chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 48 year old male who on 21-Oct-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 660718/0551X), injection route and site not reported). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed redness and swelling of his arm that extended to his "lymph nodes". The location of the affected lymph nodes was unknown. It is unknown if the patient has received PNEUMOVAX 23 in the past. Follow up information was received from a nurse concerning a 48-year-old male patient with anemia and a family history of breast cancer and prostate cancer who on 21-OCT-2008 was vaccinated intramuscularly in the right deltoid with a dose of PNEUMOVAX 23 (lot# 660718/0551X). He was concomitantly vaccinated intramuscularly in the left deltoid with the first dose of ADACEL (lot# C3033AA) at the same time. The patient woke early next day and experienced chills, body aches and redness on his arm. A puffy Red lines above area where injection given. The patient was treatment with TYLENOL, ice to arm. Symptoms better next day. Redness gone by 3rd day. Patient had been hospitalized in Feb-2007, there is possibility (small) he may have had vaccine there. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 66 year old female who on 13-Oct-2008 was vaccinated with PNEUMOVAX vaccine (injection route and site not reported). On 15-Oct-2008 the patient had a large red area that was warm to touch and was diagnosed with cellulitis at the injection site. The patient sought medical attention by coming to physician's office. The patient was treated cephalexin for 10 days. No further information was available from the caller. This is one of several cases reported by the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction, Viral infection
Clinical narrative: Information has been received from a medical assistant concerning a 61 year old female who on 14-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 660685/0619X). On 16-OCT-2008 the patient experienced "local action to PNEUMOVAX 23". The patient had red spots, tender, warm where the vaccine was given. The patient was seen at the physician's office was diagnosed on 22-OCT-2008 with a viral syndrome and treated with BIAXIN. The outcome of the events was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female who on 08-OCT-2008 was vaccinated with PNEUMOVAX 23 (LOT# 660718/0551X). On 09-OCT-2008 the patient experienced cellulitis at the injection site, and treated with cephalexin for 10 days. It was reported the patient sought medical attention: called physician's office. This was one of 4 reports from the same resource (Other 3 patient: WAES# 0810USA04401, WAES# 0810USA04371, WAES# 0810USA04374). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female who on 20-OCT-2008 was vaccinated with PNEUMOVAX (Lot#660718/0551X, therapy route, site unknown).  Subsequently, on 21-OCT-2008 the "patient had cellulitis from PNEUMOVAX".  The patient was treated with BENADRYL.  The patient outcome was unspecified.  This is one of several reports from the same source.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a physician concerning a 60 to 65 year old male patient who on 20-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 658673/0990U). On 22-OCT-2008 the patient experienced severe arm pain, swelling and redness that looked like cellulitis. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Swelling
Clinical narrative: Information has been received from a physician concerning a 60 to 65 year old male patient who on 20-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot # 658673/0990U). On 22-OCT-2008 the patient experienced severe arm pain, swelling and redness that looked like cellulitis. The patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX vaccine (Lot #660717/0224X). Subsequently, the patient could not move her arm and was treated with steroid injection. At the time of reporting the patient was recovering. The certified medical assistant reported that the last year they never received any adverse reaction complaints and this year they had already received five complaints. The reporter has requested a lot check. In follow up the medical assistant reported that the patient was vaccinated on 29-SEP-2008. In approximately September 2008, the administered right arm was a painful reaction. The patient had to be injected with KENALOG. The patient was back in the office on 22-OCT-2008 reporting numb hand and arm. The patient's painful arm and numb hand and arms persisted. The medical assistant still administered additional patients using lot # 660717/0224X. However, she now administered it in the patients' hips instead of arms. No adverse events have been reported after she changed injection sites. A standard lot check investigation was performed. All in process quality checks for the lot number 660717/0224X was satisfactory. The lot number 660717/0224X met the requirements of the Center and was released. This is one of several reports provided by the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX (Lot #660717/0224X).  Subsequently, the patient experienced tenderness and heat at injection site.  At the time of reporting the patient was recovering.  