chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 a patient (age and gender unknown) who on approximately 11-MAR-2008, in the last two days, was vaccinated (route unknown) with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 659149/1383U). On approximately 11-MAR-2008, in the last two days, the patient experienced an injection site reaction. There was a large red area that was swollen and painful. At the time of this report, the patient had not recovered. The reporter is requesting a lot check be done on this lot number. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Mass
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified date was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine (lot # unspecified). It was reported that the "patient developed a softball size lump on their arm after receiving their second shot". Unspecified medical attention was sought. No further information was available. At the time time of this report the outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2008.  Information has been received from a physician concerning a patient who on unspecified date was vaccinated with second dose of PNEUMOVAX (lot # unspecified).  It was reported that the "patient developed a softball size lump on their arm after receiving their second shot".  Unspecified medical attention was sought.  No further information was available.  At the time of this report the outcome was unknown.  No additional information is available.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 78 year old female with high cholesterol, gastrooesophageal reflux disease and degenerative joint and a history of renal artery stent placement who on 03-MAR-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #658673/0990U). Concomitant therapy included atorvastatin calcium (LIPITOR), esomeprazole magnesium (NEXIUM) and alendroanate sodium (MSD). On 06-MAR-2008 (a couple of days later), the patient experienced syncope. The patient was taken to the Emergency Room but it was unknown if the patient was admitted. Subsequently on an unspecified date, the patient recovered from syncope. The discharge papers stated that syncope was related to therapy with pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient (gender and age unknown) who on an unknown date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # unknown). Subsequently, on an unknown date the patient developed a rash. The outcome is unknown. It is unknown if patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no allergies, who on 06-MAR-2008 was vaccinated subcutaneously with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 655291/0985F). On 06-MAR-2008 the patient developed pain at the injection site and flu like symptoms including vomiting. The patient went to the emergency room and was released, but it was not known if the patient received any treatment. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a female patient with no allergies, who on 06-MAR-2008 was vaccinated subcutaneously with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot # 655291/0985F). On 06-MAR-2008, the patient developed redness and warmth at the injection site and body chills. The patient sought unspecified medical attention. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product complaint was involved. This is one of three reports from the same source. 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 health professional concerning a patient who about two weeks ago was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (658450/1380U). On the same day of vaccination, the patient experienced injection site redness, swelling and pain. Unknown medical attention was sought. The patient's was recovered. No product quality complaint was involved. This is one of multiple reports from the same source. Other (WAES# 0802USA02058 and 0802USA05541). 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 health professional concerning a patient who about two weeks ago was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (658450/1380U). On the same day of vaccination, the patient experienced injection site redness, swelling and pain. Unknown medical attention was sought. The patient's was recovered. No product quality complaint was involved. This is one of multiple reports from the same source. Other (WAES# 0802USA02058 and 0802USA05540). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Neuropathy peripheral
Clinical narrative: Information has been received from a physician concerning a patient with no reported medical history, who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included interferon (unspecified). The physician reported that in 2005, the patient experienced neuropathy after receiving pneumococcal 23v polysaccharide vaccine for the second time. The physician reports the patient was given a dose of pneumococcal 23v polysaccharide vaccine and then another dose was given 18 months later. No reaction was reported after the first dose, but the neuropathy occurred after the second dose that was given inadvertently. Unspecified medical attention was sought. At the time of this report the event has not recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a female (age unknown) with a history of bronchitis and allergies to erythromycin and LORTAB, who, on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 25-FEB-2008, the patient was vaccinated intradermally with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 659147/1381U). On 25-FEB-2008, the patient developed redness, warmth and pain at the injection site. The patient was seen at an office visit. No laboratory diagnostics were performed. At the time of the report the patient had not recovered. No product quality complaint was involved. Additional information is not available.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a Medical Assistant concerning a female patient with iodine allergy, allergic reaction to "amoxicillin," drug hypersensitivity to PRILOSEC and CARDEZIUM who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine at an unknown time. The reporter reported that the patient had a "reaction" to the vaccine. She did not know any details of the reaction and had no information about the patient. The outcome was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, White blood cell count normal
