chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a woman in a doctor's office concerning a 56 year old female who on 05/14/2002 (also reported as 05/23/2002) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). "The next day", on 05/15/2002, or 05/24/2002, the pt developed local redness, local soreness, and local swelling. Subsequently, the pt recovered. Unspecified medical attention was sought. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also noted that similar experiences occurred with other patients from the same source (WAES #s 0206USA00883 and 0206USA00271). No additional info has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pyrexia, Tenderness
Clinical narrative: Info has been received from a registered nurse concerning a 72 year old female (conflicting follow-up info indicated pt was male) with allergies to propoxyphene HCl (DARVON), naproxen (NAPROSYN), ibuprofen (MOTRIN) and hydromorphone HCl (DILAUDID) who on 06/06/2002 was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent intramuscularly in the deltoid (lot 640577/0995L). Concomitant therapy included fosinopril sodium (MONOPRIL), hydrochlorothiazide (manufacturer unknown), estrogens, conjugated (PREMARIN), aspirin and vitamins (unspecified). It was reported that the pt received a 1st dose of pneumococcal vaccine 23 polyvalent in 1993 without reaction. On 06/07/2002, the pt presented to the office with a temperature and her left upper arm was red, swollen and tender with the site extremely warm to the touch. The entire outer upper arm from mid deltoid to elbow was affected. The pt was treated with cephalexin 500 mg TID and prednisone 60 mg x 3 days, 40 mg x 3 days, and 20 mg x 3 days. The pt recovered on 06/08/2002. The nurse reported that the pt's injection site erythema, swelling, pain, and inflammation were considered other medical events. No additional info is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered pharmacist and a licensed practical nurse (nurse manager) concerning a 78 year old retired female in a long term care facility with diabetes mellitus nos, coronary artery disease nos, hypertension nos, meperidine allergy (unspecified) and dementia nos, who on 03/05/2002 at 14:00 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #641027/1051L), intramuscularly, in the right deltoid. There was no concomitant therapy. On 03/06/2002 at 06:00 the pt awoke with complaints of pain/sore arm, redness/red arm and swelling at the injection site. No laboratory tests were performed. On 03/08/2002, the pt recovered from her pain, swelling and redness at the injection site. The physician pharmacy were "updated" with no orders. The licensed practical nurse reported that there were no long-term effects. The registered pharmacist and the licensed practical nurse reported that another pt was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #641027/1051L) from the same multidose vial and developed a sore, very red arm at the site of the injection (WAES #0203USA00901). No additional info is expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Info has been received from a nurse practitioner concerning a 48 year old female who on 06/27/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). On 06/28/2002 the pt developed a fever (104F) and "migrating" arthralgias. The fever and "migrating" arthralgias continued for 24 to 48 hours. Unspecified medical attention was sought. The nurse practitioner believes the pt was not previously vaccinated with pneumococcal vaccine 23 polyvalent. The nurse practitioner expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain, Pyrexia
Clinical narrative: Info has been received from a registered nurse concerning a 56 year old female with a penicillin allergy who on 06/06/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L) intramuscularly in the left deltoid. There was no illness at the time of vaccination. Concomitant therapy included methimazole (TAPAZOLE), propranolol and metformin HCl (GLUCOPHAGE). On 06/06/2002 the pt presented to the office with a temperature, and her arm was red, swollen and tender with the site extremely warm to the touch. Half of the upper arm was affected. The nurse also reported another pt (WAES #0206USA00895) developed a fever and injection site erythema, swelling, pain and inflammation post vaccination with pneumococcal vaccine 23 polyvalent. Follow-up info received from the nurse indicated that on 06/07/2002 the pt had developed a "10x12cm area of erythema" around the injection site which was treated with triamcinolone cream and cephalexin. The pt recovered from the injection site erythema on 06/08/2002. Follow-up info received from the registered nurse indicated that the pt "made full recovery 1 day past injection." Additional info is not expected.
