chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old retired female with no known drug allergies who on 12-JUN-2007 at 11:40 am was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX (Lot #655288/1174F).  Illness at the time of vaccination included chronic bronchitis.  On 12-JUN-2007 the post vaccination the patient experienced swelling and warmth in most of her right upper arm.  It was reported that on 13-JUN-2007, the patient reported back to the clinic.  His right arm was "edematous" from the shoulder to the elbow, red, and warm to touch.  The patient also reported pain from the shoulder to the tips of the fingers.  Approximately one week later, the patient recovered.  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old retired female with no known drug allergies who on 12-JUN-2007 at 11:40 am was vaccinated IM in the right deltoid with a first dose of PNEUMOVAX (Lot #655288/1174F).  Illness at the time of vaccination included chronic bronchitis.  On 12-JUN-2007 the post vaccination the patient experienced swelling and warmth in most of her right upper arm.  It was reported that on 13-JUN-2007, the patient reported back to the clinic.  His right arm was "edematous" from the shoulder to the elbow, red, and warm to touch.  The patient also reported pain from the shoulder to the tips of the fingers.  Approximately one week later, the patient recovered.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female with no known drug allergies who at 9:10 am on 21-MAY-2007 was vaccinated IM in the left deltoid with a second dose (date of first dose not reported) of PNEUMOVAX 23 (Lot#655588/0883F). Post vaccination with in 24 hours on approximately 22-MAY-2007 the patient developed redness, tenderness and swelling at the injection site down to her elbow. On 23-May-2007 the patient was seen in the physicians office, no edema or warmth were noted. Redness was noted from the elbow to the shoulder and the area was tender to the touch. Subsequently, approximately one week later the patient recovered from the events. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 60 year old female with diverticulitis, myalgia, and allergies to penicillin, codeine, doxycycline, CIPRO, and BIAXIN, who on 31-JUL-2007 was vaccinated intramuscularly into the left arm with a 0.5mL dose of PNEUMOVAX 23 (Lot# 655290/0959F). On 31-JUL-2007 the patient experienced some tenderness and pain at the injection site. The patient was examined in the office on 01-AUG-2007 and complained of injection site pain (painful to the touch), swelling, warm to the touch and redness. The patient also complained of fever and upset stomach. At the time of the report, the patient was recovering. The healthcare worker requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot# in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Stomach discomfort
Clinical narrative: Information has been received from a health professional concerning a 60 year old female with diverticulitis, myalgia, and allergies to penicillin, codeine, doxycycline, CIPRO, and BIAXIN, who on 31-JUL-2007 was vaccinated intramuscularly into the left arm with a 0.5mL dose of PNEUMOVAX 23 (Lot# 655290/0959F). On 31-JUL-2007 the patient experienced some tenderness and pain at the injection site. The patient was examined in the office on 01-AUG-2007 and complained of injection site pain (painful to the touch), swelling, warm to the touch and redness. The patient also complained of fever and upset stomach. At the time of the report, the patient was recovering. The healthcare worker requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot# in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 65 year old male patient with diabetes and hypertension who on 30-JUL-2007 was vaccinated IM with PNEUMOVAX 23 lot #655290/0959F.  The patient was seen in the doctor's office on 31-JUL-2007 for injection site soreness.  It was unclear when the soreness started but on 31-JUL-2007 the injection site was swollen, red and painful.  On 31-JUL-2007, the patient was given CLARITIN and CELEBREX for the pain and swelling.  No other information to report at this time.  The outcome was unknown.  The reporter has requested a lot check on behalf of the physician.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male (age not reported) who was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported).  Subsequently, within a 5 year time limit, the patient developed a benign rash on his hand.  The patient's status was not reported.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a medical assistant (MA), concerning a patient (age and gender not specified) who was vaccinated on an unspecified date, with a dose of PNEUMOVAX 23 (Lot #657039/0698U).  Subsequently the patient developed a "minimal reaction," though the patient did not return to the office for evaluation.  The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 1 patient experienced cellulitis (WAES #0707USA04634), and 4 patients developed significant reactions of fatigue, warmth, redness, unable to lift arm, and pain, after vaccination (WAES #0707USA04971).  Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a one year old patient who on 10-JUL-2007, was vaccinated IM with a first dose of PNEUMOVAX 23. