chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, General symptom, Injection site lymphadenopathy
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 2 year old female (also reported as a preemie and 6 year old) who on 15-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# unknown) injection. On an unspecified date the patient developed cellulitis after the vaccine. The physician reported that the patient experienced symptoms 48 hours after the injection was given. It was also reported that the patient was on antibiotics (therapy unspecified) for a swollen lymph node at the injection site. Medical attention was sought. No further information was provided. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested. This is one of two reports from the same source.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) who on 16-OCT-2007 was vaccinated in the right arm with both a dose of PNEUMOVAX 23 (lot # not reported), and a dose of influenza vaccine (manufacturer not specified). After an unknown duration of time, the patient developed redness at the injection site that spread down her arm. On 19-OCT-2007, the patient returned to the office and was diagnosed with cellulitis. Treatment included an injection of ROCEPHIN, and a prescription of LEVAQUIN. On 22-OCT-2007, the patient returned to the office, and was advised to "ice the area." At the time of this report, the outcome of the event was unknown, and additional appointments had been scheduled. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: DTAP, PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 67 year old male who on 11-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# unknown) 0.5mL IM. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot# unknown) at a different site. On an unspecified date, the patient developed pain, swelling and redness at injection site. Medical attention was sought. On an unspecified date the patient recovered from pain, swelling and redness at injection site. No other symptoms were noted. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a 78 year old female with allergies to penicillin, morphine and eggs who was vaccinated (date of vaccination, site and route not reported) with PNEUMOVAX 23 (lot not reported) manufacturer unknown. Post vaccination, subsequently the patient's "arm doubled in size". It is unknown if the patient sought medical attention. Per the nurse the patient had recovered. No further information is available. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female in her 40's who on 25-OCT-2007 was vaccinated with PNEUMOVAX 23 single dose. On an unspecified date "last week" the patient experienced fever, myalgia and redness at injection site. Medical attention was sought via telephone conversation. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested. This is one of two reports from the same source.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on approximately 24-SEP-2007 about a month ago, was vaccinated with a PNEUMOVAX 23. Subsequently, the patient experienced cellulitis in an unspecified area. Unspecified medical attention was sought. It is unknown if 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 has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Local reaction, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 36 year old female who on 11-SEP-2007 was vaccinated subcutaneously (site not reported) with the 1st 0.5ml dose of PNEUMOMAX 23 (lot # 655500/1005F). On 12-SEP-2007 the patient developed a large local reaction at injection site and a low grade fever. The patient received unspecified medical attention on 14-SEP-2007 and recovered on an unspecified date. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 59 year old female who on 22-OCT-2007 was vaccinated with a possible first dose of PNEUMOVAX 23 (lot# 658075/0962U) 0.5mL subcutaneously. On 25-OCT-2007 the patient was seen in the office with a large area of swelling and redness at the injection site. The patient's large area of swelling at injection site and large area of redness at injection site persisted. There was no additional information at this time. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Information has been received from a  nurse concerning a patient (age and gender not reported) who was vaccinated (date of vaccination, site and route not reported) with PNEUMOVAX 23 (lot # not reported). The patient developed a fever, myalgia and redness at injection site post vaccination. It is unknown if the patient sought medical attention and if they recovered. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a patient (age and gender not specified, who on an unknown date was vaccinated with the second dose of PNEUMOVAX (lot # not provided).  Subsequently the patient developed an injection site reaction.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PPV
Symptoms: Crying, Injection site erythema, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a registered nurse, concerning a 9 week old male infant, who on 22-OCT-2007 was vaccinated IM in the upper outer left thigh, with a dose, 0.5ml, of PNEUMOVAX 23 (lot #655499/0988F). Concomitant vaccine therapy included the second dose IM in the right thigh, diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (specified as MSD, but lot # invalid), and the first dose of ACTHIB (lot # UE92899). The nurse stated that product confusion was not an issue, but the vaccination with PNEUMOVAX 23 was the result of human error. Follow up information from the nurse indicated later in the day, at 2:55 p.m., the child was crying, and the vaccination area was red. They physician instructed the caregiver to administer TYLENOL for comfort, and apply cool compresses. On 23-OCT-2007, the infant recovered from the event. Additional information is not expected.
