chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 68 yr old male who in 1995 and on 23Nov04 was vaccinated with a first and 0.5 milliliter second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot number 647681/0986N). On the day of immunization, the pt experienced a local injection site reaction of swelling and redness accompanied by body aches, chills and a fever. Unspecified medical attention was sought. It was reported that the pt's adverse events lasted one day or so. No product quality complaint was involved. The physician requested an investigation into the lot number. 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. It was also reported that a female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also experienced adverse events (WAES0412USA00928).
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose pneumococcal 23v polysaccharide vaccine (lot number not reported). Subsequently the pt experienced adverse event (unspecified). At the time of this report the outcome was unk. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Feeling hot, Hypoaesthesia, Injection site erythema, Injection site oedema
Clinical narrative: Information haws been received from a health professional concerning a 58 yr old white male with no known drug allergies and a history of cerebral vascular accident and coronary artery bypass graft with asthma, diabetes, bronchitis (chronic), gastroesophageal reflux disease, epilepsy, traumatic arthritis, depression and testosterone deficiency who on 08Dec04 at 2:00PM was vaccinated with an IM first dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (lot 647797/0987N). Concomitant therapy that day included a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (IM) (Lot U1380AA). It was noted that there was no illness at the time of vaccination. It was reported that according to chart notes, the pt went to the ER on 08Dec04 in the evening with right deltoid redness and swelling, and was treated and released. On 09Dec04 the pt went to the ER. The pt c/o right arm warmth, tenderness, redness, swelling, pain and numbness. The pt also had shortness of breath. Current medications included clopidogrel bisulfate (Plavix), alprazolam, venlafaxine hydrochloride (Effexor), theophylline, ibuprofen, acetaminophen (+) hydrocodone bitartrate (Vicodin) and albuterol. The pt was treated with ceftriaxone sodium (Rocephin) (IM), methylprednisolone (Medrol), hydroxyzine pamoate (Vistaril), cephalexin (Keflex), acetaminophen (+) hydrocodone bitartrate (Vicodin) and warm compresses. He was instructed to return if worse. It was also reported that the pt went to urgent care on 10Dec04, per doctor, for the same symptoms and was treated and released. It was noted that the pt was given antibiotics and supported care was advised. Recovery status was unk. Follow up reported that no further contact with this pt. No further information is expected.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Tenderness
Clinical narrative: Information haws been received from a health professional concerning a 58 yr old white male with no known drug allergies and a history of cerebral vascular accident and coronary artery bypass graft with asthma, diabetes, bronchitis (chronic), gastroesophageal reflux disease, epilepsy, traumatic arthritis, depression and testosterone deficiency who on 08Dec04 at 2:00PM was vaccinated with an IM first dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (lot 647797/0987N). Concomitant therapy that day included a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (IM) (Lot U1380AA). It was noted that there was no illness at the time of vaccination. It was reported that according to chart notes, the pt went to the ER on 08Dec04 in the evening with right deltoid redness and swelling, and was treated and released. On 09Dec04 the pt went to the ER. The pt c/o right arm warmth, tenderness, redness, swelling, pain and numbness. The pt also had shortness of breath. Current medications included clopidogrel bisulfate (Plavix), alprazolam, venlafaxine hydrochloride (Effexor), theophylline, ibuprofen, acetaminophen (+) hydrocodone bitartrate (Vicodin) and albuterol. The pt was treated with ceftriaxone sodium (Rocephin) (IM), methylprednisolone (Medrol), hydroxyzine pamoate (Vistaril), cephalexin (Keflex), acetaminophen (+) hydrocodone bitartrate (Vicodin) and warm compresses. He was instructed to return if worse. It was also reported that the pt went to urgent care on 10Dec04, per doctor, for the same symptoms and was treated and released. It was noted that the pt was given antibiotics and supported care was advised. Recovery status was unk. Follow up reported that no further contact with this pt. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 65 year old retired female with sulfonamide allergy, heartburn, vitamin b12 deficiency and hypertension who on Nov 16 2004, at approximately 10:00 am, was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649978/0709P). Subsequently on Nov 16 2004, the patient developed redness, pain, swelling, and heat at the site of injection, 10x15cm area. It was reported that the patient was treated with amoxicillin (+) clavulanate potassium (Augmentin), heat pad and elevation of affected area. All symptoms resolved by Nov 19 2004 except for some post inflammatory hyperpigmentation. Additional information is not expected.