chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a nurse concerning a 61 year old male with no past medical history who on approximately 06-NOV-2006, "last week," was vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot #655289/0958F).  There was no concomitant medication.  Subsequently the patient developed a very red dermatologic area covering his deltoid region.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  The reporting nurse has requested a lot check due to the patients have adverse experiences.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Pneumovax 23.  The patient received a dose of influenza virus vaccine (unspecified) at the same time.  Subsequently, the patient developed an injection site reaction from the vaccination with Pneumovax 23.  It was reported that the patient's arm swelled up "like a cellulitis".  She was treated with an unspecified antibiotic.  The patient's outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a healthcare worker concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (651401/0619F).  Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow.  At the time of this report, the patient had recovered.  No product quality complaint involved.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a healthcare worker concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (651401/0619F).  Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow.  The patient sought unspecified medical attention at the emergency room, was treated and released.  At the time of this report, the patient had recovered.  No product quality complaint involved.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a healthcare professional concerning a patient (age and gender unknown) who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (651401/0619F). Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow. At the time of this report, the patient had recovered. No product quality complaint involved. A lot check was requested by the reporter. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the agency and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypokinesia, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on 16-NOV-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL dose of Pneumovax 23 (Lot # 651406/0620F). On 17-NOV-2006 the patient developed an injection site reaction of a swollen arm which was very hard to move. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. No product quality complaint involved. Follow-up information indicated that no reaction occurred. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot #651356/0089F).  On approximately 13-NOV-2006 ("within the last week") the patient developed redness and a rash from the shoulder to the elbow.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 vaccine (Lot #651356/0089F). On approximately 13-NOV-2006 ("within the last week") the patient developed redness and a rash from the shoulder to the elbow. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Information has been received from a physician concerning a female (age unknown) who was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot #651356/0089F). On approximately 13-NOV-2006 ("within the last week") the patient developed redness and a rash from the shoulder to the elbow. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fluid retention, Injection site pain, Injection site reaction, Neck pain
Clinical narrative: Information has been received from a 67 year old female consumer with no medical history and no allergies who on 10-NOV-2006, at a store, was vaccinated in the upper arm with a 0.5 ml dose of Pneumovax 23.  Concomitant therapy included unspecified blood pressure medication.  On 10-NOV-2006, twelve hours after receiving the vaccine, the consumer experienced pain from the injection in her upper arm all the way up to her neck.  She said she developed 4 "raised welts in the general area of the injection" and an area of redness with fluid in it around her collar bone.  Unspecified medical attention was sought.  No lab tests were performed.  On 14-NOV-2006 the patient recovered.  No product quality complaint was involved.  No further information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a 67 year old female consumer with no medical history and no allergies who on 10-NOV-2006, at a store, was vaccinated in the upper arm with a 0.5 ml dose of Pneumovax 23.  Concomitant therapy included unspecified blood pressure medication.  On 10-NOV-2006, twelve hours after receiving the vaccine, the consumer experienced pain from the injection in her upper arm all the way up to her neck.  She said she developed 4 "raised welts in the general area of the injection" and an area of redness with fluid in it around her collar bone.  Unspecified medical attention was sought.  No lab tests were performed.  On 14-NOV-2006 the patient recovered.  No product quality complaint was involved.  No further information is expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Ecchymosis, Erythema, Fatigue, Injection site erythema