Clinical narrative: Information has been received from a 72 year old physician, with an allergy to Sulfa and ("VERAPAMIL"), who in December 2007, was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine. The physician stated that the injection was painful. Subsequently, the physician experienced redness and swelling at the injection site, and the swelling continued to descend below the elbow, and he could not move his arm. Two days later, the physician went to the local emergency room and was treated with dexamethasone sodium phosphate (MSD), 10 mg Intravenously and given an unspecified antibiotic for possible cellulitis. Diagnostic lab studies were performed, indicating white blood count was normal. The physician was not hospitalized. He then had a follow up appointment with a nurse practitioner specializing in Infectious Disease who told him to discontinue taking the antibiotic as he did not have cellulitis. Subsequently, the physician recovered. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Wheezing
Clinical narrative: Information has been received from a health professional concerning a 66 year old female who on 27-FEB-2008 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot #656233/0200U). There was no concomitant medication reported. On 27-FEB-2008, the patient had an injection site reaction after receiving pneumococcal 23v polysaccharide vaccine. She stated that her left arm was swollen from upper shoulder to elbow. She experienced wheezing and went to the emergency room, but was not hospitalized. The physician was requesting a lot check of this vaccine due to patients having adverse experiences. At the time of this report the patient's outcome was unknown. There was no product quality complaint involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site swelling
Clinical narrative: Information has been received from a health care professional concerning a 63 year old male with no medical history reported, who on 13-FEB-2008 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot #656233/0200U). There was no concomitant medication reported. Subsequently, in February 2008, the patient reported an injection site reaction after receiving pneumococcal 23v polysaccharide vaccine. The patient stated that his left arm was swollen from the upper shoulder to the elbow and he experienced "sweating" for 3 days. It was reported that the patient called the physician. No diagnostic studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactoid reaction, Pneumonia
Clinical narrative: Information has been received from a pharmacist concerning a female in her seventies, with no allergies, who on 04-MAR-2008 was vaccinated with her second dose of pneumococcal 23v polysaccharide vaccine. On 04-MAR-2008, the patient experienced an anaphylactoid reaction, which happened shortly after receiving pneumococcal 23v polysaccharide vaccine. It was reported that the patient was currently in the hospital with pneumonia and the anaphylactoid reaction was treated with IV corticosteroids. At the time of this report the patient was recovering and this will not prolong her hospitalization. The patient received her initial pneumococcal 23v polysaccharide vaccine 5 to 6 years ago with no problems. No product quality complaint was involved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from an office manager, physician, and medical assistant concerning a female patient over 50 years old who on 12-FEB-2008 was vaccinated with a dose of pneumococcal 23V polysaccharide vaccine (Lot #658449/0989U) intramuscularly into the deltoid of the left arm. Subsequently, the patient developed redness and swelling at the injection site. The patient recovered from the redness and swelling on an unspecified date. The physician stated that these reactions had not occurred at the office before and would like a lot check of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). This is one of three reports from the same source. One of the patients also received the flu vaccine in the other arm. A standard lot 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. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a consumer, who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown). Subsequently, the consumer developed a rash from the knee down to the ankle. No product quality complaint was involved. At the time of this report the consumer's outcome was unknown. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician and by telephone call to the doctor's office concerning a 70 year old white female patient who on 14-MAY-2007 (previously reported as 19-MAY-2007) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 655289/0958F not reported). On 19-MAY-2007, the patient experienced arm pain at injection site. No evidence of infection reported. The symptoms resolved approximately on 20-MAY-2007. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an adult male with a drug allergy to aspirin and no medical history reported, who on 05-MAR-2008 was vaccinated intramuscularly with a second 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 655501/1035F). The first vaccine was administered on an unspecified date. There was no concomitant medication. On 05-MAR-2008, the patient developed a very sore arm, tiredness and fatigue. The patient sought unspecified medical attention. The patient was told to rest, drink fluids and take TYLENOL. No diagnostic laboratory studies were performed. At the time of this report the patient was recovering. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Information has been received from a 78 year old female consumer, with an allergy to shrimp and no medical history, who either at the "end of January 2008 or beginning of February 2008" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown). Concomitant therapy included alendroanate sodium (MSD), esomeprazole magnesium (NEXIUM), metoprolol succinate (TOPROL XL TABLETS), aspirin (unspecified), pravastatin Na (PRAVACHOL) and zolpidem tartrate (AMBIEN). One day later the consumer experienced terrible chills, a temperature and hands shaking. The consumer sought unspecified medical attention. No diagnostic studies were performed. The consumer also reported that the symptoms she experienced lasted for a few hours before subsiding. Two days after the vaccination the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test, Fatigue, Influenza like illness
