chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Information has been received from a male physician concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 1667690/1158Z). The physician reported that on "this week" (on approximately 14-SEP-2010) the patient experienced severe erythema from shoulder to elbow and tenderness. The physician also reported that the patient experienced redness, soreness and swelling. The physician gave the patient steroids and antihistamines. Therapy with PNEUMOVAX 23 discontinued. At the time of the report the patient had recovered. Additional information has been received from a health care professional concerning a male patient with amoxicillin, levothyroxine and LIPITOR allergy and no illness at the time of vaccination, who on an unspecified date was vaccinated with a first dose of PNEUMOVAX 23 and experienced soreness and swelling. The patient was treated with steroids and anti-histamines which calmed down the adverse events. There was no relevant diagnostic test. The patient did not seek medical attention. Follow-up information was received from another health professional who stated that the two lot number 666639/0564Z and 667690/1158Z were both male patients. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, Injection site reaction, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) that after delivered, had sat on the counter overnight and for half the next day before it was refrigerated. Subsequently, the patient complained of muscle soreness at the injection site and painful arm. The patient mentioned it on their next office visit. It was unknown if the patient sought medical attention. On an unspecified date the patient recovered. The medical assistant contacted during telephone follow-up could not supply the following information: patient name, date of birth, date of vaccination, lot number or date of event. Follow up information was received from an office manager indicating that there was no specific patient and no specific information that they wanted to provide. This is one of several reports received from the same source. No further information is available.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning an 80 year old female who on 30-NOV-2010 was vaccinated with PNEUMOVAX 23 (lot # reported as 604101/0932V which is lot # of RECOMBIVAX HB not PNEUMOVAX 23, expiration date 18-JUL-2011). Concomitant therapy included antibiotics and antihistamines. On 01-DEC-2010 the patient reported pain, swelling of left arm, low grade fever and was diagnosed with cellulitis of the left arm. The patient was recovering at the time of report. The patient sought unspecified medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 69 year old female consumer with high blood pressure and arthritis who on 27-JUL-2010 was vaccinated with a dose of PNEUMOVAX 23 (Manufacturer unknown) in her muscle in the upper side of her arm. Concomitant therapy included antibiotics (therapy unspecified), allergy pills (therapy unspecified), high blood pressure medicine (therapy unspecified) and arthritis medication (therapy unspecified). The consumer stated that she had gotten a "pneumonia shot", but she did not remember the name of it. She stated that on 30-JUL-2010 "on the third day of had the pneumonia shot", she experienced site injection pain, swelling, redness, cakiness, fever chills and an increase in temperature at the injection site as a result of receiving the pneumonia shot. There were no laboratory tests performed. At the time of this report, the consumer was recovering from site injection pain, swelling, redness, cakiness, fever chills and an increase in temperature at the injection site. The patient sought medical attention (she went to urgent care facility but she was not hospitalized). Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 69 year old female consumer with high blood pressure and arthritis who on 27-JUL-2010 was vaccinated with a dose of PNEUMOVAX 23 (Manufacturer unknown) in her muscle in the upper side of her arm. Concomitant therapy included antibiotics (therapy unspecified), allergy pills (therapy unspecified), high blood pressure medicine (therapy unspecified) and arthritis medication (therapy unspecified). The consumer stated that she had gotten a "pneumonia shot", but she did not remember the name of it. She stated that on 30-JUL-2010 "on the third day of had the pneumonia shot", she experienced site injection pain, swelling, redness, cakiness, fever chills and an increase in temperature at the injection site as a result of receiving the pneumonia shot. There were no laboratory tests performed. At the time of this report, the consumer was recovering from site injection pain, swelling, redness, cakiness, fever chills and an increase in temperature at the injection site. The patient sought medical attention (she went to urgent care facility but she was not hospitalized). Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Adverse drug reaction, Chills, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a nurse concerning a 54 year old male school teacher with hypertension, cholesterolemia, hypothyroidism, penicillin allergy, iodine allergy, reactive airways disease and only back pain at time of vaccination and a history of feeling terrible while on therapy with SINGULAIR (WAES# 1012USA02628), bulging discs (2, 3, 4, 5), tetanus (given 2000), neck surgery, disc removal, bone graft (04-MAY-2007), and pneumonia (at age 17) who on 27-OCT-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot# not reported) in his left deltoid, after a routine follow-up visit. