chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 13 year old male pt with a history of asthma and pharyngitis and epistaxis at the time of vaccination who on 11/21/02 was vaccinated SC in the right arm with a first dose of pneumococcal vaccine 23 polyvalent (643503/0541M). Concomitant therapy on 11/21/02 included a first dose of influenza virus vaccine (Fluvirin) IM in the left arm (E31862GA). On 11/22/02 the pt developed cellulitis of the right arm (at the injection site) for two days. The pt was treated with antibiotics. It was noted that the pt recovered on 11/24/02. It was also reported that two female patients developed cellulitis at the injection site (WAES0211USA02439) and one female pt (WAES0302USA00556) developed cellulitis in the left arm at the injection site that resolved in two days. The symptoms of two of the patients cleared up without event. Two patients were seen over the weekend within "a day or two of injection" and at the time of this report follow up had not occurred. It was reported that the pt had recovered. Additional info has been requested.
Sex: M
Vaccine: PPV
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Info has been received from a physician concerning a male pt who was vaccinated SC in the left arm with a dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that 8 hours after receiving the injection, the pt developed paresthesia of the arm and is experiencing motor weakness of his left hand. No medical attention was sought. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a health professional concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently the pt developed local injection site reactions involving swelling, redness and soreness. According to the pt's physician the reaction was "mild". Unspecified medical attention was sought. The pt was not hospitalized. The reporter also described the experiences of 2 other pts who were also vaccinated with pneumococcal vaccine 23 polyvalent, (WAES #0212USA00647 and 0211USA02311). Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a health professional concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently the pt developed "severe" local injection site reactions involving swelling, redness and soreness. The pt was not hospitalized. Unspecified medical attention was sought. The reporter also described the experiences of 2 other pts who were also vaccinated with pneumococcal vaccine 23 polyvalent (WAES #0211USA02311 and 0212USA00646). 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 male pharmacist who on 12/03/2002 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Post-vaccination the pt experienced left arm pain, redness, and swelling from the deltoid to the elbow. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Info has been received from a licensed practical nurse concerning an elderly female who "early in November 2002" was vaccinated in the deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M) (it is unknown if first dose). Subsequently, the pt developed redness and induration from her elbow to her shoulder. The pt was seen at an ER, but not treated and sent home with instructions to apply cold compresses. Follow up info received from a licensed practical nurse indicated that she was "unable to locate" the elderly woman. It was noted that the pt was seen in the ER and treated for cellulitis. No further info is available due to the inability of the reporter to contact the pt and obtain a release. The reporter indicated that 9 other pts were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M) and developed induration at the injection site (WAES #0212USA00825, 0212USA01192, 0212USA01193, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 29-year-old male volunteer firefighter with no known drug allergies and no past medical history who on 12/02/2002 at 7:00 PM was vaccinated IM in the deltoid with a first dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Concomitant therapy that day at 7:00 PM included a dose of influenza virus vaccine (FLUZONE) (Batch #U0925AA) given IM in the deltoid. There was no illness at the time of vaccination. No adverse events following prior vaccinations for the pt or his siblings were reported. Two hours after receiving the vaccination, the pt was called out on a major structure fire and spent the next 20 hours at the fire scene engaged at times in heavy physical labor. On 12/03/2002 at 9:00 PM the pt developed induration and redness from his elbow to his shoulder, along with swelling, "hot to touch", and pain. He did not require medical care as a result of this. The reporter indicated that she suspects the heavy physical activity in the fire "played a major role in their reactions". It was noted that the pt recovered on 12/09/2002.The reporter indicated that 9 other pts received a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M) and developed induration at the injection site (WAES #0212USA00729, 0212USA01192, 0212USA01193, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain, Paraesthesia
Clinical narrative: Info has been received from a licensed practical nurse concerning a 58 year old male pt with a drug hypersensitivity to cephalexin (Keflex). There were no illnesses reported at the time of vaccination. On 11/13/2002 the pt was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent subcutaneously in the right arm (Lot #642720/0172M). On 11/14/2002 the pt developed paresthesias in right hand, redness in right arm and soreness in right arm. It was reported that the pt recovered. Additional info is not expected.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site induration, Injection site oedema, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning a 28-year-old female pt who on 11/06/2002 in the AM was vaccinated SQ in the right arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642720/0172M). It was reported that there was no illness at the time of vaccination. Subsequently, the pt developed swelling and tenderness at the site of the injection. The report also indicated that the site was painful and warm, with approx 3 cm by 3 cm induration. Unspecified medical attention was sought. Additional info has been requested.