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old patient who in May or June 2007, was vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot # 655766/0038U).  In May or June 2007, the patient experienced severe pain at the injection site and swelling.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a 71 year old patient who in May or June 2007, was vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot # 655766/0038U). In May or June 2007, the patient experienced severe pain at the injection site and swelling. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a consumer and a physician, concerning the consumers 12 month old ("1 year old") son with otitis media and a fever, who on 31-AUG-2007 (reported as 04-SEP-2007 by the consumer), at approximately 12:00 noon, was "by mistake" vaccinated, SC in the lower right thigh, with a dose of PNEUMOVAX 23 (Lot # 655291/0985F).  The physician noted that the vaccine that should have been administered was PREVNAR.  The mother reported she was contacted by her physician's office, and added that her son had shown no adverse reactions.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a female who in October 2006, was vaccinated with a dose of PNEUMOVAX 23.  In October 2006, 3-4 hours after vaccination the patient's arm "swelled to twice its size".  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Tenderness
Clinical narrative: Initial and follow-up information has been received from registered nurse concerning a 31 year old female with seasonal allergies who on 05-SEP-2007, at 11:00, was vaccinated IM in the right deltoid with a 0.5 ml first dose of PNEUMOVAX 23 (lot # 657627/0486U).  There was no concomitant medication.  On 05-SEP-2007, at 18:00, the patient experienced tenderness at the injection site which radiated up to the side of her neck and down her right arm.  There were no lab or diagnostic tests performed.  Subsequently, the patient recovered.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Band neutrophil count, Blood calcium decreased, Blood culture negative, Body temperature increased, Erythema
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 65 year old female inpatient with pneumonia, and allergies to codeine, hydrocodone, and antihistamines, who on 04-SEP-2007 at 15:00 was vaccinated IM in the right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 657628/0556U).  On 06-SEP-2007 (also reported as 05-SEP-2007) the patient experienced tenderness at the injection site, a 5x5 cm (also reported as 6x6 cm) induration that was swollen, warm, red, and firm to touch (also reported as hard).  At the time of the vaccination the patient was hospitalized for pneumonia.  On 05-SEP-2007 the patient had a temperature of up to 102F and was treated with doses of TYLENOL and CELEBREX twice daily to control her temperature.  On 06-SEP-2007 the patient was reported to be doing fair in the morning and her fever had cleared.  The plan was to continue the patient on IV antibiotics, ROCEPHIN, tobramycin, increase out of bed activity, and bronchodilators.  Laboratory diagnostics were performed (results found in laboratory section).  The patient recovered on an unspecified date.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Haematocrit normal, Haemoglobin normal, Induration, Injection site pain, Lymphocyte count decreased
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 65 year old female inpatient with pneumonia, and allergies to codeine, hydrocodone, and antihistamines, who on 04-SEP-2007 at 15:00 was vaccinated IM in the right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 657628/0556U).  On 06-SEP-2007 (also reported as 05-SEP-2007) the patient experienced tenderness at the injection site, a 5x5 cm (also reported as 6x6 cm) induration that was swollen, warm, red, and firm to touch (also reported as hard).  At the time of the vaccination the patient was hospitalized for pneumonia.  On 05-SEP-2007 the patient had a temperature of up to 102F and was treated with doses of TYLENOL and CELEBREX twice daily to control her temperature.  On 06-SEP-2007 the patient was reported to be doing fair in the morning and her fever had cleared.  The plan was to continue the patient on IV antibiotics, ROCEPHIN, tobramycin, increase out of bed activity, and bronchodilators.  Laboratory diagnostics were performed (results found in laboratory section).  The patient recovered on an unspecified date.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Monocyte count normal, Neutrophil count, Rhonchi, Skin warm, Sputum culture
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 65 year old female inpatient with pneumonia, and allergies to codeine, hydrocodone, and antihistamines, who on 04-SEP-2007 at 15:00 was vaccinated IM in the right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 657628/0556U).  On 06-SEP-2007 (also reported as 05-SEP-2007) the patient experienced tenderness at the injection site, a 5x5 cm (also reported as 6x6 cm) induration that was swollen, warm, red, and firm to touch (also reported as hard).  At the time of the vaccination the patient was hospitalized for pneumonia.  On 05-SEP-2007 the patient had a temperature of up to 102F and was treated with doses of TYLENOL and CELEBREX twice daily to control her temperature.  On 06-SEP-2007 the patient was reported to be doing fair in the morning and her fever had cleared.  The plan was to continue the patient on IV antibiotics, ROCEPHIN, tobramycin, increase out of bed activity, and bronchodilators.  Laboratory diagnostics were performed (results found in laboratory section).  The patient recovered on an unspecified date.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Wheezing, White blood cell count increased
