chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Abdominal pain, General physical health deterioration, Nausea, Vomiting
Clinical narrative: Information has been received from a 62 year old male registered nurse (concerning himself), with hypertension, drug hypersensitivity to refecoxib (MSD), a sulfonamide allergy, and a history of angioplasty, who in approximately 1997 ("about 10 years ago"), was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (manufacturer unspecified) and unspecified therapy for hypertension. In approximately 1997, he reported having a "violent reaction" to the vaccination, described as nausea, vomiting, "threatening cramps in the stomach," and "his whole body felt like going down the tubes." He reported the symptoms were "severe" enough that he considered calling 911, though he did not actually do so, nor did he seek any other medical attention. At the time of this report, the patient confirmed he had recovered, though the duration of the events and date of recovery was not specified. The patient had a history of cardiovascular disorder while on prior therapy with rofecoxib (MSD, WAES 0706USA02510). Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 75 year old female who on 21-JUN-2007 was vaccinated subcutaneously with a first dose of PNEUMOVAX (Lot # 655766/0038U).  On 22-JUN-2007, the patient developed a "cellulitis-type reaction" with a 17 cm red, tender, swollen area on the left arm at the injection site.  The licensed practical nurse described it as a localized reaction and reported it resolved completely in 4-5 days.  The patient's date of recovery was reported as 28-JUN-2007.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Rash macular
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with PNEUMOVAX 23 on an unspecified date.  Subsequently, the patient experienced blotches and difficulty breathing.  The patient had to go to the emergency room.  The patient recovered on an unspecified date.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who, "years ago", was vaccinated with a PNEUMOVAX 23 vaccine (manufacturer unknown).  Subsequently, the patient "broke out in hives and was rushed to the emergency room".  She has since recovered.  Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 71 year old female with hypertension, ulcerative colitis, and increased triglycerides.  At the time of being vaccinated, the patient had sinusitis and allergic rhinitis.  On 23-MAY-2007, the patient was vaccinated with a first dose of PNEUMOVAX (lot # 655152/0889F) subcutaneously.  On 25-MAY-2007, the patient developed redness at the injection site, fever, and a rash at the injection site.  The patient sought medical attention.  The patient was treated with heat and nonsteroidal anti-inflammatory drug NSAIDS.  The outcome of the events was unknown.  No additional information is expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash macular, Rash pruritic, Skin warm, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female homemaker with allergies to "statins", ezetimibe (MSD) and TRICOR, and a history of hypercholesterolaemia and hypothyroidism who on 22-JUN-2007 at 08:15, was vaccinated IM into the left deltoid with a first dose of PNEUMOVAX 23 (Lot # 656233/0200U).  Concomitant therapy included LEVOTHROID and OMEGA-3.  On 23-JUN-2007, the patient developed a rash that presented with warmth, very itchy, tenderness and pain and was macular in form.  It was reported that the rash started at the injection site and spread to the trunk, arm and face.  It was reported that the patient tried over the counter BENADRYL with no improvement.  On 26-JUN-2007 the patient was prescribed MEDROL.  On 02-JUL-2007, the physician saw the patient and prescribed prednisone 20 mg, one three dimes a day for 2 days, 1 by mouth twice a day for 3 days, half by mouth everyday for 3 days and ZYRTEC 10 mg.  No laboratory diagnostic studies were performed.  On approximately 06-JUL-2007, the patient recovered.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Blood thyroid stimulating hormone, Erythema, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female patient with asthma, hypothyroidism and no allergies who on 27-JUN-2007 at 13:30, was vaccinated IM into the deltoid with a dose of PNEUMOVAX 23 (Lot # 656233/0200U).  Concomitant therapy included LEVOTHROID, albuterol, and ASMANEX.  On 27-JUN-2007 in the evening, the patient developed a rash that presented with warmth, tenderness, and pain and was macular in form.  It was reported that the patient's left arm was painful, her skin was patch, red and tender to touch.  Her abdomen revealed a patchy, red rash to include her neck and right arm.  The patient was prescribed a MEDROL DOSE-PAC, ibuprofen and BENADRYL.  Laboratory diagnostic studies included a TSH level.  On 02-JUL-2007, the patient recovered.  It was also reported on 13-OCT-1998, the patient received a dose of the vaccine.