chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 67 year old husband with no medical history who on 15-MAY-2009 was vaccinated with PNEUMOVAX 23. There was no concomitant medication. An hour later after the vaccination the patient started to have arm pain. The nurse who gave the vaccine stated that the arm pain may occur for a week or two. At the time of report, it was reported the patient had decreased mobility in his left shoulder where he had pain when lifting his arm over his head, to the side and could not pick up items, and he could only move from his elbow down. The consumer reported that he had called his physician and they have provided him with pain pills (name and manufacturer unspecified) and had been putting a heating pad on his shoulder at night. The patient was not recovered at the time of report. The patient had sought medical attention via phone call to the physician. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning an "over 65 years old" patient who was vaccinated with PNEUMOVAX 23 (lot number not available). Subsequently the patient "experienced swelling at the injection site and was hospitalized for an unspecified length of time due to this reaction". At the time of the report, the patient recovered from swelling at the injection site. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 67 year old female patient with no known drug reactions/allergies and pertinent medical history who on 06-MAR-2009 at 14:00 was vaccinated intramuscularly into the deltoid area with the first dose of PNEUMOVAX 23. There were no concomitant medications. On 06-MAR-2009 the patient experienced mild systemic symptoms with local reaction described as cough, headache, pain/tenderness, swelling and redness at the injection site. The patient sought medical attention on 13-MAR-2009; the patient came into the office for follow-up. At the time of reporting the patient had recovered. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 67 year old female patient with no known drug reactions/allergies and pertinent medical history who on 06-MAR-2009 at 14:00 was vaccinated intramuscularly into the deltoid area with the first dose of PNEUMOVAX 23. There were no concomitant medications. On 06-MAR-2009 the patient experienced mild systemic symptoms with local reaction described as cough, headache, pain/tenderness, swelling and redness at the injection site. The patient sought medical attention on 13-MAR-2009; the patient came into the office for follow-up. At the time of reporting the patient had recovered. Additional information is not expected.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Blood count normal, Drooling, Oedema, Rash
Clinical narrative: Information has been received from a Registered Nurse concerning a 51 year old male patient with mild hypertension, diabetes and high cholesterol with no drug allergies and no illness at the time of vaccination who on 16-JUN-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 659922/1667U), expiration date 23-AUG-2009, 0.5ml, subcutaneously into left arm at 1:00 p.m.. Concomitant therapy included tetanus toxoid, COREG, aspirin, PRAVACHOL, AVANDIA, lisinopril (manufacturer unknown) and allopurinol. On 17-JUN-2009 at 10:00 a.m., the patient experienced a rash at the top of the unspecified arm with edema, slowly resolving over a week. On approximately 19-JUN-2009, 3-4 days after the shot, the patient was riding in a limo, fell asleep and drool was coming out of his mouth. The son was hysterical.  Went to an emergency room and was checked out, blood count was negative. Later AVELOX was prescribed by physician for possible cellulitis. At the time on the report on 23-JUN-2009 the patient had not recovered. No further information is available.
