chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on 10/26/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646711/1181N).  On 10/27/2004 the patient developed redness, swelling, pain and local heat at the injection site.  She also developed a mild fever.  It was reported that she was recovering and that she sought unspecified medical attention.  No other information was available.  It was reported that another female patient had similar experience.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 71 year old retired caucasian female with medication allergies to atorvastatin calcium (Lipitor), pentazocine lactate (Talwin), and butorphanol tartrate (Stadol) who on 11/09/2004 at 10:45am was vaccinated intramuscularly in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P) (first dose given in November 1999).  Concomitant medications included alendronate sodium (MSD) and calicum carbonate cholecalciferol (Caltrate D).  There was no illness at the time of vaccination.  Subsequently, at 15:30 on the same day as the vaccination the patient developed a local site reaction of slightly raised area, painful, red, hot.  The patient sought unspecified medical attention and no laboratory or diagnostic studies were performed.  The patient recovered from the swelling, redness, and fever in the arm.  It was also reported that 4 other female patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine within the last 2 months.  No product quality complaint was involved.  Additional information is not expected.
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 certified medical assistant concerning a female who, within the last 2 months, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P).  Subsequently, the patient developed a local site reaction of slightly raised area, painful, red, hot.  The patient sought unspecified medical attention.  It was also reported that 4 other female patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine within the last 2 months.  No product quality complaint was involved.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 68 year old retired black female with allergies to clarithromycin (Biaxin) and dicyclomine hydrochloride (Bentyl) who on 11/15/2004, at 10:40AM, was vaccinated intramuscularly in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P).  Concomitant therapies included alprazolam (Xanax), atorvastatin calcium (Lipitor), calcium carbonate (Caltrate), fexofenadine hydrochloride (Allegra), hydroxyzine hydrochloride (Atarax), hydrochlorothiazide and lactulose.  Subsequently, the patient developed a local site reaction of slightly raised area, painful, red, hot.  The patient sought unspecified medical attention.  Follow up information from the certified medical assistant indicated that on 11/15/2004 at 3:00PM, the patient developed swelling, pain, fever in arm and throbbing sensation.  The patient was seen in the doctor's office.  It was reported that the patient had a rash on her hands and writs at the time of vaccination.  The patient had one previous dose of pneumococcal 23v polysaccharide vaccine in 10/1998.  It was also reported that the patient recovered on an unspecified date.  It was also reported that 4 other female patients experienced these adverse events following administration of pneumococcal 23v polysaccharide vaccine within the last 2 months.  No product quality complaint was involved.  No additional information is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 68 year old retired black female with allergies to clarithromycin (Biaxin) and dicyclomine hydrochloride (Bentyl) who on 11/15/2004, at 10:40AM, was vaccinated intramuscularly in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P).  Concomitant therapies included alprazolam (Xanax), atorvastatin calcium (Lipitor), calcium carbonate (Caltrate), fexofenadine hydrochloride (Allegra), hydroxyzine hydrochloride (Atarax), hydrochlorothiazide and lactulose.  Subsequently, the patient developed a local site reaction of slightly raised area, painful, red, hot.  The patient sought unspecified medical attention.  Follow up information from the certified medical assistant indicated that on 11/15/2004 at 3:00PM, the patient developed swelling, pain, fever in arm and throbbing sensation.  The patient was seen in the doctor's office.  It was reported that the patient had a rash on her hands and writs at the time of vaccination.  The patient had one previous dose of pneumococcal 23v polysaccharide vaccine in 10/1998.  It was also reported that the patient recovered on an unspecified date.  It was also reported that 4 other female patients experienced these adverse events following administration of pneumococcal 23v polysaccharide vaccine within the last 2 months.  No product quality complaint was involved.  No additional information is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth, Oedema
