chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood sodium decreased, Cellulitis, Haematocrit decreased, Haemoglobin decreased, Hypokinesia
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician concerning a 16 year old white female student with a cefaclor (Ceclor) allergy, asthma and allergic rhinitis who on Oct 15 2004, at 1:15pm, was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant vaccination, at the same time, on Oct 15 2004 included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1496AA), also administered IM in the left deltoid. Additional concomitant therapies include desloratadine (Clarinex), drospirenone (+) ethinyl estradiol (Yasmin), escitalopram oxalate (Lexa pro), trazodone hydrochloride, fluticasone propionate (Flonase), and fluticasone propionate (+) salmeterol xinafoate (Advair)(250/50 mcg). On Oct 17 2004 the patient called the office to report a red and tender reaction at the injection site with was 3 x 6 inches. The patient was treated with ice packs and ibuprofen (Motrin) for the pain, The patient called again on Oct 18 2004 and reported a 104 degree fever and swelling and redness at the injection site of 7 x 4 inches (also reported as 10x20 centimeters). It was also reported that it was very painful and she was unable to move her arm, symptoms were not relieved by ibuprofen and ice. The patient came to the office ans was given acetaminophen (+) hydrocodone bitartrate (Vicodin) and ice packs for the pain. As of Oct 19 2004 the inject site was still painful and red, but it was reported that she was recovering. She was given naproxen (Naprosyn) for the pain, It was also reported that th patient was prescribed cephalexin (Keflex) for suspected cellulitis and referred to the emergency room for evaluation of suspected myoglobinuria, which was ruled out. The patient was seen in the hospital emergency room on Oct 22 2004 and had a left upper extremity ultrasound, which indicated subcutaneous edema and no abscess. The following diagnostic laboratory tests were performed on Oct 22 2004 and reported below normal: blood hemoglobin test 11.7 g/dl, blood lymphocyte count 24.6%, serum creatin Kinase test 27 u/l, whole blood hematocrit 34.1%, urin specific gravity measurement 1.000, serum sodium test 135 mEg/L, and red blood cell count 3.88m/mm3. Both white blood cell count and blood platelet count were reported above normal at 12.9 K/mm3 and 463 T/mm3, respectively. The physician reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine (date not reported) and more than 10 previous vaccinations with influenza virus split virion 3v vaccine inactivated. It was also reported that at the time of vaccination, the patient has generalized aches and pains with subjective fevers and sore throat, no corroborative physical findings or specific etiology. the patient recovered on Oct 31 2004. There was no product quality complaint involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Laboratory test abnormal, Lymphocyte morphology abnormal
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician concerning a 16 year old white female student with a cefaclor (Ceclor) allergy, asthma and allergic rhinitis who on Oct 15 2004, at 1:15pm, was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant vaccination, at the same time, on Oct 15 2004 included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1496AA), also administered IM in the left deltoid. Additional concomitant therapies include desloratadine (Clarinex), drospirenone (+) ethinyl estradiol (Yasmin), escitalopram oxalate (Lexa pro), trazodone hydrochloride, fluticasone propionate (Flonase), and fluticasone propionate (+) salmeterol xinafoate (Advair)(250/50 mcg). On Oct 17 2004 the patient called the office to report a red and tender reaction at the injection site with was 3 x 6 inches. The patient was treated with ice packs and ibuprofen (Motrin) for the pain, The patient called again on Oct 18 2004 and reported a 104 degree fever and swelling and redness at the injection site of 7 x 4 inches (also reported as 10x20 centimeters). It was also reported that it was very painful and she was unable to move her arm, symptoms were not relieved by ibuprofen and ice. The patient came to the office ans was given acetaminophen (+) hydrocodone bitartrate (Vicodin) and ice packs for the pain. As of Oct 19 2004 the inject site was still painful and red, but it was reported that she was recovering. She was given naproxen (Naprosyn) for the pain, It was also reported that th patient was prescribed cephalexin (Keflex) for suspected cellulitis and referred to the emergency room for evaluation of suspected myoglobinuria, which was ruled out. The patient was seen in the hospital emergency room on Oct 22 2004 and had a left upper extremity ultrasound, which indicated subcutaneous edema and no abscess. The following diagnostic laboratory tests were performed on Oct 22 2004 and reported below normal: blood hemoglobin test 11.7 g/dl, blood lymphocyte count 24.6%, serum creatin Kinase test 27 u/l, whole blood hematocrit 34.1%, urin specific gravity measurement 1.000, serum sodium test 135 mEg/L, and red blood cell count 3.88m/mm3. Both white blood cell count and blood platelet count were reported above normal at 12.9 K/mm3 and 463 T/mm3, respectively. The physician reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine (date not reported) and more than 10 previous vaccinations with influenza virus split virion 3v vaccine inactivated. It was also reported that at the time of vaccination, the patient has generalized aches and pains with subjective fevers and sore throat, no corroborative physical findings or specific etiology. the patient recovered on Oct 31 2004. There was no product quality complaint involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Platelet count increased, Pyrexia, Red blood cell count decreased, Scrotal oedema, Tenderness