Sex: F
Vaccine: FLUX, PPV, TTOX
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a dose of PNEUMOVAX 23, 0.5ml/IM. Concomitant therapy included tetanus toxoid and influenza virus vaccine (unspecified). Subsequently the patient experienced fever and muscle pain. The patient was initially admitted into the hospital to have a surgery, and then the patient had to stay 2 more days due to the development of the symptoms. At the report time the patient had recovered from fever and muscle pain. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female with penicillin and sulfonamide allergy and no pertinent medical history who in May 2009, was vaccinated with a first dose of PNEUMOVAX 23. The patient was administered PNEUMOVAX 23 at her unspecified primary care physician's office. There was no concomitant medication. The nurse reported that the patient developed hives on her arms and chest after receiving the PNEUMOVAX 23 in May 2009. The date of onset of the hives was reported as unknown. The patient self treated with BENADRYL and the hives resolved. The patient was seen in the office on 29-MAY-2009 and relayed the adverse reaction at that time. There were no lab diagnostic studies performed. No further information is available.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Oral pain, Rash, Sleep disorder
Clinical narrative: Information has been received from a 69 year old female patient with pollen allergy who on 15-JUN-2009 was vaccinated with a single dose of PNEUMOVAX 23 (lot number, route and site not reported). Concomitant therapy included allergy shots. On 15-JUN-2009, the night after received PNEUMOVAX 23 vaccine, the patient experienced a lot of pain in her shoulder and was having problems sleeping because of the pain, so she put some ice on her shoulder. Then, the next day, the patient's shoulder pain felt better, but the pain went down to her elbow and it felt like her arm "froze" because she could not move it, and she had a very red rash under her armpit. The patient took some ADVIL (manufacturer unspecified). Then the next day, the patient had bumps on the roof of her mouth that were very sore, so she went and saw her physician who took a flash light to the roof of her mouth and saw the bumps. The physician did not know why she had the bumps. The patient was given prednisone (manufacturer unspecified). No lab diagnostic study was performed. At the time of report, the patient still had some soreness on the top of her mouth, but she was recovering from the bumps and the soreness of arm. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Stomatitis
Clinical narrative: Information has been received from a 69 year old female patient with pollen allergy who on 15-JUN-2009 was vaccinated with a single dose of PNEUMOVAX 23 (lot number, route and site not reported). Concomitant therapy included allergy shots. On 15-JUN-2009, the night after received PNEUMOVAX 23 vaccine, the patient experienced a lot of pain in her shoulder and was having problems sleeping because of the pain, so she put some ice on her shoulder. Then, the next day, the patient's shoulder pain felt better, but the pain went down to her elbow and it felt like her arm "froze" because she could not move it, and she had a very red rash under her armpit. The patient took some ADVIL (manufacturer unspecified). Then the next day, the patient had bumps on the roof of her mouth that were very sore, so she went and saw her physician who took a flash light to the roof of her mouth and saw the bumps. The physician did not know why she had the bumps. The patient was given prednisone (manufacturer unspecified). No lab diagnostic study was performed. At the time of report, the patient still had some soreness on the top of her mouth, but she was recovering from the bumps and the soreness of arm. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was vaccinated with PNEUMOVAX 23 subcutaneously. Subsequently the patient developed a severe localized injection site reactions while in the hospital for other health issues. The patient was not hospitalized because of injection site reaction, but rather, the reaction occurred while in the hospital for another issues. The patient had sought medical attention. At the time of report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Full blood count normal, Hyperkalaemia, Hypertension