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Info has been received from a doctor of pharmacy concerning a "healthy" male who was vaccinated on an unknown date with one dose of pneumococcal vaccine 23 polyvalent (lot #641114/1387L). A day or two after his vaccination, the pt had blood work drawn for HIV which returned positive for ELISA and negative for Western Blot. Additional info was received on 07/17/2002, from the doctor of pharmacy, who stated that the pt had a history of "risk factors for HIV" and was vaccinated "because of his diabetes." He further clarified that the blood work was drawn on the same day, within a few hours post vaccination. The reporter felt that it "was just coincidental that the Pneumovax 23 vaccination and the serum ELISA were positive on the same day." The pt sought unspecified medical attention. Additional info has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Injection site oedema, Pain, Pyrexia
Clinical narrative: Info has been received from a physician concerning a 47 year old male with abdominal pain who on 05/07/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #637487/1071K). On 05/08/2002 at 3:30 PM the pt developed fever, pain and swelling (right arm). It was reported that the pt recovered on 05/11/2002. No further info is expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 63 year old retired female pt with a history of hypertension and no known drug allergies who on 06/17/2002 at approx 10:30 was vaccinated intramuscularly in the right deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M). There was no illness at the time of vaccination. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), bisoprolol (+) hydrochlorothiazide (ZIAC), aspirin, thyroid, salmaterol xinafoate (SEREVENT) and calcium carbonate (OS-CAL). Subsequently on 07/17/2002 the pt developed a red, hot to touch, painful 6.5 by 7.5 inch site around the injection site. Unspecified medical attention was sought. Subsequently, the pt recovered. The nurse also reported a 2nd patient that had a similar experience after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M) (WAES #0207USA01694). Additional info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Info has been received from a licensed practical nurse concerning a female patient with a history of lupus and pancreatitis who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M). One day post vaccination, the pt developed a red, hot and painful 6.5 by 7.5 site around the injection site. The pt also developed a fever. Unspecified medical attention was sought. The nurse also reported a 2nd patient that had a similar experience after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641804/0035M) (WAES #0207USA01683). Additional info has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 67-year-old female with no known allergies, type II diabetes mellitus, and hypertension who on 06/07/2002 at 5:00 PM was vaccinated IM in the left deltoid with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot #641532/1353L). On 06/07/2002 (also reported as 06/10/2002) at 5:00 PM the pt developed pain and redness in the left arm 4" above the elbow to 2" below the elbow medially reddened, mildly indurated and warm which extended to the posterior triceps area. There was no fever. The vial was cultured and showed no growth. The event required a doctor visit. It was noted that a 1st dose of pneumococcal vaccine 23 polyvalent was given in 1993 and that on return visits for other reasons there were no complaints of problems with the left arm. The pt recovered on 07/01/2002. No further info is requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site oedema, Nausea, Pain, Pyrexia
Clinical narrative: Info has been received from a medical assistant concerning a 52-year-old female with a history of polycystic kidney disease, hypothyroidism and hypokalemia who on 07/23/2002 was vaccinated IM with the 1st dose of pneumococcal vaccine 23 polyvalent (lot #640744/0994L), administered in the deltoid. The pt was "well" at the time of vaccination. Subsequently, that same evening (also reported as 07/24/2002), the pt developed a fever of 103.4 degrees F and nausea. In addition, on the evening of 07/23/2002, the pt developed swelling of the arm. She was seen in the ER and diagnosed with Serum Sickness. Laboratory findings revealed that her WBC was elevated (subsequently reported as increased WBC beginning on 07/24/2002). She was not admitted to the hospital. On 07/24/2002 she developed chills and soreness in her arm. On 07/30/2002, the pt recovered. It was noted that the pt had never been vaccinated with pneumococcal vaccine 23 polyvalent previously. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that another pt developed adverse experiences following vaccination with pneumococcal vaccine 23 polyvalent (lot #640744/0994L) (WAES #0208USA03398). No further info is available.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Serum sickness
Clinical narrative: Info has been received from a medical assistant concerning a 52-year-old female with a history of polycystic kidney disease, hypothyroidism and hypokalemia who on 07/23/2002 was vaccinated IM with the 1st dose of pneumococcal vaccine 23 polyvalent (lot #640744/0994L), administered in the deltoid. The pt was "well" at the time of vaccination. Subsequently, that same evening (also reported as 07/24/2002), the pt developed a fever of 103.4 degrees F and nausea. In addition, on the evening of 07/23/2002, the pt developed swelling of the arm. She was seen in the ER and diagnosed with Serum Sickness. Laboratory findings revealed that her WBC was elevated (subsequently reported as increased WBC beginning on 07/24/2002). She was not admitted to the hospital. On 07/24/2002 she developed chills and soreness in her arm. On 07/30/2002, the pt recovered. It was noted that the pt had never been vaccinated with pneumococcal vaccine 23 polyvalent previously. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that another pt developed adverse experiences following vaccination with pneumococcal vaccine 23 polyvalent (lot #640744/0994L) (WAES #0208USA03398). No further info is available.
