chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Information has been received concerning a female patient between 65 and 78 years old who on 10-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663888/0627Y).  Subsequently, the patient experienced a fever, severe swelling, redness and pain at the injection site after she received PNEUMOVAX 23.  The patient sought medical attention with the physician.  The patient was given unspecified oral antibiotics (manufacturers unknown).  At the time of the report, the patient recovered on an unspecified date.  All telephone attempts to obtain follow-up information have been unsuccessful.  The health care professional contacted during telephone follow-up could not supply the following information:  patient's name, or date of birth.  Follow-up information has been received from an office manager concerning a 68 year old patient who was vaccinated subcutaneously with a 0.5 mL dose of PNEUMOVAX 23.  It was reported that the patient also experienced infection at the injection site after vaccination.  This is one of several reports received from the same source.  No further information is available.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received concerning a female patient between 65 and 78 years old who on 10-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663888/0627Y).  Subsequently, the patient experienced a fever, severe swelling, redness and pain at the injection site after she received PNEUMOVAX 23.  The patient sought medical attention with the physician.  The patient was given unspecified oral antibiotics (manufacturers unknown).  At the time of the report, the patient recovered on an unspecified date.  All telephone attempts to obtain follow-up information have been unsuccessful.  The health care professional contacted during telephone follow-up could not supply the following information:  patient's name, or date of birth.  Follow-up information has been received from an office manager concerning a 68 year old patient who was vaccinated subcutaneously with a 0.5 mL dose of PNEUMOVAX 23.  It was reported that the patient also experienced infection at the injection site after vaccination.  This is one of several reports received from the same source.  No further information is available.
Sex: U
Vaccine: PNC
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up call information has been received from a pharmacist concerning three patients who were vaccinated with PREVNAR within the past two 2 weeks. The lot numbers were not recorded at the time of the vaccination. The facility was considering revaccinating all patients with PNUEMOVAX 23. No adverse effects were reported. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number, date of event, recovery status, healthcare provider name and contact information. Follow up information was received from the pharmacist who stated that the report did not involve product confusion but involved medication error. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 05-OCT-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot# 662785/1124X) SQ in the left arm. Concomitant vaccination administered on the same day included a dose of influenza virus vaccine (unspecified) in the left arm but at a different site. On 08-OCT-2009, the patient called the pharmacy to report redness, warmth and swelling at injection site. The date of onset of the symptoms was unknown. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received concerning a female patient between 65 and 78 years old who on 15-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663888/0627Y).  Subsequently, the patient experienced a fever, severe swelling, redness and pain at the injection site after she received PNEUMOVAX 23.  The patient sought medical attention with the physician.  The patient was given unspecified oral antibiotics (manufacturers unknown).  At the time of the report, the patient recovered on an unspecified date.  All telephone attempts to obtain follow-up information have been unsuccessful.  The health care professional contacted during telephone follow-up could not supply the following information:  patient's name, or date of birth.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received concerning a female patient between 65 and 78 years old who on 22-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663888/0627Y).  Subsequently, the patient experienced a fever, severe swelling, redness and pain at the injection site after she received PNEUMOVAX 23.  The patient sought medical attention with the physician.  The patient was given unspecified oral antibiotics (manufacturers unknown).  At the time of the report, the patient recovered on an unspecified date.  All telephone attempts to obtain follow-up information have been unsuccessful.  The health care professional contacted during telephone follow-up could not supply the following information:  patient's name, or date of birth.  This is one of several reports received form the same source.