Age: 41.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a physician concerning a 41 year old male pt with no known allergies and a medical history of non-hodgkins lymphoma who on 12/05/2002 at 14:00 was vaccinated intramuscularly in the left deltoid area with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642722/0165M). On 12/05/2002, the pt was concomitantly vaccinated with influenza virus vaccine. On 12/05/2002 at 5:00 PM. "3 hours post vaccination", the pt developed erythema, tenderness and edema at the injection site (left deltoid area) of the pneumococcal vaccine 23 polyvalent. Erythema and edema progressed to the elbow over the next 48 hours. There was no relevant diagnostic laboratory data. The pt was treated in the ER with antibiotics (unspecified therapy) for possible cellulitis and diphenhydramine HCl (Benadryl) and steroids (unspecified therapy) for an allergic reaction. There were no sensory or muscle damage reported and the pt did not develop fever or chills at any time. Subsequently, the pt recovered. No further info is expected.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Info has been received from a medical assistant concerning a male pt who on 12/05/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644103/0710M). On 12/07/2002 the pt developed cellulitis and was treated with injections of ceftriaxone sodium (Rocephin). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. It was also reported that another male pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644103/0710M) and developed cellulitis (WAES #0306USA02719). Additional info has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 62-year-old female pt with dilated cardiomyopathy and no known allergies and no acute process who on 12/09/2002, also reported as 12/06/2002, was vaccinated IM in the left arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #644104/0873M). Concomitant therapy that day, also reported as 12/06/2002, included a 2nd dose of influenza virus vaccine (FLUSHIELD) (Lot #400-0011) given IM in the right arm. There were no chronic medications. On 12/10/2002, also reported as 12/07/2002, the pt developed a local reaction described as a "very painful and swollen arm". The pt was seen at an ER where her HCP saw her and recommended warm compresses. It was reported that the pt was scheduled to be seen 12/10/2002, but has not been heard back from since 12/07/2002. Follow up info received from a registered nurse indicated that on 12/10/2002, the pt developed redness and edema below the injection site. There was no acute distress. It was reported that the MD impression was a chemical reaction which was due to either irritation, questionable allergic reaction, or "TMT". Initially in the ER the pt was given diphenhydramine hydrochloride (BENADRYL) and ice. The pt was instructed to continue with cool compresses for 24 hours, then switch to warm compresses, and to elevate her arm. She was prescribed antihistamines and antiinflammatories prn, and instructed to follow up with her PCP. The report indicated that the pt recovered. No further info is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Nausea, Pain, Rash
Clinical narrative: Info has been received from a woman in a medical office concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644106/0819M) intramuscularly in the deltoid. Subsequently, the pt experienced nausea and vomiting and developed a rash. He also developed redness, swelling and soreness at the injection site and down the arm. On 12/18/2002, it was reported that the pt's symptoms had subsided by the next day and that no treatment, testing or work-up was necessary. Additional info is not expected.