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) administered on 08-OCT-2010. Concomitant therapy included SYNTHROID, aspirin, famotidine (MSD), lisinopril, PRAVACOL, cyclobenzaprine HCl (MSD), mometasone furoate (MSD), TESSALON, ALEVE, econazole, ALEVE, VIMOVO and TESSALON PERLES. On 28-OCT-2010 the patient developed fever and he called the physician's office on 29-OCT-2010 complaining of temperatures up to 103, aching, swelling at injection site between baseball and golfball size and chilling. The patient also complained of sweats. The physician examined the patient in the office; no hoarseness, rhinorrhea, shortness of breath or cough. Physical examination was within normal limits except for myalgias. The patient also presented redness at the injection site. The patient was treated with ALEVE, TYLENOL, MOTRIN and BENADRYL. No lab or diagnostic tests were performed. By 01-NOV-2010 the injection site was hard and painful. At the time of the report, the injection site was still swollen. Temperature was below 100, after treatment with KEFLEX. It was also reported that there was a reaction with KEFLEX (no further explained). At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 54 year old male school teacher with hypertension, cholesterolemia, hypothyroidism, penicillin allergy, iodine allergy, reactive airways disease and only back pain at time of vaccination and a history of feeling terrible while on therapy with SINGULAIR (WAES# 1012USA02628), bulging discs (2, 3, 4, 5), tetanus (given 2000), neck surgery, disc removal, bone graft (04-MAY-2007), and pneumonia (at age 17) who on 27-OCT-2010 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot# not reported) in his left deltoid, after a routine follow-up visit. Concomitant vaccination included a dose of influenza virus vaccine (unspecified) administered on 08-OCT-2010. Concomitant therapy included SYNTHROID, aspirin, famotidine (MSD), lisinopril, PRAVACOL, cyclobenzaprine HCl (MSD), mometasone furoate (MSD), TESSALON, ALEVE, econazole, ALEVE, VIMOVO and TESSALON PERLES. On 28-OCT-2010 the patient developed fever and he called the physician's office on 29-OCT-2010 complaining of temperatures up to 103, aching, swelling at injection site between baseball and golfball size and chilling. The patient also complained of sweats. The physician examined the patient in the office; no hoarseness, rhinorrhea, shortness of breath or cough. Physical examination was within normal limits except for myalgias. The patient also presented redness at the injection site. The patient was treated with ALEVE, TYLENOL, MOTRIN and BENADRYL. No lab or diagnostic tests were performed. By 01-NOV-2010 the injection site was hard and painful. At the time of the report, the injection site was still swollen. Temperature was below 100, after treatment with KEFLEX. It was also reported that there was a reaction with KEFLEX (no further explained). At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of 0.5ml of PNEUMOVAX 23 (Lot# 665825/0832Z) (Exp 07/18/2011), IM right arm. The medical assistant stated that on unspecified date the patient developed a lump and a big red spot at the injection site that traveled down the whole right arm 24 hours post vaccination. At the time of the report the patient outcome was unknown, there were no diagnostics studies performed. The patient sought unspecified medical attention. A lot check has been initiated. 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. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 52 year old male patient who on 20-OCT-2010 was vaccinated into his right thigh with a 0.5mL dose of PNEUMOVAX 23 (lot number 664653/1337Y; expiration date 03-MAR-2011). The nurse stated that the patient on 21-OCT-2010 was seen at the office with fever of 100.4F, pain and swelling at the injection site. The patient was treated with warm compress. At the time of report, the patient's outcome was unknown. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (Lot # 664653/1337Y) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date during a several week interval in June and July 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot# 666639/0564Z). Subsequently, the patient developed a case of cellulitis center on the injection site. The patient was treated with antibiotics. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. 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. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Asthma, Chest X-ray, Lobar pneumonia
