chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 55 year old female, who on 31-OCT-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 655592/1175F). Subsequently, the patient developed injection site swelling and redness. The patient contacted the nurse practitioner. The patient was treated with warm soaks to the affected site. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacy technician and a licensed practical nurse concerning a patient (age and gender not reported) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient experienced a "similar reaction" such as warmth and redness at the injection site. However, the licensed practical nurse stated that she could not supply further details, lot number, severity and exact symptoms. The pharmacy technician noted that "it seemed like more patients had this experience this year that patients who received the vaccine last year." Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a retired Registered Nurse concerning a few patients who were vaccinated with pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced a sore arm after receiving the vaccination. No further information is available.
Age: 1.5
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a less than 18 month old female who on 05-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine instead of PREVNAR. There was no adverse event reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacy technician and a licensed practical nurse concerning a patient (age and gender not reported) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the the patient experienced a "similar reaction" such as warmth and redness at the injection site. However, the licensed practical nurse stated that she could not supply further patient details, lot number, severity and exact symptoms. The pharmacy technician noted that "it seemed like more patients had this experience this year than patients who received the vaccine last year." Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Breast swelling, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a nurse concerning an 84 year old white female patient with gastrointestinal reflux disease, mild dementia and hypercholesteremia who on 10-DEC-2007 at 3:30 pm was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #659149/1383U) intramuscularly in the right deltoid. Concomitant therapy included ezetimibe (+) simvastatin (MSD). Later that same day she experienced swelling, redness and warmth and pain in her right arm from her shoulder to her elbow. The adverse symptoms became worse during the next few days. Four or five days after receiving pneumococcal 23v polysaccharide vaccine, on approximately 15-DEC-2007, the lymph gland under her right arm became swollen and subsequently this traveled to her right breast. She was diagnosed as having cellulitis. Approximately one week after receiving pneumococcal 23v polysaccharide vaccine the swelling and redness began to diminish and fade, but this was only in her right arm, shoulder and breast. She said that beginning twenty years ago she has had a pneumonia vaccine every five years and has never had any adverse experience until the one she received in DEC-2007. Follow up information was received on 18-FEB-2008. The patient developed swelling and redness on the right arm at the injection site and cellulitis at the right arm. The patient recovered on 07-JAN-2008. No additional information is expected. This is one of several reports received from the same source.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: Initial and follow up information has been received from a nurse concerning an 84 year old white female patient with gastrointestinal reflux disease, mild dementia and hypercholesteremia who on 10-DEC-2007 at 3:30 pm was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #659149/1383U) intramuscularly in the right deltoid. Concomitant therapy included ezetimibe (+) simvastatin (MSD). Later that same day she experienced swelling, redness and warmth and pain in her right arm from her shoulder to her elbow. The adverse symptoms became worse during the next few days. Four or five days after receiving pneumococcal 23v polysaccharide vaccine, on approximately 15-DEC-2007, the lymph gland under her right arm became swollen and subsequently this traveled to her right breast. She was diagnosed as having cellulitis. Approximately one week after receiving pneumococcal 23v polysaccharide vaccine the swelling and redness began to diminish and fade, but this was only in her right arm, shoulder and breast. She said that beginning twenty years ago she has had a pneumonia vaccine every five years and has never had any adverse experience until the one she received in DEC-2007. Follow up information was received on 18-FEB-2008. The patient developed swelling and redness on the right arm at the injection site and cellulitis at the right arm. The patient recovered on 07-JAN-2008. No additional information is expected. This is one of several reports received from the same source.