chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female with asthma and allergy to "NSAID", sulfa allergy, tetracycline, CECLOR, Fentanyl patch and REGLAN who on 15-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 vaccine (lot # 663888/0627Y), 0.5 ml, intramuscularly. Concomitant therapy included FLONASE. On 15-SEP-2009 the patient experienced an injection site reaction after receiving the vaccine. The injection site has been painful and swollen. The patient also had fever. The patient claimed that she had been getting PNEUMOVAX 23 vaccine every 5 years. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Full blood count, Injection site rash, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 16-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 vaccine (lot# 662785/1124X) intramuscularly. There was no concomitant medication. "12 hours after the vaccination", the patient developed rash and hives around the injection site. The patient also had fever of 103 degrees F, shaking, chills and tired. The patient was seen by the nurse. "Complete Blood Count test was performed and the WBC value was 12,400". At the time of the report, the patient was recovering. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tremor, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 16-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 vaccine (lot# 662785/1124X) intramuscularly. There was no concomitant medication. "12 hours after the vaccination", the patient developed rash and hives around the injection site. The patient also had fever of 103 degrees F, shaking, chills and tired. The patient was seen by the nurse. "Complete Blood Count test was performed and the WBC value was 12,400". At the time of the report, the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: PNC
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacy student concerning an adult male patient who on 17-SEP-2009 was vaccinated with a dose of PREVNAR (manufacturer unknown) instead of a dose of PNEUMOVAX 23. Subsequently there were no adverse effects reported. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a female consumer who on approximately 10-SEP-2009, "a week ago" was vaccinated with a third dose of PNEUMOVAX.  The next day on approximately 11-SEP-2009 the patient started experiencing swelling of the arm, redness and warmth.  By the evening her whole top of the arm was swollen and painful.  After couple of days the patient recovered.  This was her third time she was vaccinated with a pneumonia vaccine.  The other two times were years ago and she did not remember if she had any adverse reactions to them.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a 0.5mL dose of PNEUMOVAX 23. After vaccination, the patient developed a "cellulitis type" reaction on her arm at the injection site. Additional information has been requested. This is one of several reports from the same source.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Mobility decreased, Skin warm, Vomiting, X-ray
Clinical narrative: Information has been received from a consumer concerning his 67 year old wife with allergic reactions to CIPRO and sulfa and no pertinent medical history who was vaccinated with the first dose of PNEUMOVAX 23 (lot number reported as 665763/1296Y, invalid for PNEUMOVAX 23 but is a valid lot number for VARIVAX (Merck) (MSD)) "at least 5 years ago". On 16-SEP-2009 at 10:00 AM the patient was vaccinated with the second 0.5mL dose of PNEUMOVAX 23 IM. Concomitant vaccination administered on the same day included influenza virus vaccine (manufacturer unknown). Other concomitant therapy included SYNTHROID and ALTACE. At the time of the vaccination, the patient experienced pain at the injection site, but assumed that it was from paving the vaccine injected. About two hours later, she had "extreme pain" at the injection site. The pain on a scale of 1 to 10, was rated as a 12. On 16-SEP-2009 the patient went to an unspecified clinic and was given DILAUDID (description unknown) for the pain, but it was not effective. A nurse at the clinic said that the injection site was given too high up on the arm. On the morning of 17-SEP-2009, the patient went to the ER at the hospital. The patient could barely move her arm and her arm was hot to the touch. At the hospital she was given TORADOL (description unknown) for the pain. It was noted that the patient had also been vomiting (17-SEP-2009), "but that may be from the TORADOL." A x-ray test was performed (results not reported). At the time of the report, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a HIV patient who was vaccinated with PNEUMOVAX 23 and had more of a swollen arm and fever than normal.  The patient had sought unknown medical attention.  At the time of report the patient's status was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning herself who on 18-SEP-2009 was inadvertently vaccinated with a dose of PREVNAR (manufacturer Wyeth) instead of PNEUMOVAX 23.  No adverse symptoms reported.  At the reporting time the outcome was unknown.  