chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Compartment syndrome, Injection site erythema, Local reaction, Musculoskeletal stiffness
Clinical narrative: Information has been received from a 68 year old male registered nurse with penicillin allergy and a history of aortic stenosis, gallbladder cholecystectomy, laminectomy and total knee replacement on 20-SEP-2010 at 11:00 AM was vaccinated subcutaneously in his right arm with 0.5 ml PNEUMOVAX 23 (lot# 665707/1407Y). Concomitant therapy included DIOVAN, LIPITOR, doxazosin mesylate and finasteride. On the same day, a few hours after, he stated that his right arm was very stiff, painful, swollen and warm to the touch. He stated "it was almost like I had compartment syndrome". He stated he saw his physician this morning. He was advised to take two ibuprofen and apply ice. He stated his swelling went down 30% this morning. There was no laboratory test performed. At the time of the report, he stated his muscle was edematous and hard. The outcome was reported as not recovered. Follow-up information has been received from a health professional concerning the 68 year old male with aortic stenosis, cholesterol levels raised, diabetes, morbid obesity and hypertension and no illness at time of vaccination who on 20-SEP-2010 was vaccinated in his right arm with the second dose of PNEUMOVAX 23 (lot# 665707/1407Y (Lot # also reported as 14074)). On 13-SEP-2010 at 10:18 AM, the patient was vaccinated in his left arm with a dose of FLULAVAL (LOT# AFLLA603AA). On 20-SEP-2010 at PM, the patient developed an area of erythema, extending from the top of the right shoulder down to about one inch above the elbow crease, over the anterior surface and extending ? ways around. On 20-SEP-2010 patient called after hour's number with complaint. He described compartment syndrome. He was instructed to go to the emergency room (ER) right away. Patient followed-up in my office the following morning. Diagnostic: local reaction "v." cellulitis. Injection site was cleaned with rubbing alcohol in contrast for what patient stated. Patient was started on BACTRIM DS and clindamycin. Patient responded well. There was no relevant lab data. On 22-SEP-2010, the patient recovered. Follow-up information has been received from the retired registered nurse who reported that the previous PNEUMOVAX 23 was given to him 5 years ago. His arm swelled to max size and began to worry about compartment syndrome. He had taken 600mg Non-steroidal anti-inflammatory drug (NSAID). The "next day" he recovered. According to the reporter, cellulitis, arm swelling to max size and local reaction were considered to be other important medical events. This is one of several reports received from the same source. No further information is available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Myosclerosis, Oedema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a 68 year old male registered nurse with penicillin allergy and a history of aortic stenosis, gallbladder cholecystectomy, laminectomy and total knee replacement on 20-SEP-2010 at 11:00 AM was vaccinated subcutaneously in his right arm with 0.5 ml PNEUMOVAX 23 (lot# 665707/1407Y). Concomitant therapy included DIOVAN, LIPITOR, doxazosin mesylate and finasteride. On the same day, a few hours after, he stated that his right arm was very stiff, painful, swollen and warm to the touch. He stated "it was almost like I had compartment syndrome". He stated he saw his physician this morning. He was advised to take two ibuprofen and apply ice. He stated his swelling went down 30% this morning. There was no laboratory test performed. At the time of the report, he stated his muscle was edematous and hard. The outcome was reported as not recovered. Follow-up information has been received from a health professional concerning the 68 year old male with aortic stenosis, cholesterol levels raised, diabetes, morbid obesity and hypertension and no illness at time of vaccination who on 20-SEP-2010 was vaccinated in his right arm with the second dose of PNEUMOVAX 23 (lot# 665707/1407Y (Lot # also reported as 14074)). On 13-SEP-2010 at 10:18 AM, the patient was vaccinated in his left arm with a dose of FLULAVAL (LOT# AFLLA603AA). On 20-SEP-2010 at PM, the patient developed an area of erythema, extending from the top of the right shoulder down to about one inch above the elbow crease, over the anterior surface and extending ? ways around. On 20-SEP-2010 patient called after hour's number with complaint. He described compartment syndrome. He was instructed to go to the emergency room (ER) right away. Patient followed-up in my office the following morning. Diagnostic: local reaction "v." cellulitis. Injection site was cleaned with rubbing alcohol in contrast for what patient stated. Patient was started on BACTRIM DS and clindamycin. Patient responded well. There was no relevant lab data. On 22-SEP-2010, the patient recovered. Follow-up information has been received from the retired registered nurse who reported that the previous PNEUMOVAX 23 was given to him 5 years ago. His arm swelled to max size and began to worry about compartment syndrome. He had taken 600mg Non-steroidal anti-inflammatory drug (NSAID). The "next day" he recovered. According to the reporter, cellulitis, arm swelling to max size and local reaction were considered to be other important medical events. This is one of several reports received from the same source. No further information is available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Vaccine positive rechallenge
