chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: Information has been received from a physician concerning a 68 yr old female pt with inflammatory polyarthritis, rheumatoid arthritis and some allergies who on 01Feb05 was vaccinated into the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P). Concomitant therapies included levothyroxine sodium (Synthroid), risedronate sodium (Actonel), prednisone, and OTC vitamins (unspecified). On 03Feb05, the pt experienced redness, warmth, and tenderness at the injection site. Unspecified medical attention was sought. She was treated with an antibiotic. On 05Feb05, the pt recovered. No product quality complaint was involved. No further information is expected. It was also reported that an additional pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P) and experienced adverse events (WAES0502USA01151).
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a 78 yr old female with hypertension and a history of hysterectomy, tonsillectomy and other medical procedures, who on 01Feb05 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot649979/0531P). No other vaccinations were administered at the same time. That day, the pt experienced a swollen and painful left arm. It was reported that the pt went to urgent care and was treated with cephalexin. It was also reported that the pt is recovering. No product quality complaint was involved. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from an office manager concerning a retired 75 yr old white male with an allergy to codeine who on 18Jan05 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). There was no illness at the time of vaccination. On 19Jan05 the pt developed injection site pain, redness and swelling. Unspecified medical attention was sought. The pt was treated with rest, moist heat and cephalexin (Keflex) for 7 days. No diagnostic lab tests were performed. Within 72 to 96 hrs, the pt recovered. It was also noted that there were no adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected. It was also reported that four other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed adverse events (WAES0503USA00536 through 0503USA00538, and 0503USA00540).
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a RN concerning an adult male who on approx 07Feb05 earlier this week was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). On 10Feb05, the pt was seen again in the office due to injection site reactions including redness, swelling, local heat and low grade fever. It was reported that the pt is recovering. No product quality complaint was involved. Additional information has been requested. It was also reported that an additional pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P) and experienced adverse events (WAES0502USA01620).
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a LPN concerning her mother-in-law who in 2001 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed swelling of her injection site (not reported). No medical attention was sought. Subsequently, the pt recovered. No further information is available.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Hypoaesthesia, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a retired physician concerning a 72 yr old male with a medical history of arthritis in shoulder and penicillin reaction (took 6 months to recover) who was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included simvastatin (10mg). Subsequently the pt experienced extreme pain, left arm very swollen from injection site to fingers, cellulitis, tingling sensation and felt horrible. The pt was treated by his own family physician with prednisone and diphenhydramine HC1 (Benadryl) IM.  The pt was recovering. The physician stated that the pt also on simvastatin (WAES 0502USA03454) and experienced muscle pain, unk when this occurred, but the muscle pains were attributed to arthritis and not simvastatin. No product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Paraesthesia
Clinical narrative: Information has been received from a retired physician concerning a 72 yr old male with a medical history of arthritis in shoulder and penicillin reaction (took 6 months to recover) who was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included simvastatin (10mg). Subsequently the pt experienced extreme pain, left arm very swollen from injection site to fingers, cellulitis, tingling sensation and felt horrible. The pt was treated by his own family physician with prednisone and diphenhydramine HC1 (Benadryl) IM.  The pt was recovering. The physician stated that the pt also on simvastatin (WAES 0502USA03454) and experienced muscle pain, unk when this occurred, but the muscle pains were attributed to arthritis and not simvastatin. No product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a RN concerning an adult female who on approx 07Feb05 earlier this week, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). On 10Feb05, the pt was seen again due to injection site reactions including redness, swelling, local heat and low grade fever. It was reported that the pt is recovering. No product quality complaint was involved. Additional information has been requested. It was also reported that an additional pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot650083/0746P) and experienced adverse events (WAES0502USa01308).