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician concerning a 16 year old white female student with a cefaclor (Ceclor) allergy, asthma and allergic rhinitis who on Oct 15 2004, at 1:15pm, was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant vaccination, at the same time, on Oct 15 2004 included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1496AA), also administered IM in the left deltoid. Additional concomitant therapies include desloratadine (Clarinex), drospirenone (+) ethinyl estradiol (Yasmin), escitalopram oxalate (Lexa pro), trazodone hydrochloride, fluticasone propionate (Flonase), and fluticasone propionate (+) salmeterol xinafoate (Advair)(250/50 mcg). On Oct 17 2004 the patient called the office to report a red and tender reaction at the injection site with was 3 x 6 inches. The patient was treated with ice packs and ibuprofen (Motrin) for the pain, The patient called again on Oct 18 2004 and reported a 104 degree fever and swelling and redness at the injection site of 7 x 4 inches (also reported as 10x20 centimeters). It was also reported that it was very painful and she was unable to move her arm, symptoms were not relieved by ibuprofen and ice. The patient came to the office ans was given acetaminophen (+) hydrocodone bitartrate (Vicodin) and ice packs for the pain. As of Oct 19 2004 the inject site was still painful and red, but it was reported that she was recovering. She was given naproxen (Naprosyn) for the pain, It was also reported that th patient was prescribed cephalexin (Keflex) for suspected cellulitis and referred to the emergency room for evaluation of suspected myoglobinuria, which was ruled out. The patient was seen in the hospital emergency room on Oct 22 2004 and had a left upper extremity ultrasound, which indicated subcutaneous edema and no abscess. The following diagnostic laboratory tests were performed on Oct 22 2004 and reported below normal: blood hemoglobin test 11.7 g/dl, blood lymphocyte count 24.6%, serum creatin Kinase test 27 u/l, whole blood hematocrit 34.1%, urin specific gravity measurement 1.000, serum sodium test 135 mEg/L, and red blood cell count 3.88m/mm3. Both white blood cell count and blood platelet count were reported above normal at 12.9 K/mm3 and 463 T/mm3, respectively. The physician reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine (date not reported) and more than 10 previous vaccinations with influenza virus split virion 3v vaccine inactivated. It was also reported that at the time of vaccination, the patient has generalized aches and pains with subjective fevers and sore throat, no corroborative physical findings or specific etiology. the patient recovered on Oct 31 2004. There was no product quality complaint involved. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urine abnormality, White blood cell count increased
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician concerning a 16 year old white female student with a cefaclor (Ceclor) allergy, asthma and allergic rhinitis who on Oct 15 2004, at 1:15pm, was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant vaccination, at the same time, on Oct 15 2004 included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot U1496AA), also administered IM in the left deltoid. Additional concomitant therapies include desloratadine (Clarinex), drospirenone (+) ethinyl estradiol (Yasmin), escitalopram oxalate (Lexa pro), trazodone hydrochloride, fluticasone propionate (Flonase), and fluticasone propionate (+) salmeterol xinafoate (Advair)(250/50 mcg). On Oct 17 2004 the patient called the office to report a red and tender reaction at the injection site with was 3 x 6 inches. The patient was treated with ice packs and ibuprofen (Motrin) for the pain, The patient called again on Oct 18 2004 and reported a 104 degree fever and swelling and redness at the injection site of 7 x 4 inches (also reported as 10x20 centimeters). It was also reported that it was very painful and she was unable to move her arm, symptoms were not relieved by ibuprofen and ice. The patient came to the office ans was given acetaminophen (+) hydrocodone bitartrate (Vicodin) and ice packs for the pain. As of Oct 19 2004 the inject site was still painful and red, but it was reported that she was recovering. She was given naproxen (Naprosyn) for the pain, It was also reported that th patient was prescribed cephalexin (Keflex) for suspected cellulitis and referred to the emergency room for evaluation of suspected myoglobinuria, which was ruled out. The patient was seen in the hospital emergency room on Oct 22 2004 and had a left upper extremity