chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Cellulitis, Dizziness, Erythema, Headache
Clinical narrative: Information has been received from a health professional concerning a 65 year old white female with no pertinent medical history or drug reactions/allergies who on 15-OCT-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 657626/1084U) IM in the right deltoid. Concomitant therapy on the same day included influenza virus vaccine (unspecified). On 17-OCT-2007, the patient called the office at 2:53PM and complained of dizziness, headache behind eye, fever was 101.2, right arm was swollen and hot to touch. The patient had asked to get a flu shot and pneumococcal 23v polysaccharide vaccine in the same arm on 15-OCT-2007. Diagnosis was right arm cellulitis and allergic reaction. The treatment included KEFLEX 500mg BID for 10 days, BENADRYL 25 mg at bedtime and ibuprofen HCl 200mg TID when needed. Both sites were involved. Erythematous patches. Temperature was 99.5. At the time of reporting the patient had recovered. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Oedema peripheral, Pyrexia, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 65 year old white female with no pertinent medical history or drug reactions/allergies who on 15-OCT-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 657626/1084U) IM in the right deltoid. Concomitant therapy on the same day included influenza virus vaccine (unspecified). On 17-OCT-2007, the patient called the office at 2:53PM and complained of dizziness, headache behind eye, fever was 101.2, right arm was swollen and hot to touch. The patient had asked to get a flu shot and pneumococcal 23v polysaccharide vaccine in the same arm on 15-OCT-2007. Diagnosis was right arm cellulitis and allergic reaction. The treatment included KEFLEX 500mg BID for 10 days, BENADRYL 25 mg at bedtime and ibuprofen HCl 200mg TID when needed. Both sites were involved. Erythematous patches. Temperature was 99.5. At the time of reporting the patient had recovered. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 71 year old Caucasian female with allergies to MOTRIN and LEVAQUIN, who on 29-NOV-2007 was vaccinated IM in the right deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (Lot# 659226/1419U). On 30-NOV-2007, the patient called the office to report that her right upper arm was very warm to the touch where the vaccine was given. There was no redness. The patient noticed it when rolling over in bed, and it woke her up. Treatment included cold compress and antihistamines (over the counter, not specified). At the time of the report, the outcome of the event was unknown. Additional information is not expected.
Age: 85.0
Sex: U
Vaccine: PPV
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a patient born on 25-JUN-1922, who on 31-JAN-2008 was vaccinated with a 0.5 mL dose of PNEUMOAX 23. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed a fever of 102 Fahrenheit lasting for two days. The patient sought unspecified medical attention. The patient was treated with aspirin. The patient has also received pneumococcal 23v polysaccharide vaccine in the past. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning a 71 year old female consumer with a history of renal cancer (about 3 years ago), and no drug allergies, who on 07-JAN-2008 was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (Lot#, dose and route not specified) to the right arm. Concomitant therapy included simvastatin (MSD), alendronate sodium (MSD), baby aspirin, SYNTHROID, and triamterene. The patient reported that after receiving the pneumococcal 23v polysaccharide vaccine she developed swelling below the shoulder blade and her entire arm was sore. The patient reported receiving pneumococcal 23v polysaccharide vaccine every ten years (dates unspecified), and she never experienced any bad reactions. The patient visited her primary physician and was sent to the hospital, she was not admitted into the hospital and was later released the same day (date not specified). No treatment information was provided. The patient reportedly recovered "one week after 07-JAN-2008" (about 14-JAN-2008). No product quality complaint was involved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information and follow up has been received from a health professional concerning a 68 year old patient with an allergy to tape and OMICEF, hypertension, hyperlipidemia, major depression and low back pain who on 16-OCT-2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot# not provided). Concomitant therapy included the flu vaccine (lot# not reported). On 16-OCT-2003, the patient experienced severe injection site reaction including redness, pain and swelling at the injection site. Subsequently, the patient recovered on 20-OCT-2003 from severe injection site reaction including redness, pain and swelling at the injection site. The patient also received pneumococcal 23v polysaccharide vaccine 5 years prior to this. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient (age and gender not specified), who on an unknown date was vaccinated with a dose pneumococcal 23v polysaccharide vaccine, and then developed a reaction area that was extremely red and warm to touch. The outcome of the event was not specified. No further details were provided. This is one of 2 reports from the same source. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 71 year old white male with arthritis, chronic obstructive pulmonary disease, asthma, hypertension, emphysema, hyperlipidaemia, blurred vision, difficulty swallowing, prostate problems and erectile dysfunction and a history of dyspepsia, who on 24-OCT-2007 was vaccinated intramuscularly in the right arm with pneumococcal 23v polysaccharide vaccine (Lot 658449/0989U). The patient previously received a dose of
