chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Lymphadenopathy
Clinical narrative: Information has been received from a medical assistant concerning a 46 year old male patient who on 26-FEB-2010 was vaccinated with an IM 0.5 ml dose of PNEUMOVAX 23 (Lot # 664864/1365Y) in his left arm. On 26-FEB-2010, after PNEUMOVAX 23 was given, the patient developed cellulitis. The patient also had redness at the injection site and swollen lymph nodes under the left arm. The patient sought medical attention by an office visit. At the time of the report, the patient was recovering. Follow up information has been received from a medical assistant who indicated that the patient with asthma (FG/mild BPH) on 26-FEB-2010 at 11:15 a.m. was vaccinated with a dose of PNEUMOVAX 23 in his left upper arm. The next day following vaccination (reported as 26-FEB-2010) the patient developed cellulitis. The patient had to go to a clinic where received antibiotics and unspecified (illegible) treatment. The patient was clinically evaluated and had a follow-up visit with a physician. On approximately 01-MAR-2010, the first week of March 2010, the patient recovered from cellulitis. Cellulitis was considered to be disabling and other important medical event by the reporter. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 year old male patient with many unspecified underlying problems who on 07-JUL-2008 was vaccinated with a dose of PNEUMOVAX (Lot # was 659921/1679U). On unknown date the patient experienced a fever of 101F, arm swelling and vomiting after receiving PNEUMOVAX. The patient was admitted to an unspecified hospital two days later on approximately 09-JUL-2009 for unknown numbers of days. At the time of the report, the patient recovered from the events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood bicarbonate abnormal, Blood culture negative, Blood pressure normal, Blood sodium decreased, Blood urea decreased
Clinical narrative: Information has been received from an office manager concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). On an unspecified date after receiving the vaccine the patient developed cellulitis and was hospitalized. The outcome of the patient's cellulitis was not reported. Follow up information has been received from a office manager concerning a 65 year old female with barrett's oesophagus, hypertension, osteoporosis, spinal stenosis, penicillin allergy, cephalosporin allergy, iodine allergy and a history of hysterectomy three weeks ago (in approximately 26-SEP-2009), tubal ligation and colonoscopy who on 13-AUG-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662842/1296X) subcutaneously into left arm. Concomitant therapy included benazepril HCl, calcium (unspecified), vitamin D (unspecified) and timolol maleate (manufacturer unknown). On 14-AUG-2009 the patient came into the emergency room with a complain of fever, redness and swelling in the left arm after receiving PNEUMOVAX 23. The patient stated the tech who gave the injection, scrubbed one part of her arm with alcohol and then injected a long dirty needle into other side. The patient was having fevers of 100.4 degrees F. She stated that she was feeling okay otherwise, but the rate at which this cellulitis spread alarmed the patient. On 15-AUG-2009 the patient was admitted into a hospital after she was noted to have this significant cellulitis. There was concern for the development of a necrotizing fasciitis given the extent of this cellulitis at that time she was admitted; however, the patient responded quite rapidly to clindamycin and the second hospital day, it was much improved. On the same day on 15-AUG-2009 laboratory test revealed; white blood count high, red blood count low, hematocrit low, MCH high, RDW low, neutrophil count high, sodium low, bicarbonate low and no microorganisms in blood culture. On 16-AUG-2009 laboratory test revealed monocyte low. On 17-AUG-2009 the patient was discharged. At that time, the patient cellulitis was completely resolved. There was no visualized cellulitis. Cellulitis in the left arm and flank were completely gone. The patient's blood pressure was noted to be basically normal at that point. The patient had regular rate and rhythm, S1 and S2 normal, the patient was awake, alert and in no acute distress, lungs were clear to auscultation, abdomen was soft and no cyanosis in extremities. Primary care was scheduled in two to four weeks. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Erythema, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Information has been received from an office manager concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). On an unspecified date after receiving the vaccine the patient developed cellulitis and was hospitalized. The outcome of the patient's cellulitis was not reported. Follow up information has been received from a office manager concerning a 65 year old female with barrett's oesophagus, hypertension, osteoporosis, spinal stenosis, penicillin allergy, cephalosporin allergy, iodine allergy and a history of hysterectomy three weeks ago (in approximately 26-SEP-2009), tubal ligation and colonoscopy who on 13-AUG-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662842/1296X) subcutaneously into left arm. Concomitant therapy included benazepril HCl, calcium (unspecified), vitamin D (unspecified) and timolol maleate (manufacturer unknown). On 14-AUG-2009 the patient came into the emergency room with a complain of fever, redness and swelling in the left arm after receiving PNEUMOVAX 23. The patient stated the tech who gave the injection, scrubbed one part of her arm with alcohol and then injected a long dirty needle into other side. The patient was having fevers of 100.4 degrees F. She stated that she was feeling okay otherwise, but the rate at which this cellulitis spread alarmed the patient. On 15-AUG-2009 the patient was admitted into a hospital after she was noted to have this significant cellulitis. There was concern for the development of a necrotizing fasciitis given the extent of this cellulitis at that time she was admitted; however, the patient responded quite rapidly to clindamycin and the second hospital day, it was much improved. On the same day on 15-AUG-2009 laboratory test revealed; white blood count high, red blood count low, hematocrit low, MCH high, RDW low, neutrophil count high, sodium low, bicarbonate low and no microorganisms in blood culture. On 16-AUG-2009 laboratory test revealed monocyte low. On 17-AUG-2009 the patient was discharged. At that time, the patient cellulitis was completely resolved. There was no visualized cellulitis. Cellulitis in the left arm and flank were completely gone. The patient's blood pressure was noted to be basically normal at that point. The patient had regular rate and rhythm, S1 and S2 normal, the patient was awake, alert and in no acute distress, lungs were clear to auscultation, abdomen was soft and no cyanosis in extremities. Primary care was scheduled in two to four weeks. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mean cell haemoglobin, Mean cell haemoglobin increased, Monocyte percentage increased, Neutrophil percentage increased, Oedema peripheral
Clinical narrative: Information has been received from an office manager concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). On an unspecified date after receiving the vaccine the patient developed cellulitis and was hospitalized. The outcome of the patient's cellulitis was not reported. Follow up information has been received from a office manager concerning a 65 year old female with barrett's oesophagus, hypertension, osteoporosis, spinal stenosis, penicillin allergy, cephalosporin allergy, iodine allergy and a history of hysterectomy three weeks ago (in approximately 26-SEP-2009), tubal ligation and colonoscopy who on 13-AUG-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662842/1296X) subcutaneously into left arm. Concomitant therapy included benazepril HCl, calcium (unspecified), vitamin D (unspecified) and timolol maleate (manufacturer unknown). On 14-AUG-2009 the patient came into the emergency room with a complain of fever, redness and swelling in the left arm after receiving PNEUMOVAX 23. The patient stated the tech who gave the injection, scrubbed one part of her arm with alcohol and then injected a long dirty needle into other side. The patient was having fevers of 100.4 degrees F. She stated that she was feeling okay otherwise, but the rate at which this cellulitis spread alarmed the patient. On 15-AUG-2009 the patient was admitted into a hospital after she was noted to have this significant cellulitis. There was concern for the development of a necrotizing fasciitis given the extent of this cellulitis at that time she was admitted; however, the patient responded quite rapidly to clindamycin and the second hospital day, it was much improved. On the same day on 15-AUG-2009 laboratory test revealed; white blood count high, red blood count low, hematocrit low, MCH high, RDW low, neutrophil count high, sodium low, bicarbonate low and no microorganisms in blood culture. On 16-AUG-2009 laboratory test revealed monocyte low. On 17-AUG-2009 the patient was discharged. At that time, the patient cellulitis was completely resolved. There was no visualized cellulitis. Cellulitis in the left arm and flank were completely gone. The patient's blood pressure was noted to be basically normal at that point. The patient had regular rate and rhythm, S1 and S2 normal, the patient was awake, alert and in no acute distress, lungs were clear to auscultation, abdomen was soft and no cyanosis in extremities. Primary care was scheduled in two to four weeks. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Red blood cell count decreased, Red cell distribution width decreased, White blood cell count increased