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old black female who on 04-SEP-2007 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine (Lot #657039/0698U) intramuscularly in the left arm. On 05-SEP-2007, the patient developed a severely swollen and painful left arm, and itching. On 07-SEP-2007, the patient was seen by the physician and there was a 3" X 4" red swollen area at the injection site which extended down her arm and into axilla. The patient was given 40 mg. of KENALOG intramuscularly and MEDROL DOSE PAK. The reaction was resolved within these measures. No additional information is expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain, Skin warm, Ultrasound Doppler normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 69 year old white male patient with hypertension, gastrooesophageal reflux disease and a penicillin allergy and a history of uric acid nephrolithiasis and diverticulosis who on 23-OCT-2007 at 09:30, was vaccinated SC into the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 656225/0070U). Concomitant therapy included allopurinol, amlodipine besylate, PROTONIX and vitamins (unspecified). On 23-OCT-2007 at 5:00 pm, the patient developed localized swelling and pain that extended down his arm to his mid-arm after administration of the vaccine. The affected area had "minimum redness" and was warm. It was also reported that the swelling progressed down. Unspecified medical attention was sought. Laboratory diagnostic studies performed included a duplex scan of the arm. It was reported that thrombosis was not detected. On 02-NOV-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site scab
Clinical narrative: Information has been received from a licensed practical nurse concerning a 74 year old female patient with ischaemic heart disease, hypertension, high cholesterol, aortic valve disease, thrombocytopenia, chronic obstructive pulmonary disease, anaemia and allergies to PHENERGAN and codeine and penicillin who on 20-NOV-2007 at 14:30, was vaccinated SC into the right tricep with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 657143/0380U). On 26-NOV-2007, the patient reported soreness, redness and a hard lump at the injection site. That same day the patient was started on KEFLEX, 500 mg four times a day, for 10 days. It was reported that the lump gradually resolved over the next few weeks. There was a scabbed area approximately 0.5 cm to 0.75 cm which developed at the injection site. As of 13-FEB-2008, the patient had recovered completely except for an occasional twinge in the area of the injection that the patient states is not painful. No laboratory diagnostic studies were performed. No product quality complaint was involved. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 65 year old female who on 16-NOV-2007 was vaccinated IM into the right deltoid with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). On approximately 16-NOV-2007, the patient developed hot, painful, large swelling at the injection site. It was also reported that the patient was improving. The patient sought medical attention. The physician requested a lot check. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an 81 year old male, who on 26-NOV-2007 was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658451/0963U or 0658673/0990U). On 27-NOV-2007, the patient experienced swelling of the left deltoid, redness around the site, and pain. The patient was advised to place an ice pack on the site and to take BENADRYL, two times a day. The patient recovered on an unspecified date. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 53 year old male, who on 26-NOV-2007 was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 658451/0963U or 658673/0990U). On 27-NOV-2007, the patient experienced swelling of the left deltoid, redness around the injection site, and pain in left deltoid. The patient was advised to place an ice pack on the injection site and to take BENADRYL, two times a day. The patient was also advised to see the doctor if the symptoms persisted. The patient recovered on an unspecified date. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 49 year old male who on 30-OCT-2007 was vaccinated intramuscularly into the "left deltoid" with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #658451/0963U) also reported as (Lot #0990U). On 31-OCT-2007, the patient experienced swelling and pain in the "right deltoid." The patient was advised to use an ice pack at the "injection site" and to take BENADRYL over-the-counter. If the symptoms persisted he should come to the office for an office visit with the physician. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a female patient who on an unknown date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. After the patient received the vaccine, the patient experienced pain at the injection site for two days. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received via a company representative, from a female nurse (age not specified) with diabetes, who in October 2007, was vaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported), and with a dose influenza virus vaccine (unspecified). In October 2007, following the vaccinations (duration to onset not specified), the nurse developed a temperature of 103 degrees, and "felt like her arm where vaccinations occurred was going to fall off." Subsequently, the nurse recovered (duration of events not specified). The nurse did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Erythema, Feeling hot, Nausea, Pain