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old male with hypercholesterolaemia and diabetes and no drug reactions or allergies who on 13-NOV-2006 was vaccinated intramuscularly into the right deltoid with a third dose of Pneumovax 23 (lot #655500/1005F). Concomitant therapy included omega-3 marine triglycerides, FLOMAX, metformin, lovastatin, multivitamins and aspirin. Later that evening the patient experienced chills with a fever, and the arm in which he was vaccinated was red, painful and warm to the touch. The patient also experienced increased fatigue. The next day, he had redness in the right bicep, right upper extremity and right chest wall that resolved by the time he was seen on 16-NOV-2006. He also experienced ecchymosis in the mid to lower right bicepand distal right upper extremity. No hematoma was noted. Unspecified medical attention was sought. No labs were performed. At the time of report, the patient was recovered from the events but did not recover from ecchymosis. No product quality complaint was involved. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old male with hypercholesterolaemia and diabetes and no drug reactions or allergies who on 13-NOV-2006 was vaccinated intramuscularly into the right deltoid with a third dose of Pneumovax 23 (lot #655500/1005F). Concomitant therapy included omega-3 marine triglycerides, FLOMAX, metformin, lovastatin, multivitamins and aspirin. Later that evening the patient experienced chills with a fever, and the arm in which he was vaccinated was red, painful and warm to the touch. The patient also experienced increased fatigue. The next day, he had redness in the right bicep, right upper extremity and right chest wall that resolved by the time he was seen on 16-NOV-2006. He also experienced ecchymosis in the mid to lower right bicepand distal right upper extremity. No hematoma was noted. Unspecified medical attention was sought. No labs were performed. At the time of report, the patient was recovered from the events but did not recover from ecchymosis. No product quality complaint was involved. Additional information is not expected.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning an 85 year old male (weight 168#) with hypercholesterolaemia, hypertension, glaucoma, coronary artery disease and an allergy to niacin who on 16-NOV-2006, was vaccinated subcutaneously with the second dose of Pneumovax 23 (lot #655500/1005F).  Concomitant therapy included ezetimibe (MSN), COUMADIN, lisinopril (manufacturer unknown), TOPROL XL TABLETS, LIPITOR, OCUVITE PRESERVISION, XALATAN, PRILOSEC and METAMUCIL.  On the morning of 17-NOV-2006, the patient called the office because his arm was swollen, red, warm to the touch, and very painful from the shoulder to the elbow.  He was prescribed unspecified antibiotics.  No lab studies were performed.  The patient's outcome was reported as recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Pain, Tenderness
Clinical narrative: Information has been received from a physician concerning a 61 year old female with type II diabetes mellitus, hypertension, gastroesophageal reflux disease (GERD), hepatitis B carrier and mitral valve prolapse who on the morning of 26-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #655289/0958F). Concomitant therapy included ESTRACE, hydrochlorothiazide (manufacturer unknown), PREVACID, ACTOS, GLUCOTROL and ZESTORETIC. On 26-OCT-2006, at 21:00, the patient developed local pain, tenderness, erythema and induration at the injection site which extended distally to below the elbow. The patient was seen in the physician's office, and subsequently, the local pain, tenderness, erythema and induration at the injection site began to improve after 18 hours. On 01-NOV-2006, the patient was recovered. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old male who on 17-NOV-2006 was vaccinated with Pneumovax 23 (0.5 ml) (lot # 651400/0618F), intramuscularly.  The patient was supposed to receive PREVNAR.  The reporter stated that this was not a case of product confusion.  It was a mistake due to the fact that they had just received a shipment of Pneumovax 23, which was on the shelf, and during the course of the busy day the patients were mistakenly given PREVNAR.  Subsequently, the patient had not experienced any known symptoms.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Disturbance in attention, Flushing, Inappropriate schedule of drug administration, Peripheral coldness