Clinical narrative: Information has been received from a nurse concerning a 77 year old male who on 07-FEB-1997 was vaccinated with PNEUMOVAX 23 (manufacturer unspecified, lot # not reported). On 28-NOV-2008 the patient experienced pneumonia described as involved in "left lower lobe". On 25-AUG-2010 the patient experienced asthmatic bronchitis. The patient had a chest X-ray on an unspecified date (result not reported). History of other pneumococcal vaccination was not available at the time of the report. The outcome of the events was not reported. The patient contacted office. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Lymphadenopathy, Neck pain, Pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with peanut allergy and other unspecified "bad allergies" and a history of Hashimoto's thyroiditis who in 2005 was vaccinated with the first dose of PNEUMOVAX 23 with no problems after vaccination. On 17-AUG-2010 at afternoon, the patient was vaccinated at left arm with the second dose of PNEUMOVAX 23 (664537/1193Y) and had an adverse event. There was no concomitant medication. On the same day evening the patient went to the local emergency room (ER) with left collarbone pain (the bottom of left collarbone), neck pain, and swollen lymph nodes. Chest X-ray performed at the ER with normal results. The patient was placed on BACTRIM and released, was not hospitalized. The patient's left arm was warm and sore. At this time of reporting, the patient's left collarbone pain (the bottom of left collarbone), neck pain and swollen lymph nodes, and left arm was sore and warm persisted. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a consumer concerning her 20 year old daughter with peanut allergy and other unspecified "bad allergies" and a history of Hashimoto's thyroiditis who in 2005 was vaccinated with the first dose of PNEUMOVAX 23 with no problems after vaccination. On 17-AUG-2010 at afternoon, the patient was vaccinated at left arm with the second dose of PNEUMOVAX 23 (664537/1193Y) and had an adverse event. There was no concomitant medication. On the same day evening the patient went to the local emergency room (ER) with left collarbone pain (the bottom of left collarbone), neck pain, and swollen lymph nodes. Chest X-ray performed at the ER with normal results. The patient was placed on BACTRIM and released, was not hospitalized. The patient's left arm was warm and sore. At this time of reporting, the patient's left collarbone pain (the bottom of left collarbone), neck pain and swollen lymph nodes, and left arm was sore and warm persisted. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date during a several week interval in June and July 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot#666639/0564Z). Subsequently, the patient developed a case of cellulitis centered on the injection site. The patient was treated with antibiotics. At the time of this report. the patient's outcome was not reported. This is one of several reports from the same source. 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. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date during a several week interval in June and July 2010, was vaccinated with a dose of PNEUMOVAX 23 (lot# 666639/0564Z). Subsequently, the patient developed a case of cellulitis centered on the injection site. The patient was treated with antibiotics. At the time of this report, the patient's outcome was not reported. This is one of several reports from the same source. 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. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site inflammation, Malaise, Skin warm
Clinical narrative: Information has been received from a physician concerning a 67 year old male patient who "5 years ago", in approximately October 2005, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 18-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # reported as 667913/1021Z). On an unspecified date, the patient returned to the office with inflammation from injection site all the way down the arm. The area was red and hot "top" the touch. The patient did not look good. He appeared tired, looked drained and looked like he was getting sick. The patient was treated and was recovering at the time of the report. This is one of several reports received from the same source. 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. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Generalised erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old male patient with hypertension, hyperlipidemia, drug reactions or allergies to penicillin and codeine and a history of gastrointestinal esophageal reflux disease, hepatitis unknown type, gout, neuropathy and prostatitis who in 1993 was vaccinated with the first dose of PNEUMOVAX 23. The pharmacist reported that the patient has an injection site reaction after received the second intramuscular dose in the left deltoid of PNEUMOVAX 23 (Lot # 665707/1407Y) on 18-AUG-2010. Concomitant therapy included tetanus in right arm. The reaction was a swollen left deltoid with generalized redness, warmth and pain. Patient sought medical attention by a visit to the office. He was prescribed TYLENOL for pain. The outcome of the patient was not reported. No lab diagnostics studies were performed. This is one of several reports received from the same source. Follow up information has been received from the pharmacist indicating that on 23-AUG-2010, the patient was contacted by phone. The patient stated that he had recovered with no residual side effects. The pharmacist also stated there were other patients that had received PNEUMOVAX 23 with lot number 665707/1407Y and those other patients did not have any adverse experience. 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 82 year old female who "at an unspecified time in the past" was vaccinated with PNEUMOVAX 23 (therapy route and lot # not reported). On 25-OCT-2010 the patient was vaccinated SQ with a dose of PNEUMOVAX 23, 0.5 ml (lot # 665924/0930Z, expired date 17-JUL-2011). The patient developed injection site reaction after receiving PNEUMOVAX 23. On 26-OCT-2010, she developed a red, hot, swollen area on her arm at the injection site that extended to her elbow. The patient was treated with antibiotics. No lab diagnostics studies performed. Patient's present status was not specified by reporter. The Licensed Practical Nurse requested a lot check for PNEUMOVAX 23 lot # 665924/0930Z. The nurse requested a lot check. 