Clinical narrative: Information has been received from a physician concerning himself (age unknown) with no drug allergies, who on 01-JAN-2008 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 01-JAN-2008, the patient developed redness, pain, local heat, weakness and nausea a short time after being vaccinated. The patient did not seek medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male with hypertension who in December 2007, was vaccinated SC with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine concomitantly with a dose of influenza virus vaccine (unspecified). Other concomitant therapy included ECOTRIN, MONOPRIL and simvastatin (MSD). Subsequently, the patient developed swelling, redness and pain at the injection site. Medical attention was sought at the physician's office. The patient was treated with over the counter BENDADRYL. Subsequently, the patient recovered.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 72 year old female with diabetes, asthma and osteoporosis who on 02-JAN-2008 was vaccinated SQ with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 659150/1384U). Concomitant therapy included NORVASC, GLUCOPHAGE, ezetimibe (+) simvastatin (MSD), ECOTRIN and ALTACE. On 03-JAN-2008, the patient experienced swelling, redness and pain at the injection site. Medical attention was sought. The patient was treated with BENADRYL. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Limb discomfort
Clinical narrative: Information has been received via a company representative, from a nurse, concerning a patient (age and gender not reported) at another office, who was vaccinated in the arm (date not specified) with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported), and possibly with a dose of influenza virus vaccine (unspecified). Following the vaccinations (duration to onset not specified), the patient developed an elevated temperature, possibly of 103 degrees, and felt arm where the vaccinations were administered "was going to fall off." At the time of this report, it was unknown if the patient recovered.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site induration, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Information has been received from a pharmacist and a male consumer, concerning the consumer, who in December 2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658075/0962U). The pharmacist reported on 13-DEC-2007, that the patient had a high fever after the vaccination, and that the patient had swelling and local induration at the injection site. On 13-DEC-2007, the patient also reported that he had a fever of 102 degrees, and that he "cannot stop throwing up." The consumer called to ask for treatment recommendations. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site irritation, Injection site warmth
Clinical narrative: Information has been received from a physician, concerning a 65 year old female patient with hypertension, hypercholesterolaemia and hypothyroidism, who on 29-OCT-2007 was vaccinated SQ in the right upper arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # 658555/09364U). Concomitant therapy included ZETIA, TOPROL XL TABLETS, and SYNTHROID. On 29-OCT-2007, a few hours after administration of the vaccine, the patient developed a "golf ball sized" area of warmth and irritation at the injection site. She called the office, and was prescribed BENADRYL and cold compresses. The patient subsequently recovered (duration not specified). This is one of three reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a healthcare professional, concerning a female patient (age not reported), who on 12-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658447/1132U). On 12-DEC-2007, the patient developed redness and swelling from the injection site to her elbow, and visited the emergency room (details not provided). At the time of this report (14-DEC-2007), the patient was recovering. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a 47 year old female patient with drug hypersensitivity to DEMEROL, who on 13-DEC-2007 was vaccinated SQ in the right arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # 657526/0555U). Concomitant therapy included SYNTHROID. On 13-DEC-2007, the patient developed cellulitis in the arm where the vaccine was administered "from the injection site to her elbow." She visited the emergency room, and a complete blood count was performed (details and result not provided). At the time of this report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a female in her 30's with asthma who in December 2007 "sometime this week," was vaccinated with pneumococcal 23 v Polysaccharide vaccine (lot # unknown). Subsequently, on an unspecified date the patient experienced irritation at the injection site, redness and swelling. No further information was provided. Additional information has been requested. This is one of two reports from the same source.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site mass, Pain in extremity