Clinical narrative: Information has been received from a physician concerning a 62 year old male patient with a history of carpal tunnel syndrome and no known drug allergies who on 19-OCT-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot# 663888/0627Y) IM into the right arm. Concomitant therapy included FLONASE, PREVACID, ZYRTEC and Alprazolam. On 21-OCT-2009 the patient developed redness at the injection site of the right upper arm. ON 02-NOV-2009 the patient developed widespread arthralgia. A complete blood count was normal. The patient was referred to an unspecified rheumatologist and was prescribed unspecified corticosteroids. At the time of the report, the arthralgia had not improved. Follow-up information has been received from a physician who reported that the patient's whole upper arm was red. At the time of the report, the patient now had hypertension, hyperkalemia and thrombocytopenia. The patient continued to have arthralgia. The patient visited the physician. At the time of the report, the patient had not recovered. Widespread arthralgia was considered to be disabling by the reporter. Follow-up information has been received from a physician concerning a 62 year old male patient with allergic reactions to CODEINE and TETRACYCLINE who on 19-OCT-2009 at 15:00 PM was vaccinated with a dose of PNEUMOVAX 23 (lot# 663888/0627Y) IM into the deltoid muscle. On 19-OCT-2009 afternoon the patient reported that he experienced erythema and fever, which lasted for 1 to 2 days. At the time of the report, the patient's myalgia, fever and erythema were resolved. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia, Thrombocytopenia
Clinical narrative: Information has been received from a physician concerning a 62 year old male patient with a history of carpal tunnel syndrome and no known drug allergies who on 19-OCT-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot# 663888/0627Y) IM into the right arm. Concomitant therapy included FLONASE, PREVACID, ZYRTEC and Alprazolam. On 21-OCT-2009 the patient developed redness at the injection site of the right upper arm. ON 02-NOV-2009 the patient developed widespread arthralgia. A complete blood count was normal. The patient was referred to an unspecified rheumatologist and was prescribed unspecified corticosteroids. At the time of the report, the arthralgia had not improved. Follow-up information has been received from a physician who reported that the patient's whole upper arm was red. At the time of the report, the patient now had hypertension, hyperkalemia and thrombocytopenia. The patient continued to have arthralgia. The patient visited the physician. At the time of the report, the patient had not recovered. Widespread arthralgia was considered to be disabling by the reporter. Follow-up information has been received from a physician concerning a 62 year old male patient with allergic reactions to CODEINE and TETRACYCLINE who on 19-OCT-2009 at 15:00 PM was vaccinated with a dose of PNEUMOVAX 23 (lot# 663888/0627Y) IM into the deltoid muscle. On 19-OCT-2009 afternoon the patient reported that he experienced erythema and fever, which lasted for 1 to 2 days. At the time of the report, the patient's myalgia, fever and erythema were resolved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacy student concerning a patient who was vaccinated with a dose of PNEUMOVAX 23 (lot # 662842/1296X). Subsequently the patient was diagnosed with cellulitis after the vaccine was given. The pharmacy student stated that the patient was hospitalized (date unspecified). At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 57 year old female patient with hypertension, chronic obstructive pulmonary disease, hypercholesterolaemia, ampicillin allergy and allergic reaction to AUGMENTIN, who on 01-JUN-2009 was vaccinated with 0.5 ml of PNEUMOVAX 23 (Lot: 662661/0978X) intramuscularly in the left upper arm. Concomitant therapy included lisinopril, CYMBALTA, ADVAIR, BENADRYL, KADIAN, COREG, SPIRIVA and LIPITOR. The patient developed redness, swelling, warmth, and pain at the injection site of the left upper arm 3 hours after receiving PNEUMOVAX 23 on 06/01/2009. The patient was examined in the office on 06/02/2009 and a diagnosis of cellulitis was made. The patient was treated with KEFLEX and ibuprofen. The patient was seen in the office on 06/04/2009 and was recovering. This is one of two reports from the same source. Follow up information was received from a physician regarding the 57 year old female with chronic pain and a smoker. On 01-JUN-2009, the patient was vaccinated intramuscularly into the left deltoid with first dose of PNEUMOVAX 23 (lot number 662661/0978). It was noted the patient had no known illness at the time of vaccination. It was reported that on the same day, at 10:00 p.m. the patient experienced left arm cellulitis. The patient recovered from this event on 11-JUN-2009. An ultrasound was performed on 12-JUN-2009 within normal limits. The physician considered left arm cellulitis to be an other important medical event. No further information is available.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a medical assistant concerning a 57 year old female patient with hypertension, chronic obstructive pulmonary disease, hypercholesterolaemia, ampicillin allergy and allergic reaction to AUGMENTIN, who on 01-JUN-2009 was vaccinated with 0.5 ml of PNEUMOVAX 23 (Lot: 662661/0978X) intramuscularly in the left upper arm. Concomitant therapy included lisinopril, CYMBALTA, ADVAIR, BENADRYL, KADIAN, COREG, SPIRIVA and LIPITOR. The patient developed redness, swelling, warmth, and pain at the injection site of the left upper arm 3 hours after receiving PNEUMOVAX 23 on 06/01/2009. The patient was examined in the office on 06/02/2009 and a diagnosis of cellulitis was made. The patient was treated with KEFLEX and ibuprofen. The patient was seen in the office on 06/04/2009 and was recovering. This is one of two reports from the same source. Follow up information was received from a physician regarding the 57 year old female with chronic pain and a smoker. On 01-JUN-2009, the patient was vaccinated intramuscularly into the left deltoid with first dose of PNEUMOVAX 23 (lot number 662661/0978). It was noted the patient had no known illness at the time of vaccination. It was reported that on the same day, at 10:00 p.m. the patient experienced left arm cellulitis. The patient recovered from this event on 11-JUN-2009. An ultrasound was performed on 12-JUN-2009 within normal limits. The physician considered left arm cellulitis to be an other important medical event. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning an infant who on 01-JUN-2009 was vaccinated with PNEUMOVAX 23 (0.5ml, SQ) instead of PREVNAR in error. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow-up information has been received from a nurse who stated that she was unable to determine the patient's name or date of birth. The reporter stated that the vaccination error was a human error which resulted when the employee who was not familiar with vaccines for infants pulled up the wrong pneumococcal vaccine. The patient did not have any AE's as a result. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with two doses of PNEUMOVAX 23 (Lot # not provided) within a year. The patient was admitted in hospital for unspecified reason and was administered with PNEUMOVAX 23 and experienced cellulitis at the injection site. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a male patient who was vaccinated with PNEUMOVAX 23 subcutaneously. Subsequently the patient developed a severe localized injection site reactions while in the hospital for other health issues. The patient was not hospitalized because of injection site reaction, but rather, the reaction occurred while in the hospital for another issues. The patient had sought medical attention. At the time of report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pain in extremity
Clinical narrative: Initial information received from a healthcare worker concerning 2 or 3 patients who on unspecified dates were vaccinated with doses of PNEUMOVAX 23 (lot number 662839/1089X). Subsequently, the patients developed "allergic reaction". Unspecified medical attention was sought. There were no lab diagnostic studies performed. Follow-up information has been received from an office manager concerning a 79 year old female with unknown pertinent medical history and unknown allergies who on 23-JUN-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot number 662839/1089X). The patient developed an "allergic reaction" after vaccination (date unspecified). The patient was advised on 24-JUN-2009 to take 25 mg BENADRYL. The patient was seen in the office on 25-JUN-2009 for redness and pain in right arm. She was given 5 mg CEFTIN 1 pill three times a day. The patient was seen again on 30-JUN-2009, where it was reported that she tolerated the antibiotic well, had no signs or symptoms, and rapidly recovered within 24 hours of the antibiotic (approximately 26-JUN-2009). This is one of two reports from the same source. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Haematocrit decreased, Haemoglobin decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 84 year old female patient who on 02-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot number unspecified). Subsequently in October 2009, the patient developed injection site reaction like pain, tenderness, swelling and warmth went down towards her elbow after getting PNEUMOVAX 23. At the time of the report the adverse event was improved. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse concerning an 84 year old female patient who in 2003 was vaccinated with IM the first dose of PNEUMOVAX 23. Subsequently on 02-OCT-2009 the patient was vaccinated IM with the second dose of PNEUMOVAX 23 (Lot number unspecified). It was noted that the patient had no illnesses at the time of vaccination. Concomitant vaccinations included Flu vaccine (SKG) (Lot number AFLLA275AA). The registered nurse reported that on 03-OCT-2009 the patient experienced redness, swelling of arm extending from deltoid into just proximal to the elbow, warm to touch and no fever. On 04-OCT-2009 the following laboratory tests were performed: blood hemoglobin test (HGB): 11.3 g/dl; whole blood hematocrit (HCT): 35.2%; mean corpuscular volume (MCV): 99.9 fL and mean corpuscular hemoglobin (MCH): 32.1 pg. At the time of the report the patient had recovered. Redness, swelling of arm extending from deltoid into just proximal to the elbow and warm to touch were considered to be an other important medical event by the registered nurse. No further information is available.