chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 month old male child who on 09-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine inadvertently instead of PREVNAR. This was reported as human error. No adverse event reported. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Arthritis, Condition aggravated, Dry skin, Joint lock
Clinical narrative: Information has been received from a licensed practical nurse concerning a male with arthritis who in October or November 2007 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitantly the patient was vaccinated with influenza virus vaccine (unspecified). It was reported that in January 2008, the patient developed right arm pain. The patient had a diagnosis of arthritis. The patient's arthritis was monitored by the physician; however, the date of the last office visit was unspecified. The nurse did not have access to the patient's medical record when reporting the adverse symptoms. Follow-up information indicated that the patient was diagnosed with serum sickness as a result of the vaccination with PNEUMOVAX 23. The patient experienced muscle and joint pain, episodes of "joint lock up", extremely dry skin, and an onset of aging. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not available.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Myalgia, Pain in extremity, Premature ageing, Serum sickness
Clinical narrative: Information has been received from a licensed practical nurse concerning a male with arthritis who in October or November 2007 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitantly the patient was vaccinated with influenza virus vaccine (unspecified). It was reported that in January 2008, the patient developed right arm pain. The patient had a diagnosis of arthritis. The patient's arthritis was monitored by the physician; however, the date of the last office visit was unspecified. The nurse did not have access to the patient's medical record when reporting the adverse symptoms. Follow-up information indicated that the patient was diagnosed with serum sickness as a result of the vaccination with PNEUMOVAX 23. The patient experienced muscle and joint pain, episodes of "joint lock up", extremely dry skin, and an onset of aging. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not available.
Age: 51.0
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 51 year old patient who in March 2008, was vaccinated SQ with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 659147/1381U). Subsequently, the patient experienced a mild injection site reaction. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a 76 year old female who was allergic to XYLOCAINE and BENADRYL and no pertinent medical history, who in October or November of 2007 was vaccinated with "one shot" of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included lisinopril (manufacturer unknown), LIPITOR, calcium (unspecified) and BELLASPAS. It was reported that within 24 hours of the shot the patient's left arm swelled up and she reported that she couldn't even get out of bed for days. The patient reported that a "couple of days after the shot she recovered." The patient sought medical attention and reported that she went back to her doctor. There were no laboratory studies performed. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Immunisation reaction, Incorrect route of drug administration
Clinical narrative: Information has been received from a nurse who consulted a pharmacist concerning an adult patient who was vaccinated IM inadvertently into the abdomen with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient had a reaction but the reporter did not have the details of the reaction. The patient was being monitored by the nurses. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a 73 year old female patient with hypersensitivity to alendronate sodium and "bisphosphonat" who on 29-JAN-2008 was vaccinated IM into left arm with 0.5 mL of pneumococcal 23v polysaccharide vaccine (lot # 657525/0554U). The nurse reported that patient developed redness, tenderness, and swelling in the left arm after receiving the injection on 29-JAN-2008. The adverse symptoms developed on 30-JAN-2008 at the injection site covering a 4 centimeter area. The patient was examined on 30-JAN-2008 and was given ZYRTEC and ibuprofen. The patient was instructed to call back if the treatment was unsuccessful and she had not contacted the physician with further complaints. No other symptoms and no other information available. Additional information has been requested.