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Skin warm, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female patient with asthma, hypothyroidism and no allergies who on 27-JUN-2007 at 13:30, was vaccinated IM into the deltoid with a dose of PNEUMOVAX 23 (Lot # 656233/0200U).  Concomitant therapy included LEVOTHROID, albuterol, and ASMANEX.  On 27-JUN-2007 in the evening, the patient developed a rash that presented with warmth, tenderness, and pain and was macular in form.  It was reported that the patient's left arm was painful, her skin was patch, red and tender to touch.  Her abdomen revealed a patchy, red rash to include her neck and right arm.  The patient was prescribed a MEDROL DOSE-PAC, ibuprofen and BENADRYL.  Laboratory diagnostic studies included a TSH level.  On 02-JUL-2007, the patient recovered.  It was also reported on 13-OCT-1998, the patient received a dose of the vaccine.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a licensed practical nurse concerning a male patient with asthma and a allergy to DEMEROL who on approximately 15-JUN-2007 "within the last two weeks", was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included ADVAIR. On approximately 15-JUN-2007, the patient developed itching all over the body. Unspecified medical attention was sought. The patient was given ZYRTEC 10 mg twice a day with resolution of symptoms. No laboratory diagnostics studies were performed. Follow up information indicated that the PNEUMOVAX 23 was not administered by this office. No product quality complaint was involved. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Angioedema, Folliculitis
Clinical narrative: Information has been received from a physician concerning a 62 year old male with chronic obstructive pulmonary disease (COPD) who on 13-JUN-2007 was vaccinated with a first 0.5 mL dose of PNEUMOVAX 23.  Concomitant therapy included "basely dosed" cortisone.  On 14-JUN-2007 the patient experienced angioedema of lips.  Antihistamines were given but did not show an effect.  The next day, on 15-JUN-2007 (also reported as 15-JUL-2007), the reporting physician diagnosed pustular folliculitis of a hair of the beard just above the lip and antibiotic treatment was started.  Subsequently, the patient recovered completely from pustular folliculitis.  The reporting physician did not see a relationship between pustular folliculitis and therapy with PNEUMOVAX 23.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: Information has been received from a medical assistant concerning a female (age not reported) who on an unspecified date "within the last several months, no exact date given" was vaccinated with PNEUMOVAX (lot # unknown) injection.  On an unspecified date, the patient had the onset of a few symptoms after receiving PNEUMOVAX.  The patient suffered soreness at the injection site on the first day and for the next several days, up to three days after the patient experienced soreness at the injection site, malaise and difficulty lifting her arm.  Patient was not aware of any additional medications at this time.  At the time of reporting it was not reported if the patient had recovered.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an elderly male (age not reported) who on 02-JUL-2007 was vaccinated with a second dose of PNEUMOVAX 23 (lot # 655290/0959F) 0.5 ml IM.  No other vaccines were given on that date.  On 02-JUL-2007, a few hours after being vaccinated, the patient experienced soreness at the arm.  Medical attention was sought.  There was no swelling or redness.  The patient rated his pain a 9 out of 10 on the pain scale by that evening.  The nurse was very concerned about the patient because of his pain rating especially since he has prior immunizations and was in the army.  Follow-up information was received from the registered nurse via a phone call.  The patient was seen on 04-JUL-2007 and he was feeling better, but he drove the other day and said his arm was sore again so the pain was not completely gone.  No further information is available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 73 year old female patient who on 05-JUL-2007, was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 654977/0888F). Subsequently, the patient described a severe local injection site reaction described as redness through the shoulder into the arm, pain and induration. Unspecified medical attention was sought. It was reported that the reactions subsided in several days. TYLENOL was ordered for pain. On an unspecified date, the patient fully recovered. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality check for the lot number in question were satisfactory. The lot met the requirements of the government and was released. This is one of three reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Lymphadenopathy