Clinical narrative: Information has been received from a 68 year old male registered nurse with penicillin allergy and a history of aortic stenosis, gallbladder cholecystectomy, laminectomy and total knee replacement on 20-SEP-2010 at 11:00 AM was vaccinated subcutaneously in his right arm with 0.5 ml PNEUMOVAX 23 (lot# 665707/1407Y). Concomitant therapy included DIOVAN, LIPITOR, doxazosin mesylate and finasteride. On the same day, a few hours after, he stated that his right arm was very stiff, painful, swollen and warm to the touch. He stated "it was almost like I had compartment syndrome". He stated he saw his physician this morning. He was advised to take two ibuprofen and apply ice. He stated his swelling went down 30% this morning. There was no laboratory test performed. At the time of the report, he stated his muscle was edematous and hard. The outcome was reported as not recovered. Follow-up information has been received from a health professional concerning the 68 year old male with aortic stenosis, cholesterol levels raised, diabetes, morbid obesity and hypertension and no illness at time of vaccination who on 20-SEP-2010 was vaccinated in his right arm with the second dose of PNEUMOVAX 23 (lot# 665707/1407Y (Lot # also reported as 14074)). On 13-SEP-2010 at 10:18 AM, the patient was vaccinated in his left arm with a dose of FLULAVAL (LOT# AFLLA603AA). On 20-SEP-2010 at PM, the patient developed an area of erythema, extending from the top of the right shoulder down to about one inch above the elbow crease, over the anterior surface and extending ? ways around. On 20-SEP-2010 patient called after hour's number with complaint. He described compartment syndrome. He was instructed to go to the emergency room (ER) right away. Patient followed-up in my office the following morning. Diagnostic: local reaction "v." cellulitis. Injection site was cleaned with rubbing alcohol in contrast for what patient stated. Patient was started on BACTRIM DS and clindamycin. Patient responded well. There was no relevant lab data. On 22-SEP-2010, the patient recovered. Follow-up information has been received from the retired registered nurse who reported that the previous PNEUMOVAX 23 was given to him 5 years ago. His arm swelled to max size and began to worry about compartment syndrome. He had taken 600mg Non-steroidal anti-inflammatory drug (NSAID). The "next day" he recovered. According to the reporter, cellulitis, arm swelling to max size and local reaction were considered to be other important medical events. This is one of several reports received from the same source. No further information is available.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 77 year old female patient with no pertinent medical history and allergy to Penicillin, Sulfa and Tetracycline who on 20-SEP-2010 was vaccinated with PNEUMOVAX 23. Concomitant therapy included KEFLEX. On 20-SEP-2010 evening, the patient developed cellulitis. The patient called the office and sought the medical attention. It improved after treatment with Prednisone. At the time of reporting, the patient was recovering. Cellulitis was considered to be disabling and an other important medical event by the reporter. Follow-up information was received from the nurse practitioner concerning the 77 year old female who on 20-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665924/0930Z) into her right deltoid. Subsequently, the patient experienced right arm extensive erythema, edema and pain. On 27-SEP-2010, the patient recovered. The cellulitis was considered to be other important medical events. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# 667995/1150Z, expiration date on 4-MAR-2012). Subsequently the patient experienced cellulitis and fever after administration of PNEUMOVAX 23 may have been hospitalized for two days (name of hospital was unknown). The patient was treated with antibiotics. She did not have the patient's chart so she could not provide patient specific information. She was requesting a lot check. A lot check has been initiated. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination, date of event, recovery, status, and hospital name. A standard lot check investigation has been finalized. 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 Research Center and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female patient with asthma and a history of acute sinusitis who on 04-JUN-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot# 662268/1134Y) that had expired on 14-APR-2010. No other vaccines were administered. Concomitant therapy included unnamed nasal spray. On 06-JUN-2010 the patient was seen in the office with possible cellulitis with a localized reaction and temperature to 100.2 F. She was started on AUGMENTIN. On 07-JUN-2010, the patient was seen in the office again. The physician felt that it was a localized reaction. Therapy with AUGMENTIN was continued and added MEDROL and BENADRYL. She would return to the office for follow up tomorrow. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Periarthritis
