chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site oedema, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 59 year old female with no pertinent medical history who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Subsequently, the pt experienced general malaise, fever of 101, body ache, joint pain and swelling at injection site. No labs or diagnostic studies were performed. Unspecified medical attention was sought, but no prescription drug was required. No product quality complaint was involved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a CMA concerning a 50 year old female with a drug allergy to sulfamethoxazole (+) trimethoprim (Bactrim) and sulfa medications who on 11/03/03 was vaccinated IM with a first 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 647357/0988N). Concomitant therapy included levothyroxine Na (Synthroid), cetirizine hydrochloride (Zyrtec), and mometasone furoate (Nasonex). Subsequently, the pt developed a local reaction that was described as redness and swelling of her arm. The pt went to an urgent care center. A prescription drug was not required. No diagnostic lab studies were performed. It was noted that therapy was discontinued and that the adverse event abated. A product quality complaint was not involved. Follow up information was received from the CMA which indicated that the event was "taken care of with pt." No further information is expected. It was also reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed a local reaction with a raised, warm and painful injection site (WAES #0311USA01430).
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site oedema
Clinical narrative: Information has been received from a consumer and a physician concerning a pt with no allergies and no medical history who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647028/0564N). The pt developed a reaction and was swollen from the elbow to the shoulder, and was reported to have cellulitis-like reaction. The physician reported that the pt required treatment with an antibiotic. It was reported that the therapy with pneumococcal 23v polysaccharide vaccine was discontinued. It is unknown as to whether the adverse event abated. There was no product quality complaint reported. No additional information was provided. Unspecified medical attention was sought. Additional information has been requested. The physician also mentioned that two other pt's experienced local reactions following vaccination with pneumococcal 23v polysaccharide vaccine (WAES #0312USA01176 & WAES # 0401USA00073).  The physician reported this was the first dose of pneumococcal 23v polysaccharide vaccine for two of the pt's and the third pt's vaccination history was uncertain.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a LPN concerning a pt who in approximately 2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). Subsequently in approximately 2003, the pt developed redness and edema at the injection site. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved.  The reporter also mentioned a second pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N) (WAES #0312USA00223).  Additional information has been requested.
Age: 70.0
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 health professional concerning a 70 year old white female with no medical history who on 10/30/03 at 3:15pm, was vaccinated IM in the left deltoid with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine (Lot # 345255/1212M). There was no illness at the time of vaccination. The first dose was given in 1998. Subsequently, the pt experienced hot, red, swollen and painful arm. Unspecified medical attention was sought. No lab diagnostics were performed and no treatment was required. No product quality complaint was involved.  The reporter expressed a concern with the lot. This is 1 of a total of 5 pt's reported. 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 Biologics Evaluation and Research and was released. Follow up information indicated that on 11/03/03 at 10:00am the pt had a "reaction to the Pneumovax" and had a very swollen and red arm. She went to a physician who gave her Zithromax. It was reported that it was "now pale pink-still sore". It was reported that on 11/05/03 the pt had recovered. The other pt's (WAES # 0311USA00667, 0312USA02367, 0312USA02368 & 0312USA02369) were vaccinated with pneumococcal 23v polysaccharide vaccine and had the same reaction.  Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a NP concerning an 79 year old male pt who on 10/16/03 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N). The pt presented to the MD's office on 10/17/03 with a red, swollen, and tender left arm. The pt's treatment was ice and elevate arm when needed. At the time of this report the outcome was unknown.  No product quality complaint was involved. Additional information has been requested. It was also reported from the same source that another pt had a similar experience (WAES 3
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Haematoma, Injection site haemorrhage, Injection site pain
