chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site warmth, Oedema, Pain
Clinical narrative: Initial and follow up information has been received from a certified Medical Assistant concerning a 71 year old female patient with asthma, diabetes mellitus, hyperlipidemia, insomnia, gastritis, lymphocytosis, hypertension, and allergies to sulfa, penicillin, potassium chloride and bees, and a history of splenectomy who on Oct 11 2004 at 11:00 am was vaccinated Im in the right arm with a first dose of pneumococcal 23v polysaccharide vaccine  (lot 649696/0490P). Concomitant therapy included amlodipine besylate (Norvasc), glipizide, metformin HCL (Glucophage), ezetimibe , metoprolol succinate (Toprol), albuterol sulfate (+) ipratropium bromide (Combivent), fluticasone propionate (Flovent), lorazepam (Ativan) and propranolol HCL (Inderal). On Oct 11 2004 at 11:00 am, the patient developed injection site redness and heat and her entire arm became swollen. The right arm was also sore to the touch. The patient did not have any nausea, vomiting, diarrhea or fever. The patient was treated with ciprofloxacin (+) ciprofloxacin hydrochloride (Cipro XR) 500mg daily for one week. There were no diagnostic or laboratory tests performed. On Oct 12 2004 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site hypersensitivity, Injection site pain, Injection site reaction, Listless
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old female who on Oct 18 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Subsequently, on Oct 18 2004 the patient developed injection site redness, injection site pain, hives felling of blacking out and felt unable to function. The doctor prescribe rest, fluids. Diphenhydramine hydrochloride (Benadryl) cream and acetaminophen (Tylenol). The nurse reported that the patient returned to the office for a follow up appointment (date unavailable). It was also reported that the patients symptoms persisted but were improving and the treatment remained the same as previously reported. During follow up evaluation, the patient was diagnosed with a urinary tract infection and placed on an unspecified antibiotic. It was also reported that another female patient experience an adverse event following the pneumococcal 23v polysaccharide vaccine (WAES0410USA03188). There was no product quality complaint involved. Additional information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Urinary tract infection, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old female who on Oct 18 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Subsequently, on Oct 18 2004 the patient developed injection site redness, injection site pain, hives felling of blacking out and felt unable to function. The doctor prescribe rest, fluids. Diphenhydramine hydrochloride (Benadryl) cream and acetaminophen (Tylenol). The nurse reported that the patient returned to the office for a follow up appointment (date unavailable). It was also reported that the patients symptoms persisted but were improving and the treatment remained the same as previously reported. During follow up evaluation, the patient was diagnosed with a urinary tract infection and placed on an unspecified antibiotic. It was also reported that another female patient experience an adverse event following the pneumococcal 23v polysaccharide vaccine (WAES0410USA03188). There was no product quality complaint involved. Additional information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old female who in 1999 and on Oct 14 2004 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (second dose lot 649913/0577P). That same night the patient reported that the injection site and arm felt hot, was raised and was red.. The redness spread from the elbow up to the shoulder. Medical attention was sought. The patient was prescribed fexofenadine hydrochloride (Allegra), 180 mg for 5 days and prednisone 20 mg tapering off. The patient was to call the physicians office if the problems continued but they have not heard from her. The reporter expressed a concern regarding the lot number. 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. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (second dose lot 649913/0577P) and developed AE's (WAES0411USA01579 and WAES0144USA01580). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site induration, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old female who in 1999 and on Oct 25 2004 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). On Oct 26 2004 the patient reported that she developed a fever, severe pain in the arm, shoulder and left breast and axilla area. the areas were red, hard, and raised with swelling. it was reported that it looked like cellulitis in appearance. medical attention was sought. Clarithromycin (Biaxin) was ordered. The reporter expressed a concern regarding the lot number. 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. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (second dose lot 649913/0577P) and developed AE's (WAES0410USA3951, WAES0411USA05179). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old female who in 1999 and on Oct 25 2004 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). On Oct 26 2004 the patient reported that she developed a fever, severe pain in the arm, shoulder and left breast and axilla area. the areas were red, hard, and raised with swelling. it was reported that it looked like cellulitis in appearance. medical attention was sought. Clarithromycin (Biaxin) was ordered. The reporter expressed a concern regarding the lot number. 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. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (second dose lot 649913/0577P) and developed AE's (WAES0410USA3951, WAES0411USA05179). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Hypersensitivity, Oedema, Pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 72 year old caucasian female with penicillin allergy, gastroesophageal reflux disease and allergy to benoxaprofen (Oraflex) who on Oct 25 2004 in the PM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647038/0926N) in the right deltoid. There was no concomitant medication. On Oct 25 2004 and hour and a half later after injection the patients right hand became swollen and a few hours later she had redness. The redness went up to her elbow. It was also reported that the patient experienced fever, rash, and itchiness immediately after she received the vaccination, It was described as a bad reaction to the pneumococcal 23v polysaccharide vaccine. The patient took acetaminophen (Tylenol) and complained of fevers and chills for 2 days after injection. The patient was given cetirizine hydrochloride (Zyrtec) (10 mg) given daily for 3-4 days. Subsequently, the patient recovered. There were no relevant diagnostic tests or laboratory data performed. No further information is available.