Clinical narrative: Information has been received from an office manager concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). On an unspecified date after receiving the vaccine the patient developed cellulitis and was hospitalized. The outcome of the patient's cellulitis was not reported. Follow up information has been received from a office manager concerning a 65 year old female with barrett's oesophagus, hypertension, osteoporosis, spinal stenosis, penicillin allergy, cephalosporin allergy, iodine allergy and a history of hysterectomy three weeks ago (in approximately 26-SEP-2009), tubal ligation and colonoscopy who on 13-AUG-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662842/1296X) subcutaneously into left arm. Concomitant therapy included benazepril HCl, calcium (unspecified), vitamin D (unspecified) and timolol maleate (manufacturer unknown). On 14-AUG-2009 the patient came into the emergency room with a complain of fever, redness and swelling in the left arm after receiving PNEUMOVAX 23. The patient stated the tech who gave the injection, scrubbed one part of her arm with alcohol and then injected a long dirty needle into other side. The patient was having fevers of 100.4 degrees F. She stated that she was feeling okay otherwise, but the rate at which this cellulitis spread alarmed the patient. On 15-AUG-2009 the patient was admitted into a hospital after she was noted to have this significant cellulitis. There was concern for the development of a necrotizing fasciitis given the extent of this cellulitis at that time she was admitted; however, the patient responded quite rapidly to clindamycin and the second hospital day, it was much improved. On the same day on 15-AUG-2009 laboratory test revealed; white blood count high, red blood count low, hematocrit low, MCH high, RDW low, neutrophil count high, sodium low, bicarbonate low and no microorganisms in blood culture. On 16-AUG-2009 laboratory test revealed monocyte low. On 17-AUG-2009 the patient was discharged. At that time, the patient cellulitis was completely resolved. There was no visualized cellulitis. Cellulitis in the left arm and flank were completely gone. The patient's blood pressure was noted to be basically normal at that point. The patient had regular rate and rhythm, S1 and S2 normal, the patient was awake, alert and in no acute distress, lungs were clear to auscultation, abdomen was soft and no cyanosis in extremities. Primary care was scheduled in two to four weeks. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 72 year old female patient with diabetes and with not known allergies, who on 08-FEB-2010 was vaccinated intramuscularly in the left arm with a 0.5 mL dose of PNEUMOVAX (lot number 665402/1339Y).  There was no concomitant medication.  On 08-FEB-2010 the patient experienced redness, swelling and soreness at the injection site.  The physician stated that it looked like a local reaction and did not look like an infection.  On an unknown date, the patient was told to use a cold pack followed by a hot pack.  On an unknown date, the patient recovered from redness and swelling but the patient was still experiencing soreness at the time of reporting.  No labs or diagnostics were performed.  Patient sought medical attention through an office visit.  Redness, swelling and soreness at the injection site were considered to be disabling by the physician, since the patient had difficulty moving her left arm.  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a physician (surgeon) concerning a 30 year old male with chest discomfort, diabetes and no drug allergies, who on 18-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 664445/1188Y). Concomitant therapy included insulin, BENICAR and NEURONTIN. Subsequently, the patient experienced red, hot and swollen, 10 by 12 cm, at the injection site on his arm, and he also had fever of 103.0F. There were no labs or diagnostic tests performed, but an ultrasound of the arm had been ordered. The patient was an in-patient in a hospital when the AE occurred. His diagnosis was chest discomfort. The patient had sought medical attention. At the time of the report, the patient had not recovered. Follow up information has been received from a medical assistant indicating that the patient's hospitalization had been prolonged for at least 2 days due to the injection site reaction. Follow up information received from the physician reporting that the primary care physician stated that the patient "did well and no further intervention was required". No further information is available.