Clinical narrative: Information has been received from a PA concerning a 70 year old retired female pt with PCN and sulfa allergies and a history of immunization, osteoporosis, hypercholesterolemia, gastroesophageal reflux disease, degenerative joint disease, recurrent urinary tract infection and Raynaud's syndrome who on 11/17/03 at 12:00 was vaccinated SC in the left upper arm with a second dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N). There was no illness at the time of vaccination and there were no adverse events following prior vaccinations. Previous vaccination included a dose of pneumococcal 23v polysaccharide vaccine six years ago without adverse symptoms. Concomitant therapy included alendronate sodium, folic acid, calcium supplement, raloxifene hydrochloride (Evista), vitamin E, vitamin C, multivitamin, oxybutyninCl (Ditropan XL), vitamin B12, aspirin, colesevelam hydrochloride (Welchol), rabeprazole sodium (Aciphex) and selenium. Subsequently on 11/14/03, the pt had bleeding into soft tissue from the injection site to the elbow and pain. Hematoma and ecchymosis at the injection site were also noted with an onset of 11/15/03 at approximately 08:00. On 11/18/03, the pt spoke with the medical office and was seen. The pt was healing well and no treatment was required. Lab tests were not performed. Subsequently, the pt recovered. "48 hours" was noted as the date of recovery. A product quality complaint was not involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #647272/0664N). Subsequently, "in the past few weeks", in approximately 11/03, the pt developed cellulitis with redness and induration. The pt was treated with ice and ibuprofen. Subsequently, the condition has resolved.  It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES #0309USA01513, 0309USA01722, 0309USA01723, 0309USA01724, 0311USA02366).  It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #647272/0664N). Subsequently, "in the past few weeks", in approximately 11/03, the pt developed cellulitis with redness and induration. The pt was treated with ice and ibuprofen. Subsequently, the condition has resolved.  It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES #0309USA01513, 0309USA01722, 0309USA01723, 0309USA01724, 0311USA02365).  It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 20.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 20 year old pt who on 11/19/03, "three days ago" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The pt complained of redness, pain and swelling of arm at injection site that was "getting worse". Treatment included application of hydrocortisone cream and antihistamines and there was no change in symptoms. It was noted that reporter placed the call on hold when asked for specific information and then disconnected the call.  No further information is expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a LPN concerning a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N). The pt was reported to have received the vaccine in the past 10 years and is 60 years old or older. Subsequently the pt experienced an injection site reaction with redness and warmth spreading to the entire upper arm. The pt was treated with Cefzil for 3 days and Bextra for 6 days. The medications were started on 11/20/03, and the symptoms have not yet resolved. No further information was available at the time of the report. Unspecified medical attention was sought. There was no product quality complaint; however it was noted that the physician questioned the "stability of the vaccine". 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 Biologics Evaluation and Research and was released. The reporter also indicated that 2 male pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N) and experienced a similar event (WAES # 0311USA02683).  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from MA and Physician concerning a retired 69 year old white female with a history of hypertension, osteoporosis, fibromyalgia, anxiety and allergies to sulfa, Daypro and bee stings who on 11/17/03 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647657/0947N). Concomitant therapy included "premorin", acetaminophen (+) propoxyphene napsylate (Darvocet-N), risedronate sodium (Actonel), hydrochlorothiazide, doxazosin mesylate (Cardura) and "torprol". Subsequently, the pt experienced swelling, redness and erythema. The reporter was "concerned because the swelling practically encompassed the entire arm length." As of 11/21/03, the swelling was still there. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. Follow up indicated that on 11/17/03 the pt developed an inflamed, swollen and tender left upper arm, an 11x18cm area, which was almost around the arm. The pt was seen by a physician. There were no lab or diagnostic tests performed. On 11/26/03 the pt recovered. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a RN concerning a 79 year old female who on 11/06/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On approximately 11/06/03, the pt developed redness, edema, and pruritus at the injection site. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an adult female pt, who was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported the pt developed an inflamed injection site reaction, and swelling to the elbow. The adverse event resolved within 48-72 hours and no treatment was necessary. No other information is available. There was no product quality complaint reported. The pt recovered from the adverse events, inflamed injection site reaction and swelling to the elbow. Unspecified medical attention was sought. Additional information has been requested. The reporter also mentioned another pt who had a similar experience following vaccination with the pneumococcal 23v polysaccharide vaccine (WAES # 0312USA00001).