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Injection site swelling, Oedema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 94 year old female nursing home resident with congestive heart failure and allergies to penicillin, metal, iodine, valium and vitamin K who on Oct 25 2004 at 2:30 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). There was no illness at the time of vaccination. Concomitant therapy included nitroglycerin (Nitro patch), acetaminophen (Tylenol) and warfarin sodium (Coumadin). On Oct 25 2004 at 8:30 the patient developed a red, raised area on her right upper arm, that was swollen, warm to touch, and very tender and painful to touch. On Oct 26 2004 the patient was treated with dexamethasone 10mg IM and diphenhydramine hydrochloride (Benadryl) prm. No diagnostic lab test were performed. On Oct 31 2004 the patient recovered. No further information is expected.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 94 year old female nursing home resident with congestive heart failure and allergies to penicillin, metal, iodine, valium and vitamin K who on Oct 25 2004 at 2:30 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). There was no illness at the time of vaccination. Concomitant therapy included nitroglycerin (Nitro patch), acetaminophen (Tylenol) and warfarin sodium (Coumadin). On Oct 25 2004 at 8:30 the patient developed a red, raised area on her right upper arm, that was swollen, warm to touch, and very tender and painful to touch. On Oct 26 2004 the patient was treated with dexamethasone 10mg IM and diphenhydramine hydrochloride (Benadryl) prm. No diagnostic lab test were performed. On Oct 31 2004 the patient recovered. No further information is expected.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female between the age of 14-50, who on Nov 04 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently, the patient experienced pain at the injection site, myalgia, arthralgia, low grade temperature and fatigue, The patients outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. The physician requested an investigation into this lot number. Additional information has been requested. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) and experienced adverse effects (WAES0501USA03390, WAES0501USA03391). 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.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema
Clinical narrative: Information has been received from a health professional concerning a 60 year old female who on Nov 08 2004 was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. On Nov 09 2004 the patient broke out with swelling and redness of the arms. Unspecified medical attention was sought. The patient has not yet recovered. No product quality complaint was involved. Additional information has been requested. In was also reported that a male patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA02158).
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a health professional concerning an 83 year old white female with allergies to ofloxacin (Floxin), diltiazem hydrochloride (Cardizam), and horse serum who on Dec 22 2004 was vaccinated SC in her left deltoid with first dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On Dec 24 2004 the patient presented to the office with erythema at medial part of her left arm, 3 inches diameter. The patient was prescribed azithromycin (Z Pak) and treated with warm compresses. Subsequently, the patient recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Fatigue, Oedema, Pain
Clinical narrative: Information has been received from a 61 year old white female postmenopausal patient with osteoporosis, an allergy to PCN and reactive airways disease, who on Nov 01 2004 at 4:00pm was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Concomitant therapy included alendronate sodium for the treatment of osteoporosis and estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) for post menopausal treatment. The patient was not ill at the time of vaccination. On Nov 02 2004 at 3:00 pm, the patient developed extrem fatigue, chills and her right deltoid area was erythematous, edematous, painful and very tender to light touch. the fatigue persisted for three days, the erythema and painful right deltoid lasted six days. it was noted that the patient recovered on Nov 04 2004. It was noted that the patient had experienced a disseminated rash at age 11 month from a first dose of smallpox vaccine. No additional information is expected.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a 61 year old white female postmenopausal patient with osteoporosis, an allergy to PCN and reactive airways disease, who on Nov 01 2004 at 4:00pm was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Concomitant therapy included alendronate sodium for the treatment of osteoporosis and estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) for post menopausal treatment. The patient was not ill at the time of vaccination. On Nov 02 2004 at 3:00 pm, the patient developed extrem fatigue, chills and her right deltoid area was erythematous, edematous, painful and very tender to light touch. the fatigue persisted for three days, the erythema and painful right deltoid lasted six days. it was noted that the patient recovered on Nov 04 2004. It was noted that the patient had experienced a disseminated rash at age 11 month from a first dose of smallpox vaccine. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site hypersensitivity, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a healthcare worker concerning an adult female patient who in November 2004 (date not reported), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Approximately two days post vaccination, the patient developed a cellulitis type reaction at injection site, warmth, redness and painful. It was also reported that the patient sought unspecified medical attention. There was no product quality complaint involved. It was also reported that 3 other adult female patients experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P) (WAES0412USA00679, WAES0501USA00532, WAES0501USA00533). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site hypersensitivity, Injection site pain
