chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Hypokinesia, Injection site pain, Oedema
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old female white patient with a history of stable pulmonary fibrosis and a penicillin allergy who on 10/26/2004 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577p), intramuscularly in the left deltoid.  Concomitant therapy included metoprolol (50mg) (4 times a day), vitamins and calcium.  Subsequently the patient complained that her arm was totally unusable, extreme swelling and redness.  On 10/26/2004 at approximately 3:00PM the patient complained of pain from injection site to elbow.  On 10/27/2004 the patient had redness, warmth below the site approximately 4 inches and 3 inches area with mild edema.  The patient continued to complain of pain.  The symptoms lasted 3-4 days.  The patient was advised to take acetaminophen (Tylenol) or ibuprofen (Advil) for discomfort and use warm compresses to injection site.  The patient recovered on 10/30/2004.  The medical assistant requested a lot check of 649913/0577P.  The records of testing prior to release of this lot have been check and found to be satisfactory.  The lot complies with industry standards and was released.  It was also reported that 2 other patients had a similar reaction (WAES 0410USA04368 and 0411USA00343) and were vaccinated from the same lot.  No additional information is expected.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old female white patient with a history of stable pulmonary fibrosis and a penicillin allergy who on 10/26/2004 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577p), intramuscularly in the left deltoid.  Concomitant therapy included metoprolol (50mg) (4 times a day), vitamins and calcium.  Subsequently the patient complained that her arm was totally unusable, extreme swelling and redness.  On 10/26/2004 at approximately 3:00PM the patient complained of pain from injection site to elbow.  On 10/27/2004 the patient had redness, warmth below the site approximately 4 inches and 3 inches area with mild edema.  The patient continued to complain of pain.  The symptoms lasted 3-4 days.  The patient was advised to take acetaminophen (Tylenol) or ibuprofen (Advil) for discomfort and use warm compresses to injection site.  The patient recovered on 10/30/2004.  The medical assistant requested a lot check of 649913/0577P.  The records of testing prior to release of this lot have been check and found to be satisfactory.  The lot complies with industry standards and was released.  It was also reported that 2 other patients had a similar reaction (WAES 0410USA04368 and 0411USA00343) and were vaccinated from the same lot.  No additional information is expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 76 yr old female Caucasian pt with improving right lung pneumonia (since 30Aug04), chronic obstructive pulmonary disease, asthma and chronic bronchitis who on 28Oct04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). Subsequently, on 28Oct04 at 4:00PM the pt c/o swelling, redness at injection site and was running a slight fever. The pt was treated with warm compress and acetaminophen (Tylenol) as needed. The pt recovered. The medical assistant requested a lot check of 649913/0577P. 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. It was also reported that two other pt's had a similar reaction (WAES0410USEA04368 and 0411USA00342) and were vaccinated from the same lot. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a RN concerning a pt who between 22Oct04 and 25Oct04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot647655/0869N). Subsequently, the pt experienced an injection site reaction. Unspecified medical attention was sought. The pt recovered. It was also reported that 4 out of 5 pt's (WAES0410USA04112, 0410USA4303, 0410USA04304) have had 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 by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a RN concerning a 75 yr old female who in 1999 and on 02Nov04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot 649696/0490P). Concomitant therapy included levothyroxine Na (Synthroid), estrogens, conjugated (Premarin), atorvastatin calcium (Lipitor), atenolol and fluoxetine HC1 (Prozac). Within two hours of the vaccination the pt developed an injection site reaction described as swelling and pain at the deltoid muscle. Unspecified medical attention was sought. The pt has not yet recovered and was still experiencing pain at the site. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from an approx 65 year old female RN who in 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, she developed an injection site reaction that was red and warm to the touch. No medical attention was sought. All symptoms resolved within several days. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Hypersensitivity, Influenza like illness, Injection site erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 71 yr old Caucasian male pt with allergy to tetanus, abdominal aneurysm, high cholesterol and hypertension who on 02Nov04 at 4:40PM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649912/0529P), IM in the right deltoid. On 03Nov04 the pt was now having reaction red/swollen was itchy, now painful warm to touch. The pt also c/o of flu symptoms achy all over. There was noted swelling and redness to the right upper arm. The impression was reported as cellulitis/allergic response, with an onset date of 02Nov04 at 4:40PM. The pt was prescribed cefdinir (Omnicef) (300mg) (BID) (for 10 days) and fexofenadine hydrochloride (Allegra). The pt recovered. No product quality complaint was involved. No further information is available.