chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an approximately 38 year old female who on 25-AUG-2008 was vaccinated intramuscularly with a dose of PNEUMOVAX (Lot # 661899/0519X).  Subsequently, the patient experienced severe pain, swelling and fever.  The patient sought unspecified medical attention and was treated with TYLENOL with CODEINE.  At the time of this report the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old patient who on an unspecified date was vaccinated with PREVNAR instead of PNEUMOVAX by mistake. The pharmacist stated that "this was not a product confusion". Another pharmacist reported that the PNEUMOVAX that the patient was to receive was on the wrong refrigerator. The PREVNAR was in the refrigerator where the 23v polysaccharide vaccine should have been. The person administering the drug did not look to see it was the wrong one. No adverse reactions reported. No further information available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered respiratory therapist concerning a 58 year old female with drug reaction/allergy to flu vaccination, who on 23-July-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 658763/0990U). It was unknown if this was the patient's first vaccination with PNEUMOVAX 23 vaccine. There was no concomitant medication. The respiratory therapist reported that within 24 hours of the vaccination, approximately 24-Jul-2008 the patient developed an injection site reaction. The patient developed a fever of 102 degrees F, injection site pain with significant injection site swelling and redness. The patient was seen in the office and was treated with Prednisone (unspecified). The therapist reported that on an unspecified date, the patient's injection site reaction, fever of 102 degrees F, injection site pain, significant swelling and redness had resolved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered respiratory therapist concerning a 58 year old female with drug reaction/allergy to flu vaccination, who on 23-July-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 658763/0990U). It was unknown if this was the patient's first vaccination with PNEUMOVAX 23 vaccine. There was no concomitant medication. The respiratory therapist reported that within 24 hours of the vaccination, approximately 24-Jul-2008 the patient developed an injection site reaction. The patient developed a fever of 102 degrees F, injection site pain with significant injection site swelling and redness. The patient was seen in the office and was treated with Prednisone (unspecified). The therapist reported that on an unspecified date, the patient's injection site reaction, fever of 102 degrees F, injection site pain, significant swelling and redness had resolved. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered respiratory therapist concerning a 56 year old male with no drug reactions or allergies who in 2002 was vaccinated with a first dose of PNEUMOVAX (lot # not reported) with no problems.  On an unspecified date, (approximately August 2008) the patient was vaccinated with a second dose of PNEUMOVAX (lot # 658673/0990U).  No other vaccinations were given at the same visit.  24 hours after vaccination the patient developed an injection site reaction.  The patient developed a fever of 103 degrees F, injection site pain with significant injection site swelling and redness.  At the time of the report, the patient's injection site reaction, fever or 103 degrees F, injection pain, significant swelling and redness persisted.  At the time of the report the patient was to be seen in the physician's office and was to be treated with PREDNISONE.  Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered respiratory therapist concerning a 56 year old male with no drug reactions or allergies who in 2002 was vaccinated with a first dose of PNEUMOVAX (lot # not reported) with no problems.  On an unspecified date, (approximately August 2008) the patient was vaccinated with a second dose of PNEUMOVAX (lot # 658673/0990U).  No other vaccinations were given at the same visit.  24 hours after vaccination the patient developed an injection site reaction.  The patient developed a fever of 103 degrees F, injection site pain with significant injection site swelling and redness.  At the time of the report, the patient's injection site reaction, fever or 103 degrees F, injection pain, significant swelling and redness persisted.  At the time of the report the patient was to be seen in the physician's office and was to be treated with PREDNISONE.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from an office manager concerning a 60 year old female with hyperlipidaemia, hypothyroidism and drug hypersensitivity to IODINE, CODEINE, COMPAZINE, DEMEROL and anesthetics;  a history of gastrooesophageal reflux disease (GERD), kidney stones and atrial fibrillation in 2003 who on 26-AUG-2008 was vaccinated intramuscularly into the right arm with a dose of PNEUMOVAX (Lot # 660717/0224X).  Concomitant therapy included influenza virus (unspecified) into the left arm, SYNTHROID, SIMVASTATIN (MSD), estrogens, conjugated PREMARIN and ASPIRIN.  On approximately 26-AUG-2008 the patient experienced the injection site to be hard as a rock and the size of a golf ball.  The right arm throbbed and the injection site area was red and the size of a 50 cent piece.  