chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Injection site swelling; Pyrexia; Injection site erythema; Injection site pain. Information has been received from a physician's assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650453/0791P). Subsequently the patient developed a fever and injection site swelling, pain and redness. Unspecified medical attention was sought. Subsequently, the patient recovered. The reporter expressed a concern about the lot number. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physicians assistant concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine 650453/0791P. Subsequently the pt developed cellulitis with a fever, and injection site swelling, pain and redness. The pt went to the ER. Subsequently, the pt recovered. The reporter expressed a concern about the lot number. No product quality complaint was involved. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control Quarantine rejection system revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning an adult pt, with unknown medical history and drug reaction/allergies, who on an unspecified date was vaccinated IM in the left deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Subsequently, on an unspecified date, the pt experienced cellulitis of left arm. Unspecified medical attention, treatment was sought. No product quality complaint was involved. The nurse is requesting a lot check. The records of testing prior to 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.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a pt age and sex unknown, who on an unspecified date was vaccianted route unknown with a second dose of Pneumococcal 23v polysaccharide vaccine. The pt had previously received Pneumococcal 23v polysaccharide vaccine, but this history was unknown when the pt was given the second dose. Subsequently, on an unspecified date the pt experienced arm soreness. Unspecified medical attention was sought. The pts outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician and a medical assistant concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed erythema, swelling and pain of the upper forearm. Unspecified medical attention was sought. Subsequently the pt recovered. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning an adult pt, with unknown medical history and drug reactions/allergies, who on an unspecified date was vaccinated IM in the left deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Subsequently, on an unspecified date, the pt experienced cellulitis of left arm. Unspecified medical attention/treatment was sought. No product quality complaint was involved. The nurse is requesting a lot check. The records of testing prior to 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.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Information has been received from a certified medical assistant concerning a 57 year old white female smoker with chronic obstructive pulmonary disease and a history of upper respiratory tract infection who on 10-JAN-2006 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 650648/0967P).  Concomitant therapy include albuterol MDI, tiotropium bromide (SPIRIVA), and PREDNISONE taper finished 08-JAN-2006.  At the time if vaccination, the patient was recovering from lengthy, 7 week, respiratory illness.  On 11-JAN-2006 the patient developed soreness, redness, warmth, and swelling near the injection site on the left arm.  The patient was advised to take Ibuprofen and to observe symptoms.  No relevant diagnostic or laboratory tests were performed.  The patient's symptoms resolved within 48 hours.  The patient was contacted 3 weeks post injection and reported no sequelae.  No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient developed an allergic like reaction post vaccination.  The reaction included a swollen, large red area about six inches in diameter around the injection site.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a healthcare worker, and a company representative concerning her 68 year old husband, with no allergies with diabetes, hyperlipidemia, gastroesophageal reflux disease and cardiovascular disorder, who on 12-JAN-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#551330/1048P) (0.5 ml), intramuscularly.  Concomitant therapy included amlodipine besylate (NORVASC), fluvastatin sodium (LESCOL), hydrochlorothiazide (manufacturer unknown), ramipril (ALTACE), aspirin and vitamins.  On 12-JAN-2005 the patient experienced a reaction and the affected area was "twice the size of the other arm".  The patient previously received pneumococcal 23v polysaccharide vaccine on 17-OCT-2000.  The patient had a doctor's appointment on 13-JAN-2006.  The reporter requested a lot check.  The records of testing prior  to release of this lot have been checked by the Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there was no open Quarantines registered against this lot/fill.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown), with unknown medical history and unknown drug reactions/allergies reported, who on 27-DEC-2005 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (650457/0937P).  On 27-DEC-2005 the patient experienced a sore achy arm which was red and hot to touch with swelling to the elbow.  Subsequently, on "about" 30-DEC-2005, the symptoms resolved and the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a female with drug hypersensitivity to "some antibiotics" who on 10-JAN-2006 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (lot#650457/0973P).  On 10-JAN-2006 the patient experienced a sore and achy arm that was hot to touch and with swelling halfway down the arm.  Unspecified medical attention was sought.  On approximately 13-JAN-2006, the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Sleep disorder