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received concerning a 68 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). Subsequently, the patient experienced a high temperature, swelling, pain, and redness at the injection site after she received PNEUMOVAX 23. The patient's high temperature required her to take antibiotics (manufacturer unspecified). It was unknown if the patient sought medical attention. At the time of the report, the outcome of the event was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, or recovery status. Follow-up information has been received from an office manager concerning a retired patient who was vaccinated, subcutaneously with the first dose of PNEUMOVAX 23 (Lot # 663888/0627Y). It was reported that the patient also experienced infection at the injection site after vaccination. The patient sought medical attention via doctor visit. This is one of several reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 51 year old female patient with no known drug allergies who on 07-OCT-2009 was vaccinated intramuscularly in the left arm with a 0.5ml dose of PNEUMOVAX 23 (Lot# 664653/1337Y). Concomitant therapy included aspirin, TRICOR, ADVAIR, CAMPRAL, LEXAPRO, melatonin, estrogens, PREMPRO and multivitamin. On 07-OCT-2009, the patient experienced erythema, pain, and swelling at the injection site after vaccination. The patient also felt clammy but did not know if the patient had a fever. The patient had sought medical attention via telephone. No laboratory diagnostic study was performed. The patient was treated with anti-inflammatory and cold compresses. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 60 year old female patient with a tetanus toxoid vaccine reaction who on 02-OCT-2009 was vaccinated intramuscularly into her left arm with a 0.5ml PNEUMOVAX 23 (lot number 663888/0627Y). Concomitant therapy included TOPROL XL TABLETS, benazepril HCl, CARDIZEM, TEKTURNA, PLAVIX, DETROL, vitamin D (unspecified), ubidecarenone and supplements. On 03-OCT-2009, after the vaccination the patient experienced erythema and swelling at the injection site that had spread to a "large area". She did not have a fever but the area was "really painful". She was treated with anti-inflammatory and cold compresses. The patient had sought medical attention via phone. No laboratory diagnostic studies were performed. At the time of the report, the patient's status was recovering. Follow up information was received from the office manager concerning a 60 year old female patient with no illness at time of vaccination and no drug allergies who in the morning of 02-OCT-2009 was vaccinated intramuscularly into her left deltoid with a first dose of PNEUMOVAX 23 (lot number 663888/0627Y). In the afternoon of 02-OCT-2009 the patient experienced adverse events which were reported previously. On 04-OCT-2009 the patient was recovered. There were no laboratory diagnostic studies performed. This is one of several reports received from the same source. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 66 year old female patient with no known drug allergies who on 06-OCT-2009 was vaccinated intramuscularly into her right arm with a 0.5ml PNEUMOVAX 23 (lot number 663888/0627Y). Concomitant therapy included alendronate sodium (+) cholecalciferol (MSD), LEVOXYL, aspirin and chondroitin sulfate sodium (+) glucosamine sulfate. On 06-OCT-2009, after received the vaccination the patient experienced erythema and swelling at the injection site. She was treated with anti-inflammatory and cold compresses. The patient had sought medical attention via phone. No laboratory diagnostic studies were performed. On 08-OCT-2009 the patient recovered. Follow up information was received from the office manager concerning a 66 year old female patient with no illness at time of vaccination and no drug allergies who in the morning of 06-OCT-2009 morning was vaccinated intramuscularly into her right deltoid with a first dose of PNEUMOVAX 23 (lot number 663888/0627Y). In that day afternoon, the patient experienced adverse effects (as previously reported). On 08-OCT-2009 the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 57.0
Sex: U
Vaccine: FLUX, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 57 year old patient who on 08-OCT-2009 was vaccinated with PNEUMOVAX 23 (662874/1125Y). Concomitant therapy vaccine include a flu vaccine was given in a different arm on 08-OCT-2009. One hour after the PNEUMOVAX 23 was given, the patient "felt bad". The nurse stated that on 09-OCT-2009, the patient had a red and swollen arm at the injection site and fever. The patient sought medical attention via office visit. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 66 year old male patient who on 06-OCT-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot#663888/0627Y) intramuscularly in the right arm. Concomitant therapy included HCTZ (manufacturer unknown), MICARDIS, TEKTURNA, NEXIUM, famotidine (manufacturer unknown), UROXATRAL, vitamin D (unspecified), fish oil, aspirin, fexofenadine, fluticasone, ASTELIN, citalopram and CRESTOR. Subsequently, the patient experienced soreness at injection site later that evening after administration of PNEUMOVAX 23. On 07-OCT-2009, the patient experienced erythema and swelling at the injection site. He also had a fever. The patient had sought medical attention via telephone. No laboratory diagnostic study was performed. The patient was treated with anti-inflammatory and cold compresses. On 08-OCT-2009, the patient no longer had a fever but still had some erythema and swelling at injection site. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Follow-up information has been received the office manager concerning the patient who on 06-OCT-2009, in the morning, was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663888/0627Y) intramuscularly in the right deltoid. There was no pre-existing allergies, birth defects, medical conditions. It was reported that the patient had not required emergency room/doctor visit. On 08-OCT-2009, the patient recovered. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site swelling, Injection site warmth, Type III immune complex mediated reaction
Clinical narrative: Information has been received from a 42 year old male consumer who on 07-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included LEXAPRO, RITALIN, ACIPHEX, flu vaccine, ADVAIR, BUSPAR and NASONEX. On 07-OCT-2009 the patient experienced an arthus type injection site reaction which he described as "swollen hot and uncomfortable." The patient sought unspecified medical attention. On an unknown date the patient recovered.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received concerning a 70 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). Subsequently, the patient experienced a high temperature, swelling, pain, and redness at the injection site after she received PNEUMOVAX 23. The patient's high temperature required her to take antibiotics (manufacturer unspecified). It was unknown if the patient sought medical attention. At the time of the report, the outcome of the event was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. The health care professional contacted during telephone follow-up could not supply the following information: patient's name, date of birth, dates of vaccination, lot number, date of event, or recovery status. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 65 year old female patient who on 13-OCT-2009 was vaccinated with a first dose of PNEUMOVAX 23, 0.5 mL, intramuscular (lot # 660717/0224X) that had expired on 11-SEP-2009. No adverse reactions reported. Follow up information has been received from the registered nurse concerning the 65 year old female patient without any illness at time of vaccination who on 13-OCT-2009 was vaccinated at private doctor's office/hospital with a first dose of PNEUMOVAX 23, 0.5 mL, intramuscular in the deltoid (lot # 660717/0224X) that had expired on 11-SEP-2009. The registered nurse reported that the patient experienced redness and soreness at injection site. No relevant diagnostic test and laboratory data were performed. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. No informed consent form signed. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 74 year old female patient with high blood pressure, arthritis, reflex sympathetic dystrophy and no known drug allergies who about 10 years ago in approximately 1999 and on 11-SEP-2009 was vaccinated with the first and second doses of PNEUMOVAX 23 (dose, route, and lot # not reported).  Concomitant therapy included TOPROL XL TABLETS, guanidine, NORVASC and BENICAR.  On approximately 11-SEP-2009 after her second vaccination, the patient developed an area that was "really red which travelled from the injection site to elbow".  The area was swollen, painful and hot.  She was prescribed with KEFLEX.  The patient had no adverse event at the time of receiving her first dose of PNEUMOVAX 23.  The patient sought medical attention through an office visit.  No lab diagnostic study was performed.  The patient recovered about 7 days after starting KEFLEX.  Follow up information from the consumer indicated that she developed a rash on her legs shortly after she recovered from her injection site reaction with PNEUMOVAX.  She went to a dermatologist who "tested" her and determined the rash was from PNEUMOVAX.  The consumer was currently using an unspecified ointment for the rash.  The rash was not itchy.  The consumer was recovering.  No further information is available.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: No reaction on previous exposure to drug, Rash
Clinical narrative: Information has been received from a 74 year old female patient with high blood pressure, arthritis, reflex sympathetic dystrophy and no known drug allergies who about 10 years ago in approximately 1999 and on 11-SEP-2009 was vaccinated with the first and second doses of PNEUMOVAX 23 (dose, route, and lot # not reported).  Concomitant therapy included TOPROL XL TABLETS, guanidine, NORVASC and BENICAR.  On approximately 11-SEP-2009 after her second vaccination, the patient developed an area that was "really red which travelled from the injection site to elbow".  The area was swollen, painful and hot.  She was prescribed with KEFLEX.  The patient had no adverse event at the time of receiving her first dose of PNEUMOVAX 23.  The patient sought medical attention through an office visit.  