It was unknown if the patient received the vaccine in the past.  The past sought unspecified medical attention.  The patient was given BENADRYL.  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from an office manager concerning a 44 year old female with seizure disorder, severe mental retardation, high cholesterol and no drug reactions or allergies or illness at time of vaccination who in 2005 was vaccinated with the first dose of PNEUMOVAX 23 vaccine (It was reported in follow-up that there was no previous dose). On 27-Aug-2008 at 12:00 the patient was vaccinated IM in the left arm with the second 0.5 ml dose of PNEUMOVAX 23 (lot# 660717/0224X). Concomitant therapy included influenza virus vaccine (unspecified). On 27-AUG-2008, the same day, the patient's guardian called the doctor's office to report that the arm at the injection site was hard and swelled up to a size of a baseball. The patient was taken to the emergency room by the guardian. The patient was not hospitalized, and was treated with MEDROL DOSEPAK and or BENADRYL. The patient sought medical attention in the doctor's office. No lab tests were performed. The office manager reported in follow up that after few days, the patient's injection site swelled up to a size of a baseball was recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injection site reaction, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 13 year old female patient who on 18-AUG-2008 was vaccinated intramuscularly with 0.5 mL PNEUMOVAX 23 vaccine (lot # 659010/1537U). There was no concomitant medication, no allergies and no pertinent medical history. On 19-Aug-2008 the patient developed a local reaction at injection site including pain, erythema, warmth, fever of about 102 degrees F, and tiredness. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from local reaction at injection site including pain, erythema, warmth, fever of about 102 degrees F and tiredness. No other information was available. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a health professional concerning a 13 year old female patient who on 18-AUG-2008 was vaccinated intramuscularly with 0.5 mL PNEUMOVAX 23 vaccine (lot # 659010/1537U). There was no concomitant medication, no allergies and no pertinent medical history. On 19-Aug-2008 the patient developed a local reaction at injection site including pain, erythema, warmth, fever of about 102 degrees F, and tiredness. The patient sought unspecified medical attention. On an unspecified date, the patient recovered from local reaction at injection site including pain, erythema, warmth, fever of about 102 degrees F and tiredness. No other information was available. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site reaction, Pain, Pyrexia
Clinical narrative: Information has been received from a healthcare worker (office manager) concerning a 5 year old female with no allergies/drug reactions and no pertinent medical history who on 27-AUG-2008 was vaccinated IM with PNEUMOVAX (lot # 659010/1537U). Concomitant therapy included (INFANRIX) (lot # not reported), (IPOL) (lot # not reported), MMR, (lot # not reported), and VARIVAX (lot # not reported). On 28-AUG-2008 the patient developed local reaction at injection site including pain, erythema, warmth and a fever of about 102 degrees F. The patient sought unspecified medical attention. At the time of the report the patient was recovering from local reaction at injection site including pain, erythema, warmth, and a fever of about 102 degrees F. No other information was available. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a healthcare worker (office manager) concerning a 5 year old female with no allergies/drug reactions and no pertinent medical history who on 27-AUG-2008 was vaccinated IM with PNEUMOVAX (lot # 659010/1537U). Concomitant therapy included (INFANRIX) (lot # not reported), (IPOL) (lot # not reported), MMR, (lot # not reported), and VARIVAX (lot # not reported). On 28-AUG-2008 the patient developed local reaction at injection site including pain, erythema, warmth and a fever of about 102 degrees F. The patient sought unspecified medical attention. At the time of the report the patient was recovering from local reaction at injection site including pain, erythema, warmth, and a fever of about 102 degrees F. No other information was available. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a 67 year old female consumer with a sulfonamide allergy, who on 28-AUG-2008 was vaccinated with a first dose of PNEUMOVAX. Concomitant therapy included ARMOUR THYROID TABLETS. On 28-AUG-2008, after the vaccination, the patient experienced excruciating pain at the injection site, with redness and swelling from the shoulder to the elbow. She also developed bruising on all of her fingers. She sought unspecified medical attention. No diagnostic laboratory studies were performed. She is getting better, but the site is still tender to touch. No product quality complaint was involved. Follow up information was received from a health professional who reported that in the afternoon of 28-AUG-2008 the patient vaccinated with a dose of PNEUMOVAX (lot # 659199/1541U) in her right deltoid. On 28-AUG-2008 the patient experienced injection site swollen and tender which was down to elbow in the right side. The patient was treated with elevation ice, TYLENOL. The patient was offered an appointment but declined. Subsequently, the patient recovered. Follow up information was received from the patient was a female with an allergy to BACTRIM, ZITHROMAX, AVELOX and LEVAQUIN who at 3 PM of 28-AUG-2008 was vaccinated with a dose of PNEUMOVAX. No illness was reported at the time of vaccination. At 7:22 PM of 28-AUG-2008 the patient experienced right arm swollen and tender. No laboratory or diagnostic test was performed. At the time of this report, the patient recovered. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of PNEUMOVAX. Subsequently the patient experienced swelling at the injection site. The patient was treated with KEFLEX, over the counter BENADRYL and ice. Subsequently, the patient recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Incorrect route of drug administration, Oxygen saturation decreased
Clinical narrative: Information has been received from a pharmacist concerning a 28 year old female patient with diabetes, osteomyelitis and anxiety disorder who on 02-SEP-2008, while hospitalized for vomiting, diarrhea and dehydration was vaccinated with a dose of PNEUMOVAX (lot # not provided) by the intravenous route. After the PNEUMOVAX was given IV the patient had a red face, her oxygen went down to 90% and she developed chest pain. At the time of the report the patient had not recovered. The pharmacist reported that the patient's hospitalization was not prolonged because of her reaction to PNEUMOVAX vaccine. No further information is available. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician and the Clinical operations manager concerning a 4 month old female who on 03-SEP-2008 (also reported as 04-SEP-2008) was vaccinated with PNEUMOVAX (lot # not reported) instead of (PREVNAR), (human error). The clinical operations manager said the human error was that the labels of the vaccines had the same color and the nurse accidentally grabbed the wrong vial. The clinical manager indicated that the practice has instituted changes to prevent such errors from occurring again. they are using caution stickers on the units which will remind the nurses to select the correct vial. The practice also is using separate shelves to separate adult doses from pediatric doses. No adverse effects reported. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site pain, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old male with no drug reactions/allergies who on 05-SEP-2008 was intramuscularly vaccinated with a 0.5 mL dose of PNEUMOVAX 23 (lot number 660685/0619X). Concomitant therapy included (ADACEL) given in the other arm. On 6-SEP-2008 the patient developed "shakes and chills" and a 3 x 6 inch, red area at the injection site. The red area is sore to touch. The patient is being treated with antibiotics. Medical attention was sought at the office visit. At the time of reporting the patient was recovering. No other information is available. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced swelling at the injection site. The patient was treated with (KEFLEX), over the counter BENADRYL and ice. Subsequently, the patient recovered. No product quality complaint was involved. This is one of two reported from the dame source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Information has been received from a license vocational nurse (LVN) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (lot # 655290/0959F). The patient had redness, inflammation at the injection site, swollen arm and slight fever after receiving the dose of PNEUMOVAX. The patient then developed hives. The patient sought unspecified medical attention. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia, Syncope
Clinical narrative: Information has been received from a license vocational nurse (LVN) concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (lot # 658450/1380U).  The patient fainted after receiving the dose of PNEUMOVAX.  The nurse also reported that the patient also had 102 F degrees fever with swollen arm.  The patient sought unspecified medical attention.  The patient felt better after 2.5-3 days.  No further information was provided.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Laboratory test, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter with down's syndrome, drug reactions/allergy to KEFLEX and strawberrys and a history of skin tag removal (23-JUN-2008), and "step" pneumonia" (25-JUN-2008) who one month after receiving PREVNAR, was vaccinated on 15-SEP-2008 with PNEUMOVAX (lot # not reported) into left thigh. The mother reported that on an unspecified date, her daughter developed leg and knee soreness in the injection site leg. Lab diagnostics studies performed included "strain", results not reported. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered from leg and knee soreness. No further information was reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Hyperhidrosis, Urticaria