The certified medical assistant reported that the last year they never received any adverse reaction complaints and this year they had already received five complaints.  The reporter has requested a lot check.  In follow up the medical assistant reported that the patient was vaccinated on 14-OCT-2008.  In October 2008, the patient experienced a sore arm.  Subsequently, the patient recovered from the sore arm.  The medical assistant still administered additional patients using lot # 660717/0224X.  However, she now administered it in the patient's hips instead of arms.  No adverse events have been reported after she changed injection sites.  A standard lot check investigation was performed.  All in process quality checks for the lot number 660717/0224X was satisfactory.  The lot number 660717/0224X met the requirements of the agency and was released.  This in one of several reports provided by the same source.   Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse drug reaction
Clinical narrative: Information has been received from a physician concerning one patient who was vaccinated with PNEUMOVAX (Lot#1295X, therapy date, route, site unspecified). The patient experienced reaction that required treatment with antibiotics. The reaction was "severe enough that the patient may have needed to go the emergency room but was treated in the office instead." Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 66-year-old female with a history of hypertension, heart conditions, anxiety and bleeding tendency who on 25-OCT-2008 was vaccinated with PNEUMOVAX (lot # 661529/0868X or 659147/1381U) 0.5 ml IM.  Concomitant therapy included ALTACE, ASPIRIN, METOPROLOL, REQUIP, LESCOL, ZOLOFT, montelukast sodium (MSD), TOPROL XL TABLETS and OMEPRAZOLE.  Within a few days of vaccination the patient had swelling and pain of the right upper arm.  This arm had a red streak.  The patient was not treated and was referred to see her primary physician on 27-OCT-2008 afternoon for medical attention.  The physician requested a lot check.  This one of several reports received from the same source.  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 agency and was released.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with PNEUMOVAX vaccine (dose and route not reported). On approximately 14-OCT-2008, "in the past 1 to 2 weeks" the patient developed localized redness at the injection site that involved and extensive area of the arm. The patient's symptoms did not begin until a couple days after vaccination. This is one of several reports received from the same source. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Immediate post-injection reaction, Oedema peripheral
Clinical narrative: Information has been received from an office manager concerning a 55 year old male who on 22-OCT-2008, "Wednesday of last week", was vaccinated into the arm with the first dose of PNEUMOVAX vaccine. Concomitant therapy on the same day included influenza virus vaccine (unspecified) given in a different arm. Right after getting the vaccine, the patient experienced swelling of the arm from the forearm up that lasted about 3 days. The patient recovered on 25-OCT-2008, Saturday. No lab tests were performed. The patient did not seek medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Neuralgia, Pain, Vision blurred
Clinical narrative: Information has been received from a 65 year old female with allergy to sulfonamide and "gluten" who on 17-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 660685/0619X). Concomitant therapy included CLARITIN, FLONASE, FLOVENT, "PROVELGEL", ACTONEL, SYNTHROID, estradiol and dietary supplement (unspecified). On 17-OCT-2008 the patient experienced severe pain, neurological pain and difficulty in focusing after getting PNEUMOVAX 23 vaccine. At the time of this report, the patient was not recovered. The reporter also mentioned she had allergic reaction to ezetimibe (WAES# 0810USA05059), PRAVACHOL and ALTACE. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female who on 21-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot # 660717/0224X). On approximately 21-OCT-2008, after receiving PNEUMOVAX vaccine, the patient experienced a fever, as well as redness and swelling at the injection site. It was not known if this was the patient's first dose of PNEUMOVAX vaccine. The patient had completed two courses of unspecified antibiotics but had not fully recovered at the time of this report. The patient visited the office for medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a female who on 13-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot # 660717/0224X). On 13-OCT-2008, after receiving PNEUMOVAX vaccine, the patient experienced swelling and redness at the injection site. It was not known if this was the patient's first dose of PNEUMOVAX vaccine. The patient had completed two courses of unspecified antibiotics and was recovering at the time of this report. The patient visited the office for medical attention. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who on 19-OCT-2008, "10 days ago", was vaccinated with a dose of PNEUMOVAX 23 in the left arm. Concomitant therapy included influenza virus vaccine (unspecified) given 2 to 3 weeks ago in the same arm. On 29-OCT-2008 it was reported that the patient had a baseball sized red raised area "now". The outcome was unknown. It was unspecified if the patient sought medical attention or not. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a female who in November 2002, was vaccinated with a 0.5 mL dose of PNEUMOVAX 23. In December 2007, the patient developed pneumonia. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: Information has been received from a physician concerning a 66 year old female with diabetes, hypertension, lipids high and drug allergy to CIPRO, WELLBUTRIN and Codeine who in November 2004 was vaccinated with the first 0.5mL dose of PNEUMOVAX 23 and on 28-OCT-2008 was vaccinated with the second 0.5mL dose of PNEUMOVAX 23 (lot # 660717/0224X). Concomitant therapy included insulin, "HUMLIN INSULIN 70/30"), GLUCOPHAGE, lovastatin (manufacturer unknown), lisinopril (manufacturer unknown), aspirin, calcium (unspecified) (+) vitamin D (unspecified) and NASACORT AQ. On 28-OCT-2008, within 2 hours after vaccination, the patient experienced redness and swelling at the injection site. The physician expressed a concern that injection was given higher than the deltoid region, closer to the shoulder and might have been injected in the tendon area. The patient was experiencing difficulty moving the right arm. The patient was recovering at the time of this report. The patient visited the office for medical attention. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache, Oropharyngeal pain, Pain, Wheezing
Clinical narrative: Information has been received from a medical assistant concerning a female who on 28-OCT-2008 was vaccinated with PNEUMOVAX 23 (dose and route not reported). On 29-OCT-2008 the patient experienced wheezing and achiness. It was not known if this was the patient's first dose of PNEUMOVAX 23. The patient's wheezing and achiness persisted. Follow-up information has been received from a physician concerning a 50 year old female with anxiety, rhinitis allergic and menopause and a history of irritable bowel syndrome and no illness at the time of vaccination who on 27-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot number: 660717/0224X) IM into her right upper arm. Concomitant therapy included FLUZONE and ADACEL. On 27-OCT-2008 the patient experienced wheezing, bodyaches, headache and sore throat. The patient was treated with naproxen, albuterol, QVAR, and an unspecified medication. Approximate 1 week later, the patient recovered. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 74 year old female who on approximately 12-OCT-2008 was vaccinated with PNEUMOVAX (lot number: 660718/0551X) 0.5ml (route was not reported). On 12-OCT-2008 the patient developed swelling on her arm away from the injection site. Subsequently, the patient recovered from swelling on her arm away from the injection site. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Information has been received from an adult female certified medical assistant who on an unknown date was vaccinated with a dose of PNEUMOVAX (Lot #660717/0224X). Subsequently, she experienced a shoulder joint pain. At the time of reporting the patient was recovering. The certified medical assistant reported that the last year they never received any adverse reaction complaints and this year they had already received five complaints. The reporter has requested a lot check. In follow up the medical assistant reported that she was vaccinated on 15-Oct-2008. In October 2008, then she experienced a sore achy arm with limited range of motion. Subsequently she recovered from the sore achy arm with limited range of motion. She shoulder still ached. The medical assistant still administered additional patients using lot # 660717/0224X. However, she now administered it in the patient's hips instead of arms. No adverse events have been reported after she changed injection sites. A standard lot check investigation was performed. All in process quality checks for the lot number 660717/0224X was satisfactory. The lot number 660717/0224X met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports provided by the same source. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site warmth, Lymph node pain, Malaise, Pain
Clinical narrative: Information has been received from a consumer concerning a co-worker who on 13-OCT-2008, the patient was revaccinated with PNEUMOVAX. Concomitant therapy included Influenza virus vaccine (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good, achiness after getting revaccinated and cellulitis. The patient had symptoms by the afternoon. At the time of the report, the patient was feeling better but not recovered. This is one of several reports received from the same source. No additional information is expected.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pyrexia, Sensation of heaviness
Clinical narrative: Information has been received from a consumer concerning a co-worker who on 13-OCT-2008, the patient was revaccinated with PNEUMOVAX. Concomitant therapy included Influenza virus vaccine (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good, achiness after getting revaccinated and cellulitis. The patient had symptoms by the afternoon. At the time of the report, the patient was feeling better but not recovered. This is one of several reports received from the same source. No additional information is expected.
