chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Information has been received from a pharmacist purchaser concerning a senior citizen patient ( age and gender not specified) who was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650452/0753P) in a senior center during an immunization clinic.  On an  unspecified date" recently", the patient developed "severe pain at the injection site", so much so that the patient " could not sleep at night".  It was also reported that the patient had "swelling present".  It was "unknown" if the patient sought unspecified medical attention.  At the time of the report, the outcome of the events were unknown.  Additional information is not expected.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 41 year old Caucasian male patient with cerumen impaction and otalgia and no known allergies who on 26-SEP-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (intramuscularly) (0.5 ml) (lot 649694/0386P).  On 27-Sept-2005 at 8:00 am the patient experienced pain, redness of 6 centimeter by 4 centimeter at local site where vaccine was administered.  The patient also had "shooting pain up and down the arm, right arm and warmth in this area".  The patient recovered on 24-OCT-2005.  Unspecified medical attention was sought.  No product quality complaint involved.  No further information is expected.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 83 yr old male who on 14Sep05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot 650649/0790P). On 14Sep05 the pt complained of upper arm swelling and redness at the injection site, fever and chills. The pt took over the counter medication. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacy tech concerning a pt (age and sex not specified) who on 08Oct05 was vaccinated with pneumococcal 23v polysaccharide vaccine (650456/0974P). On 08Oct05, within 24 hrs, the pt developed an injection site reaction of swelling and redness. The pt sought unspecified medical attention. It was reported they have requested a check of medical attention. It was reported, they have requested a check of Lot 650456/0974P. At the time of this report, the outcome of the events were unk. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning an adult female who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). It was noted that the pt received her first dose prior to age 65. Subsequently, the pt's arm had redness, and warm, and was tender. It was noted to be band like. Unspecified medical attention was sought and the pt was instructed to use ice packs for comfort. The pt was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a female pt in her sixties who in approx Oct 2005, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On approx 05Oct05, the pt developed upper shoulder swelling, redness and tenderness. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a nurse practitioner concerning a pt (age and gender not reported) with unk medical history and unk allergies who on an unspecified date was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed cellulitis as a result of the vaccination. It was also reported that the pt was treated with antibiotics (unspecified) and recovered from cellulitis on an unspecified date. The reporter felt that the pt's cellulitis was related to therapy with pneumococcal 23v polysaccharide vaccine. There was no product quality complaint involved. No additional information is expected.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 82 yr old female who on 28Sep05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650649/0790P). On 28Sep05 the pt complained of redness, swelling, and warmth at the injection site and fever. The pt took over the counter medication. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 79 year old female on 29-SEP-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650649/0790P).  On 29-SEP-2005 the patient complained of swelling and redness at the injection site and fever.  The patient took over the counter medication.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Angioneurotic oedema, Face oedema
Clinical narrative: Information has been received from certified medical assistants concerning a 51 yr old white male (281.5lb, 6'4") factory worker with allergies to aspirin and NSAID (not specified) who on 02Oct05 (also reported as 12Oct05), at 16:15, was vaccinated IM, into deltoid muscle, with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649981/0709P). On the next morning (also reported within the next several hours), at 7:30AM, the pt developed angioedema of face and head (also reported as swelling of his face and head). By the next afternoon, the swelling was reported by the pt as being much better. The pt was reported as recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female child (age not provided) with asthma who was initially vaccinated (date not provided) with a dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006).  Subsequently the patient developed marked, painful redness and swelling at the site of injection.  The patient's outcome was not reported.  There was no product quality complaint involved.  The physician also provided information regarding another patient's experiences with pneumococcal 23v polysaccharide vaccine.  The lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Information has been received from a pharmacy purchaser concerning a senior citizen patient (age and gender not specified) who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650452/0753P) in a senior center during an immunization clinic.  On an unspecified date. "recently", the patient developed "severe pain at the injection site", so much so the patient "could not sleep at night".  It was also reported that the patient had "swelling present".  The patient went to the emergency room for unspecified treatment.  At the time of the report, the outcome of the events were unknown.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an adult patient who " over the last week", on approximately 07-OCT-2005, was vaccinated with 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P).  