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. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician reported that a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. After receiving PNEUMOVAX 23, the patient experienced hives. Physician also mentioned that the patient experienced hives after receiving TORADOL. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. This is an amended report. ONUM type was changed from MULTIPLE to MNSC. No further information is available.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Fatigue, Malaise, Skin warm
Clinical narrative: Information has been received from a physician concerning a 79 year old male patient who "5 years ago", in approximately October 2005, was vaccinated with the first dose of PNEUMOVAX 23 without reaction. On 21-OCT-2010, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot # reported as 667913/1021Z). On an unspecified date the area was red and hot to the touch. The patient did not look good. He appeared tired, looked drained and looked like he was getting sick. The patient was treated and was recovering at the time of the report. This is one of several reports received from the same source. 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. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Skin warm, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient, who on 25-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # and expire date not reported), 0.5 ml, intramuscularly. On 26-OCT-2010 the patient experienced a severe locally reaction to PNEUMOVAX 23. The patient noticed the reaction the next evening (on 26-OCT-2010). The patient was experiencing redness, swelling, tenderness and warmth. The area was approximately 6 inches wide and wrapped around her biceps. The patient sought unspecified medical attention. At the time of the report, the patient had not yet recovered, also reported as "recovering". Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 49 year old male patient, who on 28-OCT-2005 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 an unspecified date, the patient had a systemic reaction, developed a fever of 102F which lasted 2 days and malaise. He was not seen in the office but he called. No treatment was recommended. At the time of the report, the outcome of the patient was unknown. 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.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of 0.5ml of PNEUMOVAX 23 (Lot# 665925/0932Z) (Exp 07/18/2011), IM right arm. The medical assistant stated that on unspecified date the patient developed a lump and a big red spot at the injection site that traveled down the whole right arm 24 hours post vaccination. At the time of the report the patient outcome was unknown, there were no diagnostics studies performed. The patient sought unspecified medical attention. A lot check has been initiated. 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. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of 0.5ml of PNEUMOVAX 23 (Lot# 665925/0932Z) (Exp 07/18/2011), IM right arm. The medical assistant stated that on unspecified date the patient developed a lump and a big red spot at the injection site that traveled down the whole right arm 24 hours post vaccination. At the time of the report the patient outcome was unknown, there were no diagnostics studies performed. The patient sought unspecified medical attention. A lot check has been initiated. 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. This is one of several reports from the same source. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Malaise, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 49 year old male with drug allergies to ALTACE and high blood pressure and high cholesterol who on 02-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot # 665917/1311Y, expired date 06-JUN-2011) to prevent pneumococcal disease. Concomitant therapy included AZOR, metoprolol and LIPITOR. On 02-NOV-2010 night, the patient began "to not feel well". The next morning, on 03-NOV-2010, the patient developed a red, swollen area that covered the entire deltoid where he received the injection. The patient also "developed a fever of 101". No lab diagnostics studies performed. The patient had not recovered. The patient sought unspecified medical attention. Follow up information received from a registered nurse concerning a 49 year old male with hypertension, obstructive sleep apnoea and fatty liver who on 02-NOV-2010 at 9:00 AM was vaccinated IM with a first dose of PNEUMOVAX 23 (lot # 665917/1341Y) in the left arm. It was reported that the patient showed up complaining of redness and swelling of the left arm. It was not infected and the patient was instructed to just keep an eye on it, no further complaints were received from the patient. The patient recovered. It was reported that the patient did not require emergency room/doctor visit. Additional information is not expected.