Clinical narrative: Information has been received from a 59 year old female with a "long pertinent medical history" and "multiple" drug allergies who on 21-DEC-2007 was vaccinated IM with the first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included "quite a list" of medications. On approximately 22-DEC-2007, the patient experienced flu type symptoms and tiredness. The patient also mentioned that titers were drawn and did not elevate very much after 4 weeks from vaccination. The patient sought unspecified medical attention. Subsequently, the patient recovered from flu type symptoms and tiredness "after a couple of weeks." The patient currently has a staph infection. This is the 8th staph infection in the last 2 years. The patient also has "low IgG subclass." No further information is available. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 71 inch, 190 pound, 67 year old, retired, male who on 11-OCT-2007 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot#635674/0380K), intramuscularly in the left deltoid at 10:07 am. Concomitant therapy included ADACEL (Lot #C2825AA) intramuscularly in the right deltoid on the same day at 10:07 am. On an unspecified date the patient developed pain, edema, and redness at the site for one week. The patient never had a reaction previously. The patient recovered within one week of onset. No further information is available.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old white male. The patient said he did not have any prior adverse reactions. On 04-OCT-2007 the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #657143/0380U) intramuscularly in the left deltoid at 10:00 am. Concomitant therapy included influenza virus vaccine (unspecified) (Lot #AFLLA040AA) (GlaxoSmithKline) intramuscularly in the left deltoid at 10:00 am. One week after the injection, on approximately 11-OCT-2007, the patient reported that he developed redness and pain in the left upper arm, which lasted one week and did not require any other interventions. The patient has recovered. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning "about 4" patients (ages and genders unknown), who, on unspecified dates, were vaccinated with doses of pneumococcal 23v polysaccharide vaccine (lot # 658450/1380U expiration date 28-MAR-2009). Subsequently, the patients experienced redness and swelling at the injection site. The time frame is assumed to be from 24-JAN-2008 to present time. The healthcare worker and wholesaler requested a lot check. No other details were provided. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old male with sulfonamide allergy, who in 2002 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On 12-FEB-2008, the patient experienced pain and developed swelling at the injection site. The patient called the office. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site mass
Clinical narrative: Information has been received from a health professional concerning a male (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 his 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 one of two reports from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a 74 year old male patient with cholesterol levels raised, hypertension and a penicillin allergy, who on 11-FEB-2008 was vaccinated IM in the deltoid muscle, with the first dose of pneumococcal 23v polysaccharide vaccine (lot # 658447/1132U). Concomitant therapy included clopidogrel bisulfate (PLAVIX), doxazosin mesylate (CARDURA), sildenafil citrate (VIAGRA), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and hydrochlorothiazide. On 12-FEB-2008 the patient developed a reaction on the inner aspect of the injection arm, the "reaction area is extremely red and warm to touch." The patient was seen in the office, and treatment included diphenhydramine (BENADRYL). At the time of this report, the patient had not recovered from the events. This is one of 2 reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Injection site discolouration, Injection site induration, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a 60 year old female with a history of asthma and drug hypersensitivity to amoxicillin who on 12-FEB-2008 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine (lot # 658451/0963U). Concomitant therapy included alprazolam, RELAFEN, OMAPREN, VERAMYST, PROAIR HFA and SINGULAIR. On 12-FEB-2008, the patient experienced a large red, swollen area in her upper arm, white area at injection site, injection site hardness, and burning sensation in her arm and swelling extended to under her arm. The patient previously had a local arm reaction after receiving the Flu vaccine. The patient sought medical attention with an office visit. Follow up information obtained for the physician indicated that patient has recovered. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a health professional concerning three patients who on unknown dates were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patients experienced an adverse event. At the time of this report, the patient's outcomes were unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 18-FEB-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot # reported as 1538U). On 18-FEB-2008, the patient developed a "welt" at the injection site. As of the time of this report, the patient's welt at injection site persisted. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a health professional concerning "an unknown number of patient's" who in 2007 were vaccinated with pneumococcal 23v polysaccharide vaccine (Lot # not reported) and developed cellulitis at the injection site. There were no patient specifics provided. A few of the patients my have received the influenza virus vaccine (unspecified) concomitantly. The reporter did not know if the pneumococcal 23v polysaccharide vaccine was the first or second for the patients. The patients sought unspecified medical attention. On an unspecified date, the patients recovered from the injection site cellulitis. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 18-FEB-2008 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot # reported as 0047X). On 18-FEB-2008, the patient developed a "welt" at the injection site. As of the time of this report, the patient's welt at injection site persisted. No additional information was provided. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a male physician, who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently he experienced flu like symptoms and a fever. On an unspecified date the patient recovered. No product complaint was involved. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Initial and follow up information has been received from a physician and a physician's office concerning a 60 year old retired female with a history of allergies to erythromycin, acetaminophen (+) propoxyphene napsylate (DARVOCET), doxycycline (DOXYCLIN, as reported as doxycline). On 07-DEC-2007, between 10 and 10:30 am, the patient was vaccinated subcutaneous in the left arm with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 658450/1380U). On 07-DEC-2007, between 10 and 10:30 am, the patient experienced a site reaction following pneumococcal 23v polysaccharide vaccine. A knot formed and there was swelling, redness and tenderness at the site. Follow up information indicated that the patient stated "having a great deal of pain". The left arm did not appear to be particularly swollen. The patient stated "it hurt to move: move muscle". No relevant diagnostic studies or laboratory tests were performed. Physicial illness at time of vaccination included: hyperlip, GERD, arthritis, and leg pain. In follow up it was reported that the patient recovered on an unspecified date.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Initial and follow up information has been received from a physician and a physician's office concerning a 60 year old retired female with a history of allergies to erythromycin, acetaminophen (+) propoxyphene napsylate (DARVOCET), doxycycline (DOXYCLIN, as reported as doxycline). On 07-DEC-2007, between 10 and 10:30 am, the patient was vaccinated subcutaneous in the left arm with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 658450/1380U). On 07-DEC-2007, between 10 and 10:30 am, the patient experienced a site reaction following pneumococcal 23v polysaccharide vaccine. A knot formed and there was swelling, redness and tenderness at the site. Follow up information indicated that the patient stated "having a great deal of pain". The left arm did not appear to be particularly swollen. The patient stated "it hurt to move: move muscle". No relevant diagnostic studies or laboratory tests were performed. Physicial illness at time of vaccination included: hyperlip, GERD, arthritis, and leg pain. In follow up it was reported that the patient recovered on an unspecified date.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Sleep disorder
Clinical narrative: Information has been received from a 60 year old male consumer with high blood pressure and no allergies or known drug reactions who on 23-NOV-2007 was vaccinated (route and site not reported) with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot#655766/0038U). Concomitant therapy included valsartan (DIOVAN). On 23-NOV-2007, post vaccination, the patient developed pain, sore and sleeping problems. The patient did receive unspecified medical attention. No diagnostic lab test were performed. At the time of this report the patient's pain, sore and sleeping problems had not recovered. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site discolouration, Injection site irritation, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Information has been received from a 52 year old female consumer with penicillin and erythromycin allergies and no pertinent medical history who on 14-NOV-2007 was vaccinated (route not reported) in left arm with a "1ml dose" of pneumococcal 23v polysaccharide vaccine (Batch 657042, lot#1345U). Concomitant therapy included influenza virus vaccine (unspecified). On 14-NOV-2007, post vaccination, the patient experienced pain and a burning sensation on the left arm which was the injection site right after receiving the pneumococcal 23v polysaccharide vaccine. The patient reported that the injection site became swollen, up to half the size of an egg and turned purple, then green and later yellow. This lasted for a week or more. The patient reported that she wakes up at night because her arm hurts and the pain now travels up to her neck. Per patient, to date, the swelling is gone but the pain and burning are still there. The patient did not receive medical attention and no diagnostic lab test were performed. At the time of this report the patient had not removed. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Information has been received from a 52 year old female consumer with penicillin and erythromycin allergies and no pertinent medical history who on 14-NOV-2007 was vaccinated (route not reported) in left arm with a "1ml dose" of pneumococcal 23v polysaccharide vaccine (Batch 657042, lot#1345U). Concomitant therapy included influenza virus vaccine (unspecified). On 14-NOV-2007, post vaccination, the patient experienced pain and a burning sensation on the left arm which was the injection site right after receiving the pneumococcal 23v polysaccharide vaccine. The patient reported that the injection site became swollen, up to half the size of an egg and turned purple, then green and later yellow. This lasted for a week or more. The patient reported that she wakes up at night because her arm hurts and the pain now travels up to her neck. Per patient, to date, the swelling is gone but the pain and burning are still there. The patient did not receive medical attention and no diagnostic lab test were performed. At the time of this report the patient had not removed. Additional information has been requested.