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician and a nurse concerning a female who on 17-OCT-2008 was vaccinated with PNEUMOVAX (lot #660685/0619X). She subsequently developed a reaction to the vaccine, a large axillary adenopathy. At the time of reporting, the patient's large axillary adenopathy persisted. This is one of several reports from the same physician. The physician stated he was given a "bad batch" of PNEUMOVAX. 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Chills, Erythema, Full blood count abnormal, Injection site pain
Clinical narrative: Information has been received from a physician, concerning a 60-year-old female patient with chronic cervical radiculopathy, lumber radiculopathy, depression, hyperlipidemia, hypertension, overweight, insomnia and allergies to LEVAQUIN and penicillin, who on 20-OCT-2008 received a dose of 0.5 ml PNEUMOVAX (lot # 661529/0868X, injection site unknown) via intramuscular route. Concomitant therapies included CRESTOR, HALCION, ibuprofen, levothyroxine Na, metoprolol, MAXZIDE, potassium (unspecified) and multi-vitamins (unspecified). On the same day as the administration, the patient developed pain and swelling at the injection site. On the next day, she had swelling of the arm. On 22-OCT-2008, the 3rd day, she experienced lots of erythema and pain. The patient went to the ER on 22-OCT-2008. She had chills and fever. Blood cultures were negative. CBC count was 17,000 with the left shift. She was treated with IV ROCEPHIN and IV vancomycin on an outpatient basis. Patient was on LORTAB for the pain and oral clindamycin and KEFLEX. At the time of reporting, the patient was recovering from the events. Follow-up information has been received from the physician concerning the 60-year-old female patient, who on 20-OCT-2008 received a first dose of PNEUMOVAX (lot number unknown, previously reported as 661529/0868X) via intramuscular route in her left deltoid at 5:00 PM. The patient had onset of severe painful erythematous swelling and fever 1 day after the PNEUMOVAX vaccine. Complete blood count (CBC) on an unspecified date was normal. She was treated with KEFLEX and NSAIDS but her symptoms worsened and she received 1 week of IV ROCEPHIN and IV vancomycin. On 07-NOV-2008, her symptoms resolved. This is one of two reports from the same source. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a physician, concerning a 60-year-old female patient with chronic cervical radiculopathy, lumber radiculopathy, depression, hyperlipidemia, hypertension, overweight, insomnia and allergies to LEVAQUIN and penicillin, who on 20-OCT-2008 received a dose of 0.5 ml PNEUMOVAX (lot # 661529/0868X, injection site unknown) via intramuscular route. Concomitant therapies included CRESTOR, HALCION, ibuprofen, levothyroxine Na, metoprolol, MAXZIDE, potassium (unspecified) and multi-vitamins (unspecified). On the same day as the administration, the patient developed pain and swelling at the injection site. On the next day, she had swelling of the arm. On 22-OCT-2008, the 3rd day, she experienced lots of erythema and pain. The patient went to the ER on 22-OCT-2008. She had chills and fever. Blood cultures were negative. CBC count was 17,000 with the left shift. She was treated with IV ROCEPHIN and IV vancomycin on an outpatient basis. Patient was on LORTAB for the pain and oral clindamycin and KEFLEX. At the time of reporting, the patient was recovering from the events. Follow-up information has been received from the physician concerning the 60-year-old female patient, who on 20-OCT-2008 received a first dose of PNEUMOVAX (lot number unknown, previously reported as 661529/0868X) via intramuscular route in her left deltoid at 5:00 PM. The patient had onset of severe painful erythematous swelling and fever 1 day after the PNEUMOVAX vaccine. Complete blood count (CBC) on an unspecified date was normal. She was treated with KEFLEX and NSAIDS but her symptoms worsened and she received 1 week of IV ROCEPHIN and IV vancomycin. On 07-NOV-2008, her symptoms resolved. This is one of two reports from the same source. No further information is available.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician, concerning a 51-year-old female patient with sinusitis, hyperlipidemia and no known drug allergies, who on 29-OCT-2008 received a dose of 0.5 ml PNEUMOVAX (lot # 661529/0868X, injection site unknown) via intramuscular route.  Concomitant therapies included multi-vitamins (unspecified) and FLONASE.  One hour after the administration, the patient experienced pain, redness, and swelling at the injection site.  On 30-OCT-2008 when the patient was seen for follow-up, the reaction had gotten worse.  Most of the deltoid are was affected.  There was swelling and induration.  The patient was treated with ROCEPHIN.  Blood cultures and CBC were performed without results reported.  At the time of reporting, the patient was not recovered from the events.  