Clinical narrative: Information has been received from a healthcare worker concerning an adult female patient who in November 2004 (date not reported), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Approximately two days post vaccination, the patient developed a cellulitis type reaction at injection site, warmth, redness and painful. It was also reported that the patient sought unspecified medical attention. There was no product quality complaint involved. It was also reported that 3 other adult female patients experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P) (WAES0412USA00679, WAES0501USA00531, WAES0501USA00533). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a healthcare worker concerning a 70 year old retired female patient with no reported medical history who on 12/2/04 was vaccinated in the left deltoid (route not reported) with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). Concomitant medications include lansoprazole, salcatonin, and lorazepam. Approximately two day post vaccination, the patient developed nausea and a cellulitis type reaction at the injection site with warmth, redness, pain and low grade fever. The reporter confirmed that the patient was treated with cefditoren pivoxil 2 time daily for 7 days and promethazine hydrochloride as needed for nausea. The reporter also confirmed that the patient's experienced was considered serious. It was also reported that the patient recovered on 12/15/04. The patient's experience with injection site cellulitis, low grade fever, nausea and pain, that required medical intervention, was considered to be an important medical event (OMIC). The healthcare worker reported that that patient received her first dose of pneumococcal 23v polysaccharide vaccine on 10/14/96. There was no product quality complaint involved. It was also reported that 3 other adult female patients experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P) (WAES0412USA00679, 0501USA00531, and 0501USA00532). Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia
Clinical narrative: Initial and follow up information has been received from a healthcare worker concerning a 70 year old retired female patient with no reported medical history who on 12/2/04 was vaccinated in the left deltoid (route not reported) with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). Concomitant medications include lansoprazole, salcatonin, and lorazepam. Approximately two day post vaccination, the patient developed nausea and a cellulitis type reaction at the injection site with warmth, redness, pain and low grade fever. The reporter confirmed that the patient was treated with cefditoren pivoxil 2 time daily for 7 days and promethazine hydrochloride as needed for nausea. The reporter also confirmed that the patient's experienced was considered serious. It was also reported that the patient recovered on 12/15/04. The patient's experience with injection site cellulitis, low grade fever, nausea and pain, that required medical intervention, was considered to be an important medical event (OMIC). The healthcare worker reported that that patient received her first dose of pneumococcal 23v polysaccharide vaccine on 10/14/96. There was no product quality complaint involved. It was also reported that 3 other adult female patients experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P) (WAES0412USA00679, 0501USA00531, and 0501USA00532). Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Chills, Oedema, Pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a health professional concerning a female patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). Subsequently, the patient experienced pain and tenderness, accompanied by fever, chills, and swelling from her shoulder to her elbow. Within four days, the symptoms abated and the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected. It was also reported a patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine  (WAES0501USA02933) and experienced adverse events.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a geriatric female patient who on Jan 04 2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). There were no other concomitant vaccinations reported. On Jan 05 2005 the patient experienced swelling, redness, warmth and pain in the injection site arm. It was reported that the patient was treated with prednisone. It was reported that on other female geriatric patient had a similar adverse experience following administration of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P) (WAES0502USA00097). Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: Information has been received from a licensed practical nurse concerning a 58 year old female who on Jan 06 2005 was vaccinated with a 2.5cc dose of pneumococcal 23v polysaccharide vaccine instead of a 0.5cc dose. No other information was given regarding the present status of the patient. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a patient who in approximately December 2004, was vaccinated with pneumococcal 23v polysaccharide vaccine , lot 649732/0513P. Subsequently, the patient developed a cellulitis like injection site reaction. The patient received unknown treatment for the reaction at a local emergency room Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. The nurse reported 4 other patients who developed injection site reactions after the administration of pneumococcal 23v polysaccharide vaccine  (WAES0412USA02760).