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Mean cell haemoglobin, Mean cell volume increased, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning an 84 year old female patient who on 02-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot number unspecified). Subsequently in October 2009, the patient developed injection site reaction like pain, tenderness, swelling and warmth went down towards her elbow after getting PNEUMOVAX 23. At the time of the report the adverse event was improved. The patient sought unspecified medical attention. Follow up information has been received from a registered nurse concerning an 84 year old female patient who in 2003 was vaccinated with IM the first dose of PNEUMOVAX 23. Subsequently on 02-OCT-2009 the patient was vaccinated IM with the second dose of PNEUMOVAX 23 (Lot number unspecified). It was noted that the patient had no illnesses at the time of vaccination. Concomitant vaccinations included Flu vaccine (SKG) (Lot number AFLLA275AA). The registered nurse reported that on 03-OCT-2009 the patient experienced redness, swelling of arm extending from deltoid into just proximal to the elbow, warm to touch and no fever. On 04-OCT-2009 the following laboratory tests were performed: blood hemoglobin test (HGB): 11.3 g/dl; whole blood hematocrit (HCT): 35.2%; mean corpuscular volume (MCV): 99.9 fL and mean corpuscular hemoglobin (MCH): 32.1 pg. At the time of the report the patient had recovered. Redness, swelling of arm extending from deltoid into just proximal to the elbow and warm to touch were considered to be an other important medical event by the registered nurse. No further information is available.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a nurse concerning a 59 year old female who on 18-APR-2007 was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient "had a lot of swelling from the vaccine" (date not reported). It was unknown whether medical attention was sought. At the time of the report, the patient was recovered (date unspecified). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. On an unspecified date the patient experienced high fever and was admitted in hospital after getting PNEUMOVAX 23. The patient sought unknown medical attention. The patient recovered on an unspecified date. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 65 year old male patient with "autoimmune disease" arthritis, inflammatory demyelinating neuropathy, seasonal allergy and allergy to pollens and a history of prostate cancer last year and total prostatectomy who on approximately 25-MAy-2009 ("1 week ago") was vaccinated with the first dose of PNEUMOVAX 23. Concomitant therapy included LYRICA. On approximately 26-MAY-2009 ("about 1-2 days after the vaccination"), the patient experienced redness, swelling and warmth at the injection site. The warmth and swelling had subsided, but the patient's redness at injection site persisted. No lab diagnostic studies were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Full blood count, Metabolic function test, Pyrexia, Urine analysis
Clinical narrative: Information has been received from a doctor of pharmacy (Pharm. D) concerning a 29 year old female patient inpatient at psychiatric hospital with asthma, depression and no drug reactions and allergies who on 19-MAY-2010 at 9:46 A.M. was vaccinated SQ with a dose of PNEUMOVAX 23 (dose not reported; lot number 664535/0060Z). Concomitant therapy included DEPAKOTE and "nicotine patch". At 17:30 P.M. on that same day, the patient developed fever of 101.2 F and arthralgias. She went to the emergency room where they gave her TYLENOL and ULTRAM. Then she was made inpatient at the hospital (a different campus than the 1st hospital) where she received AVELOX, TORADOL, BENADRYL, vancomycin and SOLU-MEDROL. The following laboratories were performed: CBC, urinalysis, basic metabolic profile (results not provided). The patient was getting worse and she also was unable to partake in the psychiatric programs at the 1st hospital due to this event. At the time of reporting, the patient had not recovered from the events. Pharmacist considered fever of 101.2 f and arthralgias were considered to be disabling and an other important medical event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a healthcare worker concerning seven patients who on an unspecified date were vaccinated with a dose of PNEUMOVAX 23 (Lot number was not provided). Subsequently seven patients were sent to Emergency Room with cellulitis after receiving PNEUMOVAX 23 and were hospitalized. At the time of the report, the outcome of the events was unknown. Follow-up information has been received that there were only two patients involved instead seven. The lot number for both PNEUMOVAX 23 was 662874/1125X. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning two patients who on an unspecified date, received their second dose of PNEUMOVAX 23 and their arm become swollen. Both patients were admitted to the hospital. On an unspecified date, the patients recovered from the event. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an 84 year old female with cardiac disease, penicillin and ampicillin allergy who on 01-JUN-2009 was vaccinated SQ with a 0.5ml dose of PNEUMOVAX 23 while hospitalized at a hospital with cardiac diagnosis. It was unknown if this was the patient's first dose of PNEUMOVAX 23. On 01-JUN-2009, 2 hours after administration, the patient developed an area of redness, swelling, tenderness and warmth at injection site of the right upper arm. The unspecified physician has prescribed BENADRYL, ice compresses and ordered a venous Doppler study. At the time of this report, the patient was not recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood test, Chest X-ray, Injection site erythema, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female with allergy to VALIUM, nitroglycerine, beta-blockers and calcium channel blockers, leukaemia, atrial fibrillation, gastrooesophageal reflux, obesity and hyperlipidaemia who on 09-SEP-2009 was vaccinated intramuscularly into the right arm with a 0.5mL dose of PNEUMOVAX 23 (lot number 662842/1296X). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown) (left arm on the same date), digoxin, PROTONIX, COUMADIN and SPRYCEL. Later that evening, on 09-SEP-2009 the patient experienced pain and redness of right arm where she received PNEUMOVAX 23. The next day, on 10-SEP-2009, the patient experienced fever and worsening of pain and some swelling. She was seen by a physician and admitted to the hospital on 12-SEP-2009. Laboratory tests performed included blood tests, chest X-ray and x-ray of right arm (results not provided). The patient was treated with intravenous UNASYN and was discharged from the hospital on 16-SEP-2009. It was noted that five years ago, the patient also received PNEUMOVAX 23 (dose, route and lot number not reported) and flu vaccines previously with no adverse symptoms noted. This is one of several reports from the same source. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Swelling, X-ray limb
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female with allergy to VALIUM, nitroglycerine, beta-blockers and calcium channel blockers, leukaemia, atrial fibrillation, gastrooesophageal reflux, obesity and hyperlipidaemia who on 09-SEP-2009 was vaccinated intramuscularly into the right arm with a 0.5mL dose of PNEUMOVAX 23 (lot number 662842/1296X). Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown) (left arm on the same date), digoxin, PROTONIX, COUMADIN and SPRYCEL. Later that evening, on 09-SEP-2009 the patient experienced pain and redness of right arm where she received PNEUMOVAX 23. The next day, on 10-SEP-2009, the patient experienced fever and worsening of pain and some swelling. She was seen by a physician and admitted to the hospital on 12-SEP-2009. Laboratory tests performed included blood tests, chest X-ray and x-ray of right arm (results not provided). The patient was treated with intravenous UNASYN and was discharged from the hospital on 16-SEP-2009. It was noted that five years ago, the patient also received PNEUMOVAX 23 (dose, route and lot number not reported) and flu vaccines previously with no adverse symptoms noted. This is one of several reports from the same source. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered pharmacist concerning an 84 year old female patient who on 01-JUN-2009 was vaccinated with a dose of PNEUMOVAX 23. On an unspecified date, after getting the PNEUMOVAX 23, the patient experienced swollen arm. It was reported that on unknown timeframe "in the past", the patient had received a dose of PNEUMOVAX 23. The patient sought unspecified medical attention. The patient's final outcome was not reported. No further information is available.
Age: 60.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Movement disorder
Clinical narrative: Information has been received from a Registered Nurse concerning a 60 year old male patient with anti inflammatory agents allergy, who had been admitted to the hospital on 23-SEP-2009 for chronic back pain. On 24-SEP-2009, the patient was vaccinated with a dose of PNEUMOVAX 23 IM and an unspecified influenza virus vaccine given in the same arm. The nurse reported that on 26-SEP-2009 the patient developed a cellulitis reaction. At the time of the report, the patient was still in the hospital but not believed to be prolonged by the cellulitis. The patient had not recovered. The registered nurse considered the cellulitis reaction to be disabling as the patient was unable to move his arm. Follow up information has been received from a Licensed Practical Nurse who reported that she checked with her staff and all physicians and none of them have reported a reaction to PNEUMOVAX 23. Follow up information has been received from the Licensed Practical Nurse concerning the 60 year old male patient with a chronic back pain who on 24-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose and lot # unknown). Concomitant medication was unspecified. The nurse reported that the original reporter (registered nurse), has never worked at practice and that she did not have information about that adverse event and that the physicians associated with that practice were not aware of a patient with that adverse event. Lab diagnostic studies performed were unspecified. At the time of this report the patient had not recovered. No further information is available.