Clinical narrative: Information has been received from a registered nurse concerning a 50 year old female patient who on 28-JUN-2007, was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 654977/0888F). Subsequently, the patient developed a severe injection site reaction described as redness from the shoulder to the arm, pain, axillary lymph node swelling and induration. Unspecified medical attention was sought. Within 2-3 days the reaction resolved. No product quality complaint was involved. 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. This is one of three reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a 56 year old female with a history of pneumonia and no drug allergies, who on 02-JUL-2007 was vaccinated with a single dose of PNEUMOVAX 23.  Concomitant therapy included prednisone.  On 03-JUL-2007 the patient developed redness, warmth, rash, and tenderness at the injection site.  The patient also reported that she experienced nausea and by 06-JUL-2007 the rash went down to her elbow and she felt achy and had a fever.  The patient reported that the rash was clearing up, but at the injection site it felt like there was a knot underneath the skin.  The patient sought unspecified medical attention.  No laboratory diagnostic studies were performed.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a 56 year old female with a history of pneumonia and no drug allergies, who on 02-JUL-2007 was vaccinated with a single dose of PNEUMOVAX 23.  Concomitant therapy included prednisone.  On 03-JUL-2007 the patient developed redness, warmth, rash, and tenderness at the injection site.  The patient also reported that she experienced nausea and by 06-JUL-2007 the rash went down to her elbow and she felt achy and had a fever.  The patient reported that the rash was clearing up, but at the injection site it felt like there was a knot underneath the skin.  The patient sought unspecified medical attention.  No laboratory diagnostic studies were performed.  At the time of the report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Tinnitus
Clinical narrative: Information has been received from a 68 year old female with no allergies, who on 11-JUL-2007 was vaccinated with a dose of PNEUMOVAX 23 (lot# 654977/0888F). Concomitant therapy included NEXIUM. On 11-JUL-2007, the patient experienced redness, swelling, and soreness at the injection site and ringing in her ears. It was reported that the arm swelled up to two inches. Unspecified medical attention was sought. No diagnostic laboratory studies were involved. It was also reported that her arm was still red. The patient  was recovering from swelling and soreness at the injection site and ringing in her ears. No product quality complaint was involved. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old male who in 2006 was vaccinated with a dose of the PNEUMOVAX 23. Subsequently, the patient experienced swelling in his arm from the shoulder to the elbow, fever and shortness of breath. Unspecified medical attention was sought. Laboratory tests performed included pulse oximetry, 92-94 percent. Two days after vaccination, his symptoms were gone. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 44 year old female with rheumatoid arthritis, migraine, drug hypersensitivity to codeine and sulfonamide allergy who on 11-JUL-2007 was vaccinated IM into the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 655212/0699U).  Concomitant therapy included HUMIRA, ADDERALL, PREVACID, KLONOPIN, IMITREX and ULTRAM.  On 12-JUL-2007, the patient developed an injection site reaction described as swelling of the left arm, "hard", erythema which extended to the elbow and she also experienced difficulty in lifting he arm.  Treatment included ice and ibuprofen.  The symptoms have resolved.  The medical assistant is requesting a lot check.  This is one of three reports from the as 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 and was released.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 69 year old female with hypertension, hyperlipidaemia, osteoarthritis and drug hypersensitivity to VIBRAMYCIN who on 10-JUL-2007 was vaccinated IM into the right deltoid with a 0.5 ml dose of PNEUMOVAX (Lot # 655212/0699U).  Concomitant therapy included LIPITOR, atenolol, PAXIL, NEXIUM and trazodone HC1.  On 11-JUL-2007, the patient experienced injection site reaction described as swelling of the right arm, "hard" arm, erythema which extended to the elbow and difficulty lifting the arm.  Medical attention was sought and the patient was ordered on ice and ibuprofen.  On 14-JUL-2007, the symptoms resolved.  The medical assistant is requesting a lot check.  This is one of three reports 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 research center and was released.