Follow up information has been received from the physician reported that she was actually given a dose of PREVNAR (manufacturer Wyeth) inadvertently.  The reporter noted that she would be vaccinated with a dose of PNEUMOVAX 23 in a few months.  No further information is available.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: Information has been received from a female patient who in 2001 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). The patient developed a rash at the injection site of the right upper arm immediately after the vaccination of PNEUMOVAX 23. She also developed a rash at the injection site of the left upper arm immediately after the vaccination of "influenza virus vaccine" (manufacturer unknown) on the same day. There were no labs and diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: No reaction on previous exposure to drug, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an 84 year old female with asthma and a history of hypertension hypothyroidism, bladder neoplasm and lymphoma, who on 17-SEP-2009 was vaccinated with her third dose of PNEUMOVAX 23 (lot # 663486/0507Y). She received 2 previous PNEUMOVAX 23 vaccines many years ago with no problem. On 17-SEP-2009 after the third vaccination, the patient developed what was described as "more of a reaction than you would expect". She had severe pain and swelling in her injection arm. It was reported as a 7 out 10 on a pain scale. She could barely move her arm. She self treated with TYLENOL and ice and it resolved within 48 hours. The patient went to office for medical attention. The reporter would like a lot check. Follow up has been received from a registered nurse through a telephone call indicating that the patient called the physician and complained of severe pain and swelling, and she could barely move her arm. The patient was treated with TYLENOL and warm compresses. The patient recovered. Follow up has been received from a registered nurse concerning an 84 year old female with a history of hypothyroidism, asthma, hypertension and osteoarthritis, lymphoma, aneurysm and no illness at time of vaccination, who on 17-SEP-2009 at 2:58 PM was vaccinated with her third dose of PNEUMOVAX 23 (lot # 663486/0507Y) IM in the left arm. She has received 2 doses of PNEUMOVAX 23 vaccines in past and never had reaction. Concomitant therapy included the first dose of influenza virus vaccine (Sanofi Pasteur, lot # U3199AA) IM in the right arm on 17-SEP-2009 at 2:58 PM. ON 18-SEP-2009 the patient experienced pain and swelling. Her left arm hurt when moved. She was using TYLENOL and ice for treatment. The patient recovered on an unknown date. A standard lot check investigation has been finalized. 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. No further information is available.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Movement disorder
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old female patient with a history of cerebral artery occlusion and pneumonia who on 15-SEP-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663486/0507Y). Subsequently, the patient experienced pain, redness and swelling. It was reported that the patient received the vaccine because she had pneumonia a few months ago. The nurse stated that the patient developed "more of a reaction than you would expect". The office would like a lot check on lot# 663486/0507Y. Follow-up information has been received from a registered nurse who provided the patient's name and date of birth. It was reported that on 15-SEP-2009, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663486/0507Y). The patient complained of swelling, redness and pain. The patient was treated with "ADVIL and heat". The patient was not hospitalized. The registered nurse stated that the patient's adverse events were not considered life-threatening and not considered disabling. At the time of the report, the patient recovered. 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. Follow-up information has been received from a registered nurse concerning a 42 year old female patient with no illness at the time of vaccination who on 15-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 663486/0507Y) in the right upper arm. Concomitant vaccination administered on the same day included a dose of FLUZONE (lot# U3199AA) in the left upper arm. Subsequently, the patient experienced pain, redness and swelling in the right upper arm, which lasted for 4-5 days. It was hard to move his arm. There were no relevant diagnostic tests performed. At the time of the report, the patient recovered. Additional information is not expected. This is one of several reports from the same source.