Age: 0.13
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site induration, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 50 year old female who on approximately 27-MAY-2009, last week, was vaccinated with a dose on PNEUMOVAX 23. On approximately 28-MAY-2009, one day after the PNEUMOVAX 23 was given, the patient had a "very swollen right arm with soreness". The swelling did subside several days after the vaccination. In approximately June 2009, the patient was recovered (date known). Follow-up information was received from a registered nurse concerning this 50 year old female who on 27-MAY-2009 was vaccinated SQ with the first dose of PNEUMOVAX 23 (Lot #: 661527/0112Y) into her left arm. There was no illness at the time of vaccination. On 27-May-2009, hours after vaccination, the patient's left arm had a whitish welt which developed after the injection. The next day, the patient felt sore and swollen under her arm below the injection site. A hard lump was noted at the site. It was noted that it was improving the day after the injection. Subsequently, the patient recovered 1 day later. No further information is available.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # was not provided) beginning at the age of 10 years. On an unknown date the patient experienced arm cellulitis and tingling and was treated symptomatically and with antibiotics. On unknown date, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X) at the age of 23 years. On an unknown date, the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size from deltoid and to elbow. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from the physician concerning a homemaker with an allergy to sulfa who on 25-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 into her right arm at 12:30 PM. Within 24 hours, on 26-AUG-2009 at 7:00 AM, the patient's entire upper arm from deltoid to was edematous (double in size), tender, erythematous and hot and developed cellulitis. She was unable to use her arm for next week. There was no illness at the time of vaccination. The reporting physician considered the patient's cellulitis to have resulted in persistent or significant disability/incapacity. Follow-up information has been received from the physician. It was reported that the patient with heart disease was treated with an antibiotic for the event cellulitis. The patient had recovered from the event four days later. This is one of several reports received from the same source. No further information is available.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Oedema peripheral, Pain, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 23 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # was not provided) beginning at the age of 10 years. On an unknown date the patient experienced arm cellulitis and tingling and was treated symptomatically and with antibiotics. On unknown date, the patient was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot # 662842/1296X) at the age of 23 years. On an unknown date, the patient experienced nausea, malaise, aching, an arm swollen to 2x its normal size from deltoid and to elbow. The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from the physician concerning a homemaker with an allergy to sulfa who on 25-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 into her right arm at 12:30 PM. Within 24 hours, on 26-AUG-2009 at 7:00 AM, the patient's entire upper arm from deltoid to was edematous (double in size), tender, erythematous and hot and developed cellulitis. She was unable to use her arm for next week. There was no illness at the time of vaccination. The reporting physician considered the patient's cellulitis to have resulted in persistent or significant disability/incapacity. Follow-up information has been received from the physician. It was reported that the patient with heart disease was treated with an antibiotic for the event cellulitis. The patient had recovered from the event four days later. This is one of several reports received from the same source. No further information is available.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Oedema peripheral
Clinical narrative: Information has been received from a 55 year old registered nurse female with allergy to codeine and sensitivity to peroxide such as in hair dye, and a history of swelling, redness, pain at the injection site with a typhoid vaccine (unspecified) who on 28-OCT-1998 was vaccinated with PNEUMOVAX 23 (lot # not reported). Concomitant therapy received on the same date included influenza virus vaccine (unspecified). It was reported that on 28-OCT-1998 the injection site was red and painful. On approximately 31-OCT-1998, "about 3-4 days after the vaccination" her left arm began to well from the injection site to the elbow. The swelling radiated from the left arm, across her chest and up into her throat. The arm developed a large liquid filled blister. The symptoms resolved in "two weeks", on approximately 11-NOV-1998. She mentioned that she had a similar reaction to at typhoid vaccine (unspecified) that she received in 1964 upon entering nursing school. The patient did not seek medical attention. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pharyngeal oedema