Sex: U
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Info has been received from a woman in a medical office concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644106/0819M) intramuscularly in the deltoid. Subsequently, the pt experienced nausea and vomiting and developed a rash. He also developed redness, swelling and soreness at the injection site and down the arm. On 12/18/2002, it was reported that the pt's symptoms had subsided by the next day and that no treatment, testing or work-up was necessary. Additional info is not expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Info has been received from a health professional concerning a female pt who in Nov 2002 was vaccinated with pneumococcql vaccine 23 polyvalent (Lot #643782/0675M). Hours after vaccination the pt experienced a red, warm lump at injection site. At 4 days post-vaccination, the lump was still present and measured about 2.5 x 3 x 3 inches in size. Follow up info has been received from a registered nurse concerning a 52 year old female pt, with "stable asthma", who on 11/11/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643782/0675M). It was reported that the vaccine was administered subcutaneously into the right deltoid at 0830 and sometime later that day "in the PM" the adverse event occurred. Reporter indicates that the pt recovered. Additional info is not expected.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Info has been received from a licensed practical nurse concerning her 46-year-old husband who is a machinist and volunteer firefighter and who has allergies to penicillin (unspecified), dustmites and some trees and weeds who on 12/02/2002 at 7:00 PM was vaccinated IM in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). There was no illness at the time of vaccination. No adverse events following prior vaccinations for the pt or his siblings were reported. Concomitant therapy that day at 7:00 PM included a 1x every 10 year dose of influenza virus vaccine (FLUZONE) (Batch #U0925AA) given IM in the opposite deltoid. Additional concomitant medications included cetirizine hydrochloride (+) pseudoephedrine hydrochloride (ZYRTEC-D) given q12h and budesonide (RHINECORT) nasal spray. Subsequently, the pt developed redness and induration from his elbow to his shoulder. It was reported that symptoms resolved without treatment in a couple of days. Follow up info received from a licensed practical nurse indicated that on 12/03/2002 at 9:00 PM the pt developed pain, redness and swelling, and it was noted that the area from the shoulder to the elbow was hot to the touch. No medical care was required as a result of the reaction. It was noted that 2 hours after receiving the vaccination, the pt was called out on a major structure fire and spent the next 20 hours at the fire scene engaged at times in heavy physical labor. The reporter indicated that she suspects that "this activity played a major role in their reactions". It was noted that on 12/09/2002 the pt recovered. No diagnostic tests or laboratory data were reported. The reporter indicated that 9 other pt received a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445) and developed induration at the injection site (WAES #0212USA00729, 0212USA00825, 0212USA01193, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a licensed practical nurse concerning her 14-year-old son who is a student with allergies to "sulfa", bee stings, grass, molds and trees who on 12/02/2002 at 7:00 PM was vaccinated IM in the deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). There was no illness at the time of vaccination. Concomitant therapy that day at 7:00 PM included a 1x every 5 year dose of influenza virus vaccine (FLUZONE) (Batch #U0925AA) given IM in the opposite deltoid. Additional concomitant medications included cetirizine hydrochloride (ZYRTEC) and an allergy injection for bees, grass, trees and mold. Subsequently, the pt developed redness and induration from his elbow to his shoulder. It was reported that symptoms resolved without treatment in a couple of days. Follow up info received from a licensed practical nurse indicated that on 12/03/2002 at 8:00 AM the pt developed pain, redness and swelling, and the area from the shoulder to the elbow was hot to the touch. No medical care was required as a result of the reaction. It was noted that on 12/09/2002 the pt recovered. There were no adverse events following prior vaccinations. The reporter indicated that 9 other pts received a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M) and developed induration at the injection site (WAES #0212USA00729, 0212USA00825, 0212USA01192, 0304USA02075, 0304USA02076, 0304USA02077, 0304USA02078, 0304USA02079 and 0304USA02081). No further info is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Skin burning sensation
Clinical narrative: Informaiton has been received from a female consumer with no known medical history or allergies who on 9DEC2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication. Subsequently, the consumer reported that she developed very painful burning and inflammation on her arm. No further information is available.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Info has been received from a physician concerning a 68 year old female pt with a drug hypersensitivity to sulfa and sodium pentathol and concurrent conditions of hypertension and arthritis who on 12/10/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #644217/1026M). Concurrent medications were amiloride hydrochloride (+) hydrochlorothiazide (MSD), valdecoxib (Bextra), and omeprazole (Prilosec). On 12/12/2002 the pt developed a 7 by 10 cm erythematous patch at the site of reaction. The physician reported it looked somewhat like a dermatitis. Unspecified medical attention was sought. The pt was given "palliative treatment". Additional info has been requested.