Sex: U
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Info has been received from a pharmacist concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt had an elevated white blood cell count 12 hours post vaccination. It was reported that "there were no bands, no symptoms and no fever". It is not known if medical attention was sought. Additional info has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Malaise, Pyrexia
Clinical narrative: Info has been received from a registered nurse concerning a 70 year old female with arthritis who on 08/01/2001 at 09:00 AM was vaccinated intramuscularly in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #637263/1448K). On 08/01/2001 at 13:00 PM the pt developed a 3" x 4" area at the injection site consisting of swelling, redness and warmth. The pt developed a temperature of 100.4 F and also experienced malaise lasting for 4 days. On 08/10/2001 (also reported as day 7 following the injection) the pt was treated with amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN) for a "possible cellulitis" at the same site. It was reported on 08/20/2001 that all symptoms appeared to be resolved. On 08/12/2002 the registered nurse reported that the pt has recently reported that the same area "will become red and tender for short periods at 4-6 week intervals". It was also reported that the area becomes warm. No further info is expected.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Drug administration error, Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 47year old male construction worker with no past medical history and no allergies, who on 8/20/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 637263/1448K) that expired on 6/1/02. There was no concomitant vaccination. At the time of vaccination, the patient was experiencing arthralgia due to over use. Unspecified medical attention was sought, but there were no adverse events. On 10/1/02 the patient had a negative streptococcus pneumoniae Ag test and per the physician the patient needs pneumococcal vaccine 23 polyvalent. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Malaise
Clinical narrative: Info has been received from a medical assistant concerning a female pt who on 07/23/2002 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot #640744/0994L). The pt was "well" at the time of vaccination. Subsequently, that same day, the pt developed a swollen, red, hot, hard arm and was generally not feeling well. She sought unspecified medical attention and recovered. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that another pt developed adverse experiences following vaccination with pneumococcal vaccine 23 polyvalent (lot #640744/0994L) (WAES #0208USA00021). Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema
Clinical narrative: Info has been received from a physician concerning a retired female with allergy to cerivastatin (Baycol) which she experienced rhabdomyolysis who in 1997 was vaccinated with pneumococcal vaccine 23 polyvalent. On 08/15/2002, the pt was vaccinated with pneumococcal vaccine 23 polyvalent 0.5cc IM administered via the left deltoid (lot #1050) (invalid number provided). On 08/15/2002 the pt experienced redness at injection site, swelling at injection site and local inflammatory reaction. Unspecified medical attention was sought. The pt's redness at injection site and swelling at injection site and local inflammatory reaction persisted. Additional info has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Info has been received from a 51 year old male pt with no past medical history and no known allergies, who in January 1997 and July 2002 was vaccinated with the 1st and 2nd doses of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. The pt reported that following the 2nd vaccination he had redness around the injection site which lasted for a day or two. At the time of this report, approx 6 weeks following the 2nd vaccination, there was still a faint quarter sized outline around the injection site, but it was not, swollen or itchy. The pt reported that "it just gives a slight outline about the size of a quarter" and he was told by his doctor that this was normal. Unspecified medical attention was sought. Additional info has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Oedema
Clinical narrative: Info has been received from a 68 year old male consumer with no medical history and no known allergies who was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent in approx 2000 and in May 2002, respectively. Concomitant therapy included "TOPOROL" metoprolol succinate (TOPROL XL TABLETS) and aspirin. Within 2 weeks of the 2nd dose of pneumoccal vaccine 23 polyvalent, the pt experienced unusual joint pain and swelling. On 08/28/2002 it was reported that the symptoms had not decreased. Unspecified medical attention was sought. Additional info has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Pyrexia, Rash