No lab diagnostic study was performed.  The patient recovered about 7 days after starting KEFLEX.  Follow up information from the consumer indicated that she developed a rash on her legs shortly after she recovered from her injection site reaction with PNEUMOVAX.  She went to a dermatologist who "tested" her and determined the rash was from PNEUMOVAX.  The consumer was currently using an unspecified ointment for the rash.  The rash was not itchy.  The consumer was recovering.  No further information is available.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a practical nurse concerning a 72 year old female with arthritis, a history of varicose vein and no drug allergies, who on 08-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 663012/1163X). Concomitant therapy included influenza virus vaccine (unspecified) at the same office visit. On the same day the patient had a "severe reaction". She had a swollen arm. There were no labs and diagnostic tests performed. TYLENOL and MOTRIN were prescribed to treat the reaction. The patient was seen in office. At the time of the report, the patient's status was unspecified. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging, Oedema peripheral
Clinical narrative: Information has been received from a practical nurse concerning a 65 year old female with high blood pressure, arthritis, asthma, sulfonamide and seasonal allergy, who on 12-OCT-2009 was vaccinated with her first dose of PNEUMOVAX 23 (lot # 663012/1163X).  No other vaccines at the same visit.  On the same day the patient developed a "severe reaction" after vaccination.  She had 2 swollen areas on her left upper arm.  One was near the deltoid muscle and the other area was in the antecubital area.  Lab test included MRI, result not reported.  The patient was seen in office for medical attention.  At the time of the report, the patient was not recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a physician concerning a female patient with cerebral palsy who had strong reaction to PNEUMOVAX 23 (type of reaction not reported). The reporting patient had recovered. The physician was not the patient's Primary Care Physician. The physician did not have any additional information concerning the patient. This is one of several reports from the same source. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was on an unspecified date was vaccinated with PNEUMOVAX 23. The nurse practitioner reported that on an unspecified date, "within a couple of hour after administration of PNEUMOVAX 23" the patient's arm became painful on the upper side and it was a little red. The patient sought medical attention with the nurse practitioner. The patient's symptoms lasted for 3 days but the patient did not require treatment. Follow up information has been received from a nurse practitioner regarding the 65 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. The nurse practitioner contacted during the telephone follow-up call could not supply the patient's date of birth, date of vaccination, lot number or date of the event. Follow up information has been received from the nurse practitioner who reported that it was determined that the arm became painful on the upper side and the arm was a little red was no adverse event and that was merely a localized reaction to the PNEUMOVAX 23. Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 42 year old female consumer, a "transplant candidate", who on 14-OCT-2009 was vaccinated with the third doe of PNEUMOVAX 23 (roue and lot # unknown). On 15-OCT-2009 the patient experienced painful arm and fever. The patient stated that she was a "High Risk" patient and she has been given PNEUMOVAX 23 (date, route and lot # unknown) twice before. The patient did not seek medical attention and at the time of this report the patient's outcome was not recovered. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site haemorrhage, Injection site induration, Injection site nodule
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 72 year old male with high cholesterol and without drug reactions or allergies who on an unspecified date "more than 5 years age" was vaccinated with the first dose of PNEUMOVAX 23. On 15-OCT-2009 was vaccinated with his second 0.5 ml dose of PNEUMOVAX 23 intramuscularly (Lot # 664871/1142Y). On the same day, the patient also received the flu vaccine. Concomitant therapy included FLOMAX, simvastatin (manufacturer unspecified) and ibuprofen. It was reported that when the pharmacist withdrew the needle from the patient's arm and "blood came out from the site". The pharmacist stated she applied pressure and cleansed the area with alcohol. It was also mentioned that a hard knot was formed at the site. Not specified laboratory and diagnostic test were performed. The patient sought unspecified medical attention. At the time of reporting the patient PNEUMOVAX 23 not recovered.