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 72 year old caucasian female with penicillin allergy, gastroesophageal reflux disease and allergy to benoxaprofen (Oraflex) who on Oct 25 2004 in the PM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647038/0926N) in the right deltoid. There was no concomitant medication. On Oct 25 2004 and hour and a half later after injection the patients right hand became swollen and a few hours later she had redness. The redness went up to her elbow. It was also reported that the patient experienced fever, rash, and itchiness immediately after she received the vaccination, It was described as a bad reaction to the pneumococcal 23v polysaccharide vaccine. The patient took acetaminophen (Tylenol) and complained of fevers and chills for 2 days after injection. The patient was given cetirizine hydrochloride (Zyrtec) (10 mg) given daily for 3-4 days. Subsequently, the patient recovered. There were no relevant diagnostic tests or laboratory data performed. No further information is available.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Hypokinesia, Injection site erythema, Oedema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female with hypertension and osteoporosis who on Oct 29 2004, at 10:00, was vaccinated IM with what was believed to be a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included amitriptyline hydrochloride, atenolol, alendronate sodium, simvastatin and levothyroxine (Synthroid). On Oct 29 2004, the patient developed a red ring around the injection site within 4 hours and developed swelling to the elbow as well as joint pain in the elbow. the patient was treated with diphenhydramine (Benadryl) and ibuprofen. Subsequently, the symptoms subsided in 72 hours. Conflicting information has been received from the registered nurse. The nurse reported that on Oct 29 2004, at 14:00, the patient developed a red ring at vaccination site. Then the entire arm became swollen to the wrist. The nurse reported that the swelling was so severe, the patient could not raise her arm. On approximately Oct 31 2004, 72 hours after vaccination, the patients swelling persisted, and the patient experienced pain in the elbow. The patient was then treated with diphenhydramine (Benadryl), which helped little, and was advised to use an anti inflammatory. The out come was unknown. No additional information is expected.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Inflammation, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a 89 year old white, female with no known drug allergies and hypertension and a history of breast cancer and lymph node removal who on Nov 02 2004 at 10:00am was vaccinated intramuscularly in the left deltoid with first dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529F). it was noted that the patient had a slight cold at the time of vaccination. it was reported that within 8 hours, at 6:00pm, the patient developed swelling at injection, and her arm was red and warm to touch, the redness moved down to mid forearm, It was noted that the patient had a temperature of 98.2 and no fever, the patient was instructed to use an anti inflammatrory, twice per day for 3 days, to elevate her arm, and to see physician if condition worsens. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up imformation from a registered nurse indicated that the red and swollen arm began at the injection site with then traveled down the arm and was warm to touch. The patient was diagnosed with inflammation. Follow up information from registered nurse indicated that the redness and swelling resolved tow days prior to seeing the doctor at the clinic. The patient made contact with her personal doctor and all symptoms resolved at that visit. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Infection, Injection site reaction
Clinical narrative: Information has been received from a pharmacist and a physician concerning a 21 year old female with a history of splenectomy and no know drug allergies, who on Nov 04 204 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647357/0988N). On Nov 06 2004 the patient developed a local site reaction and was hospitalized. The reaction was thought to be a possible infection, cellulitis. The patient was being treated with antibiotics. The patients outcome was unknown. the physician was requesting a lot check. 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. Local site reaction was considered to be an other important medical event. It was also reported that a male patient (WAES0411USA02641) developed pneumonia an pleural effusion after vaccination with pneumococcal 23v polysaccharide vaccine (lot 647357/0988N). Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site pain, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 79 year old female with no known drug allergies who at 2:45 on Nov 4 2004 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). On Nov 04 2004, the patient was concomitantly vaccinated in the right deltoid with a dose of influenza virus split virion 3v vaccine inactivated (Fluvax) (lot U1462AA). On Nov 05 2004, the patient developed a red, sore arm at injection site (site not specified). Her arm was painful to use. No treatment was administered. Subsequently, the patient recovered. No further information is available.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning an 85 year old male with a penicillin allergy who on Oct 26 2004, was vaccinated subcutaneously into the left deltoid, with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Concomitant therapy included an intramuscular second dose into the right deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone) influenza virus split virion 3v vaccine inactivated (batch U1462AA). Subsequently, the patients left arm was very sore. It was noted that there was no treatment given. Three or four days later, the patient recovered. No further information is expected.