Age: 53.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 53 year old patient who on 17-JUL-2009 was vaccinated with a dose of PNEUMOVAX (lot# 662664/0981X). On 17-JUL-2009 the patient developed cellulitis of the left upper extremity, status post vaccination. The patient was hospitalized from 17-JUL-2009 to 20-JUL-2009. The patient was treated with IV antibiotics for 10 days. On 21-JUL-2009 the patient had a follow-up visit. The patient had a fever and swelling (not specified). At the time of reporting the patient was recovering. Follow-up information has been received from a physician concerning the patient who on 14-JUL-2009 (not 17-JUL-2009 was previously reported) was vaccinated with a dose of PNEUMOVAX. On 15-JUL-2009 the patient had localized pain at the injection site. On 16-JUL-2009 the patient's pain had worsened and the patient developed a fever. On 16-JUL-2009 the patient went to the emergency room and was admitted to the hospital for cellulitis on 16-JUL-2009 (not 17-JUL-2009 as previously reported). The patient was treated with ANCEF, NAPHACEL. On 20-JUL-2009 the patient was discharged from the hospital. The patient was prescribed KEFLEX and clindamycin on discharge from the hospital. On 21-JUL-2009 and 31-JUL-2009 the patient was seen by the physician for a post hospital visit. 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 the Center for Biologics Evaluation and Research and was released. This is one of several cases from the same reporter. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an "over 65 years old" patient who was vaccinated with PNEUMOVAX 23 (lot number not available). Subsequently the patient "experienced swelling at the injection site". At the time of the report, the patient recovered from swelling at the injection site. Follow-up information has been received from a physician concerning a patient allergic to sulfonamide and codeine who on 15-JAN-2009 was vaccinated with a dose of PNEUMOVAX 23 into the left deltoid. Subsequently the patient developed cellulitis of injection site and experienced sore of injection site. The patient required an emergency room visit. Then the patient was hospitalized. At the time of the report, the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: Information has been received from a female patient who a "couple of years ago", was vaccinated with a dose of PNEUMOVAX 23. On an unknown date the patient experienced neck pain. The patient's final outcome was not reported. This is one of two reports received concerning the same patient. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Information has been received from a female respiratory therapist who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009. Over the weekend after receiving the vaccine the patient experienced fever, ache and pain and redness. The symptoms had been lasting about 24-48 hours. The patient sought medical attention by telephone. At the time on the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. A standard lot check investigation was performed. All in-process quality checks for lot number 659922/1667U were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of four reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site rash, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a now 74 year old female patient with sensitive to sulfites who had a localized reaction after vaccination with PNEUMOVAX 23. It's unknown if the patient had sought any medical attention. The patient subsequently experienced injection site bleeding, injection site swelling, rash and local reaction while on therapy with ZOSTAVAX (Merck) (MSD, WAES0907USA00753).  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain, Pain, Pyrexia
Clinical narrative: Information has been received from a respiratory therapist concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009. On an unspecified date after received the vaccine, she developed low grade fever and pain at the injection site. The symptoms lasted about 24-48 hours. The patient sought medical attention by telephone. At the time on the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. The reporter requested a lot check. A lot check has been initiated. Follow up information has been received from a respiratory therapist concerning the 75 year old female with elevated blood pressure at the time of vaccination; cardiac murmur and constipation started on 11-JUL-2007; ataxia started on 13-NOV-2007; hyperactive bladder, rhinitis allergic and localized primary osteoarthritis of the right knee started on 25-JUL-2008; epistaxis started on 20-AUG-2008; oesophageal reflux, fatigue, ganglion of the right wrist, osteopenia, hyperlipidaemia started on 03-FEB-2009; haematuria started on 17-FEB-2009; pollakiuria started on 26-MAY-2009; osteopenia started on 12-JUN-2009; benign essential hypertension started on 02-JUL-2009 who on 02-JUL-2009 at 09:30 a.m. was vaccinated intramuscularly into left deltoid with first dose of PNEUMOVAX 23 (lot # 659922/1667U). Concomitant therapy included aspirin, Q-10, H2OFF, multivitamins oral tablet, OCUVITE, oxybutyninCl, RESTASIS, simvastatin (manufacturer unknown) and ascorbic acid, CALTRATE-D, lisinopril (manufacturer unknown), and vitamin D. On 02-JUL-2009, she started on therapy with alendronate sodium (MSD) (70mg once weekly). On 02-JUL-2009, in the morning, the patient experienced tenderness at the injection site and low grade of fever, and achiness, a couple of days for each. On 05-JUL-2009, the patient recovered from tenderness at injection site, low grade of fever and achiness. A standard lot check investigation was performed. All in-process quality checks for the lot number 659922/1667U were satisfactory. The lot met the requirements and was released. Follow up information has been received via telephone call from a respiratory therapist who verified that the form sent was a listing of the patient's current health issues for evaluation. All the conditions listed on this form were pre-existing conditions and were present at the time of the patient's vaccination. None of the problems listed began after the patient was vaccinated with PNEUMOVAX 23. This is one of four reports from the same source. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a respiratory therapist concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009. On an unspecified date after received the vaccine she developed low grade of fever and pain at the injection site. The symptoms had been lasting about 24-48 hours. The patient sought medical attention by telephone. At the time of the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow up information has been received from a respiratory therapist concerning an 85 years old patient with a allergic to codeine and derivates, mercury and DETOX caps, localized osteoarthritis of the vertebral column (01-APR-2009), headache and joint pain, localized in the shoulder (29-APR-2009) and hypothyroidism, hypertension, peptic ulcer diseases, gastrooesophageal reflux disease at the time of vaccination and medical history of motor vehicle collision with another motor vehicle on a road, who on 01-JUL-2009 in the afternoon was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659922/1667U) intramuscular into right deltoid. Concomitant therapy include acetaminophen (+) codeine phosphate, amlodipine besylate, cephalexin, diazepam, flaxseed oil, LEVOXYL, omeprazole, PRESERVISION AREDS, temazepam, hydrochlorothiazide (+) triamterene. On 01-JUL-2009 in the afternoon the patient experienced redness and warm to touch at injection site and fever treat each lasted a few days. On 02-JUL-2009 therapy with methylprednisolone 4mg oral tablet was started. On 02-JUL-2009 following of vaccination the patient experienced cellulitis of the right arm, insomnia, neck sprain, osteoporosis senile, right trapezoid muscle strain. On 02-JUL-2009 the patient was started on therapy with CALTRATE D, alendronato (MSD), lisinopril and vitamin D. On 04-JUL-2009 the patient recovered from redness and warm to touch at injection site and fever. A standard lot check investigation was performed. All in-process quality checks for the lot number 659922/1667U were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received via telephone call from a respiratory therapist who verified cellulites of the right arm start on 02-JUL-2009, insomnia, neck sprain start on 02-JUL-2009 and right trapezoid muscle strain start on 02-JUL-2009. This is one of four reports from the same source. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Muscle strain, Pyrexia, Senile osteoporosis
Clinical narrative: Information has been received from a respiratory therapist concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009. On an unspecified date after received the vaccine she developed low grade of fever and pain at the injection site. The symptoms had been lasting about 24-48 hours. The patient sought medical attention by telephone. At the time of the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow up information has been received from a respiratory therapist concerning an 85 years old patient with a allergic to codeine and derivates, mercury and DETOX caps, localized osteoarthritis of the vertebral column (01-APR-2009), headache and joint pain, localized in the shoulder (29-APR-2009) and hypothyroidism, hypertension, peptic ulcer diseases, gastrooesophageal reflux disease at the time of vaccination and medical history of motor vehicle collision with another motor vehicle on a road, who on 01-JUL-2009 in the afternoon was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659922/1667U) intramuscular into right deltoid. Concomitant therapy include acetaminophen (+) codeine phosphate, amlodipine besylate, cephalexin, diazepam, flaxseed oil, LEVOXYL, omeprazole, PRESERVISION AREDS, temazepam, hydrochlorothiazide (+) triamterene. On 01-JUL-2009 in the afternoon the patient experienced redness and warm to touch at injection site and fever treat each lasted a few days. On 02-JUL-2009 therapy with methylprednisolone 4mg oral tablet was started. On 02-JUL-2009 following of vaccination the patient experienced cellulitis of the right arm, insomnia, neck sprain, osteoporosis senile, right trapezoid muscle strain. On 02-JUL-2009 the patient was started on therapy with CALTRATE D, alendronato (MSD), lisinopril and vitamin D. On 04-JUL-2009 the patient recovered from redness and warm to touch at injection site and fever. A standard lot check investigation was performed. All in-process quality checks for the lot number 659922/1667U were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received via telephone call from a respiratory therapist who verified cellulites of the right arm start on 02-JUL-2009, insomnia, neck sprain start on 02-JUL-2009 and right trapezoid muscle strain start on 02-JUL-2009. This is one of four reports from the same source. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a respiratory therapist concerning a male patient who on an unspecified date was vaccinated with a second dose of PNEUMOVAX 23 (lot # 659922/1667U) expiration date on 23-AUG-2009.  