Clinical narrative: Information has been received from a registered nurse, regarding a 69 year old female patient with no pertinent medical history, who on 12-DEC-2007 was vaccinated SC in the arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658451/0963U). Concomitant vaccine therapy included a dose of influenza virus vaccine (manufacturer unspecified). On 12-DEC-2007, the patient developed an injection site reaction described as redness and a lump at the injection site, with soreness of her arm. Treatment included ALEVE, with little relief of the symptoms. The patient contacted the physician. At the time of this report, the patient was recovering from the events. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Body temperature increased, Incorrect route of drug administration, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 24 year old female Caucasian with chronic sinusitis, "RAD," and allergic rhinitis, who on 06-NOV-2007, at 4:00 pm, was vaccinated SC in the arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658449/0989U). The patient had an episode of chronic sinusitis at the time of vaccination. Concomitant vaccine therapy included the first dose, IM in the right deltoid, of NOVARTIS (LOT #80433), and the first dose, IM in the left deltoid, of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (SP) (lot #C2863AA). On 07-NOV-2007, the patient developed an injection site reaction, described as a warm macule, or a 12 X 12 centimeter area of redness and swelling. The area was so tender and painful, that she couldn't lift her arm. She also had a fever of 104 degrees F. Treatment included prednisone, PERCOCET and KEFLEX. After a "few days," the patient recovered from the event. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 24 year old female Caucasian with chronic sinusitis, "RAD," and allergic rhinitis, who on 06-NOV-2007, at 4:00 pm, was vaccinated SC in the arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658449/0989U). The patient had an episode of chronic sinusitis at the time of vaccination. Concomitant vaccine therapy included the first dose, IM in the right deltoid, of NOVARTIS (LOT #80433), and the first dose, IM in the left deltoid, of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (SP) (lot #C2863AA). On 07-NOV-2007, the patient developed an injection site reaction, described as a warm macule, or a 12 X 12 centimeter area of redness and swelling. The area was so tender and painful, that she couldn't lift her arm. She also had a fever of 104 degrees F. Treatment included prednisone, PERCOCET and KEFLEX. After a "few days," the patient recovered from the event. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Incorrect route of drug administration, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 50 year old Caucasian female patient with a penicillin allergy, latex allergy, egg allergy, asthma, gastroesophageal reflux disease, fibromyalgia, and migraines, who on 12-DEC-2007 (previously reported as 11-DEC-2007) was vaccinated SC in the left arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658451/0963U), and with the first dose, IM in the left deltoid, of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (SP) (lot #C2889AA). On 12-DEC-2007 (previously reported as on 11-DEC-2007), 1/12 hour after the injections, the patient experienced fatigue, had severe pain in the left arm, and developed an injection site reaction, also described as an "intensely red inflammatory reaction with exquisite tenderness at left posterior deltoid/tricep area," measured 7 cm in diameter and warm to the touch. The patient visited the physician. At the time of this report, the patient had recovered (duration not specified). Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 50 year old Caucasian female patient with a penicillin allergy, latex allergy, egg allergy, asthma, gastroesophageal reflux disease, fibromyalgia, and migraines, who on 12-DEC-2007 (previously reported as 11-DEC-2007) was vaccinated SC in the left arm, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot #658451/0963U), and with the first dose, IM in the left deltoid, of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (SP) (lot #C2889AA). On 12-DEC-2007 (previously reported as on 11-DEC-2007), 1/12 hour after the injections, the patient experienced fatigue, had severe pain in the left arm, and developed an injection site reaction, also described as an "intensely red inflammatory reaction with exquisite tenderness at left posterior deltoid/tricep area," measured 7 cm in diameter and warm to the touch. The patient visited the physician. At the time of this report, the patient had recovered (duration not specified). Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old white female patient with a history of uterine cancer and hysterectomy who on 07-NOV-2007, was vaccinated IM  with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot #658075/0962U). Concomitant therapy included simvastatin (MSD) and DIOVAN. On 08-NOV-2007, the patient experienced swelling and inflammation of the right arm. There was a ring around the whole arm. It was hot to the touch at the area toward the middle of the arm and elbow. The physician prescribed NAPROSYN 375 mg, twice a day. The area was really red and raised. The whole arm was wrapped in bandage and the patient had been applying ice to the arm. No laboratory diagnostic studies were performed. At the time of this report, the patient had recovered. It was reported that this was a non-serious event and that the patient was not hospitalized. No product quality complaint was involved. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: PPV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a consumer, and from a physician's staff member, concerning a 6 month old white male infant who on 14-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The physician told the consumer her son was scheduled to receive pneumococcal 4 6B 9V 14 19C 19F 23F conj vaccine (CRM197) (PREVNAR), but pneumococcal 23v polysaccharide vaccine was actually administered. The staff member confirmed there were no adverse reactions noted. No further information is available.