It was reported that the patient developed a severe local reaction at the injection site including, redness, swelling, and pain.  It was reported that the patient recovered or was recovering.  Unspecified medical attention was sought.  The reporter expressed concern about the lot 650453/0791P for pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.  A lot checked has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a 64 year old female with chronic obstruction pulmonary disease, emphysema, arthritis, diabetes and cardiac failure congestive who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included " too many" medications (therapy unspecified).  Subsequently the patient experienced injection site reaction.  The patient's outcome was not reported.  The patient also reported her experiences while on therapy with ezetimibe.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness
Clinical narrative: Information has been received from a 69 year old female with lupus and allergic to sulfa who on 12-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine.  The patient reported that she received a flu vaccine at the same time that she received the pneumococcal 23v polysaccharide vaccine.  On 12-OCT-2005 the patient reported that she felt " dizzy, weak, and generally debilitated" after receiving pneumococcal 23v polysaccharide vaccine.  The patient did not seek medical attention.  Laboratory diagnostic studies were reportedly not performed.  At the time of the report the patient was recovering from feeling dizzy, weak, and generally debilitated.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Rash, Rash macular
Clinical narrative: Information has been received from a 70 year old female with high cholesterol, hypertension, glaucoma,and penicillin allergy who on 14-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5 ml), subcutaneously.  Concomitant therapy included atorvastatin calcium (LIPITOR), valsartan ( DIOVAN), amlodipine besylate (NORVASC) and atenolol.  On 14-OCT-2005, "later that night" the patient experienced severe pain in the region of the injection and red blotches on arm.  The next day she had a rash on her chest.  On 16-OCT-2005 the rash had spread to her lower abdomen.  The patient was reportedly recovering.  There were no relevant diagnostic test of laboratory data.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an adult patient who " over the last week", on approximately 07-OCT-2005, was vaccinated with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P).  It was reported that the patient developed a severe local reaction at the injection site including, redness, swelling, and pain.  The patient was seen at the emergency room.  It was reported that the patient had recovered or was recovering.  The reporter expressed concern about the lot 650453/0791P for pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an adult patient who "over the last week" on approximately 07-OCT-2005 was vaccinated with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine. (lot 650453/0791P).  It was reported that the patient developed a severe local reaction at the injection site including, redness, swelling and pain.  The patient was seen at the emergency room.  The patient also developed hives and was treated with diphenhydramine hydrochloride (BENADRYL), intravenously.  It was reported that the patient had recovered or was recovering.  The reporter expressed concern about the lot 650453/0791P for pneumococcal 23v polysaccharide vaccine.  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a physician concerning an adult patient who on 17-OCT-2005 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P).  On 17-OCT-2005 the patient developed an injection site reaction including redness and swelling , and the area was itchy.  Unspecified medical attention was sought.  Outcome was reported as recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Swelling, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 41 year old daughter with a history of cancer who on 16-OCT-2005 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (Lot 650453/0791P).  Concomitant therapy included an unspecified cancer therapy.  It was reported that on 16-OCT-2005 the patient's arm had swelled and that she had red welts covering her arm near the injection site.  The patient's mother also reported that her arm" hurts very much" near the injection site.  Medical attention was not sought.  At the time of the report, the patient had not recovered. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old male who in approximately 1995 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  In approximately 1995 the patient developed an injection site reaction with redness, swelling and pain.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Swelling
Clinical narrative: Information has been received from a physician concerning a 69 year old white male with a codeine allergy who on 18-OCT-2005 at 7:10 pm was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651523/0604R).  Concomitant vaccination on 25-OCT-2005 intramuscularly seventh dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (lot U1B33BA).  It was reported that it had been 9 years since the patient received his first dose of pneumococcal 23v polysaccharide vaccine.  On 19-OCT-2005 at 5:00 pm the patient had swelling and redness of the deltoid/upper arm after vaccination.  This was also described as " a somewhat severe local site reaction".  Unspecified medical attention was sought.  The patient recovered in " a day or two", on 29-OCT-2005.  There was no product quality complaint involved.  Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old male with asthma and no known allergies. On 10/13/05 the pt was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). Concomitant therapy included unspecified therapy two unnamed inhalers. On 10/14/05 the pt developed a localized reaction of arm with swelling, redness an skin was warm to touch. The pt was treated with diphenhydramine hydrochloride Benadryl. It was reported that it was unknown if he received vaccine in the past. The pt sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacy technician concerning a male pt who was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). Subsequently the pt experienced a local site reaction post vaccination. The pt called the office on approximately 10/12/05 to report a red, raised, warm area at the injection site, and feeling of fatigue. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 65 year old female with no pertinent medical history who on 10/14/05 was vaccinated intramuscularly in the left deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). there was no concomitant medication. There was no illness at the time of vaccination. Following vaccination (date not specified) the pt experienced upper arm swelling to the elbow, redness at the injection site and skin was warm to touch at the injection site. Unspecified medical attention was sought and no lab or diag test were performed. It was reported that the pt recovered. No product quality complaint was involved. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an 84 year old female with an allergy to penicillin, vancomycin and gentamicin. On 10/19/05, the pt was vaccianted with Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included metoprolol succinate Toprol XL tablets, alendronate sodium and cyclobenzaprine HCL. On 10/19/05, the pt developed from the injection site to the elbow, her arm was red, swollen and very warm. The pt sought unspecified medical attention. There were no lab diag studies performed. At the time of this report, the pt had not recovered. from the events. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information had been received from a pharmacist concerning a 66 year old female with an allergy to codeine who on 10/17/05 was vaccinated IM in the left arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). It was reported that the pt came into the pharmacy yesterday, 10/19/05, and complained of a swollen left arm at the injection site. It was reported that the adverse event onset was within 72 hours. Unspecified medical attention was sought. The patient was treated with oral diphenhydramine hydrochloride Benadryl. At the time of the report the patient has not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from an 84 year old female with hypertension and an allergy to cephalexin Keflex who on 10/18/05 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included amlodipine besylate Norvasc. On 10/18/05, the pts arm became very sore and red. The flab on the underside of her arm also became very swollen. No medical attention was sought and no diagnostic lab test were performed. At the time of the report, the pt had not recovered. A product quality complaint was not involved. No further information is available.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a female in her 30's with an undefined illness who was initially vaccinated (date not provided) with a dose of Pneumococcal 23v polysaccharide vaccine(lot 651318/1006). Subsequently the pt developed pain, redness and swelling at the site of injection. No treatment was ordered. The pts outcome was not reported. There was no product quality complaint involved. The physician also provided information regarding another pts experiences with Pneumococcal 23v polysaccharide vaccine (WAES0510USA07275, WAES0510USA08240. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 68 year old female with a history of multiple allergies and one time vaccination with Pneumococcal 23v polysaccharide vaccine who was vaccinated (date not provided) with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1005). Subsequently the pt developed pain, redness and swelling at the injection site extending into axillary region and posterior cervical area on same side. The pt was treated with cephalexin (Keflex). The pts outcome was not reported. There was no product quality complaint involved. The physician also provided information regarding another pts experience with Pneumococcal 23v polysaccharide vaccine (WAES0510USA07275, WAES0510USA08240. Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a health professional concerning an approx 80 year old pt who in Oct 2005 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. In Oct 2005, the pt experienced cellulitis and was hospitalized. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site induration, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old female with an allergy to penicillin and sulfa drugs, and no other medical history who on 10/15/05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (kit 647661/0055R). Concomitant therapy included levothyroxine NA Synthroid, escitalopram oxalate Lexapro, Loratadine Lorazepam, rabeprazole sodium Aciphex and zolpidem tartrate Ambien. On 10/15/2005 the pt developed a huge red knot at the injection site which was accompanied with lots of tenderness in the area. Unspecified medical attention was sought. No lab diag test were performed. At the time of the report the pt had recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a pharmacy technician concerning a male pt who on approx 10/5/05 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine vaccine lot 650083/0749P). Subsequently, in Oct 2005, the pt experienced a local site reaction post vaccination. The pt called the office to report a red, raised, warm and achy area at the injection site. He was treated with cold compresses and acetaminophen Tylenol as needed. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a pharmacy technician concerning a female pt who on approx 10/5/05 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). Subsequently, in Oct 2005, the pt experienced a local site reaction post vaccination. the pt called the office to report a red, raised, warm, and achy area at injection site. He was treated with cold compresses and acetaminophen Tylenol as needed. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning an 85 year old female with hypertension and hypohydremia and no allergies who on 10/20/2005 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included enalapril maleate. On 10/21/05 the pt stated that the site was swollen and red down to the elbow on the back side of the arm. The pt saw the physician on 10/22/05 where the condition was observed and verified. there were no labs or diagnostics done. At the time of reporting the pt had not recovered. Additional information had been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant CMA and a registered Nurse concerning an over 65 adult male with no pertinent medical history or allergies who on 10/20/05 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). the day after the injection, on 10/21/05, the pt experienced swelling, redness, induration, warmth and pain at the injection site. The swelling was described as almost like cellulitis. Unspecified medical attention was sought. The pt was reported as recovering at the time of the report. No product quality complaint was involved. No additional information is expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant CMA and a registered Nurse concerning an over 65 adult male with no pertinent medical history or allergies who on 10/20/05 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). the day after the injection, on 10/21/05, the pt experienced swelling, redness, induration, warmth and pain at the injection site. The swelling was described as almost like cellulitis. Unspecified medical attention was sought. The pt was reported as recovering at the time of the report. No product quality complaint was involved. No additional information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 72 year old female with penicillin allergy, sulfonamide allergy and dexamethasone allergy who on 10/19/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). On 10/19/05, the pt experienced raised red hot area at the injection site. Unspecified antibiotics were started on 10/21/05. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine and had a local reaction. No other information was provided. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a first and second dose of Pneumococcal 23v polysaccharide vaccine, the first in 1995 and the second on 10/24/05 (lot 650302/1039P, 0.5ml, IM). On 10/25/05 the pt was diagnosed with cellulitis of the arm. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a public health nurse concerning an adult female pt who was vaccinated with a second dose of Pneumococcal 23v polysaccharide vaccine. It was noted that the date of the first dose is unknown. Subsequently the pt experienced redness and severe swelling at the injection site, which resolved with no treatment. The adverse event improved and the pt recovered. No further information was available regarding the adverse event. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Pain, Shoulder pain
Clinical narrative: Information has been received from a health professional concerning a 31 year old female who on 10/18/2005 was vaccianted with a 0.5ml dose IM in the left deltoid of Pneumococcal 23v polysaccharide vaccine, (lot 640453/0791P). Concomitant therapy included atorvastatin calcium Lipitor. That night, on 10/18/2005, the pt experienced a red and swollen left arm and she had pain in her shoulder blade and arm pit. The symptoms subsided on their own and she received no treatment. No medical attention was sought. The pt was considered recovered on 10/6/05. No further information was available. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 month old male with no medical history and no drug allergies who on 10/18/05 in the AM was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine 0.5ml IM lot 649695/0512P, in the right thigh. There was no concomitant medication. On 10/19/05 the patient experienced a red, tender and swollen at injection site. It was also reported as patient got a severe erythematous 6cm circular region at injection site. The pt was treated with diphenhydramine HCL Benadryl and acetaminophen Tylenol. Symptoms resolved within a few days. There were no lab diagnostic testes performed. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an adult female who on 24OCT05 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 659697/1038P). On 24Oct05 the pt experienced a swollen arm and pain at the injection site. She was seen by the physician and was ordered acetaminophen (Tylenol). At the time of this report, the pt was recovering. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 39 yr old female with a history of pneumonia 2 yrs in a row. On 22Oct05 the pt was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). That same day, the pt developed redness, swelling at site, and a fever noted as 102.5. The pt sought unspecified medical attention. It was reported that there was no treatment. The fever resolved itself (date unk). At the time of the report, the pt had recovered from the events (date unk). Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature decreased, Cellulitis, Feeling hot, Injection site erythema, Spleen disorder
