chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Injected limb mobility decreased, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a 53 year old female with no pertinent medical history who on 04-NOV-2006, at 11:30, was vaccinated intramuscularly, into the right arm, with a first dose of Pneumovax 23 (lot #651400/0618F) concomitantly with a first dose of FLUVIRIN (lot #70384) intramuscularly into the left arm.  On 04-NOV-2006, at approximately 16:30, the patient experienced chills, fatigue, fever of 101.2 and redness, swelling and soreness in the affected arm.  The patient was unable to lift her arm above her head.  The patient was seen by her personal physician who placed her on therapy with BACTRIM.  There were no laboratory or diagnostic tests performed.  By 05-NOV-2006 the patient's arm was less swollen and red and the patient was released her physician to go on vacation.  Subsequently the patient recovered on 07-NOV-2006.  No additional information is expected.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 53 year old female with no pertinent medical history who on 04-NOV-2006, at 11:30, was vaccinated intramuscularly, into the right arm, with a first dose of Pneumovax 23 (lot #651400/0618F) concomitantly with a first dose of FLUVIRIN (lot #70384) intramuscularly into the left arm.  On 04-NOV-2006, at approximately 16:30, the patient experienced chills, fatigue, fever of 101.2 and redness, swelling and soreness in the affected arm.  The patient was unable to lift her arm above her head.  The patient was seen by her personal physician who placed her on therapy with BACTRIM.  There were no laboratory or diagnostic tests performed.  By 05-NOV-2006 the patient's arm was less swollen and red and the patient was released her physician to go on vacation.  Subsequently the patient recovered on 07-NOV-2006.  No additional information is expected.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Joint range of motion decreased, Swelling
Clinical narrative: Initial and follow up information has been received from a healthcare worker concerning a male patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient developed an allergic reaction to Pneumovax 23.  The reporter indicated his chief complaint was that his arm had swelled.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional follow up information has been received from a physician and a healthcare worker concerning the 65 year old male patient with a history of swelling arm from an unspecified vaccine at age 42 who on 03-JAN-2007 at 2:00 p.m. was vaccinated in left deltoid with his first dose of Pneumovax 23, lot 651321/1036P.  At 7:00 p.m., the patient had severe swelling of left arm, from site to past elbow.  It lasted 2 days.  The patient had trouble performing his job secondary to pain.  A doctor's visit was required. On 05-JAN-2007 the patient recovered from severe swelling of left arm from site to past elbow and pain.  Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Hypersensitivity, Injection site swelling, Oedema peripheral
Clinical narrative: Initial and follow up information has been received from a healthcare worker concerning a male patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient developed an allergic reaction to Pneumovax 23.  The reporter indicated his chief complaint was that his arm had swelled.  Unspecified medical attention was sought.  The patient's outcome was unknown.  Additional follow up information has been received from a physician and a healthcare worker concerning the 65 year old male patient with a history of swelling arm from an unspecified vaccine at age 42 who on 03-JAN-2007 at 2:00 p.m. was vaccinated in left deltoid with his first dose of Pneumovax 23, lot 651321/1036P.  At 7:00 p.m., the patient had severe swelling of left arm, from site to past elbow.  It lasted 2 days.  The patient had trouble performing his job secondary to pain.  A doctor's visit was required. On 05-JAN-2007 the patient recovered from severe swelling of left arm from site to past elbow and pain.  Additional information is not expected.
Age: 57.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a male patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient developed an allergic reaction to Pneumovax 23.  The reporter indicated his chief complaint was that his arm had swelled.  The patient's outcome was unknown.  Follow up information has been received from the healthcare worker and a physician concerning the 57 year old male janitor who on the p.m. of 03-JAN-2007 was vaccinated in left deltoid with his first dose of Pneumovax 23, lot #651321/1036P.  Approximately 6 hours later, the patient experienced pain and swelling at injection site, left deltoid.  It extended 12 cm to elbow with a width of 7 cm.  (The healthcare worker stated swelling measured 23 X 12 cm.)  The patient required a doctor visit.  He missed work for 2 days because of arm pain.  The patient recovered from pain and swelling at injection site on an unspecified date.  Additional information is not expected.