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. The patient experienced frozen shoulder after taking PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 61 year old male patient who on 09-JUN-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot No. not reported). On an unspecified date, the patient experienced fever, headache, muscle aches and soreness at the site. It was unknown if the patient sought medical attention. At the time of the report, outcome for the events was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: No therapeutic response, Seroconversion test negative
Clinical narrative: Information has been received from a physician and from Pfizer under case # 11655355, concerning a 23 year old female with a history of pneumonia and no spleen who in March 2010, was vaccinated with PNEUMOVAX 23 while she was hospitalized for unrelated health problem of pneumonia. Eight weeks later, approximately May 2010, titer was drawn and client had failed to seroconvert. Unspecified medical attention was sought. It was also reported that the patient was not amounting an immune response. At the time of this report, the patient's outcome was not reported. This was originally reported by a physician. This is a consolidation of two reports concerning the same patient. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Therapeutic response decreased
Clinical narrative: This report was received from Pfizer concerning adult patients on haemodialysis who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 (lot#s not reported). It was reported that the patients had been low responders to PNEUMOVAX 23. This was originally reported by a health care professional in a pharmacy intern. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 68 year old female consumer with hypertension, depression and drug hypersensitivity to a lot of medications who in 2000, 10 years ago was vaccinated with the first dose of PNEUMOVAX 23. Subsequently the patient experienced "flu-like" symptoms. On approximately 11-DEC-2009, 6 months ago the patient was vaccinated with the second dose of PNEUMOVAX 23. The patient experienced "flu-like" symptoms again after the second dose of PNEUMOVAX 23. The patient stated that she recovered fully. The patient subsequently experienced a change in mental status while on therapy with ZOSTAVAX (Merck) (WAES#1006USA01794). No further information is available.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old male patient who on 07-JUN-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot No. not reported). On an unspecified date, the patient experienced fever, headache, muscle aches and soreness at the site. It was unknown if the patient sought medical attention. At the time of the report, outcome for the events was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a case in litigation for WAES# 0810USA04095 from a physician via medical records, concerning a female who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently on an unspecified date the patient experienced allergy to the PNEUMOVAX 23. The patient's outcome was unknown. No further information is available.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a 35 year old female patient with rheumatoid arthritis and with no drug reactions/allergies who on 15-JUL-2010 (also reported as 14-JUL-2010 in date therapy started field) was vaccinated IM with a dose of PNEUMOVAX 23. Concomitant therapies included: methotrexate (manufacturer unknown) and prednisone (manufacturer unknown). She had since developed a 1-2 inch welt at the injection site that was red and sore. They mentioned "it looked like cellulitis". The patient sought medical attention by office visit. There was no lab diagnostic test performed. The patient was given KEFLEX. At the time of report the patient's status was recovering. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Visual impairment
Clinical narrative: Information has been received from a physician concerning a 90 year old female with chronic obstructive pulmonary disease, emphysema, hypertension, hyperlipidaemia, asthma and cough who on 26-JUL-2010 was vaccinated with first dose of PNEUMOVAX 23 (lot # not reported), 2.5 mL, intramuscularly. The patient was experiencing visions problems which might be pre-existing. The patient sought medical attention in office. At the time on the report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). Subsequently the patient developed pneumonia. At the time of this report, the patient's outcome was not reported. No further information is available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Localised infection, Movement disorder, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 73 year old female with tetracycline, iodine and sulfa allergies who was vaccinated with PNEUMOVAX 23 (lot # 665917/1341Y). Concomitant therapy included cholesterol medicine, acid reflux medication and hormone replacement. The patient reported within two hours of receiving her third dose in her left arm on 26JUL2010, (dates of her first and second dose of PNEUMOVAX 23 vaccine are unknown). She experienced pain in her arm. She could hardly lift her arm later that day. The following day her left arm was red, hot, and swollen. She was examined by a dermatologist on 28Jul2010 and was told she has an infection in her arm. She was prescribed KEFLEX and a topical antibiotic. It was reported the patient is recovering. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a 73 year old female with tetracycline, iodine and sulfa allergies who was vaccinated with PNEUMOVAX 23 (lot # 665917/1341Y). Concomitant therapy included cholesterol medicine, acid reflux medication and hormone replacement. The patient reported within two hours of receiving her third dose in her left arm on 26JUL2010, (dates of her first and second dose of PNEUMOVAX 23 vaccine are unknown). She experienced pain in her arm. She could hardly lift her arm later that day. The following day her left arm was red, hot, and swollen. She was examined by a dermatologist on 28Jul2010 and was told she has an infection in her arm. She was prescribed KEFLEX and a topical antibiotic. It was reported the patient is recovering. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old male physician patient with no pertinent medical history and no drug reactions/allergies who approximately was vaccinated with a dose of PNEUMOVAX 23 IM "2 years ago" in August 2008. There were no concomitant therapies. Within hours of the vaccination his arm and shoulder were swollen and enlarged. The patient did not require any treatment. The patient sought unspecified medical attention. There were no lab diagnostic tests performed. The symptoms resolved "in a few days 2 years ago". Follow up information has been received from the registered pharmacist indicated that the patient experienced this reaction at the physician's office. They merely called with additional questions. The patient's physician should have already reported. No further information is available.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 68 year old female who on an unspecified day was vaccinated with PNEUMOVAX 23 (Lot # 664653/1337Y) for the prevention of pneumonia. Subsequently the patient experienced increased redness and pain at the injection site. The patient had sought unspecified medical attention. At the time of report, the outcome was unknown. This is one of several reports received from the same source. No further information is available.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This report was received from a company (manufacturer report number not reported). A 36 year old female patient was vaccinated with a dose of PNEUMOVAX 23, on an unspecified date. No concomitant therapy. It was reported that in 2003, the patient experienced fever. The next date, in 2003, the patient recovered/resolved with sequelae. The reporter considered that fever was related to PNEUMOVAX 23. This was originally reported by the patient. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Swollen tongue
Clinical narrative: Information has been received from a registered pharmacist and a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown). After receiving the vaccine, the patient experienced light headedness and swelling of the tongue. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. Follow-up information was received from the registered pharmacist who reported that the physician did not think it was the PNEUMOVAX 23 and that the patient did not get the ZOSTAVAX (Merck). No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Nonspecific reaction
Clinical narrative: Information has been received from a physician concerning a female patient who in 2003 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). The physician reported that in 2003 the patient experienced a "severe" reaction. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is an amended report. "Unknown" was added into "vaccinated at" and "vaccine purchased with" field. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Swollen tongue
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient who on an unknown date, was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). It was reported that the patient developed a swollen tongue a few hours after receiving the vaccine. It was unspecified if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on approximately 25-JUL-2010 (reported as "last week") was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). The pharmacist reported that within one day after receiving PNEUMOVAX 23 (approximately on 26-JUL-2010), the patient developed shingles type rash. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # and expiration date unknown) and experienced an unspecified reaction to the vaccine at some time in the past. It was unknown if the patient sought medical attention. At the time of the report, the patient had recovered. Follow-up information has been received from the pharmacist who reported that he/she was unable to describe the patient had reaction to PNEUMOVAX 23 vaccine prior to admission. This was an allergy listed on his chart. The patient had the allergy prior to coming to their institution. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oedema peripheral, Skin exfoliation