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a healthcare worker concerning a 60+ year old pt (gender and age not reported), who was vaccinated (date not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P; also reported lot 649988/0692P). There were no other concomitant vaccinations at the same time. Subsequently, the pt experienced redness, heat and swelling in the injection arm from the injection site down. It was reported that warm compresses, acetaminophen (Tylenol) and ibuprofen (Motrin) were recommended as treatment for the pt. It was also reported that this pt was revaccinated with pneumococcal 23v polysaccharide vaccine within 2 yrs. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 62 yr old white female pt with hypertension who on 22Dec04 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot649988/0692P). Subsequently, on an unspecified date, the pt experienced a hot feeling where injection was given, a fever, sore, red and swollen whole upper arm and was lightheaded. It was reported that the pt went to urgent care and got amoxicillin. It was reported that the pt's whole upper arm was sore, red and swollen for least 4 days. It was unk if the pt recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 62 yr old white female pt with hypertension who on 22Dec04 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot649988/0692P). Subsequently, on an unspecified date, the pt experienced a hot feeling where injection was given, a fever, sore, red and swollen whole upper arm and was lightheaded. It was reported that the pt went to urgent care and got amoxicillin. It was reported that the pt's whole upper arm was sore, red and swollen for least 4 days. It was unk if the pt recovered. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Feeling hot, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 46 yr old white female with foot pain, pruritus and an allergy to erythromycin who on 11Jan05 at 10:00AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Subsequently, the pt developed whole left arm redness, bruised and hot touch. The pt recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 50 year old white female with chronic obstructive pulmonary disease, obstructive sleep apnea, mitral valve disorder, cardiomegaly, depression, tobacco addiction, sulfa allergy, amoxicillin allergy, and cefazolin sodium allergy, who on 2/14/05 at 13:30 was vaccinated IM into the right deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot # 649912/0529P). Illnesses at the time of vaccination were acute sinusitis, impacted cerumen, and pain in thoracic spine. Concomitant therapy included an IM dose into the left deltoid of influenza virus whole virion 3v vaccine inactivated (batch # U1500AA), azithromycin, pantoprazole sodium, sertraline HCl, estradiol, lisinopril, calcium, levofloxacin, acetaminophen/hydrocodone bitartrate, aspirin/butalbital/caffeine, and Sitrex. On 2/15/05, the patient was seen in the doctor's office with redness, swelling, and pain at the pneumococcal 23v polysaccharide vaccine injection site (right upper arm). She was treated with diphenhydramine hydrochloride, ice packs, and elevation of her arm. The patient's outcome was unknown. No product quality complaint was involved. The LPN considered the patient's adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Initial and follow up information has been received from a physician concerning a 79 yr old retired female pt who on 16Nov04 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). On 16Nov04 the pt developed cellulitis at the injection site, including symptoms of severe pain, erythema, and induration at site. It was reported that the cellulitis was self-limited and resolved in 5-7 days. The physician also noted that the pt saw local doctor for follow up and there was no illness at the time of vaccination. No treatment was required other than ice, observation and analgesics (unspecified) for one week. It was also reported that the pt recovered on an unspecified date. The physician reported that this pt received a previous dose of pneumococcal 23v polysaccharide vaccine in 1992. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site mass, Injection site reaction
Clinical narrative: Initial and follow up information  has been received from a physician concerning a 61 yr old female nurse who on approx 02Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Subsequently the pt developed cellulitis at the injection site that was self limited and resolved in 5-7 days and severe induration. The physician reported that the pt had no illness at the time of vaccination. The pt recovered on an unspecified date. There was no product quality complaint involved. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 69 yr old female with no allergies or pertinent medical history who on 17Feb05 was vaccinated in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649912/0529P). On approx 17Feb05, the pt developed a 14 cm erythematous, macular papular diameter. Unspecified medical attention was sought and the pt was treated with oral diphenhydramine hydrochloride (Benadryl) and topical hydrocortisone. At the time of the report, the pt had not recovered. The physician requested a lot number check. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647634/0863N). Subsequently, the patient experienced cellulitis and was hospitalized. The patient was treated with an IV antibiotic and reportedly recovered. No product quality complaint was involved. The RN considered cellulitis to be an other important medical event (OMIC). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Malaise, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an elderly pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Subsequently, the pt experienced a local reaction including arm redness, heat and soreness over the whole arm. The pt also had a fever and felt ill. Treatment included acetaminophen (Tylenol) and warm moist compresses. It was reported that the pt recovered. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a male pt in his sixties with no allergies or pertinent medical history who on 16-FEB-2005 was vaccinated in the left deltoid with a 0.5 ml dose of Pneumovax 23 (lot # 649912/0529P). On approximately 17-FEB-2005, the pt developed an 18 centimeter erythematous, macular-papular diameter. Unspecified medical attention was sought and the pt was treated with oral Benadryl and topical hydrocortisone. At the time of the report, the pt had not recovered. The physician requested a lot number check. 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 of CBER and was released. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site reaction, Oedema, Pruritus