Age: 0.6
Sex: M
Vaccine: PPV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 7 month old white male with no illness at the time of vaccination and no medical history, who on 14-DEC-2007 (previously reported as 24-JAN-2008) was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 658449/0989U) IM in the right thigh at 12:30 PM instead of PREVNAR. Concomitant therapy included a second dose of INFANRIX (lot # AC14B051AA) IM in the left thigh on 28-DEC-2007, and a second dose of ACTHIB/OMNIHIB (lot # UF209AA) IM in the left thigh on 17-JAN-2008. The patient had no adverse reaction to the vaccine. No additional information is expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Muscular weakness, Musculoskeletal pain
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female with no medical history or allergies, who on 12-NOV-2007 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#658673/0990U). There was no concomitant medication. On 12-NOV-2007 the patient experienced persistent pain in the shoulder and weakness in his arm. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The patient's persistent pain in the shoulder and weakness in arm persisted. No product quality complaint was involved. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, IPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health care coordinator and a nurse concerning a 7 month old female with no pertinent medical history and no known allergies who on 15-NOV-2007 was vaccinated intramuscularly in the right thigh with pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot # 655591/0886F). Concomitant vaccination on 15-NOV-2007 included the third dose of hepatitis B vaccine, recomb (manufacturer unknown), the third dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), the third dose of poliovirus vaccine live oral (manufacturer unknown), and the third dose of Hib conj vaccine (unspecified carrier) (manufacturer unknown). The nurse reported that the patient was supposed to receive pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) when pneumococcal 23v polysaccharide vaccine was given by mistake. The nurse stated that the mistake occurred because the physician may have ordered the wrong vaccine and mentioned it can be confusing as far as which vaccine needs to be given to which age group. No adverse reaction was reported post vaccination. Medical attention was sought in the physician's office. Upon follow-up received from the healthcare worker, it was reported that the error was "strictly human error" on the medical assistant's part, two different ones unfortunately". The reporter stated that " it was not a matter of product confusion, the vaccines were in different containers on different shelves, the medical assistant just made a mistake". This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a patient who on 07-NOV-2007, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658075/0962U). Subsequently, the patient experienced redness and swelling below the injection site. The area was also raised. It was reported by the nurse that the adverse event required a medical intervention. The patient was seen in the office and was given a prescription for an antibiotic. The patient was also prescribed naproxen (NAPROSYN), 375mg, twice a day. The whole arm below the elbow was wrapped in a bandage and ice was applied to the arm. It was reported that the patient was not hospitalized. The patient recovered on an unspecified date. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Induration, Pain in extremity, Pyrexia, Sensation of heaviness
Clinical narrative: Information has been received from a physician, regarding his mother-in-law, an 82 year old female patient with no known allergies, who on 18-DEC-2007, at 1:00 pm, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (invalid lot #, provided to physician from another office). Following the vaccination, at 5 or 6 pm, his mother-in-law experienced a heavy feeling of her arm. By 8 or 9:00 pm, she had pain all over her arm, and by 10:00 pm, she had developed a fever of 101 F, with induration on the deltoid that felt hot and tender. At the time of this report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician, regarding his mother-in-law, an 82 year old female patient with no known allergies, who on 18-DEC-2007, at 1:00 pm, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (invalid lot #, provided to physician from another office). Following the vaccination, at 5 or 6 pm, his mother-in-law experienced a heavy feeling of her arm. By 8 or 9:00 pm, she had pain all over her arm, and by 10:00 pm, she had developed a fever of 101 F, with induration on the deltoid that felt hot and tender. At the time of this report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 48 year old female with allergies to penicillin, latex, adhesives, nickel sulfate, neomycin sulfate, Balsam of Peru, dichloride, Nubian and ADVAIR, a history of lung cancer and no concomitant medication usage. The patient was recovering from cancer at the time of vaccination. On 13-DEC-2007, the patient was vaccinated (site and route not reported) with the 1st dose pneumococcal 23v polysaccharide vaccine (lot#657626/1084U) intramuscularly in the left arm in the pm. On 14-DEC-2007, post vaccination, the patient experienced injection site reaction that was red and swollen with white bumps. The injection site was also very sore. The patient was treated with ice and diphenhydramine hydrochloride (BENADRYL). No diagnostic lab test were performed. Subsequently, the patient recovered on a unspecified date. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Nasopharyngitis
