chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 66 year old female who on 27-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (route not reported, lot# 665300/1314Y). On 27-SEP-2010 the patient experienced injection site became warm, painful and swollen that night. She stated that the reaction cleared in three days. She did not seek medical attention and she was fully recovered at the time of this report. The nurse stated that the pharmacy that administered the vaccine had a standing order from the listed physician and that the patient was not examined prior to receiving the vaccine. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unspecified date a few years ago, was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported). Subsequently the patient experienced hives. At the time of this report, the patient had recovered from hives. No further information is available.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, PPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 62 day old female patient who on 12-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 664537/1193Y) (Expiration date: 05-FEB-2011) instead of PREVNAR (human error in ordering the vaccine in the office computer system, not PQC). No adverse effect was reported. Follow up information was received via telephone call from a Licensed Practical Nurse concerning the 54 day old patient (previously reported as 62 day old). The nurse reported that she had given the patient a dose of PNEUMOVAX 23 because that was what the physician ordered. The patient had concomitantly received a first dose of ROTATEQ (Lot# 665020/1588Y) and a dose of PENTACEL (Lot# C3265AC). Additional information was received via telephone call from the Registered Nurse indicating that the physician had written the order to give the patient PREVNAR 13. The computer system had computed the physician's order as PNEUMOVAX 23. The patient received the PNEUMOVAX 23 instead of PREVNAR 13 due to a computer problem. The Registered Nurse also stated that the computer problem had been corrected. Follow-up information has been received from a physician who indicated that the female patient with no drugs reactions or allergies no birth defects, no medical conditions and no illness at the time of vaccination was vaccinated on 20-JUL-2010 with a second dose of RECOMBIVAX HB (lot # not reported). The physician also stated that in a telephone call to the child's grand mother on 13-AUG-2010 "the next day", she reported that the child had no fever, no swelling and was eating well. On 09-SEP-2010 the child was fine. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning that an approximately 65 year old "over age 65" female patient on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot#'s 663889/0632Y or 665924/0930Z). It was reported that on an unspecified date, the patient experienced a local site reaction (redness, swelling, and pain), generalized malaise and low-grade fever. The nurse reported that two patients (not specified which patients) received either dexamethasone (MSD) or dexamethasone as treatment (thought to be an allergic reaction). On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning that an approximately 65 year old "over age 65" female patient on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot#'s 663889/0632Y or 665924/0930Z). It was reported that on an unspecified date, the patient experienced a local site reaction (redness, swelling, and pain), generalized malaise and low-grade fever. The nurse reported that two patients (not specified which patients) received either dexamethasone (MSD) or dexamethasone as treatment (thought to be an allergic reaction). On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site reaction, Pain, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning an elderly patient who on 18-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # not provided). It was reported that the patient experienced and injection site reaction. The patient experienced radiating pain and lack of functionality of the arm. The patient called 911 and was evaluated by paramedics. No treatment was reported by the paramedics. No hospitalization. The patient will be scheduled for an office evaluation. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the nurse concerning the 81 year old retired female patient with no illness at time of vaccination and with hypersensitivity to prednisone (caused illness), intolerance to many medicines and many skin allergies (including perfumes) who on 18-NOV-2010 at 11:42 was vaccinated intramuscularly in the left deltoid with a first dose of PNEUMOVAX 23 (Lot # 667271/0880Z). The nurse reported that started hurting within a couple of hours, progressed to extreme pain. No redness or swelling at the site. The patient called to emergency medical services that evening but patient did not go to the hospital. Patient could not use the arm, unable to move it due to pain, level 10. The nurse stated that gradually the patient improved over 4 to 5 days (approximately on 23-NOV-2010). No further information is available.