Age: 13.0
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 13 year old female with multiple medical problems who on 06-JUL-2007 was vaccinated with PNEUMOVAX (lot # unknown) injection.  On an unspecified date the patient developed cellulitis after the vaccine.  The physician reported that the patient experienced symptoms 48 hours after the injection was given.  Medical attention was sought.  No further information was provided.  At the time of reporting the patient had recovered.  Follow-up information was received from the physician and stated that this is not a case of cellulitis.  Additional information is not expected.  This is one of two reports from the same source.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a registered nurse concerning a female "65 years or older", who in October 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23. Subsequently, the patient developed swelling that encompassed most of the upper outer arm. The area was red and very painful. The patient had a low grade fever. 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. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female "65 years or older", who in October 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX vaccine.  Subsequently, the patient developed swelling that encompassed most of the upper outer arm.  The area was red and very painful.  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.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a female "65 years or older", who in October 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23. Subsequently, the patient developed swelling that encompassed most of the upper outer arm. The area was red and very painful. 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. Additional has been requested.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discharge, Injection site reaction, Skin lesion
Clinical narrative: Information has been received from a certified medical assistant concerning a 56 year old female with drug hypersensitivity to codeine who on 26-SEP-2007 was vaccinated IM, into the left arm, with a 0.5 ml dose of PNEUMOVAX 23 (lot#655765/0061U). Concomitant therapy included CELEBREX, hydrochlorothiazide, LEXAPRO, XANAX, atenolol and TEKTURNA. On 02-OCT-2007 the patient developed skin lesions at the injection site on the left arm. The area was "quarter sized" and described as an open area with green and yellow drainage. She was seen in the physicians office on 11-OCT-2007 and 23-OCT-2007. The patient was initially treated with KEFLEX. At the time of the report, the patient the area was about the size of a dime and the patient was bring treated with LEVAQUIN. It was reported that the physician would like to be contacted if this was a "bad lot." 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: Pneumonia
Clinical narrative: Information has been received from a physician concerning a patient whose age and gender was no reported, who on an unspecified date was vaccinated with pneumococcal 23v polysaccharide vaccine. The patient developed pneumonia 1-2 years after the immunization. The patient received unspecified medical treatment and the patient's outcome was not reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Oedema peripheral, Pyrexia, Rash
Clinical narrative: Information has been received from a certified medical assistant concerning a 25 year old female with sulfonamide allergy who on 17-OCT-2007 was vaccinated IM, into the left arm, with 0.5 ml dose of PNEUMOVAX (lot #657526/0555U).  Concomitant therapy included CLARINEX, FLONASE, ORTHO TRI-CYCLEN, MSD, ADVAIR and albuterol.  On 18-OCT-2007 the patient developed a rash, fever of 99 F and peripheral edema of the left arm.  On 22-OCT-2007, the patient was seen in the physician's office.  At the time of the report, the patient's outcome was unknown.  It was reported that the physician would like to be contacted if the lot number was a "bad lot."  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: 73.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site swelling, Nervousness, Oedema peripheral
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 73 year old male with large granular leukemia natural killer type, no drug reaction/allergies and a history of a splenectomy who in October 1997 was vaccinated with a first dose of PNEUMOVAX.  On 22-OCT-2007 the patient was vaccinated with a second dose of PNEUMOVAX (lot #654978/0880F) IM in the left arm at 9:30 AM.  On 22-OCT-2007 the patient developed a fever of 104 Fahrenheit, chills, shakes and an injection site reaction.  The patient had swollen arms 6 hours after the injection.  Unspecified medical attention was sought.  On 23-OCT-2007 the patient was doing much better.  On 24-OCT-2007, the patient recovered.  Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 73 year old male with large granular leukemia natural killer type, no drug reaction/allergies and a history of a splenectomy who in October 1997 was vaccinated with a first dose of PNEUMOVAX.  On 22-OCT-2007 the patient was vaccinated with a second dose of PNEUMOVAX (lot #654978/0880F) IM in the left arm at 9:30 AM.  On 22-OCT-2007 the patient developed a fever of 104 Fahrenheit, chills, shakes and an injection site reaction.  The patient had swollen arms 6 hours after the injection.  Unspecified medical attention was sought.  On 23-OCT-2007 the patient was doing much better.  On 24-OCT-2007, the patient recovered.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23.  Subsequently, the patient developed injection site redness and swelling.