Clinical narrative: Information has been received from a physician concerning a 54 yr old Caucasian male pt with sarcoidosis, thrombocy, and no known drug reactions/allergies, who on 24Oct2005 was vaccinated SC with a first dose pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 24Oct05 the pt developed a local reaction. The left tricep and upper arm of the pt had warmth and erythema. It was reported that the doctor gave the pt a shot of methylprednisone sodium succinate (Solumedrol) and gave cefdinir (Omnicef) (300g) to take for 7 days for cellulitis. The physician also reported that the pt was scheduled for a splenectomy. The pt reported the area affected had increased each day. On 28Oct05 the pt was seen for a follow up visit. The pt felt better. The pt had a temp of 96F. The pt recovered. No product quality complaint was involved. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a RN concerning a male (age not specified) who on approx 26Oct05, the past 48 hrs, was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649981/0704P). On approx 26Oct05, the past 48 hrs, the pt developed a significant injection site reaction and cellulitis from armpit to wrist. It was also reported that symptoms started within 12 to 24 hrs of receiving the vaccine. The pt sought unspecified medical attention. There were no lab diagnostic studies performed. On 28Oct05, the pt was treated with IV ceftriaxone sodium (Rocephin) in the clinic. At the time of this report, the pt had not recovered from the events. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 76 yr old female with hypertension. On 27Oct05 the pt was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot649913/0577P). Concomitant therapy included unspecified therapy reported as several other medications. On 27Oct05 the pt developed swelling at the injection site and area surrounding the injection site. The pt sought unspecified medical attention. At the time of this report, the pt was recovering from the event. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Myalgia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning an adult female pt with unk medical history and unk drug reactions/allergies, who on 24Oct05 was vaccinated in the right deltoid IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot649979/0531P). The pt called the office within 4 hrs complaining of redness, warmth to injection site, body aches and vomiting. She was ordered promethazine hydrochloride (Phenergan) by mouth. Subsequently, within 24 hrs vomiting and body aches had resolved. It was reported that as of 27Oct05 the pt is fine. No further information is available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 68 yr old white retired male with no pertinent medical history who on 13Jul05 was vaccinated IM in the deltoid with a second 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). There was no concomitant medication. Two hrs after the injection on 13Jul05 the pt experienced upper arm swelling, redness and skin warm to touch at the injection site. Unspecified medical attention was sought no laboratory or diagnostic tests were performed. It was reported that the pt recovered. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an adult pt who on 17Oct05 was vaccinated IM with 0.5mL pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). On 17Oct05 the pt developed an injection site reaction included redness and swelling. Unspecified medical attention was sought. Outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant (CMA) and a registered nurse (RN) concerning a 72 yr old retired Caucasian adult male (also reported as over 65) with CAD, HTN, cardiomyopathy, NIDDM, and hypercholesterolemia who on 20Oct05 at 13:30 (also reported as the second week of October and a couple weeks ago) was vaccinated IM with a second dose of 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649697/1038P). On 20Oct05 (also reported as the day after the injection), the pt experienced swelling, redness, warmth, induration and pain at the injection site. The swelling was described as almost like cellulitis. Unspecified medical attention was sought and the pt was treated with prednisone 23mg every day for 5 days and cephalexin (Keflex) 500mg, TID for 5 days. It was reported that the pt recovered as of 24Oct05. The reporter also noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine five years prior. No product quality complaint was involved. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant (CMA) and a registered nurse (RN) concerning a 72 yr old retired Caucasian adult male (also reported as over 65) with CAD, HTN, cardiomyopathy, NIDDM, and hypercholesterolemia who on 20Oct05 at 13:30 (also reported as the second week of October and a couple weeks ago) was vaccinated IM with a second dose of 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649697/1038P). On 20Oct05 (also reported as the day after the injection), the pt experienced swelling, redness, warmth, induration and pain at the injection site. The swelling was described as almost like cellulitis. Unspecified medical attention was sought and the pt was treated with prednisone 23mg every day for 5 days and cephalexin (Keflex) 500mg, TID for 5 days. It was reported that the pt recovered as of 24Oct05. The reporter also noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine five years prior. No product quality complaint was involved. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Medication error, Pyrexia, Tenderness
Clinical narrative: Information has been received from a physician concerning a 65 year old male with lymphoma who was inadvertently vaccinated with a 1.0mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt complained of tenderness and erythema at vaccination site (unspecified), as well as low grade fever. Medical attention was sought. The pt's outcome was unk. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning 3 pt's who were vaccinated with pneumococcal 23v polysaccharide vaccine (lot650327/0792P) and subsequently developed severe injection site reactions, which extended from the deltoid area to the entire arm. All 3 pts sought medical attention, outcomes were unk. The nurse requested a lot check be performed on lot 650327/0792P. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In follow up, the nurse reported that a 72 yr old white retired male pt with arthritis was vaccinated IM in the right deltoid on 26Oct05 at 1:30PM with his first dose of pneumococcal 23v polysaccharide vaccine (lot650327/0792P). Concomitant therapy included amlodipine besylate (Norvasc). She reported that the pt called the clinic on 31Oct05 with complaints of redness, swelling and warm to the touch at area where vaccine was given, onset of symptoms was 30Oct05. It was reported the pt was some better on 31Oct05. No further information was available.