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Information has been received from a RN concerning an 81 year old male who on 11/06/03 was vaccinated in the mid arm with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed tenderness and an injection site reaction to include redness, edema and pruritus.  No treatment was required. Unspecified medical attention was sought. There was no product quality complaint involved. No other information was available at the time of this report. Follow up information from the physician indicated "we didn't inject pt." and that another physician or staff at another office injected the pt. Additional information is requested.
Age: 60.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old white female with pollen allergies, hypertension, and hyperthyroidism who on 11/18/03 in the AM was vaccinated IM in the right deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot # 644217/1026M). Concomitant vaccination on the same day in the AM included a fifth dose in the left deltoid of influenza virus split virion 3v vaccine inactivated  (FLUZONE) (lot # U1136AA). There was no illness at the time of vaccination. Subsequently the patient developed redness, swelling and pain at the injection site. The patient was treated for the symptoms with over the counter acetaminophen, diphenhydramine hydrochloride, and ice. Unspecified medical attention was sought and it was noted that a prescription drug was required. A product quality complaint was not involved. Follow up information received from the licensed practical nurse which indicated that in the AM on 11/18/03, the patient developed redness and swelling instantly after receiving pneumococcal 23v polysaccharide vaccine in the right deltoid. Ice was applied and the patient was told to take diphenhydramine hydrochloride and acetaminophen every four hours. The nurse talked to the patient two days later and the swelling had gone to her elbow. The patient recovered on 11/25/03. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 60 year old adult female with no past medical history and no known allergies who on 11/19/03 at 9:00 AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. On approximately 11/20/03, within 24 hours, the patient developed cellulitis. On 11/21/03, the patient presented to the doctor's office and was given amoxicillin (+) clavulanate potassium for treatment. There was no product quality complaint involved. No other information was available at the time of this report. Follow up information received from a nurse practitioner indicated that on 11/19/03 at 12 noon, three hours after injection, the patient noted pain and swelling at the site. No adenopathy was noted. The patient was started on amoxicillin (+) clavulanate potassium for 5 days on 11/20/03 and the condition resolved. No relevant diagnostic tests or laboratory data were obtained. Upon internal review, cellulitis was considered an other important medical event (OMIC). No further information is expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from the licensed practical nurse concerning a 66 year old white female with allergies to penicillin clarithromycin, penicillin, ciprofloxacin hydrochloride, and sulfa who on 11/4/03 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/0869N). There was no illness at the time of vaccination. It was noted that the patient received a first dose of pneumococcal 23v polysaccharide vaccine in 1997. The reporter also indicated that the patient contacted that physician soon after the injection. The patient experienced a sore arm with swelling, redness, and tightness on or near the injection site. It was also reported that on 11/4/03 the patient developed a very red, hard, and swollen arm. The patient was treated with ice and ibuprofen. Subsequently the patient recovered. A product quality complaint was not involved. Additional information is not expected. The reporter also indicated that two other patients experienced similar reactions after therapy with pneumococcal 23v polysaccharide vaccine.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from the licensed practical nurse concerning a 68 year old white male with no known allergies who was vaccinated IM with a dose second dose of pneumococcal 23v polysaccharide vaccine (lot # 647039/0604N). It was noted that the patient received a first dose of pneumococcal 23v polysaccharide vaccine in 1997. The patient experienced a sore arm with swelling, redness, and tightness on or near the injection site. The reporter indicated swollen and sore he reported later on 11/4/03. It was noted that the patient never came to the office during the reaction. The patient was treated with ice and ibuprofen. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected. The reporter also indicated that two other patients experienced similar reactions after therapy with pneumococcal 23v polysaccharide vaccine.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 80 year old female who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the patient recently developed a site reaction after vaccination. The reaction was marked by redness, swelling, and pain at the injection site. The patient did not have an extended recovery period. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. The physician also reported similar reactions in two other adult patients after therapy with pneumococcal 23v polysaccharide vaccine.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site inflammation, Swelling
