chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Culture urine negative, Discomfort, Glucose urine, Headache
Clinical narrative: Information has been received from a physician and an advanced practice nurse concerning a male over 50 years old with diabetes, who on approximately 28-AUG-2008 was vaccinated with a dose of PNEUMOVAX. On 28-AUG-2008 later in the day the patient developed severe edema and swelling at the injection site and the arm. It was reported that the patient had been hospitalized over the past few years for unspecified conditions and may have previously received a dose of PNEUMOVAX during that time. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Follow-up information has been received from medical records and an advanced practice nurse who reported that the 55 year old disabled male (previously reported as 50 year old), with allergy to steroids, ULTRAM, PHENERGAN, ACTOS and celucophage (therapy unspecified) was vaccinated on 10-SEP-2008 with a dose of PNEUMOVAX, 0.5 mL, in the left deltoid in the morning. This date, the patient experienced left extremity tender to touch, warm to touch, weakness, not able to raise without pain or discomfort, discomfort in neck, shoulder and in arm, headache, he felt lousy and chills fever. The patient sought medical attention. On 11-SEP-2008, were performed some labs and the relevant results were: serum sodium test: low; anion gap: low, serum glucose test: high; urine microalbumin test, high; seg manual: high; urine glucose test: negative : white blood cell count:high; seg: high; blood monocyte count: high; blood lymphocyte count: low; mean corpuscular hemoglobin concentration: high; blood in urine: trace A; erythrocyte sedimentation rate: high; blood lymphocyte count: high and serum high-density lipoprotein cholesterol test: low. On 12-SEP-2008, a left upper extremity venous doppler evaluation was performed which showed no evidence of DVT. On 16-SEP-2008, the patient recovered. No additional information is expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: High density lipoprotein decreased, Injection site oedema, Injection site swelling, Laboratory test abnormal, Lymphocyte count increased
Clinical narrative: Information has been received from a physician and an advanced practice nurse concerning a male over 50 years old with diabetes, who on approximately 28-AUG-2008 was vaccinated with a dose of PNEUMOVAX. On 28-AUG-2008 later in the day the patient developed severe edema and swelling at the injection site and the arm. It was reported that the patient had been hospitalized over the past few years for unspecified conditions and may have previously received a dose of PNEUMOVAX during that time. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Follow-up information has been received from medical records and an advanced practice nurse who reported that the 55 year old disabled male (previously reported as 50 year old), with allergy to steroids, ULTRAM, PHENERGAN, ACTOS and celucophage (therapy unspecified) was vaccinated on 10-SEP-2008 with a dose of PNEUMOVAX, 0.5 mL, in the left deltoid in the morning. This date, the patient experienced left extremity tender to touch, warm to touch, weakness, not able to raise without pain or discomfort, discomfort in neck, shoulder and in arm, headache, he felt lousy and chills fever. The patient sought medical attention. On 11-SEP-2008, were performed some labs and the relevant results were: serum sodium test: low; anion gap: low, serum glucose test: high; urine microalbumin test, high; seg manual: high; urine glucose test: negative : white blood cell count:high; seg: high; blood monocyte count: high; blood lymphocyte count: low; mean corpuscular hemoglobin concentration: high; blood in urine: trace A; erythrocyte sedimentation rate: high; blood lymphocyte count: high and serum high-density lipoprotein cholesterol test: low. On 12-SEP-2008, a left upper extremity venous doppler evaluation was performed which showed no evidence of DVT. On 16-SEP-2008, the patient recovered. No additional information is expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Mean cell volume increased, Mobility decreased, Monocyte count increased, Pyrexia, Red blood cell count increased