Clinical narrative: Information has been received from a registered nurse concerning an adult female patient with drug allergies to penicillin, AMBIEN and ULTRAM and no medical history reported, who on 28-JAN-2008 was vaccinated intramuscularly with the first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 655501/1035F). There was no concomitant medication. On 04-FEB-2008 (reported as one week after vaccination) the patient developed an injection site reaction including redness the size of a quarter and a cold. The patient sought unspecified medical attention and called the office. No diagnostic laboratory studies were performed. The patient did not report the symptoms until after she had recovered. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Arthritis reactive, Blood pressure increased, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: Information has been received from a licensed practical nurse concerning a 62 year old female with hypothyroidism and pneumonia (01-JAN-2008), and no allergies, who on approximately 15-JAN-2008 (also reported as "February 2008" and "2 weeks later"), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 657145/1226U). Concomitant therapy included a thyroid medication and amlodipine besylate. That day the patient experienced a burning sensation with the injection. The following day, the patient's arm was painful and the pain spread across her shoulders, and to her hands, knees and foot. The patient's eyes were reportedly bloodshot. The patient saw an eye doctor who stated she had inflammation of the eyes. The patient was treated with ALREX ophthalmic drops. The patient's ocular symptoms worsened so she went to the emergency room, where she was treated with intravenous steroids. In the emergency room the patient had an elevation in blood pressure with the highest reading being 200/78. She also had an elevated sedimentation rate and an electrocardiogram revealed left ventricular hypertrophy. The emergency room physician diagnosed her with "reactive arthropathy." He noted that other than these symptoms the patient appears healthy. An eye doctor (unknown if this was the same original eye doctor or a new eye doctor) said that she does not have iritis but said the patient has eye pain from an unknown source. The patient currently was on oral prednisone and has decreased muscle tone. She still was not feeling well. The patient's new family physician has ordered an echocardiogram. She has also started the patient on blood pressure medication (unspecified manufacturer). At the time of this report the patient's outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Eye inflammation, Eye pain, Hypotonia, Injection site irritation, Left ventricular hypertrophy
Clinical narrative: Information has been received from a licensed practical nurse concerning a 62 year old female with hypothyroidism and pneumonia (01-JAN-2008), and no allergies, who on approximately 15-JAN-2008 (also reported as "February 2008" and "2 weeks later"), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 657145/1226U). Concomitant therapy included a thyroid medication and amlodipine besylate. That day the patient experienced a burning sensation with the injection. The following day, the patient's arm was painful and the pain spread across her shoulders, and to her hands, knees and foot. The patient's eyes were reportedly bloodshot. The patient saw an eye doctor who stated she had inflammation of the eyes. The patient was treated with ALREX ophthalmic drops. The patient's ocular symptoms worsened so she went to the emergency room, where she was treated with intravenous steroids. In the emergency room the patient had an elevation in blood pressure with the highest reading being 200/78. She also had an elevated sedimentation rate and an electrocardiogram revealed left ventricular hypertrophy. The emergency room physician diagnosed her with "reactive arthropathy." He noted that other than these symptoms the patient appears healthy. An eye doctor (unknown if this was the same original eye doctor or a new eye doctor) said that she does not have iritis but said the patient has eye pain from an unknown source. The patient currently was on oral prednisone and has decreased muscle tone. She still was not feeling well. The patient's new family physician has ordered an echocardiogram. She has also started the patient on blood pressure medication (unspecified manufacturer). At the time of this report the patient's outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Ocular hyperaemia, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a licensed practical nurse concerning a 62 year old female with hypothyroidism and pneumonia (01-JAN-2008), and no allergies, who on approximately 15-JAN-2008 (also reported as "February 2008" and "2 weeks later"), was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 657145/1226U). Concomitant therapy included a thyroid medication and amlodipine besylate. That day the patient experienced a burning sensation with the injection. The following day, the patient's arm was painful and