chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a female in 40s who was vaccinated with the first and second dose of PNEUMOVAX 23 within one year. After the second dose of PNEUMOVAX 23 the patient developed reaction. The patient had sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow-up information has been received from a physician concerning a patient with no illness at time of vaccination who was vaccinated with the first and second dose of PNEUMOVAX 23 within one year (per the patient's report) apart. Concomitant vaccination included influenza virus vaccine (unspecified). With the second dose of PNEUMOVAX 23, the patient experienced a large injection site reaction. There was no relevant diagnostic test performed. At the time of the report, it was unknown if the patient had recovered from the event. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a male consumer who on an unspecified date was vaccinated with PNEUMOVAX 23. Subsequently, he experienced swelling in his arm. At the time of the report the patient's outcome was not specified. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who within the last couple of days was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). "Right after getting the vaccine" the patient experienced fever and significant swelling of the arm. The patient was administered an epinephrine shot and recovered. The nurse also stated that she will hold off on administering the PNEUMOVAX 23 vaccine with that lot number to the patients. Follow up information has been received from the licensed visiting nurse who indicated that the patient was vaccinated with PNEUMOVAX 23 (Lot # 665300/1314Y) on approximately 09-FEB-2010. The licensed visiting nurse thought that the patient had been treated with SOLUMEDROL and an antibiotic (unspecified). The licensed visiting nurse did not consider the patient's fever or swelling of the arm to be life - threatening. The licensed visiting nurse stated that according to the office's policy they were not administering PNEUMOVAX 23 with the lot # 665300/1314Y. The nurse also stated that the patient had not received epinephrine as previously reported. A standard lot check investigation was performed. 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 two reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulin therapy, Infusion site cellulitis, Injection site cellulitis
Clinical narrative: This report was received from CSL Behring and was assigned manufacturer report number 2010021861 for VIVAGLOBIN, concerning a 61 year old female who was also a physician, with hypogammaglobulinaemia, allergic asthma, allergic rhinitis, allergy to montelukast sodium (WAES 1002USA01909), recurrent pneumonia and a history injection site cellulitis from other injections including the flu shot (brand name unspecified) and an increased liver function test, who on approximately 05-APR-2009, was vaccinated with PNEUMOVAX 23 (route and lot # unknown). It was reported that on 05-APR-2009, once after the vaccine, the patient experienced cellulitis. It was unspecified if the patient sought medical attention. At the time of the report the patient's outcome was unknown. The nurse also reported that in December 2009, after the second dose of VIVAGLOBIN, the patient developed minor cellulitis at the infusion site which then resolved. Concomitant therapy included SYMBICORT, NASACORT, ASTELIN, CYMBALTA, XOPENEX, COUMADIN, ADVAIR, TEKTURNA, MODURETIC, PREVACID, REGLAN, LEXAPRO, DARVOCET-N, steroid injection, RECLAST IV,  QVAR, MICARDIS, CELEBREX and BONIVA. This was originally reported by a registered nurse. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a 60 year old female patient with penicillin allergy, cephalosporins allergy and VICODIN allergy and with no pertinent medical history who on 12-FEB-2010 was vaccinated IM with her first 0.5 ml dose of PNEUMOVAX 23 (Lot # 665401/1320Y). Concomitant therapies included LEXAPRO, DIOVAN, hydrochlorothiazide (manufacturer unknown), LIPITOR and KLONOPIN. On 13-FEB-2010 the patient experienced cellulitis at the injection site. On 14-FEB-2010 the patient was evaluated in the emergency department but released on the same day. There were no lab diagnostic tests performed. She was treated with IV antibiotics. The physician requested a lot check. At the time of report the patient's status was not recovered. Additional information has been requested. 