Age: 53.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 54 year old patient who in March 2008, was vaccinated subcutaneously with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 659147/1381U). In March 2008 (reported as sometime in March 2008) the patient developed a 3-4 inch red, swollen area at the injection site after receiving pneumococcal 23v polysaccharide vaccine. The patient was evaluated in the office and treated with hydroxyzine pamoate (VISTARIL). No diagnostic laboratory studies were performed. The patient had received pneumococcal 23v polysaccharide vaccine about three years ago. It was reported that the patient recovered on an unspecified date. No product quality complaint was involved. This is one of three cases received by the same source. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a Registered Nurse concerning a 77 year old male patient who on 29-JAN-2008 was vaccinated IM not left arm with 0.5 mL of pneumococcal 23v polysaccharide vaccine (lot # 657525/0554U). The nurse stated that the patient developed a painful, reddened arm after receiving the pneumococcal 23v polysaccharide vaccine on 29-JAN-2008. The patient was examined on 31-JAN-2008 and the arm was described as reddened, indurated, and hot to touch from the shoulder to the wrist. He was given ZYRTEC and KEFLEX. The patient was instructed to call back if the treatment was unsuccessful and he had not contacted the physician with any further complaints. No other symptoms and no other information available. The outcome was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site rash, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 65 year old male with coronary artery disease, oesophageal reflux, hearing loss, herpes simplex type II, and drug hypersensitivity to acyclovir and ranitidine HCL capsules, who on 01-FEB-2008 was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot# 659150/1384U). Concomitant therapy included aspirin, CIALIS, PRILOSEC, and omega-3 marine triglycerides. On 02-FEB-2007, the patient experienced body aches, low grade fever of 99-100F, sensitive skin and rash at the injection site. Medical attention was sought by calling the doctor's office on 04-Feb-2008. The patient's body aches and low grade fever of 99-100F and sensitive skin and rash at the injection site persisted. No product quality complaint was involved. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 38 year old male who on 19-MAR-2008 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 659147/1381U). On 23-MAR-2008 the patient developed swelling and discomfort from the injection site down to his elbow after receiving the pneumococcal 23v polysaccharide vaccine. The patient was evaluated initially at an urgent care clinic and then was seen at the physician's office and treated with cephalexin (KEFLEX). No diagnostic laboratory testing was performed. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three cases received by the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Erythema, Heart rate, Induration, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a 69 year old female smoker with hypothyroidism, hypertension, osteoporosis and hypercholesterolaemia, and as of 29-NOV-2007 no known allergies, who on 02-OCT-2007 at 10:16 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot# 656233/0200U). Concomitant suspect therapy included FOSAMAX. Concomitant therapy included calcium, hydrochlorothiazide, lisinopril, lovastatin, LEVOXYL, and nifedipine. On 02-OCT-2007, the patient developed swelling, redness, and induration of the left arm. On 05-OCT-2007, the patient was seen by the physician. It was reported that the patient presented with pale red and yellow discoloration, edema, and mild induration of the left arm, there were no signs of infection and the injection site was clean. The patient's blood pressure was 120/80, pulse 68, temperature 96.6F. The patient was diagnosed with an allergic reaction to pneumococcal 23v polysaccharide vaccine and advised to take NSAIDs as needed. The patient was instructed to observe the symptoms, and report promptly if there was any worsening or unexpected persistence. The patient was also advised on signs and symptoms that would need immediate attention in the emergency room. The patient recovered on 07-OCT-2007. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin discolouration
Clinical narrative: Information has been received from a health professional concerning a 69 year old female smoker with hypothyroidism, hypertension, osteoporosis and hypercholesterolaemia, and as of 29-NOV-2007 no known allergies, who on 02-OCT-2007 at 10:16 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot# 656233/0200U). Concomitant suspect therapy included FOSAMAX. Concomitant therapy included calcium, hydrochlorothiazide, lisinopril, lovastatin, LEVOXYL, and nifedipine. On 02-OCT-2007, the patient developed swelling, redness, and induration of the left arm. On 05-OCT-2007, the patient was seen by the physician. It was reported that the patient presented with pale red and yellow discoloration, edema, and mild induration of the left arm, there were no signs of infection and the injection site was clean. The patient's blood pressure was 120/80, pulse 68, temperature 96.6F. The patient was diagnosed with an allergic reaction to pneumococcal 23v polysaccharide vaccine and advised to take NSAIDs as needed. The patient was instructed to observe the symptoms, and report promptly if there was any worsening or unexpected persistence. The patient was also advised on signs and symptoms that would need immediate attention in the emergency room. The patient recovered on 07-OCT-2007. No further information is available.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dizziness, Erythema, Hyperhidrosis, Injection site erythema