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain upper, Pain, Retching, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 8 year old son who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot # not reported). The mother reported that her son, who could skid down the sidewalk on his face with barely a tear, was curled up in a fetal position in horrible pain and throwing up every ten minutes, because of this vaccine. On 21-SEP-2010, the patient required an emergency room visit secondary to side effects experienced as a result of PNEUMOVAX 23. He and his father spent almost six hours at the emergency room. His pain was so intense, so they gave him VICODIN and they had to give him a medicine for cancer patients to stop the dry heaves and stomach convulsions. The reporter was angry that PNEUMOVAX 23 resulted in unnecessary pain and misery for the patient. At the time of report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a patient who on approximately 08-NOV-2010 ("in the past week") was subcutaneously vaccinated with a dose of PNEUMOVAX 23 (lot # not reported). On approximately 08-NOV-2010 ("in the past week") the patient experienced a case of cellulitis at the injection site of a subcutaneous vaccination with PNEUMOVAX 23. Unspecified medical attention had been sought. At the time of reporting, the outcome of the patient was unknown. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Migraine, Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 39 year old female with drug allergies to MORPHINE and DARVOCET and medical history of "pain", splenectomy and pneumonia who on 17-NOV-2010 at 6:30pm was vaccinated intramuscularly with a dose of 0.5 ml expired PNEUMOVAX 23 in the right deltoid (lot # 663889/0632Y, expiration date 12-NOV-2010). Concomitant therapy included FLUZONE in left deltoid on the same day, doxepin hydrochloride 50mg, oxycodone, methadone hydrochloride and occasional generic AMBIEN. At 10pm the patient experienced pain and swelling at the site, migraine, nausea and vomiting. The patient had sought unspecified medical attention. At the time of reporting, the outcome was unknown. Due to the patient's medical history, the pharmacist stated the patient got a PNEUMOVAX 23 every year or had for the last couple of years. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Arthritis, Injected limb mobility decreased, Insomnia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 79 year old female with allergies (allergic to BIAXIN) and anxiety disorder who "6 year ago", in 2004 was vaccinated with the first dose of PNEUMOVAX 23. On 12-OCT-2010 the patient was intramuscularly vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 (lot # 667913/1021Z, expiration date 27-FEB-2012) in her left arm. Concomitant therapy during the same visit included a dose of influenza virus vaccine (unspecified) in her left arm and a dose of ADACEL in her right arm. Other concomitant therapy included loratadine, ADVAIR, albuterol, FLONASE and XANAX. On 13-OCT-2010 the patient experienced pain in her left arm and was unable to lift her arm. The patient was unable to sleep because of pain. The patient was examined with x-ray in the office on 02-OCT-2010 and the result showed normal with some arthritis. She experienced some improvement but still complained of left shoulder pain. The patient was prescribed KEFLEX. At the time of the report, the patient was recovering. Additional information has been requested. This is one of several reports received from the same source.
Age: 79.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: X-ray normal
Clinical narrative: Information has been received from a medical assistant concerning a 79 year old female with allergies (allergic to BIAXIN) and anxiety disorder who "6 year ago", in 2004 was vaccinated with the first dose of PNEUMOVAX 23. On 12-OCT-2010 the patient was intramuscularly vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 (lot # 667913/1021Z, expiration date 27-FEB-2012) in her left arm. Concomitant therapy during the same visit included a dose of influenza virus vaccine (unspecified) in her left arm and a dose of ADACEL in her right arm. Other concomitant therapy included loratadine, ADVAIR, albuterol, FLONASE and XANAX. On 13-OCT-2010 the patient experienced pain in her left arm and was unable to lift her arm. The patient was unable to sleep because of pain. The patient was examined with x-ray in the office on 02-OCT-2010 and the result showed normal with some arthritis. She experienced some improvement but still complained of left shoulder pain. The patient was prescribed KEFLEX. At the time of the report, the patient was recovering. Additional information has been requested. This is one of several reports received from the same source.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 59 year old female consumer who on 11-NOV-2010 or 12-NOV-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (Lot # not reported). There was no concomitant medication. The consumer reported that on 11-NOV-2010 or 12-NOV-2010 after receiving the first dose, her upper arm was a little sore near the injection site that lasted for 2 days. The patient had recovered (approximately on 13-NOV-2010). There were not laboratories performed. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 667590/1158Z). The physician reported that on "this week" (on approximately 14-SEP-2010) the patient experienced 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. This is one of several reports received from the same source. Follow-up information was received from an other health care professional who stated that the female patient with allergies to albuterol, AVAPRO, ALUPENT, and Ciprofloxacine and no illness at time of vaccination, on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23 (lot# 667690/1158Z). It was reported that the patient experienced soreness and swelling. The patient was treated with steroids and anti-histamines which calmed down the adverse events. There was not 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 numbers 666639/0564Z and 667690/1158Z were both male patients. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a female consumer with a history of spleen removed in 2005 who Thursday 8/19 (year not given), was vaccinated with a dose of PNEUMOVAX 23 (lot#665902/1426Y). The patient stated that she had her spleen removed in 2005 and at that time it was suggested by her physician that she receive the PNEUMOVAX 23 every 5 years. Six hours later her upper arm became extremely swollen, red, very hot to the touch and very painful. She returned to her physician the following day to be seen about this and the symptoms continued to spread around her entire upper arm and into her shoulder area. Low grade fever at 24 hours. At the time of the letter she had been taking methylprednisolone tablets, antibiotics (unspecified) and BENADRYL for 4 days and the swelling started to subside. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a female consumer with a history of spleen removed in 2005 who Thursday 8/19 (year not given), was vaccinated with a dose of PNEUMOVAX 23 (lot#665902/1426Y). The patient stated that she had her spleen removed in 2005 and at that time it was suggested by her physician that she receive the PNEUMOVAX 23 every 5 years. Six hours later her upper arm became extremely swollen, red, very hot to the touch and very painful. She returned to her physician the following day to be seen about this and the symptoms continued to spread around her entire upper arm and into her shoulder area. Low grade fever at 24 hours. At the time of the letter she had been taking methylprednisolone tablets, antibiotics (unspecified) and BENADRYL for 4 days and the swelling started to subside. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Body temperature increased, Erythema, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 41 year old male patient with bicuspid aortic valve and no illness at time of vaccination who on 14-SEP-2010 03:00 PM was vaccinated IM into the left deltoid with the first dose of PNEUMOVAX 23 (lot number 667136/0499Z), and a dose of FLUVIRIN (lot number 112946P1). Concomitant therapy included ALTACE. On 15-SEP-2010, "24 hours after injection", the patient presented to ER with temperature 38.1 degrees centigrade, mild redness and tenderness in left deltoid area of PNEUMOVAX 23 injection, and into axilla. The patient was treated with doxycycline to prevent cellulitis. On an unspecified date, the patient recovered from the adverse events. No diagnostic laboratory tests performed. Additional information is not expected. This one of several reports received from the same source.
Age: 0.74
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning an 8 month old (also report as 4 month old) male who on 21-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (therapy route and lot # not reported). No AE occurred. Additional information has been requested. Follow up information received from the certified medical assistant indicated that it was "product confusion". PNEUMOVAX 23 and PREVNAR were pretty similar and they both looked alike. She further stated that they had now highlighted the packages to "please read before dispensing" so that this did not occur again in the future. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a physician's assistant concerning a female patient with no pertinent medical history and no drugs reactions or allergies who on 15-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # unknown). There was no concomitant medication. The physician's assistant reported that on 16-SEP-2010 "within 24 hours after received the vaccine" the patient developed fever, a large welt at the injection point and redness. No laboratory diagnostics studies were performed. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the medical assistant concerning a 43 year old female patient with viral sinusitis at the time of vaccination, with asthma, Polycythaemia rubra vera, and drug allergy (TYLENOL) who on 15-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667418/0978Z) in the right arm. It was reported that on 15-SEP-2010, the patient developed 3-5 days of febrile illness, generalized myalgias, injection site tenderness and diffuse with diffuse swelling and erythema of involved deltoid/triceps. The patient sought medical attention at doctor visit. It was reported that on approximately 20-SEP-2010 the patient recovered from the febrile illness, generalized myalgias, injection site tenderness with diffuse swelling and erythema of involved deltoid/triceps. No relevant diagnostic test was performed. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician's assistant concerning a female patient with no pertinent medical history and no drugs reactions or allergies who on 15-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # unknown). There was no concomitant medication. The physician's assistant reported that on 16-SEP-2010 "within 24 hours after received the vaccine" the patient developed fever, a large welt at the injection point and redness. No laboratory diagnostics studies were performed. At the time of report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information has been received from the medical assistant concerning a 43 year old female patient with viral sinusitis at the time of vaccination, with asthma, Polycythaemia rubra vera, and drug allergy (TYLENOL) who on 15-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 667418/0978Z) in the right arm. It was reported that on 15-SEP-2010, the patient developed 3-5 days of febrile illness, generalized myalgias, injection site tenderness and diffuse with diffuse swelling and erythema of involved deltoid/triceps. The patient sought medical attention at doctor visit. It was reported that on approximately 20-SEP-2010 the patient recovered from the febrile illness, generalized myalgias, injection site tenderness with diffuse swelling and erythema of involved deltoid/triceps. No relevant diagnostic test was performed. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Dyskinesia, Injection site erythema, Injection site reaction, Injection site streaking, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 38 year old female patient with no drug reactions or allergies and a history of sarcoidosis who on approximately 06-SEP-2010 was vaccinated with her first 0.5ml dose of PNEUMOVAX 23 (Lot # not provided). Concomitant therapy included IMURAN. The physician reported that on approximately 07-SEP-2010 "the next day", that the patient received the dose of PNEUMOVAX 23, she was experiencing "red streaks", hot, swollen and isolated movement in the arm that she was vaccinated in". The patient sought unspecified medical attention. At the time of report, the patient's outcome was unknown. Follow-up information was received from a licensed practical nurse who reported that the 38 year old female patient with a history of sarcoidosis and fibromyalgia, on 17-SEP-2010, was administered a dose of PNEUMOVAX 23 (lot # 667912/0933Z, expiry date on 25-FEB-2012), intramuscularly into her right deltoid in the morning. The nurse stated that the morning of 19-SEP-2010, the patient experienced redness, heat, swelling and isolated movement at the injection site, with red streaks toward the elbow. On 20-SEP-2010, at 08:30 A.M., the patient went to the physician's office. On 22-SEP-2010, the patient recovered. No further information is available.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 38 year old female patient with no drug reactions or allergies and a history of sarcoidosis who on approximately 06-SEP-2010 was vaccinated with her first 0.5ml dose of PNEUMOVAX 23 (Lot # not provided). Concomitant therapy included IMURAN. The physician reported that on approximately 07-SEP-2010 "the next day", that the patient received the dose of PNEUMOVAX 23, she was experiencing "red streaks", hot, swollen and isolated movement in the arm that she was vaccinated in". The patient sought unspecified medical attention. At the time of report, the patient's outcome was unknown. Follow-up information was received from a licensed practical nurse who reported that the 38 year old female patient with a history of sarcoidosis and fibromyalgia, on 17-SEP-2010, was administered a dose of PNEUMOVAX 23 (lot # 667912/0933Z, expiry date on 25-FEB-2012), intramuscularly into her right deltoid in the morning. The nurse stated that the morning of 19-SEP-2010, the patient experienced redness, heat, swelling and isolated movement at the injection site, with red streaks toward the elbow. On 20-SEP-2010, at 08:30 A.M., the patient went to the physician's office. On 22-SEP-2010, the patient recovered. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacy tech concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665903/1427Y) from a multi dose vial. After vaccination the patient experienced an injection site reaction. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. 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: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Condition aggravated, Headache, Influenza like illness, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning his approximately 54 year old wife with autoimmune issues, scleroderma, spinal problems, arachnoiditis, histal hernia and thimerosal allergy who "about 6 years ago" in approximately 2004 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# unknown). Second 0.5 ml dose of PNEUMOVAX 23 (Lot# unknown) was given on 21-SEP-2010 in the shoulder. Concomitant therapy included estrogen therapy (unspecified), pain medication (unspecified), TOPAMAX and other unspecified medications. The consumer reported that after receiving her first dose of PNEUMOVAX 23 in approximately 2004 hie wife developed a hot, swollen 7 inch welt at the injection site, 101 degrees fever, headache, flu-like symptoms and gastrointestinal (GI) upset. The consumer stated that this reaction was less severe than the reaction that the patient experienced after the second dose of PNEUMOVAX 23. On 21-SEP-2010, the patient developed a hot, swollen, 7 inch welt at the injection site, 101 degrees fever, headache, flu-like symptoms and gastrointestinal (GI) upset. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. On follow up information received on 20-OCT-2010, the patient's husband added that his wife, soon after receiving PNEUMOVAX 23, experienced an exacerbation of the generalized muscle spasms due to her "degenerative spinal disease". At the time of the report, the patient continued to have residual swelling at the injection site and the outcome of the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Injection site warmth, Muscle spasms, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his approximately 54 year old wife with autoimmune issues, scleroderma, spinal problems, arachnoiditis, histal hernia and thimerosal allergy who "about 6 years ago" in approximately 2004 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# unknown). Second 0.5 ml dose of PNEUMOVAX 23 (Lot# unknown) was given on 21-SEP-2010 in the shoulder. Concomitant therapy included estrogen therapy (unspecified), pain medication (unspecified), TOPAMAX and other unspecified medications. The consumer reported that after receiving her first dose of PNEUMOVAX 23 in approximately 2004 hie wife developed a hot, swollen 7 inch welt at the injection site, 101 degrees fever, headache, flu-like symptoms and gastrointestinal (GI) upset. The consumer stated that this reaction was less severe than the reaction that the patient experienced after the second dose of PNEUMOVAX 23. On 21-SEP-2010, the patient developed a hot, swollen, 7 inch welt at the injection site, 101 degrees fever, headache, flu-like symptoms and gastrointestinal (GI) upset. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. On follow up information received on 20-OCT-2010, the patient's husband added that his wife, soon after receiving PNEUMOVAX 23, experienced an exacerbation of the generalized muscle spasms due to her "degenerative spinal disease". At the time of the report, the patient continued to have residual swelling at the injection site and the outcome of the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Information has been received form a pharmacy tech concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665903/1427Y) from a multi dose vial. After vaccination the patient had red swollen feverish injection site reactions with temperatures to 103 degrees F and feeling achy. The patient was treated with antibiotics (unspecified). At the time of the report the patient's outcome as unknown. It was unspecified if the patient sought medical attention. This is one of several reports received 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 665903/1427Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with hypertension, gastrooesophageal reflux disease, hyperlipidaemia, depression and opioid analgesic allergy, who on 14-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # 666639/0564Z, Exp 09-OCT-2010) (route no reported). Concomitant therapy included citalopram, ZIAC, NEXIUM and LIPITOR. On 15-SEP-2010 the patient experienced redness, swelling and heat at injection site. Patient was given DEPO-MEDROL. At the time of the report, the patient was recovering. There were no laboratory tests performed. The patient sought unspecified medical attention. Follow up information has been received from the registered nurse concerning the 65 year old female patient who on 14-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # 666639/0564Z, Exp 09-OCT-2010) (route no reported) into her left arm. It was reported that there were no illness at time of vaccination. On 14-SEP-2010 the patient developed left upper extremity pain, warmth and malaise. The patient's final outcome was not reported. Follow-up information has been received from the registered nurse who reported that no further appointments or follow-up were made for the patient. The outcome of events was unknown. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 50 year old female patient with arthritis and fibromyalgia and a history of drug hypersensitivity who on 14-SEP-2010 was vaccinated with a 0.5 ml dose, intramuscularly of PNEUMOVAX 23 (Lot # 665402/1339Y, Exp date 22-JUN-2011). Concomitant therapy included warfarin. On 14-SEP-2010 the patient experienced red streaks on skin which ran from under the injection side to her arm pit after receiving the vaccine. She also complained of soreness at the injection site. At the time of the report, the patient had no recovered. The patient sought unspecified medical attention. There were no laboratories performed. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a current 56 year old female patient with asthma and no drug reactions or allergies who 3-4 years ago, in approximately 2006 was vaccinated with the first dose of PNEUMOVAX 23 and on 15-SEP-2010, was vaccinated intramuscularly into the deltoid of left arm with a 0.5 ml second dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date: 04-JUL-2011). The pharmacist reported that the patient experienced her injection arm being real heavy and sore for a couple of days the first dose of PNEUMOVAX 23 3-4 years ago, in approximately 2006. One month ago, on approximately 16-AUG-2010, the patient was vaccinated into the right arm with a dose of FLUVIRIN. Pharmacist also reported that on 15-SEP-2010, when the patient received the second dose of PNEUMOVAX 23, later that evening the patient experienced at the injection site swelling, redness and warmth. The next morning, on 16-SEP-2010, the injection site was fine but the swelling, redness and warmth migrated to the back of arm. At the time of the report the patient had not recovered. Patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Sensation of heaviness, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a current 56 year old female patient with asthma and no drug reactions or allergies who 3-4 years ago, in approximately 2006 was vaccinated with the first dose of PNEUMOVAX 23 and on 15-SEP-2010, was vaccinated intramuscularly into the deltoid of left arm with a 0.5 ml second dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date: 04-JUL-2011). The pharmacist reported that the patient experienced her injection arm being real heavy and sore for a couple of days the first dose of PNEUMOVAX 23 3-4 years ago, in approximately 2006. One month ago, on approximately 16-AUG-2010, the patient was vaccinated into the right arm with a dose of FLUVIRIN. Pharmacist also reported that on 15-SEP-2010, when the patient received the second dose of PNEUMOVAX 23, later that evening the patient experienced at the injection site swelling, redness and warmth. The next morning, on 16-SEP-2010, the injection site was fine but the swelling, redness and warmth migrated to the back of arm. At the time of the report the patient had not recovered. Patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Full blood count, Oedema peripheral