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 agency and was released.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 76 year old male insurance agent with no pertinent medical history who on 02-FEB-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (664864/1365Y) into his left deltoid at 10:30 AM. On 03-FEB-2010 at the early morning the patient experienced swelling of left arm, tender and redness. It was reported that the patient did not require emergency room or doctor visit. On 06-FEB-2010 the patient recovered from these events. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a 68 year old female who on 26-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided) and a dose of influenza virus vaccine (unspecified) in the same arm. On 26-JAN-2010 the patient experienced warmness in her arm as well as swelling. The patient sought medical attention and was on therapy. On 01-FEB-2010, the patient had recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local swelling
Clinical narrative: Information has been received from a nurse concerning a female physician with rhinitis allergic, allergic asthma and drug allergy to montelukast sodium (MSD, WAES # 1003USA00136), and a history of injection site cellulitis, liver function tests raised, pneumonia recurrent, hypogammaglobulinemia and pneumonia recurrent who on 05-NOV-2009 was vaccinated with PNEUMOVAX 23 (Lot # 663888/0627Y). Secondary suspect vaccination included FLUVAX. Concomitant therapy included PEPCID, HYDRODURIL, VIVAGLOBIN, SYMBICORT, NASACORT, ASTELIN, CYMBALTA, XOPENEX, COUMADIN, ADVAIR, TEKTURNA, PREVACID, REGLAN, LEXAPRO, DARVOCET-N, corticosteroids (unspecified), RECLAST, QVAR, MICARDIS HCT, CELEBREX and BONIVA. The patient had a history of developing cellulitis after VIVAGLOBIN injection (manufacturer case # 2010021861). Patient also reports cellulitis after other injections (not specified). An unspecified time after influenza vaccination, the patient developed cellulitis. Treatment details and event outcome was unknown. Follow-up was received from a physician on 02-FEB-2010. The physician reported having no record of a local reaction to flu shot injection. It was reported that the 61 year old female physician had a large local swelling and mild cellulitis within 2-3 days after vaccinating her with PNEUMOVAX 23 (Lot # 663888/0627Y) 0.5 mL in the left deltoid at the physician's office on 05-NOV-2009. There were no known vaccinations 4 weeks prior to that. She was not pregnant at the time of vaccination. On 09-NOV-2009, the patient was treated with unspecified antibiotic and "cleared up". The physician reported the causality as possible for the PNEUMOVAX 23. Additional information has been requested. This is one of several reports received from the same source.
Age: 1.07
Sex: M
Vaccine: HIBV, MMR, PPV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male patient with no pertinent medical attention or drug reactions who on 21-DEC-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 into his thigh instead of PREVNAR. Concomitant therapy included the first dose of MMR II, the first dose of VARIVAX (Merck) and the fourth dose of ACTHIB (manufacturer: Sanofi). The nurse stated that this was a staff error only. No adverse effects were reported. No laboratory studies were performed. The patient sought unspecified medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient who in approximately January 2010, "within the last week or within the last 30 days", was vaccinated with PNEUMOVAX 23 (lot # 663936/0508Y) through subcutaneous injection (dose and site not reported). In approximately January 2010, "within the last week or within the last 30 days", the patient experienced injection site reaction soon after. The patient was in the hospital before receiving the vaccine and hospitalization was not due to vaccination. The outcome of injection site reaction was not reported. This is one of the several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 663936/0508Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1), PPV