Clinical narrative: Information has been received from a physician and an advanced practice nurse concerning a male over 50 years old with diabetes, who on approximately 28-AUG-2008 was vaccinated with a dose of PNEUMOVAX. On 28-AUG-2008 later in the day the patient developed severe edema and swelling at the injection site and the arm. It was reported that the patient had been hospitalized over the past few years for unspecified conditions and may have previously received a dose of PNEUMOVAX during that time. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Follow-up information has been received from medical records and an advanced practice nurse who reported that the 55 year old disabled male (previously reported as 50 year old), with allergy to steroids, ULTRAM, PHENERGAN, ACTOS and celucophage (therapy unspecified) was vaccinated on 10-SEP-2008 with a dose of PNEUMOVAX, 0.5 mL, in the left deltoid in the morning. This date, the patient experienced left extremity tender to touch, warm to touch, weakness, not able to raise without pain or discomfort, discomfort in neck, shoulder and in arm, headache, he felt lousy and chills fever. The patient sought medical attention. On 11-SEP-2008, were performed some labs and the relevant results were: serum sodium test: low; anion gap: low, serum glucose test: high; urine microalbumin test, high; seg manual: high; urine glucose test: negative : white blood cell count:high; seg: high; blood monocyte count: high; blood lymphocyte count: low; mean corpuscular hemoglobin concentration: high; blood in urine: trace A; erythrocyte sedimentation rate: high; blood lymphocyte count: high and serum high-density lipoprotein cholesterol test: low. On 12-SEP-2008, a left upper extremity venous doppler evaluation was performed which showed no evidence of DVT. On 16-SEP-2008, the patient recovered. No additional information is expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Tenderness, Ultrasound scan normal, Urine analysis abnormal, White blood cell count increased
Clinical narrative: Information has been received from a physician and an advanced practice nurse concerning a male over 50 years old with diabetes, who on approximately 28-AUG-2008 was vaccinated with a dose of PNEUMOVAX. On 28-AUG-2008 later in the day the patient developed severe edema and swelling at the injection site and the arm. It was reported that the patient had been hospitalized over the past few years for unspecified conditions and may have previously received a dose of PNEUMOVAX during that time. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Follow-up information has been received from medical records and an advanced practice nurse who reported that the 55 year old disabled male (previously reported as 50 year old), with allergy to steroids, ULTRAM, PHENERGAN, ACTOS and celucophage (therapy unspecified) was vaccinated on 10-SEP-2008 with a dose of PNEUMOVAX, 0.5 mL, in the left deltoid in the morning. This date, the patient experienced left extremity tender to touch, warm to touch, weakness, not able to raise without pain or discomfort, discomfort in neck, shoulder and in arm, headache, he felt lousy and chills fever. The patient sought medical attention. On 11-SEP-2008, were performed some labs and the relevant results were: serum sodium test: low; anion gap: low, serum glucose test: high; urine microalbumin test, high; seg manual: high; urine glucose test: negative : white blood cell count:high; seg: high; blood monocyte count: high; blood lymphocyte count: low; mean corpuscular hemoglobin concentration: high; blood in urine: trace A; erythrocyte sedimentation rate: high; blood lymphocyte count: high and serum high-density lipoprotein cholesterol test: low. On 12-SEP-2008, a left upper extremity venous doppler evaluation was performed which showed no evidence of DVT. On 16-SEP-2008, the patient recovered. No additional information is expected.
Sex: M
Vaccine: DTAP, MNQ, PPV, VARCEL
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Information has been received from a Licensed Practical Nurse 1 concerning a male patient who was vaccinated With a dose of PNEUMOVAX. Concomitant therapy included DTaP (manufacturer unknown) and MENACTRA. Patient received two injections in each arm. The reporter reported that patient experienced fever, redness and soreness after the vaccination. the outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 65 year old husband with an allergic reaction to sulfa drugs and no pertinent medical history who on 08-SEP-2008 was vaccinated IM with PNEUMOVAX (lot # 659487/1960U) 0.5mL/single dose.  Concomitant therapy included influenza virus vaccine (unspecified).  On 09-SEP-2008 the patient developed a "streaking rash" that went around both arms and on the skin of his testicles after receiving PNEUMOVAX.  The patient sought unspecified medical attention.  The reporter had no additional information.  At the time of the report the patient had not recovered from "streaking rash" that went around both arms and on the skin of his testicles.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Cold sweat, Cough, Erythema, Flushing