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning an 82 year old male oncology patient, who on Dec 20 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On Dec 23 2004, the patient experienced pain, redness and swelling from the injection site to the elbow. The patient was treated with antibiotics. The patients outcome was unknown. Unspecified medical attention was sought, No product quality complaint was involved. The reporter expressed a concern would with lot 0692P. It was also reported that tow other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) and experienced adverse events (WAES0412USA02891, WAES0501USA00661). 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.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female oncology patient, who on Dec 21 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On Dec 2004, the patient experienced pain, redness and swelling from the injection site to the elbow. The patient was treated with antibiotics, The patients outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. The nurse would like a lot check for lot 0692P. It was also reported that tow other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) and experienced adverse events (WAES0412USA02891, WAES0501USA00660). 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.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Hypokinesia, Oedema, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a patient over 65 years old who on approximately Nov 15 2004 during the past month was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P). During the past month, the patients arm was swollen affecting the whole arm, with warmth, tenderness and redness after the swelling was resolved. The patient also had difficulty raising the arm. It was noted that the patient was afebrile. The patient was treated with ice packs and ibuprofen, it was reported that the patient is recovering. The reporter was unsure if the patient was previously vaccinated in the past. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a pharmacist concerning an 85 year old male who on Nov 09 2004 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). The patient came to the pharmacy and reported that, on Nov 12 2004, he began feeling pain in the shoulder blade area and it lasted three days then went away. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information from the pharmacist indicated that the patient slept wrong on his back again. The pain was not from the vaccine and the patient recovered. There were no problems with any other patients and pneumococcal 23v polysaccharide vaccine. Additional infromation is not expected.
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning an adult male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). It was reported that the patient developed injection site reactions to include redness, warmth, swelling and pain. The patient was treated with antibiotics. Subsequently the patient was recovering. Unspecified medical attention was sought, No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity, Oedema
Clinical narrative: Information has been received from a health professional concerning a 67 year old female who on Oct 28 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). it was reported that the patient was seen on Nov 01 2004 and her arm was swollen down to mid forearm, red warm to the touch. unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a female who on Dec 22 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Subsequently, the patient experienced cellulitis at the injection site which spread to her elbow, The patient was seen at the emergency room, She was treated with antibiotics and was released. The patients outcome was unknown. The nurse requested a lot check into this lot number. No product quality complaint was involved. Additional information had been requested. It was also reported that another patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) and experienced adverse events (WAES0501USA04327). 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 standdards of the Center for Biologics Evaluation and Research and was released.