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently the patient's arm hurt so much she could not sleep.  The patient went to the emergency room was given medicine, and sent home.  The patient recovered.  Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a healthcare worker and a physician concerning a 46 year old male software developer with diabetes and high blood pressure who on 13-JAN-2006 was vaccinated intramuscularly (previously reported as subcutaneous), into the right arm, with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Concomitant therapy included metformin HCL (GLUCOPHAGE), olmesartan medoxomil (BENICAR), rosiglitazone maleate (AVANDIA) and rosuvastin calcium (CRESTOR).  On 16-JAN-2006 the patient developed a knot and swelling at the injection site.  Unspecified medical attention was sought.  On 18-JAN-2006, the patient recovered from knot and swelling at the injection site.  Follow up information received from the physician reported that the patient called the doctors office on 13-JAN-2006 at 11:42 am. to report that his right arm was swollen at injection site of pneumococcal 23v polysaccharide vaccine.  It was reported that the patient did not seek medical attention.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a male who in January 2006, was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine.  In January 2006, after the vaccination, the patient developed a swollen arm and difficulty breathing.  The patient was treated with unspecified antibiotics and diphenhydramine hydrochloride (BENADRYL).  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Information has been received from a healthcare worker concerning a 56 year old female with a penicillin allergy and allergy to ticlopidine hydrochloride (TICLID) who on 28-DEC-2005 was vaccinated subcutaneously with a first  0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#650329/0747P).  Concomitant therapy included levothyroxine Na (SYNTHROID) and estrogens, conjugated (PREMARIN).  The healthcare worker reported that on 30-DEC-2005 the patient's "arm was red and swollen" and there were "there red welts around the injection site".  Medical attention was sought.  A methylprednisone dose pack (MEDROL DOSEPACK) was administered.  Subsequently, on an unspecified date, the patient recovered.  Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 81 year old (also reported as "71" years old) white male retired pharmacist, with an allergy to celecoxib (CELEBREX), who on 26-OCT-2005 (also reported as 26-OCT-2005), was vaccinated intramuscularly at 2:20 pm in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot#unknown).  It was reported that the patient was vaccinated in 1999 with a dose of pneumococcal 23v polysaccharide vaccine.  On 26-OCT-2005 (also reported as 26-OCT-2006), the patient developed a severe local cellulitis-like reaction.  Follow up information indicated that on 26-OCT-2005 (also reported as 26-OCT-2006), the patient developed redness of the left acromion with a streak going down axillary nodes.  The patient was treated with amoxicillin 500 mg, three times a day, and a Medrol dose pack.  There was no illness at the time of the vaccination.  Subsequently, on an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning an 80 year old retired female patient, with multiple drug allergies (codeine ("codine"), quinine, cyclobenzaprine hydrochloride (FLEXERIL), acetaminophen (+) hydrocodone bitartrate (Lortab), celecoxib ("CELEBRAN" CELEBRA), and acetaminophen (+) propoxyphene napsylate (DARVOCEY-N), who at 11:20 am on 17-JAN-2006 was vaccinated intramuscularly in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 651330/1048P). On 17-JAN-2006 the patient developed severe, local cellulitis-like reaction. Follow up information indicated that on the evening of 17-JAN-2006 the patient developed painful, swollen, red left arm, that also itched. The patient was treated with cephalexin (KEFLEX) 250 mg and desloratadine (CLARINEX) 5 mg. There was no illness at the time of vaccination. No product quality complaint was involved. On an unspecified date the patient recovered. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning 78 year old (also reported as 80) retired female patient, with an unknown medical history and unknown drug reactions/allergies, who on 10-OCT-2005 at 11:30 AM was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal 23v polysaccharide (Lot# 649989/0579P). On 10-OCT-2005, the patient developed a severe local cellulitis-like reaction. Follow up information indicated that on the evening of 10-OCT-2005, the patient developed pain and swelling at the injection site. Ice was applied. The swelling decreased by the AM on 11-OCT-2005. At the time of report it was noted that area was very tender to touch. There was no illness at the time of vaccination. Subsequently, on an unspecified date the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site abscess, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a nurse practitioner who initially reported that "over the years" several patients were vaccinated (route unknown) with pneumococcal 23v polysaccharide vaccine (Lot #'s unknown) and subsequently experienced local abscesses. Follow up information from the nurse practitioner indicated that there was only one patient who developed a local abscess following vaccination with pneumococcal 23v polysaccharide vaccine in her office. The nurse practitioner clarified that the patient was a 70 year old retired female, with unknown medical history, who at 10:00 AM on 10-NOV-2005, was vaccinated 9route unknown) in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine  (Lot #650331/0749P). There was no illness at the time of the vaccination. On 12-NOV-2005, at approximately 10:00 AM, the patient developed a large, hot, painful lump, that was deep pink at the injection site. The patient took diphenhydramine hydrochloride (BENADRYL) and applied cool compresses. the patient recovered on 17-NOV-2005. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient experienced pain and swelling with erythema on the injection arm which lasted for a couple of days. Medical attention was not sought. There was no product quality complaint involved. No further information is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Swelling