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Eosinophil count increased, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female with hypothyroidism, penicillin allergy, tremors, gastrooesophageal reflux disease and hyperlipidaemia who on 03-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included NEXIUM, ELAVIL, XOPENEX, LEVAQUIN, SYNTHROID and simvastatin (MSD). On approximately 04-OCT-2007 the patient had extreme pain in the arm at the injection site. The injection site was tender and red. The patient had a 3 inch by 1 inch area that was red. The patient was unable to move her arm. The patient was given TYLENOL. That laboratory data revealed that the patient's eosinophils were elevated. The patient spoke with the pharmacist. At the time of the report the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Syncope
Clinical narrative: Information has been received from a pharmacist (PharmD) concerning a 54 year old male with possible pneumonia who on 03-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 657042/1374U).  Concomitant vaccination included ZOSTAVAX (Oka/Merck) (MSD). Concomitant therapy included heparin, ROCEPHIN and ZITHROMAX.  Within 12-24 hours after PNEUMOVAX 23 was given, the patient experienced pain in the arm at the injection site and down to the elbow.  The patient also fainted 12-24 hours after PNEUMOVAX 23 was given.  It was noted that the patient complained to the nurse.  The patient was treated with TYLENOL.  At the time of this report, the patient was recovering.  This is one of three reports from the same source.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a health care care worker concerning a 75 year old female with no pertinent medical history who in 1999 was vaccinated with a dose of PNEUMOVAX 23. On 18-OCT-2007 the patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot #658075/0962U). Concomitant vaccination on the same day included a influenza virus vaccine (unspecified). On 18-OCT-2007 during the day the patient developed fever and chills, in the evening the patient developed pain at the injection site. the patient called the office. Subsequently the symptoms lasted for 24 hours and resolved on 19-OCT-2007. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 26 year old female who, on an unspecified date, was vaccinated with a dose of PNEUMOVAX 23. Subsequently, on an unspecified date, the patient developed swelling of both arms. It was noted that the patient went to the emergency room. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female with a drug hypersensitivity to DEMEROL who on 19-OCT-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot# 657529/0993U) 0.5 mL IM in the right arm.  Concomitant therapy included influenza virus vaccine (unspecified) in the left arm.  On 20-OCT-2007 "24 hours post vaccination" the patient developed a fever of 101 degrees F, headache, achiness and redness and swelling at the injection site of the right arm.  The swelling at the injection site was the size of a baseball.  Medical attention was sought.  The patient was seen in the office on 22-OCT-2007.  The symptoms were subsiding and the patient was recovering.  The treatment for the patient included comfort measures ice compress as needed.  No other information was given.  No further information is expected.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old female with a drug hypersensitivity to DEMEROL who on 19-OCT-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot# 657529/0993U) 0.5 mL IM in the right arm.  Concomitant therapy included influenza virus vaccine (unspecified) in the left arm.  On 20-OCT-2007 "24 hours post vaccination" the patient developed a fever of 101 degrees F, headache, achiness and redness and swelling at the injection site of the right arm.  The swelling at the injection site was the size of a baseball.  Medical attention was sought.  The patient was seen in the office on 22-OCT-2007.  The symptoms were subsiding and the patient was recovering.  The treatment for the patient included comfort measures ice compress as needed.  No other information was given.  No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Drug administration error, Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning herself on an unspecified date she was accidentally vaccinated with PNEUMOVAX 23 (Lot# not provided) "instead of a TB test". She subsequently developed injection site redness. On an unspecified date she recovered from the events. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 73 year old female patient who on 26-OCT-2007, was vaccinated IM into the right deltoid with a 0.5ml dose of PNEUMOVAX 23 (Lot# 655500/1005F). Concomitant therapy included a dose of FLUVIRIN (Lot# 80062) given IM into the left deltoid. After receiving the vaccine, the patient experienced pain in her left upper arm. It was reported that her pain was 10 on a pain scale with 10 being the most pain and the least amount of pain. Unspecified medical attention was sought. On 01-NOV-2007, the patient recovered. It was also reported that the physician advised when the injection was given a nerve may have been damaged. No product quality complaint was involved. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female who on 23-OCT-2007 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX.  On 25-OCT-2007 the patient complained of arm pain with cellulitis at the injection site.  Unspecified medical attention was sought.  29-OCT-2007 the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23.  Subsequently, the patient experienced an unknown adverse event.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Bacteraemia