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on an unspecified date was vaccinated IM with 0.5 ml of PNEUMOVAX 23 (lot# 667913/1021Z). It was reported that the patient experienced extensive redness, pain and feeling of heat at injection site. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Follow-up information has been received from a licensed practical nurse concerning a patient who on 26-OCT-2010, was vaccinated subcutaneously (previously reported as IM) with a dose of PNEUMOVAX 23 (lot# 667913/1021Z). It was reported that the patient called to say she had been seen by ortho "for bump she has from [PNEUMOVAX 23]," and that she was told this is a reaction to the injection. The area was now peeling, "not so much pain, but lump is still present from injection." The patient was taking BENADRYL for three weeks and it was noted that this was continued. The patient was instructed to watch for blood pressure elevation, to check at a pharmacy at least once a week. At the time of reporting the outcome was unknown. All available medical records will be provided upon request. No further information is expected.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Skin test positive
Clinical narrative: Information has been received from a physician and his wife concerning a 20 year old female patient, with no pertinent medical history and no drug reactions or allergies, who on 12-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot #08662 - lot # not valid as reported, expire date not reported), 0.1 ml, intradermally, instead of administering TUBERSOL. There was no concomitant medication. On 12-NOV-2010 the patient was experiencing a localized "wheal and flare" reaction with redness and swelling at the site of the injection. There were no laboratory diagnostics studies performed. The patient sought medical attention; she was monitored by physician in the office. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a male patient who on 23-OCT-2010 was vaccinated IM with a dose of PNEUMOVAX 23 0.5ml. A pharmacist reported that a patient received a dose of PNEUMOVAX 23 and experienced a sore arm at the injection site. At the time of reporting, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Inflammatory bowel disease, Malaise, Rash, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old female patient with questionable penicillin allergy and no pertinent medical history, who on 04-OCT-2010 at 15:00 was inadvertently vaccinated with less than a 0.5 ml dose of PNEUMOVAX 23 (Lot # 664654/0823Y EXP 09-MAR-2011) IM right deltoid instead of flu vaccine due to staff error. There was no concomitant medication. The nurse said that patient was not feeling well post vaccination. At 05:00 on 05-OCT-2010 the patient had diarrhea and by 14:00 a rash on her back. On this same day 05-OCT-2010 the patient went to emergency room with inflammation of bowel. The patient was given a medication to control the diarrhea and BENADRYL for the rash. The patient was not hospitalized. At the time of the report the patient was feeling much better. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Arthralgia, Erythema, Influenza like illness, Injection site abscess, Injection site cellulitis
Clinical narrative: Information has been received from a certified medical assistant concerning a 65 year old male with hypertension, emphysema and hyperlipidaemia and "no known drug allergies" who in 2005 was vaccinated IM with the first 0.5ml dose of PNEUMOVAX 23 (Lot number was unknown). On 28-SEP-2010 the patient was vaccinated IM in his left arm with the second dose of PNEUMOVAX 23 (Lot number 667913/1021Z, expiration date 27-FEB-2012). During the same visit the patient were administered a flu vaccine (manufacturer unknown) in his left arm and Tdap in his right arm. Concomitant therapy included DIOVAN HCT, BYSTOLIC, ADVAIR, CRESTOR and aspirin. On 30-SEP-2010 the patient experienced fever of 99F and swelling of his left arm after administration of his second dose of PNEUMOVAX 23 intramuscularly in his left arm on 28-SEP-2010. He also experienced redness and warmth of his left arm. The patient sought medical attention by office visit. The patient was prescribed OMNICEF. No lab diagnostics studies was performed. At the time of reporting, the patient was recovered (date unknown). Information has been received from medical records and a medical assistant concerning a 65 year old male ex-smoker (90phy, quit in 05), with alcohol use (one drink per day) who in 2005 was vaccinated with PNEUMOVAX 23 (lot # unknown) for the first time. On 31OCT08 the pt was vaccinated for the second time with PNEUMOVAX 23 (lot number unknown). On 28SEP10 he was vaccinated with PNEUMOVAX 23 (lot number unknown) (left deltoid), FLUVIRIN (Novartis, Lot #111807P1, exp 30APR2011) (left deltoid) and ADACEL (Sanofi Pasteur, lot # unknown) (right deltoid). The next day the patient had flu like symptoms, including nausea and joint and muscular pain, that lasted for 24 hours without fever but did not look at his arm. He noticed his arm swelling for the first time 30SEP2010, and it was painful to the touch. He was seen by his physician the same day with swollen left upper arm area and had a slight elevation in temperature