ultrasound, which indicated subcutaneous edema and no abscess. The following diagnostic laboratory tests were performed on Oct 22 2004 and reported below normal: blood hemoglobin test 11.7 g/dl, blood lymphocyte count 24.6%, serum creatin Kinase test 27 u/l, whole blood hematocrit 34.1%, urin specific gravity measurement 1.000, serum sodium test 135 mEg/L, and red blood cell count 3.88m/mm3. Both white blood cell count and blood platelet count were reported above normal at 12.9 K/mm3 and 463 T/mm3, respectively. The physician reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine (date not reported) and more than 10 previous vaccinations with influenza virus split virion 3v vaccine inactivated. It was also reported that at the time of vaccination, the patient has generalized aches and pains with subjective fevers and sore throat, no corroborative physical findings or specific etiology. the patient recovered on Oct 31 2004. There was no product quality complaint involved. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a nurse concerning an approx 60 yr old female who, in the past two weeks, on approx 04Oct04, was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #'s reported as 649696/0490P and 649732/0513P). It was reported that the pt developed red, swollen arm at the injection site after receiving pneumococcal 23v polysaccharide vaccine. It was also reported that the pt was seen in clinic and diagnosed with cellulitis. The pt was treated with antibiotic as an intervention. The reporter indicated that cellulitis was considered to be an other important medical event (OMIC). The nurse reported that 2 other female pt's had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA02650 and 0410USA03089) in the past two weeks. There was no product quality complaint involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Myalgia, Pyrexia, Urticaria
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 45 year old female with no known allergies who on Oct 10 2004 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649693/0486P). On Oct 10 2004, the patient was concomitantly vaccinated in the right arm with a dose of influenza virus vaccine. Subsequently, in October 2004, the patient developed a fever, hives and severe muscle pain. The patient sought unspecified medical attention. At the time of this report, the patients hives had decreased. The Doctor of Pharmacy also reported another patient who had similar reaction post vaccination with pneumococcal 23v polysaccharide vaccine  (lot # 649693/0486P) (WAES0411USA01558). Additional information has been requeste.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema, Pain, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning an 80 year old retired white female with an allergy to indomethacin (Indocin) who on Oct 19 2004 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Concomitant vaccine therapy given intramuscularly included a dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (batch R1410BA). there was no illness at the time of vaccination . On oct 06 2004 the patients arm hurt and had developed diffuse erythema, tenderness, and swelling of the right arm. The area was about 5 inches long by 3 inches wide from the top of her arm to the elbow. On Oct 20 2004 the patient was seen in the physicians office. The patient was treated with cetirizine hydrochloride (Zyrtec), celecoxib (celebrex) and warm compresses. On Oct 27 2004 the patient recovered. No product quality complaint was involved. No further information is expected. This is a consolidation of two reports concerning the same patient.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 56 year old female patient who on Oct 19 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0514P). Within 24 hours, the patient developed a site reaction which included swelling, soreness, redness and local heat extending from the site down to her wrist, The patient treated the symptoms with ice and diphenhydramine HCL (Benadryl). At the time of this report, the patient was recovering. Unspecified medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity
Clinical narrative: Information has been received from doctor of pharmacy concerning  an elderly, male who on Oct 20 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). Subsequently the patient developed redness at the injection site. The patient was to be seen in the office. At the time of the report, it was unknown if the patient had any induration of hematoma. the patients outcome was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a female patient in her 60's who on an unspecified date was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P) (first vaccination with pneumococcal 23v polysaccharide vaccine was in 2002). Subsequently following the second vaccination, the patient developed a reaction at the site of the injection. the arm was red, warm and swollen. Unspecified medical attention was sought. At the time of this report, the outcome of the events was unknown. Additional information has been requested. The health care professional also reported that another female in her 60,s also developed injection site erythema, warmth, and swelling following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0411USA00894).