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 54 year old male pharmacist who 21-NOV-2006, at 9:00 a.m., was vaccinated IM in the left arm with a second 0.5 ml dose of Pneumovax 23 (lot # 655669/1128F).  The same day, the patient was vaccinated in the same arm with a dose of influenza vaccine.  It was reported that the patient was vaccinated with a previous dose of Pneumovax 23 "one year ago."  Other concomitant therapy included losartan potassium (MSD), sulfasalazine and VOLTAREN.  On 21-NOV-2006, at 3:00 p.m., the patient's cheeks were flushed, his hands felt cold and he had trouble focusing on work.  Unspecified medical attention was sought.  On 22-NOV-2006, the patient recovered from the attention disturbance.  The outcome of the patient's flushing and peripheral coldness was unknown.  No additional information is expected.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Fatigue, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 71 year old female with no medical history who, on an unknown date, was vaccinated intramuscularly in the left deltoid with a second dose of Pneumovax 23 (Lot# 651320/1008P).  Concomitant therapy included a dose of Zostavax (MSD) (Lot # 652936/0981F) subcutaneously in the right arm, atenolol, hydrochlorothiazide (manufacturer unknown) and CELEBREX.  On 27-OCT-2006 the patient experienced swelling, redness and aching that extended 3/4 of the arm and systemic fatigue.  Subsequently, the patient recovered gradually over the next week.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 73 year old female diabetic with thyroid disease and "cholesterol" and no known drug allergies who on 20-NOV-2006 at 10:00 AM was vaccinated with a first dose of Pneumovax 23 (lot # 651148/0087F) (0.5 ml), intramuscularly in the right arm. Concomitant therapy included metformin, glyburide, SYNTHROID and ZOCOR. There was no illness at the time of vaccination. On 20-NOV-2006 the patient experienced severe pain in the upper arm which persisted for four days. There was no redness or swelling. The patient took LORTAB with no relief. The patient recovered. Additional information is not expected.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 56 year old male with COPD (emphysema) and thyroid disease and no drug allergies who on 24-NOV-2006 (also reported as 21-NOV-2006) at 11:30 AM was vaccinated with a first dose of Pneumovax 23 (0.5 ml) (lot # 651148/0087F), intramuscularly in the left arm.  Concomitant therapy included SYNTHROID.  On 24-NOV-2006 the patient had "severe arm pain" within one hour of receiving Pneumovax 23 that persisted for 24 hours.  The patient stated that "pain was worse than past surgical pain."  There was no redness or swelling.  The patient took PERCOCET with no relief.  At the time of the report, the patient was considered to be not recovered.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a patient with no past medical history who "about a month ago" approximately on 22-OCT-2006 was vaccinated with Pneumovax 23 (0.5 ml) (lot # 650541/1004P), intramuscularly. There was no concomitant medication. On approximately 23-OCT-2006 the patient experienced redness and soreness around the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. This report also involved two other patients, for a total of three, and it was reported that "two of the patients developed a fever."  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who an on unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23.  Subsequently, on an unspecified date, the patient complained of injection site reactions.  The patient sought unspecified medical attention.  At the time of this report, the patient was recovering.  No product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on an unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23. Subsequently, on an unspecified date, the patient complained of injection site reactions. The patient sought unspecified medical attention. At the time of this report, the patient was recovering. No product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on an unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23. Subsequently, on an unspecified date, the patient complained of injection site reactions. The patient sought unspecified medical attention. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on an unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23. Subsequently, on an unspecified date, the patient complained on injection site reactions. The patient sought unspecified medical attention. At the time of this report, the patient was recovering. No product quality complaint involved. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site reaction, Muscular weakness, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 54 year-old male patient who on 16-NOV-2006 was vaccinated intramuscularly in the left thigh with a 0.5 mL dose of Pneumovax 23 (Lot #651406/0620F). On 16-NOV-2006 at 13:00, the patient's leg became very weak and "agony" started. The patient developed a temperature of 103 F, the left thigh was tender and warm to touch and a lacy pattern like rash developed from the thigh to below the knee. On an unspecified date, the patient complained injection site reactions. The patient sought unspecified medical attention. The patient was placed on MEDROL, ibuprofen and CLARITIN. At the time of this report, the patient was recovering from the injection site redness but the outcome of the other events was unknown. No product quality complaint involved. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 54 year-old male patient who on 16-NOV-2006 was vaccinated intramuscularly in the left thigh with a 0.5 mL dose of Pneumovax 23 (Lot #651406/0620F). On 16-NOV-2006 at 13:00, the patient's leg became very weak and "agony" started. The patient developed a temperature of 103 F, the left thigh was tender and warm to touch and a lacy pattern like rash developed from the thigh to below the knee. On an unspecified date, the patient complained injection site reactions. The patient sought unspecified medical attention. The patient was placed on MEDROL, ibuprofen and CLARITIN. At the time of this report, the patient was recovering from the injection site redness but the outcome of the other events was unknown. No product quality complaint involved. Additional information is not expected.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Injection site reaction, Joint range of motion decreased, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 53 year-old patient with asthma who on 17-Oct-2006 was vaccinated intramuscularly in the right deltoid with a 0.5 mL third dose of Pneumovax 23 (651320/1008P). Subsequently, the patient complained of injection site reactions. On 18-OCT-2006, the patient experienced weakness, pain and limited range of motion for a week. The patient sought unspecified medical attention. No product quality complaint involved. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Flushing, Heart rate normal
Clinical narrative: Information has been received from a health professional concerning a 48 year old female who on 14-NOV-2006 at 09:45 am was vaccinated with Pneumovax 23 (lot #651148/0087F), IM in the left deltoid and influenza virus vaccine (unspecified) (lot #AFLMA237), IM in the right deltoid (number of previous doses 15+).  Concomitant therapy was not reported.  On 14-NOV-2006, at approximately 09:52 am, the patient became flushed, mottled and heart rate was 96.  The patient then complained of heart palpitations, chest tightness, lightheadedness and shortness of breath.  Subsequently, the patient began feeling better approximately 5-10 minutes later.  The patient took BENADRYL, 25 mg by mouth.  The patient remained at work and returned to the flu shot site without any complaints.  The patient's skin was normal color, there was no rash or redness.  The patient denied chest heaviness or shortness of breath.  The patient recovered on 14-NOV-2006.  Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Livedo reticularis, Palpitations
