chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 78 year old female who on 29-OCT-2007 was vaccinated with PNEUMOVAX 23 (Lot #655500/1005F). On 30-OCT-2007 the patient experienced injection site pain, redness, swelling, warmth and a blister. As of 31-OCT-2007, the patient had not recovered. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning an 83 year old female who on 30-OCT-2007 was vaccinated with PNEUMOVAX 23 (Lot #655500/1005F).  On 31-OCT-2007 the patient experienced injection site pain, swelling, redness, warmth and a blister.  As of 31-OCT-2007, the patient had not recovered.  Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Swelling face
Clinical narrative: Information has been received from a physician concerning a male who "a week ago" on approximately 24-OCT-2007 was vaccinated with PNEUMOVAX.  Concomitant therapy included influenza virus vaccine (unspecified) same day and in the same arm.  On the same day of the vaccination, the patient experienced pain, swelling, redness at the injection site and fever.  By the next day the pain, swelling and redness on the arm as well as fever went away.  However, swelling on the patient's face had occurred.  Unknown medical attention was sought.  The outcome on face swelling was unknown.  No product quality complaint was involved.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a Certified Medical assistant (C.M.A) concerning a 67 year old male patient with hyperlipidaemia, coronary artery disease and peripheral vascular disorder who on 24-JUL-2007 was vaccinated IM into the left arm with a first dose of PNEUMOVAX 23, lot # 654977/0888F. Concomitant therapy included simvastatin (MSD), NORVASC, ALTACE, AXID, PLAVIX and TOPROL XL TABLTS. The reporter reported that the patient's wife called the office "2 weeks ago" to say that her husband had arm pain since he received the PNEUMOVAX 23. He also had redness and warmth at the injection site after the injection. No other information available at this time. The outcome was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A.) concerning a 72 year old male patient who on 30-OCT-2007 was vaccinated IM into left arm with a dose of PNEUMOVAX 23, lot # 655765/0061U.  Concomitant therapy included simvastatin (manufacturer unknown), FLEXERIL, flaxseed, "Omega 3", aspirin, LEXAPRO, calcium (unspecified), vitamins (unspecified), glucosamine, metoprolol, JANUVIA, fluticasone furoate, enalapril maleate (manufacturer unknown), omeprazole, terazosin hydrochloride and DHEA.  The next morning the patient had small hives and urticaria at the injection site that went over the shoulder and on to the chest.  The patient was seen in the office on 01-NOV-2007 and the reaction was improving.  She took BENADRYL for the reaction.  No other information reported.  The outcome of the patient was recovering.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 66 year old female patient with gastroesophagel reflux disease and an allergy to DARVOCET who on 31-OCT-2007 was vaccinated IM into the right arm with a first 0.5ml dose of PNEUMOVAX 23 (Lot# 658447/1132U). Concomitant therapy included influenza virus vaccine (unspecified) and PRILOSEC. On 01-NOV-2007, the patient experienced arm pain, redness at the injection site, warmth at the injection site and swelling to her right arm. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. This is one of 4 reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Pain in extremity, Ultrasound scan normal
Clinical narrative: Information has been received from a certified medical assistant concerning a 72 year old female patient with hypertension, chronic obstructive pulmonary disease and gastrooesophageal reflux disease and a history of cerebrovascular accident and diverticulitis who on 23-OCT-2007, was vaccinated IM into the right arm with a first 0.5ml dose of PNEUMOVAX 23 (Lot# 658555/0964U).  Concomitant therapy included influenza virus vaccine (unspecified) administered into the left arm, KLOR-CON, COZAAR, ZOCOR, CARTIA XT, metoprolol, AGGRENOX, ADVAIR, PRILOSEC and LASIX.  Subsequently, the patient experienced arm pain, redness at the injection site, warmth at the injection site and swelling in the right arm.  Unspecified medical attention was sought.  Laboratory diagnostic studies included an ultrasound of the arm which was reported as negative for deep vein thrombosis (DVT).  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  This is one of 4 reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who was "recently" vaccinated with a 0.5ml dose of PNEUMOVAX 23 (Lot# 655592/1175F). Subsequently, the patient experienced redness at the injection site and swelling at the injection site. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a licensed practical nurse, concerning a patient (age and gender not specified) in October 2007, was vaccinated IM with a dose, 0.5 ml, PNEUMOVAX 23 (lot #655290/0959F). In October 2007, the patient developed "a big welt at the injection site." The patient recovered "within the week" of the vaccination. The reporter felt that developed a big welt at the injection site was related to therapy with PNEUMOVAX 23. The patient sought unspecified medial attention. This is one of two reports received from the same source (WAES #0711USA00003) following vaccination with PNEUMOVAX 23 (lot #655290/0959F). The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research, and was released. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Local reaction, Pain, Rash