Age: 44.0
Sex: M
Vaccine: DTOX, FLUX, PPV, TTOX
Symptoms: Feeling hot, Injection site induration, Injection site pain, Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning a 44 year old disabled white male with chronic obstructive pulmonary disease and joint disease, who on Jan 12 2005 at 8:00, was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647681/0986N). There was no illness at the time of vaccination. Concomitant therapy included an intramuscular dose of tetanus toxoid (batch U1341AA) into the right deltoid, a tuberculin purified protein derivative test (batch C1710AA) given into the left forearm and an intramuscular dose of influenza virus vaccine (unspecified) (U1499AA) into the left deltoid. That night, the patient awoke with a sore site, Unspecified medical attention was sought. An exam of the patient noted that he developed a 5x7 cm area of induration, warmth, and tenderness at the site. The patient was treated with prednisone 50 mg 40/30/20/10 one day each, diphenhydramine hydrochloride (Benadryl) 25mg four times daily, for 48 hours and cool packs for comfort, No diagnostic laboratory test were performed. On Feb 16 2005, the patient wsa seen for follow up an he had no complaints. the patient recovered at that time or sooner. It was also reported that there were no adverse events following prior vaccinations. No product quality complaint was involved. Additional information is not expected. It was also reported that another patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647681/0986N) and experienced adverse events (WAES0501USA04214).
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a physician concerning a female patient in her 60's who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  It was reported that the patient was vaccinated shortly after she was discharged from the hospital where she was treated for Legionnaire's Disease.  Subsequently, the patient experienced a severe local reaction.  Unspecified medical attention was sought.  She was treated with acetaminophen (Tylenol) and amoxicillin.  The patient's outcome was unknown.  No product quality complaint was involved.  It was also reported that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (MSD) and had adverse events.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia, Skin disorder, Sneezing
Clinical narrative: Information has been received from a physician concerning an approximately 73 year old white retired female who on 11/22/2004 was vaccinated into the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient reported by phone that she had a fever, and myalgia that continued 2 days later with cold symptoms and sneezing.  She also reported a severe local reaction with indentations in the skin of her arm.  It was reported that the patient never came back nor did we see the actual reaction.  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  It was also reported that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (MDS) and had adverse events.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female patient 60 to 70 years of age with an allergy to codeine and prednisone who on 01/13/2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 647660/0945N).  There was no concomitant medication.  Subsequently, about 10 to 12 hours after the injection the patient experienced redness and swelling at injection site and whole upper arm.  The patient also experienced fever and chills.  Unspecified medical attention was sought.  There were no relevant diagnostic laboratory tests performed.  No product quality complaint involved.  The patient was reported to be recovering.  It was also reported that other patients had a similar reaction.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a male patient 60 to 70 years of age with no known allergies and no medical history who on 01/13/2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 647660/0945N).  There was no concomitant medication.  Subsequently, about 10 to 12 hours after the injection, the patient experienced redness and swelling at injection site and whole upper arm.  The patient also experienced fever and chills.  Unspecified medical attention was sought.  There were no relevant diagnostic laboratory tests performed.  No product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a female consumer who on 11/23/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647635/0864N).  On 11/23/2004 the patient reported that she had received the vaccine in her physicians office and that afternoon her arm started to hurt and it was very painful to raise my arm.  The consumer reported it felt like there was a lead weight in my arm.  The consumer reported that this continued over the next 2 days and finally subsided the third day.  She also reported that the site was slightly swollen, but not really hot to touch or red.  She reported that this was the third pneumonia vaccine she has received and never had this severe of a reaction.  Further information has been received.  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 industry standards.  Follow up information from the doctor's office reported that this patient is not one of their patients and they do not have any information to provide.  No further information is available.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old hospitalized female with no known allergies who on 01/12/2005 was vaccinated with pneumococcal 23v polysaccharide vaccine .5ml subcutaneously (lot # 650087/0815P).  The pharmacist reported that on 01/15/2005 the patient had redness, swelling, tenderness and heat at the right deltoid injection site.  The physician was notified.  