Clinical narrative: Information has been received from a physician concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with PNEUMOVAX 23. The patient developed bacteremia after the immunization. The patient received unspecified medical treatment. The patient's outcome was not reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Pain
Clinical narrative: Information has been received from a health professional concerning a patient (age and gender unknown), who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658074/0961U).  Subsequently, the patient developed an injection site reaction.  The patient was instructed to apply ice to the injection site and to treat the pain with TYLENOL or ADVIL.  At the time of the report, the patient's outcome was unknown.  This report is 1 of 3 reports from the same source.  Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a less than 18 month old female who on 05-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23 instead of PREVNAR. There was no adverse event reported. No product quality complaint was involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 53 year old female with hypertension, diabetes mellitus insulin-dependent and goitre who on 03-OCT-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of PNEUMOVAX 23 (lot # 655765/0061U).  Concomitant therapy included unspecified influenza virus vaccine (Novartis) on 03-OCT-2007 administered in the right arm, aspirin, lorazepam, losartan potassium (MSD), SYNTHROID, diclofenac Na, insulin aspart, NOVOLOG MIX 70/30 and LIPITOR.  On 03-OCT-2007 the patient experienced "severe localized reaction" after vaccination with PNEUMOVAX 23.  The site was described as large, red and swollen.  Symptoms were located from the injection site down to the inner aspect of the elbow of the left arm.  The patient was instructed to contact the doctor's office with any symptoms.  On 05-OCT-2007, the patient reported that symptoms improved, using a warm compress.  The site was described as "red".  On 08-OCT-2007, the symptoms resolved.  No laboratory diagnostic tests were performed.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Poor quality drug administered
Clinical narrative: Information has been been received from a pharmacist concerning a patient (age and gender not reported) who was vaccinated with a dose of improperly stored PNEUMOVAX 23. The patient was then revaccinated with a dose of PNEUMOVAX 23. Subsequently the patient experienced an injection site reaction. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Malaise
Clinical narrative: Information has been received from a physician concerning an attorney who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine administered one year after the first dose. The physician received an email which reported that the patient was "very sick" and was taking an unspecified medication for the "illness." At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Arthralgia, Axillary pain, Lymphadenopathy, Myalgia
Clinical narrative: Information has been received from a healthcare professional and a female consumer who was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658075/0962U). After receiving the vaccine, the consumer experienced no appetite, muscle and joint pain, swollen lymph glands and pain in her armpit. It was reported that the patient was put on oral antibiotics. The swelling had gone down and the pain had lessened but had not gone away. It was reported that "presently" she felt "shaky." She still has joint and muscle pain and the pain has lessened but not gone away. No product quality complaint was involved. A lot check has been requested. 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 government and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Nervousness
Clinical narrative: Information has been received from a healthcare professional and a female consumer who was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658075/0962U). After receiving the vaccine, the consumer experienced no appetite, muscle and joint pain, swollen lymph glands and pain in her armpit. It was reported that the patient was put on oral antibiotics. The swelling had gone down and the pain had lessened but had not gone away. It was reported that "presently" she felt "shaky." She still has joint and muscle pain and the pain has lessened but not gone away. No product quality complaint was involved. A lot check has been requested. 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 government and was released. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site mass, Mobility decreased, Muscle injury, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with no medical history or allergies who on 15-SEP-2007, was vaccinated IM into the left arm with a first dose of PNEUMOVAX (Lot# 658075/0962U).  Concomitant therapy included MOTRIN.  After the injection the patient experienced a painful arm that was too sore to move.  The patient reported a lump under the skin at the injection site that was hard to touch.  It was reported that the site did not appear reddened or swollen.  The patient went to the doctor.  No laboratory diagnostic studies were performed.  The patient was taking MOTRIN for the pain and applied ice and warmth to the site without pain relief.  It was reported that the patient is now doing physical therapy and her deltoid muscle was damaged.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information is not expected.