Clinical narrative: Information has been received from a female consumer (age unknown), who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX (manufacturer unknown). Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant therapy included SYNVISC. Subsequently, on an unspecified date, the patient experienced sweating, difficulty breathing, and developed hives. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Follow up information received from the patient and she reported that she didn't remembered the name because it has been several years since and she didn't know how to contact or if still in business (physician was elderly). Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and an assistant director of nursing concerning a male nursing home patient who was vaccinated by a licensed practical nurse with PNEUMOVAX (lot # 658072/1416U), and developed severe adverse reactions including redness and swelling at the injection site. Unspecified medical attention was sought. The director of nursing reported that the patient was improving. No additional information was provided. This is one of several reports received from the same source. additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inappropriate schedule of drug administration, Rash
Clinical narrative: Initial and follow up information has been received from a physician concerning a 47 year old female x ray technician who on 09?-SEP-2008 was vaccinated with a second dose of PNEUMOVAX lot # 658074/0803U. Post vaccination the patient told the physician that she had PNEUMOVAX a few weeks ago. In follow information from the doctor's office it was reported that patient received two different injection and post vaccinations she had extensive rash and red skin. The patient reported as recovered. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 63 year old female registered nurse with drug hypersensitivity to CECLOR, high cholesterol and osteoporosis who on 17-SEP-2008 was vaccinated with a first dose of PNEUMOVAX. Concomitant therapy included BONIVA and CRESTOR. On 18-SEP-2008, the patient experienced a local site reaction after she received what her physician told her was PNEUMOVAX. However, she got a red vaccine instead of a clear, colorless solution, so she suspects it was not PNEUMOVAX. She was concerned since her husband is immunocompromised and she dose not want to pass anything to him. Follow-up information from the consumer. She spoke with the physician's office and they confirmed that she received PNEUMOVAX. They informed her that the hub of the needles are red. The injection site reaction with redness, warmth and swelling at the injection site started on 18-SEP-2008. At the time of this report, the patient had not recovered. No product quality complaint was involved. Follow-up information was received from the patient. Administering physician's name was provided. Follow up information was received from a health professional at the physician's office. The patient had no illness at the time of being vaccinated. It was reported the patient was vaccinated intramuscularly 0.5 mL on 18-SEP-2008 at 11:00 am (previously reported as 17-SEP-2008) with PNEUMOVAX (lot # 659487/1960U). At 11:03 am on 18-SEP-2008, the patient experienced an injection site reaction with redness and swelling. The reporter offered the patient to come if worse, but the patient did not call back. On unknown date, the patient recovered. No further information was available.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: Information has been received from a physician concerning an approximately 32 year old female who on 17-SEP-2008 was vaccinated intradermally into the right forearm with a dose of PNEUMOVAX. On 18-SEP-2008, the patient experienced a baseball size reaction at the injection site. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality control complaint was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and an assistant director of nursing concerning a male nursing home patient who was vaccinated by a licensed practical nurse with PNEUMOVAX (lot # 658072/1415U), and developed severe adverse reactions including redness and swelling at the injection site.  Unspecified medical attention was sought.  The director of nursing reported that the patient was improving.  No additional information was provided.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 97.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and an assistant director of nursing concerning an approximately 97 year old female nursing home patient concerning an nursing home patient who was vaccinated by a licensed practical nurse with PNEUMOVAX (lot # 658072/1416U), and developed severe adverse reactions including redness and swelling at the injection site. Unspecified medical attention was sought. The director of nursing reported that the patient had improved. No additional information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a female 72 year old retired registered nurse (R.N.) with drug hypersensitivity to PRAVASTATIN sodium, AMOXICILLIN and niacin.  In approximately September 2007, she was vaccinated with a dose of PNEUMOVAX.  Concomitant therapy included alendronate sodium (MSD) and CRESTOR.  The reporter reported that within the hour of the administration of the injection she experienced redness and swelling at the injection site.  She recovered five days later.  No further information available.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient (gender not specified) who was vaccinated with a dose of PNEUMOVAX. The physician reported that the patient experienced redness, swelling and pain at the injection site, on the arm, that extended to the shoulder and neck. The patient also experienced fever. The patient reported recovered on an unspecified day. No other information was available at this time. Additional information has been requested.