Clinical narrative: Information has been received from a certified medical assistant concerning a 73 year old white female with allergies to sulfa and meperidine hydrochloride (Demerol) who on Sept 29 2004 at 11:30 am was vaccinated IM in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). There was no illness at the time of vaccination. Concomitant therapy included estrogens conjugated (Premarin), lisinopril (Zestril), alendronate sodium (Fosamax), fenofibrate (Tricor) and levothyroxine Na (Levoxyl). Subsequently, the patient developed a local site reaction of lightly raised area, painful, red, hot. The patient sought unspecified medical attention. No product quality complaint was involved. Follow up information indicated that on Sept 29 2004 at 4:00pm the patient developed swelling, pain, redness, and a fever in her arm. The outcome was reported as recovered. There were no relevant diagnostic test or laboratory data. There were no adverse events following prior vaccinations. It was also reported that 4 other female patients experienced these adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P) within the last 2 months (WAES0411USA02135, WAES0411USA02760, WAES0411USA02761, WAES0411USA02762). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 65 year old white retired female patient who on approximately Nov 09 2004 (several days ago) was vaccinated (route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). shortly after being vaccinated, on Nov 09 2004 she developed an injection site reaction including erythema, swelling and pain, the nurse also reported that shortly after being vaccinated (date unspecified), the patient developed induration and local heat. It was reported that the patient developed pain from her elbow to her neck. the patient was treated with topical steroids and she recovered from the injection site redness, swelling and pain on an unspecified date. There was no product quality complaint involved. Additional information is not expected. It was also reported that on additional patient experienced an adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P0 (WAES0412USA00290).  This is in follow-up to report (s) previously submitted on 7/29/2005.  Initial and follow up information has been received from a registered nurse concerning a 65 year old white retired female patient who on approximately 09-NOV-2004 ("several days ago") was vaccinated (route not reported) with a dose of PNEUMOVAX (lot # 648138/0009P).  "Shortly after being vaccinated", on 09-NOV-2004 she developed an injection site reaction including erythema, swelling and pain.  The nurse also reported that shortly after being vaccinated (date unspecified), the patient developed induration and local heat.  It was reported that the patient developed pain from her elbow to her neck.  The patient was treated with topical steroids and she recovered from the injection site redness, swelling and pain on an unspecified date.  Follow-up information was received from the nurse indicating that "they never heard any information about this lot, and they were never advised as to what they should do".  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  It was also reported that one additional patient experienced and adverse event following administration of PNEUMOVAX (lot # 648139/0009P) (WAES # 0412USA00290).
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 65 year old white retired female patient who on approximately Nov 09 2004 (several days ago) was vaccinated (route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). shortly after being vaccinated, on Nov 09 2004 she developed an injection site reaction including erythema, swelling and pain, the nurse also reported that shortly after being vaccinated (date unspecified), the patient developed induration and local heat. It was reported that the patient developed pain from her elbow to her neck. the patient was treated with topical steroids and she recovered from the injection site redness, swelling and pain on an unspecified date. There was no product quality complaint involved. Additional information is not expected. It was also reported that on additional patient experienced an adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P0 (WAES0412USA00290).  This is in follow-up to report (s) previously submitted on 7/29/2005.  Initial and follow up information has been received from a registered nurse concerning a 65 year old white retired female patient who on approximately 09-NOV-2004 ("several days ago") was vaccinated (route not reported) with a dose of PNEUMOVAX (lot # 648138/0009P).  "Shortly after being vaccinated", on 09-NOV-2004 she developed an injection site reaction including erythema, swelling and pain.  The nurse also reported that shortly after being vaccinated (date unspecified), the patient developed induration and local heat.  It was reported that the patient developed pain from her elbow to her neck.  The patient was treated with topical steroids and she recovered from the injection site redness, swelling and pain on an unspecified date.  Follow-up information was received from the nurse indicating that "they never heard any information about this lot, and they were never advised as to what they should do".  A lot check has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  It was also reported that one additional patient experienced and adverse event following administration of PNEUMOVAX (lot # 648139/0009P) (WAES # 0412USA00290).