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 49 year old male with drug allergies to ALTACE and high blood pressure and high cholesterol who on 02-NOV-2010 was vaccinated IM with a first dose of PNEUMOVAX 23 (lot # 665917/1311Y, expired date 06-JUN-2011) to prevent pneumococcal disease. Concomitant therapy included AZOR, metoprolol and LIPITOR. On 02-NOV-2010 night, the patient began "to not feel well". The next morning, on 03-NOV-2010, the patient developed a red, swollen area that covered the entire deltoid where he received the injection. The patient also "developed a fever of 101". No lab diagnostics studies performed. The patient had not recovered. The patient sought unspecified medical attention. Follow up information received from a registered nurse concerning a 49 year old male with hypertension, obstructive sleep apnoea and fatty liver who on 02-NOV-2010 at 9:00 AM was vaccinated IM with a first dose of PNEUMOVAX 23 (lot # 665917/1341Y) in the left arm. It was reported that the patient showed up complaining of redness and swelling of the left arm. It was not infected and the patient was instructed to just keep an eye on it, no further complaints were received from the patient. The patient recovered. It was reported that the patient did not require emergency room/doctor visit. Additional information is not expected.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product label confusion, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 37 year old male patient with concurrent condition of cerebral palsy with mental retardation who in approximately 2009 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# unknown). On unspecified date the patient was vaccinated intradermally with 0.1 ml a second dose of 0.1ml of PNEUMOVAX 23 (Lot# 665925/0932Z). The physician's assistant stated that the patient was vaccinated with PNEUMOVAX 23 instead of a PPD, tuberculin injection test because of product confusion. He stated that the box of PNEUMOVAX 23 2.5 ml looked like the box of PPD, tuberculin test and he had been asking the patient to return to the office to examine the injection site. No adverse reaction noted. Physician assistant had been asking the patient to return to the office to examine the injection site. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from Licensed Practical Nurse concerning a female who "at an unspecified time in the past" was vaccinated with PNEUMOVAX 23 (therapy route and lot # not reported). On 03-NOV-2010 the patient was vaccinated SQ with a dose of PNEUMOVAX 23, 0.5 ml (lot # 665924/0930Z, expired date 17-JUL-2011). The patient developed injection site reaction after receiving PNEUMOVAX 23. The same day she developed a red, hot, swollen area the "size of a baseball" on her arm at the injection site. The patient was treated with antibiotics. No lab diagnostics studies performed. Patient's present status was not specified by reporter. The Licensed Practical Nurse requested a lot check for PNEUMOVAX 23 lot # 665924/0930Z. The nurse requested a lot check. 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. This is one of several reports received from the same source. No further information is available.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 63 year old female with asthma and rhinitis allergic and penicillin allergy who on 21-OCT-2010 was intramuscularly vaccinated with a dose of PNEUMOVAX 23 (lot number 665917/1341Y). Concomitant therapy included ADVAIR, albuterol and ALLEGRA. The reporter stated that on 22-OCT-2010 a red, swollen area "about the size of a golf ball" developed at the injection site. "It felt like a huge knot was in there." Sometime after 23-OCT-2010 the patient recovered. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 44 year old female patient who on 21-OCT-2010 was vaccinated into her left deltoid with a 0.5mL dose of PNEUMOVAX 23 (lot number unspecified). The nurse stated that on 22-OCT-2010 the patient was seen at the doctor's office with pain and swelling at the injection site. The patient was treated with MEDROL dose pack. At the time of report, the patient's outcome was unknown. The nurse was unsure about which lot number was used. Lot # may have been 667914/1067Z. A lot check has been initiated. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested. Follow-up information received via telephone call from the registered nurse who indicted that the lot # of PNEUMOVAX 23 was 667914/1067Z. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Rash
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a patient who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23 (lot # 664864/1365Y, expire date not reported), 0.5 ml, intramuscularly. After immunization with PNEUMOVAX 23, the patient developed rash, pain and numbness of the arm. This patient also reported difficulty moving that same arm. The arm affected was the arm that this patient received PNEUMOVAX 23. The patient sought medical attention by telephone call. At the time of the report, the outcome of the patient was unknown. A lot check has been initiated. Additional information has been requested. This is one of several reports from the same source.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 52 year old male patient who on 08-OCT-2010 was vaccinated into his right deltoid with a 0.5mL dose of PNEUMOVAX 23 (lot  number unknown). The nurse stated that on 11-OCT-2010 the patient was seen at the doctor's office with pain and swelling at the injection site. He also had a previous appointment scheduled for non related blood work on 13-OCT-2010 and was examined by the nurse on that day too. At the time of report, the patient's outcome was unknown. Follow up information has been received from the nurse who stated that she would report back with the lot information if it were available. A lot check has been initiated. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested. Follow-up information received via telephone call from the registered nurse who indicated that the lot 3 of PNEUMOVAX 23 was 664653/1307Y and expiration date was 03-MAR-2011. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female patient, who on 21-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. The medical assistant reported that 18 hours later the vaccination, on 23-OCT-2010, the patient experienced a fever of 102.0. Left arm had some swelling and redness. Patient went to the emergency room on 23-OCT-2010, but no admission was required. At the time of the report the patient was recovering. Follow up information was received and indicated that there was no additional information other than it was already reported. This is one of several reports from the same source. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning an 81 year old female patient, who on 26-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. On 26-OCT-2010 the patient experienced redness, inflammation and pain in her right arm. The patient sought unspecified medical attention. At the time of the report the patient was recovering. Follow up information was received and indicated that there was no additional information other than the previously reported. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a female patient between 60-70 years old with penicillin allergy who "6 year ago", on approximately 2004 was vaccinated with a first dose of 0.5 ml of PNEUMOVAX 23 (Lot#Unknown), second dose on 20-OCT-2010 (lot no. 665902/1426Y), IM respectively. The registered nurse stated that the patient had experienced local reaction at site of injection after receiving second dose of PNEUMOVAX 23. On 22-OCT-2010 the patient had complained of redness, swelling, warmth and red bumpy rash around site of injection. The patient had been diagnosed during office visit with cellulitis and prescribed Z-PAK. All drop down boxes had referred to this patient. At the time of the report the patient's outcome was recovering. Follow-up information has been received from the physician, who reported that the patient experienced local cellulitis. At the time of the report the patient had recovered. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a female patient between 60-70 years old with penicillin allergy who "6 year ago", on approximately 2004 was vaccinated with a first dose of 0.5 ml of PNEUMOVAX 23 (Lot#Unknown), second dose on 20-OCT-2010 (lot no. 665902/1426Y), IM respectively. The registered nurse stated that the patient had experienced local reaction at site of injection after receiving second dose of PNEUMOVAX 23. On 22-OCT-2010 the patient had complained of redness, swelling, warmth and red bumpy rash around site of injection. The patient had been diagnosed during office visit with cellulitis and prescribed Z-PAK. All drop down boxes had referred to this patient. At the time of the report the patient's outcome was recovering. Follow-up information has been received from the physician, who reported that the patient experienced local cellulitis. At the time of the report the patient had recovered. No further information is available.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female patient with no allergies and no pertinent medical history who on 07-NOV-2010 was vaccinated with the 0.5 ml dose of PNEUMOVAX 23 (Lot# 665904/0866Z) (Exp 04-07-2011), IM. There was no concomitant medication. Pharmacist stated that on 07-NOV-2010 later the same night after the patient had received her first dose of PNEUMOVAX 23, experienced tingling and difficulty moving her arm. The patient called the pharmacist to state that she was a little better. There were no laboratories diagnostic studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 74 year old female who on an unknown date, was vaccinated with a dose of PNEUMOVAX 23 (Lot#664653/1337Y). On an unknown date, the patient had increased redness and pain at the injection site. There was no lab diagnostics studies performed. At the time of the report, the outcome were unknown. The patient did not seek medical attention. No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old female patient with no known drug allergies, neuropathy and depression who on 25-MAY-2010 was vaccinated IM with a 0.5 ml first dose of PNEUMOVAX 23 (lot number 665402/1339Y, expiration date 22-MAY-2011) in the left deltoid. Concomitant therapy included LEXAPRO and NEURONTIN. The nurse reported that on 25-MAY-2010 the patient's site of injection became very red, swollen and painful after administration of the first dose of PNEUMOVAX 23. No laboratory tests were performed. At the time of the report the patient's outcome was unknown. The patient sought medical attention via telephone. Follow up information has been received from a registered nurse who reported that the 64 year old patient (also reported as 65 year old) with polycythaemia vera and osteopenia was vaccinated in the deltoid with the first dose of PNEUMOVAX 23. The nurse reported that in the night of 25-MAY-2010 the patient's arm was red, painful and swollen. On 03-JUN-2010 the patient recovered. The patient did not seek medical attention. No further information is expected.
