chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 73 year old female with severe asthma, allergies to tetanus and prochlorperazine (COMPAZINE) and no illness at the time of vaccination who on 10/15/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 64279/0111M) IM in the right deltoid. On 10/15/2002, the pt was concomitantly vaccinated with the 3rd dose of influenza virus vaccine (FLUZONE) (lot U0881AA). On 10/15/2002, the pt developed a reddened, swollen area 3 times size of silver dollar at the site of injection. The area was hot to the touch. The arm was extremely sore and difficult to move. Ice was applied and the pt was given acetaminophen (TYLENOL) for the pain. On 10/17/2002, the symptoms became worse. The pt was treated with methylprednisolone (MEDROL). The pt had a reaction to the methylprednisolone, and therapy with methylprednisolone was discontinued on 10/20/2002. The pt's symptoms were better and resolved on 10/21/2002. The nurse also reported that a pt developed cellulitis, flushing, pyrexia, headache, injection site erythema, injection site inflammation, movement disorder, and nausea (WAES #0210USA02344) and another pt developed injection site erythema and inflammation (WAES #0210USA02662) post vaccination with pneumococcal vaccine 23 polyvalent. No additional info is expected.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a registered nurse concerning a 73 year old female with allergies to penicillin and sulfa and was noted to be "healthy" at the time of vaccination who on 10/23/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 642749/0111M) IM in the right deltoid. On 10/22/2002, the pt was concomitantly vaccinated with a 7th dose of influenza virus vaccine (FLUZONE) IM in the left deltoid (lot U0881AA). On 10/23/2002, the pt developed a large reddened area at the injection site. The area was warm to the touch. The pt had a body temperature measurement of 98.2. Ice was applied and the pt was given acetaminophen (TYLENOL) as needed and methylprednisolone (MEDROL) as directed. On 10/25/2002, the pt was contacted and was improving. The pt was to continue methylprednisolone as directed. Subsequently, the pt recovered. The nurse also reported that a pt developed cellulitis, flushing, pyrexia, headache, injection site erythema, injection site inflammation, movement disorder and nausea (WAES #0210USA02344) and another pt developed injection site erythema, inflammation, swelling, pain in limb and drug hypersensitivity (WAES #0210USA02661) post vaccination with pneumococcal vaccine 23 polyvalent. No additional info is expected.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Oedema
Clinical narrative: Info has been received from an office manager concerning a male pt who was vaccinated in his left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed swelling and difficulty lifting his left arm. The reporter indicated that a pt was treated with antibiotics, but did not specify if it was this pt or a second pt (WAES #0210USA02466) that experienced an adverse event post pneumococcal vaccine 23 polyvalent vaccination. Unspecified medical attention was sought. Additional info has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Erythema, Injection site oedema, Pain, Somnolence
Clinical narrative: Info has been received from a 74 year old female with no known allergies, a history of prior vaccination with pneumococcal vaccine 23 polyvalent without an adverse reaction and soreness in her arm from an influenza virus vaccination on 10/21/2002 and no prior medical history as per pt report who on 10/23/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #09962-invalid). Concomitant therapy included metoprolol succinate (TOPROL XL TABLETS), atorvastatin calcium (LIPITOR) and paroxetine HCl (PAXIL). The pt reported that on 10/25/2002, she was "quite ill." She was extremely weak and slept much of the time. Her body ached all over. She had swelling of her shoulders, upper arms, and fingers. She also had some red marks on her body. The pt noted, she did not seek medical attention, therefore she had no physician info to provide. Additional info is not expected.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Malaise, Pain
Clinical narrative: Info has been received from a male physician who on 10/25/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 642719/0376M). On 10/25/2002, the pt was concomitantly vaccinated with a dose of influenza virus vaccine in the opposite arm. Approx 24 hours post vaccination on approx 10/26/2002, the physician reported that his arm was sore and tender. At 36 hours post vaccination, he had a red, triangular, raised area at the site of the injection. He also developed chills and malaise. On 10/28/2002, he was beginning to feel more normal. He took acetaminophen for the symptoms. Additional info is not expected.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pain
Clinical narrative: Info has been received from a nurse practitioner concerning an 82 year old male with a pacemaker, hypertension, no known drug allergies, a history of polio and no illness at the time of vaccination who at 0900 on 10/24/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent IM in the right deltoid (lot 641116/1160L). On 10/24/2002, the pt developed redness and swelling. The area was also sore and hard.  The nurse reported that the swelling had moved into his hand. The pt was treated with elevation, warm compresses, acetaminophen (TYLENOL) and diphenhydramine (BENADRYL). The pt subsequently recovered 2 weeks later. The nurse indicated that she would like a lot check performed on lot 641116/1160L. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional info is expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a physician concerning a male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641115/1159L). Within 24 to 48 hours post vaccination, the pt developed redness, swelling and pain at the injection site. The pt sought unspecified medical attention. Additional info has been requested.