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Initial and follow up information have been received from a pharmacist concerning a 73 year old female with concomitant medications, drug allergies, and pertinent medical history not specified, who on 12-MAY-2008 was vaccinated, Sub Q, with a dose of pneumococcal 23v polysaccharide vaccine (Lot #, while hospitalised for diverticulitis. On 12-MAY-2008, the patient's left upper arm began to swell. The injection site became puffy and warm to the touch with redness along the edges. The doctor was notified. Ice was wrapped around the site. The patient also developed a red and itchy scalp. The patient was given BENADRYL for the itching. On 13-MAY-2008, the patient developed a rash on the left inner arm. Ice was applied. The patient noted feeling better with the ice. Follow up phone call to the pharmacist reported that the patient was discharged from the hospital on 16-MAY-2008, and the pharmacist reported that as far as she could tell by what was noted in the chart, hospitalisation was not prolonged by the patient's experiences with pneumococcal 23v polysaccharide vaccine. Upon discharge, the patient had recovered from itching, swelling, edema, redness of the scalp, rash and redness of the left inner arm. The discharge diagnosis was diverticulitis, and the patient reportedly recovered from the diverticulitis. At the time of discharge, the patient was prescribed AUGMENTIN for diverticulitis as they were questioning an early abscess. No additional information is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Rash
Clinical narrative: Initial and follow up information have been received from a pharmacist concerning a 73 year old female with concomitant medications, drug allergies, and pertinent medical history not specified, who on 12-MAY-2008 was vaccinated, Sub Q, with a dose of pneumococcal 23v polysaccharide vaccine (Lot #, while hospitalised for diverticulitis. On 12-MAY-2008, the patient's left upper arm began to swell. The injection site became puffy and warm to the touch with redness along the edges. The doctor was notified. Ice was wrapped around the site. The patient also developed a red and itchy scalp. The patient was given BENADRYL for the itching. On 13-MAY-2008, the patient developed a rash on the left inner arm. Ice was applied. The patient noted feeling better with the ice. Follow up phone call to the pharmacist reported that the patient was discharged from the hospital on 16-MAY-2008, and the pharmacist reported that as far as she could tell by what was noted in the chart, hospitalisation was not prolonged by the patient's experiences with pneumococcal 23v polysaccharide vaccine. Upon discharge, the patient had recovered from itching, swelling, edema, redness of the scalp, rash and redness of the left inner arm. The discharge diagnosis was diverticulitis, and the patient reportedly recovered from the diverticulitis. At the time of discharge, the patient was prescribed AUGMENTIN for diverticulitis as they were questioning an early abscess. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Cough, Pneumonia
Clinical narrative: Information has been received from a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown). Subsequently, the patient reported that the "pneumonia shot did not work." She experienced pneumonia and her chest "feels weird." The patient was treated with cough syrup for cough. At the time of the report the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2008.  Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hyperaesthesia, Injection site pain, Injection site warmth, Paraesthesia
Clinical narrative: Information has been received from a medical assistant concerning a 41 year old female with hypothyroidism who on 12-MAY-2008 was vaccinated intramuscularly in the right arm with her first dose of pneumococcal 23v polysaccharide vaccine (lot # 659199/1541U). Concomitant therapy included vaccination with ADACEL (not further specified) and unspecified therapies for hypothyroidism. On 12-MAY-2008, the patient developed an injection site reaction. The patient's right arm was warm to the touch, with tingling down the arm, and sensitive to touch. The patient also had pain during administration. The patient sought unspecified medical attention in the office. The patient outcome was not reported. No additional information was provided. 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 certified medical assistant concerning a 41 year old female teacher with hypothyroidism, asthma and allergies who on 12-MAY-2008 was vaccinated intramuscularly in the right deltoid with her first dose of PNEUMOVAX (Lot # 659159/1541U). Concomitant therapy included vaccination with ADACEL (lot # C2927AA) and unspecified therapies for hypothyroidism. There was no illness at the time of vaccination. On 12-MAY-2008 the patient developed an injection site reaction. The patient's right arm was sore, warm to the touch, with tingling down the arm, and very sensitive to touch, and the right hand was cold. The patient also had pain during administration. The patient sought unspecified medical attention in the office. The patient was given a referral to neurology clinic for an EMG, but the patient did not make the appointment. On an unspecifed date the patient recovered from sore, warm tingling right arm, arm very sensitive to touch, and cold right hand. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a school nurse concerning a patient who reported to the nurse that 10-15 years ago (approximately 1993), she was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #, dose and route not reported). The nurse reported that 10-15 years ago when the pneumococcal 23v polysaccharide vaccine was given, the patient broke out in hives. The nurse hade no further information. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on 23-MAY-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported). On 24-MAY-2008, the patient developed a rash and was taken to the emergency room. It was not known if the patient was admitted. The pharmacist reported that the patient may have had an allergic reaction to something that was eaten on leave from the facility. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a school nurse concerning a patient who 10-15 years ago (approximately 1993), was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #, dose and route not reported). The nurse reported that 10-15 years ago when the pneumococcal 23v polysaccharide vaccine was given, the patient broke out in hives. The nurse had no further information. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a 64 year old female with hives with suldinac (WAES 0805USA06072) and horse serum who on an unspecified date was vaccinated with an unspecified pneumonia "shot" (manufacturer not reported). After she received the shot, the patient reported that her arm swelled up at the injection site. The patient also reported her experiences with zoster vaccine live (Oka/Merck) (WAES 0805USA03822). Additional information is not expected.
Age: 2.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received form a medical assistant concerning a 24 month old patient who on 27-MAY-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 27-MAY-2008, it was reported that the 2 year old patient received pneumococcal 23v polysaccharide vaccine instead of PREVNAR due to human error. No adverse effect was reported. 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: Allergy to vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a female with hypertension, hyperthyroidism, hyperlipidaemia, migraine and an allergy to ALEVE who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On an unspecified date the patient experienced an allergy to 23v polysaccharide vaccine. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The patient also had an adverse experience with zoster vaccine live (Oka/Merck) (MSD) (WAES # 0805USA02113). Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning her 76 year old mother, with a recent diagnosis of mycobacterium avium intracellulare lymphadenitis (MAI/MAC), who on 29-JAN-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 29-JAN-2008, the patient experienced redness and swelling at the injection site. The patient visited another country in November 2007, and in December 2007 saw her cardiologist and was diagnosed with MAI/MAC infection which may have been present at the time of the pneumococcal 23v polysaccharide vaccine. On 02-FEB-2008, the patient recovered. No further information is available.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: 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. A follow up telephone call to the doctor's office was made to obtain more information about the patient's. 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.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: 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. A follow up telephone call to the doctor's office as 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.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a senior technician certified concerning a patient who on 02-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 03-OCT-2007, the patient developed a rash and swelling at the injection site. The patient may have also developed a fever. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a senior technician certified concerning a patient who on 02-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 03-OCT-2007, the patient developed a rash and swelling at the injection site. The patient may also have developed a fever. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a senior technician certified concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed raised, hot, tender lump at the injection site. At the time of the report, the patient's outcome was known. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a patient who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced fever, redness, soreness and swelling at the injection site and was hospitalized. At the time of the report the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports for the same source. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Anaphylactic reaction, Cough, Flushing, Swelling face