Age: 57.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Hypersensitivity, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a healthcare worker concerning a male patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient developed an allergic reaction to Pneumovax 23.  The reporter indicated his chief complaint was that his arm had swelled.  The patient's outcome was unknown.  Follow up information has been received from the healthcare worker and a physician concerning the 57 year old male janitor who on the p.m. of 03-JAN-2007 was vaccinated in left deltoid with his first dose of Pneumovax 23, lot #651321/1036P.  Approximately 6 hours later, the patient experienced pain and swelling at injection site, left deltoid.  It extended 12 cm to elbow with a width of 7 cm.  (The healthcare worker stated swelling measured 23 X 12 cm.)  The patient required a doctor visit.  He missed work for 2 days because of arm pain.  The patient recovered from pain and swelling at injection site on an unspecified date.  Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Joint stiffness, Myalgia
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 40 year old female with an allergy to codeine and rheumatoid arthritis who on 10-JAN-2007 at 12:05 PM was vaccinated intramuscularly in the left deltoid with the first dose of Pneumovax 23 (lot #655290/0959F). There were no illness at the time of vaccination. Concomitant therapy included Enbrel, Effexor and Feldene. On 11-JAN-2007, at 9:00 to 10:00 AM the patient experienced severe arthralgias and myalgias. It was reported that the patient could not walk due to joint pain/stiffness. The patient sought medical attention, and was treated with prednisone. The patient was to have labs drawn including CBC, CMP and CK, and was to follow-up with her physician in her hometown. At the time of this report, the outcome of the events was unknown. The patient's arthralgias and myalgias were considered to be disabling events and other important medical events. No further information is expected.
Age: 40.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Gait disturbance, Joint stiffness, Myalgia
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 40 year old female with an allergy to codeine and rheumatoid arthritis who on 10-JAN-2007 at 12:05 PM was vaccinated intramuscularly in the left deltoid with the first dose of Pneumovax 23 (lot #655290/0959F). There were no illness at the time of vaccination. Concomitant therapy included Enbrel, Effexor and Feldene. On 11-JAN-2007, at 9:00 to 10:00 AM the patient experienced severe arthralgias and myalgias. It was reported that the patient could not walk due to joint pain/stiffness. The patient sought medical attention, and was treated with prednisone. The patient was to have labs drawn including CBC, CMP and CK, and was to follow-up with her physician in her hometown. At the time of this report, the outcome of the events was unknown. The patient's arthralgias and myalgias were considered to be disabling events and other important medical events. No further information is expected.
Age: 86.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning an 86 year old female with no known allergies who on 11-JAN-2007 at 15:07 was vaccinated IM into the left arm with a third dose of Pneumovax 23 (lot number 651331/0577R).  Concomitant therapy included cyanocobalamin injections.  On 12-JAN-2007 the patient experienced swelling in the arm where vaccination occurred and a low grade fever.  The patient reported the adverse experiences to a physician the day after vaccination.  On 16-JAN-2007, the patient recovered.  Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning an 86 year old female with no known allergies who on 11-JAN-2007 at 15:07 was vaccinated IM into the left arm with a third dose of Pneumovax 23 (lot number 651331/0577R).  Concomitant therapy included cyanocobalamin injections.  On 12-JAN-2007 the patient experienced swelling in the arm where vaccination occurred and a low grade fever.  The patient reported the adverse experiences to a physician the day after vaccination.  On 16-JAN-2007, the patient recovered.  Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Lacrimation increased, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old self-employed male with no medical history or known drug allergies who on 02-FEB-2007 at 09:45 (during a physical exam) was vaccinated intramuscularly into the right deltoid with a first 0.5 mL dose of Pneumovax (Lot # 655500/1005F). Concomitant therapy included ACCUPRIL), aspirin and omega-3 marine triglycerides. Within 2-3 hours of receiving the vaccination (13:45), the patient complained of severe pain/hurting in injection site arm (previously reported as left arm). The pain radiated down the arm to the fingers which could not be moved (time frame unspecified). At 16:00, the patient took TYLENOL 9 grams. no rash was noted, however, there was swelling, erythema and it was very tender to touch. The patient placed his arm in a sling and was instructed to use ice for 20 minutes every 2-3 hours. At 16:53 that same day, the patient still had pain but could move his fingers. the patient was given a prescription for MOTRIN 800 mg every 6 hours which was taken at 17:10. No laboratory diagnostic studies were performed. No product quality complaint was involved. As of 20-MAR-2007, the patient still complained of pain but refused to be re-evaluated. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Injection site pain, Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old self-employed male with no medical history or known drug allergies who on 02-FEB-2007 at 09:45 (during a physical exam) was vaccinated intramuscularly into the right deltoid with a first 0.5 mL dose of Pneumovax (Lot # 655500/1005F). Concomitant therapy included ACCUPRIL), aspirin and omega-3 marine triglycerides. Within 2-3 hours of receiving the vaccination (13:45), the patient complained of severe pain/hurting in injection site arm (previously reported as left arm). The pain radiated down the arm to the fingers which could not be moved (time frame unspecified). At 16:00, the patient took TYLENOL 9 grams. no rash was noted, however, there was swelling, erythema and it was very tender to touch. The patient placed his arm in a sling and was instructed to use ice for 20 minutes every 2-3 hours. At 16:53 that same day, the patient still had pain but could move his fingers. the patient was given a prescription for MOTRIN 800 mg every 6 hours which was taken at 17:10. No laboratory diagnostic studies were performed. No product quality complaint was involved. As of 20-MAR-2007, the patient still complained of pain but refused to be re-evaluated. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old self-employed male with no medical history or known drug allergies who on 02-FEB-2007 at 09:45 (during a physical exam) was vaccinated intramuscularly into the right deltoid with a first 0.5 mL dose of Pneumovax (Lot # 655500/1005F). Concomitant therapy included ACCUPRIL), aspirin and omega-3 marine triglycerides. Within 2-3 hours of receiving the vaccination (13:45), the patient complained of severe pain/hurting in injection site arm (previously reported as left arm). The pain radiated down the arm to the fingers which could not be moved (time frame unspecified). At 16:00, the patient took TYLENOL 9 grams. no rash was noted, however, there was swelling, erythema and it was very tender to touch. The patient placed his arm in a sling and was instructed to use ice for 20 minutes every 2-3 hours. At 16:53 that same day, the patient still had pain but could move his fingers. the patient was given a prescription for MOTRIN 800 mg every 6 hours which was taken at 17:10. No laboratory diagnostic studies were performed. No product quality complaint was involved. As of 20-MAR-2007, the patient still complained of pain but refused to be re-evaluated. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old self-employed male with no medical history or known drug allergies who on 02-FEB-2007 at 09:45 (during a physical exam) was vaccinated intramuscularly into the right deltoid with a first 0.5 mL dose of Pneumovax (Lot # 655500/1005F). Concomitant therapy included ACCUPRIL), aspirin and omega-3 marine triglycerides. Within 2-3 hours of receiving the vaccination (13:45), the patient complained of severe pain/hurting in injection site arm (previously reported as left arm). The pain radiated down the arm to the fingers which could not be moved (time frame unspecified). At 16:00, the patient took TYLENOL 9 grams. no rash was noted, however, there was swelling, erythema and it was very tender to touch. The patient placed his arm in a sling and was instructed to use ice for 20 minutes every 2-3 hours. At 16:53 that same day, the patient still had pain but could move his fingers. the patient was given a prescription for MOTRIN 800 mg every 6 hours which was taken at 17:10. No laboratory diagnostic studies were performed. No product quality complaint was involved. As of 20-MAR-2007, the patient still complained of pain but refused to be re-evaluated. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Lacrimation increased, Pain in extremity
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a male patient "in his sixties" who in approximately February 2007 "within the past 6 weeks", was vaccinated with IM with a 0.5 ml dose of Pneumovax 23. In approximately February 2007 "within the past 6 weeks", the patient  experienced "excessive pain" at the injection site. Unspecified medical attention was sought. Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Initial and follow up information has been received from a registered nurse concerning a 61 year old male patient who on 02-FEB-2007 at 9:45 am was vaccinated IM with his first dose of PNEUMOVAX (Lot#655500/1005F). Two to three hours post vaccination that day the patient complained of pain at the injection site stating that it was tender to the touch, that there was swelling and erythema, but no rash. At 3 pm that same day the patient took acetaminophen for the discomfort. On an unspecified date the patient sought medical attention in the physician's office. The patient's arm was placed in a sling and he was instructed to ice the injection site area for 20 minutes every two to three hours and take ibuprofen 800 mg, every 6 hours, PRN discomfort. As of 20-MAR-2007 the patient had not recovered from the events. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Injection site pain, Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a male patient "in his sixties" who in approximately February 2007 "within the past 6 weeks", was vaccinated with IM with a 0.5 ml dose of Pneumovax 23. In approximately February 2007 "within the past 6 weeks", the patient  experienced "excessive pain" at the injection site. Unspecified medical attention was sought. Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Initial and follow up information has been received from a registered nurse concerning a 61 year old male patient who on 02-FEB-2007 at 9:45 am was vaccinated IM with his first dose of PNEUMOVAX (Lot#655500/1005F). Two to three hours post vaccination that day the patient complained of pain at the injection site stating that it was tender to the touch, that there was swelling and erythema, but no rash. At 3 pm that same day the patient took acetaminophen for the discomfort. On an unspecified date the patient sought medical attention in the physician's office. The patient's arm was placed in a sling and he was instructed to ice the injection site area for 20 minutes every two to three hours and take ibuprofen 800 mg, every 6 hours, PRN discomfort. As of 20-MAR-2007 the patient had not recovered from the events. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a male patient "in his sixties" who in approximately February 2007 "within the past 6 weeks", was vaccinated with IM with a 0.5 ml dose of Pneumovax 23. In approximately February 2007 "within the past 6 weeks", the patient  experienced "excessive pain" at the injection site. Unspecified medical attention was sought. Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Initial and follow up information has been received from a registered nurse concerning a 61 year old male patient who on 02-FEB-2007 at 9:45 am was vaccinated IM with his first dose of PNEUMOVAX (Lot#655500/1005F). Two to three hours post vaccination that day the patient complained of pain at the injection site stating that it was tender to the touch, that there was swelling and erythema, but no rash. At 3 pm that same day the patient took acetaminophen for the discomfort. On an unspecified date the patient sought medical attention in the physician's office. The patient's arm was placed in a sling and he was instructed to ice the injection site area for 20 minutes every two to three hours and take ibuprofen 800 mg, every 6 hours, PRN discomfort. As of 20-MAR-2007 the patient had not recovered from the events. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse via a company representative concerning a male patient "in his sixties" who in approximately February 2007 "within the past 6 weeks", was vaccinated with IM with a 0.5 ml dose of Pneumovax 23. In approximately February 2007 "within the past 6 weeks", the patient  experienced "excessive pain" at the injection site. Unspecified medical attention was sought. Additional information has been requested.  07/30/2008 This is in follow-up to report(s) previously submitted on 7/30/2007. Initial and follow up information has been received from a registered nurse concerning a 61 year old male patient who on 02-FEB-2007 at 9:45 am was vaccinated IM with his first dose of PNEUMOVAX (Lot#655500/1005F). Two to three hours post vaccination that day the patient complained of pain at the injection site stating that it was tender to the touch, that there was swelling and erythema, but no rash. At 3 pm that same day the patient took acetaminophen for the discomfort. On an unspecified date the patient sought medical attention in the physician's office. The patient's arm was placed in a sling and he was instructed to ice the injection site area for 20 minutes every two to three hours and take ibuprofen 800 mg, every 6 hours, PRN discomfort. As of 20-MAR-2007 the patient had not recovered from the events. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia, Chills, Dyspnoea, Mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old male with no medical history or allergies, who on 21-DEC-2006 was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot# 655288/0534F).  One hour later, the patient experienced pain and a heavy feeling in his arm and was unable to lift his arm.  He was examined by the physician that same day and was treated with prednisone.   The patient felt better soon after the prednisone was administered.  No diagnostic studies were performed.  It was noted that the patient was moving a lot of furniture the day before he received the vaccine so the nurse was not sure if the reaction was related to the vaccine or not.  Subsequently, the patient recovered.  It was also reported that the patient received Pneumovax 23 before without any reaction (date not reported).  No product quality complaint was involved.  Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity, Sensation of heaviness