Age: 74.0
Sex: U
Vaccine: PNC, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old patient who on an unspecified date was vaccinated with PREVNAR instead of PNEUMOVAX by mistake. The pharmacist stated that "this was not a product confusion". Another pharmacist reported that the 23v polysaccharide vaccine that the patient was to receive was in the wrong refrigerator. The PREVNAR was in the refrigerator where the 23v polysaccharide vaccine should have been. The person administering the drug did not look to see it was the wrong one. No adverse reactions reported. No further information available. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a male who on 20-June-2008 was vaccinated via subcutaneous route with a first dose of PNEUMOVAX 23 (lot# 655501/1035F), and or DTP vaccine. On 20-June-2008 the patient developed a fever of 103 F and chills later that day. He also experienced redness and swelling at the injection site of the PNEUMOVAX 23 vaccine. The patient sought medical attention via an office visit. The patient was treated with Keflex. On an unknown date, the patient recovered from cellulitis, fever of 103 F, chills, and redness and swelling at the site of injection. No additional information was provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Diagnostic procedure, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 86 year old male who on 26-AUG-2008 was vaccinated via subcutaneous route into right arm with a first dose of PNEUMOVAX (lot # 659150/1384U) and or DTaP (manufacturer unknown) and developed cellulitis after after administration of the PNEUMOVAX and or DTaP. On 27-AUG-2008 the patient developed a fever of 103 F and chills. He also experienced edema and redness of his right arm. His right hand was cooler to touch than his left hand. The nurse reported that the patient underwent imaging study for right hand which was negative. The patient sought medical attention via an office visit. On an unknown date, the patient recovered from cellulitis, fever of 103, chills, edema and redness of his right arm. No additional information was provided. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 86 year old male who on 26-AUG-2008 was vaccinated via subcutaneous route into right arm with a first dose of PNEUMOVAX (lot # 659150/1384U) and or DTaP (manufacturer unknown) and developed cellulitis after after administration of the PNEUMOVAX and or DTaP. On 27-AUG-2008 the patient developed a fever of 103 F and chills. He also experienced edema and redness of his right arm. His right hand was cooler to touch than his left hand. The nurse reported that the patient underwent imaging study for right hand which was negative. The patient sought medical attention via an office visit. On an unknown date, the patient recovered from cellulitis, fever of 103, chills, edema and redness of his right arm. No additional information was provided. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activated partial thromboplastin time, Angiogram abnormal, Body temperature increased, Cellulitis, Chills
Clinical narrative: Information has been received from a registered nurse concerning a 86 year old male who on 26-AUG-2008 was vaccinated via subcutaneous route into right arm with a first dose of PNEUMOVAX (lot # 659150/1384U) and or DTaP (manufacturer unknown) and developed cellulitis after after administration of the PNEUMOVAX and or DTaP. On 27-AUG-2008 the patient developed a fever of 103 F and chills. He also experienced edema and redness of his right arm. His right hand was cooler to touch than his left hand. The nurse reported that the patient underwent imaging study for right hand which was negative. The patient sought medical attention via an office visit. On an unknown date, the patient recovered from cellulitis, fever of 103, chills, edema and redness of his right arm. No additional information was provided. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Full blood count normal, Haemoglobin decreased, International normalised ratio, Oedema peripheral, Prothrombin level normal