Clinical narrative: Information has been received from a physician concerning an 84 year old male pt, who was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine.  The physician reported the pt developed an inflamed injection site reaction and swelling to the elbow. The adverse event resolved within 48-72 hours and no treatment was necessary. No other info is available. There was no product quality complaint reported. The pt recovered from the adverse events, inflamed injection site reaction and swelling to the elbow. Unspecified medical attention was sought. Additional info has been requested. The reporter also mentioned another pt who had a similar experience following vaccination with the dose of pneumococcal 23v polysaccharide vaccine.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash maculo-papular
Clinical narrative: Information has been received from an RN concerning a 72 year old white female pt with hypertension, diabetes, and a hx of irritable bowel syndrome, obesity and previous vaccination with dose of pneumococcal 23v polysaccharide vaccine in 1996, who on 24NOV2004 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine.  Other therapy administered on 24NOV2003 included a dose of influenza virus vaccine. Concomitant therapy included Lipitor, Xanax, Bentyl, Anafranil and Avandia. The registered nurse reported that the pt developed a local site reaction described as redness, swelling, pain and splotchiness on the arm. It was noted the pain at the site radiated to her neck. The reporter noted that on 25NOV2003 the symptoms were getting worse and were being treated with Benadryl and "soma". Unspecified medical attention was sought. There was no product quality complaint reported. Additional information received from the RN reported the pt recovered. Additional information is not expected. The registered nurse also mentioned that three other pts experienced similar site reactions: redness, swelling, pain and splotchiness following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from a consumer concerning his 72 year old wife with diabetes and heart problems and no known allergies who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Lipitor, Synthroid, metroplol, Glynase Prestab Tablets and excelon. Subsequently, two to three days after vaccination, the pt began to experience a rash, hives and itchiness all over her body. The physician prescribed a lotion and Benadryl to treat the event; however, it has not completely resolved. The reporter indicated that "the rash still flares up all over her body and on her scalp." Unspecified medical attention was sought. The outcome was reported as recovering with sequelae. There was no product quality complaint. Follow up information received on 01DEC2003 from the pt's husband indicated that the pt had tried the lotion and Benadryl to treat her hives as recommended by her physician, but she has still not recovered from her reaction. Additional information has been requested.
Age: 35.0
Sex: F
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 a 35 year old female who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt recently developed a site reaction after vaccination. The reaction was marked by redness, swelling and pain at the injection site. The pt did not have an extended recovery period. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. The physician also reported similar reactions in two other adult pts after therapy with pneumococcal 23v polysaccharide.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information ahs been received from physician concerning a 50 year old male who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt recently developed a site reaction after vaccination. The reaction was marked by redness, swelling and pain at the injection site. The pt did not have an extended recovery period. Unspecified medical attention was sought. A product quality complaint was not involved. Additional info has been requested. The physician also reported similar reactions in two other adult patient after therapy with penuemococcal 23v polysaccharide vaccine.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received form a physician concerning a 60 year old male with COPD who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The following day the pt had developed a swollen arm and redness from the shoulder to the wrist. He was prescribed abx and the adverse events had started to resolved by the next day. The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at". The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional info has been requested. It was also reported that a male pt was vaccinated with a dose f pneumococcal 23v polysaccharide vaccine and developed a fever of 103 to 104 degrees, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a licensed nurse concerning a pt who in approximately 2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, in approximately 2003, the pt developed redness and edema at the injection site. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved. The reporter also mentioned a second pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Erythema, Hyperaemia, Injection site reaction, Malaise