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an adult female who on 10/19/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  On 10/20/2004 the patient developed a site reaction about 5 inches in diameter.  The site was red, swollen and very warm to the touch.  Unspecified medical attention was sought.  The patient was recovering.  Follow up information from the pharmacist noted that the patient had checked out and she would be unable to retrieve and additional information.  No product quality complaint was involved.  No further information is expected.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Pain, Skin burning sensation
Clinical narrative: Information has been received from an approximately 47 year old male physician with CIPD, which is an autoimmune neuropathy who on approximately 10/07/2004 was vaccinated in the deltoid with a second dose of pneuomococcal 23v polysaccharide vaccine.  He reported that he experienced burning when the vaccine was injected and that post-vaccination his left arm was sore and he could not lift it for 3-4 days.  No medical attention was sought.  The physician noted that he received 2 doses of the vaccine over a period of 1.5 years.  He did not want his physician contacted.  No product quality complaint was involved.  Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old male with benign prostatic hypertrophy who on 10/19/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included aspirin, MSD, Flomax.  On 10/20/2004 the patient developed a 2 inch reddened welt at the injection site.  It was also reported that the site was warm to touch.  The patient applied ice to the site as an intervention.  Unspecified medical attention was sought.  At the time of this report, the patient was recovering from the injection site erythema and injection site warmth.  No further information is available.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 79 year old male with penicillin allergy who on 10/21/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine, in the right arm deltoid area.  On 10/21/2004, in the evening, the patient developed warmth, redness and slight swelling of right arm.  The patient was treated with diphenhydramine hcl and ice pack as needed.  It was also reported that the patient's wife also had an adverse experience and was vaccinated in the same lot.  The reporting nurse requested a lot check.  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: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Information has been received from a physician concerning a 76 year old female with no known allergies who on 10/20/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine, in the right deltoid.  On 10/20/2004, that same evening, the patient developed right arm swelling, but not near the injection site, more towards medial aspect of arm, warmth and redness.  The physician was reportedly trying to determine if vaccine reaction or cellulitis.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 60 year old caucasian female who on 10/20/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine, subcutaneously in the left arm.  Therapy on 10/13/2004 included influenza virus split virion 3v vaccine inactivated influenza virus split virion 3v vaccine, also in the left arm.  There was no illness at the time of vaccination.  On 10/21/2004 the patient developed minor pain and redness at injection site.  On 10/22/2004 the patient developed swelling and redness 3 inch diameter, 2-3 inches away from the injection site had a patch of redness approximately 2x3.  There was no itching, but a little warm.  There was no treatment given.  It was reported that two days later, the redness disappeared.  No additional information is expected.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an 81 year old white retired male patient with osteoarthritis who on 09/20/2004 at 1:45PM was vaccinated into the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  On 09/20/2004 at 07:00PM the patient's arm became stiff and sore for 2 days.  His arm was fevered and swollen.  Subsequently, the patient recovered from his experience on 09/23/2004.  Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old retired white female with osteoporosis who on 09/23/2004 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  On 09/23/2004 at 2000 the patient's arm was very sore and hurting, was feverish and there was inflammation from the shoulder to the armpit.  The patient also had a red line in the armpit area.  On 09/25/2004 the patient recovered.  No further information is expected.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning her approximately 61 year old mother with lung disease, heart problems, iodine allergy, penicillin allergy, MSG allergy, sulfa allergy and morphine allergy who was vaccinated on an unspecified date with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). The reporter stated that the patient was on other medications but she could not recall the names. In 2000 the patient became extremely ill for at least one week. Unspecified medical attention was sought. The patient's outcome was not reported. Extremely ill was considered to be disabling. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a health care worker concerning a 56 year old female with penicillin and codeine allergies and a history of rash and swelling with a pneumonia vaccine in 1999 who on 10/20/2004 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included Ambien, Methocarbamol and Rabeprazole sodium.  On 10/21/2004 the patient developed a rash and swelling from the deltoid down to her elbow.  The patient sought medical attention and was given an unspecified antibiotic.  At the time of this report, the outcome was unknown.  The healthcare worker reported another patient who had a similar reaction post vaccination with pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cough, Pain, Petechiae, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient with acute lymphocyctic leukaemia who in 1996 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine.  Shortly after administration of the vaccine, the patient experienced achiness, a slight fever and a cough.  Subsequently, the patient recovered.  In 2001 the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine and had achiness again but more severe involving the entire side of the body where the vaccine was administered and petechiae on the injection arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  No product quality complaint was involved.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed an injection site reaction that included local heat, swelling and redness. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been received from the pharmacist who indicated that his report originated from an allergic reaction and not from another adverse effect (nothing serious). No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a health care worker concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Subsequently the patient developed a red, puffy rash, The patient went to the emergency room. The outcome was unknown. No product quality complaint was involved. The health care worker noted that he had sold the vaccines to the doctors office and they were returned to him because of the AE's. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0410USA02477). Additional information has been requested.