Age: 93.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: Info has been received from a nurse concerning a 93 year old female who on approx 12/02/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the left arm. Subsequently the pt developed a "marble like bump" on the left arm post vaccination. Additional info has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a Medical Assistant concerning a male pt in his mid-70's with hypertension and hypercholesterolemia who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #644218/1027M). Concomitant therapy was unspecified. Subsequently the pt developed swelling and redness at the injection site 24-48 hrs. post vaccination. Unspecified medical attention was sought. The reporter expressed concern with the lot. The medical assistant reported on another male pt (WAES #0301USA01827). 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: FLUX, PPV
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Info has been received from a pharmacist concerning a female pt who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent. Vaccination on the following day included a dose of influenza virus vaccine in the other arm. Subsequently, the pt developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent. The pharmacist reported 2 other pts who had similar experiences following vaccination with pneumococcal vaccine 23 polyvalent (MSD) (WAES #0211USA01830 and 021USA01470). Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected. Additional info has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. It was reported that the pt was previously vaccinated with pneumococcal vaccine 23 polyvalent "at least" 5 years ago. The pt subsequently developed a local reaction. Unspecified medical attention was sought. The nurse also reported that two other patients developed local reactions, one of which developed fever and aches (WAES0212USA01989), the other developed a high fever and went to the ER (WAES0212USA01988). Additional info has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Nasopharyngitis, Nausea
Clinical narrative: Information has been received from a physician concerning a 67 year old female pt with "a touch of insomnia," a history of a "recent cold" and no allergies who in October 2002, was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (640744/0994L). Concomitant vaccine therapy included a dose of influenza virus vaccine (Fluzone). There was no illness at the time of vaccination. Concomitant therapy included alendronate sodium, Ceftin and azithromycin. Subsequently, the pt developed nausea that started 7-10 days after the injection and lasted for 30 days (previously reported as being present since right after the pt received the shot). The pt also had difficulty sleeping and had a cold. The physician feels as if the cold was unrelated to the shot but questioned if the injection could possibly cause the nausea. On 12/17/02, no intervention was reported. On 1/10/03, it was reported that the pt had a GI consult, unspecified blood tests and an MRI of the head, all of which were negative. Subsequently, on 12/23/02, the pt recovered. Additional info is not expected.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site oedema, Oedema peripheral
Clinical narrative: Information has been received from a RN concerning a 67 year old retired male with sinusitis and no prior medical history who on 12/16/02 at 11:45 was vaccinated SC in the right arm with a second dose of pneumococcal vaccine 23 polyvalent (643783/0709M). Concomitant vaccination on 12/16/02 included a dose of influenza virus vaccine in the left arm. The pt was reported as afebrile at the time of the vaccination. There were no other concomitant medications. On 12/17/02 at 10:00, the pt developed increased warmth, edema, and erythema in his right upper arm. The pt was seen in the physician's office with fever of 100.6 F and localized swelling and redness at the injection site. The pt had full ROM in his hands and fingers bilaterally. It was also noted that there was no SOB and no wheezing for 2-3 days post vaccination. The pt was treatted with Clarinex 5mg daily as needed. Subsequently the pt recovered. Additional info is not expected.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a RN concerning a 67 year old retired male with sinusitis and no prior medical history who on 12/16/02 at 11:45 was vaccinated SC in the right arm with a second dose of pneumococcal vaccine 23 polyvalent (643783/0709M). Concomitant vaccination on 12/16/02 included a dose of influenza virus vaccine in the left arm. The pt was reported as afebrile at the time of the vaccination. There were no other concomitant medications. On 12/17/02 at 10:00, the pt developed increased warmth, edema, and erythema in his right upper arm. The pt was seen in the physician's office with fever of 100.6 F and localized swelling and redness at the injection site. The pt had full ROM in his hands and fingers bilaterally. It was also noted that there was no SOB and no wheezing for 2-3 days post vaccination. The pt was treatted with Clarinex 5mg daily as needed. Subsequently the pt recovered. Additional info is not expected.