Age: 78.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 78 year old female who on 10/24/2002 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M).  That same day, the pt also received an influenza virus vaccine. In October 2002, the pt experienced swelling and developed tenderness in the injected arm. The pt was diagnosed with right shoulder and arm cellulitis and was treated with cephalexin (KEFLEX). As of 10/29/2002, the nurse reported that the pt was "better". The nurse also provided info regarding other pts' experiences (WAES #0211USA00085, 0211USA00086 and 0211USA00087). The pt sought unspecified medical attention. Additional info has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site oedema, Lethargy, Nausea, Pain
Clinical narrative: Info has been received from a medical assistant concerning a 53 year old female who on 10/28/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641532/1353L). On approx 10/28/2002 the pt developed arm swelling, soreness, and flu-like symptoms such as nausea, vomiting and lethargy. The pt had received a dose of pneumococcal vaccine 23 polyvalent in the past. The medical assistant also provided info regarding another pt (WAES #0211USA00180). The pt sought unspecified medical attention. Additional info has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Info has been received from a medical assistant concerning a 53 year old female who on 10/28/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641532/1353L). On approx 10/28/2002 the pt developed arm swelling, soreness, and flu-like symptoms such as nausea, vomiting and lethargy. The pt had received a dose of pneumococcal vaccine 23 polyvalent in the past. The medical assistant also provided info regarding another pt (WAES #0211USA00180). The pt sought unspecified medical attention. Additional info has been requested.
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Headache, Injection site induration, Myalgia, Pain
Clinical narrative: Info has been received from a male physician who on 10/24/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, he developed local induration, tenderness, significant headache, myalgias and arthralgias. The physician sought unspecified medical attention. He was not hospitalized and was treated with methylprednisolone (MEDROL). No further info is available.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Feeling hot, Hypokinesia, Nausea, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 53 year old female with fibromyalgia, gastroesophageal reflux disease, irritable bowel syndrome and an allergy to propoxyphene HCl (DARVON) who was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent in approximately 1995 and on 10/28/2002 in the right arm (lot 642720/0172M), respectively. On an unspecified date, the pt was vaccinated with a dose of influenza virus vaccine. Concomitant therapy included citalopram hydrobromide (CELEXA), medroxyprogresterone acetate (PROVERA), estrogens, conjugated (PREMARIN), esomeprazole magnesium (NEXIUM), amitriptyline hydrochloride (ELAVIL), fexofenadine (ALLEGRA), hydroxyzine and "bellaspas". On 10/29/2002, the pt developed a fever of 101 which resolved on 10/30/2002. On 10/30/2002, the pt presented with a rash. The welts were the size of a quarter, very warm to the touch and painful. There were 3 welts just below the injection site and 3 were under the arm. Her arm was sore, and she had difficulty moving her arm. Overall, her joints ached, and she had nausea but no vomiting. The pt sought unspecified medical attention and was treated with promethazine HCl (PHENERGAN) for the nausea. Additional info has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Info has been received from a licensed practical nurse concerning a 53 year old female with fibromyalgia, gastroesophageal reflux disease, irritable bowel syndrome and an allergy to propoxyphene HCl (DARVON) who was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent in approximately 1995 and on 10/28/2002 in the right arm (lot 642720/0172M), respectively. On an unspecified date, the pt was vaccinated with a dose of influenza virus vaccine. Concomitant therapy included citalopram hydrobromide (CELEXA), medroxyprogresterone acetate (PROVERA), estrogens, conjugated (PREMARIN), esomeprazole magnesium (NEXIUM), amitriptyline hydrochloride (ELAVIL), fexofenadine (ALLEGRA), hydroxyzine and "bellaspas". On 10/29/2002, the pt developed a fever of 101 which resolved on 10/30/2002. On 10/30/2002, the pt presented with a rash. The welts were the size of a quarter, very warm to the touch and painful. There were 3 welts just below the injection site and 3 were under the arm. Her arm was sore, and she had difficulty moving her arm. Overall, her joints ached, and she had nausea but no vomiting. The pt sought unspecified medical attention and was treated with promethazine HCl (PHENERGAN) for the nausea. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a nurse practitioner concerning an adult female who on 10/23/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot 641116/1160L). On 10/23/2002, the pt developed redness and swelling. The pt was treated with warm compress, acetaminophen (TYLENOL), and diphenhydramine (BENADRYL). On 10/28/2002, the pt's symptoms were resolving. The nurse indicted that she would like a lot check performed on lot 641116/1160L. 