of 99F. Assessment included cellulitis and abscess of upper arm and forearm and other vaccines and biological substances causing adverse effects in therapeutic use. The pt was to elevate and rest his arm, take ibuprofen 400-600 mg q 6hr prn for pain or fever and BENADRYL that night and be re-checked in 2 days. The physician suggested he take off from work the following day, but the patient did not want to. He was also prescribed OMNICEF 300mg one capsule bid for 10 days. It was reported the patient had recovered by 05OCT2010. The physician felt it was probably a reaction to the PNEUMOVAX 23. This is one of several reports received from the same source. This is an amended report. Vaccinated at: private doctor/hospital and vaccine purchased with: Unknown were added to Therapy. All available medical records will be provided upon request. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site swelling, Myalgia, Nausea, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 65 year old male with hypertension, emphysema and hyperlipidaemia and "no known drug allergies" who in 2005 was vaccinated IM with the first 0.5ml dose of PNEUMOVAX 23 (Lot number was unknown). On 28-SEP-2010 the patient was vaccinated IM in his left arm with the second dose of PNEUMOVAX 23 (Lot number 667913/1021Z, expiration date 27-FEB-2012). During the same visit the patient were administered a flu vaccine (manufacturer unknown) in his left arm and Tdap in his right arm. Concomitant therapy included DIOVAN HCT, BYSTOLIC, ADVAIR, CRESTOR and aspirin. On 30-SEP-2010 the patient experienced fever of 99F and swelling of his left arm after administration of his second dose of PNEUMOVAX 23 intramuscularly in his left arm on 28-SEP-2010. He also experienced redness and warmth of his left arm. The patient sought medical attention by office visit. The patient was prescribed OMNICEF. No lab diagnostics studies was performed. At the time of reporting, the patient was recovered (date unknown). Information has been received from medical records and a medical assistant concerning a 65 year old male ex-smoker (90phy, quit in 05), with alcohol use (one drink per day) who in 2005 was vaccinated with PNEUMOVAX 23 (lot # unknown) for the first time. On 31OCT08 the pt was vaccinated for the second time with PNEUMOVAX 23 (lot number unknown). On 28SEP10 he was vaccinated with PNEUMOVAX 23 (lot number unknown) (left deltoid), FLUVIRIN (Novartis, Lot #111807P1, exp 30APR2011) (left deltoid) and ADACEL (Sanofi Pasteur, lot # unknown) (right deltoid). The next day the patient had flu like symptoms, including nausea and joint and muscular pain, that lasted for 24 hours without fever but did not look at his arm. He noticed his arm swelling for the first time 30SEP2010, and it was painful to the touch. He was seen by his physician the same day with swollen left upper arm area and had a slight elevation in temperature of 99F. Assessment included cellulitis and abscess of upper arm and forearm and other vaccines and biological substances causing adverse effects in therapeutic use. The pt was to elevate and rest his arm, take ibuprofen 400-600 mg q 6hr prn for pain or fever and BENADRYL that night and be re-checked in 2 days. The physician suggested he take off from work the following day, but the patient did not want to. He was also prescribed OMNICEF 300mg one capsule bid for 10 days. It was reported the patient had recovered by 05OCT2010. The physician felt it was probably a reaction to the PNEUMOVAX 23. This is one of several reports received from the same source. This is an amended report. Vaccinated at: private doctor/hospital and vaccine purchased with: Unknown were added to Therapy. All available medical records will be provided upon request. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Information has been received from a certified medical assistant concerning a 65 year old male with hypertension, emphysema and hyperlipidaemia and "no known drug allergies" who in 2005 was vaccinated IM with the first 0.5ml dose of PNEUMOVAX 23 (Lot number was unknown). On 28-SEP-2010 the patient was vaccinated IM in his left arm with the second dose of PNEUMOVAX 23 (Lot number 667913/1021Z, expiration date 27-FEB-2012). During the same visit the patient were administered a flu vaccine (manufacturer unknown) in his left arm and Tdap in his right arm. Concomitant therapy included DIOVAN HCT, BYSTOLIC, ADVAIR, CRESTOR and aspirin. On 30-SEP-2010 the patient experienced fever of 99F and swelling of his left arm after administration of his second dose of PNEUMOVAX 23 intramuscularly in his left arm on 28-SEP-2010. He also experienced redness and warmth of his left arm. The patient sought medical attention by office visit. The patient was prescribed OMNICEF. No lab diagnostics studies was performed. At the time of reporting, the patient was recovered (date unknown). Information has been received from medical records and a medical assistant concerning a 65 year old male ex-smoker (90phy, quit in 05), with alcohol use (one drink per day) who in 2005 was vaccinated with PNEUMOVAX 23 (lot # unknown) for the first time. On 31OCT08 the pt was vaccinated for the second time with PNEUMOVAX 23 (lot number unknown). On 28SEP10 he