Sex: M
Vaccine: PPV
Symptoms: Bronchial obstruction, Lung disorder, Pyrexia
Clinical narrative: Information has been received from an adult male pt with no known drug allergies and no past medical history who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included Klonopin. Subsequently the pt experienced burning in his lungs and developed a temperature that "went to 101.8 deg." The reporter indicated that he initially went to a physician and was diagnosed with bronchitis. He later went to his family physician and was told he had bronchitis which might turn into pneumonia. Follow-up info was received from the pt's family physician indicating that she was not aware of the event. Additional info has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Dizziness, Dysphoria
Clinical narrative: Information has been received from a woman in a medical office concerning a 59 year old female pt who on 11/22/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (644107/0955M). It was noted that ten minutes after receiving the vaccination the pt experienced the following: got lightheaded, scratchy throat, dysphoria, and anxiety. The pt was given a nebulizer treatment and she went to an emergency room. It was noted the pt was not hospitalized and everything resolved. The reporter has requested a lot check. The records of testing prior to release of this low 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 mentioned that another pt also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0212USA02009).
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a female who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (site and dose not reported). Subsequently the pt's arm swelled up and was red. The pt sought unspecified medical attention. Additional info has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old male pt with no known drug allergies who on 12/17/02 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included simvastatin, Ditropan, Tricor, and amitriptyline. On 12/17/02 the pt developed warmth and swelling in his arm at the injection site two hours post vaccination. Eight hours later, the arm was swollen from the injection site to the elbow. The pt presented to the ER and was given ibuprofen and was told to apply ice at the injection site. At the time of this report, the pt's condition was unknown. Additional info has been requested.
Age: 48.0
Sex: F
Vaccine: DTAP, FLU3, PPV
Symptoms: Ageusia, Dysgeusia, Viral infection
Clinical narrative: Information has been received from a medical assistant concerning a 48 year old female housewife with no known drug allergies, and a viral infection at time of vaccination who on 10/15/02 at 10am was vaccinated SC in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (643782/0675M). On 10/15/02 at 10:05am the pt was concomitantly vaccinated with a SC dose of influenza virus vaccine (Fluvirin) (E30132FA) and at 10:15am an IM dose of diphtheria toxoid/pertussis vaccine/teta (Acelluvax DTP) (U0521AA). Subsequently the pt developed a metallic taste in her mouth, which progressed to no taste and then became a sweet taste. The physician reported that the pt developed a virus of her trigeminal nerve which caused her metallic taste that was discussed with "ENT" physicians and was not associated with her vaccine. However, the pt stated that this metallic taste did occur after she received her influenza and pneumococcal shots. It was noted that the pt recovered. No further info is requested.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female patient, who on Nov 18, 2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot#643251/045M). Concomitant vaccination included a dose of influenza virus vaccine in the left arm. On Nov 20,2002 the patient called the doctor's office reporting that she had developed a rash from her elbow to her shoulder on her right arm. No other symptoms were reported. The patient was expected to be seen at the doctor's office. Subsequently, the patient fully recovered. The reporter indicated that two other patients (WAES0212USA01991 and 0212USA01970) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced "worse than usual local reactions". The reporter also noted that "This office has given (pneumococcal vaccine 23 polyvalent) for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced" (WAES0303USA00344). The reporter stated that she was "uncomfortable using the rest of the vial or other vials from the same 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 evaluation and research and was released. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old male patient,who on Nov 18, 2002 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (lot# 643251/0445M). There was no concomitant vaccination. On Nov 19, 2002 the patient called the doctor's office reporting that his left arm was swollen 2 inches in diameter and that his whole arm was very sore. No systemic side effects were reported. The patient was advised to take ibuprofen (Advil) as needed and to apply ice. The patient did not wish to come to the doctor's office to be seen. Subsequently, the patient fully recovered. The reporter indicated that two other patients (WAES0211USA01991 and 0212USA01969) received pneumococcal vaccine 23 polyvalent from the same lot and also experienced "worse than usual local reactions". The reporter also noted that"This office has given pneumococcal vaccine 23 polyvalent for over 10 years and we have never had the type of reactions that these 3 (and subsequent) patients experienced" (WAES0303USA00344). The reporter stated that she was "uncomfortable using the rest of the vial or other vials from the same 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 evaluation and research and was released. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. It was reported that the patient was previously vaccinated with pneumococcall vaccine 23 polyvalent. The patient subsequently developed a local reaction, fever, and aches. Unspecified medical attention was sought. The nurse also reported that two other patients developed local reactions, one of which developed a high fever and went to the ER (WAES0212USA01473 and WAES0212USA01988). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Information has been received from a physician's assistant concerning a 62 year old female patient who on Dec 16, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that since receiving the vaccination, she has developed a low-grade fever and tachycardia. It is unknown if medical attention was sought. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a physician concerning a 66 year old female patient with hypertension NOS and arthritis NOS and a history of lymphoma NOS who on Dec 19, 2002 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included glipizide (Glucotrol), metformin HCl (Glucophage), tradolapril (Mavik), nizatidine (Axid), dilitiazem hydrochloride (Tiazac), meloxicam (Mobic) and alendronate sodium (MSD). A few hours later on Dec 19, 2002, the patient experienced a red rash (6 inches in diameter) around injection site, 101 degree fever, vomiting and nausea. These symptoms persisted into Dec 21, 2002 and now have started to abate. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a female patient who on approximately Dec 5, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 644105/0820M). in the right deltoid. Subsequently the patient developed symptoms of red, hot, painful to touch and swollen arm from elbow to shoulder. The nurse requested a lot check be performed on lot 644105/0820M. The nurse also reported another patient that developed a red, hot,painful to touch and swollen right arm from wrist to site of injection (WAES0212USA02343). Unspecified medical attention was sought. The records of testing to release of this lot has been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the center for evaluation and research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a female who on approximately Dec 13, 2002 was vaccinated with pneumococcal vaccine 23 polyvalent in the left deltoid. A couple of days post vaccination,on approximately Dec 15, 2002, the patient experienced pain in her left arm and under her armpit, which has now resolved. As reported on Dec 27, 2002, the patient was still experiencing pain from injection site and pain radiates down her arm. It was reported that no medications or treatment were provided for the patient. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema, Pain
Clinical narrative: Information has been received from a nurse concerning a female patient who on approximately Dec 5, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 644105/0820M). Subsequently, the patient developing symptoms of red, hot, painful to touch and swollen right arm from wrist to the site of injection. Unspecified medical attention was sought. The nurse requested that a  lot check be performed on lot #644105/0820M. The nurse also reported another patient that developed a red, hot, painful to ouch and swollen right arm from elbow to shoulder (WAES0212USA02156). 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 of the center for evaluation and research and was released. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Injection site oedema, Nausea, Rash
Clinical narrative: Information has been received from a "wholesaler" concerning a 71 year old male who on Dec 6, 2002 at 13:00 was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #644106/0819M). On Dec 6, 2002, the patient developed swelling and weakness of the vaccinated arm, nausea, vomiting, dizziness when he turned his head to either side and a rash. It was also reported that the patient was "very concerned". Unspecified medical attention was sought. As of Dec 27, 2002, it was reported that the patient was still experiencing weakness in the right arm and was now experiencing dizziness when he turns his head from side to side. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a "wholesaler" concerning a 71 year old male who on Dec 6, 2002 at 13:00 was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #644106/0819M). On Dec 6, 2002, the patient developed swelling and weakness of the vaccinated arm, nausea, vomiting, dizziness when he turned his head to either side and a rash. It was also reported that the patient was "very concerned". Unspecified medical attention was sought. As of Dec 27, 2002, it was reported that the patient was still experiencing weakness in the right arm and was now experiencing dizziness when he turns his head from side to side. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Headache, Injection site induration, Injection site oedema, Pyrexia, Skin striae