Clinical narrative: Information has been received concerning a male who on 11-SEP-2010 was vaccinated with PNEUMOVAX 23 (lot # 663889/0632Y). There was no concomitant medication. On 11-SEP-2010 the patient experienced a reaction to the pneumonia vaccination. The customer's arm became swollen and red. Follow-up information has been received from a lawyer and medical records concerning a 66 year old male who had what was reported as a severe reactions to a 0.5mL PNEUMOVAX 23 (lot #0632Y) on 11SEP2010. He has sustained damages as a result. On an unspecified date, the patient had an office visit and had a CBC (results not provided). He was also given ROCEPHIN 1 gram injection and a prescription for BACTRIM DS/KEFLEX. The patient was instructed to return in two weeks. All available medical records will be provided upon request. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a Pharmacist (R.Ph.) concerning a 64 year old male with no medical history and no drug reaction/allergies who on 15-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot#663889/0632Y). Concomitant therapy included FLUVIRIN. On 16-SEP-2010 the patient developed a red, hot, swollen area on his left arm below the injection site after receiving PNEUMOVAX 23. The pharmacist described this area was wrapping around the patient's arm. No lab diagnostics studies performed. The patient's redness, hotness and swelling of the area on his left arm below the injection site persisted. The patient came back to pharmacist to sought medical attention. Follow-up information was received from the physician's assistant (PA) concerning a 64 year old male with no pre-existing medical condition who on an unspecified date was vaccinated with the first dose of PNEUMOVAX 23. Concomitant vaccination included influenza virus vaccine (unspecified). Both vaccines were given in the left upper arm by a pharmacist. When evaluated the patient, his arm was swollen, red, erythematous. The patient had taken flu vaccine before with no reaction. This was the first time for PNEUMOVAX 23. At the time of the report the outcome was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient who on 20-SEP-2010 was vaccinated into her right arm (also reported into the left deltoid) with her first dose of PNEUMOVAX 23 (lot # 665904/0866Z). Concomitant therapy included FLUVIRIN into her left arm. The pharmacist reported that on 20-SEP-2010, the patient experienced numbness, fever and decreased limb mobility. The patient sought medical attention by a telephone call. At the time of report, the patient had not recovered from numbness, fever and decreased limb mobility. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Injection site pain, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old male with high cholesterol, hypothyroidism, nerve pain, benign prostatic hyperplasia and high blood pressure and sulfonamide allergy who on 11-SEP-2010 was vaccinated intramuscularly with a dose PNEUMOVAX 23 (lot number 667912/0933Z; expiration date 25-FEB-2010. Concomitant therapy included LYRICA, LIPITOR, levothyroxine Na, hydrocodone, terazosin hydrochloride, lorazepam, lisinopril (manufacturer unknown) and testosterone. The pharmacist stated that the patient received PNEUMOVAX 23 and a few hours later he developed pain at the injection site, and severe swelling. He went to the emergency room and received an antibiotic and TORADOL. At the time of the report, the patient was recovering. This is one of three 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: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old male patient with no pertinent medical history and no drug reactions or allergies who on 13-SEP-2010 was vaccinated intramuscularly into the left arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 667912/0933Z). Concomitant therapy included vaccination into the right arm with a dose of influenza virus vaccine (unspecified) (manufacturer unknown). The pharmacist reported that the patient developed 2-3 inch red area on his left arm at the injection site after receiving PNEUMOVAX 23. Patient came back to pharmacy to seek medical attention on an unspecified date. The outcome of the patient was not reported. No lab diagnostics studies were performed. Follow up information has been received from a registered pharmacist. It was reported that on 13-SEP-2010 the patient was vaccinated IM in the left deltoid with a dose of PNEUMOVAX 23 (Lot # 667912/0933Z) at 13:00. The registered pharmacist reported that on 15-SEP-2010 (reported as 15-SEP-2011) the patient experienced redness and swelling at the site of injection 2-3 inches wide. The patient recovered on 18-SEP-2010 (reported as 18-SEP-2011). The patient did not seek medical attention. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a male patient who in 2010 was vaccinated with a dose of 0.5 ml of PNEUMOVAX 23 (lot# not reported). The nurse stated that the patient after getting the vaccine, experienced nausea and vomiting for 36 hours. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no pertinent medical history who on unspecified date in 2001 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# not reported), and on 17-NOV-2010 was vaccinated with a second dose of 0.5 ml of PNEUMOVAX 23 (Lot # 665903/1427Y) (Exp date 03-JUL-2011). The nurse stated that the patient contacted office by phone on 17-NOV-2010 and reported that she had swelling which extended from her shoulder to her elbow. The nurse also stated, it was localized swelling and the physician recommended patient used warm compresses on area and TYLENOL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. The patient had a history of allergy to alendronate sodium (MSD, WAES 1012USA03173). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Back pain, Dyspnoea, Flushing
Clinical narrative: Information has been received from a male consumer who on 15SEP2010 was vaccinated with a dose of PNEUMOVAX 23, lot #5632Y, with an expiration date of 12NOV2010. It was reported that the consumer had an adverse reaction to the vaccine and experienced shortness of breath, flushing and low back pain. Subsequently, the patient recovered from shortness of breath, flushing and low back pain. Additional information is expected.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: Information has been received from a 42 year old female with drug highly allergic to BIAXIN and also to Quinolones, who on Tuesday, 16-NOV-2010 at 3 pm was vaccinated IM on left arm with a 0.5 ml dose of PNEUMOVAX 23 (lot number not provided) to prevent pneumonia. Concomitant therapy included cefdinir. On 16-NOV-2010 the patient experienced some pain throughout the day. The patient stated that she developed a fever that rose to 102 degrees, and she could not get the fever down below 100.6 degrees, even though she took ibuprofen and acetaminophen. The patient also experienced "nausea" and her arm felt like it was on fire. The patient felt "immobilized" by her symptoms. No lab diagnostic studies performed. The patient sought unspecified medical attention. At the time of report, the patient's present status was not recovered. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old male with type 2 diabetes mellitus (DM 2), hyperlipidaemia, hypertension (HTN), gastrooesophageal reflux disease (GERD) and iron deficiency (FE def.) anaemia and no illness at time of vaccination who on 28-OCT-2010 9:00 AM was vaccinated IM into the right deltoid with the first dose of PNEUMOVAX 23 (lot number 667271/0880Z). Concomitant therapy included the third dose of FLUZONE given IM into the left deltoid on 28-OCT-2010, LIPITOR, metformin, lisinopril (manufacturer unknown), iron (unspecified), omeprazole (manufacturer unknown) and low dose aspirin (ASA). On 28-OCT-2010 9:00 PM, "day after immunization", the patient reported by phone that right arm was sore, swollen, red and itchy. Advised symptomatic treatment of ice, TYLENOL and BENADRYL and to call if worsened or not resolving. On an unspecified date, the patient recovered from right arm was sore, swollen, red and itchy. No diagnostic laboratory tests performed. No further information is available. This one of several reports received from the same source.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning an approximately 66 year old female with auto-immune system disorder who on 04-NOV-2010 was vaccinated with one injection of 0.5ml PNEUMOVAX 23. The patient experienced redness and a 'hot' sensation in the right arm at the injection site immediately after receiving the vaccination and both reactions were attended to by physician. At the time of report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered pharmacist (R.PH.) concerning a number of patients who on unknown dates were vaccinated with PNEUMOVAX 23 (lot # not reported). The reporter stated that the hospital had to quarantine a lot of PNEUMOVAX 23 because it was thought to be causing cellulitis in a number of patients who had received the vaccination. It was unknown if the patient sought medical attention. Follow-up information has been received which reported the patient was a 59 years old female. The patient might have been given Tdap (manufacturer unknown). The lot number for PNEUMOVAX 23 may have been 667692/1110Z. The patient was given an antibiotic. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning an approximately 66 year old female with auto-immune system disorder who on 11-NOV-2010 was vaccinated with one injection of 0.5ml PNEUMOVAX 23. The patient experienced redness and a 'hot' sensation in the right arm at the injection site immediately after receiving the vaccination and both reactions were attended to by physician. At the time of report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.26
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning an 13 week old male who on 23-NOV-2010 was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 at left thigh (lot # 664079/0633Y). The reporter stated that the patient was inadvertently vaccinated with PNEUMOVAX 23 instead of PREVNAR 13, staff error. No adverse effects reported. The patient sought unspecified medical attention. Follow up information was received from the licensed practical nurse who reported the patient was continuing to do well. Regarding the wrong drug administered, the reporter confirmed it was staff error and had nothing to do with improper labeling. Additional information is not expected.