with a sulfonamide allergy and no other relevant medical history who in 2005 was vaccinated subcutaneously with a 0.5 mL first dose of Pneumovax 23. On 02-OCT-2006, the physician was vaccinated subcutaneously with a 0.5 mL second dose of Pneumovax 23 (lot 651399/0486F). There was no concomitant medication. On 02-OCT-2006, soon after the second vaccination, the physician developed a localized reaction on his right upper deltoid arm where he received the vaccination. The reaction consisted of painful swelling with edema. He also felt some nausea and arthralgia. The physician sought unspecified medical attention. At the time of this report, the physician was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 66 year old female with no allergies or medical history, who on 07-SEP-2006 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (lot# 651319/1007P).  There was no concomitant medication.  Within 24 hours later, the patient developed swelling and a rash at the injection site from her shoulder to her elbow.  It was noted that the swelling has mostly resolved, however, a marble sized area of swelling has remained.  The patient was treated with ice for the swelling.  No other symptoms were reported.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: Information has been received from a 62 year old female with allergy to azithromycin (ZITHROMAX), acetaminophen (TYLENOL) and bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate (NEOSPORIN) who on 04-OCT-2006 was vaccinated with a dose of PNEUMOVAX (0.5 ml), intramuscularly.  Concomitant therapy that day included FLUZONE (influenza virus split virion 3v vaccine inactivated).  Other concomitant therapy included eszopiclone (LUNESTA).  On 04-OCT-2006 the patient experienced chills, fever, and "waves of pain."  The patient stated that "it hurts to raise the arm" she got vaccination in.  She also reported that the injection really hurt going in.  At the time of the report, the patient was recovering.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received from a 62 year old female with allergy to azithromycin (ZITHROMAX), acetaminophen (TYLENOL) and bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate (NEOSPORIN) who on 04-OCT-2006 was vaccinated with a dose of PNEUMOVAX (0.5 ml), intramuscularly.  Concomitant therapy that day included FLUZONE (influenza virus split virion 3v vaccine inactivated).  Other concomitant therapy included eszopiclone (LUNESTA).  On 04-OCT-2006 the patient experienced chills, fever, and "waves of pain."  The patient stated that "it hurts to raise the arm" she got vaccination in.  She also reported that the injection really hurt going in.  At the time of the report, the patient was recovering.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old male with diabetes, hypertension, arthritis, diverticulitis, emphysema and CELEBREX hypersensitivity who on 03-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (lot # 654594/0359F) (0.5 ml), subcutaneously "on the right upper back of the arm in the fatty tissue."  Concomitant therapy included GLUCOPHAGE, FLOMAX, COMBIVENT, ULTRAM, aspirin and ZESTRIL.  On 03-OCT-2006 the patient experienced local injection site reaction.  The patient had six inches induration, redness and tenderness.  The patient also "felt sick" from the first day of the vaccination.  It was also reported that 05-OCT-2006 the patient "had redness at site 3" X 3" and tender to touch noticeable induration."  Unspecified medical attention was sought.  The patient recovered.  Additional information is not expected.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a patient "over 55 or 60 years of age who "two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651399/0486F). Subsequently, the patient experienced redness and swelling at the site of injection. The patient was reportedly recovering. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 75 year old female with high cholesterol, mild chronic obstructive pulmonary disease, osteoporosis and no allergies, who on 04-OCT-2006 was vaccinated SC with a dose of PNEUMOVAX (lot# 651320/1008P).  Concomitant therapy included ezetimibe (MSD), "ENTERA", risedronate sodium (ACTONEL) and aspirin.  On 05-OCT-2006, the patient experienced swelling of arm and redness at the injection site.  Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information and follow-up information has been received from a physician concerning "five out of a total of approximately eight" patients who were vaccinated with Pneumovax 23 (lot number 651399/0486F). Subsequently the patients experienced severe localized injection site reactions. The patients received anti-inflammatory agents. Subsequently all five patients recovered from the severe localized injection site reactions. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with 0.5 mL of Pneumovax 23 (Lot# 651373/0320F).  Subsequently, the patient developed cellulitis.  The patient sought unspecified medical attention.  At the time of this report, the outcome of the event was unknown.  A lot check of concern has been requested.  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 regulatory agency and was released by the regulatory agency.  Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a patient "over 55 or 60" years of age who "two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot #651399/0486F). Subsequently, the patient experienced redness and swelling at the site of injection. The patient was reportedly recovering. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a patient "over 55 or 60" years of age who "two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot # 651399/0486F). Subsequently, the patient experienced redness and swelling at the site of injection. The patient was reportedly recovering. Additional information has been requested.