Sex: F
Vaccine: PPV, TTOX
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 in August 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23.  Concomitant therapy included tetanus toxoid.  Subsequently, the patient developed redness at the injection site.  The patient sought unspecified medical attention.  The patient was placed on prednisone.  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.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 55 year old female who on 23-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# 658075/0926U).  There was no concomitant medication.  Subsequently on an unspecified date the patient experienced redness and swelling at the injection site of the upper arm.  It was unknown which arm was vaccinated.  The patient called the office on 25-OCT-2007 and had a follow-up visit the physician in the afternoon.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 66 year old female who on 03-OCT-2007 was vaccinated with PNEUMOVAX (lot# 0658075/0962U) in her upper arm (unknown which arm).  There was no concomitant medication.  On 25-OCT-2007 the patient was seen in the office with redness and swelling at the injection site.  Medical attention was sought.  There was no treatment.  At the time of reporting the patient was recovering.  Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a nurse concerning a 57 year old male with one kidney, renal insufficiency, hypertension, hyperlipidaemia, chronic ployps and drug hypersensitivity to sulfa and SUDAFED who on 24-OCT-2007 was vaccinated intramuscularly in the left arm with his first 0.5ml dose PNEUMOVAX 23 (lot# 657526/0555U). On 24-Oct-2007, the patient was concomitantly vaccinated with influenza virus vaccine (manufacturer unknown) in the right arm. Concomitant therapy included LIPITOR, LOTENSIN, hydrochlorothiazide (manufacturer unknown), aspirin and oxycodone. On the evening of 24-Oct-2007, post vaccination, the patient stated that his arm hurt at bedtime. On 25-Oct-2007, the patient presented to the office. The patient's arm was red and swollen. The doctor stated that the patient's arm had induration, slight calor and erythema. The patient was being treated with KEFLEX 500mg twice a day, BENADRYL and TYLENOL. The patient was to return to the doctor's office if symptoms worsen or did not improve. Additional has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a male patient (age not reported) who was vaccinated (date not reported) subcutaneously with the first 0.5ml dose of PNEUMOVAX 23 (lot# 658074/0961U). Subsequently, the patient developed cellulitis. The patient had an office visit and received medical treatment with unspecified antibiotics and anti-inflammatories. At the time of this report the outcome was unknown. The pharmacist requested a lot check for PNEUMOVAX 23 (lot# 658074/0961U). 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 government and was released. This is one of several reports from the same source. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Injected limb mobility decreased, Injection site nodule, Mobility decreased
Clinical narrative: Information has been received from a 42 year old female consumer allergic to penicillin and many pain medications who was vaccinated (route and site not reported) on 09-OCT-2007 with PNEUMOVAX 23 (lot # 655766/0038U) and FLUVIRIN (Novartis). Concomitant therapy included ZYRTEC, EFFEXOR, and hormonal contraceptives (unspecified). On the evening of 09-OCT-2007, post vaccination, the caller stated she had developed an allergic reaction. Per the patient, her arm swelled up and began getting real red, 2 days later she could barely use the arm because it was very painful. The swelling and redness lasted about 1 week to 10 days. The caller stated that there was still "a knot" at the injection site. The caller stated she had received pneumonia vaccine in the past with no adverse effect. The caller sought unspecified medial attention and stated that her symptoms had improved since they started. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: No reaction on previous exposure to drug, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 42 year old female consumer allergic to penicillin and many pain medications who was vaccinated (route and site not reported) on 09-OCT-2007 with PNEUMOVAX 23 (lot # 655766/0038U) and FLUVIRIN (Novartis). Concomitant therapy included ZYRTEC, EFFEXOR, and hormonal contraceptives (unspecified). On the evening of 09-OCT-2007, post vaccination, the caller stated she had developed an allergic reaction. Per the patient, her arm swelled up and began getting real red, 2 days later she could barely use the arm because it was very painful. The swelling and redness lasted about 1 week to 10 days. The caller stated that there was still "a knot" at the injection site. The caller stated she had received pneumonia vaccine in the past with no adverse effect. The caller sought unspecified medial attention and stated that her symptoms had improved since they started. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 77 year old male with an allergy to sulfonamides and IV dye for allergies and no illness at the time of vaccination who on 24-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# 655501/1035F) 0.5mL in the left arm injection.  On 16-OCT-2007 therapy included influenza virus vaccine (unspecified) (lot# U244AU) in the left arm.  On 25-OCT-2007 the patient experienced soreness in his left arm, red streaks up the arm and redness around the injection site after vaccination with PNEUMOVAX 23.  Medical attention was sought.  Patient was treated with antibiotics (therapy unspecified) with resolution of streaks.  No further information was provided.  At the time of reporting it was unknown if the patient had recovered.  Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male in his late 50's who on an unspecified date was vaccinated with PNEUMOVAX 23 single dose (lot# unknown). On an unspecified date the patient experienced fever, myalgia and redness at injection site. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested. This is one of two reports from the same source.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 73 year old female with osteoporosis and renal insufficiency and a history of hypothyroidism and high blood pressure who the year 2000 was vaccinated with a dose of PNEUMOVAX 23. The patient did not experienced any symptoms after being vaccinated with the first dose of PNEUMOVAX 23. On 27-OCT-2007 the patient was vaccinated intramuscularly in the left arm with a "standard dose " of PNEUMOVAX 23 (lot # 655233/0200U). Concomitant therapy included DIOVAN, FELODIPIN, ACTONEL, vitamin D unspecified, calcium (unspecified) and levothyroxine Na. On 27-OCT-2007 the patient developed an allergic reaction after vaccination. Symptoms began about one hours after vaccination. The patient developed symptoms of pain and swelling at the injection site on the left arm. The site was also "itchy". The worst of the symptoms was dated on Saturday 27-OCT-2007. The patient took aspirin (unspecified brand) for the pain. Follow up information obtained indicated that the now 74 year old patient weighing 123 pounds and with no known allergies, was vaccinated in the left arm with a dose of PNEUMOVAX 23 (lot# 656233/0200U). On 27-OCT-2007 the patient developed erythema, edema, and pain in the left arm. Subsequently the patient recovered. No further information is available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 73 year old female with osteoporosis and renal insufficiency and a history of hypothyroidism and high blood pressure who the year 2000 was vaccinated with a dose of PNEUMOVAX 23. The patient did not experienced any symptoms after being vaccinated with the first dose of PNEUMOVAX 23. On 27-OCT-2007 the patient was vaccinated intramuscularly in the left arm with a "standard dose " of PNEUMOVAX 23 (lot # 655233/0200U). Concomitant therapy included DIOVAN, FELODIPIN, ACTONEL, vitamin D unspecified, calcium (unspecified) and levothyroxine Na. On 27-OCT-2007 the patient developed an allergic reaction after vaccination. Symptoms began about one hours after vaccination. The patient developed symptoms of pain and swelling at the injection site on the left arm. The site was also "itchy". The worst of the symptoms was dated on Saturday 27-OCT-2007. The patient took aspirin (unspecified brand) for the pain. Follow up information obtained indicated that the now 74 year old patient weighing 123 pounds and with no known allergies, was vaccinated in the left arm with a dose of PNEUMOVAX 23 (lot# 656233/0200U). On 27-OCT-2007 the patient developed erythema, edema, and pain in the left arm. Subsequently the patient recovered. No further information is available.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 71 year old female with a sulfonamide allergy and penicillin allergy who on 16-OCT-2007 was vaccinated with a dose of PNEUMOVAX (Lot #655291/0985F).  Concomitant therapy included SYNTHROID.  On 16-OCT-2007 the patient experienced injection site swelling and warmth.  Subsequently, the patient recovered from injection site swelling and warmth on 23-OCT-2007.  No product quality complaint was involved.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female patient with a history of pneumonia "about 2 months ago", who was vaccinated on 03-OCT-2007 with her first dose of PNEUMOVAX 23 (0.5 mL). Subsequently, on an unspecified date in October 2007, the patient experienced elevated fever and lymphadenopathy that lasted for about 3 days. The patient was reported as recovered. Unknown medical attention was sought. No product quality complaint was involved. This is one of the multiple patients report from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has bee received from a pharmacist concerning a female patient (age not reported) who was vaccinated (date not reported) subcutaneously with the first 0.5ml dose of PNEUMOVAX 23 (lot# 658074/0961U). Subsequently, the patient developed cellulitis. The patient had an office visit and received medical treatment with unspecified antibiotics and anti-inflammatories. At the time of this report the outcome was unknown. The pharmacist requested a lot check for PNEUMOVAX 23 (lot# 658074/0961U). A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a female patient (age not reported) who was vaccinated (date not reported) subcutaneously with the first 0.5ml dose of PNEUMOVAX (lot # 658074/0961U).  