Clinical narrative: Initial and follow-up information has been received from a 76 year old white male with a history of hernia and 2 colon cancer operations, no drug reactions/allergies and no illness at the time of vaccination who on 04-FEB-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine IM (lot# 656233/0200U) subcutaneous in the right arm at 2:40 PM. Secondary suspect therapy on the same date included zoster vaccine live (Oka/Merck) (MSD) in his left arm. Other concomitant therapy included vitamins (unspecified) and asthma medications (therapy unspecified). On 04-FEB-2008 the patient experienced severe pain in the right arm when he went to bed that night. On 05-FEB-2008 at 10 AM the patient had swelling, redness and was sore at the injection site. The redness spread to under the arm and into the armpit area. The patient also experienced swelling and redness about 6 inches down his arm and 3 inches wide. The patient also developed fever, chills, sweating and feeling of being lightheaded. Medical attention was sought. However the patient's right arm is still sore and he feels lightheaded. The symptoms lasted approximately 72 hours before receding. On 07-FEB-2008, the patient had recovered. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a 76 year old white male with a history of hernia and 2 colon cancer operations, no drug reactions/allergies and no illness at the time of vaccination who on 04-FEB-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine IM (lot# 656233/0200U) subcutaneous in the right arm at 2:40 PM. Secondary suspect therapy on the same date included zoster vaccine live (Oka/Merck) (MSD) in his left arm. Other concomitant therapy included vitamins (unspecified) and asthma medications (therapy unspecified). On 04-FEB-2008 the patient experienced severe pain in the right arm when he went to bed that night. On 05-FEB-2008 at 10 AM the patient had swelling, redness and was sore at the injection site. The redness spread to under the arm and into the armpit area. The patient also experienced swelling and redness about 6 inches down his arm and 3 inches wide. The patient also developed fever, chills, sweating and feeling of being lightheaded. Medical attention was sought. However the patient's right arm is still sore and he feels lightheaded. The symptoms lasted approximately 72 hours before receding. On 07-FEB-2008, the patient had recovered. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Bone pain, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a consumer concerning her 10 year old daughter with a history of severe allergies who on 01-FEB-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included montelukast sodium (MSD), (dose, duration and indication not reported). Other concomitant therapy included fexofenadine hydrochloride and fluticasone furoate (VERAMYST). On 03-FEB-2008 the patient experienced pain in spine, neck, shoulder and knee. She received pneumococcal 23v polysaccharide vaccine to help with her chronic sinus problems. She has many allergies, but none to medications. The patient's pain in spine, neck, shoulder and knee persisted. She sought unspecified medical attention with the physician. Unspecified blood work was performed. Additional information has been requested. Changed Singular to a concomitant therapy instead of secondary suspect and added (MSD) to montelukast sodium in the narrative.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed visiting nurse concerning an 8 week old female patient with no known allergies reported, who on 16-APR-2008 at 10:30 was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. It was reported that on 16-APR-2008 at 10:30 the medical assistant gave the pneumococcal 23v polysaccharide vaccine instead of PREVNAR. No adverse reactions were reported. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a patient with diabetes who on 07-FEB-2008 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. On 07-FEB-2008 the patient experienced injection site redness, swelling and pain. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. This is one of multiple reports from the same source (WAES# 0802USA05540 and 0802USA05541). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a registered nurse, concerning a 71 year old female patient, who on 16-APR-2008 was vaccinated IM in the left arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # 658673/0990U). Concomitant therapy included lisinopril (manufacturer not specified). On approximately 17-APR-2008, the patient developed an "injection site reaction," with redness and pain at the site. On 18-APR-2008, she was seen in the office and stated she "felt better than yesterday" (treatment not specified). At the time of this report the patient was recovering. This is one of 3 reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2008.  Initial and follow up information has been received from a registered nurse and a licensed practical nurse concerning a 71 year old female who on 16-APR-2008 was vaccinated IM in the left deltoid with a 0.5 ml of PNEUMOVAX (lot # 658673/0990U) at 2:00 PM.  Concomitant therapy included lisinopril (manufacturer not specified).  On 16-APR-2008 (previously reported as approximately 17-APR-2008) the patient developed an "injection site reaction," with redness and pain at the site and surrounding area.  