Clinical narrative: Information has been received from a registered nurse and a health professional concerning a 44 year old female with allergic reaction to antibiotics (+) CLAVULANTE POTASSIUM, a history of rash to AUGMENTIN and adverse reaction to TETANUS TOXOID (manufacturer and date unspecified) and slight cold symptoms at time of vaccination, which she was treated with FLAGYL 500 mg (unknown date). On 18-SEP-2008, the patient was vaccinated with PNEUMOVAX (lot # 657626/1084U (previously reported as lot # 662020/0614X)), 0.5 mL intramuscularly in the right arm. Concomitant therapy included LEXAPRO, PATANASE, NASONEX, MSD, AUGMENTIN. On 18-SEP-2008, the patient experienced nausea, chills, clammy, runny nose and some coughing. On 19-SEP-2008, at an office visit the day after the vaccination it was reported that the patient experienced very large local reaction at injection site (previously reported as the patient had no local injection site reaction), the patient had an extremely painful arm that she could not move or touch and she had a fever of 101.9 degrees F. The patient was flushed with the face, neck, chest and breast area beet red. On an unspecified date, was performed to the patient a metabolic panel which was normal and white blood cell count which showed the white blood cells slightly elevated. On 20-SEP-2008, the patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number 662020/0614X was satisfactory. The lot # 662020/0614X met the requirements of the Agency and released. Follow-up information has been received from a registered nurse who confirmed that the patient was dosed with PNEUMOVAX, lot # 657626/1084U. A standard lot check investigation was performed. All in-process quality checks for the lot number 657262/1084U were satisfactory. The lot met the requirements of the Agency and was released. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site reaction, Metabolic function test normal, Nausea, Pain in extremity
Clinical narrative: Information has been received from a registered nurse and a health professional concerning a 44 year old female with allergic reaction to antibiotics (+) CLAVULANTE POTASSIUM, a history of rash to AUGMENTIN and adverse reaction to TETANUS TOXOID (manufacturer and date unspecified) and slight cold symptoms at time of vaccination, which she was treated with FLAGYL 500 mg (unknown date). On 18-SEP-2008, the patient was vaccinated with PNEUMOVAX (lot # 657626/1084U (previously reported as lot # 662020/0614X)), 0.5 mL intramuscularly in the right arm. Concomitant therapy included LEXAPRO, PATANASE, NASONEX, MSD, AUGMENTIN. On 18-SEP-2008, the patient experienced nausea, chills, clammy, runny nose and some coughing. On 19-SEP-2008, at an office visit the day after the vaccination it was reported that the patient experienced very large local reaction at injection site (previously reported as the patient had no local injection site reaction), the patient had an extremely painful arm that she could not move or touch and she had a fever of 101.9 degrees F. The patient was flushed with the face, neck, chest and breast area beet red. On an unspecified date, was performed to the patient a metabolic panel which was normal and white blood cell count which showed the white blood cells slightly elevated. On 20-SEP-2008, the patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number 662020/0614X was satisfactory. The lot # 662020/0614X met the requirements of the Agency and released. Follow-up information has been received from a registered nurse who confirmed that the patient was dosed with PNEUMOVAX, lot # 657626/1084U. A standard lot check investigation was performed. All in-process quality checks for the lot number 657262/1084U were satisfactory. The lot met the requirements of the Agency and was released. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Rhinorrhoea, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse and a health professional concerning a 44 year old female with allergic reaction to antibiotics (+) CLAVULANTE POTASSIUM, a history of rash to AUGMENTIN and adverse reaction to TETANUS TOXOID (manufacturer and date unspecified) and slight cold symptoms at time of vaccination, which she was treated with FLAGYL 500 mg (unknown date). On 18-SEP-2008, the patient was vaccinated with PNEUMOVAX (lot # 657626/1084U (previously reported as lot # 662020/0614X)), 0.5 mL intramuscularly in the right arm. Concomitant therapy included LEXAPRO, PATANASE, NASONEX, MSD, AUGMENTIN. On 18-SEP-2008, the patient experienced nausea, chills, clammy, runny nose and some coughing. On 19-SEP-2008, at an office visit the day after the vaccination it was reported that the patient experienced very large local reaction at injection site (previously reported as the patient had no local injection site reaction), the patient had an extremely painful arm that she could not move or touch and she had a fever of 101.9 degrees F. The patient was flushed with the face, neck, chest and breast area beet red. On an unspecified date, was performed to the patient a metabolic panel which was normal and white blood cell count which showed the white blood cells slightly elevated. On 20-SEP-2008, the patient recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number 662020/0614X was satisfactory. The lot # 662020/0614X met the requirements of the Agency and released. Follow-up information has been received from a registered nurse who confirmed that the patient was dosed with PNEUMOVAX, lot # 657626/1084U. A standard lot check investigation was performed. All in-process quality checks for the lot number 657262/1084U were satisfactory. The lot met the requirements of the Agency and was released. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 46 year old female with chronic obstructive pulmonary disease and a sulfonamide allergy, who on 01-FEB-2008 was vaccinated with a first dose of PNEUMOVAX.  On 22-SEP-2008 the patient was vaccinated IM with a 0.5mL second dose of PNEUMOVAX (Lot# 660685/0619X).  Concomitant therapies included ADVAIR, VERAMYST, PROAIR HFA and SYNTHROID.  On 22-SEP-2008 the patient developed a red, warm, painful, swollen area, about 10 centimeters by 18 centimeters on her arm at the injection site post vaccination.  The patient was seen at the office.  No laboratory diagnostics were performed.  At the time of report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Staphylococcal infection
Clinical narrative: Information has been received from a physician concerning a 31 year old female with asthma who on approximately 01-APR-2008 was vaccinated with a dose of PNEUMOVAX (dose, route and lot # not reported).  On an unspecified date the patient developed a cellulitis after vaccination with PNEUMOVAX.  The physician did not treat the patient for the cellulitis, and did not have information about its time frame development or resolution.  The patient went to the emergency room and was told that the cellulitis was caused by a "Staph infection."  The emergency room physician (name unspecified) told the patient that her arm was not properly cleansed prior to vaccination.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Injection site reaction, Pain in extremity, Swelling
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 69 year old female with penicillin allergy and allergy to aspartame who on 15-SEP-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX, 0.5 ml, (lot # 661899/0519X).  It was reported that on 15-SEP-2008, the patient developed an injection site reaction.  The symptoms included pain in upper arm (grade 7), hurt to move her arm, redness, tenderness and swelling, and a possible cellulitis.  The patient went to the doctor's office and was treated with KEFLEX and ROCEPHIN.  On 19-Sep-2008, the patient recovered from the events.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 69 year old female with penicillin allergy and allergy to aspartame who on 15-SEP-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX, 0.5 ml, (lot # 661899/0519X).  It was reported that on 15-SEP-2008, the patient developed an injection site reaction.  The symptoms included pain in upper arm (grade 7), hurt to move her arm, redness, tenderness and swelling, and a possible cellulitis.  The patient went to the doctor's office and was treated with KEFLEX and ROCEPHIN.  On 19-Sep-2008, the patient recovered from the events.  Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner student concerning her 61 year old father who in July 2008, while hospitalized for another condition (unspecified) was vaccinated with PNEUMOVAX vaccine (lot # not reported). "The same day the vaccination was given" the patient had severe swelling and pain in the arm and injection site where the vaccine was given. "1 week later" the patient recovered. No further information was available. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a female who on an unknown date was vaccinated with a dose of PNEUMOVAX.  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently the patient developed and injection site reaction that was described as PNEUMOVAX vaccine site swelling up to the size of a baseball.  All the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  This is one of tree reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 26-SEP-2008 were vaccinated with PNEUMOVAX (lot # 659487/1960U) 0.5 mL "interdermally" instead of PPD (manufacturer unspecified), (human error/no PQC involvement).  The nurse reported that the patient had not recovered.  No additional information was available.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with penicillin, codeine, sulfa, DARVON, DEMEROL, morphine, ezetimibe, simvastatin allergies and a history of thyroidism who on 30-SEP-2008 was vaccinated with PNEUMOVAX vaccine IM (lot # 658496/1225U) 0.5 ml and FLUZONE on the same arm. Other concomitant therapy included, SYNTHROID, aspirin, calcium (unspecified) and vitamins (unspecified). On 04-OCT-2008 the patient developed hives. The itchy welts were on the neck, breast, and stomach. The patient had shortness of breath and felt heaviness of chest while sleeping that week. She was given ZYRTEC and was seen on 06-OCT-2008. On an unspecified date the patient recovered from hives, shortness of breath and felt heaviness of chest. This is one of several reports from the same source. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a nurse concerning a 56 year old male with glaucoma, headache, depression and diabetes who in 2003 was vaccinated IM with his first dose of PNEUMOVAX (lot number not reported).  The patient was vaccinated IM with his second dose of PNEUMOVAX (lot number 661899/0519X).  Concomitant therapy included METFORMIN, ZOLOFT, glyburide, LANTUS and NEURONTIN.  Subsequently the patient developed allergic reaction.  The medical attention was sought.  There are no other information for now.  The patient also developed an adverse event while on therapy with LISINOPRIL (manufacturer unknown) (WAES #.......).  This is one of several reports received from the same source.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Injection site erythema, Injection site rash, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old female with chronic fatigue syndrome, hyperthyroidism, arthritis, stress and incontinence and coeliac disease who in 1995 was vaccinated with PNEUMOVAX vaccine IM 0.5 ml. In 2003 the patient was vaccinated with PNEUMOVAX vaccine IM 0.5 ml. On 03-OCT-2008 the patient was vaccinated with PNEUMOVAX (lot # 662100/0742X) IM 0.5 ml on the right arm and FLUZONE vaccine on the left arm. Other concomitant therapy included LEVOXYL, aspirin, PREVACID, PLAQUENIL, estrogens, PREMARIN, vitamin E, calcium (unspecified) (+) vitamin D (unspecified) and omega-3 marine triglycerides. On 03-OCT-2008 the patient developed temperature of 103f, chills and body aches. On 04-OCT-2008 the patient experienced red raised bumps at injection site of the right arm. On 06-OCT-2008 the patient recovered from temperature of 103f, chill, body aches and red raised bumps at injection site. The patient sought medical attention and spoke with physician on 06-OCT-2008. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Tuberculin test positive
Clinical narrative: Information has been received from a nurse concerning a 60 year old male with gout, thalamic syndrome, gastroesophageal reflux disease, benign prostatic hyperplasia, ppd skin test positive and a history of bladder cancer who on 08-OCT-1998 was vaccinated IM with his first dose of PNEUMOVAX vaccine (lot number not reported). On 03-OCT-2008, he was vaccinated IM with the second dose of PNEUMOVAX vaccine (lot number 662100/0742X) into the left arm. Concomitant therapy included FLUZONE which was vaccinated IM into the right arm on the same day, metoprolol, allopurinol, omeprazole, LIPITOR, amlodipine, ascorbic acid/vitamin B complex, vitamins (unspecified), aspirin, testosterone and VIAGRA. On 06-OCT-2008 the patient experienced redness and swelling of the whole arm from the shoulder to the wrist. patient was seen on 07-OCT-2008 and his symptoms receded drastically. He was diagnosed with cellulitis and was treated with KEFLEX. This one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 64 year old male with diabetes, low back pain, knee pain and hypertension and no allergies who in 2003 was vaccinated with the first dose of PNEUMOVAX, 0.5 ml IM. On 17-SEP-2008, the patient was vaccinated with a second dose of PNEUMOVAX (lot no. 661899/0519X) 0.5 ml, IM. Concomitant therapy included VIAGRA, Aspirin, MOTRIN, LOTREL, GLUCOVANCE, ACTOS, FLEXERIL, hydrochlorothiazide, simvastatin, nystatin and FLUZONE. In 2003 the patient experienced quite a reaction. On 17-SEP-2008 the patient experienced redness, swelling and warmth on the right upper arm, the patient was diagnosed with cellulitis and was given KEFLEX. The patient recovered from both events. The patient sought medical attention as he was seen. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inflammation, Oedema peripheral
Clinical narrative: Information has been received from a license vocational nurse (LVN) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (lot # not reported). The patient had inflamed swollen arm for 1.5 weeks. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Pain, Urticaria
Clinical narrative: Information has been received from a license vocational nurse (LVN) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (lot # no reported).  The patient had developed hives, large raised, hot area and the patient felt achy after receiving the dose of PNEUMOVAX.  No further information was provided.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician an approximately 66 year old female who on an unspecified date was vaccinated at the health department with PNEUMOVAX 23 (lot # not reported). On the same date, the patient was also vaccinated with influenza virus vaccine (unspecified). Subsequently, on an unspecified date the patient experienced tender, large, erythematous, raised area below the injection site. The physician reported that the are is getting worse and that the patient is not allowing her to even touch the are as it is so painful. The patient also experienced flu-like symptoms. The patient sought unspecified medical attention. No further information was available.