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. No additional info is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a nurse practitioner concerning an adult female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641116/1160L). Subsequently, the pt developed redness and swelling. The pt was treated with warm compress, acetaminophen (TYLENOL), and diphenhydramine HCl (BENADRYL). The nurse indicated that she would like a lot check performed on lot #641116/1160L. 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 reported that 4 other adult females (WAES #0210USA02724, 0210USA02963, 0303USA02211 and 0306USA02761) and a male (WAES #0303USA02104) had a similar experience. No additional info is expected.
Sex: U
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Info has been received from a registered nurse concerning a pt who was vaccinated for the 1st time with a dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Concomitant therapy included "some type of allergy medicine" including loratoadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) or fluticasone propionate (FLONASE). Subsequently the pt experienced a lot of pain in the axilla (injection was given in the deltoid). The pt sought unspecified medical attention. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a physician concerning an adult female pt who "within the last 2 months" in approx October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). Subsequently in approx October 2002, the pt developed very sore arms, redness and swelling that went from her shoulders down her entire arm. The pt sought unspecified medical attention and was treated with anti-inflammatory agents (unspecified). Subsequently, all of the pt's symptoms resolved. The physician indicated that in his "many, many years" of experience with vaccinations, he had never seen such "an inordinate amount of reports" of "severe reactions" to pneumococcal vaccine 23 polyvalent as he had recently. He requested a lot check of Lot #643249/0358M. 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. The physician also mentioned that 2 other female pts (WAES #0306USA02608 and 0306USA02609) and a male pt (WAES #0211USA00320) had experiences following vaccination with pneumococcal vaccine 23 polyvalent (Lot #643249/0358M). Additional info has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning an adult male pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Subsequently, the pt developed swelling, redness and soreness at the injection site. It was reported that the pt sought medical attention. The outcome of the pt's swelling, redness and soreness at the injection site was unknown. The reporter expressed concern regarding 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. The reporter also mentioned a second male pt that had a similar experience following vaccination with pneumococcal vaccine 23 polyvalent (lot #641532/1353L) (WAES #0306USA02624). Additional info has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old female who was vaccinated with a first dose of pneumococcal vaccine 23 poyvalent (lot # 643504/0735M). Subsequently, the patient found that her injected arm was painful with no redness. The patient was treated with ibuprofen and ice application. As of 10/29/02, the nurse reported that the patient was feeling better. The patient sought unspecified medical attention. A product quality complaint was not involved. The nurse also provided information regarding other patients' experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician via a registered nurse concerning his sister who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient found that her injected arm became swollen, warm, and painful. The nurse also provided information regarding other patient's experiences. The patient sought unspecified medical attention. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician and an employee in a physician's office concerning a 50 year old male who within the last two weeks in October 2002, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 640981/1050L). Subsequently in October 2002, the patient developed erythema, warm, silver dollar swelling of the vaccinated arm. The physician requested that a lot check be initiated. 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. The patient sought unspecified medical attention. The physician also provided information concerning another patient's experience. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician's office employee concerning an adult male who on 10/30/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 6075M - invalid). On approximately 10/30/02 the patient developed swelling, redness, and soreness on the arm where he received the shot. The patient sought unspecified medical attention. It was reported that another adult male patient had a similar reaction. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Swelling