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been  received from a nurse concerning an approximately 74 year old female patient with no drug allergies who on Oct 21 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). the nurse reported the symptoms began two to three hours post vaccination. The patient presented to the doctors office Oct 22 2004 with complaints of injection site swelling, soreness, and redness. The patient was treated with oral diphenhydramine (Benadryl), heat or ice pack, and acetaminophen (Tylenol). It was reported that another female had a similar experience (WAES0410USA04294). Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site oedema, Rash
Clinical narrative: Information has been received from a physician concerning a 54 year old male with diabetes mellitus who on 11:05 on Oct 26 2004 was vaccinated intramuscularly with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). On Oct 27 2004, the patient developed a severe local reaction including an area of swelling at the injection site of approximately 12cm in diameter, a rash that covered the upper deltoid to armpit and erythema. Unspecified medical attention was sought. On Oct 30 2004, the patient recovered. No additional information is expected.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Pain
Clinical narrative: Information has been received from a pharmacist concerning an 81 year old male who on Nov 04 2004 was vaccinated Im in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). That evening, the patient began feeling pain behind his shoulders in the shoulder blade area on both sided, not only the side the vaccine was given. The patient reported that the pain became progressively worse. He was instructed by a physician to take over the counter pain medication and to apply heat. The pharmacist noted that there was no evidence of local swelling or pain at the injection site. The patient said the pain is still present on Nov 17 2004 and some nights he had difficulty sleeping. No product quality complaint was involved. Follow up information from the pharmacist indicated that the shoulder blade pain was due to the patient falling down an not the pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). The patient has dementia and had actually fallen. The pain is not from the vaccine. The patient recovered. There were no problems with any other patients and pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Medication error, Pain
Clinical narrative: Information has been received from a physician concerning a 79 year old female with an allergy to pseudoephedrine hydrochloride (Sudafed), hypertension, anxiety, gastroesophageal reflux disease, osteoporosis, depression, hypothyroidism and a history of pneumonia (2003 and 2 prior episodes in last 3-4 years) who in 1997, on Jan 07 2004 and Nov 17 2004 was vaccinated with a first, second and third dose of pneumococcal 23v polysaccharide vaccine , respectively (third dose lot 649988/0692P). Concomitant therapy included many unnamed medications. There was no illness at the time of vaccination. It was reported that the patient had received a third dose of the vaccine due to charting confusion. No adverse symptoms were noted. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that on Nov 17 2004 at 10 am the patient was vaccinated IM in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P) (previously reported as lot 649988/05692P). On Nov 17 2004 the patient experienced some soreness and erythema which resolved in a week and the patient recovered. It was noted that no lab or diagnostic tests were performed except observation. No further information is available.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Agitation, Aphthous stomatitis, Arthralgia, Feeling hot, Headache
Clinical narrative: Information has been received from a 37 year old female with asthma, hypertension, high cholesterol, allergies to ofloxacin (Floxin), trimethoprim sulfamethoxazole (Septra) and statin meds, generalized allergies, and history of antihistamines being too dry and montelukast sodium (MSD) causing backaches (WAES0502USA02083), who on Oct 29 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included colesevelam hydrochloride (Welchol), benazepril HCL (Lotensin), ranitidine HCL (Zantac), ibuprofen (Advil), budesonide (Rhinocort), fluticasone propionate (Flovent), albuterol, acetaminophen (Tylenol), guaifenesin, and olopatadine hydrochloride (Patanol). Starting 3 days after vaccination, the patient developed a fever, swollen glands, headache, and joint pain. She went to see her physician who prescribed cephalexin (Keflex), and she felt better. After she finished the antibiotic regime, she was feeling those same reactions including headache, swollen gland on the same side as the injection site, stiff neck, joint pain, and a bit feverish. Follow up information from the physician indicated that on Oct 30 2004, the next day after vaccination, the patients left arm was swollen, hot and mottled. Subsequently the patient developed increased lymp nodes in the left axilla and pain in the left axilla. On Nov 01 2005 the patients complete blood cell count was within normal limits. Within last 24 hours, on approximately Nov 02 2004, the patients nodes in her antecubital area and neck area were hurting. During a physical exam on Nov 03 2004 the patient was described as upset and frustrated. The physical exam also showed that she was tender in her left pericervical area  but had no pericervical nodes, that her left antecubical was tender, 1.5 cm of her left axilla area was tender, and her left deltoid area was tender with out redness, fluctuation or heat. On approximately Nov 06 2004 the patient developed a ulcer in her left posterior pharynx and a fever. It was reported that there was no rash or cough and the patients asthma was ok. The patients experience was assesses as reaction to pneumococcal 23v polysaccharide vaccine vs. secondary infection after injection. Treatment included cephalexin (Keflex) 500 tid 7d and diclofenac sodium (Voltaren) 75 bid 20. The patient was to return to the office if not responding. At the time of the report the patients status was unknown. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Livedo reticularis, Lymphadenopathy, Musculoskeletal stiffness, Oedema