On an unspecified date after he received the vaccine he developed low grade of fever 100-101 degrees F, swelling from the elbow to the shoulder and painful at the injection site. The symptoms had been lasting about 24 to 48 hours. The patient sought medical attention by telephone. At the time on the report on 06-JUL-2009 the patient was recovering. There were no laboratories diagnostics studies performed. Follow up information has been received from a respiratory therapist concerning a 75 year old patient with cervical spondylosis started on 08-NOV-2006; hyperactivity of the bladder started on 22-OCT-2007; esophageal reflux started on 17-SEP-2008; cerebellar ataxia and impaired fasting glucose started on 15-JAN-2009; abnormal weight loss, and taking high-risk medication started on 17-MAR-2009; benign essential hypertension, bipolar disorder, bladder cancer, hyperlipidaemia, hypothyroidism, prostate cancer, and rheumatoid arthritis started on 01-JUL-2009; and hypertension illness at the time of vaccination who on 01-JUL-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659922/1667U) intramuscular into left deltoid at 2:00pm. Concomitant therapy included aspirin, CADUET, folic acid, acetaminophen/ hydrocodone bitartrate, lithiumC03, methotrexate, metoprolol succinate, MIRALAX, MUCINEX, nabumetone, pantoprazole sodium, TYLENOL, vitamin D (unspecified) and VOLTAREN. On 01-JUL-2009, in the PM, the patient experienced achiness, low grade fever and tenderness at injection location. On 01-JUL-2009 fluocinonide 0.05% external cream therapy was started. On 02-JUL-2009 methylprednisolone 4 mg oral tablet therapy was started. On 04-JUL-2009, the patient recovered from fever, achiness, tenderness at the injection location. The outcome for swelling from elbow to the shoulder was reported as recovering. On 13-JUL-2009, levothyroxine sodium 88 mg oral tablet therapy was started. A standard lot check investigation was performed. All in-process quality checks for the lot number 659922/1667U were satisfactory. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. Follow up information has been received via telephone call from a respiratory therapist who verified that the form sent was a listing of the patient's current health issues for evaluation. All the conditions listed on this form were pre-existing conditions and were present at the time of the patient's vaccination. None of the problems listed began after the patient was vaccinated with PNEUMOVAX 23. This is one of four reports from the same source. Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain in extremity
Clinical narrative: Information has been received from an office manager concerning a 73 years old female with unknown pertinent medical history and unknown allergies who on 23-JUN-2009 was vaccinated with a dose of PNEUMOVAX (lot number 662839/1089X). The patient developed an "allergic reaction", redness and pain in her right arm after vaccination (date unspecified). The patient was seen in the office on 25-JUN-2009 and was given 5 mg CEFTIN 1 pill three times a day. She had not been in for a follow up visit. At the time of the report, the outcome of the patient was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Weight increased
Clinical narrative: Information has been received from a 65 year old female who on 08-JUL-2009 was vaccinated with "1 dose of PNEUMOVAX 23 and "a" dose of ZOSTAVAX (Merck) (MSD) (dose, route and lot# not reported). Concomitant therapy included gonadotropin, chorionic. The patient mentioned that she began the "HCG diet" in June, 2009. She underwent a 9 days of liver and colon cleansing period. On 06-JUL-2009 she began the new phase of the diet that required her to inject 0.02 cc of HCG hormone subcutaneously into her abdomen. Her weight on 06-JUL-2009 was 163 pounds. Starting on 09-JUL-2009 she was restricted to 500 calories/day for the remaining 3 weeks of the diet. On 08-JUL-2009 she received PNEUMOVAX 23 and ZOSTAVAX (Merck). Then on 10-JUL-2009 her weight was 168 pounds. She also mentioned that she developed a slight red area at the injection site. She stated that she had bloodwork completed prior to beginning the diet. At the time of reporting, the patient had not recovered. No further information is available.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Haematoma, Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning her husband who in December 2008, was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported) with no reactions. On 09-JUL-2009 the patient received his second dose of PNEUMOVAX 23 (lot number not reported) (unspecified if this was the right or left arm). Concomitant therapy included cyanocobalamin. In July 2009, the patient experienced swelling from the elbow to the shoulder in the arm where the vaccine was given. The registered nurse stated her husband was not able to move his arm and he also had a fever of 101F. The nurse stated her husband was given another dose, because the physician did not have the correct medical records and did not know that he was already given a dose. The registered nurse reported on 09-JUL-2009 night she took her husband to the Emergency room but he was not admitted. The emergency room reported he had a "hematoma" and he was also treated with antibiotics. Subsequently, the patient recovered from swelling from the elbow to the shoulder, not able to move his arm, fever of 101 degrees F and hematoma. Follow up information has been received from a medical assistant concerning a 57 year old male patient with a history of coronary artery disease (CAD) in December 2008, allergy to LIPITOR (myalgia) and iodine solution (Hives), who in December 2008 was vaccinated with the first dose of PMEUMOVAX 23. On 09-JUL-2009 at 8:30 AM, the patient received a second dose of PNEUMOVAX 23 (Lot: 661527/0122Y) intramuscularly in the left deltoid (The physician's office did not know of the previous vaccination). On 09-JUL-2009, the patient experienced swelling, fever and hematoma which required an emergency room visit. Additional information is not expected.