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 65 year old female inpatient with pneumonia, and allergies to codeine, hydrocodone, and antihistamines, who on 04-SEP-2007 at 15:00 was vaccinated IM in the right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 657628/0556U).  On 06-SEP-2007 (also reported as 05-SEP-2007) the patient experienced tenderness at the injection site, a 5x5 cm (also reported as 6x6 cm) induration that was swollen, warm, red, and firm to touch (also reported as hard).  At the time of the vaccination the patient was hospitalized for pneumonia.  On 05-SEP-2007 the patient had a temperature of up to 102F and was treated with doses of TYLENOL and CELEBREX twice daily to control her temperature.  On 06-SEP-2007 the patient was reported to be doing fair in the morning and her fever had cleared.  The plan was to continue the patient on IV antibiotics, ROCEPHIN, tobramycin, increase out of bed activity, and bronchodilators.  Laboratory diagnostics were performed (results found in laboratory section).  The patient recovered on an unspecified date.  Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Erythema, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a respiratory therapist concerning a 60 year old male with a penicillin allergy who on 07-AUG-2007 was vaccinated with PNEUMOVAX 23. Concomitant therapy included metformin, niacin, HYDRODIURIL (manufacturer unknown), CRESTOR, AVAPRO, CELEBREX and VICODIN. Subsequently the patient experienced a large area on his arm that was red and puffy. The patient also had a low grade temperature, nausea, sweats and chills. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a respiratory therapist concerning a 60 year old male with a penicillin allergy who on 07-AUG-2007 was vaccinated with PNEUMOVAX 23. Concomitant therapy included metformin, niacin, HYDRODIURIL (manufacturer unknown), CRESTOR, AVAPRO, CELEBREX and VICODIN. Subsequently the patient experienced a large area on his arm that was red and puffy. The patient also had a low grade temperature, nausea, sweats and chills. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chest X-ray normal, Cough, Face and mouth X-ray normal, Peak expiratory flow rate
Clinical narrative: Initial and follow up information has bee received from a registered nurse and a physician concerning a 62 year old female with no drug allergies and with hypertension, diabetes, hypothyroid, high cholesterol, depression and myalgia, who on 19-JUN-2007 was vaccinated intramuscularly with a dose of PNEUMOVAX 23. Concomitant suspect therapies included losartan potassium-HCTZ, tablet (MSD) (dose, duration and indication not reported) and simvatatin, tablet (MSD) (dose, duration and indication not reported). Other concomitant therapy included levothyroxine Na, glipizide, metformin, ZOLOFT, ACIPHEX and ALLEGRA. On 05-JUL-2007 the patient's temperature was 101F. On 06-JUL-2007 the patient experienced a wheezing, and tickling in throat. On 19-JUN-2007, (also reported as 06-JUL-2007) the patient developed a cough. The patient was seen in the office on 27-JUL-2007 and was still coughing and wheezing, no fever. She was seen on 08-AUG-2007 with coughing and wheezing in her chest. The patient was treated with an unspecified cough syrup. The cough coincided with receiving the vaccination. The physician thought it was a coincidence, however the patient insisted. On 27-JUL-2007 a chest x-ray was taken and was negative. The patient was given pulmonary function tests and a sinus x-ray, which were both negative. The patient was also given a peak expiratory flow rate test with the value being 25 to 75. The patient has an appointment with the pulmonologist on 10-SEP-2007. No product quality complaint was involved. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pulmonary function test normal, Throat irritation, Wheezing
Clinical narrative: Initial and follow up information has bee received from a registered nurse and a physician concerning a 62 year old female with no drug allergies and with hypertension, diabetes, hypothyroid, high cholesterol, depression and myalgia, who on 19-JUN-2007 was vaccinated intramuscularly with a dose of PNEUMOVAX 23. Concomitant suspect therapies included losartan potassium-HCTZ, tablet (MSD) (dose, duration and indication not reported) and simvatatin, tablet (MSD) (dose, duration and indication not reported). Other concomitant therapy included levothyroxine Na, glipizide, metformin, ZOLOFT, ACIPHEX and ALLEGRA. On 05-JUL-2007 the patient's temperature was 101F. On 06-JUL-2007 the patient experienced a wheezing, and tickling in throat. On 19-JUN-2007, (also reported as 06-JUL-2007) the patient developed a cough. The patient was seen in the office on 27-JUL-2007 and was still coughing and wheezing, no fever. She was seen on 08-AUG-2007 with coughing and wheezing in her chest. The patient was treated with an unspecified cough syrup. The cough coincided with receiving the vaccination. The physician thought it was a coincidence, however the patient insisted. On 27-JUL-2007 a chest x-ray was taken and was negative. The patient was given pulmonary function tests and a sinus x-ray, which were both negative. The patient was also given a peak expiratory flow rate test with the value being 25 to 75. The patient has an appointment with the pulmonologist on 10-SEP-2007. No product quality complaint was involved. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Local reaction, Medication error