Age: 87.0
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a 87 year old patient (gender not reported) who was vaccinated (date, route, dosage and site not reported) with pneumococcal 23v polysaccharide vaccine (lot# 658074/0961U). Subsequently, post vaccination, the patient experienced "severe injection site reaction". The patient did receive unspecified medical attention and improved. Additional information has been requested.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a 56 year old patient (gender not reported) who was vaccinated (date,route, dosage and site not reported) with pneumococcal 23v polysaccharide vaccine (lot# 658451/0963U). Subsequently, post vaccination, the patient experienced "severe injection site reaction". The patient did receive unspecified medical attention and improved. Additional information has been requested.
Age: 42.0
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a 42 year old patient (gender not reported) who was vaccinated (date, route, dosage and site not reported) with pneumococcal 23v polysaccharide vaccine (lot# 658074/0961U). Subsequently, post vaccination, the patient experienced "severe injection site reaction". The patient did receive unspecified medical attention and improved. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse concerning a 69 year old patient (gender not reported) who was vaccinated (date, route, dosage and site not reported) with PNEUMOVAX (lot #658074/0961U).  Subsequently, post vaccination, the patient experienced "severe injection site reaction".  The patient did receive unspecified medical attention and improved.  Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 54 year old male with a history of pneumonia (twice) and no drug reactions (allergies who on 10-DEC-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown) IM (lot# 658449/0989U) IM. Concomitant therapy included influenza virus vaccine (unspecified) and (therapy unspecified) (ANAFRIL). On "11-OCT-2007" after being administered his first dose of pneumococcal 23v polysaccharide vaccine the patient developed fever and chills. The patient's arm was also sore and swollen. Medical attention was sought. The patient is currently taking ibuprofen hcl (ADVIL). At the time of reporting it was unknown if the patient had recovered. No further information was available. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female with no pertinent medical history or drug reactions/allergies who in 2006 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot# unknown) and did not experience any problems. On an unspecified date, the patient was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently on an unspecified date the patient experienced a reaction that was very red and swollen at the injection site and flu-like symptoms that lasted for 3 days. Medical attention was sought. At the time of reporting the patient had recovered. No further information was available. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a pharmacist concerning 2 patients who on unspecified dates were vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 659148/1382U). On unspecified dates both patients developed cellulitis after vaccination. Medical attention was sought at the urgent care center. At the time of reporting it was unknown if the patients had recovered. The pharmacist had no other information and could not provide answers to AE questions. Follow-up information was received from a registered nurse concerning a 91 year old white female with penicillin allergy and no illness at the time of vaccination who on 17-DEC-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine IM in the left arm at 18:00 PM. On 18-DEC-2007 at 15:00PM the patient experienced swelling, redness and heat at injection site. Dependent swelling was also noted under the injection site at the elbow and significant pain occurred in both areas. The duration was approximately one week. At the time of reporting on an unspecified date the patient recovered. Additional information is not requested.
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning 2 patients who on unspecified dates were vaccinated with pneumococcal 23v polysaccharide vaccine (lot# 659148/1382U). On unspecified dates both patients developed cellulitis after vaccination. Medical attention was sought at the urgent care center. At the time of reporting it was unknown if the patients had recovered. The pharmacist had no other information and could not provide answers to AE questions. Follow-up information was received from a registered nurse concerning a 91 year old white female with penicillin allergy and no illness at the time of vaccination who on 17-DEC-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine IM in the left arm at 18:00 PM. On 18-DEC-2007 at 15:00PM the patient experienced swelling, redness and heat at injection site. Dependent swelling was also noted under the injection site at the elbow and significant pain occurred in both areas. The duration was approximately one week. At the time of reporting on an unspecified date the patient recovered. Additional information is not requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a female in her 30's with asthma who in December 2007 "sometime this week," was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# unknown). Subsequently, on an unspecified date the patient experienced irritation at the injection site, redness and swelling. No further information was provided. Additional information has been requested. This is one of two reports from the same source. Follow-up information has been received from a health professional concerning a 72 year old white female with asthma, penicillin allergy, sulfonamide allergy, drug hypersensitivity to flu serum and allergic reaction to LEVAQUIN who on 11-DEC-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot# "1344U") at 11AM. On 11-DEC-2007, the patient called the office with complaints of swollen red localized reaction. The patient was icing and was to start BENADRYL. On 12-DEC-2007, the patient experienced some swelling but felt better. On 13-DEC-2007, the patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 60 year old female who on 14-NOV-2007 was vaccinated IM into the right deltoid with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658673/0990U). On 16-NOV-2007 the patient came into the office with hot, painful, large swelling at the injection site and she felt dizzy. It was also reported that the patient was improving. The patient sought medical attention. The physician requested a lot check. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pruritus, Yellow skin