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Myalgia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 71 yr old Caucasian male pt with allergy to tetanus, abdominal aneurysm, high cholesterol and hypertension who on 02Nov04 at 4:40PM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649912/0529P), IM in the right deltoid. On 03Nov04 the pt was now having reaction red/swollen was itchy, now painful warm to touch. The pt also c/o of flu symptoms achy all over. There was noted swelling and redness to the right upper arm. The impression was reported as cellulitis/allergic response, with an onset date of 02Nov04 at 4:40PM. The pt was prescribed cefdinir (Omnicef) (300mg) (BID) (for 10 days) and fexofenadine hydrochloride (Allegra). The pt recovered. No product quality complaint was involved. No further information is available.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning an adult male pt who on approx 20Oct04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 0386P). Subsequently, the pt developed an injection site reaction that included redness, warmth and pain. Unspecified medical attention was sought. The pt was recovering. No product quality complaint involved. No further information is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 69 yr old female who on 01Nov04 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot647655/0869N). On 02Nov04 the pt called and reported that she developed a red, swollen, and painful arm. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's (WAES0411USA00945 through 0411USA00947).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning an approx 69 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently the pt c/o injection site pain, redness and swelling toward the elbow. Medical attention was sought and the pt was treated with warm compresses and ibuprofen (Advil). The AE's resolved after 5 days. No product quality complaint was involved. It was also reported that within the same week two other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649732/0513P) and developed AE's (WAES0410USA02673 and 0411USA00720). Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning an approx 75 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649732/0513P). Subsequently the pt c/o injection site pain, redness and swelling toward the elbow. Medical attention was sought and the pt was treated with warm compresses and ibuprofen (Advil). The AE's resolved after 5 days. No product quality complaint was involved. It was also reported that within the same week two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) and developed AE's (WAES0411USA00719 and 0410USA02673). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling hot, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a 61 yr old female physician with reactive airway disease who about 7 years ago and on 01Nov04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot649914/0578P). Subsequently, after 24 hrs her arm became red, swollen and hot. She also felt exhausted and was febrile. Unspecified medical attention was sought. No product quality complaint involved. The pt was considered to be recovering. The pt took tramadol hydrochloride (Ultram) to help sleep after vaccination. It was also reported that her husband had a similar reaction after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES0411USA00917). Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 63 yr old white male in refrigeration with no allergies and no medical history who on 01Nov04 at 18:00 was vaccinated in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot (649732/0513P). There was no illness at the time of vaccination. On 02Nov04 at 08:00 the pt developed inflammation and swelling at the injection site. On 04Nov04 he came into the office complaining of redness, soreness and warmth at the injection site. The physician reported that it was a local reaction. The pt was given a prescription for methylprednisolone (Medrol Dosepak) 4mg. No diagnostic lab tests were performed. Subsequently, the pt recovered. It was also noted that the pt had no adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Influenza like illness, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a 71 yr old Caucasian female RN with no allergies and no medical history who on 03Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 6499130577P), high on her right arm. Concomitant therapy the same visit included influenza virus vaccine (unspecified), in the left arm. There was no illness at the time of vaccination. Subsequently, about 3-4 hrs after vaccinations, she developed pain and is now unable to use her right arm. She was treated with ice, ibuprofen and heat. Follow up reported that the pt developed swelling, redness, pain, flu-like symptoms lasting 36 hrs from onset. There were no relevant diagnostic tests or lab data. The pt took naproxen sodium (Aleve). No further information is expected.