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old female with a penicillin allergy, who on 18-JAN-2005 at approximately 16:00, was vaccinated IM into the right arm with a dose of Pneumovax 23 (lot # 647657/0947N). There was no illness at the time of vaccination. At approximately 18:00 "dinner time", the pt complained of increased itching and swelling on her right arm. Four hours after vaccination, she experienced SOB. The pt was noted to have a local reaction to the injection. It was reported that her doctor told her to take Benadryl which improved her symptoms. On approximately 19-JAN-2005, the pt recovered. It was also reported that this was not her first dose of Pneumovax 23. No product quality complaint was involved.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 63 year old male with no known drug allergies, and with coronary artery disease, chronic obstructive pulmonary disease, and hypertension, and a history of coronary artery bypass surgery and cardiac pacemaker insertion. It was noted that the patient was in the hospital for the unrelated event of angina when on 2/21/05 when was vaccinated in the right tricep with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649978/0709P). Concomitant therapy included sodium folate, aspirin, acetaminophen, temazepam, lovastatin, enalapril maleate, carvedilol, digoxin, and propranolol HCl. On 2/21/05, approximately 50 minutes post vaccination, the patient developed pain, redness, and swelling from his tricep to his elbow, a temperature of 101, and a white blood cell count of 25,000. He was diagnosed with presumptive cellulitis. He was treated with IV antibiotics. At the time of the report, it was noted that he almost fully recovered. There was no product quality complaint. Follow up information indicated that the patient was hospitalized due to an underlying cardiac disease. He also stated that the patient had improved clinically after therapy with IV vancomycin. The physician indicated that the last time he saw the patient, the cellulitis was almost completely gone. He did not feel that the cellulitis was life-threatening or a cause of disability. The physician stated that he had signed off this patient's case and had no further information. The reporter indicated that the event was an other important medical event (OMIC). No additional information is expected.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Leukocytosis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 63 year old male with no known drug allergies, and with coronary artery disease, chronic obstructive pulmonary disease, and hypertension, and a history of coronary artery bypass surgery and cardiac pacemaker insertion. It was noted that the patient was in the hospital for the unrelated event of angina when on 2/21/05 when was vaccinated in the right tricep with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649978/0709P). Concomitant therapy included sodium folate, aspirin, acetaminophen, temazepam, lovastatin, enalapril maleate, carvedilol, digoxin, and propranolol HCl. On 2/21/05, approximately 50 minutes post vaccination, the patient developed pain, redness, and swelling from his tricep to his elbow, a temperature of 101, and a white blood cell count of 25,000. He was diagnosed with presumptive cellulitis. He was treated with IV antibiotics. At the time of the report, it was noted that he almost fully recovered. There was no product quality complaint. Follow up information indicated that the patient was hospitalized due to an underlying cardiac disease. He also stated that the patient had improved clinically after therapy with IV vancomycin. The physician indicated that the last time he saw the patient, the cellulitis was almost completely gone. He did not feel that the cellulitis was life-threatening or a cause of disability. The physician stated that he had signed off this patient's case and had no further information. The reporter indicated that the event was an other important medical event (OMIC). No additional information is expected.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 57 year old male patient who on Feb 24 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P). Subsequently, the same day, the patient developed a fever, redness and swelling at the injection site. It was reported that the patient will be treated with diphenhydramine hydrochloride (Benadryl). The physician reported that the patient is recovering from fever, redness, and swelling at the injection site. There was no product guality complaint involved. Additional information has been requested.