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 78 year old female with no past medical history , who on 21-NOV-2005 at 14:0 PM was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot# 650330/0748P). There was no concomitant medication. On the morning of 22-NOV-2005, the patient developed swelling of her arm to her wrist and complained of numbness. It was reported that the patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: A company representative reported that on an unspecified date a pt (NOS) was vaccinated with pneumococcal 23v polysaccharide vaccine (lot not provided). The pt developed cellulitis and was treated with an unspecified anti inflammatory medication. Subsequently, the pt recovered from the cellulitis. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received via a company rep from a physician concerning a male pt who on an unspecified date was revaccinated (after 5 yrs) with pneumococcal 23v polysaccharide vaccine (lot not provided). Subsequently, the pt developed an unspecified injection site reaction. The pt recovered from the injection site reaction without any intervention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed an allergic like reaction post vaccination. The reaction included a swollen, large red area about 6 inches in diameter around the injection site. The pt sought unspecified medical attention. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a physician concerning a 39 to 40 yr old female, with unk medical history or drug reaction/allergies reported, who on 23Jan06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). There was no concomitant medication. On 24Jan06 the pt developed redness and swelling of the injected arm, pain, fever of 102, and shaking chills. On 25Jan06 the physician saw the pt and sent her to the ER. It was noted that the pt had possible cellulitis. However, the physician did not feel the pt's reaction was cellulitis. The pt was not admitted and was treated with cephalexin. On 27Jan06, the physician saw the pt and the symptoms still persisted. She started the pt on therapy with amoxicillin/clavulanic acid (Augmentin). On 01Feb06, the pt was seen again by the physician. There was still an area of erythema and pain, but the physician considered the pt recovering. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Initial and follow up information has been received from a physician concerning a 39 to 40 yr old female, with unk medical history or drug reaction/allergies reported, who on 23Jan06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). There was no concomitant medication. On 24Jan06 the pt developed redness and swelling of the injected arm, pain, fever of 102, and shaking chills. On 25Jan06 the physician saw the pt and sent her to the ER. It was noted that the pt had possible cellulitis. However, the physician did not feel the pt's reaction was cellulitis. The pt was not admitted and was treated with cephalexin. On 27Jan06, the physician saw the pt and the symptoms still persisted. She started the pt on therapy with amoxicillin/clavulanic acid (Augmentin). On 01Feb06, the pt was seen again by the physician. There was still an area of erythema and pain, but the physician considered the pt recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a RN concerning an adult white female (age unk), with no illnesses at the time of the vaccination or preexisting allergies, birth defects or medical conditions, who at 11:00AM on 12Dec05 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. At 11:00AM, on 12Dec05 the pt experienced injection site redness and painful to touch. Subsequently, on 19Dec05 the pt recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Information has been received from a physician concerning a white, 75 yr old, retired female, whose reported weight was 131 pounds with allergies to penicillin, naproxen sodium (Aleve) and Neosporin who on 01Nov05 was vaccinated SC with a 0.5cc dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P). The physician reported that this was the pt's 3rd vaccination of pneumococcal 23v polysaccharide vaccine following an every 5 yr pattern. The pt was seen by the physician on 23Jan06. The pt reported to the physician that after receiving the pneumococcal 23v polysaccharide vaccination, she began to experience for 1 wk a sore, swollen arm and was very nauseated. The physician stated the following about the pt being the stoic individual she is, she sought no medical attention and took no treatment. The physician reported that the pt had recovered 1 wk later, after receiving  the pneumococcal 23v polysaccharide vaccination without incident. The pt was advised to no longer receive the pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a health professional concerning a female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). Subsequently, the pt experienced swelling at the site of injection, numbing of the lips, and itching eyes. No product quality complaint was involved. No other information was provided. The pt recovered. It was also reported that another pt had a similar reaction (WAES0512USA04076). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Sensation of heaviness, Similar reaction on previous exposure to drug