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old male with no medical history or allergies, who on 21-DEC-2006 was vaccinated with a 0.5 ml dose of Pneumovax 23 (lot# 655288/0534F).  One hour later, the patient experienced pain and a heavy feeling in his arm and was unable to lift his arm.  He was examined by the physician that same day and was treated with prednisone.   The patient felt better soon after the prednisone was administered.  No diagnostic studies were performed.  It was noted that the patient was moving a lot of furniture the day before he received the vaccine so the nurse was not sure if the reaction was related to the vaccine or not.  Subsequently, the patient recovered.  It was also reported that the patient received Pneumovax 23 before without any reaction (date not reported).  No product quality complaint was involved.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Lymphadenopathy, Rash
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 61 year old retired female. On 13-NOV-2006, at approximately 10:00 AM, the patient was vaccinated intramuscularly in the left arm with Pneumovax 23 (Lot# 655290/0959F). Concomitant therapy included vitamins (unspecified), omega-3 urine triglycerides, an unspecified therapy ("WELLCHOL"), red yeast, "rice", OS-CAL, ezetimibe (MSD) and MIACALCIN. At the time of vaccination, the patient was noted to have pain in shoulders "left greater than right". On 13-NOV-2006, in the PM, the patient developed redness to anterior right shoulder and into axilla with slight right axilla lymph node swelling (previously reported as an immediate localized reaction with swelling, redness and "heat" immediately upon getting the injection). This was not the normal next day soreness that was common with the injection. It was reported that the patient had a right shoulder rash. The patient was treated with moist heat, alternated with ice "max 20 min" and KEFLEX 50 mg times 10 days. On 17-NOV-2006, the patient had recovered from the events. The reporter started "they have other vials of a different lot number that was not causing this same reaction that they were using. They had sequestered these vials and were not using them". The reporter stated that "17 vials of a 5-dose Pneumovax 23 vaccine that she has had some issues with, the lot number for these vials was (Lot# 655290/0959F)". The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government agency and was released by the regulatory agency. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Lymphadenopathy, Rash, Skin warm
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 61 year old retired female. On 13-NOV-2006, at approximately 10:00 AM, the patient was vaccinated intramuscularly in the left arm with Pneumovax 23 (Lot# 655290/0959F). Concomitant therapy included vitamins (unspecified), omega-3 urine triglycerides, an unspecified therapy ("WELLCHOL"), red yeast, "rice", OS-CAL, ezetimibe (MSD) and MIACALCIN. At the time of vaccination, the patient was noted to have pain in shoulders "left greater than right". On 13-NOV-2006, in the PM, the patient developed redness to anterior right shoulder and into axilla with slight right axilla lymph node swelling (previously reported as an immediate localized reaction with swelling, redness and "heat" immediately upon getting the injection). This was not the normal next day soreness that was common with the injection. It was reported that the patient had a right shoulder rash. The patient was treated with moist heat, alternated with ice "max 20 min" and KEFLEX 50 mg times 10 days. On 17-NOV-2006, the patient had recovered from the events. The reporter started "they have other vials of a different lot number that was not causing this same reaction that they were using. They had sequestered these vials and were not using them". The reporter stated that "17 vials of a 5-dose Pneumovax 23 vaccine that she has had some issues with, the lot number for these vials was (Lot# 655290/0959F)". The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government agency and was released by the regulatory agency. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Headache, Injection site rash, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 54 year old male with diabetes and dyslipidemia who on 17-OCT-2006 was vaccinated with Pneumovax 23 (lot # 655290/0959F) (0.5 ml), intramuscularly.  Concomitant therapy included aspirin, ACTOS, GLUCOPHAGE XR, LANTUS, VYTORIN, and HUMALOG.  On 17-OCT-2006 the patient experienced chills, fever, severe headache and arm very sore.  The patient was seen by primary care provider on 18-OCT-2006.  On 19-OCT-2006 the patient experienced rash (right arm - injection site), scattered erythema and right deltoid slightly bruised.  There were no signs of cellulitis.  The patient was seen at the practice by nurse practitioner.  The patient was given ULTRACET for headache and arm pain.  The patient recovered on 24-OCT-2006.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 54 year old male with diabetes and dyslipidemia who on 17-OCT-2006 was vaccinated with Pneumovax 23 (lot # 655290/0959F) (0.5 ml), intramuscularly.  Concomitant therapy included aspirin, ACTOS, GLUCOPHAGE XR, LANTUS, VYTORIN, and HUMALOG.  On 17-OCT-2006 the patient experienced chills, fever, severe headache and arm very sore.  The patient was seen by primary care provider on 18-OCT-2006.  On 19-OCT-2006 the patient experienced rash (right arm - injection site), scattered erythema and right deltoid slightly bruised.  