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Oedema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old Hispanic male, with hepatitis C and diabetes and latent tuberculosis who on the afternoon of Mar 01 2005 was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). Concomitant therapy included metformin, glipizide (Glucotrol). isoniazid and pyridoxine. On Mar 02 2005, he experienced a large, red, swollen area on the left upper arm from the shoulder to the elbow and the underarm to the axillary area. The area was warm to the touch. he also complained of pain, It was reported that he was in the infirmary for 24 hours. No diagnostic laboratory tests were performed. The patient was treated with cephalexin (Keflex) 500g, TID, for 7 days and diphenhydramine hydrochloride (Benadryl) 25 mg, PRN, PO, every 6 hours, for tow days to treat symptoms. On Mar 04 2005, the patients arm was checked by the doctor and there was no redness or swelling. There was mild pain on palpitation, That same day, the patient was reported as recovered. No product quality complaint was involved. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 69 year old white male who on Feb 10 2005 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). On Feb 11 2005 the patient experienced injection site redness, pain and swelling, The patient was treated with rest, moist heat, and cephalexin (Keflex) for seven days. Subsequently, the patient recovered from the events approximately 72-96 hours after onset. No further information is available.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from health professional concerning an 85 year old white male with penicillin allergy hives who on Jan 25 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649695/0512P), intramuscularly. There was no illness at the time of vaccination. Subsequently the patient experienced pain, redness and swelling at the injection site. The patient was treated with rest, moist heat and cephalexin (Keflex) (x 7 days). Subsequently, the patient recovered after 72 to 96 hours. There were no relevant diagnostic test or laboratory data performed. it was noted that the patient and the patients sibling did not experience any adverse symptoms following prior vaccination. It was noted  that four other patients had a similar reaction (WAES0502USA00745, WAES0503USA00537, WAES0503USA00538, WAES0503USA00540). No further information is available.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 72 year old white male with no past medical history who on Jan 04 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649694/0386P), intramuscularly, There was no illness at the time of vaccination. On Jan 05 2005, in the morning, the patient experienced pain, redness and swelling at the injection site. The patient was treated with rest, moist heat and Caphalexin (Keflex (x 7 days). Subsequently, the patient recovered after 72 to 96 hours. There were no relevant diagnostic teat or laboratory date performed. It ws noted that the patient and the patients sibling did not experience any adverse symptoms following prior vaccinations. It was noted that four other patients had similar reaction (WAES0502usa00745, WAES0503USA00536, WAES0503USA00538, WAES0503USA00540). No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning an 64 year old white female with IVP dye allergy who on Nov 08 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649694/0386P), in the left deltoid. There was no illness at the time of vaccination. Subsequently, On Nov 09 2004, the patient experienced pain, redness and swelling at the injection site, The patient was treated with rest, moist heat and cephalexin (Keflex) (x 7 days). Subsequently, the patient recovered after 72 to 96 hours. There were no relevant diagnostic tests or laboratory data performed. It was noted that the patient and the patients sibling did not experience and adverse symptoms following prior vaccination. It was noted that four other patients had a similar reaction (WAES0502USA00745, WAES0503USA00536, WAES0503USA00537, WAES0503USA00540). No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 65 year old white female with no medical history who on Jan 03 2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649694/0386P), in left deltoid. There was no illness at the time of vaccination. On Jan 03 2005, in the evening, the patient experienced pain, redness and swelling at the injection site. The patient was treated with rest, moist heat and levofloxacin (Levaquin). Subsequently, the patient recovered after 72 to 96 hours, There were no relevant diagnostic test or laboratory date preformed. It was noted that the patient and the patients sibling did not experience any adverse symptoms following prior vaccination. It was noted that four other patients had similar reaction (WAES0502USA00745, WAES0503USA00536, WAES0503USA00537, WAES0503USA00538). No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a patient (age and gender not reported) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (date not reported) (lot not reported). Subsequently the patient experienced pain, swelling and redness at the injection site. The patient was recommended to rest and apply moist heat and given cephalexin, 7 days. It was reported that the patient recovered from pain, swelling and redness at injection site 72 to 96 hours post vaccination. The patient had no illness at the time of vaccination. Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old male with no medical history or allergies, who on Mar 08 2005 was vaccinated subcutaneously into the right upper arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). On Mar 10 2005 this morning, the patient was seen at the doctors office with a 5 inch diameter sized swelling at the site of the injection. He was treated with fexofenadine hydrochloride (Allegra) and he will have a follow up visit, At the time of the report, the patients adverse event had improved, but he had not recovered. No product quality complaint was involved. The nurse requested a lot number 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 has been requested. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P) and developed adverse events (WAES0503USA03372).