Symptoms: Cellulitis, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker and from Claim Management Services, INC. (claim number 30100122931-0001) concerning a 58 year old female who on 10-JAN-2010 was vaccinated with PNEUMOVAX 23 in her left arm (dose and route not reported). Concomitant therapy included H1N1. The patient stated that on 11-JAN-2010 she had an infection in left arm from PNEUMOVAX 23 shot. The patient experienced swelling, redness, warmth and pain in her arm. Unspecified medical attention was sought. At the time of reporting, the patient had not recovered from the event. Follow-up information was received from the patient via Claim Management Services. The patient stated that there was not anything wrong with PNEUMOVAX 23. The patient's arm became infected and swollen after vaccine shot. The pharmacist explained that her dose had come from a multi-dose vial and the vial was open. This contamination led to the patient's infection. Whether an open vial or an unopened vial was used, contamination can occur with preparation. The patient had already been examined in the emergency room and after examination by the doctor the patient was found to have cellulitis. She was given an antibiotic and a pain medication LEVAQUIN and VICODIN to treat her symptoms. The patient had eight hours of sick time. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX(H1N1), PPV
Symptoms: Injection site warmth, Product contamination
Clinical narrative: Information has been received from a healthcare worker and from Claim Management Services, INC. (claim number 30100122931-0001) concerning a 58 year old female who on 10-JAN-2010 was vaccinated with PNEUMOVAX 23 in her left arm (dose and route not reported). Concomitant therapy included H1N1. The patient stated that on 11-JAN-2010 she had an infection in left arm from PNEUMOVAX 23 shot. The patient experienced swelling, redness, warmth and pain in her arm. Unspecified medical attention was sought. At the time of reporting, the patient had not recovered from the event. Follow-up information was received from the patient via Claim Management Services. The patient stated that there was not anything wrong with PNEUMOVAX 23. The patient's arm became infected and swollen after vaccine shot. The pharmacist explained that her dose had come from a multi-dose vial and the vial was open. This contamination led to the patient's infection. Whether an open vial or an unopened vial was used, contamination can occur with preparation. The patient had already been examined in the emergency room and after examination by the doctor the patient was found to have cellulitis. She was given an antibiotic and a pain medication LEVAQUIN and VICODIN to treat her symptoms. The patient had eight hours of sick time. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Blood test abnormal, Infection, Joint swelling, Mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female patient who in 2000 was vaccinated with the first dose of PNEUMOVAX 23 (662100/0742X). In October 2009, the patient was vaccinated with the second dose of PNEUMOVAX 23 (662100/0742X). 2 and 1/2 hours after the second vaccination, the patient had pain in the arm and could not move her arm. The patient contacted the nurse. The patient had an X-ray conducted at the time and was treated with unspecified antibiotics. The patient also had a magnetic resonance imaging (MRI) conducted and the evaluation physician stated the vaccine might have been given in the bursa. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a registered nurse concerning the female patient with no illness at the time of vaccination and no pre-existing allergies who on 22-OCT-2009 at approximately 15:00 was vaccinated with the second dose of PNEUMOVAX 23 (662100/0742X) IM into the right deltoid. Concomitant therapy included PLAVIX, SYNTHROID and LIPITOR. On 26-OCT-2009, the patient called and reported that on 22-OCT-2009 at approximately 17:30 she experienced "excruciating pain" in her right shoulder. She stated that she must hold her arm over her chest. The patient had vomited for 24 hours after vaccination. There was no redness, swelling or warmth. The patient took TYLENOL for pain and used ice for the first 12 hours and heat each night. On 28-OCT-2009 (also reported as 29-OCT-2009), the patient saw a physician. An X-ray was performed that showed no problems and "blood work" was also performed that showed infection. The patient was prescribed KEFLEX for right shoulder infection. The patient also had fever and right shoulder swelling. In November 2009, the patient had repeat "blood work" (results not reported) and a magnetic resonance imaging (MRI) (results not reported) performed. At the time of the report, the patient's status was unknown. It was noted that there was no adverse event following prior vaccination. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Pyrexia, Vomiting, X-ray normal