Clinical narrative: Information has been received from a physician concerning a 34 year old female American Indian pt in marketing with hypothyroidism who on 05NOV2003 was vaccinated in the left deltoid with a second IM 0.5 ml dose of pneumococcal 23v polysaccharide vaccine . Concomitant vaccinations on 05NOV2003 included a second IM dose in the R deltoid of influenza virus. Concomitant therapy included "replacement" for hypothyroidism. There was no illness at the time of vaccination. Upon receiving the vaccine on 05NOV2003, the pt developed asthenia, malaise, body aches, subjective fever and a local reaction around the injection site., which progressed to swelling, edema, pain, redness/ erythema and +/- hyperemia. The pt went to the ER, but treatment was not required and laboratory tests were not performed. The local rxn resolved in a few days with, but the asthenia and malaise were still present three weeks later. On 25NOV2003,the he pt was documented as recovered. It was noted that the experience resolved with time and local measures. A product quality complaint was not involved. Additional info is not expected.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a 34 year old female American Indian pt in marketing with hypothyroidism who on 05NOV2003 was vaccinated in the left deltoid with a second IM 0.5 ml dose of pneumococcal 23v polysaccharide vaccine . Concomitant vaccinations on 05NOV2003 included a second IM dose in the R deltoid of influenza virus. Concomitant therapy included "replacement" for hypothyroidism. There was no illness at the time of vaccination. Upon receiving the vaccine on 05NOV2003, the pt developed asthenia, malaise, body aches, subjective fever and a local reaction around the injection site., which progressed to swelling, edema, pain, redness/ erythema and +/- hyperemia. The pt went to the ER, but treatment was not required and laboratory tests were not performed. The local rxn resolved in a few days with, but the asthenia and malaise were still present three weeks later. On 25NOV2003,the he pt was documented as recovered. It was noted that the experience resolved with time and local measures. A product quality complaint was not involved. Additional info is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from an nurse practitioner concerning a female pt in her seventies with coronary disease, diabetes, hypertension and thyroid problems who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt was vaccinated at another physician's office. concomitant therapy included Micadis, Lipitor, aspirin, Evista, Synthroid, metoprolol, Glyburide and Exelon. The pt developed a rash about three weeks after vaccination The rash started on her chest and primarily on her trunk. She visited her general practitioner and a dermatologist for treatment which included a topical steroid. A product quality complaint was not involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received form a health professional concerning a 62 year female pt with a hx of chronic obstructive pulmonary disease who in November 2003, was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently in November 2003, the pt experienced injection site reactions which included injection site swelling, soreness and erythema. It was reported that the swelling went past her elbow. She was treated with Benadryl and cold compress The reporter indicated that three other pts had similar experiences following exposure to dose of pneumococcal 23v polysaccharide vaccine . The reporter indicated that the pt's swelling "was more sever than the others and went past here elbow". as of 03DEC2003, the pt's adverse events abated. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from an RN concerning a retired 60 year old white female pt with allergies to NSAIDS, Augmentin and Novocain who on 28OCT2003 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 31OCT2003 the pt developed left arm redness and pain. The pt recovered from left arm redness and pain on 02NOV2003. There were no laboratory or diagnostic tests performed. The pt was not ill at the time of vaccination and had no adverse events prior vaccination. No additional information is expected The RN also reported that three other pts who had similar experiences following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from an RN concerning a retired 57 year old white female pt with no known allergies who on 03NOV2003 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 05NOV2003 the pt developed left arm redness and pain. The pt recovered form left arm redness and left arm pain on 07NOV2003. There was no lab or diagnostic studies performed. The pt was not ill at the time of vaccination. It was noted the pt did not have adverse evens following prior vaccinations. No additional info is expected. The RN nurse also reported three other pts who experienced similar reactions following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received form an RN concerning a 63 year old white female with allergies to codeine and Amoxil who on 23OCT2003 at an unknown time, was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. On 24OCT2003 the pt developed right arm redness and pain. The pt recovered form right arm redness and pain on 26OCT2003. There were no lab or diagnostic tests performed.  The pt was not ill at the time of vaccination. It was noted that the pt did not have adverse events following prior vaccination. No additional information is expected. The RN also mentioned that three other pts who had similar experiences following vaccinations with dose of pneumococcal 23v polysaccharide vaccine.