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old female patient with a history of cerebral artery occlusion and pneumonia who on 15-SEP-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663486/0507Y). Subsequently, the patient experienced pain, redness and swelling. It was reported that the patient received the vaccine because she had pneumonia a few months ago. The nurse stated that the patient developed "more of a reaction than you would expect". The office would like a lot check on lot# 663486/0507Y. Follow-up information has been received from a registered nurse who provided the patient's name and date of birth. It was reported that on 15-SEP-2009, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663486/0507Y). The patient complained of swelling, redness and pain. The patient was treated with "ADVIL and heat". The patient was not hospitalized. The registered nurse stated that the patient's adverse events were not considered life-threatening and not considered disabling. At the time of the report, the patient recovered. 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. Follow-up information has been received from a registered nurse concerning a 42 year old female patient with no illness at the time of vaccination who on 15-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (lot# 663486/0507Y) in the right upper arm. Concomitant vaccination administered on the same day included a dose of FLUZONE (lot# U3199AA) in the left upper arm. Subsequently, the patient experienced pain, redness and swelling in the right upper arm, which lasted for 4-5 days. It was hard to move his arm. There were no relevant diagnostic tests performed. At the time of the report, the patient recovered. Additional information is not expected. This is one of several reports from the same source.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning an employee who was vaccinated with a dose of PNEUMOVAX 23.  Subsequently last year, the patient developed cellulitis.  At the time of the report, the patient's status was unknown.  Follow-up information has been received from a registered nurse who reported that the patient had recovered.  The health care professional contacted during telephone follow-up could not supply the following information:  dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event and hospital name (if applicable).  Additional information has been requested.  This is one of several reports from the same source.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Information has been received from a medical assistant concerning a female patient (date of birth unknown at time of report) with an extensive unspecified medical history, including allergic to flu shot in the past, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 663889/0632Y). Subsequently the patient had a very red arm after vaccination. The patient went to office for medical attention. At the time of the report, the patient was not recovered. It was reported that the patient sees an allergy specialist. The office requested a lot check. Information has been received indicating the 63 year old patient had experienced localized redness 9 days after vaccination with a dose of PNEUMOVAX 23. A standard lot check investigation has been finalized. 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. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who was vaccinated with PNEUMOVAX 23 (no lot number provided).  Subsequently the patient experienced a hot, red, golf ball sized injection site swelling.  The patient recovered on an unspecified date.  The patient sought unspecified medical attention.  No further information is available.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 70 year old female patient who "about four years" ago, in approximately 2005, was vaccinated with PNEUMOVAX 23 vaccine. It was reported that "about two weeks ago", on approximately 18-SEP-2009, the patient received a booster 0.5 mL dose of PNEUMOVAX 23 vaccine and experienced increased injection site reactions like swelling, pain and asthenia. The patient sought medical attention by a call to the physician's office. The outcome of the patient was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician and a nurse concerning a patient who on an unspecified date was vaccinated with standard dose injection of PNEUMOVAX 23 (lot number not reported). Subsequently the patient developed a local site reaction and experienced a lot of pain and redness on the injection site. Unspecified medical attention was ought. On an unspecified date the patient recovered. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old female who on 05-OCT-2009 was inadvertently vaccinated with a dose of PREVNAR instead of PNEUMOVAX 23. The reporter indicated that the registered nurse who inadvertently administered the wrong vaccine was not as familiar with the immunization to realize that there were 2 different pneumonia vaccines. Follow up information has been received from a registered nurse concerning a 66 year old female with sulfa allergy and no illness at time of vaccination, who on 05-OCT-2009 was vaccinated with a first dose of PREVNAR (lot # P87186) instead of PNEUMOVAX 23 in the right deltoid. There were no labs and diagnostic tests performed. No adverse effects were reported. Follow up information has been received from a registered nurse indicating that the patient on 05-OCT-2009 was vaccinated with a first dose of PREVNAR (lot # D87186) IM in the right deltoid. The patient did not received any Merck vaccines and did not have any adverse event. No further information is available.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site mass, Injection site streaking, Oedema peripheral, Pain