was vaccinated with PNEUMOVAX 23 (lot number unknown) (left deltoid), FLUVIRIN (Novartis, Lot #111807P1, exp 30APR2011) (left deltoid) and ADACEL (Sanofi Pasteur, lot # unknown) (right deltoid). The next day the patient had flu like symptoms, including nausea and joint and muscular pain, that lasted for 24 hours without fever but did not look at his arm. He noticed his arm swelling for the first time 30SEP2010, and it was painful to the touch. He was seen by his physician the same day with swollen left upper arm area and had a slight elevation in temperature of 99F. Assessment included cellulitis and abscess of upper arm and forearm and other vaccines and biological substances causing adverse effects in therapeutic use. The pt was to elevate and rest his arm, take ibuprofen 400-600 mg q 6hr prn for pain or fever and BENADRYL that night and be re-checked in 2 days. The physician suggested he take off from work the following day, but the patient did not want to. He was also prescribed OMNICEF 300mg one capsule bid for 10 days. It was reported the patient had recovered by 05OCT2010. The physician felt it was probably a reaction to the PNEUMOVAX 23. This is one of several reports received from the same source. This is an amended report. Vaccinated at: private doctor/hospital and vaccine purchased with: Unknown were added to Therapy. All available medical records will be provided upon request. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 70 year old female patient with no medical history and no drug reactions/allergies, who on 28-OCT-2010 was vaccinated with a dose of influenza vaccine (manufacturer unspecified) and in the morning of 12-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665924/0930Z) IM. Pharmacist reported that by the afternoon on 12-NOV-2010 the patient experienced a dull, achy pain in her right arm. In the morning of 15-NOV-2010 she was still experiencing this pain. She said ibuprofen had not helped. There were no Lab diagnostics/studies performed. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Follow up information was received from a nurse of physician's office indicating that this patient was not a patient who had received any medical care at this physician's office. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning 3 patients who "within the last two weeks" (on approximately 01-NOV-2010) were vaccinated with doses of PNEUMOVAX 23 (with two different lot numbers, one of them was lot number 667271/0880Z). The pharmacist reported that within the last two weeks (on approximately 01-NOV-2010) the patients complained of soreness, redness, swelling, and a "burning pain" in their upper arms. At the time of the report the outcome of the patients was unknown. It was unspecified if the patients sought medical attention. Follow up information was received via telephone call from a doctor of pharmacy concerning a 65 year old female patient, who on 10-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667271/0880Z EXP 11-DEC-2011). The pharmacist reported that the patient experienced soreness, redness, swelling, and a "burning pain" in her upper arms. She had no fever but was issued a prescription for BACTRIM in case she got worse. At the time of the report, the outcome of the patient was unknown. This is one of three reports from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Information has been received from a 65 year old female patient with allergy to penicillin, sulfa, codeine and possibly thimerosal who on 11-NOV-2010 at 15:00, was vaccinated with a dose of PNEUMOVAX 23 (Lot #, expire date and route not reported), 0.5 ml. Concomitant therapy included LIPITOR, NEXIUM, SYNTHROID, FENHRT and DIOVAN HCT. The patient reported that on 13-NOV-2010 at 04:00, she developed urticaria from receiving a PNEUMOVAX 23 injection. She went to the emergency room and received a cortisone injection which helped relieve her symptoms. No lab diagnostics studies were performed. At the time of the report, the patient was recovering. On follow up information received on 08-DEC-2010, the physician reported that the patient was in his office on 08-DEC-2010 with one hive remaining at the PNEUMOVAX 23 injection site. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 65 year old female with drug allergies to alendronate sodium (WAES # 1011USA00485) and allergies to adhesive tapes who on 15-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot number not reported) by intramuscular injection. Over the next two days (also reported as on 16-OCT-2010), the patient's injection site developed swelling and tenderness. This had since resolved and the reporting physician had not personally seen the patient. Subsequently, the patient recovered from injection site swelling and tenderness on 02-NOV-2010. Lab diagnostics studies were not performed. The account was from the patient to the physician via phone. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 IM in the shoulder bursa. The patient experienced "high fever and pain at injection site". The patient received unspecified medical attention. At the time of the reporting, the patient had not recovered. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an approximately 73 year old male patient with no pertinent medical history or drug reactions/allergies who on 03-NOV-2010 was vaccinated with the first dose of PNEUMOVAX 23 (lot number reported as 1425Y (which is not validated for PNEUMOVAX 23), exp date not provided). Patient was experiencing swelling, "size of baseball", which spread down to elbow and forearm. Patient also complained of redness and warmth. The patient was seen by the physician. At the time of report the patient's status was unknown. No further information is available.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Local reaction, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 59 year old female patient, who on 16-DEC-2004 was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expire date and route not reported). On 01-NOV-2010 the patient received the second dose of PNEUMOVAX 23 (lot # 665903/1427Y) (expire date and route not reported). On 01-NOV-2010, the patient had a local and systemic reaction. She developed a fever of 102F, injection site swelling and lymphadenopathy. She was seen in the office but no treatment was recommended. At the time of the report, the outcome of the patient was unknown. On follow up information received from office manager reported that the patient was vaccinated with a dose of PNEUMOVAX 23 and the patient had a local reaction with fever. Office manager indicated that on an unspecified date, the patient recovered with no problems and also said that physician felt that the case was closed. This is one of several reports received from the same source. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 62 year old male patient, who on 16-DEC-2004 was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expire date and route not reported). On 01-NOV-2010 the patient received the second dose of PNEUMOVAX 23 (lot # 665903/1427Y) (expire date and route not reported). On 01-NOV-2010, the patient had a local and systemic reaction. He developed a fever of 101, injection site reaction. He was seen in the office but no treatment was recommended. At the time of the report, the outcome of the patient was unknown. Follow up information has been received from the office manager concerning the male patient. The office manager stated that the patient was vaccinated from a five dose of PNEUMOVAX 23 vial. It was reported that the patient had a local reaction with fever and that the patient recovered with no problems (date unknown). This is one of several reports received from the same source. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site haematoma, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with no known allergies, who on 25-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23, 0.5 mL intramuscularly into the right arm. In approximately 2007, the patient was vaccinated with the first dose of PNEUMOVAX 23 prior to her 65th birthday. Concomitant therapy included FLUVIRIN into the left arm. On 25-AUG-2010, the patient called the pharmacy later that evening to report that her right arm hurt and that she was developing a small bruise at the injection site and a larger area, warm to the touch, red, swollen, and painful, located approximately four inches below the injection site on her right arm. Pharmacist reported that he suggested the patient take ibuprofen and apply cold compresses to the arm. Pharmacist also reported that the patient tolerated well the injection of FLUVIRIN. At the time of this report the patient had not recovered. No laboratory or diagnostic tests were performed. The patient sought medical attention calling pharmacy. Additional information has been requested.
Age: 78.0
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 78 year old female patient with osteoporosis, hypertension and hyperlipidaemia and no drug reactions or allergies who on 20-JUL-2010 was vaccinated intramuscularly into the left arm with the first 0.5 ml dose of PNEUMOVAX 23 (Lot # 665707/1407Y, expiration date 12-JUL-2010). Concomitant therapy included alendronate sodium (MSD) and lovastatin. Within 48 hours post vaccination, on 22-JUL-2010, the patient had pain, soreness, erythema and swelling at the injection site. Patient was seen at the office and was prescribed MOTRIN for 3 days. At the time of the report the patient had recovered. No lab diagnostics studies were performed. The physician reported that he wanted a lot check for Lot# 665707/1407Y. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning her daughter, a 22 year old female with asthma, food, insect, and environmental allergies including anaphylaxis to bee stings and to dairy consumption, who on 30-AUG-2010 was vaccinated with the first dose of PNEUMOVAX 23 (LOT# 665402/1339Y, expiration 22-MAY-2011). Concomitant therapy included ASMANEX, albuterol and hormonal contraceptives (unspecified). On 31-AUG-2010, the onset of symptoms approximately 24 hours after vaccination, the patient experienced fever, body ache, and a local injection site reaction described as red, hot, swollen, and approximately six inches in diameter. There was no lab diagnostics studies performed. The patient sought medical attention by contacting pharmacist. At this time of reporting, the patient's symptoms persisted. Additional information has been requested.