The pharmacist reported that triamcinolone cream was to be applied to the site and acetaminophen was given for discomfort.  The pharmacist reported that the injection site swelling, tenderness redness prolonged hospitalization.  The pharmacist reported that the patient was recovering.  The pharmacist expressed a concern regarding the lot.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17-50 year old female who on 12/21/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649732/0513P).  Subsequently, the patient experienced pain at the injection site, myalgia, arthralgia, low grade temperature and fatigue.  The patient's outcome was unknown.  Unspecified medical attention was sought.  No product quality complaint was involved.  The physician requested an investigation into this lot number.  Additional information has been requested.  It was also reported that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experienced adverse effects.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a 42 year old female physician who on 12/28/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the physician experienced pain at injection site, myalgia, arthralgia, low grade temperature and fatigue.  Subsequently, it took a while but the doctor stated she has just now recovered.  Unspecified medical attention was sought.  She took Motrin for treatment.  No product quality complaint was involved.  The physician requested an investigation in this lot number.  Additional information has been requested.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from medical records concerning a black female who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient was allergic to pneumococcal 23v polysaccharide vaccine.  Patient outcome was not reported.  At the time of this report the patient was 55 years of age.  The patient's experience with rofacexib was repored in WAES 0306USA00923.  No additional information was provided.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional, with no medical history and no allergies, who was vaccinated intradermally with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine.  There was no concomitant medication.  On 01/25/2005 the patient had a local injection site reaction with swelling, redness, pain and warmth to the touch.  The patient was treated with ibuprofen and ice.  It was reported that the patient showed slight improvement after taking medication.  There were no laboratory or diagnostic tests performed.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a female office staff member, with no medical history and no allergies, who was vaccinated intradermally with a 0.5ml dose of pneumococcal vaccine.  There was no concomitant medication.  On 01/25/2005 the patient had a local injection site reaction with swelling, redness, pain, and warmth to the touch.  The patient was treated with ibuprofen and ice.  It was reported that the patient showed slight improvement after taking medication.  There were no laboratory or diagnostic tests performed.  No product quality complaint was involved.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 43 year old white female with no medical history or allergies, who on 01/10/2005 at 09:30, was vaccinated intramuscularly into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  There was not concomitant medication.  That evening, the patient experienced pain at the site of injection, axilla, and breast.  She also experienced warmth and firmness at the injection site.  Unspecified medical attention was sought.  The patient took Motrin, 800mg.  It was reported that the symptoms were gone 24 hours later.  On 01/11/2005, the patient recovered.  It was also reported that there were no adverse events following prior vaccinations.  No product quality complaint was involved.  Additional information is not expected.  It was also reported that another patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine and experienced adverse events.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a male who on 01/11/2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced pain, swelling, and warmth at the injection site.  Unspecified medical attention was sought.  The patient was treated with Tylenol.  The patient's outcome was unknown.  The nurse requested a lot check into this lot number.  No product quality complaint was involved.  Additional information has been requested.  It was also reported that another patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experienced adverse events.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.
Age: 58.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a retired 56 year old caucasian male with an allergy to codeine who on 01/21/2005 at 08:30AM was vaccinated intramuscularly in the right arm with the first dose of pneumococcal 23v polysaccharide vaccine.  Vaccination given on that same day included:  influenza virus split virion 3v vaccine inactivated given subcutaneously.  Concomitant medication included Celebrex 200mg daily.  There was no illness at the time of vaccination.  On 01/21/2005 at 16:30PM, the patient called the office to state that his arm was red, swollen and painful.  He was also short of breath and had a headache and fever.  As of 01/24/2005, his arm was still red, swollen and painful.  He was not short of breath, but was not feeling well.  It was reported that he recovered as of 01/26/2005.  Follow up information reported that the patient's left arm where injection was given was swollen, red, and very painful.  There was no diagnostic or laboratory tests performed.  No further information is available.