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 74 year old female with rheumatoid arthritis, coronary artery disease and osteoporosis and a history cancer who on 16-JUL-2007 was vaccinated IM into the left deltoid with a 0.5  ml dose of PNEUMOVAX 23 (Lot # 655592/1175F). Concomitant therapy included LIPITOR, alendronate sodium (MSD), methotrexate, folic acid, PLAQUENIL, MEDROL, aspirin and torsemide. On 17-JUL-2007, the patient experienced an injection site reaction. Symptoms were described as swelling of the left arm, "hard" and erythema which extended to the elbow. Also, the patient had difficulty in lifting the arm. Unspecified medical treatment was sought. The patient was ordered on ice and TYLENOL. At the time of the report, the patient had not recovered. The medical assistant is requesting a lot check. This is one of three reports 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: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female who on 13-JUL-2007 was vaccinated with a dose of PNEUMOVAX 23.  On 13-JUL-2007 the patient developed swelling, itching, redness and tenderness at the injection site.  Unspecified medical attention was sought and it was noted that five days after the vaccination the patient still had a 20 centimeter circle of redness around the injection site.  The patient was treated with BENADRYL and KEFLEX.  At the time of the report the patient was recovering from swelling, itching, tenderness at the injection site, and a 20 centimeter circle of redness around the injection site.  Additional information has been requested.
Age: 80.0
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Information has been received from a medical assistant concerning an 80 year old patient who in May or June 2007, was vaccinated with a second 0.5ml dose of PNEUMOVAX (Lot # 655766/0038U).  In May or June 2007, the patient experienced severe pain at the injection site and swelling.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare student (Pharm D) concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# 655289/0958F) IM in the deltoid. The patient experienced swelling from the shoulder to the elbow and the swollen area was hot to the touch. On an unspecified date the patient recovered from the reaction within 24 hours of administration of the dose. No further information is available. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a healthcare worker concerning a 61 year old male with a history of lymphoma with no drug reactions/allergies who on 16-JUL-2007 was vaccinated with PNEUMOVAX 23 (lot # unknown) at another physician office practice.  On an unspecified date the patient developed redness and soreness at the injection site.  Medical attention was sought.  The patient will be following up with his primary care physician.  At the time of reporting the patient has not recovered.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a healthcare professional (Pharm D) concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# 655289/0958F) IM in the thigh. On an unspecified date the patient developed swelling from the hip to the knee and the swollen area was hot to the touch. At the time of reporting the patient recovered from the reaction within 24 hours of administration of the dose. No further information was available. This reporter is case 2 of 2. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received regarding a case in litigation from a physician concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown).  Subsequently the patient experienced an allergy to the vaccine.  At the time of this report, the patient's outcome was unknown.  No further information is available.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Hot flush, Oxygen supplementation, Pharyngeal oedema
Clinical narrative: Information has been received from a physician concerning a 38 year old female with asthma and no history of drug reactions/allergies who on 25-JUL-2007 was vaccinated with PNEUMOVAX injection for prophylaxis against pneumonia.  On 25-JUL-2007, after being vaccinated, the patient experienced hot flashes as well as her throat began to swell.  Medical attention was sought.  She was given oxygen and all symptoms were gone within 7 minutes.  The patient was prescribed an epi pen and was told to take BENADRYL if swelling reoccurred.  On 25-JUL-2007, the patient recovered.  Additional information was received from the physician who reported that the reaction was anaphylaxis.  No other information was provided.  No further information is expected.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old female patient who on 26-JUN-2007, was vaccinated IM into the left deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 654977/0888F).  Subsequently, the patient described a severe local injection site reaction described as redness through the shoulder into the arm, pain and induration.  Unspecified medical attention was sought.  It was reported that the reactions subsided in several days.  TYLENOL was ordered for pain.  On an unspecified date, the patient fully recovered.  No product quality complaint was involved.  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 and was released.  This is one of three reports from the same source.  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram abnormal, Hypersensitivity, Induration, Rash