Clinical narrative: Information has been received from a registered nurse concerning a 86 year old male who on 26-AUG-2008 was vaccinated via subcutaneous route into right arm with a first dose of PNEUMOVAX (lot # 659150/1384U) and or DTaP (manufacturer unknown) and developed cellulitis after after administration of the PNEUMOVAX and or DTaP. On 27-AUG-2008 the patient developed a fever of 103 F and chills. He also experienced edema and redness of his right arm. His right hand was cooler to touch than his left hand. The nurse reported that the patient underwent imaging study for right hand which was negative. The patient sought medical attention via an office visit. On an unknown date, the patient recovered from cellulitis, fever of 103, chills, edema and redness of his right arm. No additional information was provided. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Diagnostic procedure, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender unknown) who in June 2008, was vaccinated SQ with a dose of PNEUMOVAX 23 vaccine. Subsequently the patient later developed fever, chills and a swollen arm. The patient developed fever, chills, and a swollen arm. The patient developed cellulitis. The patient was seen at the office. The patient recovered on an unspecified date. No product quality complaint was involved. Follow up information was received from medical records and the registered nurse who reported that the patient was a male with a history of ischaemia in his right hand/ fingers, ulcer disease complicated by bleeding and a "history of clot". The patient received the PNEUMOVAX 23 (lot# 659150/1384U) SQ, into his right arm, on 26-Aug-2008. The nurse reported that on 27-Aug-2008, the patient began running temperature of 103F with right arm edema. The patient saw the physician on 28-Aug-2008 and was ordered an imaging study to rule out deep venous thrombosis (DVT) due to patient's history of clots. Test was negative and the patient returned to office on 29-Aug-2008 doing better. On 29-Aug-2008, the patient had normal complete blood cell count and an unknown test was also performed. On 29-Aug-2008, the patient's hemoglobin was low: 13.8 g/dl and coagulation test were as follows: Activated partial thromboplast in time: 27 seconds, normal. Prothrobin time (PT): 12.9, normal. Pt international Normalized ratio: 1.1 which was not a risk value. On 29-Aug-2008, the patient underwent a right upper extremity arteriogram with ultrasound guidance for vascular access. There was a conscious sedation and an arteriotomy closure. Findings were as follows: The right subclavian, axillary, brachial, radial, ulnar and interosseous arteries were patent. There was hyperemia in the axilla likely due to reactive lymph nodes. There was hyperemia of the right forearm in the area of the patient's skin erythema. The deep arch was small. Superficial arch poorly formed. Metacarpal arteries, common digital arteries and proper digital arteries filled very slowly. The physician saw no emboli. Vessels were mildly irregular. Conclusion: poor flow to digits. Vessels were small in size and were mildly irregular. Findings were consistent with spasm and physician also suspected an element of allergic vasculopathy. Plan for the patient was to continue his steroids. Short course of Aspirin and Plavix to avoid potential thrombosis of the patient's digits. It was also reported by the physician that the patient felt swelling improved. The patient started Bactrim DS without further fevers or chills. Right upper extremity erythema stable. Patient was with full range of movement (ROM) right elbow. Diminished right radial pulse with some coolness in right fingers compared with left. Cellulitis diminished radial pulse. The patient fully recovered. No further information is availble.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender unknown) who in June 2008, was vaccinated SQ with a dose of PNEUMOVAX 23 vaccine. Subsequently the patient later developed fever, chills and a swollen arm. The patient developed fever, chills, and a swollen arm. The patient developed cellulitis. The patient was seen at the office. The patient recovered on an unspecified date. No product quality complaint was involved. Follow up information was received from medical records and the registered nurse who reported that the patient was a male with a history of ischaemia in his right hand/ fingers, ulcer disease complicated by bleeding and a "history of clot". The patient received the PNEUMOVAX 23 (lot# 659150/1384U) SQ, into his right arm, on 26-Aug-2008. The nurse reported that on 27-Aug-2008, the patient began running temperature of 103F with right arm edema. The patient saw the physician on 28-Aug-2008 and was ordered an imaging study to rule out deep venous thrombosis (DVT) due to patient's history of clots. Test was negative and the patient returned to office on 29-Aug-2008 doing better. On 29-Aug-2008, the patient had normal complete blood cell count and an unknown test was also performed. On 29-Aug-2008, the patient's hemoglobin was low: 13.8 g/dl and coagulation test were as follows: Activated partial thromboplast in