Clinical narrative: Info has been received from a medical assistant concerning a 66 year old male pt with penicillin, codeine and lodine allergies, who on 08/19/2002 was vaccinated subcutaneously in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot #641531/1352L). Concomitant therapy included simvastatin (MSD), amiodarone hydrochloride (MSD), paroxetine HCl (PAXIL), lisinopril (ZESTRIL), metoprolol succinate (TOPROL XL TABLETS), glyburide (+) metformin hydrochloride (GLUCOVANCE), rosiglitazone maleate (AVANDIA), methadone HCl, furosemide sodium (LASIX (furosemide sodium)), fosinopril sodium (MONOPRIL) and warfarin sodium (COUMADIN). On 08/22/2002 the pt presented at the doctor's office with rash, fever, edema, tenderness and erythema at the site of injection. The physician diagnosed cellulitis secondary to the pneumococcal vaccine 23 polyvalent injection. The pt was treated with methylprednisolone sodium succinate benzyl alcohol (Solu-Medrol) and antibiotics. On 08/23/2002 the pt was seen on a follow-up visit and it was determined that he recovered. Additional info is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Info has been received from a medical assistant concerning a 66 year old male pt with penicillin, codeine and lodine allergies, who on 08/19/2002 was vaccinated subcutaneously in the left arm with a dose of pneumococcal vaccine 23 polyvalent (Lot #641531/1352L). Concomitant therapy included simvastatin (MSD), amiodarone hydrochloride (MSD), paroxetine HCl (PAXIL), lisinopril (ZESTRIL), metoprolol succinate (TOPROL XL TABLETS), glyburide (+) metformin hydrochloride (GLUCOVANCE), rosiglitazone maleate (AVANDIA), methadone HCl, furosemide sodium (LASIX (furosemide sodium)), fosinopril sodium (MONOPRIL) and warfarin sodium (COUMADIN). On 08/22/2002 the pt presented at the doctor's office with rash, fever, edema, tenderness and erythema at the site of injection. The physician diagnosed cellulitis secondary to the pneumococcal vaccine 23 polyvalent injection. The pt was treated with methylprednisolone sodium succinate benzyl alcohol (Solu-Medrol) and antibiotics. On 08/23/2002 the pt was seen on a follow-up visit and it was determined that he recovered. Additional info is not expected.
Age: 36.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Injection site erythema, Malaise, Oedema, Pain
Clinical narrative: Info has been received from a physician and a 36 year old female medical assistant who on 08/27/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L) intramuscularly in her left arm. Concomitant vaccination included a dose of influenza virus vaccine administered in the right arm. That night the pt developed swelling from her shoulder to her elbow. The injection site had an inner red circle that was surrounded by a larger wheal of redness. The physician reported that the pt experienced a severe local reaction; arthralgia and malaise. The pt also experienced severe arm pain and "heat". The pt immediately took acetaminophen (TYLENOL) and diphenhydramine HCl (BENADRYL). Subsequently, she was treated with diphenhydramine HCl (BENADRYL) 50 mg HS. On 09/05/2002 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other pts (WAES # 0209USA00030 and 0209USA01591 through 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Erythema, Feeling hot, Malaise, Pain
Clinical narrative: Information has been received from a male physician who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the physician experienced a severe local reaction, swelling from his elbow to his armpit, severe arm pain, redness, heat, arthralgia and malaise. The symptoms radiated to his neck. The physician was treated with a methylprednisone acetate pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a male physician who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the physician experienced a severe local reaction, swelling from his elbow to his armpit, severe arm pain, redness, heat, arthralgia and malaise. The symptoms radiated to his neck. The physician was treated with a methylprednisone acetate pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pyrexia, Rash
Clinical narrative: Information has been received from a medical assistant concerning a female patient who was vaccinated SC with a dose of pneumococcal vaccine 23 polyvalent (lot # 641531/1352L). Subsequently, the patient developed rash, edema and fever. Unspecified medical attention was sought. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Laboratory test abnormal, Rash
Clinical narrative: Information has been received from a physician concerning a 58 year old female with a history of urinary tract infections who on 7/20/02 at 9:30AM was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant medication included estrogen therapy. The patient also had a Mantoux test (lot # C0942AB). The patient was reportedly not ill at the time of vaccination. After receiving the vaccination, the patient developed extensive urticaria and hives followed by polyarthralgias in the knees, ankles, wrists, and fingers. It was reported on 8/19/02, that the patient's rash has essentially subsided and the patient continues to have polyarthritis or at least polyarthralgias with a little bit of swelling in her knees and certainly some stiffness. It was reported that during the acute phase of this progression, the patient's serum iron was depressed which the reporter stated it might have been a viral reaction, viral anathem, such as Parvo virus 19 or something followed by a polyarthritis. The reporter also stated that the polyarthralgias will subside. Labs were performed on 8/15/02 