Clinical narrative: Information has been received from a health professional concerning a 48 year old female who on 14-NOV-2006 at 09:45 am was vaccinated with Pneumovax 23 (lot #651148/0087F), IM in the left deltoid and influenza virus vaccine (unspecified) (lot #AFLMA237), IM in the right deltoid (number of previous doses 15+).  Concomitant therapy was not reported.  On 14-NOV-2006, at approximately 09:52 am, the patient became flushed, mottled and heart rate was 96.  The patient then complained of heart palpitations, chest tightness, lightheadedness and shortness of breath.  Subsequently, the patient began feeling better approximately 5-10 minutes later.  The patient took BENADRYL, 25 mg by mouth.  The patient remained at work and returned to the flu shot site without any complaints.  The patient's skin was normal color, there was no rash or redness.  The patient denied chest heaviness or shortness of breath.  The patient recovered on 14-NOV-2006.  Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 32 year old male with asthma, ULTRACET and tramadol allergy who on 19-NOV-2006 was vaccinated with Pneumovax 23 (lot #651437/0899f), 0.5 ml, once, IM. Concomitant therapy included montelukast sodium (MSD), albuterol and FLONASE. On 21-NOV-2006, the patient developed pain, redness, warmth and 15 cm swelling at injection site two days after receiving Pneumovax 23. On 21-NOV-2006, the patient sought medical attention, was examined and was prescribed ice compress and non-steroidal anti-inflammatory drugs (NSAIDs). On 22-NOV-2006, the patient reported taking chills but did not check his temperature. On 27-NOV-2006, the patient was re-examined which revealed improvement of swelling but the redness continued. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 32 year old male with asthma, ULTRACET and tramadol allergy who on 19-NOV-2006 was vaccinated with Pneumovax 23 (lot #651437/0899f), 0.5 ml, once, IM. Concomitant therapy included montelukast sodium (MSD), albuterol and FLONASE. On 21-NOV-2006, the patient developed pain, redness, warmth and 15 cm swelling at injection site two days after receiving Pneumovax 23. On 21-NOV-2006, the patient sought medical attention, was examined and was prescribed ice compress and non-steroidal anti-inflammatory drugs (NSAIDs). On 22-NOV-2006, the patient reported taking chills but did not check his temperature. On 27-NOV-2006, the patient was re-examined which revealed improvement of swelling but the redness continued. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Headache, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a healthcare worker concerning a 58 year old male lawyer with allergies to penicillin, tetracycline, AUGEMENTIN, sulfa, NAPROSYN, cephalexin, prednisone, iodine, erythromycin and a history of myalgia who on 06-NOV-2006 at 11:15 a.m. was vaccinated IM in the right deltoid with the second dose of Pneumovax 23 (0.5 mL) (Lot# 651357/0391F) (first vaccination with Pneumovax 23 was in September 2000).  There were no illnesses at time of vaccination.  Concomitant therapy included AMBIEN and SKELAXIN.  On 08-NOV-2006 the patient was seen in his physician's office with complaints of fever, rash on his chest and chills.  It was also previously reported that the patient complained of a headache along with redness, swelling and pain of the right arm.  The patient was given amoxicillin 500 mg three times daily and an injection of KENALOG in the left hip as the patient had been seen on 25-OCT-2006 with complaints of a rash on his chest with complaints of a possible allergic reaction from MUCINEX.  Subsequently, on an unspecified date, the patient recovered.  There was no product quality complaint involved.  No further information is expected.  This is one of three reports from the same source.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Initial and follow-up information has been received from a healthcare worker concerning a 58 year old male lawyer with allergies to penicillin, tetracycline, AUGEMENTIN, sulfa, NAPROSYN, cephalexin, prednisone, iodine, erythromycin and a history of myalgia who on 06-NOV-2006 at 11:15 a.m. was vaccinated IM in the right deltoid with the second dose of Pneumovax 23 (0.5 mL) (Lot# 651357/0391F) (first vaccination with Pneumovax 23 was in September 2000).  There were no illnesses at time of vaccination.  Concomitant therapy included AMBIEN and SKELAXIN.  On 08-NOV-2006 the patient was seen in his physician's office with complaints of fever, rash on his chest and chills.  It was also previously reported that the patient complained of a headache along with redness, swelling and pain of the right arm.  The patient was given amoxicillin 500 mg three times daily and an injection of KENALOG in the left hip as the patient had been seen on 25-OCT-2006 with complaints of a rash on his chest with complaints of a possible allergic reaction from MUCINEX.  Subsequently, on an unspecified date, the patient recovered.  There was no product quality complaint involved.  No further information is expected.  This is one of three reports from the same source.