Sex: U
Vaccine: PPV
Symptoms: Headache, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a pt (age and gender not specified) who on an unspecified date, was vaccinated with pneumococcal 23v polysaccharide vaccine. On an unspecified date, the pt developed swelling at the injection site and headaches. At the time of this report, the outcome of the events were unk. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning an adult pt (age and gender not reported) with an unk medical history and unk allergies who on 27Oct05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (651524/0605R). Subsequently, the pt developed an injection site reaction including swelling, redness, pain and local heat. The pt was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Information has been received from a female consumer (age not reported) with no reported medical history and an allergy to ampicillin who on 21Oct05 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant therapy included losartan potassium HCTZ. The pt reported that on 22Oct05 she developed two separate rashes on the arm she received the injection and that same arm was sore. Subsequently, the pt recovered three days after the injection, 24Oct05. There was no product quality complaint involved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a healthy 54 yr old female pt with a shellfish allergy who on 24Oct05 was vaccinated IM in the left arm with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot unk). Concomitant therapy included a dose of influenza virus vaccine, given about a week before. On approx 25Oct05, within 24 hrs of the vaccination, the pt experienced severe pain, developed red streaks down the arm and cellulitis. She was treated first with clindamycin and then with levofloxacin (Levaquin). She was reported to be almost recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Asthma, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and the step daughter of a 64 yr old male with asthma. On 25Oct05, the pt was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649988/0692P). On an unspecified date, the pt developed redness and swelling of the injection site arm. The pt was prescribed antibiotics. It was further reporter that the pt developed significant swelling, redness and pain from the top of his shoulder down past his elbow. The pt sought unspecified medical attention. At the time of this report, the outcome of the events were unk. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a pharmacist and the daughter of a 58 yr old female with asthma. On 25Oct05, the pt was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649988/0692P). In Oct 2005, the pt developed redness and swelling of injection site arm. The pt was prescribed antibiotics. It was further reported that the pt developed significant swelling, redness from the top of shoulder to the middle of forearm and pain. The pt sought unspecified medical attention. At the time of this report, the outcome of the events were unk. In follow up it was reported that the pt developed pneumonia (date unk). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and a friend concerning a 69 yr old female. On 25Oct05, the pt was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649988/0692P). In Oct 2005, the pt developed redness and swelling of injection site arm. It was further reported that the pt developed significant swelling, redness and pain from the top of the shoulder down to the middle of the forearm. The pt sought unspecified medical attention. At the time of this report, the outcome of the events were unk. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and a fried concerning a 73 yr old male who on 25Oct05 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). In Oct 2005, the pt developed redness and swelling of the injection site arm. It was further reported that the pt developed significant swelling, redness and pain from top of the shoulder down to his wrist. The pt sought unspecified medical attention. At the time of this report, the outcome of the events were unk. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female (age not specified) who on approx 10/26/05, the past 48 hours was vaccinated with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649981/0704P). On approx 10/26/05, the past 48 hours, the pt developed significant injection site reaction, fever, chills, swelling and redness from elbow to deltoid at injection site. it was also reported that symptoms started within 12 to 24 hours of receiving the vaccine. The pt sought unspecified medical attention. There were no lab diag studies performed. The pt had been taking acetaminophen Tylenol every four hours for the events. At the time of this report, the pt had no recovered from the events. Additional information has been requested.