Clinical narrative: Information has been received from a health professional concerning a 35 year old female with no drug allergies and no medical history, who on 08-AUG-2007 was vaccinated Subqutaneously with a 0.1mL dose of PNEUMOVAX 23 (Lot# 655501/1035F). Subsequently, the patient developed a local reaction at the injection site, "It was 2" x 3" red and itchy." The patient was suppose to have been given a TB test. The medical assistant had just reached in an pulled out a vial and did not look at the label. The product was in a separate container from the TB test. There was no concomitant medication. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning 5 patients who were vaccinated with PNEUMOVAX 23. Subsequently the patient experienced redness, soreness and warmth to the touch in a 3-4 inch area around the injection site after immunization with PNEUMOVAX 23. It was reported that 2 of these cases happened recently, and 3 of them happened about 6 months ago. The patients sought unspecified medical attention. No other information was available at this time. 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.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Swollen tongue
Clinical narrative: Information has been received from a medical assistant concerning a 74 old female with Meniere's disease, gastrooesophageal reflux disease, osteopenia and hypercholesterolaemia who was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23. There was no concomitant medication. Subsequently the patient developed "blotchy skin" and tongue swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a physician concerning a 73 year old female who on  an unspecified date was vaccinated with a first dose of PNEUMOVAX 23 (lot# unknown). On 31-JUL-2007 the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot# 657143/0380U) in the right deltoid. On 01-AUG-2007 the patient developed redness, swelling and the arm was very painful. The doctor recommended BENADRYL every 6 hours when needed and ice. Medical attention was sought. On 03-AUG-2007 the reaction was spreading 6 inches down the arm and 3 inches wide from the injection site. Patient scheduled by the physician to be seen on 04-AUG-2007. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Oedema peripheral, Pyrexia, Tunnel vision, Vertigo
Clinical narrative: Information has been received from licensed practical nurse concerning a 32 year old female with exercise induced asthma and no allergies who on 14-AUG-2007 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot #0959F/655290) intramuscularly. Concomitant therapy included FLONASE and ALLEGRA. On 15-AUG-2007 the patient developed a fever, headache, arm swelling and experienced tunnel vision and vertigo. The patient was evaluated in the emergency room and was treated with MOTRIN, BENADRYL, and prednisone. No other information is available at this time. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Diabetes mellitus, Expired drug administered
Clinical narrative: Information has been received from a registered nurse as reported by a medical assistant at the physician's office concerning a 46 year old male patient with chronic back syndrome, allergic rhinitis, hypertension and elevated lipids who on AUG-10-2007 was vaccinated with PNEUMOVAX 23 (Lot #651406/0620F) in the left deltoid, and the vaccine had expired on 12-MAY-2007. The patient was notified and on 24-AUG-2007 was revaccinated with PNEUMOVAX 23 (Lot #654977/0888F) in the right deltoid. The patient was diagnosed with Diabetes Mellitus in AUG-2007. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a medical assistant (MA), concerning a 28 year old female patient who on 23-JUL-2007 was vaccinated SC in the left arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U). On 23-JUL-2007, following the vaccination. The patient experienced extreme tenderness and arm pain, and redness at the injection site. At the time of this report, the patient had recovered from the events. The patient sought unspecified medical attention. The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 3 additional patients experienced similar symptoms involving pain, warmth, swelling, redness at the injection site, difficulty with arm movement, and fatigue (WAES 0707USA04971, 0708USA04275), 1 patient developed cellulitis (WAES #0707USA04634), and 1 patient experienced a "minimal reaction" (WAES 0708USA00702). 