Clinical narrative: Information has been received from a registered nurse concerning an adult employee who on Nov 20, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #643785/0872M). Subsequently, the patient developed a headache and a temperature of 102F for four days. The Patient also developed an injection site reaction with swelling, induration, edema, and red streaks from the shoulder to the elbow. Unspecified medical attention was sought. The reporter mentioned that other patients also had experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES0211USA02459 and WAES0301USA00466). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Rash, Vomiting
Clinical narrative: Information has been received from a health care professional concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot#644106/0819M) intramuscularly in the deltoid. Subsequently, the patient developed redness,swelling and soreness at the injection site and down the arm as well as a rash and vomiting. On Dec 18, 2002, it was reported that the patient's symptoms had subsided by the next day and that no treatment, testing or work-up was necessary. It was also reported that two other patients were vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot#644106/0819M) and developed swelling of the arm, a rash, and nausea and vomiting (WAES0212USA01110 and 0212USA02496). Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Fatigue, Injection site oedema, Pyrexia, Rash erythematous
Clinical narrative: information has been received from a female medical assistant with seasonal and environmental allergies which included mold and dander, cardiac disorder, a history of pulmonary valve replacement and tricuspid valve repair who on Jan 07, 2003 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent (lot#643251/0445M). It was noted that there were no concomitant therapies. On Jan 7, 2003 the patient developed a red, slight bump, with injection site swelling. She also developed fatigue. On Jan 8, 2003 the patient developed a fever of 101 and shortness of breath. It was noted that the patient was under the care of a physician. On Jan 9, 2003 the patient was treated with diphenhydramine (Benadryl) and all of her symptoms resolved.  Additional information is requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 48 year old disabled male patient, with asthma and  an allergy to methotrexate, who on Jan 6, 2003 was vaccinated intramuscularly into the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot#644217/1026M). Concomitant therapy included albuterol "nebulizations", albuterol (Ventolin), lansprazole (Prevacid), MgCl (Slow-Mag), potassium chloride (Klor-Con), prednisone, fluticasone prpionate and salmeterol xinafoate (Advair Diskus) and sucralfate (Carafate). It was reported that the patient developed a large, red, swollen area at the injection site on Jan 8, 2003. On Jan 09, 2003 the patient came to the office complaining of an injection site reaction. According to the reporting, the patient had a large, swollen, red area at the injection site (3.5 - 4 inches in diameter) which was painful and itchy. Patient did not have a fever and was diagnosed with cellulitis. Subsequently, the patient was started ontherapy with cefprozil (Cefzil) 500mg twice a day for 10 days. The patients symptoms resolved after approximately 2 weeks. Additional information from a registered nurse indicates that she did not think that the event would have resulted in death, a life threatening illness, hospitalization, or a significant disability if left untreated. Additional information is not expected.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Information has been received from a nurse concerning a 48 year old disabled male patient, with asthma and  an allergy to methotrexate, who on Jan 6, 2003 was vaccinated intramuscularly into the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot#644217/1026M). Concomitant therapy included albuterol "nebulizations", albuterol (Ventolin), lansprazole (Prevacid), MgCl (Slow-Mag), potassium chloride (Klor-Con), prednisone, fluticasone prpionate and salmeterol xinafoate (Advair Diskus) and sucralfate (Carafate). It was reported that the patient developed a large, red, swollen area at the injection site on Jan 8, 2003. On Jan 09, 2003 the patient came to the office complaining of an injection site reaction. According to the reporting, the patient had a large, swollen, red area at the injection site (3.5 - 4 inches in diameter) which was painful and itchy. Patient did not have a fever and was diagnosed with cellulitis. Subsequently, the patient was started ontherapy with cefprozil (Cefzil) 500mg twice a day for 10 days. The patients symptoms resolved after approximately 2 weeks. Additional information from a registered nurse indicates that she did not think that the event would have resulted in death, a life threatening illness, hospitalization, or a significant disability if left untreated. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Ecchymosis, Erythema, Fatigue, Oedema