Subsequently, the patient developed cellulitis.  The patient had an office visit and received medical treatment with unspecified antibiotics and anti-inflammatories.  At the time of this report the outcome was unknown.  The pharmacist requested a lot check for PNEUMOVAX (lot# 658074/0961U).  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.  This is one of several reports from the same source.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 24 year old female patient with no medical history or allergies who on 01-OCT-2007, was vaccinated IM into the right arm with a first 0.5 ml dos of PNEUMOVAX 23 (Lot# 658555/0964U). There was no concomitant medication. On 03-OCT-2007 at 10:00 am, the patient complained of a very painful arm. She stated she was unable to touch it and the pain radiated into her back. She complained of not being able to life her arm. It was reported that the pain resolved on its own with ice and ibuprofen. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Rash
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, of PNEUMOVAX 23 (lot #655290/0959F).  In October 2007, the patient developed "rashes on the trunk."  The patient recovered "within the week" of the vaccination.  The reporter felt that developed rashes on the trunk was related to therapy with PNEUMOVAX 23.  The patient sought unspecified medical attention.  This is one of two reports received from the same source (WAES #0711USA00525) 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, and was released.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female "over 65 years old" who was vaccinated with a dose of PNEUMOVAX (lot # not reported).  Concomitant therapy included influenza virus vaccine (unspecified).  Subsequently the patient experienced 102 degree fever and body aches.  The patient's status was not reported.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) who on 11-OCT-2007 was vaccinated intramuscularly in the right deltoid with the first 0.5 mL dose of PNEUMOVAX 23 (lot # 657529/0993U).  After receiving the first dose of PNEUMOVAX 23 the patient on an unspecified date developed an adverse reaction.  It was reported that it was not known if the reaction was localized or generalized.  There was no product quality complaint involved.  Follow up information obtained on 29-JAN-2008.  The licensed practical nurse reported that the 65 year old female weighing 158 pounds and height of 65 inches and with no known drug allergies and a history of epistaxis, fatigue, menopause and diverticular bleed, developed on approximately 11-OCT-2007 a "red and inflamed around the site of injection".  The patient was treated with BENADRYL and ice pack.  On an unspecified date the patient recovered.  Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) who on 25-OCT-2007 was vaccinated subcutaneously with  0.5 mL dose of PNEUMOVAX 23. On an unspecified date, the patient developed redness, warmth and swelling in the arm which she was vaccinated. The symptoms spread down to her elbow (the elbow was swollen as well). The nurse was unsure if this was the first dose or a booster dose of PNEUMOVAX 23. The patient sought unspecified medical attention as was "told to treat area with an ice pack and BENADRYL 25 mg every 6 hours. The patient's status was not reported. There was no product quality complaint. Following information obtained on 23-JAN-2008. It was reported that on 25-OCT-2007, the 79 year old female patient weighing 79 pounds with a history of hypertension and elevated cholesterol was vaccinated subcutaneously in the right arm with the first dose of PNEUMOVAX 23. On 26-OCT-2007, the patient complaint of her arm being red, warm and swollen down to her right elbow. The patient was treated with BENADRYL oral, 25 mg six times a day and to apply ice to injection site. On an unspecified date the patient recovered. It was also reported that that patient had back/hip pain at time of vaccination. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an 80 year old female (145 lbs., 59 in.) who on 25-OCT-2007 was vaccinated IM with the second dose of PNEUMOVAX (Lot #658200/0804U).  Concomitant therapy included influenza virus vaccine (unspecified) and tetanus toxoid.  Subsequently the patient experienced injection site swelling and injection site redness.  The symptoms went 2 inches passed her elbow.  The patient was treated with ice packs, ALEVE, E-MYCIN and CLARITIN.  As of 31-OCT-2007, the patient was recovering.  Follow-up information reported that the patient received 2 tablets BID with food and erythromycin 333mg, Claritin 10 mg BID, cold pack 20 min 3-4 times a day.  Additional information has been requested.