Age: 83.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from an 83 yr old female with no past medical history and no allergies who on 03Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included influenzae virus vaccine (unspecified). On 03Nov04, about three hours after getting injection the pt experienced swollen and red injection site. No medical attention was sought. The pt was considered to be recovering. There were no lab or diagnostic tests performed. No product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: Initial and follow up information has been received from a RN and a clinical manager, concerning a male with senile dementia, who on an unspecified date was vaccinated IM in the left thigh with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot not reported). Post vaccination, the pt was unable to move his leg. The nurse was not sure if the vaccination caused the problem because the pt had other (issues). Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that after vaccination, the pt complained of pain, soreness at the injection site, and he refused to walk. It was confirmed that the pt never lost the ability to walk. At the time of the report the pt had recovered from the pain, soreness at the injection site. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a medical assistant and a physician's assistant concerning a white female patient in her 60s with an allergy to penicillin who on 10/18/04 was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (lot # 649692/0371P). Subsequently, the patient developed a reaction at the site of the injection. The arm was red, warm, and swollen. The patient was diagnosed with cellulitis and was treated with Cephalexin. Unspecified medical attention was sought. It was reported that the patient recovered by 10/26/04. The cellulitis was felt to be an other important medical event (OMIC). No further information is expected. The health care professional also reported that another female patient in her 60s also developed injection site erythema, warmth, and swelling following vaccination with pneumococcal 23v polysaccharide vaccine (WAES0410USA03389).
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Medication error, Pruritus, Similar reaction on previous exposure to drug
Clinical narrative: Initial and follow up information has been received from a physician and a 78 yr old retired white male with medically controlled hypertension who on 29Oct04 at approx 1300 was vaccinated IM in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot649914/0578P). Concomitant medication included amlodipine besylate (Norvasc) and hydrochlorothiazide (+) losartan potassium for hypertension. There was no illness at the time of vaccination. AT the time of vaccination the pt developed a slight burning sensation which was unremarkable. At approx 1600 the pt developed a very painful feeling at the site of vaccination and when he massaged the area he noticed that his arm was swollen from his shoulder to the elbow and was itchy. The pain and swelling persisted for many days. The pt reported that it was now more than 2 months since his immunization and he still felt an abnormal tightness at the injection site. Sometimes it was accompanied by an intense flash of pain down his arm to a point below his elbow; as if it is following a nerve track. The pt wondered whether the injection accidentally hit a nerve. Unspecified medical attention was sought. The pt took tramadol hydrochloride (Ultram) to help sleep after vaccination. The pt noted that he had at least two previous vaccinations of pneumococcal 23v polysaccharide vaccine (one about 7 yrs ago) without any remarkable response. He also noted that only tetanus immunizations have ever produced a short term local cramping response. No product quality complaint was involved. It was also reported that the pt's wife was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA00725). Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Initial and follow up information has been received from a physician and a 78 yr old retired white male with medically controlled hypertension who on 29Oct04 at approx 1300 was vaccinated IM in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot649914/0578P). Concomitant medication included amlodipine besylate (Norvasc) and hydrochlorothiazide (+) losartan potassium for hypertension. There was no illness at the time of vaccination. AT the time of vaccination the pt developed a slight burning sensation which was unremarkable. At approx 1600 the pt developed a very painful feeling at the site of vaccination and when he massaged the area he noticed that his arm was swollen from his shoulder to the elbow and was itchy. The pain and swelling persisted for many days. The pt reported that it was now more than 2 months since his immunization and he still felt an abnormal tightness at the injection site. Sometimes it was accompanied by an intense flash of pain down his arm to a point below his elbow; as if it is following a nerve track. The pt wondered whether the injection accidentally hit a nerve. Unspecified medical attention was sought. The pt took tramadol hydrochloride (Ultram) to help sleep after vaccination. The pt noted that he had at least two previous vaccinations of pneumococcal 23v polysaccharide vaccine (one about 7 yrs ago) without any remarkable response. He also noted that only tetanus immunizations have ever produced a short term local cramping response. No product quality complaint was involved. It was also reported that the pt's wife was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES0411USA00725). Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Information has been received for interferon beta 1a (Rebif). This was originally reported by a physician concerning a 60 yr old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot not reported). Concomitant medications included interferon beta 1a (Rebif). Subsequently the pt experienced flu like symptoms consisting of an increased temp (fever of 104.4F), chills, nausea and fatigue. The physician reported that she was not sure if the symptoms were due to the vaccine, the interferon beta 1a (Rebif), or a combination of the two. The pt's outcome was not reported. No further information is expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 68 yr old female who on 02Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N). On 03Nov04 the pt called and reported that she developed a red, swollen, and painful arm. Her left arm was 2 inches larger than the other. Unspecified medical attention was sought. The pt was treated with ice and acetaminophen (Tylenol). The pt's outcome was unk. It was also noted that in 1998 the pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's (WAES0411USA00638, 0411USA00946 and 0411USA00947).
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a RN concerning a 56 yr old female who on 03Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N). On the evening of 03Nov04 and again on 04Nov04 the pt developed explosive diarrhea. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information has been requested. It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (647655/0869N) and also developed AE's (WAES0411USA00638, 0411USA00945 and 0411USA00946).
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a pharmacist concerning a female pt who works in a nursing home who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649694/0396P). Subsequently the pt experienced swelling and severe redness at injection site which lasted 2-3 days. The pt self medicated with diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered from swelling at injection site and severe redness at injection site. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Immunoglobulins decreased, Injection site oedema, Injection site pain, Spleen disorder
Clinical narrative: Information has been received from a RN concerning a 79 yr old white male photographer with a systolic murmur at the apex, a slow heart rate, no allergies and chronic lymphocytic leukaemia who on 15Oct96 was vaccinated IM in the left deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine. On 16Oct96 the pt developed swelling and pain at the injection site and surrounding tissue into the deltoid of the left arm. On 18Oct96 the pt was seen for an office visit where it was noted that the pt's pulse was 52 and the physician likes the slow heart rate. His spleen was noted to be decreased by 2cm which was reported as unchanged. On 23Oct96 the pt was seen at the physician's office who noted that the pt had had a hypersensitivity reaction to the vaccine and it was noted that he was now better and had recovered. An IgG test drawn on 18Oct96 was reported as increased. On 25Oct96 a repeat IgG test was noted as no change and then was noted as a lab error. An IgM test was reported as stable. It was also noted that there were no adverse events following prior vaccinations. No product quality complaint was involved. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction, Pain
Clinical narrative: Information has been received from a female pharmacist who was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine about five years and tow months after her first dose. subsequently the patient experienced arm pain and cellulitis which lasted for several days. Unspecified medical attention was sought. No further information is available.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 75 year old male patient who on Nov 03 2004 was vaccinated with 0.5 dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). Concomitant therapy included trandolapril (+) verapamil hydrochloride (Tarka), fluticasone propionate (+) salmeterol xinafoate (Advair), levothyroxine Na (Levoxyl), doxazosin mesylate, Pletol and folic acid. On Nov 04 2004 the patient experienced erythema of upper arm. Unspecified medical attention was sought. No further information is available.
Age: 40.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Nausea, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 40 year old male with an allergy to penicillin who on Oct 29 2004 at 2:20 was vaccinated in the left 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 (unspecified0 (lot U1449AA). There was no illness at the time of vaccination. On Oct 30 2004 at 2:30 the patient woke up with nausea and vomiting. He had a red, swollen, painful area where the injection was given. His had a temperature of 100.1 and he had pain in his neck that radiated across to his right shoulder. Unspecified medical attention was sought. No treatment or diagnostic lab tests were performed. On Nov 01 2004 the patients aches and temperature decreased and the redness and swelling went down. Subsequently, the patient recovered. No product quality complaint was involved. No further information expected. No further information is expected. It was also reported that another patient was vaccinated with dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0411USA00295).