Clinical narrative: Information has been received from a physician and a 68 year old female licensed practical nurse who on 10/30/02 (also reported as November 2002 by the physician) was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent, 0.5mL, in her arm (lot # NDC0006 - invalid). On 10/31/2002, the patient's arm was swollen from her elbow to her shoulder and it was hot and painful to the touch (also reported as local soreness by the physician). The outcome was not reported. The patient sought unspecified medical attention. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: Information has been received from a health professional concerning a 59 year old male who on 10/30/02 was vaccinated in the right arm with pneumococcal vaccine 23 polyvalent (lot # 641116/1160L). On 11/1/02 the patient experienced redness, erythema, soreness, and arthralgia at injection site (right arm) and mild tenderness in his left arm. The patient was seen by his physician on 11/1/02. The patient was instructed to take diphenhydramine HCl 25 mg every 6 hours prn and 50mg at night for 3 days. It was reported if the events persisted the patient would be prescribed levofloxacin 500mg daily for 7 days. Additional information has been requested.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Influenza like illness, Nausea, Swelling, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 56 year old patient who on 10/28/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 641532/1353L). On approximately 10/28/02 the patient developed a swollen arm and flu-like symptoms such as nausea and vomiting. This was not the first dose of pneumococal vaccine 23 polyvalent that the patient had received. The patient sought unspecified medical attention. A product quality complaint was not involved. The medical assistant also provided information regarding another patient's experience after vaccination with a dose of pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site induration, Joint range of motion decreased, Paraesthesia
Clinical narrative: Information has been received from a registered pharmacist concerning a 42 year old female with no known allergies who on 10/29/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 643782/0675M). Concomitant therapy that day included a dose of influenza vaccine. On 10/30/02 the patient developed a 6 inch induration, tingling in the arm and difficulty using the arm. The patient sought unspecified medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a female adult patient with a ciprofloxacin hydrochloride allergy and no other past medical history who on 10/30/02 was vaccinated with pneumococcal vaccine 23 polyvalent (lot # 643784/0676M). Concomitant therapy that day included a flu vaccine and estrogens, conjugated. On 11/1/02 the patient developed redness and erythema area on her right arm which measured 4 inches. The patient was treated with diphenhydramine hydrochloride and warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Information has been received from a wife concerning her 65 year old husband with no known allergies and a history of hip replacement (3 years ago) who on 10/29/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 643783/0709M). Concomitant therapy included naproxen. On 10/29/02 the patient experienced pain and lost the ability to move his arm above his waist. As of 11/4/02, the patient gained minimal movement in his arm since vaccination. The patient was treated with ibuprofen. The patient sought medical attention from his primary care doctor. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 71 year old retired white female with diabetes who on 10/15/02 (previously reported as 10/28/02), at 10:00am, was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 643503/0541M), IM in the left deltoid. That same day, on 10/15/02 (previously reported as approximately 10/28/02), the patient experienced an injection site reaction described as redness from the shoulder to the elbow, swelling extending to the armpit, hot to the touch and soreness. The nurse reported that the patient did not require treatment and was not hospitalized. As of 11/4/02, the nurse indicated that the patient was fine. Follow up information from the nurse indicated that the patient did not require any diagnostic or lab tests and that the patient had not recovered from the injection site redness and soreness. The nurse also provided information regarding another patient's experience. The patient sought unspecified medical attention. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a physician concerning a male patient who within the last 2 months in approximately October 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 643249/0358M). Subsequently in October 2002, the patient experienced a very sore arm, developed redness and swelling that went from his shoulder down his entire arm. The patient was treated with anti-inflammatory agents (unspecified) and subsequently, all of his symptoms resolved. The physician indicated that in his many, many years of experience with vaccinations, he had never seen such an inordinate amount of reports of severe reactions to pneumococcal vaccine 23 polyvalent as he had recently. He requested a lot check of lot # 643249/0358M. The record 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. The patient sought unspecified medical attention. The physician also reported on other patient's experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Chills, Erythema, Feeling hot, Injection site swelling