Clinical narrative: Information has been received from a physician assistant concerning a 9 year old male patient with a history of chronic urticaria who on 03-JAN-2008 was vaccinated IM into left arm with 0.5 mL of pneumococcal 23v polysaccharide vaccine, lot # 658555/0964U. The reporter reported that the patient experienced an anaphylactic reaction which consisted of facial swelling, flushing, tightness of the throat, coughing and gastrointestinal upset within a few minutes of receiving the injection. He was administered epinephrine, intramuscular BENADRYL, ranitidine and oxygen at the physician's office. The patient also received three teaspoonsful of PRELONE prior to being transported to the emergency room. The patient was kept at the emergency room overnight so he could be monitored but was not admitted to the hospital. On 04-JAN-2008, the patient recovered. The reporter indicated that the patient's adverse event anaphylactic reaction, was disabling and life threatening. She also believed patient getting epinephrine, IM BENADRYL, ranitidine, oxygen and getting 3 teaspoonsful of PRELONE prior to being transported to the emergency room were interventions to prevent a serious criteria and the the event reported was an other medical event. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Throat tightness
Clinical narrative: Information has been received from a physician assistant concerning a 9 year old male patient with a history of chronic urticaria who on 03-JAN-2008 was vaccinated IM into left arm with 0.5 mL of pneumococcal 23v polysaccharide vaccine, lot # 658555/0964U. The reporter reported that the patient experienced an anaphylactic reaction which consisted of facial swelling, flushing, tightness of the throat, coughing and gastrointestinal upset within a few minutes of receiving the injection. He was administered epinephrine, intramuscular BENADRYL, ranitidine and oxygen at the physician's office. The patient also received three teaspoonsful of PRELONE prior to being transported to the emergency room. The patient was kept at the emergency room overnight so he could be monitored but was not admitted to the hospital. On 04-JAN-2008, the patient recovered. The reporter indicated that the patient's adverse event anaphylactic reaction, was disabling and life threatening. She also believed patient getting epinephrine, IM BENADRYL, ranitidine, oxygen and getting 3 teaspoonsful of PRELONE prior to being transported to the emergency room were interventions to prevent a serious criteria and the the event reported was an other medical event. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a physician's office via a healthcare professional concerning a 60 year old white male physician who on 07-JAN-2008 was vaccinated IM into left arm with a first dose of pneumococcal 23v polysaccharide vaccine, lot # 658200/0804U. On 09-JAN-2008, the patient developed pain and redness at and below site. The outcome was unknown. The reporter indicated that the patient required medical intervention (not specified) to prevent a serious criteria and thus the event was reported as an other medical event. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood culture negative, Chills, Injection site induration, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 58 year old female with a penicillin allergy and allergies to CIPRO and KEFLEX and a history of breast cancer who on 02-NOV-2007 was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). Concomitant therapy included ZOLOFT and influenza virus vaccine (unspecified). On 03-NOV-2007 (14 to 15 hours after the injection), the patient developed chills, fever of 102F, and local induration at the site of injection. The patient was instructed to take TYLENOL and apply a topical steroid cream to the area. Within 48 hours the area increased in size from about 4 by 6 inches to 6 by 8 inches. The patient was examined by the physician on 05-NOV-2007. The patient's white blood cell count was 20,000 cells per cubic millimeter of blood. The patient was started on clindamycin. On 06-NOV-2007, the patient was admitted in the hospital and started on IV vancomycin. As of 07-NOV-2007, the patient does not have a fever and her WBC is 11,000 cells per cubic millimeter of blood. She has been examined by an infectious disease physician and a surgeon. The patient is scheduled for an MRI to rule out an abscess. The physician requested a lot check. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Oedema peripheral, Pain in extremity, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmD concerning a 47 year old male with asplenia and no history of drug reactions/allergies who received his 1st dose of pneumococcal 23v polysaccharide vaccine at least 6 years ago. On 09-NOV-2007, the patient was vaccinated intramuscularly with the 2nd dose of pneumococcal 23v polysaccharide vaccine (lot#658673/0990U). Concomitant therapy included analgesics (unspecified). On 10-NOV-2007, post vaccination, the patient developed severe pain, swelling in his arm and a temperature of 105F. On 10-Nov-2007, the patient was examined in the emergency room and was admitted into ICU with a white blood cell count of 13.8 with left shift. The patient was administered IV fluids and given an analgesic. The patient was released from the hospital on 11-Nov-2007. On 13-Nov-2007, the patient