including a blood count, erythrocyte sedimentation rate, serum C-reactive protein test, RA factor, serum antinuclear antibodies test, and serum antistreptolysin O antigen test. The results were reported as: CBC w/ diff = WBC 6.7x10*3/CUMM, RBC 4.15x10*6/CUMM, hemoglobin 13.1 grams/DL, hematocrit 39.6%, MCV 95fL, MCH 31.5pg, MCHC 33.0 G?DL, RDW 11.9%, platelet count 287x10*3, MPV 9.3 FL, neutrophils 58%, lymphocytes 35%, monocytes 6%, eosinophils 1%, basophils 0%. Absolute counts: neutrophils 3886 cells/cumm, lymphocytes 2345 cells/cumm, monocytes 402 cells/cumm, eosinophils 67 cells/cumm, basophils 0 cells/cumm, ESR - Westergren 6 MM/HR, ANA 0.3 EIA units. Rheumatoid factor = negative. Streptococcal AB, OT = < 50IU/ML. Small amounts of Group B beta strep, 10,000 colonies or less, were isolated in the patient's urine just before this started and as not considered significant in view of her history of UTI's but the physician planned to repeat the urine and culture. The patient's uterine ultrasound showed a thin endometrial stripe and was otherwise completely normal which made her unopposed estrogen therapy reassuring and the patient's dose of estrogen was reduced. It was reported on 8/19/02, that the patient was started on celecoxib 200mg once a day and the physician plans to follow up with the patient in a couple of weeks. The reporter also stated that of course, this whole reaction occurred right after a pneumococcal vaccine in which case, of course, it should subside. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 58 year old female with a history of urinary tract infections who on 7/20/02 at 9:30AM was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant medication included estrogen therapy. The patient also had a Mantoux test (lot # C0942AB). The patient was reportedly not ill at the time of vaccination. After receiving the vaccination, the patient developed extensive urticaria and hives followed by polyarthralgias in the knees, ankles, wrists, and fingers. It was reported on 8/19/02, that the patient's rash has essentially subsided and the patient continues to have polyarthritis or at least polyarthralgias with a little bit of swelling in her knees and certainly some stiffness. It was reported that during the acute phase of this progression, the patient's serum iron was depressed which the reporter stated it might have been a viral reaction, viral anathem, such as Parvo virus 19 or something followed by a polyarthritis. The reporter also stated that the polyarthralgias will subside. Labs were performed on 8/15/02 including a blood count, erythrocyte sedimentation rate, serum C-reactive protein test, RA factor, serum antinuclear antibodies test, and serum antistreptolysin O antigen test. The results were reported as: CBC w/ diff = WBC 6.7x10*3/CUMM, RBC 4.15x10*6/CUMM, hemoglobin 13.1 grams/DL, hematocrit 39.6%, MCV 95fL, MCH 31.5pg, MCHC 33.0 G?DL, RDW 11.9%, platelet count 287x10*3, MPV 9.3 FL, neutrophils 58%, lymphocytes 35%, monocytes 6%, eosinophils 1%, basophils 0%. Absolute counts: neutrophils 3886 cells/cumm, lymphocytes 2345 cells/cumm, monocytes 402 cells/cumm, eosinophils 67 cells/cumm, basophils 0 cells/cumm, ESR - Westergren 6 MM/HR, ANA 0.3 EIA units. Rheumatoid factor = negative. Streptococcal AB, OT = < 50IU/ML. Small amounts of Group B beta strep, 10,000 colonies or less, were isolated in the patient's urine just before this started and as not considered significant in view of her history of UTI's but the physician planned to repeat the urine and culture. The patient's uterine ultrasound showed a thin endometrial stripe and was otherwise completely normal which made her unopposed estrogen therapy reassuring and the patient's dose of estrogen was reduced. It was reported on 8/19/02, that the patient was started on celecoxib 200mg once a day and the physician plans to follow up with the patient in a couple of weeks. The reporter also stated that of course, this whole reaction occurred right after a pneumococcal vaccine in which case, of course, it should subside. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a medical assistant and a person from the office concerning a 74 year old female patient who on 9/4/02 at 10:56 was vaccinated in the right arm with a first dose of pneumococcal vaccine 23 polyvalent (lot # 640576/0923L). There was no concomitant medication and the patient was well at the time of vaccination. On 9/4/02 in the afternoon the patient complained that her arm where she had received the injection was itchy. On 9/6/02 at 11:00 the patient developed a hot area around the injection site that was swollen to an area larger than a tennis ball and injection site redness. The patient presented to the doctor's office, and her experience was reported to be a severe topical reaction at the site of injection. The physician prescribed levofloxacin 500mg PO for five days and instructed the patient to call the office in two days if the symptoms persisted. As of 9/16/02 the patient has not called and has not been seen in the office again. On 12/20/02, it was reported that the patient had recovered. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Oedema, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient (demographics unknown) who on 09/03/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640576/0923L).  