Age: 78.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Headache, Inappropriate schedule of drug administration, Listless
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with high blood pressure who on 19-NOV-2006 was vaccinated IM with a 0.5 mL second dose of Pneumovax 23 (Lot# 655289/0958F), one to two years after her first dose. Concomitant vaccination on 19-NOV-2006 included a dose of influenza virus vaccine (unspecified). Other concomitant therapy included 2 unknown high blood pressure medications. On 21-NOV-2006 the patient was listless, tired, and had a headache. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Antinuclear antibody negative, Arthralgia, Blood pressure normal, Blood uric acid normal, C-reactive protein normal
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 69 year old female who on 18-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included SYNTHROID, NASONEX and PREMPRO.  The physician reported that the "patient had a reaction to Pneumovax 23" (date not provided).  A certified medical assistant in the office further indicated that on 13-NOV-2006 the patient returned to the office complaining of muscle and joint pain since the vaccination.  On 13-NOV-2006, an antinuclear antibody test, sedimentation rate, C-reactive protein, complete blood count and uric acid test were all normal.  The patient was reported to be afebrile with normal blood pressure.  The patient was given a MEDROL dose pack on 13-NOV-2006.  On 20-NOV-2006 and 27-NOV-2006, the patient returned to the office still complaining of muscle pain and joint pain.  The patient was referred to a rheumatologist.  An MRI of the c-spine was normal.  MRI results of the brain were not yet reported.  The patient was diagnosed with myopathy and polyarthralgia.  The physician felt that the patient's reaction was related to therapy with Pneumovax 23.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count normal, Myalgia, Myopathy, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 69 year old female who on 18-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included SYNTHROID, NASONEX and PREMPRO.  The physician reported that the "patient had a reaction to Pneumovax 23" (date not provided).  A certified medical assistant in the office further indicated that on 13-NOV-2006 the patient returned to the office complaining of muscle and joint pain since the vaccination.  On 13-NOV-2006, an antinuclear antibody test, sedimentation rate, C-reactive protein, complete blood count and uric acid test were all normal.  The patient was reported to be afebrile with normal blood pressure.  The patient was given a MEDROL dose pack on 13-NOV-2006.  On 20-NOV-2006 and 27-NOV-2006, the patient returned to the office still complaining of muscle pain and joint pain.  The patient was referred to a rheumatologist.  An MRI of the c-spine was normal.  MRI results of the brain were not yet reported.  The patient was diagnosed with myopathy and polyarthralgia.  The physician felt that the patient's reaction was related to therapy with Pneumovax 23.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Red blood cell sedimentation rate normal, Vaccination complication
Clinical narrative: Information has been received from a physician and a certified medical assistant concerning a 69 year old female who on 18-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included SYNTHROID, NASONEX and PREMPRO.  The physician reported that the "patient had a reaction to Pneumovax 23" (date not provided).  A certified medical assistant in the office further indicated that on 13-NOV-2006 the patient returned to the office complaining of muscle and joint pain since the vaccination.  On 13-NOV-2006, an antinuclear antibody test, sedimentation rate, C-reactive protein, complete blood count and uric acid test were all normal.  The patient was reported to be afebrile with normal blood pressure.  The patient was given a MEDROL dose pack on 13-NOV-2006.  On 20-NOV-2006 and 27-NOV-2006, the patient returned to the office still complaining of muscle pain and joint pain.  The patient was referred to a rheumatologist.  An MRI of the c-spine was normal.  MRI results of the brain were not yet reported.  The patient was diagnosed with myopathy and polyarthralgia.  The physician felt that the patient's reaction was related to therapy with Pneumovax 23.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 80 year old female with quinine, codeine and celecoxib allergy, osteoporosis, osteopenia, degenerative disc disease, degenerative joint disease, short term memory loss and hypertension who on 22-NOV-2006 was vaccinated with Pneumovax 23 (lot 3651357/0391f), 0.5 ml, IM in the left upper arm. Concomitant therapy included alendronate sodium (MSD), ADALAT and diazepam. Previous vaccination with Pneumovax 23 vaccine was on 06-NOV-1990. On 25-NOV-2006, the patient experienced cellulitis of the left upper arm (also reported as red, swollen, painful left upper arm). The patient went to the emergency room and was treated with antibiotics 3 days after an immunizaton with Pneumovax 23. On 26-NOV-2006, the patient experienced diarrhea. The patient was discharged from the hospital on 26-NOV-2006. On 28-DEC-2006, the patient recovered from the events of cellulitis and diarrhea. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site reaction, Injection site warmth, Oedema peripheral