Age: 92.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 91 year old male who on Nov 02 2004 at 10:30, was vaccinated into the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). On the morning of Nov 03 2004, the patients left arm was red and sore, It was noted that no treatment was given. Subsequently, the patient recovered. No further information is expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning an 81 year old female who on Oct 20 2004 at 10:30 was vaccinates with a dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P), in the left arm subcutaneously. On Oct 21 2004 the patient experienced left arm at injection site red, swollen, painful, warm and very tender. The patient was treated with diphenhydramine HCL ( Benadryl), ice pack and dexamethasone (Decadron) (8 mg). The patient recovered. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning an 81 year old female who on Oct 20 2004 at 10:30 was vaccinates with a dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P), in the left arm subcutaneously. On Oct 21 2004 the patient experienced left arm at injection site red, swollen, painful, warm and very tender. The patient was treated with diphenhydramine HCL ( Benadryl), ice pack and dexamethasone (Decadron) (8 mg). The patient recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old male who on 10/20/04 at 10:30 AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649913/0577P). On 10/21/04 at 1:00 PM, .the patient's right arm swollen and very sore, woke him in the night. There was no treatment. Subsequently, the patient recovered. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Oedema, Pain
Clinical narrative: information has been received from a registered nurse concerning a 50 year old white female who on Oct 27 2004 at 11:00 was vaccinated intramuscularly into the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot number 649695/0512P). There was no illness at the time of vaccination. Two hours after receiving the vaccination, the patient complained of feeling hot all over, but was afebrile. The patients right upper arm began swelling from the deltoid to the elbow. her arm was very red, hot to the touch, and was extremely painful. The patient said that her arm looked like the arm of Popeye. No medical attention was sought. No diagnostic laboratory test were performed. On Nov 03 2004, the patient recovered. No product quality complaint was involved. Additional information is not available. It was also reported that an adult patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine and experienced adverse events (WAES0412USA02912).
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain
Clinical narrative: information has been received from a registered nurse concerning a 71 year old white retired male with no medical history, who on Nov 22 2004 at 14:00 was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot number 650082/0691P). there were no illnesses at the time of vaccination. At 14:00, the patient developed red streaks underneath the side of the left upper arm, and had extreme pain and soreness. No medical attention was sought. No laboratory diagnostic tests were performed. The symptoms lasted 5 days. On Nov 27 2004, the patient recovered. No product quality complaint was involved. Additional information has been requested. It was also reported that an adult patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine and experienced adverse events (WAES0502USA00637).