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a 49 year old female with PENICILLIN and SULFONAMIDE allergies and a history of splenectomy who on an unspecified date was vaccinated with a first dose of PNEUMOVAX.  (Lot # not reported).  On 08-OCT-2008, the patient was vaccinated IM into the right arm with a second dose of 0.5 mL of PNEUMOVAX.  (lot #659778/0024X given is for MMR).  Concomitant therapy included influenza virus vaccine (unspecified) into the left arm, and hormonal contraceptives (unspecified).  The medical assistant reported that on 10-OCT-2008 the patient was seen in the office and was diagnosed with cellulitis of her right arm at the injection site.  At the time of the report, the cellulitis of her right arm at the injection site had not resolved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with no major medical history, who in March 2008, was vaccinated with a dose of PNEUMOVAX 23 (Lot # 658673/0990U). Concomitant therapies included calcium (unspecified) (+) vitamin D (unspecified) and vitamins (unspecified). Subsequently the patient experienced extreme, severe pain in her left shoulder. It was reported that as of 29-SEP-2008 the patient was still stiff and sore. The physician noted that the patient had a good range of motion. However the patient had to take narcotic pain relievers for pain. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with hypertension and no allergies who on "08-OCT-2008" was vaccinated IM in arm with 0.5mL- first dose of PNEUMOVAX (lot #662020/0614X).  Concomitant therapy included influenza virus vaccine (unspecified), SIMVASTATIN (manufacturer unknown), enalapril maleate (manufacturer unknown) and AMOXICILLIN.  On 09-OCT-2008 the patient experienced injection site events which included redness, swelling, and heat at injection site.  At the time  of the report the events had expanded from shoulder joint to elbow.  The patient sought unspecified medical attention.  At the time of reporting the patient had not recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction that was described as the PNEUMOVAX 23 vaccine site swelling up to the size of a baseball. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old female patient with arthritis, chronic back pain, hyperthyroidism and hypertension. Patient's drug reactions/allergies included DECADRON, inhaled steroids, BUSPAR, spectazole, scerzone, NORVASC, codeine, propranolol, erythromycin, prednisone, estradiol and methylpred. The patient on 30-SEP-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (lot # 662020/0614X) intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified) in opposite arm, CELEBREX, timolol maleate, felodipine, benazepril HCl, albuterol, MYCOLOG III, hydrochlorothiazide, SYNTHROID, omeprazole and estrogens, PREMARIX. On 02-OCT-2008 the patient experienced redness, swelling, itching an hot to touch at injection site. The patient sought medical attention. Subsequently, the patient recovered from these events "after 1 week". This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX (unspecified). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction that was described as the PNEUMOVAX site swelling up to the size of a baseball. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a physician concerning himself, a 60 year old male with no pertinent medical history and no drug reactions or allergies who on 26-SEP-2008 was vaccinated intramuscularly with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included influenza virus vaccine (unspecified) which was administered in the same arm at the same office visit. On 26-SEP-2008 the patient developed fever, chills, and a sore arm 8-9 hours after receiving the PNEUMOVAX 23 vaccine. The patient's fever (unspecified as low-grade fever) and chills lasted 48 hours. At the time of the report the arm pain was resolving. The physician reported that he took ALEVE and TYLENOL for the symptoms. No other symptoms or treatment reported. No other information was available. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a healthcare worker concerning a female who on 26-SEP-2008 was vaccinated with PNEUMOVAX 23 (lot #658074/0961U) 0.5 mL/one dose IM. On 26-SEP-2008 after receiving the dose of PNEUMOVAX 23, the patient experienced swelling, pain, cellulitis and fever. The swelling, cellulitis and pain were experienced in the arm of PNEUMOVAX 23 vaccine administration. The healthcare worker reported that the patient was seen in the practice. At the time of reporting the patient had not recovered from swelling, pain, cellulitis and fever. No further information was provided. This is one of two reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Incorrect route of drug administration, Injection site reaction, Lymphadenopathy, Musculoskeletal pain