time: 27 seconds, normal. Prothrobin time (PT): 12.9, normal. Pt international Normalized ratio: 1.1 which was not a risk value. On 29-Aug-2008, the patient underwent a right upper extremity arteriogram with ultrasound guidance for vascular access. There was a conscious sedation and an arteriotomy closure. Findings were as follows: The right subclavian, axillary, brachial, radial, ulnar and interosseous arteries were patent. There was hyperemia in the axilla likely due to reactive lymph nodes. There was hyperemia of the right forearm in the area of the patient's skin erythema. The deep arch was small. Superficial arch poorly formed. Metacarpal arteries, common digital arteries and proper digital arteries filled very slowly. The physician saw no emboli. Vessels were mildly irregular. Conclusion: poor flow to digits. Vessels were small in size and were mildly irregular. Findings were consistent with spasm and physician also suspected an element of allergic vasculopathy. Plan for the patient was to continue his steroids. Short course of Aspirin and Plavix to avoid potential thrombosis of the patient's digits. It was also reported by the physician that the patient felt swelling improved. The patient started Bactrim DS without further fevers or chills. Right upper extremity erythema stable. Patient was with full range of movement (ROM) right elbow. Diminished right radial pulse with some coolness in right fingers compared with left. Cellulitis diminished radial pulse. The patient fully recovered. No further information is availble.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activated partial thromboplastin time, Angiogram abnormal, Body temperature increased, Cellulitis, Chills
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender unknown) who in June 2008, was vaccinated SQ with a dose of PNEUMOVAX 23 vaccine. Subsequently the patient later developed fever, chills and a swollen arm. The patient developed fever, chills, and a swollen arm. The patient developed cellulitis. The patient was seen at the office. The patient recovered on an unspecified date. No product quality complaint was involved. Follow up information was received from medical records and the registered nurse who reported that the patient was a male with a history of ischaemia in his right hand/ fingers, ulcer disease complicated by bleeding and a "history of clot". The patient received the PNEUMOVAX 23 (lot# 659150/1384U) SQ, into his right arm, on 26-Aug-2008. The nurse reported that on 27-Aug-2008, the patient began running temperature of 103F with right arm edema. The patient saw the physician on 28-Aug-2008 and was ordered an imaging study to rule out deep venous thrombosis (DVT) due to patient's history of clots. Test was negative and the patient returned to office on 29-Aug-2008 doing better. On 29-Aug-2008, the patient had normal complete blood cell count and an unknown test was also performed. On 29-Aug-2008, the patient's hemoglobin was low: 13.8 g/dl and coagulation test were as follows: Activated partial thromboplast in time: 27 seconds, normal. Prothrobin time (PT): 12.9, normal. Pt international Normalized ratio: 1.1 which was not a risk value. On 29-Aug-2008, the patient underwent a right upper extremity arteriogram with ultrasound guidance for vascular access. There was a conscious sedation and an arteriotomy closure. Findings were as follows: The right subclavian, axillary, brachial, radial, ulnar and interosseous arteries were patent. There was hyperemia in the axilla likely due to reactive lymph nodes. There was hyperemia of the right forearm in the area of the patient's skin erythema. The deep arch was small. Superficial arch poorly formed. Metacarpal arteries, common digital arteries and proper digital arteries filled very slowly. The physician saw no emboli. Vessels were mildly irregular. Conclusion: poor flow to digits. Vessels were small in size and were mildly irregular. Findings were consistent with spasm and physician also suspected an element of allergic vasculopathy. Plan for the patient was to continue his steroids. Short course of Aspirin and Plavix to avoid potential thrombosis of the patient's digits. It was also reported by the physician that the patient felt swelling improved. The patient started Bactrim DS without further fevers or chills. Right upper extremity erythema stable. Patient was with full range of movement (ROM) right elbow. Diminished right radial pulse with some coolness in right fingers compared with left. Cellulitis diminished radial pulse. The patient fully recovered. No further information is availble.