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old male patient who on Dec 16, 2002 was vaccinated IM with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot #644219/1079M). On Dec 17, 2002 the patient developed swelling in his upper arm that spread down the entire arm as well as ecchymosis, redness and cellulitis. He also felt fatigued and achy. The patient was treated with cephalexin monohydrate (Keflex) (500mg TID x five days). On Dec 23, 2002 the patient recovered. The report also indicated that the patient was recovering and the duration if the events was 10 days. No further information is expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old male patient who on Dec 16, 2002 was vaccinated IM with a 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot #644219/1079M). On Dec 17, 2002 the patient developed swelling in his upper arm that spread down the entire arm as well as ecchymosis, redness and cellulitis. He also felt fatigued and achy. The patient was treated with cephalexin monohydrate (Keflex) (500mg TID x five days). On Dec 23, 2002 the patient recovered. The report also indicated that the patient was recovering and the duration if the events was 10 days. No further information is expected.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received concerning a male patient, with no allergies, who on Jan 11, 2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 644219/1079M). Subsequently  the patient developed swelling "up under the arm, not at the injection site". Unspecified medical attention was sought. Follow up information has been received from a physician concerning a 89 year old female patient (previously reported as male), who on Jane 09, 2003 (previously reported as Jan 11, 2003) was vaccinated with a second dose of pneumococcal vaccine 23 polyvalent (lot#644219/1079M) into the left arm. Concomitant medications include levothyroxine sodium (Synthryoid), glipizide (Glucotrol), atenolol and aspirin. Subsequently, on Jan 10, 2003 the patient developed erythema on the side of the arm opposite the injection site, 4 inches by 6 inches. It was noted that the patient required a doctor visit. It was reported that the patient recovered. It was noted that a male patient (previously reported as female) from the same source had a similar experience (WAES0301USA01241). Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Information has been received from a 72 year old female patient with a drug allergy to penicillin and a history of open heart surgery who on approximately Dec 6, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The patient was concomitantly vaccinated with influenza virus vaccine. Subsequently the patient developed "severe pain and immobility in her left arm where she received the pneumonia shot and it is almost better now. The physician treated her with celecoxib (Celebrex) for the pain, but it did not help. He switched her rofecoxib (MSD) and it helped her pain. No further information is expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Asthma
Clinical narrative: Information has been received from a 45 year old female patient with diabetes, a penicillin allergy and a history  of carpal tunnel syndrome who over 5 years ago in approximately 1997, was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The patient indicated the reason for vaccination was prevention of asthmatic bronchitis and peumonia. Concomitant therapy included cetrizine hydrocholoride (Zyrtec),lisinopril (Zestril), atorvastatin calcium (Lipitor), pentoxifylline (Trental ), glyburide and metformin hydrocholride (Glucovance), amitriptyline hydrochloride, diltiazem hydrochloride and furosemide. On Jan 13, 2003, the patient reported that the effectiveness of the pneumococcal vaccine 23 polyvalent has worn off because she developed an asthmatic bronchitis cold within the last two weeks. Follow up information was received from a physician stating that the patient received the pneumococcal vaccine 23 polyvalent about  5 years ago with no adverse events. The patient presented to the clinic requesting a booster. The physician noted that the patient had no medical indication for a booster. The patient was upset that she was getting a lot of colds this winter and felt that was an indication her pneumococcal vaccine 23 polyvalent had worn off. The patient has had no documented pneumonia or pneumococcal infection this year. The physician stated"I do not know how to call this vaccine adverse event....I feel the patient is having no symptoms or problems related to her original (pneumococcal vaccine 23 polyvalent. Additional information is not expected.