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 is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot 3 657143/0380U). Subsequently, the patient developed erythema at the injection site within one day. The erythema was described as swollen, painful and warm from the injection site to the elbow. The pain and swelling prevented the patient from her arm. Unspecified medical attention was sought. At the time of the report, the outcome was unknown. The physician requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for the Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose PNEUMOVAX 23 (lot # 657143/0380U). Subsequently, the patient developed erythema at the injection site within one day. The erythema was described as swollen, painful and warm from the injection site to elbow. The pain and swelling prevented the patient from using her arm. Unspecified medical attention was sought.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose (lot # 657143/0380U). Subsequently, the patient developed erythema at the injection site within one day. The erythema was described as swollen, painful and warm from the injection site to the elbow. The painful and swelling prevented the patient from using her arm. Unspecified medical attention was sought. At the time of the report, the outcome was unknown. The physician requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a female patient (age not reported) who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced a reaction on the injection site (unspecified). Unspecified medical attention was sought. The outcome of the event was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Pyrexia, Urticaria
Clinical narrative: Information has been received from a health professional concerning a male who on 06-SEP-2007 was vaccinated IM, into the left arm, with a 0.5 ml dose of PNEUMOVAX 23. On 07-SEP-2007 the patient developed welts on his left arm. On 09-SEP-2007 the patient had a fever of 108 F. On 10-SEP-2007, the patient was seen in the physician's office. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a consumer concerning a 64 year old female with fibromyalgia, allergic rhinitis and benign colonic neoplasm who on 31-JUL-2007 at 08:35 was vaccinated with a second dose of PNEUMOVAX 23 (lot# 656222/0381U). There was no concomitant medication. On 31-JUL-2007 at 19:00, the patient experienced large swelling of the right arm. There were no laboratory diagnostic studies performed. Subsequently, the patient recovered. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 16 year old male patient who was vaccinated IM with a single dose from a 5-dose vial of PNEUMOVAX 23 lot #655291/0985F. The reporter that the patient developed immediate swelling at the injection site. No other symptoms were reported. The pharmacist referred to this immediate reaction as "cellulitis". The patient was taken to the local emergency room for evaluation but details of the examination and treatment were unavailable. The outcome was unknown. The pharmacist has requested  A lot check for PNEUMOVAX 23 lot 3655291/0985F. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. In addition an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a health professional concerning an 81 year old male with drug hypersensitivity to LORTAB and an unknown anesthetic who on 12-SEP-2007 was vaccinated intramuscularly into the left deltoid with a dose of PNEUMOVAX (Lot 655766/0038U).  There was no concomitant medication.  On 12-SEP-2007 the patient's injection site arm was swollen, red, and itchy.  The patient was instructed to take BENADRYL for the injection site reaction.  No laboratory or diagnostic tests were performed.  The patient called the office.  At the time of the report the patient had not recovered.  Follow-up information revealed that there was no further information to provide on this patient and that the physician "will not use the rest of the vaccine" from Lot # 655766/0038U.  The office requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information is not available.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 76 year old female with drug hypersensitivity to clonidine, Codeine, tetracycline, penicillin, MACRODANTIN, MAXZIDE, propranolol hydrochloride, MEVACOR, MOTRIN, ULTRAM, RELAFEN, and CELEBREX who on 06-SEP-2007 was vaccinated intramuscularly in the left deltoid with a dose of PNEUMOVAX (Lot #655765/0061U).  There was no concomitant medication.  On 07-SEP-2007 the patient experienced injection site redness, swelling, and itchiness.  The patient was told to take BENADRYL for the injection site reaction.  There were no laboratory or diagnostic tests performed.  The patient called the physician over the weekend.  On an unspecified date the patient recovered.  The office requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Lip swelling, Pyrexia
Clinical narrative: Information has been received from a health care worker concerning a 44 year old female patient with hyperlipidaemia who on 05-SEP-2007 was vaccinated with a dose of PNEUMOVAX, lot #655765/0061U.  Concomitant therapy included CRESTOR.  The patient reported fever and swollen lips and the injection site area was red and swollen starting on 07-SEP-2007.  The patient was instructed to take BENADRYL for symptoms.  She was seen in the office of 11-SEP-2007 and was given a prescription for a MEDROL DOSPAK.  The patient was reported to be recovering.  The doctor's office has requested a lot check for PNEUMOVAX lot #655765/0061U.  A standard lot check investigation was performed.  All in process quality checks for the lot number in question were satisfactory.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the research center and was released.  