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female patient who in 2000 was vaccinated with the first dose of PNEUMOVAX 23 (662100/0742X). In October 2009, the patient was vaccinated with the second dose of PNEUMOVAX 23 (662100/0742X). 2 and 1/2 hours after the second vaccination, the patient had pain in the arm and could not move her arm. The patient contacted the nurse. The patient had an X-ray conducted at the time and was treated with unspecified antibiotics. The patient also had a magnetic resonance imaging (MRI) conducted and the evaluation physician stated the vaccine might have been given in the bursa. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from a registered nurse concerning the female patient with no illness at the time of vaccination and no pre-existing allergies who on 22-OCT-2009 at approximately 15:00 was vaccinated with the second dose of PNEUMOVAX 23 (662100/0742X) IM into the right deltoid. Concomitant therapy included PLAVIX, SYNTHROID and LIPITOR. On 26-OCT-2009, the patient called and reported that on 22-OCT-2009 at approximately 17:30 she experienced "excruciating pain" in her right shoulder. She stated that she must hold her arm over her chest. The patient had vomited for 24 hours after vaccination. There was no redness, swelling or warmth. The patient took TYLENOL for pain and used ice for the first 12 hours and heat each night. On 28-OCT-2009 (also reported as 29-OCT-2009), the patient saw a physician. An X-ray was performed that showed no problems and "blood work" was also performed that showed infection. The patient was prescribed KEFLEX for right shoulder infection. The patient also had fever and right shoulder swelling. In November 2009, the patient had repeat "blood work" (results not reported) and a magnetic resonance imaging (MRI) (results not reported) performed. At the time of the report, the patient's status was unknown. It was noted that there was no adverse event following prior vaccination. Additional information has been requested.
Age: 64.0
Sex: M
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 male patient with history of "immunosuppression of unspecified etiology" who on 04-MAR-2010 was vaccinated intramuscularly with his first 0.5 ml dose of PNEUMOVAX 23 (Lot # 664537/1193Y). It was reported that one day after receiving the PNEUMOVAX 23, on 05-MAR-2010, the patient experienced an injection site reaction, she was seen at the office exhibiting redness, swelling and severe pain at the injection site and down the arm. No treatment was prescribed. The patient recovered on an unspecified date. No diagnostic tests were performed. The report is related with WAES # 1003USA00920, WAES # 1003USA00981, WAES # 1003USA00982 and WAES # 1003USA00983, same source, same adverse experience. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Movement disorder, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient with drug hypersensitivity to codeine and simvastatin (MSD) who on 06-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y) into her arm. On 07-JAN-2010 the patient developed an injection site reaction and pain in the arm where the vaccine was given. The physician stated that the patient was not able to lift her arm. The patient called the physician for medical attention. At the time of this report, the patient had not recovered. Follow-up information has been received from a physician who reported that on 06-JAN-2010 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y) into her arm IM. On 07-JAN-2010 the patient experienced sore arm with swelling. The patient did not seek medical attention. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient who in approximately January 2010, "within the last week or within the last 30 days", was vaccinated with PNEUMOVAX 23 (lot # 664478/1191Y) through subcutaneous injection (dose and site not reported). In approximately January 2010, "within the last week or within the last 30 days", the patient experienced injection site reaction soon after. The patient was in the hospital before receiving the vaccine and hospitalization was not due to vaccination. The outcome of injection site reaction was not reported. All telephone attempts to obtain follow up information have been unsuccessful. 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.