Clinical narrative: Initial and follow up information has been received from a 65 yr old white female registered nurse with asthma, hypertension, sulfonamide allergy, atropine and epinephrine drug hypersensitivity, who on 12Dec05 (previously reported as 22Dec05) was vaccinated (route unk) in her right upper arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). Concomitant therapy included Lisinopril (manf unk), hydrochlorothiazide (manf unk), fluticasone propionate (+) salmeterol xinafoate (Advair), albuterol and albuterol sulfate. Follow up information from the pt, a nurse, confirmed that at 10:30AM on 13Dec05, within 24 hrs of vaccination, her right upper arm stung at the site of injection and at times there is still discomfort in the site area. She also experienced a heaviness and a general ache of the entire upper arm. She indicated that it would come and go and lasted almost two months. No lump was noted previously; however, the pt reported in follow up that the site still feels somewhat lumpy, when manual pressure is applied. The nurse also indicated that many years ago, she had a flu shot with a gun in her left arm and experienced swelling from the shoulder down to the elbow. She indicated that she has never taken another flu shot and that she is sensitive to many recommended dose amounts. She also felt croupy in the past few weeks. No product quality complaint was involved. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 50 year old female with HIV disease, hypertension, shellfish allergy and sulfonamide allergy who on 26-JAN-2006 was vaccinated (route unknown) with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 27-JAN-2006 the patient developed swelling at the injection site, a red 1.25 inch area, tenderness, firmness, and induration after vaccination with pneumococcal 23v polysaccharide vaccine. The patient's present status was reported as not recovered. Registered nurse also indicated that the patient was able to lift her arm but that it was very sore. The patient was still able to perform her activities of daily living. The nurse did note consider it to be a serious/significant disability. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on 31-JAN-2006 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 650302/1039P). On 31-JAN-2006, the patient experienced a swollen arm "twice the size" and was warm to the touch. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning a patient who on an unspecified date was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 649697/1038P). "Within the last 2 months", the patient developed "redness and swelling of the arm where the injection was given". Subsequently, on an unspecified date, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Injection site reaction, Pain, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning an approximately 59 year old white male retired pharmaceutical executive with an allergy to Penicillin who on 13-OCT-2005 was vaccinated in the right deltoid with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine (Lot#650453/0791P).  Concomitant therapy included glyburide, atorvastatin calcium (LIPITOR), lisinopril (ZESTRIL), hydrochlorothiazide (manufacturer unknown), levothyroxine Na (SYNTHROID) and Allopurinol.  It was reported that on 14-OCT-2005, the patient developed a severe local reaction at the injection site including, redness, swelling, and pain.  Follow up information from the physician confirmed that the patient developed fever (>103), severe pain, swelling in his right arm and lightheadedness and was seen by his doctor or in the emergency room.  There was no illness at the time of vaccination.  The patient was reported to have recovered on 21-OCT-2005.  The reporter expressed concern about the lot#650453/0791P) for pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Initial and follow up information has been received from a physician concerning an approximately 59 year old white male retired pharmaceutical executive with an allergy to Penicillin who on 13-OCT-2005 was vaccinated in the right deltoid with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine (Lot#650453/0791P).  Concomitant therapy included glyburide, atorvastatin calcium (LIPITOR), lisinopril (ZESTRIL), hydrochlorothiazide (manufacturer unknown), levothyroxine Na (SYNTHROID) and Allopurinol.  It was reported that on 14-OCT-2005, the patient developed a severe local reaction at the injection site including, redness, swelling, and pain.  Follow up information from the physician confirmed that the patient developed fever (>103), severe pain, swelling in his right arm and lightheadedness and was seen by his doctor or in the emergency room.  There was no illness at the time of vaccination.  The patient was reported to have recovered on 21-OCT-2005.  The reporter expressed concern about the lot#650453/0791P) for pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Malaise, Myalgia, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning his wife, a 67 year old white female, with no pertinent medical history and no history and no drug reactions/allergies reported, who on 02-FEB-2006 at approximately 9:30 am was vaccinated (route unknown) with another 0.5 ml dose of pneumococcal 23v polysaccharide vaccine  (Lot# unknown).  Concomitant therapy included paroxetine HCL (PAXIL), and levothyroxine sodium (SYNTHROID).  Within a few hours of vaccination, on 02-FEB-2006 (also reported as 20-FEB-2006), the patient developed a fever, some soreness at the injection site.  The symptoms continued through the night and she had no fever on 03-FEB-2006.  Follow up information from the physician also indicated that on 20-FEB-2006 the patient developed high temperature, sore arm prostration, malaise, and anorexia.  No urticaria or respiratory problems were reported.  She took acetaminophen (TYLENOL) for generalized pain.  The patient recovered several days later.  There was no illness at the time of vaccination.  No product quality compliant was involved.  The physician reported in follow up that the patient had her first dose about 10 years ago, a second dose in October 2005.  Her doctor insisted she get the shot, "didn't think of recent vaccination".  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician, via a company representative, concerning a patient who, on unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported).  On an unspecified date, ("not recently") the patient developed arm swelling around the injection site.  The patient sought unspecified medical attention.  Outcome was not reported.  There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Malaise, Myalgia