Follow-up information has been received from the physician concerning the 51-year-old female patient with no illness at the time of vaccination, who on 29-OCT-2008 received the first dose of PNEUMOVAX (lot # 661529/0868X) via intramuscular route in her right deltoid at 9:00 AM.  She developed swelling within 1 hour after vaccination.  Within 24 hours, there were pain, erythema, swelling over most of deltoid area and upper arm.  ER/DR visit was required.  She was treated for cellulilits with IV ROCEPHIN and CLINDAMYCIN.  On 03-NOV-2008, she recovered from the events.  This is one of two reports received from the same source.  No further information is available.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 70 year old male with no medical history who on 27-OCT-2008 was vaccinated with PNEUMOVAX, injection (lot # not provided). On 27- OCT-2008, after getting vaccination, the patient experienced swelling at the injection site, fever and chills. The patient sought unspecified medical attention. Subsequently, the patient recovered from the adverse events. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a nurse concerning a 53-year-old female patient who on 27-OCT-2008 was administered a dose of PNEUMOVAX (lot # 659149/1383U, route and injection site not reported).  Subsequently, the patient experienced cellulitis at the injection site.  She contacted the physician for medical attention and was treated with antibiotics and pain medication (unspecified).  At the time of reporting, the patient was recovering from the event.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Swelling
Clinical narrative: Information has been received from a health professional concerning a patient who on unknown dates was vaccinated with PNEUMOVAX (lot # 660685/0619X). The patient experienced pain, swelling and unable to lift arm after getting the vaccine. Unspecified medical attention was sought. The outcomes of the events were not reported. This is one of several report received from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray abnormal, Chills, Condition aggravated, Cough, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 69 year old female with drug hypersensitivity to IMURAN (caused by diffuse swelling), lupus and  pulmonary fibrosis who 5 or more years ago was vaccinated with the first dose of PNEUMOVAX. On 27-OCT-2008 at 10:00, the patient received the second dose of PNEUMOVAX (lot #657525/0554U) 0.5 ml IM into the right deltoid and a dose of influenza virus vaccine (SANOFI PASTEUR) (lot#: 62805AA) IM into the left arm. Concomitant  therapy included vitamins (unspecified), calcium (unspecified) and oxygen at night or with exercise of physical activity. On 27-OCT-2008 at 14:00. The patient was starting to get some swelling, soreness and erythema and heat at the injection site in the upper arm on the right side. She had no systemic symptoms of any other swelling. The redness persisted on the second day. On 29-OCT-2008, the patient visited the doctor's office. Physical exam demonstrated: right arm showed some mild erythema and swelling, and warmth involving most of the posterolateral aspect of the right upper arm. The patient was prescribed BENADRYL and cold compresses. On 05-NOV-2008, the patient developed a pain just under the left breast that increased with a cough, a deep breath, but also with any kind of twisting or turning motion. On 06-NOV-2008 the patient visited the physician and complained that since she got PNEUMOVAX vaccine that her lungs had just been a little worse than usual/ She may have some wheezed. The patient felt like she had fevers and chills. She had a chronic cough, with some mild chronic sputum and that was unchanged. Physical exam showed the patient's respirations were even relaxed and no observed cough or sputum production. Her lungs sounded perfectly clear posteriorly without rales or wheezes. No dullness in the bases. Anteriorly there was faint, inspiratory squeak, but otherwise clear. The previous swelling and erythema in the right arm from the reaction to the PNEUMOVAX was totally cleared with complete resolution. The reporter felt that injection site reaction was related to therapy with PNEUMOVAX. Chest X-ray showed the pulmonary fibrotic changes which was no change at all from the X-ray of March, 2008. The physician didn't see infectious process. The patient symptoms suggested she may have some flare of her pulmonary fibrosis. The pain may be a little pleuritis as well. This is one of several reports received from the same source. All three patients developed reactions after receiving PNEUMOVAX (lot# 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the Center and was released. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain, Pleurisy