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 64 year old male with elevated cholesterol, hypertension, hyperlipidemia, coronary artery disease and intervertebral disc degeneration and no drug allergies who on 17-OCT-2006, at 08:15, was vaccinated intramuscularly, in the right arm, with a first 0.5 ml dose of Pneumovax 23 (lot #651357/0391F).  Concomitant therapy included CRESTOR, VALIUM and FIORINAL.  Subsequently, on 17-OCT-2006, the patient experienced redness, swelling and pain of the right arm.  On the same day, the patient returned to the physician's office with a "silver dollar size mark" on her right upper arm that was sore and hot to touch.  The patient was given instructions to apply ice.  The patient returned to the physician's office when the mark became the size of a pancake.  The patient was instructed to take BENADRYL.  On 20-OCT-2007 the patient was given a prescription for Z-PAK.  Subsequently, the patient recovered.  There were no relevant diagnostic or laboratory tests performed.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 64 year old male with elevated cholesterol, hypertension, hyperlipidemia, coronary artery disease and intervertebral disc degeneration and no drug allergies who on 17-OCT-2006, at 08:15, was vaccinated intramuscularly, in the right arm, with a first 0.5 ml dose of Pneumovax 23 (lot #651357/0391F).  Concomitant therapy included CRESTOR, VALIUM and FIORINAL.  Subsequently, on 17-OCT-2006, the patient experienced redness, swelling and pain of the right arm.  On the same day, the patient returned to the physician's office with a "silver dollar size mark" on her right upper arm that was sore and hot to touch.  The patient was given instructions to apply ice.  The patient returned to the physician's office when the mark became the size of a pancake.  The patient was instructed to take BENADRYL.  On 20-OCT-2007 the patient was given a prescription for Z-PAK.  Subsequently, the patient recovered.  There were no relevant diagnostic or laboratory tests performed.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Pneumovax 23. The physician reported that the patient had a headache. The patient sought unspecified medical attention. At the time of the report, it was unknown if the patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacy intern student concerning a patient who on 10-NOV-2006 was vaccinated intramuscularly in the deltoid muscle with a 1 inch needle close to the elbow with a dose of Pneumovax 23.  That same day the patient experienced a cellulitis-like reaction near the injection site that appeared red and swollen.  Unspecified medical attention was sought.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Joint range of motion decreased
Clinical narrative: Information has been received from a certified medical assistant concerning a male patient (age unknown) who was vaccinated on an unspecified date with a dose of Pneumovax 23 (655289/0958F). Subsequently, on an unspecified date, the patient developed injection site redness and swelling and experienced a decreased range of motion of the arm. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint involved. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the agency and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a male patient (age unknown) who was vaccinated on an unspecified date with a dose of Pneumovax 23 (655289/0958F).  Subsequently, on an unspecified date, the patient developed injection site redness and swelling and experienced a decreased range of motion of the arm.  The patient sought unspecified medical attention.  At the time of this report, the outcome was unknown.  No product quality complaint involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a registered nurse and a physician concerning a 64 year old, male, patient, whose reported weight was 176 pounds and whose reported height was 66 inches who on 27-OCT-2006 was vaccinated into the left deltoid muscle with the second dose of Pneumovax 23 (lot # 651332/1049P). Subsequently on 27-OCT-2006, the patient developed redness and swelling at the injection site with warmth and tenderness, 8 centimeters (cm) area. At the time of the report, it was unknown if the patient recovered. A lot check of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old male with medical history and drug reactions/allergies reported as unspecified who on 28-NOV-2006 was vaccinated with Pneumovax 23.  Concomitant therapy unspecified.  On 29-NOV-2006, the patient experienced redness at the site of injection.  The patient sought medical attention.  The patient was treated with antibiotics.  No lab diagnostic tests were performed.  At the time of reporting, the patient was recovering.  No further information is available.