Age: 70.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Feeling hot, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female who on Dec 03 2004 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). concomitant therapy included tetanus toxoid (Tetanus Toxoid) (lot V1282AA) given GM. Subsequently, it was reported that the patient contacted the physician sometime over the weekend with a chief complaint of hot spots on her arm, following the vaccination. The physician followed up with the patient on Dec 06 2004, and the patient reported that the hot spots had improved, although her arm was sore. the outcome of the patients arm soreness was not known at present. The physician expressed a concern regarding the 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. Follow up information from the nurse indicated that the patient called the clinic with symptoms of hot spots on the arm. the patient stated that the symptoms had improved, but she had a sore arm on Dec 06 2004. No further work up was done on the patients and the symptoms resolved. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female who on Dec 02 2004 was vaccinated with a first dose in the deltoid of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). in the evening of Dec 02 2004 the patient complained of extreme arm pain, weakness, dizziness and felt faint to the point of needing to lie down. The patient did not faint. The patient laid down for a half hour, and subsequently, her symptoms improved. There was no other treatment needed for this patient, The physician felt that the patient experienced a possible allergic reaction to pneumococcal 23v polysaccharide vaccine since it was her first dose. The physician expressed a concern for the 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. Follow up information from the nurse indicated that the patient experienced extreme pain in the arm, was weak, dizzy and faint. Symptoms passed after 1/2 hour and the patient called the office to report a possible reaction to vaccine. No further work up was done on the patient and symptoms had resolved. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Influenza like illness, Insomnia, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old male who on Dec 08 2004 was vaccinated with a first dose in the deltoid of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). After vaccination on Dec 08 2004, the patient experienced a sore arm and difficulty sleeping that night. On Dec 09 2004 the patient experienced stomach flu like symptoms with headache and achiness, and his arm remained sore. Later on Dec 09 2004 the patients condition improved, and he slept better that night. The patient needed no treatment. The physician expressed a concern regarding the 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 of Biologics Evaluation and Research and was released. Follow up information from the nurse indicated that the patient noted a sore arm and difficulty sleeping. The next day he felt like the stomach flu and had an achy sore arm. On Dec 10 2004 the arm was better and he slept better. No further work up was done on the patient and the symptoms had resolved. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a female in a physician's office concerning a 71 year old retired female who on 07-DEC-2004 was vaccinated in the left deltoid with a second dose of Pneumovax 23 (lot # 649979/0531P). On the afternoon of Thursday 09-DEC-2004, the pt called the physician's office with a chief complaint of redness and swelling of her arm. On 10-DEC-2004 she saw the physician and was treated with antibiotics for a diagnosis of bacterial cellulitis. At the time of this report there was no information regarding the pt's present medical status. The bacterial cellulitis was considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bacterial infection, Cellulitis, Erythema, Oedema, Pain
Clinical narrative: Information has been received from a woman at a physician's office concerning a 70 year old retired female pt who on 07-DEC-2004 was vaccinated in the left deltoid with a second dose of Pneumovax 23 (lot # 649732/0513P). She called the physician's office on Thursday, 09-DEC-2004 and complained of redness and swelling and pain. She came into the physician office and the physician diagnosed her with bacterial cellulitis and treated her with antibiotics. Subsequently, the pt recovered after antibiotic treatment. Bacterial cellulitis was considered an other important event (OMIC) by the reporter. No further information is expected.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a woman at a physician's office concerning a 70 year old retired female pt who on 07-DEC-2004 was vaccinated in the left deltoid with a second dose of Pneumovax 23 (lot # 649732/0513P). She called the physician's office on Thursday, 09-DEC-2004 and complained of redness and swelling and pain. She came into the physician office and the physician diagnosed her with bacterial cellulitis and treated her with antibiotics. Subsequently, the pt recovered after antibiotic treatment. Bacterial cellulitis was considered an other important event (OMIC) by the reporter. No further information is expected.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bacterial infection, Cellulitis, Erythema, Oedema, Pain
Clinical narrative: Information has been received from a RN concerning a 70 yr old female pt who was vaccinated in the arm on 07Dec04 with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). It was reported that the pt subsequently developed redness and swelling of the arm and experienced arm pain. The pt was diagnosed with bacterial cellulitis from pneumococcal 23v polysaccharide vaccine (lot649732/0513P). The doctor believed the reaction was from the vaccine. The pt was treated with unnamed antibiotics. It was also reported that the pt received pneumococcal 23v polysaccharide vaccine five years ago. At the time of the report, the pt's outcome was unk. The physician expressed a concern regarding the lot. 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. The nurse reported that three other pt's experienced adverse events after administration of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) (WAES 0412USA01335 and 0412USA01727).  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a RN concerning a 70 yr old female pt who was vaccinated in the arm on 07Dec04 with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). It was reported that the pt subsequently developed redness and swelling of the arm and experienced arm pain. The pt was diagnosed with bacterial cellulitis from pneumococcal 23v polysaccharide vaccine (lot649732/0513P). The doctor believed the reaction was from the vaccine. The pt was treated with unnamed antibiotics. It was also reported that the pt received pneumococcal 23v polysaccharide vaccine five years ago. At the time of the report, the pt's outcome was unk. The physician expressed a concern regarding the lot. 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. The nurse reported that three other pt's experienced adverse events after administration of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) (WAES 0412USA01335 and 0412USA01727).  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 27 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649981/0704P). Subsequently, the patient experienced redness and soreness at the injection site. It was reported that the patient was told to treat her reaction with warm compresses. the patients outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Hypersensitivity