the pain spread across her shoulders, and to her hands, knees and foot. The patient's eyes were reportedly bloodshot. The patient saw an eye doctor who stated she had inflammation of the eyes. The patient was treated with ALREX ophthalmic drops. The patient's ocular symptoms worsened so she went to the emergency room, where she was treated with intravenous steroids. In the emergency room the patient had an elevation in blood pressure with the highest reading being 200/78. She also had an elevated sedimentation rate and an electrocardiogram revealed left ventricular hypertrophy. The emergency room physician diagnosed her with "reactive arthropathy." He noted that other than these symptoms the patient appears healthy. An eye doctor (unknown if this was the same original eye doctor or a new eye doctor) said that she does not have iritis but said the patient has eye pain from an unknown source. The patient currently was on oral prednisone and has decreased muscle tone. She still was not feeling well. The patient's new family physician has ordered an echocardiogram. She has also started the patient on blood pressure medication (unspecified manufacturer). At the time of this report the patient's outcome was not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no allergies, who on 06-MAR-2008 was vaccinated subcutaneously with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 655766/0038U). On 06-MAR-2008 the patient experienced cellulitis at the injection site. The patient went to the emergency room and was treated with antibiotics and was then released. No diagnostic laboratory 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. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female with no drug allergies, who in November 2007 or December 2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. In February 2008 the patient received a second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced a sore arm. The patient sought unspecified medical attention via the pharmacist. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on approximately 11-MAR-2008, in the last two days, was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 659149/1383U). On approximately 11-MAR-2008, in the last two days, the patient experienced an injection site reaction. There was a large red area that was swollen and painful. At the time of this report, the patient had not recovered. The reporter is requesting that a lot check be done on this lot number. 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. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 65 year old female patient with drug allergies to EFFEXOR XR, simvastatin (MSD), LIPITOR and ezetimibe (MSD), who on 07-MAR-2008 was vaccinated intramuscularly into the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 658449/0989U). There was no concomitant medication. On 07-MAR-2008, the patient developed an injection site rash. The rash was described as a large, round 4X4 area of redness, was swollen, with minimal warmth to touch at the injection site. The patient called the office three days after the vaccination to report the reaction. The patient stated she received the ADACEL vaccination on 07-NOV-2007 and had an identical reaction. No diagnostic laboratory studies were performed. At the time of this report the patient recovered from the redness and warmth. The outcome of the rash and swelling was unknown. It was reported that no previous vaccination with pneumococcal 23v polysaccharide vaccine was noted. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Local swelling, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 40 year old male patient with a recent history of myocardial infarction who on an unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient developed a severe localized reaction including pain, fever, and swelling. The patient sought unspecified medical attention. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered
Clinical narrative: Initial and follow up information has been received from a Medical Assistant concerning a 62 year old female patient who on 11-MAR-2008 was vaccinated IM in to right arm with a dose of pneumococcal 23v polysaccharide vaccine, lot # 655765/1229F. The MA reported that a nurse might have given the patient 0.5 mL of pneumococcal 23v polysaccharide vaccine or 1.5 mL of pneumococcal 23v polysaccharide vaccine at one visit. There were three doses remaining in the multi-dose vial prior to the administration but was discarded in the sharp container after the injection was administered. It was stated that patient's pneumococcal 23v polysaccharide vaccine record was not clear. No adverse event reported. No other details available. The patient's outcome was unknown.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a nurse, female consumer, who "sometime in 2003" was vaccinated, "sometime in 2003," with a dose of pneumococcal 23v polysaccharide vaccine (Lot # unknown). Subsequently, on an unknown date in 2003, the patient experienced a large swollen area on her arm, the size larger than a golf ball. The swollen area appeared to be pear shaped, and the vaccination was close to its expiration date. Subsequently, on an unknown date, the patient recovered from large swollen area. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports from the same source. No further information is available.