Age: 40.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 40 year old male with an allergy to penicillin who on Oct 29 2004 at 2:20 was vaccinated in the left 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 (unspecified0 (lot U1449AA). There was no illness at the time of vaccination. On Oct 30 2004 at 2:30 the patient woke up with nausea and vomiting. He had a red, swollen, painful area where the injection was given. His had a temperature of 100.1 and he had pain in his neck that radiated across to his right shoulder. Unspecified medical attention was sought. No treatment or diagnostic lab tests were performed. On Nov 01 2004 the patients aches and temperature decreased and the redness and swelling went down. Subsequently, the patient recovered. No product quality complaint was involved. No further information expected. No further information is expected. It was also reported that another patient was vaccinated with dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0411USA00295).
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a physicians assistant concerning a 69 year old male who on Oct  13 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649076/0213P). On Oct 13 2004 the patient developed pain and edema at the injection site, high fever (as high as 101F), body aches and nausea. Unspecified medical attention was sought. The patients out come was not reported. There was no product quality complaint. It was noted that the patient had been vaccinated with pneumococcal 23v polysaccharide vaccine last in 1999. It was also reported that a female patient (WAES0410USA02401) and two unidentifiable patients (WAES0411USA01403) had similar experiences following vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning an 85 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 645852/0685N). The reported indicated that a nurse went to vaccinated the patient and some of the vaccine leaked out of the syringe and it smelled like glue. Therefore, they tested pneumococcal 23v polysaccharide vaccine from another lot (647660/0945N) on a gauze pad and it smelled like glue too. The reporter noted that the patient experienced a three inch lump on her arm that was tender. Unspecified medical attention was sought. A product quality complaint was not involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning an 80 year old female who on Oct 20 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). Subsequently, she experienced an injection site reaction. It was noted that hospitalization was not required. The patient was treated with fexofenadine hydrochloride (Allegra) and hydrocortisone (Hytone) (1% lotion). No product quality complaint involved. No further information is available.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Myalgia, Oedema
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 68 year old female who on Oct 11 2004 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0486P). Subsequently, in October 2004, the patient developed severe muscle pain, swelling of arm and did not feel well. The patient sought unspecified medical attention. The Doctor of Pharmacy also reported another patient who had a similar reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 649693/0486P). Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Hypokinesia, Injection site oedema, Injection site pain, Insomnia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 63 year old white male laborer with coronary artery disease, hyperlipidemia, and no known allergies who on the afternoon of Oct 04 2004 was vaccinated intramuscularly into the left deltoid muscle with a second dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). That same day, the patient developed pain in his shoulder near the injection site with swelling. The arm was very swollen, red sore and it hurt to raise it. It was reported that the patient was unable to sleep on his left side for three days. The patient sought medical attention and was treated with ice, acetaminophen (Tylenol) and ibuprofen. Subsequently, the patient recovered. The nurse also reported 2 other patients who has similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 645255/1212M) (WAES0410USA00811, WAES0411USA01577). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Insomnia, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 50 year old white female homemaker with hypertension, diabetes mellitus type 2, and rheumatic heard disease, who on the morning of Oct 05 2004 was vaccinated intramuscularly into the left deltoid muscle with a first dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M. That same day, the patient developed a sore shoulder, and the area of injection was red, swollen, and sore for two days, it was reported that the patient was unable to sleep on her left side for two nights because her shoulder hurt. in two days, the patient recovered. Unspecified medical attention was sought. The nurse also reported 2 other patients who has similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 645255/1212M) (WAES0410USA00811, WAES0411USA01576). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site reaction, Oedema, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female patient who in 1994 and on Oct 25 2004 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (second dose lot # 649913/0577P). Subsequently, the patient developed a fever, arm swelling, redness, and pitting edema in the arm, The arm had a cellulitis type of appearance, medical attention was sought. The patient was treated with a methylprednisolone (Medrol) dose pack, Diphenhydramine (Benadryl) and ice was ordered, The patients outcome was unknown. The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that two other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (second dose lot # 649913/0577P) and developed AE's (WAES0410USA03951, WAES0411USA0180). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia
Clinical narrative: Information has been received from a hospital worker concerning a 70 year white female who on Nov 08 2004 at 8:00am was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P), intramuscularly in the left deltoid. On Nov 08 2004 the patient had joint pain all through her left arm radiation up to her ear. It was also reported as joint pain in left arm pain radiating up arm into face and ear. Unspecified medical attention was sought. No product quality complaint involved. The patient recovered. No additional information is expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist via a company representative concerning a 60 year old female patient who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot # not available).  Subsequently the patient experienced a Cellulitis 5 inches square and 3 inches from the injection site.  The patient is being treated with antibiotics.  Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a registered nurse and a physician concerning an 87 year old white retired male patient with a history of fatigue, dizziness and a penicillin allergy who on Nov 04 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot  649732/0513P). On Nov 05 2004 at 9:00 am the patient developed a severe injection site reaction with severe swelling, pain, redness and cellulitis. He was not hospitalized and is improving. It was reported that his edema, redness and soreness lasted for 4 days and the patient was fine. There was concern expressed regarding the lot. Additional information 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. It was reported that the patients wife had a similar experience (WAES0411USA01465).
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Hypersensitivity, Oedema, Pyrexia
Clinical narrative: Information has been received from a physician concerning an adult female with chronic asthma who in October 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently, the patient developed swelling of the upper arm with redness, fever, chills and headache. The physician reported that the patient was to be seen in the office on Oct 29 2004. The physician reported 3 other patients who had similar reaction post vaccination with pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) (WAES0411USA00004, WAES0411USA01789). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning an adult male without a spleen who in October 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P).  Subsequently, the patient developed swelling of upper arm with redness, fever, chills and headache.  The physician reported that the patient was to be seen on 10/29/2004.  The physician reported 3 other patients who had similar reactions post vaccination with pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) (WAES 0411USA00004 and 0411USA01788).  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Oedema, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 57 year old white female with osteoarthritis, diabetes mellitus, hypertension, gastroesophageal reflux disease, smoker and ACTO's causing increased LFT's who in October 1988 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 0986N), in the right deltoid. Concomitant therapy included. rabeprazole sodium (Aciphex), atorvastatin calcium (Lipitor), gabapentin (Neurontin), lisinopril (manufacturer unk), celecoxib (Celebrex), insulin lispro (Humalog), insulin glargine (Lantus), aspirin, vitamins (unspecified) and cyanocobalamin, On Nov 09 2004, in the afternoon, the patient experienced right upper arm pain, erythema, swelling, fever and chills. Subsequently, the patient recovered. There were no relevant diagnostic tests or laboratory data. The patient had no adverse events following prior vaccinations. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a patient who on 10/20/2004 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine.  On 10/21/2004 the patient developed a rash and swelling from the deltoid down to the elbow.  the patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site pain, Injection site swelling, Rash erythematous