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 23 year old female patient who on 26-SEP-2008 was vaccinated with PNEUMOVAX 23 vaccine (lot # 659487/1960U) 0.5 mL "interdermally" instead of tuberculin purified protein derivative (PPD) (manufacturer unspecified), (human error/no PQC involvement). The patient developed severe local injection site reactions and arm pain. On 03-OCT-2008 the patient developed lymph nodes swollen with pain in arm, elbow and shoulder, which waked her at night. On 13-OCT-2008, the patient developed hives. The patient was given BENADRYL, ZYRTEC and prednisone. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Urticaria, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 23 year old female patient who on 26-SEP-2008 was vaccinated with PNEUMOVAX 23 vaccine (lot # 659487/1960U) 0.5 mL "interdermally" instead of tuberculin purified protein derivative (PPD) (manufacturer unspecified), (human error/no PQC involvement). The patient developed severe local injection site reactions and arm pain. On 03-OCT-2008 the patient developed lymph nodes swollen with pain in arm, elbow and shoulder, which waked her at night. On 13-OCT-2008, the patient developed hives. The patient was given BENADRYL, ZYRTEC and prednisone. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Arthralgia, Incorrect route of drug administration, Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female patient who on 26-SEP-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 658449/0989U) 0.5 ML "interdermally" instead of tuberculin purified protein derivative (PPD) (manufacturer unspecified), (human error/no PQC involvement). After the vaccination, the patient developed severe injection site reactions causing arm pain. She was given BENADRYL and prednisone. Subsequently the patient developed anxiety. The patient's pain in arm, elbow continued. On 05-OCT-2008 the patient experienced purpura which lasted 24 hours. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Purpura
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female patient who on 26-SEP-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 658449/0989U) 0.5 ML "interdermally" instead of tuberculin purified protein derivative (PPD) (manufacturer unspecified), (human error/no PQC involvement). After the vaccination, the patient developed severe injection site reactions causing arm pain. She was given BENADRYL and prednisone. Subsequently the patient developed anxiety. The patient's pain in arm, elbow continued. On 05-OCT-2008 the patient experienced purpura which lasted 24 hours. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 6 month old patient who on 29-SEP-2008 was inadvertently vaccinated with PNEUMOVAX 23 vaccine (lot # 655668/1004F) 0.5 mL IM, instead of  pneumococcal conj vaccine (manufacturer unspecified) because the PNEUMOVAX 23 vaccine viral did not provide an age or age group. Concomitant therapy included DTaP (+) hepatitis B virus (+) poliovirus vaccine inactivated (manufacturer unspecified), and Hib conj vaccine (manufacturer unspecified). No adverse events reported. The medical assistant indicated that one way to help prevent this from re-occurring in the future is to label the vials according to targeted age range. She reported that the patient was fine. The patient sought unspecified medical attention in the office. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a nurse concerning an adult in 50s, who in October 2008 ("past week") received a first dose of 0.5 ml PNEUMOVAX (lot # 660718/0551X, route and injection site unknown). It was reported that the patient had pain and burning while the injection was given. The events resolved in a minute or two. The patient sought unspecified medical attention; no treatment was required. Additional information has been requested. This is one of 3 reports from the same source.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning an approximately 52 year old female patient with asthma who during the past few months (2008) was vaccinated with PNEUMOVAX 23 (lot #660685/0619x) 0.5 mL IM. The physician reported that the arm in which the injection was given because swollen, red and painful from elbow to shoulder. The patient was seen in the office. The patient was treated with BENADRYL and ibuprofen. No further information was available. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a patient (gender not specified) who was vaccinated with a dose of PNEUMOVAX 23. The nurse reported that the patient had a large reaction to PNEUMOVAX 23 vaccine within the last couple of months. The outcome was unknown. No other information was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse (R.N.) and a Registered Pharmacist (R.Ph) concerning a 71 year old female patient who was vaccinated IM with a dose of PNEUMOVAX 23 vaccine lot # 662100/0742X. Concomitant therapy included FLUZONE. The reporter reported that patient developed a severe headache and severe neck pain after receiving the PNEUMOVAX 23 vaccine. Patient also developed a sore arm. Patient was told to take ibuprofen and TYLENOL. No other details was reported. The outcome was unknown. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood glucose, Blood potassium, Electrocardiogram, Headache, Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist and a registered nurse concerning an approximately 66 year old female patient with no pertinent medical history and no drug reactions or allergies who on an unspecified date was vaccinated with PNEUMOVAX (lot # 662100/0742X) 0.5 mL IM. Concomitant therapy included FLUZONE which was given the same day but in the opposite arm. On an unspecified date, the patient developed headache and nausea. The injection site was red, warm and swollen to the size of a softball and was raised. 1cm. The patient sought medical attention in the office. On an unspecified date the patient underwent an electrocardiogram (EKG) and glucose and potassium levels were drawn. Results for labs and diagnostics were not reported. The reporters stated that the patient was told to take ibuprofen and TYLENOL. It is unknown if the patient recovered. No other details were available. A lot check was requested by the nurse. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Information has been received from a registered pharmacist and a registered nurse concerning an approximately 66 year old female patient with no pertinent medical history and no drug reactions or allergies who on an unspecified date was vaccinated with PNEUMOVAX (lot # 662100/0742X) 0.5 mL IM. Concomitant therapy included FLUZONE which was given the same day but in the opposite arm. On an unspecified date, the patient developed headache and nausea. The injection site was red, warm and swollen to the size of a softball and was raised. 1cm. The patient sought medical attention in the office. On an unspecified date the patient underwent an electrocardiogram (EKG) and glucose and potassium levels were drawn. Results for labs and diagnostics were not reported. The reporters stated that the patient was told to take ibuprofen and TYLENOL. It is unknown if the patient recovered. No other details were available. A lot check was requested by the nurse. This is one of several reports received from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a registered nurse and the child's mother, concerning an approximately 2 year old male child with heart abnormalities, epilepsy, chronic pulmonary heart disease and other obstruction of duodenum who last year or the year before (2007 or 2007) was vaccinated with 0.5 mL of PNEUMOVAX (lot # not reported). The nurse reported that the child's mother called and reported that her son's doctor told her that the vaccine "did not take" and he would need to be re-vaccinated. The child was seen in the office for unspecified medical attention. The nurse reported that the child has not recovered. No additional information was available. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: PPV
Symptoms: Burning sensation, Pain
Clinical narrative: Information has been received from a nurse concerning an adult in 50s, who in October 2008 ("past week") received a first dose of 0.5 ml PNEUMOVAX (lot # 660718/0551X, route and injection site unknown).  It was reported that the patient had pain and burning while the injection was given.  The events resolved in a minute or two.  The patient sought unspecified medical attention;  no treatment was required.  Additional information has been requested.  This is one of 3 reports from a same source.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Information has been received from a pharmacist and a nurse concerning a 65 year old female patient with allergic reaction to penicillin, erythromycin and sulfonamide and a history of previous vaccination with PNEUMOVAX (date not specified) who was vaccinated IM with a dose of PNEUMOVAX lot # 662100/0742X. Concomitant therapy included FLUZONE. The reporter reported that the patient developed soreness. warmth and swelling at the injection site. She also developed nausea and body aches on 02-OCT-2008. She was given KENALOG 60 mg IM on 02-OCT-2008 because she was presented with swelling and pain from her elbow to her shoulder. No other details reported at this time. The patient had not recovered. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 65 year old female who on 10-OCT-2008 was vaccinated with the second dose of PNEUMOVAX (Lot# 660685/0619X) 0.5ml IM left deltoid. She had no drug reactions/allergies. The patient had no illness at the time of vaccination. On 11-OCT-2008 the patient developed an injection site reaction. The injection site was red, raised, hard and warm. The patient could not lift the injection site arm. The injection site reaction was 3 and 1/2 inches in length described as oblong. The patient was nauseous. She could not eat which lasted about 2 days. The patient was slight dizzy. Subsequently, the patient recovered. No further information was available.