Clinical narrative: Information has been received regarding a case in litigation, via a physician, concerning a 50 year old female with stress incontinence, asthma and hypertension and a history of total abdominal hysterectomy, Marshall Marchetti Krantz operation, menometrorrhagia, tonsillectomy and cholecystectomy who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included LOTREL, estrogens, PREMARIN, imipramine HCl, NASOCORT, CELEBREX and a "B-Agonist" (manufacturer unspecified). Following the vaccination, the patient developed a rash and induration. The reporter felt that rash and induration were an allergic reaction to therapy with PNEUMOVAX 23. No further information is available.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Myositis, Nuclear magnetic resonance imaging, Oedema peripheral, Pyrexia
Clinical narrative: Initial and follow up information has been received from a pharmacist, concerning a 36 year old male patient with pneumonia, and no allergies, who on 25-JUL-2007, at 11:30am, was vaccinated IM in the left arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U). On 26-JUL-2007 (previously reported as 25-JUL-2007), the patient developed swelling and warmth in his left upper arm. The pharmacist requested a vaccine lot check. Follow up information from the pharmacist indicated that the patient also developed a fever, and visited the emergency room where he underwent a magnetic resonance imaging (MRI) test. He also had an infectious disease consultation, and was diagnosed with cellulitis and myositis; the pharmacist noted that there was no abscess or osteomyelitis. The patient was not hospitalized, and was discharged on unspecified antibiotic therapy. At the time of this report, he had recovered from the events (date and duration not specified). The pharmacist felt that the events were caused "as a result of PNEUMOVAX 23 administration." 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 Center for Biologics Evaluation and Research, and was released. No further information is expected.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Initial and follow up information has been received from a pharmacist, concerning a 36 year old male patient with pneumonia, and no allergies, who on 25-JUL-2007, at 11:30am, was vaccinated IM in the left arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U). On 26-JUL-2007 (previously reported as 25-JUL-2007), the patient developed swelling and warmth in his left upper arm. The pharmacist requested a vaccine lot check. Follow up information from the pharmacist indicated that the patient also developed a fever, and visited the emergency room where he underwent a magnetic resonance imaging (MRI) test. He also had an infectious disease consultation, and was diagnosed with cellulitis and myositis; the pharmacist noted that there was no abscess or osteomyelitis. The patient was not hospitalized, and was discharged on unspecified antibiotic therapy. At the time of this report, he had recovered from the events (date and duration not specified). The pharmacist felt that the events were caused "as a result of PNEUMOVAX 23 administration." 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 Center for Biologics Evaluation and Research, and was released. No further information is expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Administration site pain, Administration site reaction, Swelling
Clinical narrative: Information has been received from a nurse practitioner, concerning a 67 year old male patient, who on 24-JUL-2007 was vaccinated with a dose of PNEUMOVAX 23 vaccine (Lot # not provided). On 25-JUL-2007, he experienced a reaction in the arm where the vaccine was administered, specified as pain and swelling from the administration site down to his elbow. At the time of this report, the patient had not recovered from th events. The patient sought  unspecified medical attention. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initial and follow up information has been received from a medical assistant, concerning a 61 year old male patient, who on 10-JUL-2007 was vaccinated SC in the left arm, with a dose of PNEUMOVAX (Lot #657039/0698U).  On 12-JUL-2007, he developed swelling, redness and pain that extended down to his elbow, with moderate erythema and edema, and induration of his left arm at the vaccination site.  He was diagnosed with cellulitis (treatment was not specified).  At the time of this report, the patient had recovered from the cellulitis (date and duration not provided).  The MA reported that of the 6 vaccinations with PNEUMOVAX administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 4 additional patients developed fatigue, redness, warmth and extreme pain (WAES #0707USA04971, 0708USA04275 and 0708USA04276), and 1 additional patient experienced a "minimal reaction" (WAES 0708USA00702).  