Clinical narrative: Information has been received from a 55 year old registered nurse female with allergy to codeine and sensitivity to peroxide such as in hair dye, and a history of swelling, redness, pain at the injection site with a typhoid vaccine (unspecified) who on 28-OCT-1998 was vaccinated with PNEUMOVAX 23 (lot # not reported). Concomitant therapy received on the same date included influenza virus vaccine (unspecified). It was reported that on 28-OCT-1998 the injection site was red and painful. On approximately 31-OCT-1998, "about 3-4 days after the vaccination" her left arm began to well from the injection site to the elbow. The swelling radiated from the left arm, across her chest and up into her throat. The arm developed a large liquid filled blister. The symptoms resolved in "two weeks", on approximately 11-NOV-1998. She mentioned that she had a similar reaction to at typhoid vaccine (unspecified) that she received in 1964 upon entering nursing school. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning some infant patients, patient's demographics were not available, who on unspecified dates were vaccinated with a dose of PNEUMOVAX 23 instead of giving them PREVNAR. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mention in this report. Additional information will be provided if available. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. On an unspecified date, the patient experienced injection site pain in the arm. It was reported that the pain lasted four days or so and resolved on its own. The reporter stated that no additional intervention was needed. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Antibody test abnormal, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female with asthma and no drug reactions/ allergies who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23. It was reported that the patient's titers were low, that was why the patient decided to administer a second dose. On 26-MAY-2009, the patient was vaccinated with the second dose of PNEUMOVAX 23. Concomitant medications included asthma medications. On 27-MAY-2009, a day later, the patient developed fever that had continued to persist. It was also reported that it was "now" nine days that the patient had had the fever. It was not specified if the patient had similar adverse effect the first time. The patient visit the office for medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on unspecified date was vaccinated PNEUMOVAX 23  (Lot : 662661/0978X). The patient was seen in the office approximately on 28-MAY-2009 (reported as last week) with a diagnosis cellulitis. The patient was treated with KEFLEX and ibuprofen. At the time of reporting the patient's present status was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Reaction to previous exposure to any vaccine, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 78 year old female with allergies of KETEK, PERCOCET and sulfa who was vaccinated with the first 0.5 ml dose of PNEUMOVAX 23 in 1999 (IM, lot number not reported) and the second dose (IM, lot number 662667/1435X) on 04-JUN-2009. ON 05-JUN-2009 the patient experienced injection site reaction, her right arm swelled from right shoulder to elbow and was red and warm to touch after she received the second dose of PNEUMOVAX 23. Medical attention was sought via telephone visit. No lab diagnostic study was performed. At the time of report, the patient was recovered. The patient had a history of injection site streaking and swelling of arm while on prior therapy with ZOSTAVAX (MSD, WAES0906USA03788). This is one of several reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. 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 and was released. Additional information has been requested.
Age: 58.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a reporter concerning a patient who was vaccinated with PNEUMOVAX 23 (manufacturer unknown). On an unspecified date the patient experienced severe cellulitis and "was in hospital" (date and duration unspecified). The outcome of the patient was not reported. This report was received from Watson Pharmaceuticals. Follow-up information received from a licensed practical nurse (L.P.N.) concerning a 58 year old patient who on 01-MAR-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number 665400/1315Y). In March 2010, the patient was diagnosed with cellulitis and was hospitalized. The patient's hospitalization dates were unknown to the L.P.N. It was unknown to the L.P.N. if the patient's cellulitis was disabling or life-threatening. On 16-MAR-2010 the patient had a follow-up visit and the patient had recovered. It was also stated that other patient had received the vaccine from the same vial as this patient and the patients have not had any adverse reactions. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse and a physician concerning an "occasional patient" who experienced redness at the site of injection after administration of PNEUMOVAX 23 (dose number and vaccination date not reported). It was noted that this usually occurred when it was the second dose for the patient. At the time of report, the status of the patient was unknown. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Antibody test positive
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23. The physician reported that the patient was only showing positive antibody to 14 different types of PNEUMOVAX 23. The outcome of the event was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old female with a history of alpha-1 anti-trypsin deficiency, who on 16-JUN-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 661529/0868X) 0.5 mL, I.M. Concomitant therapy included hormone patch (unspecified manufacturer), calcium and unspecified vitamin. On 16-JUN-2009 the patient experienced pain at the injection site. The patient at the time of administration told the nurse she previously received PNEUMOVAX 23 seven years ago. However, overnight, the patient remembered she received a previous dose earlier this year (unspecified date). The nurse instructed the patient to apply cool compresses to the injection site. At the time of the reporting the patient had not recovered. Additional information has been requested.