Clinical narrative: Information has been received from a physician and a woman in a physician's office concerning a 71 year old white female with hypertension, a seizure disorder and allergies to carbamazepine, phenytoin, and cefazolin sodium who on 10/25/02 (previously reported as 10/24/02) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 642750/0210M). Concomitant therapy included phenobarbital, metoprolol tartrate and possibly influenza virus vaccine. On 10/25/02, the patient presented to a physician with right arm swelling (previously reported as swollen arm), chills, fever, joint pain, redness in her hand and heat from her shoulder down to her hand. Subsequently, the patient recovered from the right arm swelling, joint pain, redness in her hand and heat from her shoulder down to her hand. It was noted that the patient was vaccinated somewhere else and then presented to the reporting physician's office. The patient sought unspecified medical attention. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician and a woman in a physician's office concerning a 71 year old white female with hypertension, a seizure disorder and allergies to carbamazepine, phenytoin, and cefazolin sodium who on 10/25/02 (previously reported as 10/24/02) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 642750/0210M). Concomitant therapy included phenobarbital, metoprolol tartrate and possibly influenza virus vaccine. On 10/25/02, the patient presented to a physician with right arm swelling (previously reported as swollen arm), chills, fever, joint pain, redness in her hand and heat from her shoulder down to her hand. Subsequently, the patient recovered from the right arm swelling, joint pain, redness in her hand and heat from her shoulder down to her hand. It was noted that the patient was vaccinated somewhere else and then presented to the reporting physician's office. The patient sought unspecified medical attention. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Fluid retention, Pain
Clinical narrative: Information has been received from a 74 year old white male with no known allergies and an LPN. The patient was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent on 10/31/95 and the second dose on 10/22/02 SQ in the right arm (lot # 643249/0358M). On 10/22/02 the patient was also vaccinated with influenza vaccine (FLUZONE) IM in the left arm. Concomitant therapy included simvastatin, diltiazem hydrochloride, isosorbide, atenolol, omeprazole, amlodipine besylate, aspirin, vitamin E, fluticasone propionate, and imipramine. On approximately 10/22/02 the patient developed redness in his arm from the shoulder to the elbow and fluid retention and pain in his arm. Subsequently, the patient went to his physician and received a steroid shot. The patient's reaction lasted for 2 days. No further information is expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 76 year old white female with no history of allergies and a sore throat who on 11/6/02 (previously reported as 10/4/02) was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot # 644103/0710M) in her right deltoid. Concomitant therapy included erythromycin. On 11/7/02 (previously reported 11/6/02 at an office visit), the nurse noted the patient had developed a cellulitis like reaction described by the patient as soreness at the area of the injection site. The nurse reported that the area of the patient's right deltoid was erythematous, tender, and painful and that the patient was diagnosed with a local reaction. The patient developed swelling, redness, and a 17x17cm erythematous, warm indurated area of her right deltoid. The nurse also provided information regarding other patients' experiences. The patient sought medical attention at her physician's office. Additional information is not expected.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 63 year old white male pt who on 10/24/2002 (previously reported as 10/28/2002) was vaccinated at 11:00 with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643503/0541M), intramuscularly in the right deltoid, with no illness present at the time of vaccination. On 10/26/2002 (previously reported as approx 10/28/2002) the pt experienced an injection site reaction described as "redness from the shoulder to the elbow, swelling extending to the armpit, hot to the touch and soreness." The nurse reported that the pt did not require treatment and was not hospitalized. As of 11/04/2002, the nurse indicated that the pt was "fine". Follow-up info received from the nurse indicated that the pt did not require diagnostic or laboratory tests and that the pt had recovered. The nurse also provided info regarding another pt's experience (WAES #0211USA00307). The pt sought unspecified medical attention. Additional info is not expected.