Clinical narrative: Information has been received from a 37 year old female with asthma, hypertension, high cholesterol, allergies to ofloxacin (Floxin), trimethoprim sulfamethoxazole (Septra) and statin meds, generalized allergies, and history of antihistamines being too dry and montelukast sodium (MSD) causing backaches (WAES0502USA02083), who on Oct 29 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included colesevelam hydrochloride (Welchol), benazepril HCL (Lotensin), ranitidine HCL (Zantac), ibuprofen (Advil), budesonide (Rhinocort), fluticasone propionate (Flovent), albuterol, acetaminophen (Tylenol), guaifenesin, and olopatadine hydrochloride (Patanol). Starting 3 days after vaccination, the patient developed a fever, swollen glands, headache, and joint pain. She went to see her physician who prescribed cephalexin (Keflex), and she felt better. After she finished the antibiotic regime, she was feeling those same reactions including headache, swollen gland on the same side as the injection site, stiff neck, joint pain, and a bit feverish. Follow up information from the physician indicated that on Oct 30 2004, the next day after vaccination, the patients left arm was swollen, hot and mottled. Subsequently the patient developed increased lymp nodes in the left axilla and pain in the left axilla. On Nov 01 2005 the patients complete blood cell count was within normal limits. Within last 24 hours, on approximately Nov 02 2004, the patients nodes in her antecubital area and neck area were hurting. During a physical exam on Nov 03 2004 the patient was described as upset and frustrated. The physical exam also showed that she was tender in her left pericervical area  but had no pericervical nodes, that her left antecubical was tender, 1.5 cm of her left axilla area was tender, and her left deltoid area was tender with out redness, fluctuation or heat. On approximately Nov 06 2004 the patient developed a ulcer in her left posterior pharynx and a fever. It was reported that there was no rash or cough and the patients asthma was ok. The patients experience was assesses as reaction to pneumococcal 23v polysaccharide vaccine vs. secondary infection after injection. Treatment included cephalexin (Keflex) 500 tid 7d and diclofenac sodium (Voltaren) 75 bid 20. The patient was to return to the office if not responding. At the time of the report the patients status was unknown. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a 37 year old female with asthma, hypertension, high cholesterol, allergies to ofloxacin (Floxin), trimethoprim sulfamethoxazole (Septra) and statin meds, generalized allergies, and history of antihistamines being too dry and montelukast sodium (MSD) causing backaches (WAES0502USA02083), who on Oct 29 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included colesevelam hydrochloride (Welchol), benazepril HCL (Lotensin), ranitidine HCL (Zantac), ibuprofen (Advil), budesonide (Rhinocort), fluticasone propionate (Flovent), albuterol, acetaminophen (Tylenol), guaifenesin, and olopatadine hydrochloride (Patanol). Starting 3 days after vaccination, the patient developed a fever, swollen glands, headache, and joint pain. She went to see her physician who prescribed cephalexin (Keflex), and she felt better. After she finished the antibiotic regime, she was feeling those same reactions including headache, swollen gland on the same side as the injection site, stiff neck, joint pain, and a bit feverish. Follow up information from the physician indicated that on Oct 30 2004, the next day after vaccination, the patients left arm was swollen, hot and mottled. Subsequently the patient developed increased lymp nodes in the left axilla and pain in the left axilla. On Nov 01 2005 the patients complete blood cell count was within normal limits. Within last 24 hours, on approximately Nov 02 2004, the patients nodes in her antecubital area and neck area were hurting. During a physical exam on Nov 03 2004 the patient was described as upset and frustrated. The physical exam also showed that she was tender in her left pericervical area  but had no pericervical nodes, that her left antecubical was tender, 1.5 cm of her left axilla area was tender, and her left deltoid area was tender with out redness, fluctuation or heat. On approximately Nov 06 2004 the patient developed a ulcer in her left posterior pharynx and a fever. It was reported that there was no rash or cough and the patients asthma was ok. The patients experience was assesses as reaction to pneumococcal 23v polysaccharide vaccine vs. secondary infection after injection. Treatment included cephalexin (Keflex) 500 tid 7d and diclofenac sodium (Voltaren) 75 bid 20. The patient was to return to the office if not responding. At the time of the report the patients status was unknown. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 78 year old female who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P). On Oct 26 2004 the patient experienced redness, soreness and pain in the arm where she was vaccinated. The symptoms subsided after one week, on approximately Nov 01 2004. The healthcare worker also reported that the patient notified the doctor office of symptoms via telephone, no diagnostic work up was performed on the patient in the hospital or as an outpatient. The patient was told to call the office or come in for a follow up visit if the reaction got worse. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 78 year old female who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P). On Oct 26 2004 the patient experienced redness, soreness and pain in the arm where she was vaccinated. The symptoms subsided after one week, on approximately Nov 01 2004. The healthcare worker also reported that the patient notified the doctor office of symptoms via telephone, no diagnostic work up was performed on the patient in the hospital or as an outpatient. The patient was told to call the office or come in for a follow up visit if the reaction got worse. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 77 yr old female (previously reported as 73 yrs old) with reported allergies to penicillin, codeine and tetanus vaccine, who on 26Oct04 (previously reported as (03Nov04) was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). Subsequently the pt developed redness, pain and swelling. It was reported that there was no concomitant medication and no laboratory diagnostic tests performed. It was also reported that the pt fully recovered. Follow up information from the health professional indicated that on 26Oct04, after the pt got home, the pt developed redness, soreness, swelling and pain in the left deltoid injection site. It was also reported that the pt recovered on 02Nov04. No product quality complaint was involved. It was also reported that there were three other pt's who experienced adverse events after admin of pneumococcal 23v polysaccharide vaccine (Lot 64911/0287P) (WAES0411USA02642, 0411USA03942, 0411USA03943). No additional information is expected.
Age: 78.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 77 yr old female (previously reported as 73 yrs old) with reported allergies to penicillin, codeine and tetanus vaccine, who on 26Oct04 (previously reported as (03Nov04) was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). Subsequently the pt developed redness, pain and swelling. It was reported that there was no concomitant medication and no laboratory diagnostic tests performed. It was also reported that the pt fully recovered. Follow up information from the health professional indicated that on 26Oct04, after the pt got home, the pt developed redness, soreness, swelling and pain in the left deltoid injection site. It was also reported that the pt recovered on 02Nov04. No product quality complaint was involved. It was also reported that there were three other pt's who experienced adverse events after admin of pneumococcal 23v polysaccharide vaccine (Lot 64911/0287P) (WAES0411USA02642, 0411USA03942, 0411USA03943). No additional information is expected.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Influenza like illness, Injection site hypersensitivity, Injection site pain
Clinical narrative: Information has been received from licensed practical nurse concerning a 50 year old female who on Nov 17 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). Concomitant therapy that day and in the same arm included influenza virus vaccine (unspecified, manufacture unknown). On Nov 17 2004 the patient experienced soreness, redness in injection are, flu like symptoms and fatigue, Over the counter anti inflammatory medication and ice were prescribed, The patient called the office on Nov 18 2004 with no improvement. It was reported that another patient had a similar reaction (WAES0412USA00149). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner via a company representative concerning a 65 year old female with egg allergy who on Oct 14 2004 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (manufacture unknown). Subsequently the patient experienced site reaction with a 6cm in diameter red area around the injection site. It was unknown when the first dose was given. Follow up information indicated that the local reaction was treated, and there was no further problem. The outcome was reported as recovered. No additional information is expected.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a physician's assistant concerning a 78 year old male who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On Oct 28 2004 the patient was seen in the doctors office and diagnosed with cellulitis at injection site which went down to elbow of left arm. The PA reported that the patient did not have a fever and that she could not read treatment given in the patients chart. It was also reported that the patient recovered (date not reported). It was also reported that one other patient experienced adverse effects following vaccination with pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) (WAES0412USA01259). there was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema, Paraesthesia, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning an adult female with no known drug allergies who on Nov 18 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine at state health department. Subsequently the patient experienced red, swollen left arm, and paresthesia with splotchy rash. Client had first dose of pneumococcal 23v polysaccharide vaccine approximately 5 years ago. the patient had not recovered as of Nov 19 2004. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on approximately Nov 05 2004 (over the last week) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Subsequently, the patient developed a local site reaction to include pain at the injection site, erythema, swelling, induration, local heat and malaise. the patient sought unspecified medical attention. it was also reported that the patient was treated with antibiotics and was recovering. There was no product quality complaint involved. It was also reported that five other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P) (WAES0411USA02321). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on approximately Nov 05 2004 (over the last week) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Subsequently, the patient developed a local site reaction to include pain at the injection site, erythema, swelling, induration, local heat and malaise. the patient sought unspecified medical attention. it was also reported that the patient was treated with antibiotics and was recovering. There was no product quality complaint involved. It was also reported that five other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P) (WAES0411USA02321). Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Oedema, Tremor
Clinical narrative: Information has been received from an 88 year old male with arthritis and no allergies who was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5ml), subcutaneously. Concomitant therapy included acetaminophen (Tylenol). Subsequently, on Nov 19 2004 the patient experienced swelling of the arm, dizziness, and tremors. At the time of the report the patient had not recovered. There were no relevant diagnostic test or laboratory data. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site reaction, Oedema
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician, respectively, concerning a 65 year old white female who on Nov 10 2004 at 9:00am was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). The physician reported that the patient developed left upper arm swelling, redness with cellulitis on Nov 14 2004 at 7:26pm (previously reported as the next day). The doctor sent her to the emergency room where she was treated (unspecified) and released. The patient was initially reported to be recovering but it was also reported by the physician that it was unknown if the patient recovered. The physician also reported that the patient was previously vaccinated at least one time per the patient, with pneumococcal 23v polysaccharide vaccine (date not reported). There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on approximately Nov 01 2004 (over the last two weeks) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Subsequently, the patient developed a reaction at the injection site including soreness, warmth, erythema, and swelling. the patient sought unspecified medical attention, It was also reported that the patient was treated with antibiotics and recovering. There was no product quality complaint involved. Three other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) (WAES0411USA02548). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site induration, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old white female with peripheral neuropathy who on Nov 19 2004 at 3:00 was vaccinated subcutaneously into the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 646078/0257N). There were no reported illnesses at the time of vaccination. That same day, the patients arm, at and around the injection site, became tender, red, and indurated. No diagnostic studies were performed. the symptoms gradually receded over 5 days and the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. It was noted that the patient had no prior AE's following vaccination. It was also reported that a male patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA04044). The vaccine was from the same lot # but a different vial. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a male over the age of 65 who in 2004 (date not reported) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Subsequently the patient developed an injection site reaction, including hot, swollen, painful area at injection site. The patient sought unspecified medical attention and was treated with acetaminophen (Tylenol) and fexofenadine hydrochloride (Allegra). it was also reported that 2 other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P) (WAES0411USA02570, WAES0411USA03859). There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a female over the age of 65 who in 2004 (date not reported) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  Subsequently the patient developed an injection site reaction, including hot, swollen, painful area at injection site. the patient sought unspecified medical attention and was treated with acetaminophen (Tylenol) and fexofenadine hydrochloride (Allegra). It was also reported that 2 other patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P) (WAES0411USA02570, WAES0411USA03858). There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Medication error, Oedema