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning a 79 year old retired white female with allergies to azithromycin (Zithromax), sulfamethoxale, trimethoprim (Septra), and ciprofloxacin hydrochloride (Cipro), who on 10/29/2004 (previously reported as September 2004), at 12:30PM, was vaccinated intramuscularly in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P).  Concomitant therapy included fexofenadine hydrochloride (Allegra), lisinopril (Zestril), acetaminophen/hydrocodone bitartrate (Vicodin tablets), calcium carbonate cholecalciferol (Caltrate + D), alendronate sodium (MSD) and clonazepam (Klonopin),  Subsequently, the patient developed a local site reaction of slightly raised area, painful, red, hot.  It was reported that on 10/29/2004, at 5:00PM, the patient developed swelling, redness, fever in arm, pain, and induration (area hard to the touch).  The patient sought unspecified medical attention.  The patient recovered on 11/20/2004.  It was reported that the patient had a sore throat, cough and runny nose at the time of vaccination.  It was also reported that the patient had one previous dose of pneumococcal 23v polysaccharide vaccine in October 1999.  It was also reported that 4 other female patients experienced adverse events within the last 2 months.  No product quality complaint was involved.  No additional information is expected.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a 51 year old male who on Nov 09 2004 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown). the patient subsequently developed an injection site reaction to include redness and swelling from his shoulder to his elbow around the injection site. It was also reported that the patient sought unspecified medical attention and was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a health professional concerning a 78 year old male with allergies to horse serum and NSAID and no drug reaction who on 11/05/2004 was vaccinated with 0.5ml dose of pneumococcal 23v polysaccharide vaccine.  On 11/09/2004 the patient broke out with swelling and redness of the arms.  Unspecified medical attention was sought.  The patient had not yet recovered.  No product quality complaint was involved.  Additional information has been requested.  It was also reported that a female patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an AE (WAES 0501USA00113).
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site pain, Injection site reaction, Swelling
Clinical narrative: Information has been received from a physician concerning a 64 year old female who on 09/11/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N).  Shortly after the vaccination, the patient developed an injection site reaction that included soreness, warmth, erythema and swelling.  Unspecified medical attention was sought.  The patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 62 year old female who on the morning of 11/12/2004 was vaccinated with a dose pneumococcal 23v polysaccharide vaccine (it was unknown if the patient had received pneumococcal 23v polysaccharide vaccine in the past).  The LPN reported that on 11/12/2004, a few hours after being vaccinated, the patient developed a half dollar sized raised are on her right arm.  Unspecified medical attention was sought and the patient was treated with ice.  at the time of this report, the outcome was unknown.
Age: 77.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Tremor
Clinical narrative: Initial and follow up information has been received from a wholesaler and a nurse concerning 77 year old patient (previously reported as 4 patients) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P).  Subsequently the patient developed the shakes and swelling around the injection site.  The patient did not undergo a work up or hospitalization.  No other information was available.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who on approximately 11/07/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649111/0287P or 649076/0213P).  Subsequently the patient experienced local reaction at injection site, soreness, warmth, erythema, swelling, induration, cellulitis-like reaction.  Unspecified medical attention was sought.  At the time of the report it was noted that the patient was recovering.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a male over the age of 65 who in 2004 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).  There was no product quality complaint involved.  Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia, Tremor
Clinical narrative: Initial and follow up information has been received from a health professional concerning an 85 year old female with no reported medical history who on 11/05/2004 was vaccinated intramuscularly in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).  It was reported that there was no concomitant medication and no laboratory diagnostic tests performed.  Subsequently the patient developed redness, pain, swelling, shaking and had a hard time sleeping.  In follow up, the healthcare professional reported that the redness, swelling and pain developed at the left deltoid injection site.  It was reported that the patient fully recovered.  No product quality complaint was involved.  It was also reported that there were 3 other patient who experienced adverse events after administration of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 75 year old white female with no known drug allergies who in 1998 and on 10/12/2004 at 12:10 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot # 649029/0514P).  Concomitant therapy that day at 12:12 included an eleventh dose of influenza virus vaccine (Fluzone) (lot # U1380AA).  There was no illness at the time of vaccination.  On 10/12/2004 approximately 4 hours later, the patient experienced spreading redness at site and cellulitis at injection site.  The report indicates that the doctor prescribed amoxicillin clavulanate potassium (Augmentin).  Subsequently, the patient recovered from spreading redness at site and cellulitis at injection site.  The report indicates that the patient required medical attention.  No additional information is expected.