Age: 20.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site warmth, Urticaria
Clinical narrative: Info has been received from a registered nurse in a clinic concerning an approx 20 year old female with no known drug allergies and asthma who on 11/05/2002 was vaccinated with pneumococcal vaccine 23 polyvalent. That same day medication included a dose of the influenza virus vaccine in the opposing arm. Subsequently the pt developed a small number of reddened welts that were approx 10 cm in diameter and were hot to touch. The pt sought unspecified medical attention. Additional info has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Pain, Pruritus
Clinical narrative: Info has been received from a registered nurse concerning a 72-year-old female who on 11/05/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642750/0210M). On approx 11/05/2002 the pt experienced local redness, induration and pain at the injection site. It was reported that she still had symptoms as of 11/07/2002, but they are improved. On 11/07/2002, "the site is now itchy". Unspecified medical attention was sought. Additional info has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 50 year old female with allergies to naproxen (NAPROSYN), loratadine (CLARITIN) and fexofenadine (ALLEGRA) (previously reported as no history of allergies), hypertension and rheumatoid arthritis who on 10/31/2002 (previously reported as 10/07/2002) was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #644103/0710M) in her right deltoid. Concomitant therapy included methotrexate sodium (METHOTREXATE (methotrexate sodium)), hydroxychloroquineSO4 (PLAQUENIL), rofecoxib (MSD), levothyroxine Na (SYNTHROID), sertraline HCl (ZOLOFT), pantoprazole sodium (PROTONIX), cyclobenzaprine HCl (FLEXERIL), ibuprofen (ADVIL), folic acid and influenza virus vaccine. On 10/08/2002, the pt developed a "cellulitis like" reaction described as "erythematous and painful" in the area of the injection. The nurse reported that at an office visit on 10/22/2002, the pt complained of painful range of motion (ROM) and that the pt was treated with diphenhydramine hydrochloride (BENADRYL) and a methylprednisolone sodium succinate (SOLU-MEDROL) dose pack. The nurse further reported that as of 11/12/2002, the pt had not been back in the office since the visit on 10/22/2002 and that she assumed that the pt had since recovered. The nurse also provided info regarding other patients' experiences (WAES #0211USA00663 and 0211USA00881). Follow-up info received from the registered nurse and medical records revealed that on 10/25/2002, the pt also received a "flu shot" and on 11/01/2002 the pt experienced a localized drug reaction described as right deltoid swelling, tenderness and erythema. Following the pt's vaccination with pneumococcal vaccine 23 polyvalent on 10/31/2002, the pt made 2 visits to her physician and on 11/03/2002, she went to the ER with complaint of "severe flu symptoms" which included aches all over (myalgias), nausea, vomiting and headaches and no respiratory symptoms. The pt also complained of being unable to move her right arm 90 degrees because of the aching. A physical examination revealed a temperature of 98.6, pulse of 80, respiratory rate of 18, and blood pressure of 140/80; right upper arm with erythematous 4 inch long distinct circular erythema area; negative vesicles; negative lymphadenopathy; local warmth; some streaking; and negative signs of infection. The pt was diagnosed with an allergic reaction in her right lateral arm. While in the ER, the pt received diphenhydramine hydrochloride, 50 mg and acetaminophen (-) hydrocodone bitartrate (LORTAB), 7.5 mg, orally. Subsequently, the pt was treated with diphenhydramine hydrochloride and methylprednisolone (MEDROL DOSEPAK). Medical records indicated that as of 11/04/2002, the pt was "improving." The pt sought medical attention at her physician's office and at an ER. Additional info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a female with no history of allergies who on 10/31/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #644103/0710M). On 11/01/2002, 24 hours after receiving the vaccination, the pt developed severe flu symptoms without respiratory symptoms and a "cellulitis like" reaction described as swelling and pain in her right shoulder. The nurse reported that the pt had 3 separate visits to ER and that on 11/03/2002, an ER summary indicated that the pt still had swelling and pain in her right shoulder and an area of erythema that measured 4x4 (not further specified) at the injection site and that she was diagnosed with a local drug reaction. The nurse further reported that the pt was prescribed diphenhydramine hydrochloride (BENADRYL) and a methylprednisolone sodium succinate (SOLU-MEDROL) dose pack and on 11/04/2002, the pt, recovering from the experience, was seen in the physician's office and was instructed to continue her therapy with diphenhydramine hydrochloride and methylprednisolone sodium succinate. The nurse also provided info regarding other patients' experiences (WAES #0211USA00663 and 0211USA00880). The pt sought medical attention from an ER physician. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pain, Vomiting