was examined at the hospital for a rash on the left axilla area. The patient had no other symptoms and was given a treatment for topical application. The patient was examined by his physician on 14-Nov-2007. At the time the rash had improved. The pharmD felt that the patient's pain, swelling in his arm, temperature of 105F and white blood cell count 13.8 with a left shift were considered to be serious and immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a pharmD concerning a 47 year old male with asplenia and no history of drug reactions/allergies who received his 1st dose of pneumococcal 23v polysaccharide vaccine at least 6 years ago. On 09-NOV-2007, the patient was vaccinated intramuscularly with the 2nd dose of pneumococcal 23v polysaccharide vaccine (lot#658673/0990U). Concomitant therapy included analgesics (unspecified). On 10-NOV-2007, post vaccination, the patient developed severe pain, swelling in his arm and a temperature of 105F. On 10-Nov-2007, the patient was examined in the emergency room and was admitted into ICU with a white blood cell count of 13.8 with left shift. The patient was administered IV fluids and given an analgesic. The patient was released from the hospital on 11-Nov-2007. On 13-Nov-2007, the patient was examined at the hospital for a rash on the left axilla area. The patient had no other symptoms and was given a treatment for topical application. The patient was examined by his physician on 14-Nov-2007. At the time the rash had improved. The pharmD felt that the patient's pain, swelling in his arm, temperature of 105F and white blood cell count 13.8 with a left shift were considered to be serious and immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Metabolic function test, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a nurse concerning an 83 year old female with a sulfonamide (sulfur) allergy, hyperlipidemia and hypothyroidism. The patient's social history includes tobacco and alcohol use. In 1999 the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 21-NOV-2007, the patient was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (Lot #655501/1035F). Concomitant therapy included BONIVA, ACIPHEX and an unspecified thyroid medication. On 21-NOV-2007, later that night the patient developed a fever. On 22-NOV-2007, the next day, the patient developed a red and swollen arm extending from the upper arm to the elbow. The patient was diagnosed with cellulitis. On 22-NOV-2007, she was examined in the emergency room, but was not admitted. In the ER she was administered ROCEPHIN intravenously and released with a prescription for KEFLEX. A complete metabolic panel was performed, results not reported. On 23-NOV-2007, she was administered a second dose of ROCEPHIN at the ER but was not admitted. On 25-NOV-2007, the patient had completely recovered. On 26-NOV-2007, she was examined by the physician. The nurse considered cellulitis with fever and red and swollen arm to be disabling events and other important medical events. Follow-up information was received from the nurse with Medical Records. The physician commented that "I would normally suspect this is a simple reaction to the vaccination but the size of this and the exquisite tenderness points to a potential cellulitis." The final impression was cellulitis in the left arm. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with diabetes who on 07-NOV-2007 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 658443/0989U). There was no concomitant medication. On 08-NOV-2007 the patient experienced inflammation and swelling in the vaccinated arm (which arm unspecified). The patient went to the emergency room and this reaction was diagnosed as cellulitis. The patient was given unspecified antibiotics. On 11-NOV-2007, the patient recovered. Inflammation and swelling in the vaccinated arm and cellulitis were considered to be immediately life-threatening. Additional information has been requested. Follow-up information was received from a Lot check investigation summary. The summary of investigations revealed that there were no Investigations related to the manufacturing of 0989U, 0658449, and 2119750. A review of the release testing data revealed that 0989U, 0658449, and 2119750 conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Induration, Pain, Pyrexia, Rash
Clinical narrative: Information has been received from a healthcare professional concerning a 72 year old white female who on 04-NOV-2007 was vaccinated on the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658449/0989U). On 04-NOV-2007, the patient became feverish with indurated rash approximately 8 X 7 cm with pain and cellulitis. The patient was treated with AUGMENTIN. The patient's outcome was not reported. Feverish with indurated rash approximately 8 X 7 cm with pain and cellulitis was considered to be an other important medical event. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 42 (also reported as 32) year old female patient "with a history of poor health" on 25-OCT-2007 was vaccinated IM into the right deltoid, into her right arm with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot# 657038/0860U). Concomitant therapy given into left arm included a first dose of FLUZONE. Other concomitant therapy included PROZAC, WELLBUTRIN XL "300," ("TRAZADONE") "100," TOPMAX "25" AND ZOVIRAX 400 mg. It was reported that initially there was no reaction. On 25-OCT-2007, 12 hours post vaccination, the patient developed pain, expanding redness consistent with right shoulder cellulitis. The patient was treated for 7 days with dicloxacillin and doxycycline. The nurse did not feel that this was an inflammatory reaction. At the time of this report, the patient was recovering. No product quality complaint was involved. Right shoulder cellulitis was considered to be another important medical event. This is an amended report. Concomitant therapy FLUZONE is not a suspect medication. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician and a healthcare professional, concerning a patient (age and gender not specified), who on 19-JUN-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 20-JUN-2007 the patient developed a fever (value not specified). On 21-JUN-2007, the fever was 101 degrees and the patient also developed a local reaction of swelling and erythema. Treatment for the fever included acetaminophen (TYLENOL), and erythromycin was also prescribed. The patient recovered after an unknown duration of time. The physician considered the injection site reaction to be serious as other important medical events. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician and a healthcare professional, concerning a patient (age and gender not specified), who on 14-MAY-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #655765/0061U) ("low titer" drawn on 27-APR-2007). On 29-MAY-2007, the patient developed an injection site reaction described as swelling, erythema and tenderness at the site of vaccination. The reaction site measured 7 cm by 5 cm. Treatment included cephalexin (KEFLEX), and the patient recovered from the events (duration not specified). The physician considered the injection site reaction to be serious as other important medical events. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical sales service distributor, concerning a female patient (age not specified), who was vaccinated (date not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot #655501/1035F). Later on the day of vaccination, the patient developed severe cellulitis and was hospitalized for an unspecified duration of time. At the time of this report, the outcome of the event was unknown. No further information was available. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 59 year old white female professor with an allergy to vancomycin (hives) and erythromycin (nausea) and no medical history who on 11-OCT-2007, was vaccinated IM into right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus whole virion 3v vaccine inactivated (FLUZONE (influenza virus whole virion 3v vaccine inactivated)) (lot # U2443AA) administered IM into left arm, levothyroxine Na (SYNTHROID) and bupropion SR 150. On 11-OCT-2007, the patient developed cellulitis in the right shoulder at the injection site with erythema and tenderness 2 inches around the injection site. It was reported that the patient required 2 different antibiotics, cephalexin (KEFLEX) 500 mg QID and amoxicillin (+) clavulanate potassium (AUGMENTION) 875 mg BID. It was reported that she was not treated with medication. Subsequently, the patient was recovering. No product quality complaint was involved. Injection site cellulitis was considered to be life threatening and an other important medical event. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot 657143/0380U). Subsequently, the patient developed arm swelling, shoulder joint pain and immobility in the arm that the injection was given in. The patient called the office to report her experience but was not evaluated in the emergency room. At the time of this report, the patient had not recovered. The nurse requested a lot check be performed on lot 657143/0380U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center of Biologics Evaluation and Research and was released. The patient's experience was considered disabling due to arm immobility. Additional information has been requested. This is one of two reports from the same source.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) who on an unspecified date was vaccinated intramuscularly with a 0.5 mL first dose of pneumococcal 23v polysaccharide vaccine (lot 6547143/0380U). Subsequently, the patient developed arm swelling, shoulder joint pain and immobility in the arm that the injection was given in. The patient was evaluated in the emergency room but was not hospitalized. At the time of this report , the patient had not recovered. The nurse requested a lot check be performed on lot 657143/0380U. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The patient's experience was considered disabling due to arm immobility. Additional information has been requested. This is one of two reports from the same source.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Malaise
Clinical narrative: Information has been received from a health professional concerning a female staff member who on 07-MAR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 658449/0989U). Subsequently, she developed cellulitis after receiving the vaccine. She was evaluated in a medical setting, and then admitted to the hospital where she was treated with intravenous antibiotics. She complained of generally not feeling well, which may have started prior to receiving pneumococcal 23v polysaccharide vaccine (Lot # 658449/0989U). On an unspecified date, she recovered. No product quality complaint involved. This is one of two reports from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Anxiety, Blood culture negative, Cellulitis, Chills, Cough