Clinical narrative: Information has been received from a 40 year old female with "mild asthma" who was vaccinated with a dose of PNEUMOVAX 23 vaccine. There was no concomitant medication. After getting the vaccine, the patient's arm swelled so it looked like she had another muscle on the top of her muscle. She had lumps and bumps on a 4" x 4" area at the injection site. There as a "dull red streak" on her arm. She had a fever of 102, chills, bodyaches. On 04-OCT-2009 the patient recovered. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 40 year old female with "mild asthma" who was vaccinated with a dose of PNEUMOVAX 23 vaccine. There was no concomitant medication. After getting the vaccine, the patient's arm swelled so it looked like she had another muscle on the top of her muscle. She had lumps and bumps on a 4" x 4" area at the injection site. There as a "dull red streak" on her arm. She had a fever of 102, chills, bodyaches. On 04-OCT-2009 the patient recovered. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 53 year old female with a history of pneumonia in early 2008 who in April 2008, was vaccinated with a dose of PNEUMOVAX 23 vaccine. On 30-SEP-2009 the patient received another dose of PNEUMOVAX 23 vaccine (0.5ml, IM, lot# 662874/1125X) in her left arm. There as no concomitant medication. On 01-OCT-2009 the patient developed redness, warmth and tenderness of her upper left arm. The patient sought medical attention. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Cough, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 vaccine (lot number 663888/0627Y or 662599/1076X). The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 vaccine ranging from fevers of 102F to 103F and cellulitis." Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 vaccine was given". At the time of the report the patient's outcome were not reported. The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital. The other patients sought medical attention at the physician's office. Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 vaccine that caused patient reactions in the office. Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 vaccine in the past but had never had reactions such as this in their office". Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 vaccine (Lot number not specified). On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23 vaccine. This is one of several reports received from the same source.
Sex: U
Vaccine: PPV
Symptoms: Respiratory tract congestion
Clinical narrative: Information has been received from a certified medical assistant concerning 12 patients who on an unknown date were vaccinated with a dose of PNEUMOVAX 23 vaccine (lot number 663888/0627Y or 662599/1076X). The certified medical assistant reported that the 12 patients had "reactions to PNEUMOVAX 23 vaccine ranging from fevers of 102F to 103F and cellulitis." Some patients had "cold like symptoms including muscle aches, fever, cough and congestion, starting the day after the PNEUMOVAX 23 vaccine was given". At the time of the report the patient's outcome were not reported. The certified medical assistant stated that 4 patients went to the emergency room and were placed on IV antibiotics but were not admitted to the hospital. The other patients sought medical attention at the physician's office. Follow up information was received from the medical assistant who stated that would like to return PNEUMOVAX 23 vaccine that caused patient reactions in the office. Nurse stated "she understands that routine reports had been noted with PNEUMOVAX 23 vaccine in the past but had never had reactions such as this in their office". Follow up information has been received from a nurse who reported that a patient who on unknown date was vaccinated with a dose of PNEUMOVAX 23 vaccine (Lot number not specified). On an unspecified date, the patient had adverse reactions to PNEUMOVAX 23 vaccine. This is one of several reports received from the same source.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female patient who in 2008 (reported as last year) was vaccinated with a dose of PNEUMOVAX 23 (dose and lot number not reported) with no problem. On 17-SEP-2009, the patient was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX 23 vaccine (LOT# 663152/0024Y). Concomitant vaccination on the same day included a dose of influenza virus vaccine (unspecified) (manufacturer unknown) in the other arm with no problem. Subsequently, after the patient received the dose of PNEUMOVAX 23 vaccine on 17-SEP-2009, she developed severe pain at the injection site. Unspecified medical was sought, but the patient did not want to see a physician. It was unspecified if lab studies were performed. At the time of the report, the patient still experienced pain but it was milder in intensity. The pharmacist requested a lot check. A lot check has been initiated. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: Information has been received from an 80 year old female consumer who in August 2009, was vaccinated with a dose of PNEUMOVAX 23.  After the vaccination, the patient had a severe allergic reaction with hives and swelling throughout her body.  Unspecified medical attention was sought.  The patient was given PREDNISONE for the allergic reaction.  At the time of the report, the patient's outcome was unknown.  No further information is available.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injected limb mobility decreased, Nasopharyngitis, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not provided).  It was reported that the patient was seen in the office on 25-SEP-2009 with complaints of cold symptoms with a cough.  The patient also complained that the arm where she received the vaccine was sore and swollen and she had trouble moving her arm.  The registered nurse was not sure where the patient received the vaccine.  It was unknown if the patient recovered.  The health care professional contacted during telephone follow-up could not supply the following information:  dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event and hospital name (if applicable).  Additional information has been requested.  This is one of several reports from the same source.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female patient who was vaccinated on unspecified date with PNEUMOVAX 23 vaccine. The pharmacist reported that the patient developed redness and swelling on her arm at the injection site after receiving the vaccine. The patient has sought unspecified medical attention. At the time of this report, the patient's outcome was unspecified. No further information is available.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test abnormal, Antibody test negative
Clinical narrative: Information has been received from a physician concerning an approximately 5 year old female patient with Down's syndrome and a lot of respiratory problems who in approximately April 2009 ("4 to 5 months ago"), was vaccinated with the first dose of PNEUMOVAX 23.  In approximately May 2009 ("1 month later"), the titer was done which showed the patient was not immune.  At the time of reporting, the outcome was unknown.  It is unknown if the patient sought medical attention.  Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site urticaria, Myalgia, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male patient with amoxicillin allergy and a history of osteosarcoma s/p chemotherapy who on 26-SEP-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 IM into his left upper arm (lot # 661527/0112Y). On the same day, the patient also received a dose of FLUZONE in the left upper arm about 1 inch from the injection site of PNEUMOVAX 23. Later that night on 26-SEP-2009 the patient developed fever of 103-104 F and myalgia. The patient then developed soreness and an urticarial rash 5 cm distal to the injection site of the left upper arm. The patient also experienced emesis. On 29-SEP-2009, the patient was seen in the office. At that time, the patient was afebrile, while taking TYLENOL, and the urticarial rash had progressed but was still localized. The patient was scheduled for a follow up office visit on 30-SEP-2009. No lab or diagnostics studies were performed. At the time of reporting, the patient's adverse events persisted. Additional information has been requested.
Sex: F
Vaccine: DTAP, PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female patient "in her 40s" who "last week", on approximately 23-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23. The lot number was not available. Concomitant therapy included a dose of DTAP (manufacturer unspecified) and COUMADIN. The patient experienced serious swelling and redness in her arm and a temperature of 102 degrees after vaccination. On an unspecified date, the patient saw the physician. There were no lab studies performed. At the time of the report, the outcome of the patient was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Cough, Pneumonia
Clinical narrative: Information has been received from a 70 year old female consumer with a previous reaction to sulpha and penicillin (unspecified) who in approximately 2005 (also reported as about 4 years ago) was vaccinated with a single dose injection of PNEUMOVAX 23 (manufacturer unknown) (lot number not reported).  On 07-SEP-2009 (also reported as "recently") the patient started coughing really badly.  The patient went to ER where she was told that it looked like beginning of pneumonia.  The patient was prescribed antimicrobial (unspecified) and stated that she was fine.  She also mentioned that she had no fever and was feeling fine except for the cough.  On approximately 14-SEP-2009 (also reported as about a week later) the patient recovered.  No further information is available.