Age: 73.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Full blood count normal, Haemoglobin decreased, International normalised ratio, Oedema peripheral, Prothrombin level normal
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender unknown) who in June 2008, was vaccinated SQ with a dose of PNEUMOVAX 23 vaccine. Subsequently the patient later developed fever, chills and a swollen arm. The patient developed fever, chills, and a swollen arm. The patient developed cellulitis. The patient was seen at the office. The patient recovered on an unspecified date. No product quality complaint was involved. Follow up information was received from medical records and the registered nurse who reported that the patient was a male with a history of ischaemia in his right hand/ fingers, ulcer disease complicated by bleeding and a "history of clot". The patient received the PNEUMOVAX 23 (lot# 659150/1384U) SQ, into his right arm, on 26-Aug-2008. The nurse reported that on 27-Aug-2008, the patient began running temperature of 103F with right arm edema. The patient saw the physician on 28-Aug-2008 and was ordered an imaging study to rule out deep venous thrombosis (DVT) due to patient's history of clots. Test was negative and the patient returned to office on 29-Aug-2008 doing better. On 29-Aug-2008, the patient had normal complete blood cell count and an unknown test was also performed. On 29-Aug-2008, the patient's hemoglobin was low: 13.8 g/dl and coagulation test were as follows: Activated partial thromboplast in time: 27 seconds, normal. Prothrobin time (PT): 12.9, normal. Pt international Normalized ratio: 1.1 which was not a risk value. On 29-Aug-2008, the patient underwent a right upper extremity arteriogram with ultrasound guidance for vascular access. There was a conscious sedation and an arteriotomy closure. Findings were as follows: The right subclavian, axillary, brachial, radial, ulnar and interosseous arteries were patent. There was hyperemia in the axilla likely due to reactive lymph nodes. There was hyperemia of the right forearm in the area of the patient's skin erythema. The deep arch was small. Superficial arch poorly formed. Metacarpal arteries, common digital arteries and proper digital arteries filled very slowly. The physician saw no emboli. Vessels were mildly irregular. Conclusion: poor flow to digits. Vessels were small in size and were mildly irregular. Findings were consistent with spasm and physician also suspected an element of allergic vasculopathy. Plan for the patient was to continue his steroids. Short course of Aspirin and Plavix to avoid potential thrombosis of the patient's digits. It was also reported by the physician that the patient felt swelling improved. The patient started Bactrim DS without further fevers or chills. Right upper extremity erythema stable. Patient was with full range of movement (ROM) right elbow. Diminished right radial pulse with some coolness in right fingers compared with left. Cellulitis diminished radial pulse. The patient fully recovered. No further information is availble.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from an approximately 69 year old female who reported that approximately "9 or 10" years ago, she was vaccinated with PNEUMOVAX. (lot # not reported) Concomitant therapy included influenza virus vaccine (unspecified). "On the same day of the vaccinations" the patient developed an injection site rash. The rash appeared on the same both of the injection sites of PNEUMOVAX and the influenza virus vaccine (unspecified). The patient reported that she was seen by a nurse. On an unreported date the patient recovered from injection site rash. No further information is available. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Albumin urine, Anion gap decreased, Asthenia, Blood glucose abnormal, Blood sodium decreased
Clinical narrative: Information has been received from a physician and an advanced practice nurse concerning a male over 50 years old with diabetes, who on approximately 28-AUG-2008 was vaccinated with a dose of PNEUMOVAX. On 28-AUG-2008 later in the day the patient developed severe edema and swelling at the injection site and the arm. It was reported that the patient had been hospitalized over the past few years for unspecified conditions and may have previously received a dose of PNEUMOVAX during that time. The patient sought unspecified medical attention. No laboratory diagnostics were performed. The patient recovered on an unspecified date. No product quality complaint was involved. Follow-up information has been received from medical records and an advanced practice nurse who reported that the 55 year old disabled male (previously reported as 50 year old), with allergy to steroids, ULTRAM, PHENERGAN, ACTOS and celucophage (therapy unspecified) was vaccinated on 10-SEP-2008 with a dose of PNEUMOVAX, 0.5 mL, in the left deltoid in the morning. This date, the patient experienced left extremity tender to touch, warm to touch, weakness, not able to raise without pain or discomfort, discomfort in neck, shoulder and in arm, headache, he felt lousy and chills fever. The patient sought medical attention. On 11-SEP-2008, were performed some labs and the relevant results were: serum sodium test: low; anion gap: low, serum glucose test: high; urine microalbumin test, high; seg manual: high; urine glucose test: negative : white blood cell count:high; seg: high; blood monocyte count: high; blood lymphocyte count: low; mean corpuscular hemoglobin concentration: high; blood in urine: trace A; erythrocyte sedimentation rate: high; blood lymphocyte count: high and serum high-density lipoprotein cholesterol test: low. On 12-SEP-2008, a left upper extremity venous doppler evaluation was performed which showed no evidence of DVT. On 16-SEP-2008, the patient recovered. No additional information is expected.