On 18-APR-2008, she was seen in the office and stated she "felt better than yesterday" (treatment not specified).  At the time of the report the patient was recovered.  This is one of 3 reports from the same source.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a 55 year old female consumer with a history of colon cancer and an immunocompromised status, who on an unspecified date was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced swelling in her arm. It was unknown whether medical attention was sought. Subsequently, the patient recovered from swelling in her arm. No product quality complaint was involved. Additional information is requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 38 year old white female who on 11-DEC-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 658450/1380U) IM in the left deltoid at 9 AM. In December 2007, the patient experienced redness, swelling and pain at injection site. The patient was sent to urgent care for treatment and was place on an antibiotic (therapy unspecified), antihistamine (therapy unspecified) and pain (therapy unspecified) medication. On an unspecified date the patient recovered. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: Information has been received from a Registered Nurse (RN) concerning a 14 year old white female child with a history of laryngotracheobronchitis, pneumonia, bronchitis and allergic rhinitis who on 22-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659149/1383U. The reporter reported that the patient got injection site reaction of pain, swelling and redness. In follow up information it was reported that patient's mother called the office to complain that on 23-JAN-2008 her child's arm was hard to touch, warm and tender which lasted couple of days. The child recovered few days after the vaccination. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a Registered Nurse (RN) concerning a 14 year old white female child with a history of laryngotracheobronchitis, pneumonia, bronchitis and allergic rhinitis who on 22-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659149/1383U. The reporter reported that the patient got injection site reaction of pain, swelling and redness. In follow up information it was reported that patient's mother called the office to complain that on 23-JAN-2008 her child's arm was hard to touch, warm and tender which lasted couple of days. The child recovered few days after the vaccination. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Limb discomfort
Clinical narrative: Information has been received from a nurse concerning a 68 year old female with concomitant medications and pertinent medical history reported as unspecified, who on 15-APR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, 0.5 mL, IM in the right arm (Lot# 658673/0990U), it was unknown if this was the patient's first or second dose. The patient developed an injection site reaction consisting of pain and redness at the site. The patient was seen in the emergency room due to the pain, she was not admitted. The patient was then seen by the physician on 17-APR-2008 and she was still complaining of discomfort to the right arm. At the time of the report, the patient was noted to be recovering. No product quality complaint was involved. Additional information is expected.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, Nausea
Clinical narrative: Initial and follow up information has been received from a Registered Nurse and physician's office concerning a 14 and 1/2 year old white female patient who on 10-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659149/1383U. The reporter reported that the patient got injection site reaction of pain, swelling and redness. In follow up the reporter reported that the patient was febrile, nauseated, did not feel well and had warm tender arm for several days. Her arm was rechecked on 24-JAN-2008 in the doctor's office visit. She had no redness, warmth, tenderness and had full range of motion. She recovered after 24-JAN-2008. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm, Tenderness
Clinical narrative: Initial and follow up information has been received from a Registered Nurse and physician's office concerning a 14 and 1/2 year old white female patient who on 10-JAN-2008 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine lot # 659149/1383U. The reporter reported that the patient got injection site reaction of pain, swelling and redness. In follow up the reporter reported that the patient was febrile, nauseated, did not feel well and had warm tender arm for several days. Her arm was rechecked on 24-JAN-2008 in the doctor's office visit. She had no redness, warmth, tenderness and had full range of motion. She recovered after 24-JAN-2008. Additional information is not expected.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered concerning an 84 year old white male with no illness at the time of vaccination, drug reactions/allergies or pertinent medical history who on 17-DEC-2007 at 18:05 PM was vaccinated with a dose pneumococcal 23v polysaccharide vaccine (lot# 659148/1382U) IM in the left arm. There was no concomitant medication. On 18-DEC-2007 at 12:00 o'clock (AM or PM not specified) the patient developed an induration, heat, surrounding redness at the injection site, dependent swelling beneath the elbow and significant pain noted at both areas. The duration was four days. On 21-DEC-2007, the patient recovered. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a Registered Nurse (RN) concerning a 72 year old male patient with "lot of different disease states" who on 16-APR-2008 was vaccinated IM into the left arm with a dose of pneumococcal 23v polysaccharide vaccine ("it was not known if this was the first or second dose of pneumococcal 23v polysaccharide injection"). Concomitant therapy included (therapy unspecified). It was reported that "patient had a lot of different disease states". The nurse reported that on 16-APR-2006 the patient developed pain at the injection site. The patient recovered on an unspecified day. No additional information was available. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a doctor of pharmacy concerning an 81 year old female patient who was vaccinated with a dose of pneumococcal a dose of 23v polysaccharide vaccine. The pharmacist reported that she was informed by the patient that she had cellulitis in the arm following pneumococcal a dose of 23v polysaccharide vaccine. The outcome was unknown. No further information was available at this time. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Dermatitis exfoliative, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a Registered Nurse concerning a 62 year old female patient with gastrooesophageal reflux disease, diabetes and hypersensitivity to cyclobenzaprine hydrochloride and LEXAPRO. She had a history of herpes zoster who on 11-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 655501/1035F). It was not clear if this was the first vaccination for the patient. Concomitant therapy included zoster vaccine live (Oka/Merck) (MSD), metoprolol, ezetimibe (+) simvastatin (MSD), RESTORIL, BYETTA, ASPIRINE and DETROL LA. It was reported that the patient received the pneumococcal 23v polysaccharide vaccine and developed rash at the injection site and low grade fever. The time development of the rash was unclear, but the patient was seen in the office for the rash the next day on 18-APR-2008. Her symptoms were described as chills and low grade temperature of 99.5 F. The rash at the injection site was described as pink, tender area 17X10 centimeter in diameter, hot to touch, described as a diffuse erythroderma. The right upper arm injection site elbow was involved and the whole arm was swollen. The patient was prescribed KELFEX 500 mg twice a daily for three days. The last contact with the patient was on 18-APR-2008. 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. The outcome was unknown. Additional information is not available.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a Registered Nurse concerning a 62 year old female patient with gastrooesophageal reflux disease, diabetes and hypersensitivity to cyclobenzaprine hydrochloride and LEXAPRO. She had a history of herpes zoster who on 11-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 655501/1035F). It was not clear if this was the first vaccination for the patient. Concomitant therapy included zoster vaccine live (Oka/Merck) (MSD), metoprolol, ezetimibe (+) simvastatin (MSD), RESTORIL, BYETTA, ASPIRINE and DETROL LA. It was reported that the patient received the pneumococcal 23v polysaccharide vaccine and developed rash at the injection site and low grade fever. The time development of the rash was unclear, but the patient was seen in the office for the rash the next day on 18-APR-2008. Her symptoms were described as chills and low grade temperature of 99.5 F. The rash at the injection site was described as pink, tender area 17X10 centimeter in diameter, hot to touch, described as a diffuse erythroderma. The right upper arm injection site elbow was involved and the whole arm was swollen. The patient was prescribed KELFEX 500 mg twice a daily for three days. The last contact with the patient was on 18-APR-2008. 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. The outcome was unknown. Additional information is not available.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a female (age unknown) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot#, Batch#, date, dose and route unknown). Pertinent medical history and concomitant medication was reported as unspecified. The reporter stated "client was vaccinated with pneumococcal 23v polysaccharide vaccine and developed an unspecified local site reaction." Unspecified medical attention was sought. It was reported that the client recovered. No product quality complaint was involved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Feeling abnormal, Headache, Injection site pain, Insomnia, Pain
Clinical narrative: Information and follow up has been received from a nurse concerning a 68 year old male who on 22-APR-2008 was vaccinated intramuscularly in the left deltoid with pneumococcal 23v polysaccharide vaccine (lot# 658074/0803U). Concomitant therapy included fenofibrate (TRICOR). On 22-APR-2008, 12 hours after the vaccination, the patient experienced a fever, headache and reported feeling bad. The fever reached 102.2 F and "he didn't sleep all night." He reported a sore injection arm and general aches and pains. He saw the physician in the office on 23-APR-2008. At the office he had a fever of 101F while taking an unspecified fever medication. The physician prescribed an unspecified pain medication on 23-APR-2008 and felt the symptoms would resolve. The patient recovered. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information and follow up has been received from a nurse concerning a 68 year old male who on 22-APR-2008 was vaccinated intramuscularly in the left deltoid with pneumococcal 23v polysaccharide vaccine (lot# 658074/0803U). Concomitant therapy included fenofibrate (TRICOR). On 22-APR-2008, 12 hours after the vaccination, the patient experienced a fever, headache and reported feeling bad. The fever reached 102.2 F and "he didn't sleep all night." He reported a sore injection arm and general aches and pains. He saw the physician in the office on 23-APR-2008. At the office he had a fever of 101F while taking an unspecified fever medication. The physician prescribed an unspecified pain medication on 23-APR-2008 and felt the symptoms would resolve. The patient recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Myalgia, Pyrexia, Rash, Swelling