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old male patient with hypertension and no known allergies who on 30-SEP-2009 was vaccinated IM in the right arm with a dose of PNEUMOVAX 23 (lot number 663889/0632Y). Concomitant therapy on the same day included a dose of influenza virus vaccine (unspecified) (manufacturer unspecified) in the left arm. On 30-SEP-2009 the patient experienced shivering, swelling at injection site on right arm and low grade fever. The patient saw the pharmacist in the pharmacy. There were no lab studies performed. The patient was treated with TYLENOL and BENADRYL which seemed to help with the symptoms. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning an 87 year old female patient in a nursing home with anaemia being treated with PROCRIT from time to time by a hematologist and no known allergies who in September 2009 was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported). The pharmacist was unsure if this was the first dose or revaccination dose. Concomitant therapy included hydrochlorothiazide (manufacturer unspecified), SPIRIVA, SYNTHROID, glipizide ER, calcium (unspecified), vitamin D (unspecified), docusate Na, lorsatan potassium(MSD), COREG, furosemide, magnesia [milk of] and insulin. On the same day of vaccination the patient had significant arm pain. The patient developed cellulitis within 2 days of vaccination. On an unspecified date, the patient recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female patient with asthma and no known allergies who in 2008, about 1.5 years ago was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported).  On 29-SEP-2009 the patient was vaccinated with the second of PNEUMOVAX 23 (lot number 663888/0627Y).  There was no concomitant medication.  In the morning of 30-SEP-2009, the patient began to vomiting and the vomiting has recovered by the evening.  The patient called the office.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Fluid retention, Hyperaesthesia, Malaise, Soft tissue infection
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female with a cardiac history (unspecified) and no drug allergies who on 24-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (LOT# 663889/0632Y). Concomitant vaccination included a dose of FLUZONE in same arm as PNEUMOVAX 23 about an inch apart on the same day. On 26-SEP-2009 the patient experienced a reaction after receiving vaccine. The patient had fluid in the tissue above her shoulder, her neck area showed soft tissue swelling and was "jelly like and tender", legs was sensitive to the touch and just didn't feel right. The patient was placed on doxycycline. The patient was not recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness, Ultrasound scan normal
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female with a cardiac history (unspecified) and no drug allergies who on 24-SEP-2009 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (LOT# 663889/0632Y). Concomitant vaccination included a dose of FLUZONE in same arm as PNEUMOVAX 23 about an inch apart on the same day. On 26-SEP-2009 the patient experienced a reaction after receiving vaccine. The patient had fluid in the tissue above her shoulder, her neck area showed soft tissue swelling and was "jelly like and tender", legs was sensitive to the touch and just didn't feel right. The patient was placed on doxycycline. The patient was not recovered. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Bed bug infestation, Confusional state, Dyspnoea, Fatigue, Headache
Clinical narrative: Information has been received from a medical assistant concerning a 47 year old female patient, who "3 weeks ago", in approximately 25-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and product lot unspecified). There was no concomitant medication, pertinent medical history and drug reactions/allergies. The patient developed hives, shortness of breath, soreness at the injection site, redness at the injection site and headaches after receiving PNEUMOVAX 23. The patient also complained of being confused and tired. At the time of the report the patient was recovering. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Follow-up information has been received from a physician. It was reported that the patient was diagnosed with bed bugs. Per the patient's allergist, these adverse events were not a reaction to the vaccine. No further information is available.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 47 year old female patient, who "3 weeks ago", in approximately 25-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and product lot unspecified). There was no concomitant medication, pertinent medical history and drug reactions/allergies. The patient developed hives, shortness of breath, soreness at the injection site, redness at the injection site and headaches after receiving PNEUMOVAX 23. The patient also complained of being confused and tired. At the time of the report the patient was recovering. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Follow-up information has been received from a physician. It was reported that the patient was diagnosed with bed bugs. Per the patient's allergist, these adverse events were not a reaction to the vaccine. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injected limb mobility decreased, Injection site reaction, Oedema peripheral