There were no signs of cellulitis.  The patient was seen at the practice by nurse practitioner.  The patient was given ULTRACET for headache and arm pain.  The patient recovered on 24-OCT-2006.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Headache, Injection site bruising, Injection site rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 54 year old male with diabetes and dyslipidemia who on 17-OCT-2006 was vaccinated with Pneumovax 23 (lot # 655290/0959F) (0.5 ml), intramuscularly.  Concomitant therapy included aspirin, ACTOS, GLUCOPHAGE XR, LANTUS, VYTORIN, and HUMALOG.  On 17-OCT-2006 the patient experienced chills, fever, severe headache and arm very sore.  The patient was seen by primary care provider on 18-OCT-2006.  On 19-OCT-2006 the patient experienced rash (right arm - injection site), scattered erythema and right deltoid slightly bruised.  There were no signs of cellulitis.  The patient was seen at the practice by nurse practitioner.  The patient was given ULTRACET for headache and arm pain.  The patient recovered on 24-OCT-2006.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 54 year old male with diabetes and dyslipidemia who on 17-OCT-2006 was vaccinated with Pneumovax 23 (lot # 655290/0959F) (0.5 ml), intramuscularly.  Concomitant therapy included aspirin, ACTOS, GLUCOPHAGE XR, LANTUS, VYTORIN, and HUMALOG.  On 17-OCT-2006 the patient experienced chills, fever, severe headache and arm very sore.  The patient was seen by primary care provider on 18-OCT-2006.  On 19-OCT-2006 the patient experienced rash (right arm - injection site), scattered erythema and right deltoid slightly bruised.  There were no signs of cellulitis.  The patient was seen at the practice by nurse practitioner.  The patient was given ULTRACET for headache and arm pain.  The patient recovered on 24-OCT-2006.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injected limb mobility decreased, Nausea, Oedema, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 49 year old female with penicillin allergy who on 15-NOV-2006 at 9:30 AM was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 655290/0959F), intramuscularly in the left arm.  Concomitant therapy included LOTREL, AMBIEN, CELEXA, amitriptyline hydrochloride and CHANTIX.  On 16-NOV-2006 in the AM, the patient developed injection site redness, swelling and tenderness after immunization with Pneumovax 23.  It was also reported that on 16-NOV-2006 the patient experienced severe left arm pain, erythema, edema (7 cm), tenderness and nausea.  It was reported that "hurts to fully raise arm."  Ice was applied. DARVOCET was given for pain.  The patient recovered on 23-NOV-2006.  It was noted that on 17-OCT-2006 at 3:15 PM the patient was vaccinated with FLUVIRIN, intramuscularly in the left arm.  There were no relevant diagnostic test or laboratory data.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a 49 year old female with penicillin allergy who on 15-NOV-2006 at 9:30 AM was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 655290/0959F), intramuscularly in the left arm.  Concomitant therapy included LOTREL, AMBIEN, CELEXA, amitriptyline hydrochloride and CHANTIX.  On 16-NOV-2006 in the AM, the patient developed injection site redness, swelling and tenderness after immunization with Pneumovax 23.  It was also reported that on 16-NOV-2006 the patient experienced severe left arm pain, erythema, edema (7 cm), tenderness and nausea.  It was reported that "hurts to fully raise arm."  Ice was applied. DARVOCET was given for pain.  The patient recovered on 23-NOV-2006.  It was noted that on 17-OCT-2006 at 3:15 PM the patient was vaccinated with FLUVIRIN, intramuscularly in the left arm.  There were no relevant diagnostic test or laboratory data.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 49 year old female with penicillin allergy who on 15-NOV-2006 at 9:30 AM was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 655290/0959F), intramuscularly in the left arm.  Concomitant therapy included LOTREL, AMBIEN, CELEXA, amitriptyline hydrochloride and CHANTIX.  On 16-NOV-2006 in the AM, the patient developed injection site redness, swelling and tenderness after immunization with Pneumovax 23.  It was also reported that on 16-NOV-2006 the patient experienced severe left arm pain, erythema, edema (7 cm), tenderness and nausea.  It was reported that "hurts to fully raise arm."  Ice was applied. DARVOCET was given for pain.  The patient recovered on 23-NOV-2006.  It was noted that on 17-OCT-2006 at 3:15 PM the patient was vaccinated with FLUVIRIN, intramuscularly in the left arm.  There were no relevant diagnostic test or laboratory data.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea, Oedema, Pain in extremity, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a 49 year old female with penicillin allergy who on 15-NOV-2006 at 9:30 AM was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 655290/0959F), intramuscularly in the left arm.  Concomitant therapy included LOTREL, AMBIEN, CELEXA, amitriptyline hydrochloride and CHANTIX.  On 16-NOV-2006 in the AM, the patient developed injection site redness, swelling and tenderness after immunization with Pneumovax 23.  