Age: 90.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received form an RN concerning a retired 90 year old white male with no known allergies who on 21OCT2003 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 24OCT2003 the pt developed left upper arm redness and pain below the injection site. The RN reported that the pt recovered from left upper arm redness and pain below injection site on 26OCT2003. There were no lab or diagnostic tests performed. it was noted the pt was not ill at the time of vaccination and had not experience adverse events prior to vaccinations. No additional info is expected. The RN also reported three other pts who had similar experiences following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: Information has been received from a health care worker reporting on behalf of a physician concerning an elderly male pt between the age of 65-80 years old, who last Wednesday 26NOV2003 or Friday 28NOV2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The health care worker reported that after receiving the vaccine the pt experienced nausea and weakness. The pt recovered. The health care worker wanted to know if there have been any reports of problems with this specific lot of pneumococcal 23v polysaccharide vaccine; however there was no product quality complaint reported. No additional information was provided. Unspecified medical attention was sought. The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the physician who confirmed the pt was a  59 year old male on 26NOV2003, at an unspecified time in the AM, was vaccinated in the upper arm with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported the pt experienced all over body aches and a local reaction which lasted for one day. The physician confirmed the pt was not hospitalized and he is recovering. The reporter also mentioned another pt who had an experience following vaccination with pneumococcal 23v polysaccharide vaccine.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received from a 50 year old male company representative with no pertinent medical history who on 12/02/03 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included interferon (unspecified) and "ribovioren".  On 12/03/03 the pt experienced soreness in his tricep muscle, a fever below 102, a headache and muscle aches throughout his body. Medical attention has not been sought and no lab tests were performed. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site inflammation
Clinical narrative: Information has been received from a LPN concerning a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646156/80287N). The LPN reported that the pt subsequently developed cellulitis of the injection site characterized by inflammation of the injection site. Unspecified medical attention was sought and the pt was treated with an unspecified antibiotic. At the time of this report, the outcome was unknown. Lot check results are as followed: 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 Biologics Evaluation and Research and was released. The LPN also reported that two males also developed cellulitis of the injection site and inflammation of the injection site after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0311USA02604).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a healthcare worker in a physician's office concerning a female pt who in the beginning of the week of 12/01/03 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647635/0864N). The pt experienced fever and cellulitis at the injection site. It was noted that the pt stayed home from work for three days. Unspecified medical attention was sought. It was noted that the physician was concerned about the vaccine because the injections were from the same lot.  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 Biologics Evaluation and Research and was released.  Additional information has been requested. The reporter also indicated that a 27 year old female had a similar reaction after therapy with pneumococcal 23v polysaccharide vaccine (Lot # 647635/0864N)(WAES#0312USA00917).
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a 61 year old male pt with no known allergies who in December 2002 and on 12/04/03 at 13:20 was vaccinated in the right deltoid with a first and second dose of pneumococcal 23v polysaccharide vaccine, respectively (Lot #: second dose 646322/0530N). It was noted that the pt inquired "as to a possible overdose". There was no illness at the time of vaccination. It was noted that the "HCP'S" at the office were not aware that he received the vaccine last year. Concomitant therapy included a dose influenza vaccine in the left deltoid. Concomitant medication included Lipitor, "bisoprolol" and aspirin 81mg. On 12/05/03, he stated his "site is swollen, red and very painful" and "he cannot raise his right arm". A prescription drug was not required. There were no diagnostic lab tests performed. Unspecified medical attention was sought. It was noted initially that the pt had not recovered; however subsequent recovery status was reported as "unknown" by another reporter. There was no product quality complaint involved. Follow up information from a health care professional indicated that the pt did not contact the MD's office with any adverse reactions. "The pt requested 'Pneumovax' and after receiving it, he asked when he should get another one as he received a vaccine in 2002 also." No further information is available.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker in a physician's office concerning a 27 year old white female with an allergy to morphine who on 12/01/03 at 4:45pm was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #647635/0864N)(also reported as Lot # U1291AA).  There was no illness at the time of vaccination. The pt experienced fever and cellulitis at the injection site. Unspecified medical attention was sought.  It was noted that the physician was concerned about the vaccine because the injections were from the same lot. Follow up was received from the healthcare worker in the physician's office who indicated that on 12/01/03 the pt developed a severe local reaction with pain, erythema, warmth, swelling and fever. No diagnostic lab tests were performed. Subsequently, the pt recovered. It was noted that the pt and her sibling had no adverse events following prior vaccination.  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 Biologics Evaluation and Research and was released.  No further information is expected.  The reporter also indicated that a female pt had a similar reaction after therapy with pneumococcal 23v polysaccharide vaccine (Lot # 647635/0864N)(WAES#0312USA00798).