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 73 year old male without a pertinent medical history and drug reactions or allergies who more than 5 years ago, in approximately 2004 was vaccinated with a first dose of PNEUMOVAX 23 with no adverse symptoms. On 13-OCT-2009 the patient was subcutaneously vaccinated with his second dose of PNEUMOVAX 23 (Lot # 664654/0823Y). There was no concomitant medication. The reporter mentioned that on 15-OCT-2009 the patient came back to the pharmacy, stating he had experienced swelling and redness below the injection site around his elbow and lower left arm. Patient's Doctor ordered him BENADRYL for symptoms. Not specified laboratory and diagnostic test were performed. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a 69 year old female patient who in 2001 was vaccinated with the first dose of PNEUMOVAX 23. After the patient received the first dose she did not have adverse reactions. "Last week" (appropriately on 05-OCT-2009) the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot number unspecified). On approximately 06-OCT-2009 the patient experienced vomiting the morning after she received the second dose of PNEUMOVAX 23. At the time of the report the patient had recovered from vomiting. The patient sought unspecified medical attention. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site cellulitis, Pyrexia
Clinical narrative: Information has been received from a 79 year old male physician with no medical history and no drug allergies concerning himself who in 1999 was vaccinated subcutaneously with a first 0.5ml PNEUMOVAX 23 and on 15-OCT-2009 was vaccinated subcutaneously with a second 0.5ml PNEUMOVAX 23 (lot number 662905/1162X). Secondary suspect therapy included HYZAAR. Concomitant therapy included LIPITOR, ZYRTEC and aspirin. On the same day, after receiving the vaccination the physician experienced chills, fever and cellulitis on the injected arm. On 20-OCT-2009 the physician recovered. There was no laboratory diagnostics studies performed. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 59 year old female registered nurse with diabetes who on 14-OCT-2009 was vaccinated intramuscularly with her first dose of PNEUMOVAX 23. The registered nurse reported that on 14-OCT-2009, she withdrew PNEUMOVAX 23 from a multidose vial and she had another nurse give her the dose. The registered nurse could not recall if she withdrew 0.5mL or 1mL and had not way to tell. Subsequently the nurse experienced pain and swelling at the injection site that get worse at night. The swelling extends down to the registered nurse elbow. No lab tests were performed. The registered nurse sought medical attention by consulting a pharmacist. At the time of the report the patient had not recovered from pain and swelling. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Information has been received from a physician concerning that his wife, also a physician, had a female patient who "sometime last week" was vaccinated with a dose of PNEUMOVAX 23 (lot # not available). "Right after the vaccination", the patient had a bad rash. The patient visited the physician for medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Vaccination complication
Clinical narrative: Information has been received from a 61 year old female with no pertinent medical history and allergies to medications, food and environments. The consumer reported that she had a reaction to the PNEUMOVAX 23 after receiving a small amount under her skin as a testing for PNEUMOVAX 23 allergic reaction. The reaction consisted of warm itchy red area the size of a nickel. The patient was also tested with a flu vaccine that contained a thimerosal and she had the same reaction. The reactions occurred at the office. No lab diagnostic study was performed. At the time of the report, the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an "adult" female patient with no know drug allergies who within the past 3 weeks on approximately 01-OCT-2009 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot# 663889/0632Y). It was not known if she had received PNEUMOVAX 23 in the past. On approximately 01-OCT-2009 "within 12 hours of vaccination" the patient experienced pain, swelling, heat, redness and possible bruising at the injection site. The patient did not have fever. The patient was instructed to take diphenhydramine and ibuprofen. At the time of the  report, the patient was recovering. The patient came to the pharmacy to seek medical attention. No lab diagnostic study was performed. This is one of several reports  received from the same source Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an approximately 66 year old female who on 14-OCT-2009 was vaccinated in the right deltoid with a dose of PNEUMOVAX 23 (injection dose unknown). The patient's concomitant medications include a flu shot (manufacturer unknown) on 14-OCT-2009 in her left deltoid. The patient's relevant medical history and past drug history were unknown. On 15-OCT-2009 the patient reported to the pharmacist that she had swelling, radiating pain, redness, warmth and black and blue around the injection site on the right deltoid. She stated that her left deltoid was fine. It was unknown if there was any relevant laboratory data. As of 15-OCT-2009 the patient continued to had swelling, radiating pain, redness, warmth and black and blue around the injection site. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient had no reaction after receiving her first dose of PNEUMOVAX 23 few years ago, who on 09-OCT-2009 was vaccinated with a second dose of PNEUMOV.5AX 23, 0.5 ml, SQ (Lot # not provided). Concomitant therapy included "anticholesterol medications". On 09-OCT-2009 the patient developed an injection site reaction after receiving PNEUMOVAX 23. The patient developed redness, pain and swelling on the injection site. The affected area was whole upper arm. The patient called the nurse practitioner. The patient recovered "3 days after the injection date". Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Drug administered at inappropriate site, Injection site haematoma