Sex: U
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient who in approximately January 2010, "within the last week or within the last 30 days", was vaccinated with PNEUMOVAX 23 (lot # 662270/1135Y) through subcutaneous injection (dose and site not reported). In approximately January 2010, "within the last week or within the last 30 days", the patient experienced injection site reaction soon after. The patient was in the hospital before receiving the vaccine and hospitalization was not due to vaccination. The outcome of injection site reaction was not reported. All telephone attempts to obtain follow up information have been unsuccessful. A standard lot check investigation has been finalized. All in-process quality checks form 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 the several reports form the same source. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 52 year old male smoker with no allergies who on 13-DEC-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot # 665300/1314Y) into right deltoid. There was no concomitant medication. On approximately 14-DEC-2009 ("a few days after 13-DEC-2009"), the patient developed pain at the injection site when he moved his arm. He went to see the nurse practitioner to seek medical attention. There were no laboratory diagnostics studies performed. The nurse practitioner would like an investigation of the lot number to see if other people had similar reactions. At the time of this report, the patient had not recovered. A standard lot check investigation was performed. 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: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age who in February 2005, was vaccinated with a first dose of PNEUMOVAX 23. On 19-FEB-2010 the patient was vaccinated with a second dose of PNEUMOVAX 23. Concomitant therapy included NEXIUM, XANAX and levothyroxine Na. On 20-FEB-2010 the patient developed redness and a warming sensation extending about 4 inches around the injection site. No laboratories studies performed. At the time of this report the patient had not recovered from redness and a warming sensation extending about 4 inches around the injection site. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a 67 year old female patient with diabetes, hypertension and no drug reactions/allergies, who in August 1998, was vaccinated with a dose of PNEUMOVAX 23. On 11-FEB-2010, the patient vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot number 665300/1314Y). It was reported that the patient experienced redness swelling and pain on the arm at the injection site after receiving PNEUMOVAX 23. At the time of the report the patient's outcome was unknown. The patient sought medical attention (office visit). A lot check has been initiated. A standard lot check investigation was performed.  All in-process quality checks for 665300/1314Y was satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of two reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: A non-serious spontaneous report of she got a flu shot and then FLUMIST was received from a medical assistant concerning a 19-year-old female. No relevant medical history information has been reported for this patient. On 01-Oct-2009, the patient received a flu shot. On 23-Oct-2009, the patient went to get an H1N1 but was inadvertently given a FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reported causality assessments are not applicable, and the event is considered resolved.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Overdose
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female who on 23-FEB-2010 was inadvertently vaccinated with a first single 2.5ml dose of PNEUMOVAX 23, SC in the left upper arm. The patient experienced no adverse effect. Follow up information has been received from a physician concerning a 60 year old female with no illness at time of vaccination and no drug allergies, who on 23-FEB-2010 at 8:30 AM was vaccinated with a dose of PNEUMOVAX 23 (lot # 665300/1314Y, IM (previously reported as SC) in the left deltoid, and a dose of ZOSTAVAX (Merck) (lot # 663881/0197Y, SC) in the right arm on 23-FEB-2010 at 8:30 AM. On 25-FEB-2010 the patient experienced mild redness, soreness and bruising at site. On 04-MAR-2010, the patient recovered. No further information is available.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 54 year old female patient who on 06-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y). On 07-JAN-2010 the patient experienced an injection site reaction after the PNEUMOVAX 23 was given. The patient contacted the physician for medical attention. At the time of this report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of expired FLUMIST administered has been received from a healthcare provider concerning a 39-year-old patient. The patient a physician self administered FLUMIST before realizing the expiration date was for last season. There was no adverse event associated with this vaccination error: therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Local reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who was vaccinated with PNEUMOVAX 23. The patient was given ZOSTAVAX and PNEUMOVAX 23 at the same time and there was an increased localized reaction with the PNEUMOVAX 23. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. No further information is available.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Spirometry