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old white retired female who on Mar 07 2005 was vaccinated into the right arm with second dose of pneumococcal 23v polysaccharide vaccine (lot 649981/0704P). On Mar 08 2005, the patient developed swelling and redness. Unspecified medical attention was sought. On Mar 20 2005, the patient recovered. It was reported that the patients last dose of pneumococcal 23v polysaccharide vaccine was 7 years ago. No product quality complaint was involved. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed adverse events WAES0503USA03004). Additional information is not requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old white retired female who on Mar 01 2005 was vaccinated into the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). On Mar 03 2005, the patient developed redness, swelling, and pain. Unspecified medical attention was sought. On Mar 07 2005, the patient recovered. It was also reported that on Dec 01 1994, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649981/0704P) and developed adverse events (WAES0503USA01877). Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old male with no medical history of allergies, who on mar 09 2005 was vaccinated subcutaneously into the left upper arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). On Mar 10 2005, the patient was seen at the doctors office with a 5 inch diameter sized swelling at the site of the injection and he complained of not feeling well. He was treated with fexofenadine hydrochloride (Allegra) and will have a follow up visit, the patients outcome was unknown. No product quality complaint was involved. The nurse requested a lot number 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 has been requested. It was also reported that an additional patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P) and developed adverse events (WAES0503USA01592).
Age: 1.03
Sex: M
Vaccine: PPV
Symptoms: Irritability, Medication error, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 month old male with an allergy to amoxicillin who on Jan 11 2005 was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot 649977/0706P). The physician indicated that the child was given the adult vaccine accidentally. Shortly after the vaccination the patient developed fever and irritability. Medical attention was sought. The physician indicated that the fever irritability lasted for several days. On Jan 21 2005, the patient recovered. No further information is available.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker concerning a 61 year old white female with a codeine allergy who at 3:45 on Mar 17 2005 was vaccinated in the left deltoid with a second doses of pneumococcal 23v polysaccharide vaccine (first dose administered in approximately 1995) (lot 648139/0009P). It was reported that the patient has an ear infection at the time of vaccination. At 4:30 on Mar 17 2005, the patient developed redness, swelling, soreness, and hotness to touch at injection site traveling to the elbow. The patient had a limited range of motion and area was tender to the touch. Unspecified medical attention was sought. the symptoms subsided in 4 days. The patient recovered on Mar 23 2005. No additional information is expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a healthcare worker concerning a 61 year old white female with a codeine allergy who at 3:45 on Mar 17 2005 was vaccinated in the left deltoid with a second doses of pneumococcal 23v polysaccharide vaccine (first dose administered in approximately 1995) (lot 648139/0009P). It was reported that the patient has an ear infection at the time of vaccination. At 4:30 on Mar 17 2005, the patient developed redness, swelling, soreness, and hotness to touch at injection site traveling to the elbow. The patient had a limited range of motion and area was tender to the touch. Unspecified medical attention was sought. the symptoms subsided in 4 days. The patient recovered on Mar 23 2005. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a pharmacist concerning an elderly clinic patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649989/0579P). On approximately Mar 08/2005 two weeks ago, the patient experienced unknown adverse reactions. Unspecified medical attention was sought, the patients out come was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a certified medical assistant concerning an 81 year old female with hypertension, arthritis and iron deficiency, noted to be overall healthy who on 1/27/05 was vaccinated with 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 650084/0605P). Concomitant therapy included lisinopril. On 1/27/05 the patient called the doctor's office complaining of redness and soreness at the injection site. The office told her that was normal. The patient was then seen later in the office with a red, hot, and swollen arm. Her whole left arm swelled from injection site down. The patient was noted to have developed cellulitis. The patient was started on a week of steroid treatments and a week of antibiotics and required a few office visits. Subsequently, the patient recovered from cellulitis. The reporter indicated that something must be wrong