It was also reported that on 16-NOV-2006 the patient experienced severe left arm pain, erythema, edema (7 cm), tenderness and nausea.  It was reported that "hurts to fully raise arm."  Ice was applied. DARVOCET was given for pain.  The patient recovered on 23-NOV-2006.  It was noted that on 17-OCT-2006 at 3:15 PM the patient was vaccinated with FLUVIRIN, intramuscularly in the left arm.  There were no relevant diagnostic test or laboratory data.  A lot number check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 53.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Cold compress therapy, Headache, Heat therapy, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 53 year old male with drug allergies to NAPROSYN and HALCION who on 13-NOV-2006 at 0915 was vaccinated with Pneumovax 23 (lot number 655290/0959F) intramuscular in left arm.  On 13-NOV-2006 at 0915, concomitant vaccination included FLUARIX (lot number AFLUA234AA) intramuscular in left arm.  Concomitant therapy also included DIOVAN, hydrochlorothiazide (manufacturer unknown), NIASPAN, aspirin, PLAVIX, ezetimibe (MSD), COREG, AMARYL, CADUET, LANTUS, nitroglycerin, ULTRACET, AVANDIA, metformin and HUMALOG.  On 14-NOV-2006, in the evening, the patient experienced fever of 103.6, axillary lymph nodes swollen/"feels like a baseball in my armpit" and headache.  The patient was treated with moist heat, cold compress and cephalexin.  On 19-NOV-2006, the patient recovered from fever of 103.6, axillary lymph nodes swollen/"feels like a baseball in my armpit" and headache.  Additional information is not expected.
Age: 53.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 53 year old male with drug allergies to NAPROSYN and HALCION who on 13-NOV-2006 at 0915 was vaccinated with Pneumovax 23 (lot number 655290/0959F) intramuscular in left arm.  On 13-NOV-2006 at 0915, concomitant vaccination included FLUARIX (lot number AFLUA234AA) intramuscular in left arm.  Concomitant therapy also included DIOVAN, hydrochlorothiazide (manufacturer unknown), NIASPAN, aspirin, PLAVIX, ezetimibe (MSD), COREG, AMARYL, CADUET, LANTUS, nitroglycerin, ULTRACET, AVANDIA, metformin and HUMALOG.  On 14-NOV-2006, in the evening, the patient experienced fever of 103.6, axillary lymph nodes swollen/"feels like a baseball in my armpit" and headache.  The patient was treated with moist heat, cold compress and cephalexin.  On 19-NOV-2006, the patient recovered from fever of 103.6, axillary lymph nodes swollen/"feels like a baseball in my armpit" and headache.  Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: Information has been received from a registered nurse via a company representative concerning an approximately 40 year old male patient who was vaccinated IM inthe right arm with a dose of Pneumovax 23. concomitant therapy included diptheria toxoid. It was reported that the patient had a previous dose of pneumovax 23 vaccine on an unknown date.The same day the patient experienced pain, redness and swelling at the injection site. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV, TDAP, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse via a company representative concerning an approximately 40 year old male patient who was vaccinated IM inthe right arm with a dose of Pneumovax 23. concomitant therapy included diptheria toxoid. It was reported that the patient had a previous dose of pneumovax 23 vaccine on an unknown date.The same day the patient experienced pain, redness and swelling at the injection site. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Blood glucose abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with diabetes and environmental allergies who on 10-OCT-2006 at 11:30 AM was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 651330/1048P), in the right deltoid intramuscularly.  Concomitant therapy included HUMULIN, HUMALOG, ACCUPRIL and diuretic.  There was no illness at the time of vaccination.  On the morning of 11-OCT-2006 in the AM her fasting blood sugar was 300, also reported as 294.  She was later able to go to work.  She had not received Pneumovax 23 in the past but had received the influenza vaccine last year without adverse symptoms noted.  The patient fully recovered.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Blood glucose increased
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with diabetes and environmental allergies who on 10-OCT-2006 at 11:30 AM was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 651330/1048P), in the right deltoid intramuscularly.  Concomitant therapy included HUMULIN, HUMALOG, ACCUPRIL and diuretic.  There was no illness at the time of vaccination.  On the morning of 11-OCT-2006 in the AM her fasting blood sugar was 300, also reported as 294.  She was later able to go to work.  She had not received Pneumovax 23 in the past but had received the influenza vaccine last year without adverse symptoms noted.  The patient fully recovered.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: TDAP, FLU3, MNQ, TDAP