Clinical narrative: Initial information has been received from a 74 year old female consumer with an allergy to corns and sulfonamide who on 22-APR-2008 was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot# not provided). There was no concomitant medication. On 22-APR-2008 the patient experienced redness, swelling, fever up to 102d, muscle aches and rash. Follow up information received from the physician indicated that the patient called the physician and reported that she had a localized reaction to her arm which included redness, swelling and pain. The patient never mentioned to him that she had fever. At the time of reporting the patient had not recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a registered nurse and from the doctor's office, concerning a 27 year old female teacher with chronic sinusitis, asthma, dermatitis atopic, a dust mite allergy and a retention cyst, who on 06-MAY-2004 was vaccinated IM, with the first dose (lot # 644217/1026M), and on 24-APR-2008 at 01:30 PM was vaccinated IM in the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 657143/0380U). On 25-APR-2008, following the second dose, the patient experienced soreness at the site of injection. On 26-APR-2008, red blotches appeared, and the area was very painful. In follow up information it was reported that patient's arm was very painful at site next day. She was unable to lift arm. She also had peach sized swelling which was warm to touch. On 28-APR-2008, the swelling was reported to be 6.5X8 centimeter. Treatment included cool compresses, and CEFTIN 500 milligram twice a day for ten days. The patient was to be examined in the office. The patient recovered on an unknown day. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Initial and follow up information has been received from a registered nurse and from the doctor's office, concerning a 27 year old female teacher with chronic sinusitis, asthma, dermatitis atopic, a dust mite allergy and a retention cyst, who on 06-MAY-2004 was vaccinated IM, with the first dose (lot # 644217/1026M), and on 24-APR-2008 at 01:30 PM was vaccinated IM in the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 657143/0380U). On 25-APR-2008, following the second dose, the patient experienced soreness at the site of injection. On 26-APR-2008, red blotches appeared, and the area was very painful. In follow up information it was reported that patient's arm was very painful at site next day. She was unable to lift arm. She also had peach sized swelling which was warm to touch. On 28-APR-2008, the swelling was reported to be 6.5X8 centimeter. Treatment included cool compresses, and CEFTIN 500 milligram twice a day for ten days. The patient was to be examined in the office. The patient recovered on an unknown day. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old female with no medical history or allergies who on 25-APR-2008 was vaccinated SQ with a second or third dose of pneumococcal 23v polysaccharide vaccine (Lot# 659199/1541U). Concomitant therapy included FOSAMAX, PROCARDIA, ZOCOR and folic acid. On 29-APR-2008, the patient experienced cellulitis from the injection site to the whole upper arm. On that same day, she was treated with an unspecified antibiotic. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. This is one of three reports from the same source. 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. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old female with lipidaemia, rhinitis allergic, hypertension, coronary artery disease, hypothyroidism and homocysteine level increased and a history of menopause who on 15-APR-2008 was vaccinated SQ with a second or third 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 659199/1541U). Concomitant therapy included AVALID, PREMARIN, TRIGLIDE, TOPROL XL TABLETS, LIPITOR, LEVO, ZYRTEC, folic acid and NASACORT. On 19-APR-2008, the patient developed cellulitis. The patient had a high temperature, a swollen lymph node under the arm and malaise. On 21-APR-2008, she was treated with an unspecified antibiotic. At the time of this report, the patient was recovering. 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: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female with lipidaemia, breast cancer, lumbar disc disease and osteopenia who was vaccinated SQ with a second or third 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 659199/1541U). Concomitant therapy included BONIVA. On 19-APR-2008, the patient experienced cellulitis. She was treated with an unspecified antibiotic on 21-APR-2008. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. The reporter is requesting a lot check for the brand new vial of pneumococcal 23v polysaccharide vaccine (Lot # 659199/1541U) that she just opened. 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.