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse through a company representative concerning a 37 year old white male state systems analyst with asthma, sleep apnea, and no known allergies who on 1/24/05 was vaccinated IM in the left deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot # 649912/0529P) at approximately 4:00 PM. Concomitant therapies included montelukast sodium, fluticasone propionate, albuterol and guaifenesin/pseudoephedrine HCL. There was no illness at the time of vaccination. On 1/25/05 the patient developed redness, swelling, and pain and warmth at the site of injection. The swelling and redness increased and radiated down to his hand and thumb in the vaccinated arm with increasing pain. It was also reported that the patient was treated with amoxicillin (+) clavulanate potassium and diphenhydramine hydrochloride, acetaminophen (+) diphenhydramine hydrochloride and cold packs. It was reported that the patient refused to go to the emergency room or RTC. The patient was reported to be recovered on 2/1/05. It was also reported that it was unknown if the patient had a previous dose of pneumococcal 23v polysaccharide vaccine. The reporter considered the patient's experiences to be a medically important event (OMIC). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning an adult female client with an unknown previous vaccination history who was Pneumovax 23 (lot unknown). Subsequently the client experienced a "severe local site reaction" and "induration the size of a softball." It was reported that the client sought unspecified medical attention. No other information was available at the time of call. There was no product quality complaint involved. It was reported that two other adult females experienced local site reactions and induration after administration of Pneumovax 23 (lot unknown) (WAES0412USA01332 and WAES0502USA00005).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning an adult female client with an unknown previous vaccination history who was Pneumovax 23 (lot unknown). Subsequently the client experienced a "severe local site reaction" and "induration the size of a softball". It was reported that the client sought unspecified medical attention. No other information was available at the time of call. There was no product quality complaint involved. It was reported that two other adult female experienced local site reactions and induration after administration of Pneumovax 23 (lot unknown) (WAES0412USA01332 and WAES0502USA00004). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a geriatric female pt who on 04-JAN-2005 was vaccinated with a first dose of Pneumovax 23 (lt # 649692/0371P). There were no other concomitant vaccinations reported. On 05-JAN-2005 the pt experienced "swelling, redness, warmth, fever, and pain in the injection site arm." It was reported that the pt was treated with prednisone. It was reported that one other female geriatric pt had a similar adverse experience following administration of Pneumovax 23 (lot# 649692/0371P) (WAES0501USA00578). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a health professional concerning a pt who was vaccinated with a dose of Pneumovax 23 (lot # 649988/0692P). Subsequently, the pt experienced an inflammatory allergic reaction to the vaccine. The pt's outcome was unknown. No product quality complaint was involved. Additional information is not expected. It was also reported that two additional patients were vaccinated with a dose of Pneumovax 23 (WAES0412USA02933, WAES0501USA00539) and experienced adverse events.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Hypotonia, Injection site mass, Injection site oedema, Medication error, Myalgia
Clinical narrative: Information has been received from a 57 year old female consumer with no medical history or allergies, who on 28Jan05 was vaccinated with a 0.5ml dose of PNEUMOVAX 23. It was reported that the vaccine was given IM but some was erroneously administered ID. There was no concomitant medication. On 30Jan05, the consumer experienced edema, swelling, induration, myalgia and paresthesia. On 01Feb04, the consumer reported that her muscle tone of her deltoid muscle is flaccid. Subsequently, the consumer reported that she was recovering from edema, swelling, induration, myalgia and paresthesia. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a 57 year old female consumer with no medical history or allergies, who on 28Jan05 was vaccinated with a 0.5ml dose of PNEUMOVAX 23. It was reported that the vaccine was given IM but some was erroneously administered ID. There was no concomitant medication. On 30Jan05, the consumer experienced edema, swelling, induration, myalgia and paresthesia. On 01Feb04, the consumer reported that her muscle tone of her deltoid muscle is flaccid. Subsequently, the consumer reported that she was recovering from edema, swelling, induration, myalgia and paresthesia. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 57 yr old female who on 27Jan05 at approx 10:45AM was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). On 27Jan05, shortly after being vaccinated, the pt developed a fever, rash and local arm pain at the injection site. The pt went to the ER and was treated with diphenhydramine HC1 (Benadryl). The pt was considered to be recovering. No product quality complaint involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 52 year old female who on 31Jan05 was vaccinated (unk route) with pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Shortly after the vaccination on 31Jan05 the pt developed redness, swelling and local arm pain at injection site. The report indicated that the pt sought unspecified medical attention. The pt's outcome was reported as recovering. Additional information has been requested.