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 research center and was released.  Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Initial and follow up information has been received from a medical assistant, concerning a 61 year old male patient, who on 10-JUL-2007 was vaccinated SC in the left arm, with a dose of PNEUMOVAX (Lot #657039/0698U).  On 12-JUL-2007, he developed swelling, redness and pain that extended down to his elbow, with moderate erythema and edema, and induration of his left arm at the vaccination site.  He was diagnosed with cellulitis (treatment was not specified).  At the time of this report, the patient had recovered from the cellulitis (date and duration not provided).  The MA reported that of the 6 vaccinations with PNEUMOVAX administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 4 additional patients developed fatigue, redness, warmth and extreme pain (WAES #0707USA04971, 0708USA04275 and 0708USA04276), and 1 additional patient experienced a "minimal reaction" (WAES 0708USA00702).  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 research center and was released.  Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a medical assistant (MA), concerning a 39 year old female patient who on 17-JUL-2007 was vaccinated, SC in the right arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U).  Subsequently the patient developed redness, pain and warmth at the site of the injection that radiated into the right axilla.  At the time of this report, the patient had recovered from the events (duration not specified).  The patient sought unspecified medical attention.  The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years), 3 additional patients experienced symptoms similar to the events described above (WAES 0709USA03054, male; WAES #0707USA04634, male), and 1 additional patient experienced a "minimal reaction" (WAES 0708USA00702).  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 center, and was released.  Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a medical assistant (MA), concerning a 39 year old female patient who on 17-JUL-2007 was vaccinated, SC in the right arm, with a dose of PNEUMOVAX 23 (Lot #657039/0698U).  Subsequently the patient developed redness, pain and warmth at the site of the injection that radiated into the right axilla.  At the time of this report, the patient had recovered from the events (duration not specified).  The patient sought unspecified medical attention.  The MA reported that of the 6 vaccinations with PNEUMOVAX 23 administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years), 3 additional patients experienced symptoms similar to the events described above (WAES 0709USA03054, male; WAES #0707USA04634, male), and 1 additional patient experienced a "minimal reaction" (WAES 0708USA00702).  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 center, and was released.  Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Hypertension
Clinical narrative: Information has been received from a health professional concerning a 62 year old male with bronchial asthma who on 17-FEB-2007 was vaccinated with PNEUMOVAX 23 (lot# unknown) 0.5mL injection. Concomitant therapy included montelukast sodium (MSD).  On 27-FEB-2007 the patient experienced hypertension.  The reporter felt that hypertension was not related to therapy with PNEUMOVAX 23.  At the time of reporting the patient is recovering.  Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Blood pressure, Chest X-ray normal, Culture negative, Fungus culture positive
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 24 year old male with rheumatoid arthritis with knee pain and swelling and an allergy to ALEVE and a history of hives who on 24-AUG-2007 was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (Lot #655500/1005F). Concomitant therapy included ibuprofen. On 27-AUG-2007 three days after vaccination the patient noted an acute onset of a non-urticarial, erythematous pruritic rash on the trunk, sparing the extremities and face. Cotemporal with the onset of his rash, he noted severe low back pain. The patient self treated with 2 doses of BENADRYL at home. On 28-AUG-2007 the patient contacted the office an was scheduled for an appointment later that day. On approximately 30-AUG-2007 the patient recovered from the rash and the severe low back pain was virtually resolved and the painful knee and wrist swelling had marked improvement. On 07-SEP-2007 laboratory and diagnostic tests revealed; blood pressure was 130-90, left knee synovial fluid was inflammatory and lacked crystals, routine cultures were negative, fungal cultures ultimately grew penicillin and epicoccum species (contaminates), purified protein derivative (PPD) tuberculin skin testing was negative, chest x-rays were unremarkable, health assessment questionnaire (HAQ) disability index was 0.1. Visual analog scale (VAS) were; global 5.5, pain 6.5, GI 3.0, fatigue 4.5. Current health status was 3. The physician felt that the flat, red, itchy and wide spreading rash may be secondary to therapy with PNEUMOVAX 23. No further information is available.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Laboratory test abnormal, Rash erythematous, Rash pruritic, Synovial fluid analysis abnormal