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated I.M. with a dose of PNEUMOVAX 23 (lot # 665300/1314Y). Subsequently, the patient experienced swollen right and 103 degrees F the next day after receiving a dose of PNEUMOVAX 23. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was unknown. Follow-up information has been received from the registered nurse concerning a 72 year old non-smoker retired physician with asthma, chronic rhinitis and no known drug allergies. On 14-DEC-2009 the patient was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 into his right deltoid in the morning. At the time of vaccination the patient was experiencing asthma exacerbation, deep cough and stuffy nose. On 15-DEC-2009 in the PM, the patient complained of temperature of 100.3 F (previously reported as 103F), soreness and slight swelling at the right deltoid area of injection. On 14-DEC-2009, the patient's spirometry of pre and post bronchodilator showed no FEV1 match and no FVC match. On 16-DEC-2009, the patient recovered from these events. This is one of several reports received from the same source. The nurse has 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 of Biologics Evaluation and Research and was released. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Lymphadenopathy, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently, on an unknown date the patient experienced an enlarged lymph node and became very sick.  It was stated that a doctor said it was an allergic reaction to PNEUMOVAX 23. The patient sought medical attention via office visit. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 54 year old female consumer with asthma, and drug reactions to LEVAQUIN (reported as "LEVIQUIN") and PERCOCET who on 18-FEB-2010 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX 23. Concomitant therapy included ADVAIR and XOPENEX. On 19-FEB-2010 the patient experienced "very sore, extremely sore pain". It was reported that the pain went from the injection site to the elbow and up to the shoulder. The patient did not seek medical attention. It was also reported that the pain went away in 3 days (recovered on 22-FEB-2010). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Malaise, Musculoskeletal chest pain, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated I.M. with a dose of PNEUMOVAX 23 (lot# 665300/1314Y). Subsequently, on an unspecified date the patient developed extreme soreness in her arm. It was so severe that the patient needed to have a sling to support the arm. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was unknown. 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. Follow-up information has been received from the registered nurse concerning a 63 year old retired registered nurse with asthma and chronic rhinitis. On 04-JAN-2010 the patient was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 into her left deltoid in the morning. At the time of vaccination the patient was experiencing a cough. On 05-JAN-2010, the patient experienced pain at the site of injection and whole shoulders. The patient had to wear sling. Later it spread to chest wall, arms, elbow joint and other joints which were lasted for "several" days. On 04-JAN-2010, the spirometry was probably not accurate due to the patient's cough during test. On approximately 10-JAN-2010, the patient had recovered from these events. Follow-up information has been received from the registered nurse. It was reported that at the same day, later on 04-JAN-2010 (previously reported as 05-JAN-2010), the patient complained of pain at the injection site which progressed to her shoulder, chest wall and whole left arm to elbow. The patient also felt ill. Other joints in body were painful. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. No further information is available.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Spirometry
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated I.M. with a dose of PNEUMOVAX 23 (lot# 665300/1314Y). Subsequently, on an unspecified date the patient developed extreme soreness in her arm. It was so severe that the patient needed to have a sling to support the arm. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was unknown. 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. Follow-up information has been received from the registered nurse concerning a 63 year old retired registered nurse with asthma and chronic rhinitis. On 04-JAN-2010 the patient was vaccinated with the first 0.5 mL dose of PNEUMOVAX 23 into her left deltoid in the morning. At the time of vaccination the patient was experiencing a cough. On 05-JAN-2010, the patient experienced pain at the site of injection and whole shoulders. The patient had to wear sling. Later it spread to chest wall, arms, elbow joint and other joints which were lasted for "several" days. On 04-JAN-2010, the spirometry was probably not accurate due to the patient's cough during test. On approximately 10-JAN-2010, the patient had recovered from these events. Follow-up information has been received from the registered nurse. It was reported that at the same day, later on 04-JAN-2010 (previously reported as 05-JAN-2010), the patient complained of pain at the injection site which progressed to her shoulder, chest wall and whole left arm to elbow. The patient also felt ill. Other joints in body were painful. At the time of the report, the patient's status was unknown. This is one of several reports received from the same source. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Oropharyngeal pain, Pain in extremity, Respiratory tract congestion