On 09/11/2002, it was reported that the patient experienced a severe reaction, which consisted of swelling of the entire arm and fever.  Unspecified medical attention was sought.  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been rechecked by GMP compliance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Oedema, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 37-year old female who on 09/09/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (643249/0358M), and developed fever, pain and tenderness at the injection site on that day.  It was reported, "her condition is worsening".  She had a "7x4 inch" area of redness, swelling and induration, which was still spreading after 4 days.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Information has been received from a physician concerning an 80 year old retired white female with no known allergies who on 08/20/2002 was vaccinated intramuscularly with a 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 1050-invalid lot).  It was reported that the patient had been previously exposed to this or a related drug in 1998.  On 09/09/2002, it was reported that the patient developed a large red swollen left deltoid following vaccination.  It is unknown if medical attention was sought.  On 09/09/2002 the patient was reported as recovered.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Pain
Clinical narrative: Information has been received from a physician concerning a retired 67 year old white female with an allergy to aspirin who on 09/09/2002 was vaccinated intramuscularly in the right deltoid with a 0.5mL dose of pneumococcal vaccine 23 polyvalent (Lot # 1353-invalid lot).  It was reported that the patient had previous exposure to this or a related drug.  Following the vaccination, the patient experienced right arm inflammation and soreness.  It is unknown if medical attention was sought.  On 09/09/2002, the patient was reported as not being recovered and the experience was not still being treated.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Injection site pain, Malaise
Clinical narrative: Information has been received from a physician concerning his wife who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the wife experienced a "severe local reaction," swelling from her elbow to her armpit, severe arm pain, redness, heat, arthralgia and malaise. The wife was treated with a Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030 and 0209USA01592 through 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 48.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an approximately 48 year old male pt, who on 8/26/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) in the arm. Concomitant vaccination included a dose of influenza virus vaccine in the other arm. On approximately 8/27/02 the pt experienced an injection site reaction with swelling, warmth and redness "the size of a hand." The injection site was painful for 3 to 4 days. The pt was treated with Tylenol and cold compresses. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030, 0209USA01591, 0209USA01593 and 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a healthcare professional concerning a 36 year old male pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a "severe local reaction," swelling from his elbow to his armpit, sever arm pain, redness, heat, arthralgia, and malaise. The pt was treated with a Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030, 0209USA01591, 0209USA01592 and 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 36.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a healthcare professional concerning a 36 year old male pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a "severe local reaction," swelling from his elbow to his armpit, sever arm pain, redness, heat, arthralgia, and malaise. The pt was treated with a Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030, 0209USA01591, 0209USA01592 and 0209USA01594) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a healthcare professional concerning a 41 year old female pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalnet (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a "severe local reaction," swelling from her elbow to her armpit, severe arm pain, redness, heat, arthralgia and malaise. The pt was treated with Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030 and 0209USA01591 through 0209USA01593) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Age: 41.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a healthcare professional concerning a 41 year old female pt, who on 8/27/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalnet (641532/1353L) IM in the left arm. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. On approximately 8/29/02 the pt experienced a "severe local reaction," swelling from her elbow to her armpit, severe arm pain, redness, heat, arthralgia and malaise. The pt was treated with Depo Medrol pack for 6 days. On 9/5/02 it was reported that the symptoms were subsiding. The reporter expressed a concern with the lot. Five other patients (WAES0209USA00016, 0209USA00030 and 0209USA01591 through 0209USA01593) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a female pt with unknown medical history who on 9/19/02 was vaccianted with pneumococcal vaccine 23 polyvalent (642719/0376M) and developed shortness of breath, welts, redness, and pain around the injection site. It was reported the events continued for three days. No intervention data was provided. The pt did not seek medical attention. The medical assistant reported another pt also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0209USA02877). Additional info has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Contusion, Injection site rash, Rash