Clinical narrative: Information has been received from Sanofi Aventis (manufacturer control number 200918853US) via consumer concerning a 78 year old male husband who in approximately in October 2009, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) in the abdomen. Suspect therapy included LOVENOX (lot # 21078 and expiration date: February 2012) 100 mg twice daily starting on 01-OCT-2009 for surgery for pacemaker insertion and in approximately October 2009 a dose of influenza virus vaccine (unspecified) (dose, route and lot number not reported). The consumer reported that her husband's abdomen was all bruised from these injections (injection site haematoma). The consumer also reported that the nurse had given him his pneumonia shot and flu shot in the abdomen while he was in the hospital. Additionally the consumer reported that her husband was on LOVENOX until his COUMADIN levels returned to where the doctor wanted them. This was originally reported by the consumer. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site swelling, Paraesthesia
Clinical narrative: Information has been received from a medical technologist concerning a 39 year old female who on 12-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot # 662842/1296X). 10 hours after vaccination on 12-OCT-2009 the patient developed swelling at the injection site of the left upper arm. The patient then developed tingling and numbness of the left arm. The patient went to an office. It was unknown if treatment would be required. At the time of the report, the patient had not recovered. Follow up information has been received from the medical technologist. No additional AE information provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site nodule
Clinical narrative: Information has been received from a physician concerning a female who "a week ago" on approximately 12-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 at the hospital. Concomitant therapy included influenza virus vaccine (unspecified) in the other arm. The patient had a big knot in the shoulder that was red, swollen and a lot of pain in the arm which PNEUMOVAX 23 was given (which arm was unknown). The patient visited office for medical attention. At the time of the report, the patient was recovering. Follow up information has been received from a 33 year old female patient with seasonal allergies and asthma, who on 16-OCT-2009 (previously reported as 14-OCT-2009) at 10:15 am was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662785/1124X) in the left upper arm. There was no illness at the time of vaccination. On 16-OCT-2009, in the PM, the patient had extreme left arm pain at site, left arm swelling at site approximately the diameter of a softball with raised areas that looked like "Vienna sausages". The patient was unable to move her arm for 3 days. The patient had fever of 102F that decreased in 2 to 3 days. She had joint ache, hips were the worst area. There were no labs and diagnostic tests performed. The patient did not seek medical attention. At the time of the report, the patient recovered. It was noted that the symptoms had gone by 6 days. No further information is available.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who "a week ago" on approximately 12-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 at the hospital. Concomitant therapy included influenza virus vaccine (unspecified) in the other arm. The patient had a big knot in the shoulder that was red, swollen and a lot of pain in the arm which PNEUMOVAX 23 was given (which arm was unknown). The patient visited office for medical attention. At the time of the report, the patient was recovering. Follow up information has been received from a 33 year old female patient with seasonal allergies and asthma, who on 16-OCT-2009 (previously reported as 14-OCT-2009) at 10:15 am was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662785/1124X) in the left upper arm. There was no illness at the time of vaccination. On 16-OCT-2009, in the PM, the patient had extreme left arm pain at site, left arm swelling at site approximately the diameter of a softball with raised areas that looked like "Vienna sausages". The patient was unable to move her arm for 3 days. The patient had fever of 102F that decreased in 2 to 3 days. She had joint ache, hips were the worst area. There were no labs and diagnostic tests performed. The patient did not seek medical attention. At the time of the report, the patient recovered. It was noted that the symptoms had gone by 6 days. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Feeling hot, Malaise, Musculoskeletal pain, No reaction on previous exposure to drug