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 licensed practical nurse concerning a female patient who on Oct 26 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 646711/1181N). On Oct 27 2004 the patient developed redness, swelling, pain and local heat at the injection site. 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 (WAES0411USA02731). Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning an 80 year old female who was vaccinated with pneuomococcal 23v polysaccharide vaccine.  On 10/26/2004 the patient came into the pharmacy complaining of swelling at the injection site.  Unspecified medical attention was sought.  No product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who between 10/22/2004 and 10/25/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647655/0869N).  Subsequently, started immediately with redness, warmth and swelling at the site.  The patient was treated with diphenhydramine HCL (Benadryl).  The patient recovered.  Follow up information was received from a registered nurse who mentioned that she did not know there would be a follow up inquiry.  She reported that the physician has since retired and no further information is available.  It was also reported that 4 out of 5 patients have had injection site reactions after receiving pneumococcal 23v polysaccharide vaccine from the same vial.  The doctor questioned the vial and lot number since all doses were from the same one.  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.  No additional information is expected.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Hypoaesthesia, Myalgia, Neuralgia
Clinical narrative: Information has been received from a nurse concerning a 74 year old caucasian male who in the morning on 10/22/2004 was vaccinated intramuscularly in the left deltoid with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine (lot 649989/0579P).  Three to four days post vaccination, the patient had severe reactions to the vaccine with the development of chills, fever, trembling, numbness, tingling, redness and swelling (also reported that there was no redness or swelling) in the vaccinated limb; and nerve pain down his arm about two inches from the injections site.  The patient also lost some range of motion in the vaccinated arm.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Follow up information from a registered nurse indicated that on 10/22/2004 the patient developed myalgia, extreme pain below the injection site- radiating into fingers, chills and he was unable to raise his arm.  It was reported that the patient recovered from myalgia, extreme pain below the injection site- radiating into fingers, chills and unable to raise his arm on 10/26/2004.  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.  It was also reported that 3 other patients had adverse experiences following administration of pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia, Pyrexia, Swelling, Tremor
Clinical narrative: Information has been received from a nurse concerning a 74 year old caucasian male who in the morning on 10/22/2004 was vaccinated intramuscularly in the left deltoid with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine (lot 649989/0579P).  Three to four days post vaccination, the patient had severe reactions to the vaccine with the development of chills, fever, trembling, numbness, tingling, redness and swelling (also reported that there was no redness or swelling) in the vaccinated limb; and nerve pain down his arm about two inches from the injections site.  The patient also lost some range of motion in the vaccinated arm.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Follow up information from a registered nurse indicated that on 10/22/2004 the patient developed myalgia, extreme pain below the injection site- radiating into fingers, chills and he was unable to raise his arm.  It was reported that the patient recovered from myalgia, extreme pain below the injection site- radiating into fingers, chills and unable to raise his arm on 10/26/2004.  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.  It was also reported that 3 other patients had adverse experiences following administration of pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Joint range of motion decreased, Neuralgia, Paraesthesia
Clinical narrative: Information has been received from a nurse concerning a 52 year old caucasian female who, in the morning, on 10/25/2004 was vaccinated intramuscularly in the left deltoid with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine (lot 649989/0579P).  On 10/25/2004 (also reported as 3-4 days post vaccination) the patient had severe reactions to the vaccine with the development of chills all over her body; fever; trembling; numbness, tingling, redness and swelling (also reported that there was no redness or swelling) in the vaccinated limb; and nerve pain down her arm about two inches from the injection site.  The patient also lost some range of motion in the vaccinated arm.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Follow up information from a registered nurse indicated that on 10/25/2004, the patient developed severe arm pain (beginning 2-3 hours after injection) and chills.  The following day, on 10/26/2004, the patient was unable to use her arm.  It was reported that the patient recovered from severe arm pain, chills and inability to use her arm.  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.  It was also reported that 3 other patients had adverse experiences following administration of pneumococcal 23v polysaccharide vaccine.  Additional information has bee requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Tremor