Clinical narrative: Information has been received from a 54 year old female consumer with  no past medical history and no allergies, who on 8/19/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included Zestril, alendronate sodium 70mg once a week and "Diertic." Subsequently, the pt developed a rash on her arm and at the injection site that persisted for a couple of weeks. On 9/30/02 the pt reported that the rash was now a bruise. The pt's blood work indicated an ALT of 199, which is "not supposed to be higher than 50." Additional info has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Malaise, Oedema peripheral
Clinical narrative: Information has been received from on 9/30/02 from a consumer concerning a 73 year old female with a morphine allergy and no past medical history who "about one year ago" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included estrogens, Premarin, vitamins, Fosamax and dapsone. It was reported that on the evening of vaccination she developed a red, hot swollen arm from elbow to shoulder. The symptoms "lasted two days and started to get better." It was also reported that the pt "did not feel well during the first day either." The pt sought unspecified medical condition. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received on 10/2/02 from a licensed practical nurse concerning a female who "1.5 years ago" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed a generalized rash and itching. The pt sought unspecified medical attention. Additional info has been requested.
Age: 80.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse and the wife of an 80 year old male with arthritis NOS and penicillin allergy who on 9/30/02 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent. Concomitant vaccination on 9/30/02 included influenza virus vaccine in the left arm. Other concomitant therapy included Norvasc, Celebrex, Lipitor, Prilosec. The nurse reported that following the vaccination, the pt felt achy, and tired and had a temp of 102.8. It was also reported that by the next day, the injection site was red and swollen, then the pt's whole arm became red, hot and swollen and the pt had a fever of 103 deg. The pt was seen by a physician and was treated for cellulitis and given Levaquin. The pt's wife reported that the physician believed that the cellulitis was caused not by the vaccine, but by the way it was administered. It was reported  that the vaccine was given without the injection site being swabbed with alcohol. Also, the injection site was not bandaged or covered afterwards. It was also reported that the pt had previously received vaccination with pneumococcal vaccine 23 polyvalent more than 5 years ago without incident. At the time of this report, the outcome of the events was unknown. No further details were available. No further info is expected.
Age: 80.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse and the wife of an 80 year old male with arthritis NOS and penicillin allergy who on 9/30/02 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent. Concomitant vaccination on 9/30/02 included influenza virus vaccine in the left arm. Other concomitant therapy included Norvasc, Celebrex, Lipitor, Prilosec. The nurse reported that following the vaccination, the pt felt achy, and tired and had a temp of 102.8. It was also reported that by the next day, the injection site was red and swollen, then the pt's whole arm became red, hot and swollen and the pt had a fever of 103 deg. The pt was seen by a physician and was treated for cellulitis and given Levaquin. The pt's wife reported that the physician believed that the cellulitis was caused not by the vaccine, but by the way it was administered. It was reported  that the vaccine was given without the injection site being swabbed with alcohol. Also, the injection site was not bandaged or covered afterwards. It was also reported that the pt had previously received vaccination with pneumococcal vaccine 23 polyvalent more than 5 years ago without incident. At the time of this report, the outcome of the events was unknown. No further details were available. No further info is expected.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 47 year old female pt who on 9/30/02 was vaccinated with pneumococcal vaccine 23 polyvalent (640744/0994L). The reporter indicated that within 24hrs (approx 10/1/02) of vaccination with pneumococcal vaccine 23 polyvalent, the pt's arm, which had been injected, developed "swelling" and was "hot to touch." The reporter called the event "extreme." The pt was treated with a 40mg IM injection of Medrol, and an unspecified dose of IM Benadryl. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.