Clinical narrative: Information has been received from a female consumer licensed practical nurse (L.P.N.), with allergies to cefaclor, morphine, DEMEROL, codeine, and TEQUIN and a history of herpes zoster through secondary exposure (WAES# 0611USA01550) who reported that a 1994, at approximately 41 years of age, had an unspecified reaction to PNEUMOVAX 23. No other information was available. It is also reported in WAES# 0709USA00291 that the patient experienced a local reaction which included a large, red inflamed area that was hot and painful and a rash from vaccination with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658207/0883U) on 09-Aug-2007. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a female consumer licensed practical nurse (L.P.N.), with allergies to cefaclor, morphine, DEMEROL, codeine, and TEQUIN and a history of herpes zoster through secondary exposure (WAES# 0611USA01550) who reported that a 1994, at approximately 41 years of age, had an unspecified reaction to PNEUMOVAX 23. No other information was available. It is also reported in WAES# 0709USA00291 that the patient experienced a local reaction which included a large, red inflamed area that was hot and painful and a rash from vaccination with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658207/0883U) on 09-Aug-2007. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 76 year old female who in approximately 2002, "about 5 years ago", exact date was not known and who was vaccinated, intramuscularly with the first dose of PNEUMOVAX.  On 01-NOV-2007, the patient was vaccinated, intramuscularly with the second dose of PNEUMOVAX, (Lot # 658673/0990U or 658451/0963U).  On 02-NOV-2007, the next day, the patient developed erythema and swelling at the injection site area.  The lot number for the first dose was unknown and the lot number for the second dose was #658673/0990U or #658451/0963U.  The medical assistant requested a lot check for Lot # 658451/0963U and Lot #658673/0990U.  No further information was available.  The medical assistant reported that there were 3 other patients that had injection site reactions after the administration of PNEUMOVAX, (WAES # 0711USA01127).  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.  Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old patient with an unknown medical history who on 01-NOV-2007 was vaccinated with a pre-measured vial of PNEUMOVAX 23 intramuscularly in the upper thigh.  The patient received PNEUMOVAX 23 instead of PREVNAR.  This was not product confusion, this was a medical error.  The patient did not experience any known symptoms.  Concomitant therapy included PEDVAXHIB (MSD) (Lot #655397/0073U) and PEDIARIX (Lot #AC.  Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a consumer regarding his 21 year old son with dystonia and no allergies who on approximately 22-OCT-2007 "two weeks ago" was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included VALIUM, baclofen, BOTOX and bromocriptine. On approximately 23-OCT-2007 "within a day or two after receiving the vaccine", the patient experienced improvement with his dystonia. It was also reported that he had shown improvement when he has taken treatments for pneumonia as well. 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.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a female "between 70 to 80 years of age", who on 11-OCT-2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23.  Concomitant therapy influenza virus vaccine (unspecified).  Subsequently, the patient developed redness at the injection site.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  This report is one of three from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a female "between 70 to 80 years of age", who on 11-OCt-2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23. Subsequently, the patient developed redness at the injection site. The patient sought unspecified medical attention. No laboratory diagnostic were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. This report is one of three from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a physician concerning a 60 year old female with allergic reaction to antibiotics CEFTIN who on 25-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23.  Concomitant therapy included fluoxetine HCl and alprazolam.  On 25-OCT-2007 the patient's arm swelled 1.5 times normal and she experienced a fever, aches, pains, her arm turned red and was tender to the touch.  No diagnostic laboratory studies were performed.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Nausea, Oedema peripheral, Vomiting