Clinical narrative: Information has been received from a patient who is a nurse, who "a few years ago" was vaccinated intramuscularly with a dose of 0.5 ml of PNEUMOVAX 23. The patient reported she experienced an injection site reaction when she received PNEUMOVAX 23. She was given the dose intramuscularly and she could not lift her arm within a few hours after receiving the dose. Her arm was red, very swollen and painful in the front of her arm near the bicep not exactly where she received the vaccine. The day after vaccination she ran slight fever and was tired. The patient recovered in a few days. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a patient who is a nurse, who "a few years ago" was vaccinated intramuscularly with a dose of 0.5 ml of PNEUMOVAX 23. The patient reported she experienced an injection site reaction when she received PNEUMOVAX 23. She was given the dose intramuscularly and she could not lift her arm within a few hours after receiving the dose. Her arm was red, very swollen and painful in the front of her arm near the bicep not exactly where she received the vaccine. The day after vaccination she ran slight fever and was tired. The patient recovered in a few days. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Axillary mass, Body temperature increased, Erythema, Swelling
Clinical narrative: Information has been received from a nurse concerning a female patient with diabetes who on 14-SEP-2009 was vaccinated with the second dose of PNEUMOVAX 23, 0.5ml SC in left arm.  The nurse reported the patient received the first dose in approximately SEP-2004.  Concomitant therapy included influenza virus vaccine (unspecified) received on 14-SEP-2009 which was given at a separate site.  The nurse reported that on the evening of 14-SEP-2009, the patient developed an axillary knot.  The patient was seen in the office on 15-SEP-2009 and had a temperature of 101.3 degrees F which started on 15-SEP-2009.  She developed an irregular shaped red raised patch in front of the injection site but not exactly at site.  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: 50.0
Sex: F
Vaccine: PPV
Symptoms: Allergy test positive, Biopsy skin normal, Blister, Blood immunoglobulin E increased, House dust allergy
Clinical narrative: Information has been received from a 51 year old female consumer, allergic to penicillin, who on 27-Jul-2006 was vaccinated with a dose of PNEUMOVAX 23. "Around" September 2006 the patient developed an itchy rash that started on her neck, and since she scratched the rash, it later became a blister. The rash then went from her neck, down across her chest, back up her shoulder and down her back over, her legs, arms, stomach, buttocks, and scalp. The consumer reported she had seen two dermatologists, another primary care physician, an allergist and recently an acupuncturist, but had not seen the physician who administered her the PNEUMOVAX 23. The consumer reported that she did not have a rash on her face, palms or bottom of her feet, but had been given seven doses of prednisone and "UNIBOT wrap" which gave her some relief and had been doing this for six weeks. The consumer reporter that she had a biopsy of her rash to see if it was fungus and it was not. The patient had an allergy test done which showed she was allergic to dust mites and found out that her IgE was extremely high. The consumer also reported that in December 2008, she had a self inflicted skin infection and then starting on 19-MAR-2009, she saw an acupuncturist which had "helped" the inflammation and since then she had not had any new outbreaks. The consumer reported that the physician did not known why she developed the rash but the acupuncturist and she believed it was from PNEUMOVAX 23. On 15-SEP-2009 the patient was getting a heavy metal test. The consumer reported that in 2008 she was informed she did not have lupus and had been misdiagnosed (previously diagnosed with lupus on 27-JUL-2006). The patient also stated that "while taking BACTRIM her body became swollen" (date unknown). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Rash, Rash pruritic, Skin infection, Swelling