Clinical narrative: Information has been received from a 66 year old female consumer concerning herself with high blood pressure and a history of thyroid disorder who on 09-NOV-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot# 664653/1337Y). On an unspecified date, the patient experienced sore arm and throat and felt congested. Couple days later the patient's condition was worsen. She visited the physician and was given IV (medication name and manufacturer unknown). At the time of this report, the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Skin reaction
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on an unspecified date was vaccinated I.M. with a dose of PNEUMOVAX 23 (lot# 665300/1314Y). Subsequently, the patient complained of reaction on his arm. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was unknown. This is one of several reports from the same source. The nurse has 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. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Information has been received from a physician concerning a patient who was allergic to PNEUMOVAX 23. It was unknown if medical attention was sought. The outcome of the patient was not reported. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a patient who on unspecified dates was vaccinated with 0.5 ml injection of PNEUMOVAX 23 (lot # not reported). Subsequently the patient experienced extreme redness pain at the injection site. The patient's adverse experience improved on therapy. Unspecified medical attention was sought. Follow-up information has been received from a reporter who mentioned that the lot# for PNEUMOVAX 23 was 662270/1135Y. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning an 82 year old female patient with allergy to tetanus toxoid and who on 16-NOV-2009 was vaccinated with the first dose of PNEUMOVAX 23 (Lot number unspecified). There was no concomitant medication. On 17-NOV-2009 the patient developed a large area of swelling and warmth at the injection site of the left upper arm. The symptoms resolved without requiring therapy. The nurse reported that the patient had a similar reaction to a tetanus toxoid (manufacturer unspecified) in the past. No laboratory tests were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a Registered Pharmacist concerning an 85 year old female patient with no drug reactions/allergies, who on 25-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number unspecified). Concomitant therapy included LIPITOR, cetirizine, amlodipine, aspirin, meclizine and metoprolol. The pharmacist reported that the patient developed a rash after receiving PNEUMOVAX 23. On an unspecified date the patient recovered. It was unknown if the patient sought medical attention. No further information is available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from an approximately 73 year old female consumer with no pertinent medical history, and a swine flu vaccine reaction or allergy, who in 2008 was vaccinated with a dose of PNEUMOVAX 23 (route and lot # unknown). There was no concomitant medication. The patient reported that one day after receiving PNEUMOVAX 23, she developed severe swelling from her left shoulder to her fingers, the swelling was "like a big bag of fluid". No lab diagnostic studies were performed. The patient did not seek medical attention. The patient stated that the swelling resolved in 5 days without requiring treatment. The patient also reported that she experienced severe stiffness of her neck, arms and legs within 3 hours of receiving swine influenza virus vaccine (unspecified), in 1976. The patient stated that the symptoms resolved in a few days without requiring treatment. No further information is available.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male who on an unspecified date was inadvertently vaccinated with PNEUMOVAX 23 instead of his third dose of PREVNAR. It was unspecified if the patient sought medical attention. No adverse effect was reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 75 year old female with "allergic reactions to barbiturates and anything for pain", and no pertinent medical history, who in "October 2006", was vaccinated with a dose of 0.5ml PNEUMOVAX 23. Concomitant therapy included AFLURIA (manufacturer unknown) in the opposite arm. The patient stated that "that evening my arm became red and painful and swollen. Iced it and took TYLENOL and it was back to normal by the end of the following day. "She said that she had gotten other pneumococcal vaccines prior to this one, but she did not know if they were PNEUMOVAX 23 or not. There were no labs or diagnostic tests performed. The patient sought unspecified medication. The patient recovered at the end of the following day. Caller also stated that she has "a problem with my pancreas and will need surgery" but she does not feel that this was related to PNEUMOVAX 23. No further information is available. This is an amended report. Influenza vaccine was updated to second suspect and trade name AFLURIA. Trade name AFLURIA had been removed from narrative.