Clinical narrative: Information has been received from a registered nurse a 58 year old male consumer with hypertension, allergy to strawberries, and seasonal allergies. The patient had no illness at the time of being vaccinated. On 01-NOV-2007, the patient was vaccinated with a first dose of PNEUMOVAX 23 (lot # 657143/0380U) IM in the left tricep. Concomitant therapy included lisinopril (MSD), TENEX and montelukast sodium (MSD). On 01-NOV-2007, the patient experienced a " cellulitis like reaction". The area of the left arm from the axillae to the wrist was swollen and reddened like a sun burn. The patient sought medical attention by telephone. The patient took over the counter BENADRYL and the was seen by his employer (hospital) and was ordered KEFLEX and BACTRIM. The cellulitis like reaction resolved on 03-NOV-2007. The nurse stopped taking the cephalexin and BACTRIM. The nurse reported he was completely recovered except for a bout of nausea and vomiting this morning (05-NOV-2007). At the time of reporting, the patient was recovering from the nausea and vomiting. Additional information was received from a physician who reported that the outcome of the events was unknown. No diagnostic tests were performed. No additional information is expected.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Injection site erythema
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female who on 31-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot # 658451/0963U).  In approximately November 2007, the patient experienced an injection site reaction.  The patient was seen at the physician's office.  The patient had a 13 cm area of redness.  The injection site reaction was diagnosed as a bacterial infection.  The patient was treated with antibiotics.  At the time of reporting, the patient was recovering.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 71 year old female with a history of drug allergy/reaction to tetanus vaccine (local redness after tetanus booster 15 years ago) and hydrocodone and no pertinent medical history. The patient had no illness at the time of being vaccinated. On 31-OCt-2007, the patient was vaccinated with a first dose of PNEUMOVAX 23 vaccine (lot # 655765/0061U) 0.5 ml subcutaneously in the right arm. Concomitant therapy also given on 31-OCT-2007 in the left arm included a first dose of ZOSTAVAX vaccine (lot # 658604/1088U), and influenza virus vaccine (Sanofi Pasteur (lot # 112515AA). Other concomitant therapy included LEXAPRO and blood pressure medicine unspecified. On 31-OCT-2007 (also reported as 01-NOV-2007), the patient experienced erythema, swelling, pain, and warmth from her neck to elbow where PNEUMOVAX 23 vaccine was given. The immediate area around the injection site was normal in color. On 02-NOV-2007, the patient was seen by the physician and was started on therapy with KEFLEX. At the time of reporting, the outcome was unknown. Additional information was received from the physician. On 02-NOV-2007, the patient visited the physician's office. The patient had swelling and erythema over her right arm extending from the elbow to deltoid/base of neck. No diagnostic tests were performed. The patient was treated as cellulitis with KEFLEX. On an unspecified date, the patient recovered. No additional information is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 72 year old female who on 29-OCT-2007 was vaccinated with PNEUMOVAX 23 (Lot # 658673/0990U or 658451/0963U) intramuscularly in the right deltoid.  On 02-NOV-2007 the patient developed swelling in the right deltoid, pain, fever and localized erythema.  The patient was advised to ice pack the site area.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the center and was released.  This is one of several reports from the same source.  No further information is available.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: Information has been received from a health professional via a line listing concerning an 82 year old male patient who on 04-DEC-2002 was vaccinated with a dose of PNEUMOVAX 23.  On 02-OCT-2007, the patient was vaccinated with another dose of PNEUMOVAX 23.  The patient subsequently experienced injection site swelling.  The reporter felt that injection site swelling was related to vaccination with PNEUMOVAX 23.  It was unknown if the patient recovered from injection site swelling.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Ecchymosis, Erythema, Headache, Incorrect route of drug administration, Injection site discolouration
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 02-NOV-2007 was vaccinated intradermally into the left vulvar surface with a 0.1 dose of PNEUMOVAX 23.  Fifteen minutes after the vaccination was given, the patient developed a red, swollen area, headache as well as systemic symptoms of a scratchy throat and "stuffy nose" and slight ecchymosis.  It was reported that the injection site was black and blue and sore.  The patient was seen in the emergency room and was treated with BENADRYL, prednisone, and ZANTAC.  On 05-NOV-2007, the patient had a follow up visit and was improving, had no swelling, no systemic symptoms but did still have a slight ecchymosis.  Follow up information indicated that it could not be definitively confirmed that the vaccine used was the PNEUMOVAX 23.  The patient had a high suspicion that this was the product.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nasal congestion, Swelling, Throat irritation, Underdose
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on 02-NOV-2007 was vaccinated intradermally into the left vulvar surface with a 0.1 dose of PNEUMOVAX 23.  Fifteen minutes after the vaccination was given, the patient developed a red, swollen area, headache as well as systemic symptoms of a scratchy throat and "stuffy nose" and slight ecchymosis.  It was reported that the injection site was black and blue and sore.  The patient was seen in the emergency room and was treated with BENADRYL, prednisone, and ZANTAC.  On 05-NOV-2007, the patient had a follow up visit and was improving, had no swelling, no systemic symptoms but did still have a slight ecchymosis.  Follow up information indicated that it could not be definitively confirmed that the vaccine used was the PNEUMOVAX 23.  The patient had a high suspicion that this was the product.  No further information is available.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Lymphadenopathy, Pain