Clinical narrative: Information has been received from a nurse concerning a 52 year old caucasian female who, in the morning, on 10/25/2004 was vaccinated intramuscularly in the left deltoid with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine (lot 649989/0579P).  On 10/25/2004 (also reported as 3-4 days post vaccination) the patient had severe reactions to the vaccine with the development of chills all over her body; fever; trembling; numbness, tingling, redness and swelling (also reported that there was no redness or swelling) in the vaccinated limb; and nerve pain down her arm about two inches from the injection site.  The patient also lost some range of motion in the vaccinated arm.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Follow up information from a registered nurse indicated that on 10/25/2004, the patient developed severe arm pain (beginning 2-3 hours after injection) and chills.  The following day, on 10/26/2004, the patient was unable to use her arm.  It was reported that the patient recovered from severe arm pain, chills and inability to use her arm.  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.  It was also reported that 3 other patients had adverse experiences following administration of pneumococcal 23v polysaccharide vaccine.  Additional information has bee requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Joint range of motion decreased, Myalgia, Neuralgia
Clinical narrative: Information has been received from a nurse concerning a 52 year old caucasian female who, in the evening, on 10/18/2004 was vaccinated intramuscularly in the left deltoid with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  3 to 4 days post vaccination the patient had severe reactions to the vaccine, with the development of chills; fever; trembling; numbness; tingling, redness and swelling (also reported that there was no redness or swelling) in the vaccinated limb; and nerve pain down her arm about 2 inches from the injection site.  The patient also lost some range of motion in the vaccinated arm.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Follow up information from a registered nurse indicated that, in the evening, on 10/18/2004 the patient developed myalgia, severe pain from her wrist to shoulder and she was unable to use her arm.  It was noted that the patient missed one day of work on 10/19/2004.  It was reported that the patient recovered from myalgia, pain from wrist to shoulder and unable to use arm on 10/21/2004.  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.  It was also reported that 3 other patients had adverse experiences following administration of pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Pyrexia, Swelling, Tremor
Clinical narrative: Information has been received from a nurse concerning a 52 year old caucasian female who, in the evening, on 10/18/2004 was vaccinated intramuscularly in the left deltoid with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P).  3 to 4 days post vaccination the patient had severe reactions to the vaccine, with the development of chills; fever; trembling; numbness; tingling, redness and swelling (also reported that there was no redness or swelling) in the vaccinated limb; and nerve pain down her arm about 2 inches from the injection site.  The patient also lost some range of motion in the vaccinated arm.  Unspecified medical attention was sought.  The patient's outcome was not reported.  Follow up information from a registered nurse indicated that, in the evening, on 10/18/2004 the patient developed myalgia, severe pain from her wrist to shoulder and she was unable to use her arm.  It was noted that the patient missed one day of work on 10/19/2004.  It was reported that the patient recovered from myalgia, pain from wrist to shoulder and unable to use arm on 10/21/2004.  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.  It was also reported that 3 other patients had adverse experiences following administration of pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pruritus, Swelling
Clinical narrative: Information has been received from a nurse concerning a 74 year old female patient with no known drug allergies, elevated blood pressure, hyperlipidemia, and a pacemaker who on 10/21/2004 was vaccinated with a dose of pnuemococcal 23v polysaccharide (lot 649694/0386P).  On 10/22/2004 the patient developed injection site soreness, redness, swelling and itching.  The symptoms began two to three hours post vaccination.  The nurse measured the clients arm from the injection site down to the end of the swelling which was 15 inches; but the actual swelling began 3 inches below the injection site.  The patient was treated with oral diphenhydramine (Benadryl), heat or ice pack, and acetaminophen (Tylenol).  It was reported that another female patient had a similar experience.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who between 10/22/2004 and 10/25/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647655/0869N).  Subsequently, the patient had a reaction from shoulder to elbow.  The patient was treated with diphenhydramine hcl (Benadryl) and cool compresses as needed.  The patient recovered.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a female patient who between 10/22/2004 and 10/25/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647655/0869N).  Subsequently the patient developed redness around her arm.  Unspecified medical attention was sought.  The patient recovered.  It was also reported that 4 out of 5 patients have had injection site reactions after receiving pneumococcal 23v polysaccharide vaccine from the same vial.  The doctor questioned the vial and lot number since all doses were from the same one.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a 78 year old female caucasian patient who in approximately October 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P).  