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 24 year old male with rheumatoid arthritis with knee pain and swelling and an allergy to ALEVE and a history of hives who on 24-AUG-2007 was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (Lot #655500/1005F). Concomitant therapy included ibuprofen. On 27-AUG-2007 three days after vaccination the patient noted an acute onset of a non-urticarial, erythematous pruritic rash on the trunk, sparing the extremities and face. Cotemporal with the onset of his rash, he noted severe low back pain. The patient self treated with 2 doses of BENADRYL at home. On 28-AUG-2007 the patient contacted the office an was scheduled for an appointment later that day. On approximately 30-AUG-2007 the patient recovered from the rash and the severe low back pain was virtually resolved and the painful knee and wrist swelling had marked improvement. On 07-SEP-2007 laboratory and diagnostic tests revealed; blood pressure was 130-90, left knee synovial fluid was inflammatory and lacked crystals, routine cultures were negative, fungal cultures ultimately grew penicillin and epicoccum species (contaminates), purified protein derivative (PPD) tuberculin skin testing was negative, chest x-rays were unremarkable, health assessment questionnaire (HAQ) disability index was 0.1. Visual analog scale (VAS) were; global 5.5, pain 6.5, GI 3.0, fatigue 4.5. Current health status was 3. The physician felt that the flat, red, itchy and wide spreading rash may be secondary to therapy with PNEUMOVAX 23. No further information is available.
Age: 24.0
Sex: M
Vaccine: PPV
Symptoms: Tuberculin test negative
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 24 year old male with rheumatoid arthritis with knee pain and swelling and an allergy to ALEVE and a history of hives who on 24-AUG-2007 was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (Lot #655500/1005F). Concomitant therapy included ibuprofen. On 27-AUG-2007 three days after vaccination the patient noted an acute onset of a non-urticarial, erythematous pruritic rash on the trunk, sparing the extremities and face. Cotemporal with the onset of his rash, he noted severe low back pain. The patient self treated with 2 doses of BENADRYL at home. On 28-AUG-2007 the patient contacted the office an was scheduled for an appointment later that day. On approximately 30-AUG-2007 the patient recovered from the rash and the severe low back pain was virtually resolved and the painful knee and wrist swelling had marked improvement. On 07-SEP-2007 laboratory and diagnostic tests revealed; blood pressure was 130-90, left knee synovial fluid was inflammatory and lacked crystals, routine cultures were negative, fungal cultures ultimately grew penicillin and epicoccum species (contaminates), purified protein derivative (PPD) tuberculin skin testing was negative, chest x-rays were unremarkable, health assessment questionnaire (HAQ) disability index was 0.1. Visual analog scale (VAS) were; global 5.5, pain 6.5, GI 3.0, fatigue 4.5. Current health status was 3. The physician felt that the flat, red, itchy and wide spreading rash may be secondary to therapy with PNEUMOVAX 23. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Swelling
Clinical narrative: Information has been received from a 69 year old female with a penicillin and sulfonamide allergy and a history of vomiting who was vaccinated with a second dose of PNEUMOVAX 23.  Concomitant therapy included blood pressure medication.  Subsequently after she was given the vaccine the patient developed "arm, chest, neck, and face" swelling.  Unspecified blood work was performed.  Unspecified medical attention was sought.  Subsequently, the patient recovered "a year and half after the shot".  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Mobility decreased
Clinical narrative: Information has been received from a 52 year old female physician with a drug hypersensitivity to teraconazole and history of a spinal cord injury at L2 in 1981 who on 23-AUG-2007 was vaccinated with a dose of PNEUMOVAX.  Concomitant therapy included DITROPAN and MACRODANTIN.  On 24-AUG-2007 the patient developed redness, erythema, and soreness at the injection site.  The erythema was the size of a nickel during the day and increased to the size of a quarter by the evening.  The erythema progressed over 4 days to the size of 13 cm x 6 cm.  She had a temperature of 101 F and the erythema was 2 cm by 4 cm.  She had pain that she rated as 10 out of 10 and reported that her arm was non functional from the pain.  She went to the emergency room and was treated for cellulitis.  She was put on KEFLEX.  She called the Center for Disease Control for consult and was informed that it was probably and immune reaction.  She discontinued KEFLEX and took MOTRIN around the clock.  Subsequently, she developed 4 new satellites in which the lesions were blotchy and was about the size of a dime.  There were no laboratory or diagnostic tests performed.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Skin lesion