Clinical narrative: Info has been received from a registered nurse concerning a pt who was vaccinated for the 1st time with a dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Concomitant therapy included "some type of allergy medicine" including loratadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) or fluticasone propionate (FLONASE). Subsequently the pt experienced a lot of pain in the axilla (injection was given in the deltoid) and had an episode of vomiting the night after receiving the vaccination. The pt sought unspecified medical attention. Additional info has been requested.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 56-year-old female registered nurse with arthritis and environmental allergies who on 10/29/2002, in the AM, was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot #641532/1353L) (also reported as Pnu-immune) administered in the left deltoid. There was no illness at the time of vaccination. On that same date, in the AM, the pt was also vaccinated with a dose of influenza virus vaccine (FLUSHIELD) (lot #4020025) administered in the right deltoid. Concomitant therapy included rofecoxib (MSD) (12.5 mg daily) and montelukast sodium (MSD) ("100 mg daily"). On 10/29/2002, in the evening, the pt developed redness, a lot of erythema of the whole upper arm, a lot of warmth of the whole upper arm, tenderness and significant swelling under the left arm and axilla. The pt was unable to participate in exercise classes. The pt sought unspecified medical attention. Within 72 hours, the pt's symptoms resolved and as of 11/01/2002 she had recovered. There were no diagnostic tests or laboratory results. Additional info is not expected.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Rash maculo-papular
Clinical narrative: Info has been received from a registered nurse concerning a pt who was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Concomitant therapy included "some type of allergy medicine" including loratadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) or fluticasone propionate (FLONASE). Subsequently the pt developed 2 warm red spots on the arm (not at the injection site). Unspecified medical attention was sought. Additional info has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
Clinical narrative: Initial and follow up info has been received from a medical assistant and a physician concerning a 51 year old female teacher with a fear of injections and allergies to morphine and codeine with hallucinations and a history of migraines who on 10/17/2002, was vaccinated with her 1st dose of pneumococcal vaccine 23 polyvalent (Lot #640578/0996L), injection administered in the left hip at the pt's request. Concomitant therapy included loratadine (CLARITIN), zolmitriptan (ZOMIG) and valdecoxib (BEXTRA). On the day of the vaccination, the pt was started on therapy with valdecoxib (BEXTRA) for inflammation not related to the vaccination. On 10/18/2002 at 10:30 AM for the next week the pt experienced a headache, slept for 2 days, had pain all over including her hair and skin/ached all over for 3-4 days. The pt's developed injection site (left hip) inflammation and tenderness. The injection site was red, hot, hard to touch and the size of her hand. Subsequently, the symptoms subsided. On 10/31/2002, the pt recovered from her injection site inflammation and tenderness. The pt did not notify her physician until 11/07/2002, during an unrelated office visit. The pt did not state what or if treatment was used. Unspecified medical attention was sought. No further info is available.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Somnolence
Clinical narrative: Initial and follow up info has been received from a medical assistant and a physician concerning a 51 year old female teacher with a fear of injections and allergies to morphine and codeine with hallucinations and a history of migraines who on 10/17/2002, was vaccinated with her 1st dose of pneumococcal vaccine 23 polyvalent (Lot #640578/0996L), injection administered in the left hip at the pt's request. Concomitant therapy included loratadine (CLARITIN), zolmitriptan (ZOMIG) and valdecoxib (BEXTRA). On the day of the vaccination, the pt was started on therapy with valdecoxib (BEXTRA) for inflammation not related to the vaccination. On 10/18/2002 at 10:30 AM for the next week the pt experienced a headache, slept for 2 days, had pain all over including her hair and skin/ached all over for 3-4 days. The pt's developed injection site (left hip) inflammation and tenderness. The injection site was red, hot, hard to touch and the size of her hand. Subsequently, the symptoms subsided. On 10/31/2002, the pt recovered from her injection site inflammation and tenderness. The pt did not notify her physician until 11/07/2002, during an unrelated office visit. The pt did not state what or if treatment was used. Unspecified medical attention