Clinical narrative: Initial and follow up information has been received from a registered nurse and a pharmacist concerning the nurse, a 79 year old female patient blood pressure high, gastrooesophageal reflux disease, gout, allergy to chocolate, sulfer and carbonic anhydrase inhibitor who on 16-OCT-2009 was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 in left arm (lot #662841/0626Y). Concomitant therapy included digoxin, thyroid, enalapril maleate (MSD), PREVACID, allopurinol and "thiopyridine". On the same day 30 minutes after the vaccination the patient developed body aches. She experienced pain in the left shoulder. Heat and pain started a few hours later followed by pain in the arm, joint pain all over and malaise. She continued with arm and shoulder pain. The patient was treated with TYLENOL and ADVIL. It was also reported the patient 8 years ago approximately in October 2001, was vaccinated with PNEUMOVAX 23 and with no adverse symptoms. No laboratory tests were performed. Unspecified medical attention had been sought. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a registered nurse and a pharmacist concerning the nurse, a 79 year old female patient blood pressure high, gastrooesophageal reflux disease, gout, allergy to chocolate, sulfer and carbonic anhydrase inhibitor who on 16-OCT-2009 was vaccinated intramuscularly with 0.5 ml PNEUMOVAX 23 in left arm (lot #662841/0626Y). Concomitant therapy included digoxin, thyroid, enalapril maleate (MSD), PREVACID, allopurinol and "thiopyridine". On the same day 30 minutes after the vaccination the patient developed body aches. She experienced pain in the left shoulder. Heat and pain started a few hours later followed by pain in the arm, joint pain all over and malaise. She continued with arm and shoulder pain. The patient was treated with TYLENOL and ADVIL. It was also reported the patient 8 years ago approximately in October 2001, was vaccinated with PNEUMOVAX 23 and with no adverse symptoms. No laboratory tests were performed. Unspecified medical attention had been sought. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blood pressure normal, Chills, Dizziness, Heart rate normal, Hyperhidrosis
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient with seasonal allergy, Erythromycin allergy manifests as rash and no pertinent medical history who on 21-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 in right arm and dose of ZOSTAVAX (Merck) in her left arm subcutaneously. Instantly post vaccination the patient had a pain shoot down her right arm and immediately spread around her body myalgias, camping in legs, dizzy, saw spots, syncope type of episode, sweaty, chills. The patient's blood pressure and heart rate were normal. The patient was monitored at the office for thirty minutes lying down. At the time of the report, the patient had fully recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle spasms, Myalgia, Pain
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient with seasonal allergy, Erythromycin allergy manifests as rash and no pertinent medical history who on 21-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 in right arm and dose of ZOSTAVAX (Merck) in her left arm subcutaneously. Instantly post vaccination the patient had a pain shoot down her right arm and immediately spread around her body myalgias, camping in legs, dizzy, saw spots, syncope type of episode, sweaty, chills. The patient's blood pressure and heart rate were normal. The patient was monitored at the office for thirty minutes lying down. At the time of the report, the patient had fully recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Syncope, Visual impairment
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient with seasonal allergy, Erythromycin allergy manifests as rash and no pertinent medical history who on 21-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 in right arm and dose of ZOSTAVAX (Merck) in her left arm subcutaneously. Instantly post vaccination the patient had a pain shoot down her right arm and immediately spread around her body myalgias, camping in legs, dizzy, saw spots, syncope type of episode, sweaty, chills. The patient's blood pressure and heart rate were normal. The patient was monitored at the office for thirty minutes lying down. At the time of the report, the patient had fully recovered. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 56 year old female with no pertinent medical history and no drug reactions/allergies who on 15-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23. There was no concomitant medication. On 16-OCT-2009 the patient developed redness, swelling and tenderness to touch at the injection site of the right upper arm. The patient also experienced fatigue and fever of 101.5F. The patient self-treated with ibuprofen and fully recovered on 19-OCT-2009. Additional information is not expected.