Clinical narrative: Information has been received from a registered pharmacist concerning a 61 year old white female with no allergies or past medical history who on Jan 11 2005 at 4:00 pm was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P), in the left deltoid. Concomitant therapy that day and time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (lot 41559BA), in the left deltoid. Other therapy included alendronate sodium and atorvastatin calcium (Lipitor). The patient experienced red radial streaks from the injection site to her hand. The streaks seemed to follow her lymph ducts. There was also erythema and redness. It was reported that she was given something for the allergic response and an antibiotic. Follow up from a nurse in the patients doctors office reported that the patient also had swelling. It was also reported that on Jan 12 2005 the patient had left arm pain, red and swelling which started over night from deltoid down to antecubital fossa. The patient was treated with cephalexin (Keflex) 500 mg (QID x 7 days), diphenhydramine HCL (Benadryl) every 4-6 hours, and otc pain reliever. On Jan 13 2005 the patient took acetaminophen (Tylenol) (one to two tablet every 4 hours) for pain. The patient recovered. It was noted that the patient did not experience an adverse event following prior vaccination. No product quality complaint involved. No further information is expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site reaction, Oedema
Clinical narrative: Information has been received from a registered pharmacist concerning a 61 year old white female with no allergies or past medical history who on Jan 11 2005 at 4:00 pm was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P), in the left deltoid. Concomitant therapy that day and time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (lot 41559BA), in the left deltoid. Other therapy included alendronate sodium and atorvastatin calcium (Lipitor). The patient experienced red radial streaks from the injection site to her hand. The streaks seemed to follow her lymph ducts. There was also erythema and redness. It was reported that she was given something for the allergic response and an antibiotic. Follow up from a nurse in the patients doctors office reported that the patient also had swelling. It was also reported that on Jan 12 2005 the patient had left arm pain, red and swelling which started over night from deltoid down to antecubital fossa. The patient was treated with cephalexin (Keflex) 500 mg (QID x 7 days), diphenhydramine HCL (Benadryl) every 4-6 hours, and otc pain reliever. On Jan 13 2005 the patient took acetaminophen (Tylenol) (one to two tablet every 4 hours) for pain. The patient recovered. It was noted that the patient did not experience an adverse event following prior vaccination. No product quality complaint involved. No further information is expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 61 year old white female with no allergies or past medical history who on Jan 11 2005 at 4:00 pm was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P), in the left deltoid. Concomitant therapy that day and time included influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (lot 41559BA), in the left deltoid. Other therapy included alendronate sodium and atorvastatin calcium (Lipitor). The patient experienced red radial streaks from the injection site to her hand. The streaks seemed to follow her lymph ducts. There was also erythema and redness. It was reported that she was given something for the allergic response and an antibiotic. Follow up from a nurse in the patients doctors office reported that the patient also had swelling. It was also reported that on Jan 12 2005 the patient had left arm pain, red and swelling which started over night from deltoid down to antecubital fossa. The patient was treated with cephalexin (Keflex) 500 mg (QID x 7 days), diphenhydramine HCL (Benadryl) every 4-6 hours, and otc pain reliever. On Jan 13 2005 the patient took acetaminophen (Tylenol) (one to two tablet every 4 hours) for pain. The patient recovered. It was noted that the patient did not experience an adverse event following prior vaccination. No product quality complaint involved. No further information is expected.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Chest pain, Chills, Headache, Hypokinesia
Clinical narrative: Information has been received from a female licensed practical nurse who on Jan 14 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 0386P). Subsequently, the patient experienced redness, pain and swelling at the injection site, fever of 102.1 and lower back pain. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia, Similar reaction on previous exposure to drug, Tachycardia
Clinical narrative: Information has been received from a female licensed practical nurse who on Jan 14 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 0386P). Subsequently, the patient experienced redness, pain and swelling at the injection site, fever of 102.1 and lower back pain. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Back pain, Injection site hypersensitivity, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a female licensed practical nurse who on Jan 14 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 0386P). Subsequently, the patient experienced redness, pain and swelling at the injection site, fever of 102.1 and lower back pain. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a female licensed practical nurse who on Jan 14 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 0386P). Subsequently, the patient experienced redness, pain and swelling at the injection site, fever of 102.1 and lower back pain. Subsequently, the patient recovered. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, TD, DT, PPV
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female patient with a drug hypersensitivity to Tetanus anti serum and penicillin who on 01/18/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P) in the right arm.