Clinical narrative: Information has been received from a 51 year old female consumer, allergic to penicillin, who on 27-Jul-2006 was vaccinated with a dose of PNEUMOVAX 23. "Around" September 2006 the patient developed an itchy rash that started on her neck, and since she scratched the rash, it later became a blister. The rash then went from her neck, down across her chest, back up her shoulder and down her back over, her legs, arms, stomach, buttocks, and scalp. The consumer reported she had seen two dermatologists, another primary care physician, an allergist and recently an acupuncturist, but had not seen the physician who administered her the PNEUMOVAX 23. The consumer reported that she did not have a rash on her face, palms or bottom of her feet, but had been given seven doses of prednisone and "UNIBOT wrap" which gave her some relief and had been doing this for six weeks. The consumer reporter that she had a biopsy of her rash to see if it was fungus and it was not. The patient had an allergy test done which showed she was allergic to dust mites and found out that her IgE was extremely high. The consumer also reported that in December 2008, she had a self inflicted skin infection and then starting on 19-MAR-2009, she saw an acupuncturist which had "helped" the inflammation and since then she had not had any new outbreaks. The consumer reported that the physician did not known why she developed the rash but the acupuncturist and she believed it was from PNEUMOVAX 23. On 15-SEP-2009 the patient was getting a heavy metal test. The consumer reported that in 2008 she was informed she did not have lupus and had been misdiagnosed (previously diagnosed with lupus on 27-JUL-2006). The patient also stated that "while taking BACTRIM her body became swollen" (date unknown). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 57 year old female patient who on unspecified dates was vaccinated too many times with "pneumococcal vaccine" (manufacturer unknown). It was reported that the patient experienced unspecified allergies to "pneumococcal vaccine". The patient's also experienced adverse events when vaccination with ZOSTAVAX (Merck) (WAES0909USA01309). This is one of the two reports for the same patient. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on 10-SEP-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported).  On 10-SEP-2009 the patient experienced pain at the injection site, fever and had difficulty raising her arm.  It is unknown if the patient recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Insomnia, Malaise
Clinical narrative: Information has been received from a 70 year old physician (pediatrician) with Cholesterol high and high blood pressure, allergy to ZESTRIL and a history of an operation on his maxillary sinus because of pneumococcal maxillary sinusitis (date unknown) who starting in 1990 and every five years until 2000 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) and on 01-OCT-2009 at approximately 12:00 was vaccinated with a dose of PNEUMOVAX 23 in the left deltoid (route and lot # not reported). Concomitant therapy included AVALIDE and ezetimibe (+) simvastatin (MSD). He reported that almost every time he received the vaccine in the past he experienced a site injection reaction, further described as redness and tenderness. On 01-OCT-2009, around 21:00, he experienced heat and pain at the injection site and he was not able to sleep on his left side that night. On 02-OCT-2009, he felt ill, further described as he felt like he was having a low grade fever and his legs were hurting him. On 02-OCT-2009, he noticed erythema on his left biceps and toward his left axilla. On the same day, he was able to sleep on his left side. It was unknown if there were any relevant laboratory data. It was reported that he was feeling better in general; it was unknown if his legs still hurt or if he continued to have low grade fever; the injection site was less tender and was not red. He continued to experienced erythema on his left arm. It was not specified if the patient sought medical attention. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a 70 year old physician (pediatrician) with Cholesterol high and high blood pressure, allergy to ZESTRIL and a history of an operation on his maxillary sinus because of pneumococcal maxillary sinusitis (date unknown) who starting in 1990 and every five years until 2000 was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported) and on 01-OCT-2009 at approximately 12:00 was vaccinated with a dose of PNEUMOVAX 23 in the left deltoid (route and lot # not reported). Concomitant therapy included AVALIDE and ezetimibe (+) simvastatin (MSD). He reported that almost every time he received the vaccine in the past he experienced a site injection reaction, further described as redness and tenderness. On 01-OCT-2009, around 21:00, he experienced heat and pain at the injection site and he was not able to sleep on his left side that night. On 02-OCT-2009, he felt ill, further described as he felt like he was having a low grade fever and his legs were hurting him. On 02-OCT-2009, he noticed erythema on his left biceps and toward his left axilla. On the same day, he was able to sleep on his left side. It was unknown if there were any relevant laboratory data. It was reported that he was feeling better in general; it was unknown if his legs still hurt or if he continued to have low grade fever; the injection site was less tender and was not red. He continued to experienced erythema on his left arm. It was not specified if the patient sought medical attention. Additional information has been requested.