On 10/19/2004 the patient developed swelling from shoulder to elbow with hard area at site, fever with chills and increased WBC and HGB (per phone conversation with patient).  The patient was reportedly seen by oncologist and antibiotics were given.  The patient reportedly recovered on approximately 10/22/2004.  (It was also reported that on 10/28/2004 the patient called the doctor's office complaining of swelling (size of fist) and redness at injection site.  The patient also had a fever.)  It was also reported that two other patients had a similar reaction and were vaccinated from the same lot.  The medical assistant requested a lot check of 649913/0577P.  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.  No additional information is expected.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an approximately 90 year old female who in approximately 1997, 6 or 7 years ago, was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed a severe injection site reaction which required hospitalization. At the time of this report, the outcome was unknown. The reporting physician felt that the patient's injection site reaction was an other medical event (OMIC). No additional information is expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 73 year old female who on 10/21/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647635/0864N), in the right arm deltoid area.  On 10/21/2004, in the evening, the patient developed cellulitis band around the muscle and vomiting.  The patient was treated with diphenhydramine HCL (Benadryl by mouth) and ice pack as needed.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Insomnia, Pain, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 53 year old female housewife with diabetes mellitus and allergies to sulfa and penicillin who on Oct 28 2004 was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). On approximately Oct 28 2004, the patient developed pain and soreness in her shoulder post vaccination. The patient sought unspecified medical attention. Additional information has been received from the physician. About 4 days ago in the office the patient was given boosters. Her last pneumococcal 23v polysaccharide vaccine was reported to have been 1999. The patient was cautioned about a possible local reaction, which she also experienced with her first vaccination with pneumococcal 23v polysaccharide vaccine. She presented with a complaint of continued severe shoulder pain. She was unable to sleep in bed because of the pain and had to sleep in a recliner and really had difficulty moving her arm around and has to help her right arm with with left arm. She reported today the pain was slightly better than previously, but still present to very uncomfortable degree. Her blood pressure was 150/90. pulse 84 and respirations 18. There were no obvious external abnormalities. Palpitation over the deltoid was tender in the injection was applied. She had not tried icing the shoulder. She had tried some heat, which was only effective for as long as it was applied. The patient was place on Naprosyn 500 mg BID for the discomfort. No additional information is expected.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning an 89 year old female patient who on 09/23/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P).  On 09/23/2004 the patient had a swollen arm.  On 09/24/2004 the patient developed a rash all over the body.  Unspecified medical attention was sought.  No product quality complaint involved.  It was reported to be unknown if this was the first or second vaccination.  It was also reported that another patient had a similar reaction.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old white female adult who, may be allergic to mercury thimerosal, and who in the PM on 10/27/2004 was vaccinated subcutaneously in the right arm with a first dose of pneuomococcal 23v polysaccharide vaccine (lot 649732/0513P).  Concomitant medications included lisinopril (manufacturer unknown), trazodone, and levothyroxine sodium (Levoxyl).  It was noted that the patient was not ill at the time of vaccination.  On 10/27/2004, the patient developed soreness/pain, redness/erythema and warmth at the injection site, which continued for 3 days and she started feeling better on the fourth day.  It was noted that on the third day the patient called the physician (a relative) to prescribe an antibiotic.  the patient took 4 doses and stopped when she started to feel better on the 4th day (also reported as 4 days after injection).  The patient sought unspecified medical attention.  At the time of this report, the patient was fully recovered.  No further information is expected.
Age: 47.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Feeling hot, Injection site swelling, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 48 year old female with an allergy to Biaxin who on 10/28/2004 at 1548 was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N).  Concomitant vaccine therapy given in the left deltoid included a first dose of influenza virus vaccine (unspecified) (lot u1449AA).  There was no illness at the time of vaccination.  At 1730 the patient developed pain, redness, warmth and swelling at the injection site.  The arm was very sore and it hurt to use it.  The patient was afebrile.  Unspecified medical attention was sought.  No diagnostic lab tests were performed.  The symptoms lasted one day and the patient recovered.  It was also noted that the patient had no AE's following prior vaccinations.  No product quality complaint was involved.  No further information is expected.  It was also reported that another patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0411USA01318).