was sought. No further info is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a medical assistant concerning a 66 year old female pt who on 09/10/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #640576/0923L). Subsequently, the pt had a "severe topical reaction at the site of injection". On 09/11/2002 the pt presented to the doctor's office with injection swelling, injection site redness and the pt complained of pain. The physician prescribed doxycycline 500 mg every 6 hours for 10 days. As of 09/16/2002 the office has not heard from the pt. Additional info has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Info has been received from a Pharm D concerning a male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number not reported). Concomitant vaccination on the same day included a dose of influenza virus vaccine in the opposite arm. Subsequently the pt developed itching, swelling and redness on the underside of his arm that was injected with pneumococcal vaccine 23 polyvalent. The outcome of the pt's itching, swelling and redness was unknown. The Pharm D reported that the pt sought unspecified medical attention. A product quality complaint was not involved. Additional info has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Info has been received from a registered pharmacist concerning an 83 year old retired male with an allergy to codeine, coronary artery disease, chronic obstructive pulmonary disease and hyperlipidemia who was vaccinated IM in the right deltoid on 11/04/2002 at 10:00 with a second dose of pneumococcal vaccine 23 polyvalent (Lot #643783/0709M). There was no illness at the time of vaccination. In the evening, on 11/07/2002, the pt developed redness and tissue swelling on the right arm between the shoulder and elbow, also noted as cellulitis. The pt was treated in the ER with an unspecified IM antibiotic and cephalexin. There were no diagnostic or laboratory tests performed. The pt recovered on an unknown date. The reporter stated that the physician would like a lot check performed for this 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. No further info is expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Info has been received from a licensed practical nurse concerning a pt who was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent. Subsequently the pt developed cellulitis. The pt sought medical attention and was reportedly treated with antibiotics. It was that the pt was not hospitalized. It was also reported that some other patients and employees developed injection site soreness and redness (WAES #0211USA01238) after vaccination with pneumococcal vaccine 23 polyvalent. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Info has been received from a registered nurse concerning a female with an allergy to cefpodoxime proxetil, lactose (VANTIN) who on 11/06/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #644103/0710M). On 11/07/2002 the pt was seen in the doctor's office with "a local reaction to the (pneumococcal vaccine 23 polyvalent)." It was also reported that 3 other patients had a similar reaction following vaccination (WAES #0211USA00663, 0211USA00880 and 0211USA00881). Additional info has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Pain, Rash
Clinical narrative: Info has been received from a health care professional concerning a disabled 59 year old female pt with no known drug allergies who on 11/11/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent intramuscularly in the bicep (lot #643785/0872M). Concomitant vaccination the same day included a dose of influenza virus vaccine. After administration, the pt went to the ER because her arm was swollen and painful. She was treated with diphenhydramine hydrochloride (BENADRYL) and unspecified steroids. Follow-up info from a health care professional reported that on 11/11/2002 at 6:30 PM the pt called to report she had developed a rash with no itching and swelling the size of an egg that was extremely tender to the touch. She went to the ER where her arm was extremely painful with burning to the shoulder. It was also reported that this arm pain caused her blood pressure to go up. Subsequently, the pt recovered. It was also reported that a 62 year old male was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and extremely sore and painful arm. (WAES #0211USA01581). No further info is expected.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Info has been received from a registered nurse concerning a 44 year old female who on 10/16/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641115/1159L). Concomitant therapy that day included a dose of an influenza virus vaccine and interferon beta-la (AVONEX). Subsequently, the pt developed severe swelling above elbow, and entire posterior left arm was red and hot. The pt was also reportedly "short of breath, light headed." The reporter considered this as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt sought medical attention and was treated with cetirizine (Zyrtec). Additional info has been requested.