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a healthcare worker in a physician's office concerning a 27 year old white female with an allergy to morphine who on 12/01/03 at 4:45pm was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #647635/0864N)(also reported as Lot # U1291AA).  There was no illness at the time of vaccination. The pt experienced fever and cellulitis at the injection site. Unspecified medical attention was sought.  It was noted that the physician was concerned about the vaccine because the injections were from the same lot. Follow up was received from the healthcare worker in the physician's office who indicated that on 12/01/03 the pt developed a severe local reaction with pain, erythema, warmth, swelling and fever. No diagnostic lab tests were performed. Subsequently, the pt recovered. It was noted that the pt and her sibling had no adverse events following prior vaccination.  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 Biologics Evaluation and Research and was released.  No further information is expected.  The reporter also indicated that a female pt had a similar reaction after therapy with pneumococcal 23v polysaccharide vaccine (Lot # 647635/0864N)(WAES#0312USA00798).
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a 75 year old Caucasian female with allergies to codeine, "Epi" and verapamil hydrochloride (Calan) who on 11/18/03 was vaccinated IM in the left deltoid with a first dose in of pneumococcal 23v polysaccharide vaccine (Lot # 647636/0944N). There was no illness at the time of vaccination. On 11/19/03, the pt developed left arm pain, swelling, tenderness and was unable to use her arm. Treatment included anti-inflammatories and pain medication. Medical attention was sought. It was unknown if the pt had recovered. The reporter also mentioned (WAES # 0311USA00842 N& 0312USA00976) who experienced similar reactions after vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a 51 year old physician with multiple sclerosis and hypertension who on 12/08/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included interferon bega-la (Avonex), lisinopril (Prinivil) and hydrocodone HC1.  The physician reported that in December 2003, he developed a fever of 102F, myalgia, injection site pain and injection site induration. Unspecified medical attention was sought and the physician was treated with acetaminophen for the fever and pain. At the time of this report, the outcome were unknown. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a LPN concerning an approximately 77 year old white male with PCN allergy who in 2000 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, per the pt's spouse, the pt developed red left upper arm red and hot to touch. On 10/31/03 at 9:15am the pt was vaccinated with another dose of pneumococcal 23v polysaccharide vaccine (Lot # 647655/0869N, IM in the left deltoid. On 11/01/03 in the AM the pt developed cellulitis described with redness, tenderness, edema to the elbow. The pt was treated with an illegible reported therapy (20mg per day) and acetaminophen (Tylenol, 3 times a day). The pt recovered between 11/05/03 & 11/10/03.  It was also reported that several other pt's had a similar reaction (WAES # 0311USA00334).  No further information is expected.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a consumer and a physician concerning a 46 year old white female pt with no allergies and a history of renal stones, appendectomy and hysterectomy who on 11/14/03 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647028/0564N). Concomitant vaccination on 11/14/03 included an IM dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone)(Lot # U1058AA).  There was no illness at the time of vaccination and there were no adverse events following prior vaccination. On 11/15/03, the pt developed a very large red area surrounding the site, a headache and a low grade fever. It was also reported that the pt developed a local reaction and was swollen from the elbow to the shoulder. Medical attention was sought and the pt was treated with Benadryl and Zantac. Lab tests were not performed. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. On 11/21/03, the pt recovered from the red area, headache and fever. A product quality complaint was not involved. The reporters also mentioned two other pt's who experienced local reactions following vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647028/0564N)(WAES#0311USA01984 & 0401USA00073).  Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a physician's assistant concerning a 4 year old healthy male who on 12/09/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # not available). There were no concomitant medications. On 12/10/03 the pt developed swelling from shoulder to elbow in the injection arm. No other information was available. Unspecified medical attention was sought. There was no product quality complaint.  There were no lab diagnostic studies performed. Additional information has been requested.