Clinical narrative: Information has been received from a 63 year old female consumer, who on 05-DEC-2007 was vaccinated in the arm with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # not reported). On 05-DEC-2007, the patient experienced itching and redness in the arm she received the vaccine in. On 06-DEC-2007, the patient reported her arm swelled to double the size. Subsequently, the patient recovered from itching, redness and the swelling, but at the time of this report (13-DEC-2007), her arm was "a little yellow above the elbow." No further information is available.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician, concerning a 49 year old female patient with breast cancer, who on 07-DEC-2007 was vaccinated, SQ, with the first dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included tamoxifen citrate. On 08-DEC-2007, the patient developed redness and warmth at the injection site. The patient was examined in the office later that day, and the area of redness measured 6 cm but was resolving without requiring medical therapy. No further information was available. This is one of three reports from the same source. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a physician, concerning a 66 year old male patient with a sulfonamide allergy, who on 12-NOV-2007 was vaccinated SQ with a dose, 0.5 ml, of pneumococcal 23v polysaccharide vaccine (lot # 658447/1132U). On 14-NOV-2007 the patient developed redness, warmth and a 5 cm area of induration at the injection site, and was seen in the office. Treatment included levofloxacine (LEVAQUIN), diphenhydramine (BENADRYL), and cold compresses. On 15-NOV-2007, the patient was reexamined and the symptoms had not improved, so clindamycin and methylprednisolone (MEDROL DOSE PAK) were added as therapy. The following day, 16-NOV-2007, the symptoms had improved significantly, and the patient subsequently fully recovered (date not specified). This is one of three cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on 03-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 03-DEC-2007, the patient experienced arm pain, myalgia with full range of motion and trouble sleeping,and subsequently, visited an emergency room. It was unknown if the patient was hospitalized. The patient was treated with TYLENOL and naproxen without relief. At the time of this report, the patient was not recovered. Additional information has been requested.
Age: 0.08
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 4 week old patient who was vaccinated with pneumococcal 23v polysaccharide vaccine by mistake. No other information was available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Malaise, Urticaria
Clinical narrative: Information has been received from a physician concerning a 66 year old female who has had "hives from something in caffeine free coke" and a reaction to an allergy shot, who on 19-DEC-2007 was vaccinated with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included MAXIDE, PRILOSEC, ZYRTEC, NASONEX and "aspilin." On 19-DEC-2007, the patient reported that a 5 inch part of her arm turned to beet red and welts after receiving the vaccination. The patient also felt warmth and was not feeling good. Subsequently, the patient recovered about 3-4 days later. She sought unspecified medical attention. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: Information has been received concerning a 79 year old female with penicillin allergy, drug hypersensitivity to codeine, drug hypersensitivity to acetaminophen (+) oxycodone hydrochloride (PERCOCET), diabetes and hyperlipidaemia who on 07-FEB-2008 was vaccinated intramuscularly into the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # reported as "1417U"). It was reported that the patient's "left arm began to hurt the same day in the afternoon (1:00 pm). The patient was not able to lift arm. Later that night, arm was still hurting. The sheet of her bed hurt to lay on her arm. Patient described the pain as being constant. Pain continued for the rest of the week. Patient took acetaminophen (TYLENOL) but that didn't help relieve pain." It was reported the patient recovered from the pain in the left arm on 10-FEB-2008. It was reported that the patient was "in for flu to blood pressure check." Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health care professional concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine, lot # 659083/1418U. Subsequently, the patient experienced reaction around the injection site extended to forearm. The outcome was unknown. The health care reporter has requested for a lot check for this report. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from an office manager, physician, and medical assistant concerning a female over 50 years old who on 31-JAN-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U) intramuscularly in the deltoid of the left arm. Subsequently, the patient developed redness and swelling at the injection site. The patient recovered from the redness and swelling on an unspecified date. The physician stated that these reactions had not occurred at the office before and would like a lot check for pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). This is one of three reports from the same source. One of the patients also received the flu vaccine in the other arm. A standard lot 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. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on an unknown date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On an unknown date, an unspecified adverse event occurred. At the time of this report, the patient's outcome was unknown. Additional information has been requested.