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning her husband who in December 2008, was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported) with no reactions. On 09-JUL-2009 the patient received his second dose of PNEUMOVAX 23 (lot number not reported) (unspecified if this was the right or left arm). Concomitant therapy included cyanocobalamin. In July 2009, the patient experienced swelling from the elbow to the shoulder in the arm where the vaccine was given. The registered nurse stated her husband was not able to move his arm and he also had a fever of 101F. The nurse stated her husband was given another dose, because the physician did not have the correct medical records and did not know that he was already given a dose. The registered nurse reported on 09-JUL-2009 night she took her husband to the Emergency room but he was not admitted. The emergency room reported he had a "hematoma" and he was also treated with antibiotics. Subsequently, the patient recovered from swelling from the elbow to the shoulder, not able to move his arm, fever of 101 degrees F and hematoma. Follow up information has been received from a medical assistant concerning a 57 year old male patient with a history of coronary artery disease (CAD) in December 2008, allergy to LIPITOR (myalgia) and iodine solution (Hives), who in December 2008 was vaccinated with the first dose of PMEUMOVAX 23. On 09-JUL-2009 at 8:30 AM, the patient received a second dose of PNEUMOVAX 23 (Lot: 661527/0122Y) intramuscularly in the left deltoid (The physician's office did not know of the previous vaccination). On 09-JUL-2009, the patient experienced swelling, fever and hematoma which required an emergency room visit. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a physician concerning a female patient who on 01-JUN-2009 was vaccinated with 0.5 ml PNEUMOVAX 23 (lot # 661528/0867X). On 03-JUN-2009 the patient developed edema at the injection site. On 04-JUN-2009, the patient went to emergency room and was given antibiotics and was "sent home". The patient was not admitted to hospital. Follow-up information was received from the physician who indicated that the patient did not report an adverse event to him, that the information came from the patient's husband. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 and experienced severe arm swelling. Its unknown if the patient has sought any medical attention. The pharmacist did not want to report this because she didn't administer the shot. This is one of several reports received from the same source. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning two male patients who on 17-JUN-2009 were subcutaneously vaccinated with PNEUMOVAX. Subsequently the patients developed cellulitis in the injection arm. The patients were seen on 20-JUN-2009 and the diagnosis was confirmed. The patients were not recovered at the time of reporting. Follow-up information was received from the pharmacist. The pharmacist provided the lot number 662840/1577X but clearly stated that after talking to her supervisor, the name of the patient would not be provided. This is one of several reports from the same source. No further information was available.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 8 week female patient with no pertinent medical history reported who on 13-JUL-2009 was possibly vaccinated with a dose of PNEUMOVAX 23 accidentally. It was reported that late on 13-JUL-2009 the physician was doing dictation and noticed that his nurse had signed out the PNEUMOVAX 23 instead of another similar sounding vaccine which had been intended for this child. No relevant laboratory testing had been performed. It was unknown if the child will receive any more PNEUMOVAX 23 and the child's father reported that she was showing no adverse effects from this event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with one dose of PNEUMOVAX 23 (lot # 662667/1435X). The patient had cellulitis like arm reactions, body aches, headaches, fever and dizziness after the vaccination. It's unknown if the patient had sought any medical attention. A lot check for PNEUMOVAX 23 was requested. Follow up information received from a nurse who reported that the patient's symptoms were the worst because she was immunocompromised. She had leukemia. The patient was considered to be recovered at the time of this report. A standard lot check investigation was performed on Lot # 662667/1435X. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Headache, Injection site pain, Pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient (age not reported) patient who was vaccinated with one dose of PNEUMOVAX 23 (lot # 662667/1435X). The patient had cellulitis like arm reactions after the vaccination. It was unknown if the patients had sought any medical attention. A lot check for PNEUMOVAX 23 was requested. Follow up information has been received from the registered nurse practitioner who reported that the female patient had reactions of injection site pain, body aches, headaches and dizziness. Subsequently, on an unspecified date recovered. This is one of several reports received from the same source. A standard lot check investigation was performed for lot no. 662667/1435X. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. This is one of several reports from the same source. Additional information has been requested.