Age: 1.42
Sex: M
Vaccine: HIBV, PPV
Symptoms: Feeling abnormal, Gait disturbance, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 month old male who on 13-MAY-2010 was vaccinated intramuscularly into the leg with a 0.5mL dose of PNEUMOVAX 23 (lot number 665707/1407Y). Concomitant therapy included PEDVAXHIB (dose, route and lot number not reported). No adverse effects were reported at this time. It was not specified if the patient sought medical attention. Follow up information was received from a Health professional. It was reported that the patient had no pre-existing allergies, birth defects, medical condition or illnesses at the time of vaccination. On 13-MAY-2010 at 03:00p.m., the patient's mother called to say that her child was not walking (refusing to walk) and developed fever (99.4 in office). It was noted that the patient was also fuzzy. The patient was seen again in the office on 14-MAY-2010 and was improving. The patient recovered on 16-MAY-2010. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Laboratory test
Clinical narrative: Information has been received from a pharmacy technician concerning a female in-house hospital patient with no drug reactions/allergies, who on 28-OCT-2010 was vaccinated in her right deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667405/0884Z). It was unknown if the patient had received PNEUMOVAX 23 in the past. The patient experienced erythema, 5 inches x 8 inches area at the injection site. No treatment was required. The reaction did not prolong her hospital stay. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. An "unnamed" laboratory test was performed (no result was provided). This is one of two reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old male patient who on 09-NOV-2010 was vaccinated IM in the right thigh inadvertently with a dose of PNEUMOVAX 23 (Lot# 663997/0622Y). The nurse stated that it was a staff err; they grabbed the wrong vaccine. No adverse effects were reported. Follow up information was received concerning a 12 month old female (previously reported as male) patient with no pertinent medical history who on 09-NOV-2010, at 2:30 pm, was vaccinated IM in the right thigh inadvertently with a dose of PNEUMOVAX 23 (Lot# 663997/0622Y). Wrong vaccine was given. There were no illnesses at the time of vaccination. No adverse events reported. No further information is available.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Local reaction, Oedema peripheral, Wrong drug administered
Clinical narrative: Information has been received from a doctor's office concerning a female patient who on approximately 08-NOV-2010 or 09-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). It was reported that the patient unfortunately got two PNEUMOVAX 23 vaccines within a 7 day period. She experienced a localized reaction, including redness and swelling. What happened was she came back to get the flu vaccine (the reporter supposed the doctor did not want her to receive both the same day) but when she returned, she said she was supposed to get PNEUMOVAX 23. The office employees took her by her word, instead of reading from the chart, and proceeded to give her the PNEUMOVAX 23. At the time of this report, the patient's outcome was unknown. Follow up information was received from a doctor of osteopathy concerning a 80 year old female with chronic obstructive pulmonary disease (COPD), allergy to codeine and morphine, coronary artery disease (CAD), breast cancer and hypertension who on 01-NOV-2010, was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml (Lot No 667271/0680Z). The patient returned to office on 09-NOV-2010 for flu vaccine and was given erroneously an other dose of PNEUMOVAX 23. The physician spoke with the patient on 09-NOV-2010 due to swelling and redness on the right arm, which alerted them to mistaken dose. At the time of the report the patient had recovered. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Activities of daily living impaired, Blood pressure decreased, Chills, Dehydration, Feeling abnormal
Clinical narrative: Information has been received from a male consumer who on 26OCT2010 was vaccinated with a dose of PNEUMOVAX 23 into the right arm by a pharmacist and "the next couple days" "felt miserable," had flu-like symptoms, chills, and a fever of 101.9. It was reported that the patient had an adverse reaction to the vaccine. On Friday (29NOV2010), the patient's blood pressure dropped and he sought medical treatment at the doctor's and was diagnosed with cellulitis and found out he was dehydrated. The consumer missed a couple days of work because of this incident. At the time of reporting the patient's outcome was not provided. Additional information is expected.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pyrexia, Vaccination complication
Clinical narrative: Information has been received from a male consumer who on 26OCT2010 was vaccinated with a dose of PNEUMOVAX 23 into the right arm by a pharmacist and "the next couple days" "felt miserable," had flu-like symptoms, chills, and a fever of 101.9. It was reported that the patient had an adverse reaction to the vaccine. On Friday (29NOV2010), the patient's blood pressure dropped and he sought medical treatment at the doctor's and was diagnosed with cellulitis and found out he was dehydrated. The consumer missed a couple days of work because of this incident. At the time of reporting the patient's outcome was not provided. Additional information is expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 67 year old male patient who on 04-MAY-2010 was vaccinated subcutaneously into his left arm with a dose of PNEUMOVAX 23 (lot# 662268/1134Y) that had expired on 11-APR-2010. No adverse effects were reported. The patient did not seek medical attention. Follow-up information has been received from a doctor concerning a 67 year old patient who on 04-MAY-2010 was vaccinated with the first dose of PNEUMOVAX 23 into his left deltoid. On 05-MAY-2010, the patient stated he had about softball size redness, hardness and warm feeling at the site of the injection for 2 weeks. No further information is available.