The reporter indicated there were 2 other patients who also had injection reactions after vaccination with PNEUMOVAX.  Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old female who was in the hospital at the time of being vaccinated because she was recovering from pneumonia. She has a history of allergy to codeine. On 12-SEP-2007, the patient was vaccinated with PNEUMOVAX 23 0.5 ml subcutaneously in the deltoid. Concomitant medication was reported as none. On 13-SEP-2007, the patient developed an injection site reaction. The patient reported to the nurse that her arm hurt (arm unspecified). The injection site was reddened and swollen to the size of a grapefruit. Ice was applied to her arm and the arm was elevated. The physician ordered BENADRYL. No other symptoms or treatment were reported. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 80 year old female who in 2002 received the first dose of PNEUMOVAX 23. On 11-SEP-2007, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot #655499/0988F), 0.5 ml, IM in the left arm deltoid. Concomitant therapies were unspecified at the time of the report. On 12-SEP-2007 (the next day), the patient experienced a red and really large swollen area at injection site. The nurse stated that the patient also had what looked like an insect bite near the injection site too, so she was unsure if that could have caused the swelling. The patient was treated with over the counter BENADRYL and ice for comfort measures. On 14-SEP-2007, the patient called the office and stated that she was "feeling better". No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a female patient who in September 2007, "last week" was vaccinated SQ with 0.5 ml dose of PNEUMOVAX.  Subsequently the patient experienced injection site reaction and the arm was swollen.  Medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 61 year old female who on 11-SEP-2007 was vaccinated IM in the left arm with a dose of PNEUMOVAX.  One day post vaccination on 12-SEP-2007 the patient experienced an adverse reaction.  The patient was in the physician's office, her left arm was red, swollen 6 to 8 centimeter area at the injection site.  The physician thought it might be an allergic reaction, no cellulitis, no treatment.  The patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 75 year old female who on 12-SEP-2007 was vaccinated IM in the left arm with a dose of PNEUMOVAX (Lot# 657525/0554U).  Next day the patient called the physician's office to report warm, raised area at the injection site, that was painful and tender to the touch.  The patient was seen in the office and was diagnosed with cellulitis and treated with amoxicillin (+) Augmentin.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a hospital pharmacy technician via a pulmonogist concerning a 67 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 (Lot #658175/0856U). Subsequently the patient "got sick" and required bed rest. She had body aches and a low grade fever. Treatment was specified. At the time of the report the patient's outcomes was unknown. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 4 month old male who on 17-SEP-2007 was vaccinated in the right thigh with a dose of PNEUMOVAX (Lot # 656233/0200U).  Concomitant vaccination on the same day included PREVNAR.  Other concomitant vaccination included ACTHIB (Lot #UF160AA).  Other concomitant therapies included DTPA (unspecified) (Lot #C2651AA) and tetanus toxoid and poliovirus vaccine and poliovirus vaccine inactivated (unspecified) (Lot #20547-2).  The physician also called Poison Control.  The baby waited in the office for 2 hours and no adverse symptoms were noted.  At the time of the report the patient's outcome was unknown.  On 26-SEP-2007 the physician reported that the boy was doing well and he had been calling daily to follow-up.  He also reported that the nurse had mistakenly given the child PNEUMOVAX instead of PREVNAR.  He reported that both vaccines were stored in the same refrigerator; however, they are clearly labeled and located on different shelves.  Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Information has been received from a nurse, via a company representative, concerning "a  number of patients" who were vaccinated with a dose of PNEUMOVAX 23 (dates, and lot # not provided), and developed cellulitis. Follow up information received from a healthcare professional identified a 58 year old female patient who was vaccinated with a dose of PNEUMOVAX 23 (lot #654977/0888F) and subsequently developed "redness that radiated down her arm from the injection site." Therapy included VICODIN. At the time of this report, the outcome of cellulitis was unknown. Attempts to obtain additional identifying information to distinguish the individual patients mentioned in this report, resulted in two additional reports of patients who developed cellulitis following vaccinations with PNEUMOVAX 23 (lot #654977/0888F) (WAES #0709USA03917 and 0709USA03918). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Drug toxicity