Clinical narrative: Information has been received from a registered nurse concerning an adult patient who on 02-NOV-2005 was vaccinated with pneumococcal 23v polysaccharide (0.5 ml) (subcutaneous) (Lot#649912/0529P).  On 02-NOV-2005 the patient experienced injection site soreness, warmth, erythema, swelling and general malaise.  The patient was considered to be recovering.  Unspecified medical attention was sought.  Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: Initial and follow up information had been received from a registered nurse and another healthcare professional at the doctors office, respectively concerning a 79 year old white female patient, with allergies to amlodipine besylate (NORVASC), atropine sulfate (+) diphenoxylate hydrochloride (LOMOTIL), acebutolol hydrochloride (SECTRAL), verapamil hydrochloride (CALAN), alendronate sodium (MSD), and metoprolol tartrate (LOPRESSOR), who on the morning of 25-JAN-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#651320/1008P).  Initially it was reported that in February 2006, the patient developed redness and swelling at the injection site, and has chills.  The patient's status was reported as recovering for swelling and redness at the injection site and "subjective" chills.  Follow up information from the healthcare professional confirmed that at 3:30 pm on 25-JAN-2006 the patient developed swelling and "subjective" chills.  The patient also developed myalgia, pain, and 'subjective" fever.  The patient was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) and tramadol hydrochloride (TRAMADOLOR).  Outcome of myalgia, pain, and "subjective" fever was not reported.  It was also reported that there was no illness at the time of vaccination.  No product quality complaint was involved.  Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Neck pain, Pruritus
Clinical narrative: Initial (via a company rep) and follow up information has been received from a RN concerning a retired 85 yr old white female, with a penicillin allergy, an allergy to alendronate sodium, codeine, aspirin and chlorpheniramine maleate (+) phenylpropanolamine hydrochloride (Ornade), and a history of immunization and vaccination adverse reaction, who at 11:30am on 31Jan06 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 650456/0974P). There was no illness at the time of the vaccination. The nurse previously reported that on approx 01Feb06 the pt experienced itching at the injection site and neck pain, and developed redness at the injection site. The pt had indicated that the neck felt like they hit a nerve when they gave the injection. The pt said she had this pain with a previous unk vaccination. The nurse reassured the pt it was IM and not nerve pain. The nurse also reported that on 01Feb06 at 10:00PM the pt's arm became red, swollen and painful. No product quality complaint was involved. Outcome unk. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 60 yr old white female restauranteer who on 06Feb06, at 9:00AM was vaccinated IM, into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot651322/1044P). On 06Feb06, in the evening, it was noted that her arm was red, hot, swollen and hard from the injection site to elbow and halfway around her arm. The pt was able to use arm but hurt. Medical attention was sought and the pt was advised treated with ice and ibuprofen (Advil). On 11Feb06, the pt recovered. The office is concerned and reluctant to administer the remaining 3 doses from this vial. The doctor would like a lot investigation. A lot check has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a physician concerning a female with a history of unspecified hypersensitivity reactions who was recently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed severe allergic  reaction and rash. Medical attention was sought and the pt was treated with 2 courses of unspecified therapies. The pt's outcome was unk. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: DTP, PPV
Symptoms: Headache, Injection site mass, Pyrexia
Clinical narrative: Initial and follow up information has been received from a registered medical assistant and a 48 yr old white female homemaker with a sulfonamide allergy, allergy to sulfamethoxazole (+) trimethoprim (Septra) and had a history of breast cancer (previously reported as unspecified cancer (cancer a year ago) ). On 08Feb06 at 12:10PM (also reported as 12:00PM), the pt was vaccinated SC in the upper right arm with the first dose of pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). At the same time, the pt was vaccinated IM in the opposite arm with an unspecified diphtheria toxoid (+) pertussis vaccine. Concomitant therapy included fluoxetine HC1 (Prozac) and an unspecified therapy (Temoxypin). There were no known illnesses reported at the time of vaccination. On 08Feb06 (also reported as 09Feb06), at 4:30PM, the pt developed a headache, fever, localized site with injection lump (also reported as huge knot with injection site) and body aches (previously reported to have developed chills). There were no laboratory diagnostic studies performed. The pt sought unspecified medical attention (also reported as spoke with office staff). The pt was treated with acetaminophen (Tylenol), ibuprofen and ice. On 13Feb06, 5 days later, the site was still swollen, PNFL, and a large knot was present (also reported as symptoms resolved gradually and knot was still present on 13Feb06 at last communication with pt). As of 16Feb06 the pt had recovered from the events. Additional information is not expected.