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male patient with history of "immunosuppression of unspecified etiology" who on 28-OCT-2009 was vaccinated intramuscularly with his first 0.5 ml dose of PNEUMOVAX 23 (Lot # 664554/1243Y). It was reported that one day after receiving the PNEUMOVAX 23, on 29-OCT-2009, the patient experienced an injection site reaction, he was seen at the office exhibiting redness, swelling and severe pain at the injection site and down the arm. No treatment was prescribed. The patient recovered within one week, on approximately 05-NOV-2009. No diagnostic tests were performed. This report is related with WAES # 1003USA00981, WAES # 1003USA00982, WAES # 1003USA00983 and WAES # 1003USA00984, same source, same adverse experience. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 87 year old male patient with history of "immunosuppression of unspecified etiology" who on 14-JAN-2010 was vaccinated intramuscularly with his first 0.5 ml dose of PNEUMOVAX 23 (Lot # 664537/1193Y). It was reported that one day after receiving the PNEUMOVAX 23, on 15-JAN-2010, the patient experienced an injection site reaction, he was seen at the office exhibiting redness, swelling and severe pain at the injection site and down the arm. No treatment was prescribed. The patient recovered within one week, on approximately 22-JAN-2010. No diagnostic tests were performed.  This report is related with WAES # 1003USA00920, WAES # 1003USA00982, WAES # 1003USA00983 and WAES # 1003USA00984, same source, same adverse experience. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site swelling, No reaction on previous exposure to drug, Pain in extremity
Clinical narrative: Information has been received from an approximately 56 year old male consumer with type 2 diabetes mellitus and no drug reaction or allergy who in 2006 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 and there was no adverse reaction. In 2007 the patient was vaccinated with another 0.5 ml dose of PNEUMOVAX 23 (lot# 658449/0989U). Concomitant therapy included metformin, GLUCOTROL and GLUCOPHAGE. The patient indicated that in 2007 he developed swelling on the injection site "a couple of days after the shot was given and the swelling goes away but come back every now and then." The patient also reported that he was still experiencing some pain on his arm and it won't go away. The patient sought medical attention via visit physician. No laboratory diagnostics studies were performed. At the time of the report, the patient did not recover. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Infection, Pain
Clinical narrative: Information has been received from a Claims Supervisor concerning a male who on approximately 30-Sep-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose, route, and lot# not reported). On 01-OCT-2009 the patient experienced a severe infection and pain after receiving an injection of PNEUMOVAX 23 on the deltoid portion of his left arm. The onset of the infection and pain took place within 24 hours of the injection administered by pharmacist. This infection was reported to pharmacy on 06-OCT-2009. At the time of the report, the patient's outcome was not reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 54 year old male patient with history of "immunosuppression of unspecified etiology" who on 02-FEB-2010 was vaccinated intramuscularly with his first 0.5 ml dose of PNEUMOVAX 23 (Lot # 664537/1193Y). It was reported that one day after receiving the PNEUMOVAX 23, on 03-FEB-2010, the patient experienced an injection site reaction, he was seen at the office exhibiting redness, swelling and severe pain at the injection site and down the arm. No treatment was prescribed. The patient recovered within one week, on approximately 10-FEB-2010. No diagnostic tests were performed. This report is related with WAES # 1003USA00920, WAES # 1003USA00981, WAES # 1003USA00983 and WAES # 1003USA00984, same source, same adverse experienced. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, No reaction on previous exposure to drug, Oedema peripheral
Clinical narrative: Information has been received from a Healthcare Worker concerning a 44 year old female patient with diabetes, hypothyroidism, hypertension, mitral regurgitation, asthma, chronic renal failure, migraine, high cholesterol, depression and a possible allergy to latex and a history of a drug reaction with ULTRAM and codeine, who on 18-MAR-2004 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 and on 20-JAN-2010 was vaccinated with the second dose of PNEUMOVAX 23 (lot number 665270/1398Y). Concomitant therapy included insulin, LIPITOR, aspirin, NOVOLIN, NORVASC, PLAVIX, SYNTHROID, PERCOCET, ZYRTEC, FLOVENT and albuterol. The patient developed a large red area "this size of an orange" and soreness at the injection site in the right arm, after the second dose of PNEUMOVAX 23. There were no problems after the first dose.  No treatment was recommended. At the time of the report the patient had not recovered. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from the physician concerning the patient who after received the second dose of PNEUMOVAX 23 (lot number 665270/1398Y) in the right deltoid on 20-JAN-2010, her arm swelled (the whole arm) with in hours of injection. On an unspecified date the patient recovered from the arm swell. The physician disregarded the bottle. This is one of two reports received form the same source. Additional information is not expected.