with the lots since the patient was vaccinated before without any problems. The reporter felt the patient's cellulitis was considered an other important medical event (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a certified medical assistant concerning a reportedly healthy 61 year old male with no medical history and no allergies who was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Concomitant therapy included an unspecified blood pressure medication. Subsequently the patient developed swelling and redness at injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered from swelling and redness at injection site. The reporter indicated that something must be wrong with the lots since the patient was vaccinated before without any problems. The records of testing prior to release of this lot have checked by Quality Assurance and found to be satisfactory, the lot complies with the standards of Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a certified medical assistant concerning a female reportedly in her 70's who was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Concomitant therapy included an unspecified blood pressure medication .Subsequently the patient developed swelling and redness at injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered from swelling and redness at injection site. The reporter indeicated the something must be wrong with the lots since the patient was vaccinated before without any problem. 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.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient received second dose within 6 months of the first one. Subsequently, the patient experienced pain and swelling at the injection site. Unspecified medical attention was sought. The patients outcome was unknown. No product quality complaint was involved. No further information is expected. It was also reported that two additional patients were vaccinated and experienced adverse events, one with a dose of pneumococcal 23v polysaccharide vaccine (WAES0504USA01870) and the other with a dose of varicella virus vaccine live (WAES0504USA01871).
Age: 0.17
Sex: F
Vaccine: PPV
Symptoms: Irritability, Medication error, Nasal congestion, Pyrexia
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse and an unspecified member of the physician's office concerning a 9 week old white female with no known allergies who was born at 36 weeks and had a history of developing a rash to cedar. On 4/5/04, the patient was vaccinated IM with the first dose of 0.5ml pneumococcal 23v polysaccharide vaccine (lot 649979/0531P). Concomitant suspect therapy previously reported included diphtheria toxoid (+) hepatitis B virus vaccine (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid and HIB conjugate vaccine. At the time of vaccination, it was reported that the patient had a slight cold. On 4/6/05 the patient was noted to have a temperature of 99.6 F. At that time it was reported that the patient was a little cranky and had a slight congestion that was no worse than yesterday. It was reported that the patient sought unspecified medical attention. The reporter assessed that initially the patient did not have any change in her history and physical, however, several days later, she was admitted to the hospital, much for which we have no follow up. It was reported that the patient had not returned to the physician's office for follow up. At the time of this report, the outcome of the events were unknown (previously reported that the patient had not recovered from the pyrexia, irritability, and nasal congestion). No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a RN concerning a 79 year old female with Tylenol, Floxin and tetanus toxoid allergy who on 04-NOV-2004 was vaccinated with a third dose of Pneumovax 23, IM in the left deltoid. On 04-NOV-2004 the pt developed "increased left arm red, hot hard, sore 6x8 cm lasting 1.5 days." Subsequently, the pt recovered on 07-NOV-2004. It was noted that the pt at 74 years of age experienced "swelling, hot" following vaccination with tetanus toxoid. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site oedema, Urticaria
Clinical narrative: Information has been received from a physician concerning a 49 year old female who on 05-APR-2005 was vaccinated with a dose of Pneumovax 23 (lot# 650330/0748P). Subsequently, the pt experienced "hives and swelling in the area where the shot was given, all around the arm." She also developed headache and chills, 24 hours after the vaccination. The pt was treated with Tylenol and supportive measures. The pt was considered to be recovering. It was also reported that another pt had an adverse experience (WAES0504USA00903). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site haemorrhage