Age: 45.0
Sex: U
Vaccine: HEP, HEPA, PPV, TTOX
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX (lot # 662664/0981X). Subsequently the patient experienced cellulitis and was admitted to hospital. The patient was still hospitalization at the time of reporting. Follow up information has been received from the pharmacist reported that the 45 years old patient (date of birth unknown to reporter) who was vaccinated with PNEUMOVAX on 17-JUL-2009. The pharmacist did not know if the patient received any concomitant vaccinations at the time of the vaccine administration. The patient developed cellulitis (date unknown to the reporter). The patient was not hospitalized. It was unknown if the patient recovered. Follow up information has been received from a physician reported that on 29-MAY-2009 (not on 17-JUL-2009 as previously reported), the patient received PNEUMOVAX and concomitantly received in the same arm a Tetanus vaccination (manufacturer and lot number unknown to the physician). The patient also received a Hepatitis A, (manufacturer and lot number unknown to the physician) and Hepatitis B, (manufacturer and lot number unknown to the physician) in the other arm. The onset of cellulitis was 30-MAY-2009. The patient was seen by the physician on 02-JUN-2009. The patient started treatment for cellulitis on 02-JUN-2009. The patient was placed on therapy with AVELOX. The patient had recovered. This is one of several reports from the same source. 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 the Center of Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an "over 65 years old" patient who was vaccinated with PNEUMOVAX 23 (lot number not available). Subsequently the patient "experienced swelling at the injection site". At the time of the report, the patient recovered from swelling at the injection site. 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. This is one of several reports received from the same source. Additional information has been requested.
Age: 77.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX 23 (lot # 662664/0981X). Subsequently the patient experienced cellulitis. It's unknown if the patient had sought any medical attention. Follow up information has been received from the pharmacist reported that the 77 years old patient (date of birth unknown to the reporter) who was vaccinated with PNEUMOVAX 23 on 09-JUL-2009. The pharmacist did not know if the patient received concomitant vaccines when the vaccine was administered. The patient had pain at the injection site after the vaccination (not cellulitis as previously reported). The patient was not hospitalized. It was unknown if the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Eructation, Flatulence, Swelling
Clinical narrative: Information has been received from a 60 year old female patient with type 1 diabetes mellitus, egg allergy and poultry allergy who in December 2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included insulin. It was reported that she began "burping eggs" and could not stop 15 minutes after administration of PNEUMOVAX. The patient then experienced gas, massive diarrhea and swelling. The patient reported the physician administered oxygen and "shots". The patient reported the physician said that she nearly died, however, she recovered in an hour (December 2008). There were no laboratory diagnostic tests performed. The patient was not hospitalized. No further information is available.
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 8 week old patient who on 22-JUL-2009 was vaccinated with a dose of PNEUMOVAX 23. No symptoms were reported. Follow up information was received from the physician's office. It was reported that the patient was suppose to receive PREVNAR, but accidentally received PNEUMOVAX 23. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Burning sensation, Pain in extremity, Pruritus, Swelling
Clinical narrative: Information has been received from a female consumer in her 70's with drug hypersensitivity who was vaccinated with a dose of PNEUMOVAX 23 (name and manufacturer unspecified) about 4 years ago, in approximately 2005. Concomitant therapy included influenza virus vaccine (unspecified). In approximately 2005 the patient experienced swelling, itching and burning on her inner forearm of the arm that she received the vaccine. The patient saw her physician who gave her a steroid (name and manufacturer unspecified) and several days later she had recovered. The patient also mentioned that she experienced soreness at the injection site after receiving the influenza virus vaccine (unspecified) about 4 years ago, in approximately 2005. No further information is available.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 40 year old female patient with no pertinent medical history and no known drug allergies, who on 24-JUL-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot : 662599/1076X). There was no concomitant medication. In 2009 the patient developed pain and swelling from elbow to shoulder of the arm where PNEUMOVAX 23 was administered. The patient sought unspecified medical attention. The physician did not have the patient's chart at the time of reporting. At the time of reporting on 27-JUL-2009, the patient status was unknown. The physician requested a lot check to be conducted because he does not feel comfortable using the vaccine. This is one of several reports from the same source. Additional information has been requested. A standard lot check investigation has been finalized. 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 the Center for Biologics Evaluation and Research and was released.