Clinical narrative: Information has been received from a health professional concerning a 59 year old female patient with seasonal allergies and a history of nicotine dependence who on 06-NOV-2007, was vaccinated IM into the left arm with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 655501/1035F). Concomitant therapy included influenza virus vaccine (unspecified) also administered into the left arm, triamcinolone acetonide (NASACORT AQ) and varenicline tartrate (CHANTIX). The next morning (reported as 06-NOV-2007), the patient experienced severe pain at the injection site, overall body aches and swollen glands. The patient was treated with acetaminophen (+) hydrocodone bitartrate (LORTAB) and cool compresses to the sites. No laboratory diagnostic studies were performed. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 75 year old male with hypertension, arthritis, atrial fibrillation and hypothyroidism and with a recent history of shingles, gout and no drug allergies, who on 20-OCT-2007 was vaccinated intramuscularly with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot# 651331/0577R). Concomitant vaccinations included influenza virus vaccine (unspecified). Concomitant therapies included COUMADIN, INDOCIN, LYRICA, LIDODERM, VALTREX. On 21-OCT-2007 the patient experienced fever, injection site soreness, body aches, and felt very ill. The patient was treated with TYLENOL, MOTRIN, hydrocodone, and cool compresses to the injection site. The patient was seen in the office. No laboratory diagnostics were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a health professional concerning a female (age Unknown), who on 02-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 02-NOV-2007 the patient developed a large lump on her arm at the injection site. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a health professional concerning a 60 year old white female who 02-JUL-2007, was vaccinated intramuscularly on the left side with a first dose of pneumococcal 23v polysaccharide vaccine (lot 655592/1175F). Subsequently, the patient developed a bad rash at injection site. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Information has been received from a health professional concerning a 67 year old white female with hyperlipidaemia and no illness at the time of vaccination who on 29-JUN-2007 was vaccinated in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 655592/1175F). On 29-JUN-2007 the patient developed pain and rash at the injection site lasting 4 to 5 days. Subsequently, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old female who on 30-OCT-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (lot # "0099U") and concomitantly was vaccinated with influenza virus vaccine (unspecified). It was reported that the patient experienced soreness and pain up her arm but not at the injection site, with a rash or redness of the blood vessels of her hands and wrists. She was treated with ibuprofen and ice. It was not known if the patient had received a pneumococcal 23 v polysaccharide vaccine in the past. The patient sought unspecified medical attention by phone. At the time of the report, it was unknown if the patient recovered. The nurse reported on two other patients that experienced adverse events after receiving pneumococcal 23v polysaccharide vaccine (0711USA02461 and 0711USA00610). The patient worked with 45 persons that were vaccinated during a vaccine clinic at their company. A total of 45 persons received the influenza virus vaccine (unspecified) and 12 persons received pneumococcal 23v polysaccharide vaccine. There have been no other adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning about 5 or 6 patients who on approximately 24-SEP-2007 about a month ago, were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced a sore arm, swelling and redness around the injection site. Unspecified medical attention was sought. It is unknown if laboratory diagnostic studies were performed. At the time of this report, the patients outcomes were unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Information has been received from a registered nurse concerning a female who on 30-OCT-2007 was vaccinated intramuscularly with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (lot # "0099U"). Concomitantly the patient was vaccinated with influenza virus vaccine (unspecified). The patient received the influenza virus vaccine (unspecified) and the pneumococcal 23v polysaccharide vaccine in one arm each. It was reported that the patient experienced soreness and pain in her arm, but not at the injection site, with a rash or redness of the blood vessels of her hands and wrists. She was treated with ibuprofen and ice. It was not known if the patient had received pneumococcal 23v polysaccharide vaccine in the past. It was reported that a total of 45 persons who worked together were vaccinated during a vaccine clinic at their company. All patients received the influenza virus vaccine (unspecified) and 12 persons received the pneumococcal 23v polysaccharide vaccine. There have been no adverse symptoms reported. The nurse reported that two other patients had adverse events after receiving the pneumococcal 23v polysaccharide vaccine. (WAES #0711USA00610 and WAES # 0711USA02460). In follow-up the registered nurse stated that the problem that the patient had did not have anything to do with the vaccine. She stated that it was a coincidence that the "two events" occurred in the "shot" time frame. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 65 year old female patient with gastroesophageal reflux disease, hyperlipidaemia, hypothyroidism, atrial fibrillation, drug hypersensitivity to "CODEINE" and drug hypersensitivity to DEMEROL who on 24-JUL-2007 was vaccinated IM into the right arm with a dose of pneumococcal 23v polysaccharide vaccine, lot # 654977/0888F. Concomitant therapy included SYNTHROID, PREVACID, CORGARD, hydrochlorothiazide, LIPITOR, aspirin, ATIVAN, NEXIUM and ACTONEL. The patient called the office "2 weeks ago" to say that she had arm pain since she received the injection. She also had redness and warmth at the injection site after the injection. No other information available at this time. The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a medical assistant concerning a female patient with no known history who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964U). The patient developed redness and inflammation at the injection site> The symptoms appeared either one or two days after the vaccination. It was reported that three patients all received the same vaccination, two females and one male, all from the same lot number and they all developed redness and inflammation. Only one of the three patients recovered from the symptoms. The other two patients are either recovering or unknown. One patient received the flu vaccine along with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964U) on a different arm. No further information is available. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a medical assistant concerning a female patient with no known medical history who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964U). The patient developed redness and inflammation at the injection site. The symptoms appeared either one or two days after the vaccination. It was reported that three patients all received the same vaccination, two females and one male, all from the same lot number and they all developed redness and inflammation. Only one of the three patient's recovered from the symptoms. The other two patients are either recovering or unknown. One patient received the flu vaccine along with pneumococcal 23v polysaccharide vaccine (lot #658555/0964U) on a different arm. No further information is available. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Within 5 to 10 minutes of vaccination, the patient experienced redness, swelling, pain and itchiness. The patient was seen on 07-NOV-2007 and the symptoms had resolved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experience redness, swelling and discomfort in arm that she received the immunization with pneumococcal 23v polysaccharide vaccine. The patient's status was not reported. There was no product quality complaint involved. No further information is available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old male with no relevant medical history reported or illness at the time of vaccination who on 21-MAY-2007 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 655588/0883F). On 21-MAY-2007, the patient experienced pain and swelling at the injection site and erythema from shoulder to elbow for 1 week. Subsequently, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 49 year old female patient who on 12-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658200/0804U). On 12-NOV-2007, the patient experienced cellulitis like reaction. The patient's entire upper arm from shoulder to elbow was red and hot to touch. Unknown medical attention was sought. At the time of report the patient had not recovered. No product quality complaint was involved. This is one of multiple patient report from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female who on 30-OCT-2007 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine, (Lot # "0099U") and concomitantly was vaccinated with influenza virus vaccine (unspecified). It was reported that the patient experienced soreness of the arm, not the injection site, and a fever within hours of receiving the vaccines. The fever had gone to 102 Fahrenheit. She had seen her doctor each day since then. It was reported that the patient also sought medical attention by phone. It was unknown if the patient had received pneumococcal 23v polysaccharide vaccine in the past. The registered nurse reported that two other patients experienced adverse reactions after receiving pneumococcal 23v polysaccharide vaccine (WAES # 0711USA02460 and WAES # 0711USA02461). The patient was vaccinated with a total of 45 persons. They all worked together and were vaccinated during a vaccine clinic at their company. A total of 45 persons received the influenza virus vaccine (unspecified) and 12 persons received the pneumococcal 23v polysaccharide vaccine. There have been no other adverse symptoms reported. In follow-up the registered nurse stated that the problem that the patient had did not have anything to do with the vaccine. She stated that it was coincidence that the two events occurred in the "shot" time frame. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 13-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658673/0990U). Subsequently the patient experienced injection site pain and swelling. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of the multiple patient report from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female in her 30's or 40's who in October 2007, "earlier this week," was vaccinated with pneumococcal 23v polysaccharide vaccine. It was thought that this was the first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date. In approximately October 2007, the patient contacted her physician because she had developed redness, itching, and swelling of her hands as well as a high fever. At the time of reporting, the outcome of the events was unknown. Follow-up information was received from the registered nurse who reported that the patient thought her problem was vaccine related, but further investigation by her physician determined the problem was not vaccine related. It was just a coincidence that she happened to be vaccinated at the time of the problem. No additional information is expected.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Aldolase, Blood creatine phosphokinase increased, Blood creatine phosphokinase normal, Cellulitis
Clinical narrative: Initial and follow-up information has been received from a physician and a licensed practical nurse concerning a 64 year old male with no known drug allergies, hyperlipidemia, gout, gastrooesophageal reflux, nephrolithiasis, Borrelia burgdorferi infection, and "positive" immunoglobulin G and immunoglobulin M in 2000 who on 04-APR-2007 was vaccinated SC in the left arm with 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot #655668/1004P). On 05-APR-2007, at approximately 10:00, the patient developed cellulitis. It was reported that the patient developed erythema and swelling of the distal left arm and forearm. The patient was treated with diphenhydramine HCL and famotidine (MSD). On 10-APR-2007, the patient was seen in the office. At the time, the patient's swelling persisted. On 27-APR-2007, the patient's creatine phosphokinase was noted to be 331. On 05-JUN-2007, the patient's CPK was decreased to 158. On an unspecified date, the patient recovered. A lot check was requested for this vaccine due to the patient's adverse reaction. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. It was also reported that three other patients developed cellulitis after vaccination with pneumococcal 23v polysaccharide vaccine (lot #655668/1004F) (WAES #0704USA01549). No additional information is expected.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her 51 year old father who on 12-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Suspect vaccination included influenza virus vaccine (unspecified) and tetanus toxoid. On 12-NOV-2007 the patient experienced very sore arm and flu-like symptoms. The patient's very sore arm and flu-like symptoms persisted. No further information is available.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash macular, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 71 year old white retired female with osteopenia, hypertension and hyperlipidaemia and no drug reactions/allergies who on 12-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 658074/0803U), 0.5mL, intramuscularly in the right deltoid. Concomitant therapy included LIPITOR, DYAZIDE, calcium (unspecified), vitamin D (unspecified) and baby aspirin. On the evening of 13-NOV-2007, the patient developed red blotches that were warm to the touch all over her shoulders and arm. On 14-NOV-2007, the patient sought medical attention. The physician recommended that the patient ice the area (s) and take ADVIL. As of 14-NOV-2007, the patient had not recovered. The product quality complaint unit was not involved. Follow up information received, stated that the patient was recovered on 19-Nov-2007. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on an unknown date was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced arm pain, redness at the injection site and warmth at the injection site. It is unknown if medical attention was sought. At the time of this report, the patient's outcome was unknown. This is one of 4 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Influenza like illness
Clinical narrative: Information has been received from a Registered Nurse concerning a female who was vaccinated with pneumococcal 23 v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experienced an elevated response and flu-like symptoms. Subsequently, the patient recovered from her experiences. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on an unknown date was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced arm pain, redness at the injection site and warmth at the injection site. It is unknown if medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of 4 reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site bruising, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner and a 62 year old white female registered nurse consumer (220 pounds, 64 inches) with hypothyroidism and high blood pressure and no history of drug reactions/allergies. On 22-OCT-2007, the patient received a first dose of zoster vaccine live (Oka/Merck) (lot # 658081/0743U) in the right arm in the afternoon. On 26-OCT-2007 at the time of being vaccinated, the patient hand no illness. On 26-OCT-2007, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 655499/0988F) subcutaneously in the left arm in the evening. Concomitant therapy also given on 26-OCT-2007 included a 10 plus dose of FLUVIRIN (lot # 86435) given in the right arm about 1:30 PM. Other concomitant therapy included SYNTHROID, ezetimibe (+) simvastatin (MSD), metoprolol, sitagliptin phosphate (MSD), OMACOR, MOBIC, vitamins (unspecified) and niacin. On 27-OCT-2007, in the evening, the patient experienced arthralgia all over her body, nausea and a fever. At the injection site she developed a golf-sized lump that was warm, red and swollen. She was at the nurse's office on 29-OCT-2007 and the morning office manager told her that she had a small bruise at the injection site after getting pneumococcal 23v polysaccharide vaccine. The nurse practitioner also reported that the patient experienced an unspecified local reaction. Subsequently, the patient recovered from the events. Additional information was received from the registered nurse consumer. The patient had also experienced malaise. No diagnostic tests were performed. Subsequently, the patient recovered from the events. No additional information is expected.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Local reaction, Malaise, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner and a 62 year old white female registered nurse consumer (220 pounds, 64 inches) with hypothyroidism and high blood pressure and no history of drug reactions/allergies. On 22-OCT-2007, the patient received a first dose of zoster vaccine live (Oka/Merck) (lot # 658081/0743U) in the right arm in the afternoon. On 26-OCT-2007 at the time of being vaccinated, the patient hand no illness. On 26-OCT-2007, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 655499/0988F) subcutaneously in the left arm in the evening. Concomitant therapy also given on 26-OCT-2007 included a 10 plus dose of FLUVIRIN (lot # 86435) given in the right arm about 1:30 PM. Other concomitant therapy included SYNTHROID, ezetimibe (+) simvastatin (MSD), metoprolol, sitagliptin phosphate (MSD), OMACOR, MOBIC, vitamins (unspecified) and niacin. On 27-OCT-2007, in the evening, the patient experienced arthralgia all over her body, nausea and a fever. At the injection site she developed a golf-sized lump that was warm, red and swollen. She was at the nurse's office on 29-OCT-2007 and the morning office manager told her that she had a small bruise at the injection site after getting pneumococcal 23v polysaccharide vaccine. The nurse practitioner also reported that the patient experienced an unspecified local reaction. Subsequently, the patient recovered from the events. Additional information was received from the registered nurse consumer. The patient had also experienced malaise. No diagnostic tests were performed. Subsequently, the patient recovered from the events. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a patient who was "recently" vaccinated with 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 655592/1175F). Subsequently, the patient experienced redness at the injection site. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 33 year old female patient with a history of asthma, who on 03-Oct-2007, was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient experienced fever and lymphadenopathy and that was lasted for about 3 days. Unknown medical attention was sought. Subsequently the patient recovered from fever and lymphadenopathy. No product quality complaint was involved. This is one of the multiple patients report from the same source. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an physician concerning a female who on 02-NOV-2007 was vaccinated SQ with pneumococcal 23v polysaccharide vaccine (Lot #658447/1132U). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently the patient experienced soreness at the injection site 5 minutes post vaccination. The patient called the office the same day about 1.5 hours post vaccination complaining of soreness and swelling at the injection site. The patient was treated with BENADRYL and cold compresses. On 04-NOV-2007, the swelling had increased in size and the patient went to the ER. The patient was treated with antibiotics for possible cellulitis. The patient was not hospitalized. As of 07-NOV-2007, the patient had not recovered. Follow up information: It was reported that on 02-NOV-2007 at 11:00 the 54 year old female patient developed a large arm, raised area on right arm and continued to swell. The patient went to the emergency room on weekend. The patient recovered on 05-NOV-2007. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female patient with a history of smoking, who on 03-Oct-2007, was vaccinated with 0.5 ml second dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient experienced fever and lymphadenopathy which lasted for about 3 days. Unknown medical attention was sought. Subsequently the patient recovered from fever and lymphadenopathy. No product quality complaint was involved. This is one of the multiple patients report from the same source. Additional information has been requested.