Age: 76.0
Sex: F
Vaccine: PPV, TD, DT, PPV
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female patient with a drug hypersensitivity to Tetanus anti serum and penicillin who on 01/18/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P) in the right arm.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female patient with a drug hypersensitivity to sulfa and penicillin who on 01/18/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #649914/0578P) in the right arm.  On 01/18/2005, a few hours post vaccination, the patient experienced a red, hard, edematous, swollen right arm from injection site to inside of the arm.  She was treated with an ice pack, Benadryl intramuscularly, and Ibuprofen.  The patient's outcome was not reported.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards.  Follow up information was received from a registered nurse which indicated that the patient was white and had received one dose of the pneumococcal 23v polysaccharide vaccine in 1997.  On 01/18/2005, at approximately 01:30PM, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P), intramuscularly in the right deltoid.  The patient had no illness at time of vaccination.  On 01/18/2005, at approximately 03:30PM, the patient complained of right upper arm discomfort, redness, and swelling.  The area was at her right upper arm moving.  The area was reported as red, hard, tender to touch, and edematous.  She was treated with Ibuprofen 600mg, Benadryl 25mg as needed.  The patient's adverse events were reported as non-serious and the outcome was unknown.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female patient with a drug hypersensitivity to sulfa and penicillin who on 01/18/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #649914/0578P) in the right arm.  On 01/18/2005, a few hours post vaccination, the patient experienced a red, hard, edematous, swollen right arm from injection site to inside of the arm.  She was treated with an ice pack, Benadryl intramuscularly, and Ibuprofen.  The patient's outcome was not reported.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards.  Follow up information was received from a registered nurse which indicated that the patient was white and had received one dose of the pneumococcal 23v polysaccharide vaccine in 1997.  On 01/18/2005, at approximately 01:30PM, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P), intramuscularly in the right deltoid.  The patient had no illness at time of vaccination.  On 01/18/2005, at approximately 03:30PM, the patient complained of right upper arm discomfort, redness, and swelling.  The area was at her right upper arm moving.  The area was reported as red, hard, tender to touch, and edematous.  She was treated with Ibuprofen 600mg, Benadryl 25mg as needed.  The patient's adverse events were reported as non-serious and the outcome was unknown.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Oedema peripheral, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 43 month old male with a history of slightly low immune globulins for his age and no allergies who on 2/11/05 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot # 650454/0751P). There was no concomitant medication. On 2/12/05 the patient experienced vomiting. On 2/13/05 the patient had 101 F temperature with swollen arm size of tennis ball, hot, painful when moving arm. The patient was seen in the emergency room but not admitted. The patient was diagnosed with cellulitis, and was treated with oral antibiotics. The patient responded within 3 days, and condition resolved. No product quality complaint was involved. It was reported that other patients also had an adverse experience following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0502USA03041 and WAES0502USA03082). The registered nurse considered the cellulitis to be an other important medical event (OMIC). Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Feeling hot, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a 43 month old male with a history of slightly low immune globulins for his age and no allergies who on 2/11/05 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot # 650454/0751P). There was no concomitant medication. On 2/12/05 the patient experienced vomiting. On 2/13/05 the patient had 101 F temperature with swollen arm size of tennis ball, hot, painful when moving arm. The patient was seen in the emergency room but not admitted. The patient was diagnosed with cellulitis, and was treated with oral antibiotics. The patient responded within 3 days, and condition resolved. No product quality complaint was involved. It was reported that other patients also had an adverse experience following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0502USA03041 and WAES0502USA03082). The registered nurse considered the cellulitis to be an other important medical event (OMIC). Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Pyrexia, Swelling, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 6 year old male with asthma, no drug allergies and a history of recurrent ear infections and sinus infections. Who on Feb 18 2005 at 4:45pm was vaccinated Im into the left arm with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot 650454/0751P). There was no illness at the time of vaccination. It was reported that on Feb 18 2005 the patient left the clinic in good health. On Feb 22 2005, the patients mother called the health care professional and stated the patient had redness and swelling all the way down left arm, vomiting and fever since Feb 18 2005. it was reported that the child was taken to the emergency room for evaluation and was released. The patients outcome was unknown. No product quality complaint was involved. The pharmacist requested a lot check. 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 is not expected.
Age: 7.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Hypersensitivity, Oedema, Pyrexia, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 6 year old male with asthma, no drug allergies and a history of recurrent ear infections and sinus infections. Who on Feb 18 2005 at 4:45pm was vaccinated Im into the left arm with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot 650454/0751P). There was no illness at the time of vaccination. It was reported that on Feb 18 2005 the patient left the clinic in good health. On Feb 22 2005, the patients mother called the health care professional and stated the patient had redness and swelling all the way down left arm, vomiting and fever since Feb 18 2005. it was reported that the child was taken to the emergency room for evaluation and was released. The patients outcome was unknown. No product quality complaint was involved. The pharmacist requested a lot check. 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 is not expected.
Age: 7.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Oedema, Pyrexia, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 6 year old male with asthma, no drug allergies and a history of recurrent ear infections and sinus infections. Who on Feb 18 2005 at 4:45pm was vaccinated Im into the left arm with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot 650454/0751P). There was no illness at the time of vaccination. It was reported that on Feb 18 2005 the patient left the clinic in good health. On Feb 22 2005, the patients mother called the health care professional and stated the patient had redness and swelling all the way down left arm, vomiting and fever since Feb 18 2005. it was reported that the child was taken to the emergency room for evaluation and was released. The patients outcome was unknown. No product quality complaint was involved. The pharmacist requested a lot check. 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 is not expected.
Age: 6.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Erythema, Pyrexia, Swelling, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 year old male with asthma and azithromycin allergy who on 18-FEB-2005 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included Nasonex, Zantac and montelukast sodium. On 18-FEB-2005 the pt felt sick that night with fever and arm swelling. The pt also had vomiting. On 22-FEB-2005 the whole arm was red from injection site to past elbow. the pt was being treated in the ER. It was reported that other patients also had an adverse experience following vaccination with Pneumovax 23 (WAES0502USA03041 and WAES0502USA03081). Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Hypersensitivity, Oedema, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 year old male with asthma and azithromycin allergy who on 18-FEB-2005 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included Nasonex, Zantac and montelukast sodium. On 18-FEB-2005 the pt felt sick that night with fever and arm swelling. The pt also had vomiting. On 22-FEB-2005 the whole arm was red from injection site to past elbow. the pt was being treated in the ER. It was reported that other patients also had an adverse experience following vaccination with Pneumovax 23 (WAES0502USA03041 and WAES0502USA03081). Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Oedema, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 year old male with asthma and azithromycin allergy who on 18-FEB-2005 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included Nasonex, Zantac and montelukast sodium. On 18-FEB-2005 the pt felt sick that night with fever and arm swelling. The pt also had vomiting. On 22-FEB-2005 the whole arm was red from injection site to past elbow. the pt was being treated in the ER. It was reported that other patients also had an adverse experience following vaccination with Pneumovax 23 (WAES0502USA03041 and WAES0502USA03081). Additional information has been requested.