Sex: U
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced a localized reaction. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown), who, on an unspecified date "a while back," was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, "a while back" the patient developed severe redness. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old male, who, on an unspecified date, was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient experienced pain and developed swelling at the injection site. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning female "over 60 years of age" who, on an unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed an injection site reaction with redness, swelling, and tenderness. The reaction was treated with cool cloths and ADVIL or TYLENOL for pain if needed. The patient was seen in the office. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Influenza like illness, Injection site pain, Pain
Clinical narrative: Initial and follow up information has been received from a registered nurse and from the doctor's office concerning a 46 year old female patient who was allergic to dust, who on 06-FEB-2008 at 03:30 PM was vaccinated subcutaneous into left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658447/1132U). In follow up report it was reported that on 07-FEB-2008, a day after the injection was administered, the patient experienced achy, had flu like symptoms, her arm was sore at injection site and developed cellulitis. She saw her primary doctor and on 08-FEB-2008 was prescribed ZITHROMAX. On 11-FEB-2008, the patient's injection site reported as "OK." She recovered on an unknown day. This is one of 3 cases from the same source. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from an other healthcare professional concerning a 63 year old female with concomitant medications and pertinent medical history reported as unspecified, who in 2003 ("5 years ago not at their office") was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported). The patient developed an injection site reaction where her arm became swollen and red from the injection site to below the elbow. Unspecified medical attention was sought. It was reported that the patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a male "over 70 years of age" who, on an unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 657143/0380U). Concomitant vaccination included influenza virus vaccine (unspecified), administered in the opposite arm. Subsequently, the patient developed an injection site reaction with redness, swelling, and tenderness. The reaction was treated with cool cloths and ADVIL or TYLENOL for pain if needed. The patient called the office. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 65 year old female patient who, on unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed a very large circular rash accompanied with swelling at the injection site. The nurse stated "In the last month, this is more than she has seen historically." At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from Hoffman-LaRoche Inc. (#084505864), via a male consumer (age not reported), with concomitant medications and pertinent medical history not specified, who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# date, dose and route not reported). It was reported that on an unspecified date the patient experienced "Compromised therapy." No outcome information was provided. Additional information is not expected.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site reaction
Clinical narrative: Information has been received from a physician concerning three patients over the age of 65 years old who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658450/1380U). The physician reported that the patients had injection site reactions after the injection was administered. The physician had no specific information on two of the patients. He mentioned that one patient who had extreme redness extending into the axillary area which seemed to follow the lymphatic system. A follow up telephone call to the doctor's office was made to obtain more information about the patients. No more information was available at this time. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Sinusitis
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on 05-MAY-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine. On 06-MAY-2008, the patient experienced a sinus infection. A second doctor prescribed clarithromycin for sinus infection. The patient sought unspecified medical treatment. Follow up information indicated there was no adverse event, the pharmacist called because he wanted to know if taking the clarithromycin would effect the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 4 year old male with a history of one undescended testicle who on 06-MAY-2008 was vaccinated subcutaneously in the left arm with pneumococcal 23v polysaccharide vaccine (lot# 656233/0200U). Concomitant therapy included measles-mumps-rubella vaccine, for the treatment of prophylaxis (duration and dose not reported) and varicella virus vaccine live, for the treatment of prophylaxis (duration and dose not reported). Other concomitant therapy included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and hepatitis A virus vaccine (unspecified). On 06-MAY-2008, the patient was inadvertently given pneumococcal 23v polysaccharide vaccine. This was a nurse error. He was suppose to receive tuberculin purified protein derivative. The patient experienced a red, raised, painful injection site reaction. The red, raised, painful injection site reaction persisted. The patient was seen in the office. He will not receive the tuberculin purified protein derivative until his arm heals. Additional information has been requested.