Symptoms: Abdominal pain, Abortion spontaneous, Drug exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: This case was received from another manufacturer (reference numbers A0648430A / 1-115313236) on 21 July 2007. The following information is verbatim as it appears in the other manufacturer's report: "This case was reported by a healthcare professional and described the occurrence of miscarriage in a 17 year old female subject who was vaccinated with Boostrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received unspecified dose of Boostrix (unknown). The subject participated in an observational study. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject became pregnant. This was her first pregnancy. The subject was seen in the emergency room for vaginal bleeding and abdominal pain at approximately seven weeks of pregnancy. Per the reporter, 'this would indicate that she was vaccinated approximately 13 days prior to the last menstrual period prior to her pregnancy. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject had a miscarriage. This case was assessed as medically serious. At the time of reporting the outcome of the events were was unspecified. Follow-up information received on 11 May 2007 indicated that the subject's last menstrual period was on 23 October 2006. On 13 November 2006, the subject received vaccination with Boostrix at 0.5 ml, intramuscularly in the left deltoid. On the same date, the subject received intramuscular injections of 0.5 ml Menactra and 0.5 ml Vaxigrip in the right deltoid. These vaccinations were also considered to be suspect. A spontaneous abortion began on 11 January 2007. The subject had an emergency room visit on 14 January 2007. The events resolved by 14 January 2007. In the reporter's opinion, the events were not related to Boostrix. An ultrasound dated 26 December showed that conception was 29 November 2006 and the subject was at 5 weeks and 6 days gestation. Ultrasound on 11 January 2007 showed a spontaneous abortion at 8 weeks and 1 day gestation." Vaxigrip lot# was reported as U2166KA. This lot# corresponds to Fluzone. Menactra lot# was reported as U1920AA. Boostrix lot# was reported as AC52B011BA.
Age: 17.0
Sex: F
Vaccine: TDAP, FLU3, MNQ, TDAP
Symptoms: Abdominal pain, Abortion spontaneous, Ultrasound scan abnormal, Vaginal haemorrhage
Clinical narrative: This case was received from another manufacturer (reference numbers A0648430A / 1-115313236) on 21 July 2007. The following information is verbatim as it appears in the other manufacturer's report: "This case was reported by a healthcare professional and described the occurrence of miscarriage in a 17 year old female subject who was vaccinated with Boostrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not provided. On an unspecified date the subject received unspecified dose of Boostrix (unknown). The subject participated in an observational study. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject became pregnant. This was her first pregnancy. The subject was seen in the emergency room for vaginal bleeding and abdominal pain at approximately seven weeks of pregnancy. Per the reporter, 'this would indicate that she was vaccinated approximately 13 days prior to the last menstrual period prior to her pregnancy. On an unspecified date, an unspecified time after vaccination with Boostrix, the subject had a miscarriage. This case was assessed as medically serious. At the time of reporting the outcome of the events were was unspecified. Follow-up information received on 11 May 2007 indicated that the subject's last menstrual period was on 23 October 2006. On 13 November 2006, the subject received vaccination with Boostrix at 0.5 ml, intramuscularly in the left deltoid. On the same date, the subject received intramuscular injections of 0.5 ml Menactra and 0.5 ml Vaxigrip in the right deltoid. These vaccinations were also considered to be suspect. A spontaneous abortion began on 11 January 2007. The subject had an emergency room visit on 14 January 2007. The events resolved by 14 January 2007. In the reporter's opinion, the events were not related to Boostrix. An ultrasound dated 26 December showed that conception was 29 November 2006 and the subject was at 5 weeks and 6 days gestation. Ultrasound on 11 January 2007 showed a spontaneous abortion at 8 weeks and 1 day gestation." Vaxigrip lot# was reported as U2166KA. This lot# corresponds to Fluzone. Menactra lot# was reported as U1920AA. Boostrix lot# was reported as AC52B011BA.
Age: 80.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 80 year old female with a history of breast cancer and cardiac arrhythmia who on 15-MAR-2007 was vaccinated with Pneumovax 23 (lot #655152/0889F), 0.5 ml, IM in the left deltoid.  Concomitant therapy included DEMEROL and LEXAPRO.  The patient was previously vaccinated with Pneumovax 23 in 1997.  On 17-MAR-2007, the patient called the physician's office and reported a swollen, painful left arm with red streaking.  The patient went to the emergency room but left before treatment.  The patient then went home and applied heat to her sore arm.  On 19-MAR-207, the patient called the physician's office to report that her arm was sore but the redness was fading.  Subsequently on an unspecified date, the patient recovered from swollen, painful left arm with red streaking.  No further information is available.