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Concomitant medication was not reported. On 14-SEP-2007, the patient developed "serum toxicity" after she received PNEUMOVAX 23. She went to an emergency room on 14-SEP-2007 because of the symptom. The patient was treated with prednisone. The nurse was not sure if the patient was hospitalized. The patient was recovering from the serum toxicity. No product quality complaint was involved. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Information has been received from a medical assistant, concerning a 55 year old male patient, who on 23-JUL-2007 was vaccinated SC in the left arm, with a dose of PNEUMOVAX (lot #657039/0698U).  On the same day, the patient developed extreme fatigue, body aches, and pain at the site of injection.  After an unknown duration of time, the patient recovered.  The MA reported that of the 6 vaccinations with PNEUMOVAX administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years), 3 patients experienced events similar to the events above (WAES 0708USA04275, male; 0708USA04276, female; 0707USA04971, female), 1 additional patient experienced cellulitis (WAES #0707USA04634), and 1 additional patient experienced a "minimal reaction" (WAES 0708USA00702).  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 research center and was released.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 68 year old female who on approximately 12-SEP-2007 "a week ago" was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL, IM. Concomitant medication was not reported. Subsequently on an unspecified date, the patient experienced pain in her left hip, at the injection site after immunization with PNEUMOMAX 23. Unspecified medical attention was sought as the patient called the pharmacist. The patient's pain her left hip persisted. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of PNEUMOVAX.  Concomitant medication was not reported.  Subsequently on an unspecified date, the patient experienced a large, swollen and red area at the injection site.  Unspecified medical attention was sought.  Subsequently on an unspecified date, the patient recovered from a large, swollen and red area at the injection site.  No product quality complaint was involved.  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 pharmacist concerning 4 patients (ages and genders not reported) who on unspecified dates in September 2007 during a vaccination clinic, were vaccinated with doses of PNEUMOVAX.  Concomitant therapy included influenza virus vaccine (unspecified).  In September 2007 one or two days following vaccination with PNEUMOVAX the patients presented to the pharmacist with injection site reaction described as red, swollen and warm.  The pharmacist considered most of these events as "minor".  The relationship of the event to therapy with PNEUMOVAX was reported as unknown.  The outcome of the event was not reported.  No product quality complaint was involved.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pain, Rash macular
Clinical narrative: Information has been received from a 71 year old female consumer, with a thyroid disorder, who on 17-SEP-2007 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included SYNTHROID and CRESTOR. On 17-SEp-2007, following the vaccination, she experienced flu like symptoms, including pain over her entire body, and developed redness and soreness at injection site in a 3 inch diameter "blotch." The patient visited her physician, though no treatment was administered. On 20-SEP-2007, the consumer had recovered from flu like symptoms, redness at injection site and soreness at injection site, though the general body pain continued. No further information is available.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Pyrexia
Clinical narrative: Initial and follow up information has been received from a healthcare professional concerning a 76 year old male patient with no known drug allergies and a thyroid disorder, who on 18-SEP-2007, at 10:00 am, was vaccinated IM in the left deltoid, with a dose, 0.5 ml, of PNEUMOVAX (lot #658075/0962U).  Later that day, he developed swelling and redness of his whole left arm, as well as a fever (value not specified).  On 19-SEP-2007 ("the next morning"), the reaction had moved up and down the whole upper arm.  On 20-SEP-2007, he visited the physician and was treated with BENADRYL, an injection of KENALOG, and an injection of ROCEPHIN.  At the time of this report, the patient had recovered from the events (duration not specified).  The HCP requested that a lot check be performed.  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 research center and was released.  Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse, concerning a 74 year old female patient, who had been vaccinated 10 years prior with a dose of PNEUMOVAX, and on 21-SEP-2007 was vaccinated IM in the left arm with a second dose, 0.5ml, of PNEUMOVAX (lot #657525/0554U).  Concomitant therapy at the visit, included an IM vaccination in the left arm of FLUZONE.  The nurse stated that following the vaccination with PNEUMOVAX, the patient "developed adverse symptoms" described as immediate redness, swelling and soreness at the injection site, as well as a headache.  At the time of this report, the patient had not recovered.  This is one of two reports received from the same source (WAES #0709USA03759) following vaccination with PNEUMOVAX (lot #657525/0554U).  The nurse 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 research center and was released.  Additional information has been requested.