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine in the tissue rather than in the muscle and the area puffed up. The patients outcome was unknown. Unspecified medical attention was sought. No lot number or additional information was provided. No product quality complaint was involved. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a health professional concerning an 39 yr old female with allergy to codeine who on 10Nov04 was vaccinated IM left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot 649111/0287P). It was reported that there was no concomitant medication and no lab diagnostic tests were performed. Subsequently the pt developed redness, pain and swelling. In follow up, the health professional reported that on 11Nov04 the pt developed redness, pain and swelling at the injection site. The pt was treated with ice application to alleviate pain. It was also reported that the pt fully recovered. No product quality complaint was involved. It was also reported that there were three other pt who experienced adverse events after administered of pneumococcal 23v polysaccharide vaccine (Lot 649111/0287P) (WAES0411USA02642, 0411USA03941, 0411USA03943).  No additional information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a health professional concerning an 44 yr old female with no reported medical history who on 29Oct04 was vaccinated IM in left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). Subsequently the pt developed redness, pain and swelling. In follow up, the healthcare professional reported that on 29Oct04 the pt developed redness, pain and swelling at the left deltoid injection site. It was reported that there was no concomitant medication and no lab diagnostic tests were performed. It was also reported that the pt fully recovered. No product quality complaint was involved. It was also reported that three other pt's experienced adverse events following admin of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P) (WAES0411USA02642, 0411USA03941, and 0411USA03942). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional, a nurse, concerning a 69 yr old female who on 19Nov04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649988/0692P). On 22Nov04 the pt experienced super swollen site reaction that was red and pink down to the elbow. Also reported that two other pt's (WAES No 0411USA04074 and 0411USA04075) experienced the same super swollen site reaction that were red and pink down to the elbow, onset date was 23Nov04 and 24Nov04, respectively. No further information is available.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 37 yr old white male with no known allergies or medical history, who on 11Nov04 at 15:00 was vaccinated SC with a first dose of pneumococcal 23v polysaccharide vaccine (lot number 646078/0257N). The pt denied illness at the time of vaccination. On 12Nov04 the pt experienced a localized site reaction that included redness and warm to the touch. On 16Nov04 the pt stated that the doctor told him to call to report that his reaction was an infection related to a multidose vial. It was reported that the vial was discarded. No diagnostic studies were performed. The pt was treated with an unnamed antibiotic. Subsequently, the pt recovered. No product quality complaint was involved. It was also reported that a female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA03801). The vaccine was from the same lot number but a different vial. 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.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional, a nurse, concerning a 74 yr old female who on 22Nov04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649988/0692P). On 23Nov04 the pt experienced super swollen site reaction that was red and pink down to the elbow. Also reported that two other pt's (WAES No0411USA04075 and 0411USA03975) experienced the same super swollen site reaction that were red and pink down to the elbow onset date was 24Nov04 and 22Nov04, respectively. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional, a nurse, concerning a 79 yr old female who on 23Nov04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On 24Nov04 the pt experienced super swollen site reaction that was red and pink down to the elbow. Also reported that two other pt's (WAES No 0411USA04074 and 0411USA03975) experienced the same super swollen site reaction that were red and pink down to the elbow onset date was 23Nov04 and 22Nov04. No further information is available.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a 57 yr old female who on 15Nov04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot649692/0371P). On 16Nov04 the pt called the office with fever, chills, headache and injection site pain. The report indicates that the office suggested ibuprofen (Advil) and ice as treatment. It was also reported that another pt (WAES0411USA031790) had a similar experience. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a RN concerning a female pt (age not reported) who was vaccinated on an unspecified date (previously reported as approx Nov04) (route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot648139/0009P). Subsequently, on 28Sep04 the pt developed an injection site reaction, including erythema, swelling, induration, local heat and pain. It was reported that the pt was treated with topical steroids and that she recovered from the injection site pain, redness and swelling on an unspecified date. Follow-up information has been received from the nurse indicating that "they never heard any information about this lot, and they were never advisied as to what they should do. A lot check has been requested. The records of testing prior to release of this lot have been checked by quality Assurance and foundt to be satisfactory. The lot complies with the standards of the center for Biologics Evaluation and Research and released. In addition, a review of the quality control Quarantine/Rejection system revealed that there were no open Quarantines registered against this lot/fill. It was also reorted that one additional patient experienced an adverse event following administration of PNEUMOVAX 23 (lot 645139/0005F)There was no product quality complaint involved. Additional information is not expected. It was also reported that one additional pt experienced an adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot648139/0009P) (WAES0411USA02810).