Age: 86.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Initial information has been received from a pharmacist concerning an 86 year old male patient with chronic respiratory disease and no known drug allergies who in approximately 2004 (at least 5 years ago) was vaccinated with a dose of PNEUMOVAX 23 (lot#, route and site of administration not reported). On 16-OCT-2009 the patient was vaccinated intramuscularly with another 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 662841/0626Y) into the left arm. Concomitant therapy included PLAVIX, " blood pressure medication" and "cholesterol medication". On 16-OCT-2009 30 minutes after vaccination, the patient experienced body aches. It was reported that the patient was experiencing joint pain and pain in the left shoulder. Unspecified medical attention was sought and there was no laboratory diagnostics studies performed. Additional information has been received from a consumer, the 86 year old male patient's wife who stated the patient had a history of mild stroke and hypertension. She reported that in approximately 2001 (8 years ago) the patient was vaccinated with a dose of the influenza virus vaccine (unspecified) (lot#, route and site of administration not reported) and a dose of PNEUMOVAX 23 vaccine (lot#, route and site of administration not reported) with no adverse symptoms. On approximately 02-OCT-2009 (2 weeks ago) was vaccinated with another dose of the influenza virus vaccine (unspecified) (lot#, route and site of administration not reported). On 16-OCT-2009 the patient was vaccinated intramuscularly with another 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 662841/0626Y) into the left arm. Concomitant therapy included PROCARDIA, ZOCOR, PLAVIX and BENICAR. On 16-OCT-2009 the patient experienced pain in the neck and shoulder immediately. Heat and pain started a few hours later followed by pain in the arm. The patient was treated with TYLENOL and ADVIL. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Skin warm
Clinical narrative: Initial information has been received from a pharmacist concerning an 86 year old male patient with chronic respiratory disease and no known drug allergies who in approximately 2004 (at least 5 years ago) was vaccinated with a dose of PNEUMOVAX 23 (lot#, route and site of administration not reported). On 16-OCT-2009 the patient was vaccinated intramuscularly with another 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 662841/0626Y) into the left arm. Concomitant therapy included PLAVIX, " blood pressure medication" and "cholesterol medication". On 16-OCT-2009 30 minutes after vaccination, the patient experienced body aches. It was reported that the patient was experiencing joint pain and pain in the left shoulder. Unspecified medical attention was sought and there was no laboratory diagnostics studies performed. Additional information has been received from a consumer, the 86 year old male patient's wife who stated the patient had a history of mild stroke and hypertension. She reported that in approximately 2001 (8 years ago) the patient was vaccinated with a dose of the influenza virus vaccine (unspecified) (lot#, route and site of administration not reported) and a dose of PNEUMOVAX 23 vaccine (lot#, route and site of administration not reported) with no adverse symptoms. On approximately 02-OCT-2009 (2 weeks ago) was vaccinated with another dose of the influenza virus vaccine (unspecified) (lot#, route and site of administration not reported). On 16-OCT-2009 the patient was vaccinated intramuscularly with another 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 662841/0626Y) into the left arm. Concomitant therapy included PROCARDIA, ZOCOR, PLAVIX and BENICAR. On 16-OCT-2009 the patient experienced pain in the neck and shoulder immediately. Heat and pain started a few hours later followed by pain in the arm. The patient was treated with TYLENOL and ADVIL. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old female patient with no pertinent medical history who on 20-OCT-2009 was vaccinated intramuscularly with the first 0.5 ml dose of PNEUMOVAX 23 (lot# 663369/0506Y). There was no concomitant medication. On 21-OCT-2009 the patient experienced red, warm to touch, and swelling at the site of injection after receiving her first dose of PNEUMOVAX 23. The affected area was large. The patient also had a fever on 21-OCT-2009. The patient sought medical attention via office visit. No laboratory diagnostics studies were performed. The patient was treated with BENADRYL, ADVIL or TYLENOL as needed. At the time of the report, the patient had not recovered. Additional information has been requested.