Clinical narrative: Information has been received from a 52 year old female physician with a drug hypersensitivity to teraconazole and history of a spinal cord injury at L2 in 1981 who on 23-AUG-2007 was vaccinated with a dose of PNEUMOVAX.  Concomitant therapy included DITROPAN and MACRODANTIN.  On 24-AUG-2007 the patient developed redness, erythema, and soreness at the injection site.  The erythema was the size of a nickel during the day and increased to the size of a quarter by the evening.  The erythema progressed over 4 days to the size of 13 cm x 6 cm.  She had a temperature of 101 F and the erythema was 2 cm by 4 cm.  She had pain that she rated as 10 out of 10 and reported that her arm was non functional from the pain.  She went to the emergency room and was treated for cellulitis.  She was put on KEFLEX.  She called the Center for Disease Control for consult and was informed that it was probably and immune reaction.  She discontinued KEFLEX and took MOTRIN around the clock.  Subsequently, she developed 4 new satellites in which the lesions were blotchy and was about the size of a dime.  There were no laboratory or diagnostic tests performed.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 61.0
Sex: U
Vaccine: PNC
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old patient who was vaccinated with PREVNAR instead of PNEUMOVAX 23.  No symptoms were reported.  At the time of the report the patient's outcome was unknown.  Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 69 year old male with hypertension and high cholesterol, who on 28-AUG-2007 was vaccinated with a 0.5mL dose of PNEUMOVAX (Lot# 658074/0961U).  Subsequently, soon after receiving the vaccination the patient experienced fatigue, followed by a delayed onset of left arm pain, swelling and redness from elbow to shoulder.  At the time of the report, the patient's outcome was unknown.  This report is one report of three provided by the same source.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a certified medical assistant concerning a 52 year old female with diabetes and high cholesterol, who on 28-AUG-2007 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (Lot# 658074/0961U).  Subsequently, the patient complained of a swollen red hot left arm.  At the time of the report, the patient's outcome was unknown.  This report is one report of three received by the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a patient (age and gender unknown), who on 28-AUG-2007 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (Lot# 658074/0961U).  Subsequently, the patient experienced arm pain, swelling, and redness.  At the time of the report, the patient's outcome was unknown.  This report is one of three reports received by the same source.  Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 69 year old male with hyperlipidaemia, hypertension, a history of prostate cancer, and no drug allergies, who on 28-AUG-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658074/0961U). On 31-AUG-2007 the patient developed an injection site reaction with left arm swelling, redness from the left elbow to the shoulder, and fatigue.  The patient called the physician and was instructed to apply ice to the injection site reactions and to take TYLENOL or ADVIL for discomfort.  No laboratory diagnostics were performed.  At the time of the report, the patient's outcome was unknown.  No product quality complaint was involved.  This report is 1 of 3 reports from the same source.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 52 year old female, who on 29-AUG-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658074/0961U) . On 31-AUG-2007 the patient developed an injection site reaction with swelling and injection site was warm to touch (arm unspecified). The patient called the office and was instructed to apply ice to the affected arm and use TYLENOL or MOTRIN for pain. No other symptoms or treatments were noted. At the time of the report the patient's outcome was unknown. No product quality complaint was involved. This is 1 of 3 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a health professional concerning a patient (age and gender unknown), who, on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# 657039/0698U). Subsequently, on an unspecified date the patient experienced severe pain and swelling from shoulder to wrist. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.