Clinical narrative: Information has been received from Sentrx and was assigned manufacturer report number MC200800078, concerning a 61 year old male who is a smoker and has a history of hyperlipidaemia, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA)/PCI and a family history of coronary artery disease who on 02-FEB-2008, was vaccinated IM into his right deltoid muscle with a 25 "ug" dose of pneumococcal 23v polysaccharide vaccine for pneumonia prevention. The patient experienced right arm cellulitis while enrolled in protocol TMC-CAN-05-02, a clinical trial comparing cangrelor to clopidogrel in subjects undergoing percutaneous coronary intervention (PCI). Other concomitant therapy included bivalirudin. On 31-JAN-2008, the patient was admitted to the hospital, enrolled in the study and underwent PCI. He received an intravenous bolus dose of the blinded study medication 5.8 ml on 01-FEB-2008 at 17:09, followed by an infusion of 95.48 mL from 17:11 to 19:15. Additionally, the patient received an oral dose of blinded study medication, four pre-procedure capsules on 01-FEB-2008 at 17:11 and four post procedure capsules on 01-FEB-2008 at 19:20. On 02-FEB-2008 at 13:00, the patient was discharged immediately after receiving the pneumococcal 23v polysaccharide vaccine. On 02-FEB-2008 at 13:30, the patient experienced right arm cellulitis. He developed redness and gradual swelling of the injection site and later in the day he developed fever and chills. Additional presenting symptoms included pain at the injection site, cough, myalgia, rash and anxiety. The patient presented back to the emergency room on 03-FEB-2008 for treatment. Laboratory tests performed included absolute neutrophil count of 10.2 Thou/uL and a white blood cell count of 12.4 Thou/uL. A blood culture was negative with no growth seen on a culture taken from the peripheral line on the right arm. The patient was treated with IV cefepime, 1 g bid from 04-FEB-2008 at 07:00 to 06-FEB-2008 at 07:00 and IV vancomycin, 1g every day on 04-FEB-2008 at 20:00 to 06-FEB-2008 at 12:15 for an infection in the right arm. Laboratory results normalized on 06-FEB-2008 with absolute neutrophils of 5.8 Thou/uL and WBC of 8.4 Thou/uL. On 13-FEB-2008, the event was considered to be resolved. This was originally reported by a physician. The reporting investigator considered the event to be probably related to the pneumococcal 23v polysaccharide vaccine and unrelated to the study medications. No further information is available.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site swelling, Myalgia, Neutrophil count increased
Clinical narrative: Information has been received from Sentrx and was assigned manufacturer report number MC200800078, concerning a 61 year old male who is a smoker and has a history of hyperlipidaemia, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA)/PCI and a family history of coronary artery disease who on 02-FEB-2008, was vaccinated IM into his right deltoid muscle with a 25 "ug" dose of pneumococcal 23v polysaccharide vaccine for pneumonia prevention. The patient experienced right arm cellulitis while enrolled in protocol TMC-CAN-05-02, a clinical trial comparing cangrelor to clopidogrel in subjects undergoing percutaneous coronary intervention (PCI). Other concomitant therapy included bivalirudin. On 31-JAN-2008, the patient was admitted to the hospital, enrolled in the study and underwent PCI. He received an intravenous bolus dose of the blinded study medication 5.8 ml on 01-FEB-2008 at 17:09, followed by an infusion of 95.48 mL from 17:11 to 19:15. Additionally, the patient received an oral dose of blinded study medication, four pre-procedure capsules on 01-FEB-2008 at 17:11 and four post procedure capsules on 01-FEB-2008 at 19:20. On 02-FEB-2008 at 13:00, the patient was discharged immediately after receiving the pneumococcal 23v polysaccharide vaccine. On 02-FEB-2008 at 13:30, the patient experienced right arm cellulitis. He developed redness and gradual swelling of the injection site and later in the day he developed fever and chills. Additional presenting symptoms included pain at the injection site, cough, myalgia, rash and anxiety. The patient presented back to the emergency room on 03-FEB-2008 for treatment. Laboratory tests performed included absolute neutrophil count of 10.2 Thou/uL and a white blood cell count of 12.4 Thou/uL. A blood culture was negative with no growth seen on a culture taken from the peripheral line on the right arm. The patient was treated with IV cefepime, 1 g bid from 04-FEB-2008 at 07:00 to 06-FEB-2008 at 07:00 and IV vancomycin, 1g every day on 04-FEB-2008 at 20:00 to 06-FEB-2008 at 12:15 for an infection in the right arm. Laboratory results normalized on 06-FEB-2008 with absolute neutrophils of 5.8 Thou/uL and WBC of 8.4 Thou/uL. On 13-FEB-2008, the event was considered to be resolved. This was originally reported by a physician. The reporting investigator considered the event to be probably related to the pneumococcal 23v polysaccharide vaccine and unrelated to the study medications. No further information is available.