Age: 32.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Haematoma, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a 32 year old female with no medical history who on 25-NOV-2006 was vaccinated with a first dose of Pneumovax 23 SC into the left deltoid (Lot # 655054/0749F).  Concomitant therapy included a dose of influenza virus vaccine (unspecified) (lot # AFLUA239AA) administered into the other arm (SC right deltoid) at the same visit (no reaction noted).  On approximately 26-NOV-2006 the patient developed a circular red area and swelling around the injection site (left deltoid) the day after vaccination.  The patient was told to take TYLENOL but the red area spread to a streak (8 to 10 inch line) that extended down her arm.  The patient went to a local urgent care clinic where the physician assistant treating her told her "it was a staph infection from the Pneumovax 23" and prescribed an oral antibiotic.  She was diagnosed with cellulitis and it was reported "given her history and presence of a hematoma this is most likely due to her pneumonia shot injection."  The patient had recovered on an unknown date.  The pharmacist confirmed proper aseptic vaccination technique was used.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Staphylococcal infection
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a 32 year old female with no medical history who on 25-NOV-2006 was vaccinated with a first dose of Pneumovax 23 SC into the left deltoid (Lot # 655054/0749F).  Concomitant therapy included a dose of influenza virus vaccine (unspecified) (lot # AFLUA239AA) administered into the other arm (SC right deltoid) at the same visit (no reaction noted).  On approximately 26-NOV-2006 the patient developed a circular red area and swelling around the injection site (left deltoid) the day after vaccination.  The patient was told to take TYLENOL but the red area spread to a streak (8 to 10 inch line) that extended down her arm.  The patient went to a local urgent care clinic where the physician assistant treating her told her "it was a staph infection from the Pneumovax 23" and prescribed an oral antibiotic.  She was diagnosed with cellulitis and it was reported "given her history and presence of a hematoma this is most likely due to her pneumonia shot injection."  The patient had recovered on an unknown date.  The pharmacist confirmed proper aseptic vaccination technique was used.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: Information has been received from a physician concerning a 61 year old male with no known allergies, hypercholesterolemia, gastroesophageal reflux disease and cardiac disorder and a history of coronary stent placement (2006) who on 25-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (651404/0352F), 0.5 mL, IM.  Concomitant included LIPITOR, PLAVIX, PRILOSEC and TOPROL XL.  On 25-OCT-2006, the patient experienced swelling, fever, pain and rash (also reported as large swollen area/lump of deltoid).  The patient was seen in the physician's office on 26-OCT-2006 when he received the vaccination but was not seen again until 27-OCT-2006 as he was out of town.  In the meantime, the patient experienced rash and itch.  On 15-JAN-2007, "90 persistent rash on upper extremity".  The patient was taking BENADRYL as needed.  It was reported that "throughout period had been asked to see dermatologist."  The patient was treated with MEDROL, CLARITIN, ALLEGRA, tablet, 60 mg, daily from 03-NOV-2006 to 21-NOV-2006 and KEFLEX.  The patient's swelling, fever, pain, upper extremity mass, pruritis and rash persisted.  At the time of the report, the patient still had the rash.  Follow-up information has been received regarding the lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Upper extremity mass
Clinical narrative: Information has been received from a physician concerning a 61 year old male with no known allergies, hypercholesterolemia, gastroesophageal reflux disease and cardiac disorder and a history of coronary stent placement (2006) who on 25-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (651404/0352F), 0.5 mL, IM.  Concomitant included LIPITOR, PLAVIX, PRILOSEC and TOPROL XL.  On 25-OCT-2006, the patient experienced swelling, fever, pain and rash (also reported as large swollen area/lump of deltoid).  The patient was seen in the physician's office on 26-OCT-2006 when he received the vaccination but was not seen again until 27-OCT-2006 as he was out of town.  In the meantime, the patient experienced rash and itch.  On 15-JAN-2007, "90 persistent rash on upper extremity".  The patient was taking BENADRYL as needed.  It was reported that "throughout period had been asked to see dermatologist."  The patient was treated with MEDROL, CLARITIN, ALLEGRA, tablet, 60 mg, daily from 03-NOV-2006 to 21-NOV-2006 and KEFLEX.  The patient's swelling, fever, pain, upper extremity mass, pruritis and rash persisted.  At the time of the report, the patient still had the rash.  Follow-up information has been received regarding the lot number.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.