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a RN concerning a pt "over the age of 65 yrs" who was vaccinated on 09Feb06 with pneumococcal 23v polysaccharide vaccine (.25cc), ID. Within 8 hrs post vaccination, the pt had local site reaction of swelling. It was noted that most clients injection site was left arm. At the time of the report the pt had not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult pt (age and gender unk) with unk pertinent medical history and unk drug reactions/allergies, who, within the last week, in Feb 2006, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). In Feb 2006, the pt developed redness and swelling at the injection site. The pt's present status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult pt (age and gender unk) with unk pertinent medical history and unk drug reactions/allergies who, within the last week, in Feb 2006, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651320/1008P). In Feb 2006, the pt developed redness and swelling at the injection site. The pt's present status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a 28 yr old female nurse practitioner who on 10Feb06 was vaccinated IM into the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). By the next day, 11Feb06, the pt developed hives, "swelling warmth" and "redness at the injection site". The nurse practitioner further reported that she had "decrease use of left limb for 1 day". The pt sought unspecified medical attention. It was reported that there was "no treatment". At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypokinesia, Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 58 yr old white female with no medical history who on 10Feb06 at 2:00PM (also reported as 1:00PM) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P), IM in the left deltoid. Concomitant therapy included sertraline HC1 (Zoloft), alendronate sodium (Fosamax) and atorvastatin calcium (Lipitor). There was no illness at the time of vaccination. On 11Feb06 the pt developed hives, swelling, warmth, redness at injection site and decreased use of limb for 4 days. Hives lasted for 3 days, no treatment. It was reported that the pt recovered on 13Feb06. There were no relevant lab or diagnostic tests. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 59 yr old female who in approx 2005 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine. In Jan 2006, the pt was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine. In Jan 2006, the pt developed an injection site reaction. The physician reported that the pt's arm was swollen and red. The pt sought unspecified medical attention. At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 48 yr old female with asthma and allergies to aspirin and ibuprofen (Advil) who on 31Jan06 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). The same day, the pt experienced pain and swelling in the injection site arm. She went to the ER, but it was unk what treatment the pt received. On 03Feb06, the pt recovered. The nurse requested a lot check be performed on this lot since she was concerned about using it again. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a RN concerning a 66 yr old male who on 31Jan06 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot650453/0791P). On an unspecified date in 2006, the pt developed redness at injection site, the size of a baseball. the redness continued down his arm to his wrist. His entire arm was swollen, red, and tender to touch, and warm to touch. It resolved in 3 days. The pt sought unspecified medical attention. The RN reported that another pt received pneumococcal 23v polysaccharide vaccine with the same (lot650453/0791P) and had a reaction (WAES0603USA00281). A lot check of concern has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a RN concerning a pt over the age of 65 yrs who on 09Feb06 was vaccinated with pneumococcal 23v polysaccharide vaccine (.25cc), ID. Within 8 hrs post vaccination, the pt had local site reaction of swelling. The pt was treated with ice and diphenhydramine HC1 (Benadryl). The pt was also treated with heat. At the time of the report the pt had not recovered. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse and a health professional concerning a 70 yr old white retired male with a penicillin allergy, IV dye allergy, COPD, recurrent bronchitis, osteoporosis and a history of smoking (ceased in 1980's) who on 07Feb06 was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). Concomitant therapy included doxycycline. Since the pt was vaccinated he has been achy in his arm. He had developed some redness and swelling as well. He also developed a headache, was not sleeping well and had been feverish with no documented temps. The pt was diagnosed with cellulitis and was treated with cephalexin (Keflex) 500mg, four times daily for seven days. The pt was advised to rest that arm and keep it elevated as much as possible. It was noted that if the pt's conditions worsened he should follow up with his primary care physician and the pt will follow up in prompt care as needed. It was also noted on 09Feb06, the pt called and complained that his right arm was red and sore and the redness to the right arm was spreading downward. At the time of this report, the pt fully recovered. No product quality complaint was involved. Additional information is not expected.