Clinical narrative: Information has been received from a RN concerning a female pt who in the last week of March or first week of April 2005, was vaccinated with a dose of Pneumovax 23. Concomitant therapy included Lovenox. Subsequently the pt developed a large hematoma at the injection site. The nurse stated that this may have been because the pt was on therapy with Lovenox. Unspecified medical attention was sought. The pt's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male with asthma, a amoxicillin allergy and a history of pneumonia, who on 05 APR 2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included CLARINEX, MSD, ADVAIR, XOPENEX, and FULMICORT.  On 07 APR 2005 it was noted that the patient had been place on therapy PREVACID.  On 07 APR 2005, it was reported by the patient's mother that the patient's right arm was sore and he was "feverish and achy".  It was also reported that he was treated with TYLENOL or ADVIL and cold compresses.  Unspecified medical attention was sought.  No diagnostic studies were performed.  The patient's outcome was unknown.  No product quality complaint was involved.    Additional information was requested.    It was also reported that an additional patient was vaccinated with a dose of PPV and experienced adverse events.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Information was received from a registered nurse concerning a 58 year old female with lymphatic lymphoma who on 04 MAR 2005 at 4:00 pm was vaccinated with a first dose of PPV in the left deltoid.  There was no illness at the time of vaccination.  On 04 MAR 2005 the patient experienced "soreness, redness, pain from injection site to elbow".  Unspecified medical attention was sought.  There were no relevant diagnostic or laboratory tests.  On 08 MAR 2005 the patient recovered.    It was also reported that another patient had an adverse event after being vaccinated with PPV.    No further information is available.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information was received from a registered nurse concerning an 81 year old male patient with a penicillin allergy who on 15 FEB 2005 at 11:00 was vaccinated with a second dose of PPV in the left deltoid.  There was no illness at the time of vaccination.  On 15 FEB 2005 at 6:00pm the patient experienced "local reaction, plus fever, aching, sweating, headache, left arm swelling, red from injection site to elbow".  There were no relevant diagnostic tests or laboratory data.  The patient recovered on 22 FEB 2005.    It was also reported that another patient had an adverse event after being vaccinated with PPV.    No further information is available.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information was received from a registered nurse concerning an 81 year old male patient with a penicillin allergy who on 15 FEB 2005 at 11:00 was vaccinated with a second dose of PPV in the left deltoid.  There was no illness at the time of vaccination.  On 15 FEB 2005 at 6:00pm the patient experienced "local reaction, plus fever, aching, sweating, headache, left arm swelling, red from injection site to elbow".  There were no relevant diagnostic tests or laboratory data.  The patient recovered on 22 FEB 2005.    It was also reported that another patient had an adverse event after being vaccinated with PPV.    No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information was received from a registered nurse concerbing a patient who was vaccinated with a second dose of PPV.  It was reported that the patient received a second dose within 6 months of the first dose.  Subsequently the patient experienced "systemic reactions" (e.g. fever).  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.
Age: 11.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information was received from a registered nurse concerning an approximately 11 year old patient who was "deficient in pneumococcal antibodies" who an approximately 05 APR 2005 was vaccinated with a dose of PPV.  Subsequently the patient developed swelling and erythema.  Unspecified medical attention was sought.  The treatment was unknown.  The patient was not hospitalized.  The patient was reported to be recovering.  No product quality complaint was involved.    Additional information was requested.  it was also noted that another child was vaccinated with PPV and developed adverse events.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: Information was received from a registered nurse concerning a healthy 52 year old female with allergy to ACCUPRIL who on 04-APR-2005 was vaccinated with PNEUMOVAX (lot # 649913/0577P).  The nurse reported that the patient developed erythema and hardness of the injection arm within 24 hours.  The nurse also reported that the patient experienced pain and itching on the whole arm of injection.  The patient was treated with warm compresses and BENADRYL at bedtime.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from erythema, hardness of the injection arm, pain and itching. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration
Clinical narrative: Information was received from a nurse concerning a healthy female with allergy to MSD and DIAZIDE who on 12 APR 2005 was vaccinated with PPV.  The nurse reported that the patient developed erythema and hardness of the injection arm within 24 hours.  The nurse also reported that the erythema and hardness was on the back on the arm of injection.  The patient was treated with warm compresses and BENADRYL at bedtime.  The patient sought unspecified medical attention.  At the time of the report the patient had not recovered.  Additional information was requested.