Clinical narrative: Information has been received from a physician concerning a 69 year old female with drug hypersensitivity to IMURAN (caused by diffuse swelling), lupus and  pulmonary fibrosis who 5 or more years ago was vaccinated with the first dose of PNEUMOVAX. On 27-OCT-2008 at 10:00, the patient received the second dose of PNEUMOVAX (lot #657525/0554U) 0.5 ml IM into the right deltoid and a dose of influenza virus vaccine (SANOFI PASTEUR) (lot#: 62805AA) IM into the left arm. Concomitant  therapy included vitamins (unspecified), calcium (unspecified) and oxygen at night or with exercise of physical activity. On 27-OCT-2008 at 14:00. The patient was starting to get some swelling, soreness and erythema and heat at the injection site in the upper arm on the right side. She had no systemic symptoms of any other swelling. The redness persisted on the second day. On 29-OCT-2008, the patient visited the doctor's office. Physical exam demonstrated: right arm showed some mild erythema and swelling, and warmth involving most of the posterolateral aspect of the right upper arm. The patient was prescribed BENADRYL and cold compresses. On 05-NOV-2008, the patient developed a pain just under the left breast that increased with a cough, a deep breath, but also with any kind of twisting or turning motion. On 06-NOV-2008 the patient visited the physician and complained that since she got PNEUMOVAX vaccine that her lungs had just been a little worse than usual/ She may have some wheezed. The patient felt like she had fevers and chills. She had a chronic cough, with some mild chronic sputum and that was unchanged. Physical exam showed the patient's respirations were even relaxed and no observed cough or sputum production. Her lungs sounded perfectly clear posteriorly without rales or wheezes. No dullness in the bases. Anteriorly there was faint, inspiratory squeak, but otherwise clear. The previous swelling and erythema in the right arm from the reaction to the PNEUMOVAX was totally cleared with complete resolution. The reporter felt that injection site reaction was related to therapy with PNEUMOVAX. Chest X-ray showed the pulmonary fibrotic changes which was no change at all from the X-ray of March, 2008. The physician didn't see infectious process. The patient symptoms suggested she may have some flare of her pulmonary fibrosis. The pain may be a little pleuritis as well. This is one of several reports received from the same source. All three patients developed reactions after receiving PNEUMOVAX (lot# 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the Center and was released. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pulmonary fibrosis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 69 year old female with drug hypersensitivity to IMURAN (caused by diffuse swelling), lupus and  pulmonary fibrosis who 5 or more years ago was vaccinated with the first dose of PNEUMOVAX. On 27-OCT-2008 at 10:00, the patient received the second dose of PNEUMOVAX (lot #657525/0554U) 0.5 ml IM into the right deltoid and a dose of influenza virus vaccine (SANOFI PASTEUR) (lot#: 62805AA) IM into the left arm. Concomitant  therapy included vitamins (unspecified), calcium (unspecified) and oxygen at night or with exercise of physical activity. On 27-OCT-2008 at 14:00. The patient was starting to get some swelling, soreness and erythema and heat at the injection site in the upper arm on the right side. She had no systemic symptoms of any other swelling. The redness persisted on the second day. On 29-OCT-2008, the patient visited the doctor's office. Physical exam demonstrated: right arm showed some mild erythema and swelling, and warmth involving most of the posterolateral aspect of the right upper arm. The patient was prescribed BENADRYL and cold compresses. On 05-NOV-2008, the patient developed a pain just under the left breast that increased with a cough, a deep breath, but also with any kind of twisting or turning motion. On 06-NOV-2008 the patient visited the physician and complained that since she got PNEUMOVAX vaccine that her lungs had just been a little worse than usual/ She may have some wheezed. The patient felt like she had fevers and chills. She had a chronic cough, with some mild chronic sputum and that was unchanged. Physical exam showed the patient's respirations were even relaxed and no observed cough or sputum production. Her lungs sounded perfectly clear posteriorly without rales or wheezes. No dullness in the bases. Anteriorly there was faint, inspiratory squeak, but otherwise clear. The previous swelling and erythema in the right arm from the reaction to the PNEUMOVAX was totally cleared with complete resolution. The reporter felt that injection site reaction was related to therapy with PNEUMOVAX. Chest X-ray showed the pulmonary fibrotic changes which was no change at all from the X-ray of March, 2008. The physician didn't see infectious process. The patient symptoms suggested she may have some flare of her pulmonary fibrosis. The pain may be a little pleuritis as well. This is one of several reports received from the same source. All three patients developed reactions after receiving PNEUMOVAX (lot# 657525/0554U) from the same multiple dose vial. A standard lot check investigation was performed. All in-process quality checks for the lot number 657525/0554U in question were satisfactory. The lot met the requirements of the Center and was released. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 69 year old female who at 9:26 am on 22-OCT-2008 with a first dose of PNEUMOVAX (lot # 656233/0200U) in the left deltoid. Concomitant therapy included FLUZONE (lot # U2747AA) in the right deltoid which was vaccinated at 9:05 am on 14-OCT-2008. On the morning of 22-OCT-2008, after getting the vaccine, the patient developed swelling, pain, and redness at the injection site and also underarm redness. The swelling and soreness lasted one week. The medical attention was sought. The body temperature was normal (reported as "no temp"). The patient refused treatment. On 30-OCT-2008, the patient recovered. No further information is available.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Local reaction, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 20-year-old female patient, who on 28-OCT-2008 was vaccinated with a dose of PNEUMOVAX (lot number, route and injection site unknown).  Subsequently the patient developed fever, chills and local reaction.  It was unknown whether the patient sought medical attention.  The patient's outcome was unknown.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a female patient over 60 years of age who in October 2008 was vaccinated with PNEUMOVAX vaccine (Lot#662599/1076X, therapy date, route, site unknown). "In the last 10 days", approximately 19-OCT-2008, this patient developed severe local reactions in the injection arm. The patient experienced welts and swelling on the arm. A lot check is requested for PNEUMOVAX Lot#662599/1076X. Unspecified medical attention was sought. The patient's outcome was unknown. This is one of several reports received from the same source. Follow-up information has been received from a physician and medical records concerning this patient. She was an 81 year old female with chronic abdominal pain, knee pain, irritable bowel syndrome, constipation, energy decreased, hypercholesterolemia, hypothyroidism, dementia, colonic polyp, uterine fibroids, cardiomegaly, drug hypersensitivity and a history of rib fracture, "valium in past for sleep" and kidney stone. The patient was allergic to "AUGMENTIN, VICODIN, PERCOCET, Codeine, IV Dye, Sulfa, Hyoscyamine, ASA, Tetanus, MOTRIN, NEOSPORIN, ERYC, Ibuprofen, Anti-inflammatories, ATIVAN, LEVSIN, DONNATAL, Pcn: Can Take Amox, Amitriptyline, Bella Alkaloids, Cephalexin, Hydroxyzine, Alprazolam, ZANTAC, Simethicone, Lovastatin: Myalgias, LIPITOR: Myalgias." Concomitant therapy included LIBRAX capsules, vitamin D (unspecified), ascorbic acid, omega-3 marine triglycerides, levothyroxine Na, folic acid, "therebec plus" garlic, COLACE, "SENOKOT", NIASPAN and zoster vaccine (Merck) (therapy date, route, dose unknown). On 27-OCT-2008 the patient was vaccinated with the first dose of PNEUMOVAX vaccine on left deltoid (therapy route unknown). On 30-OCT-2008 the patient experienced injection site welts on the arm and injection site swelling on the arm. She went to emergency room and was diagnosed as "Cellulitis NOS" and "Allergic reaction NOS". The patient outcome was unknown. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient over 60 years of age who in October 2008 was vaccinated with (Lot #662599/1076X, therapy date, route, site unknown).  "In the last 10 days", approximately 19-OCT-2008,  this patient developed severe local reactions in the injection arm.  The patient experienced welts and swelling on the arm.  A lot check is requested for PNEUMOVAX Lot #662599/1076X.  Unspecified medical attention was sought.  The patient's outcome was unknown.  This is one of several reports received from the same source.  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 agency and was released.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female who on 27-OCT-2008 was vaccinated with (lot #660685/0619X). In October 2008, the patient experienced spiking fever and a big arm and was admitted to the hospital. The patient's spiking fevers and a big arm persisted. The physician stated he was given a "bad batch" of PNEUMOVAX. A lot check has been requested. This is one of several reports from the same physician. 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 Agency and was released.
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a male patient with no known drug reactions/allergies, who on 03-NOV-2008, was vaccinated with a dose of PNEUMOVAX (lot # 659148/1382U).  Concomitant therapy included influenza virus vaccine (unspecified) (manufacturer unknown).  The medical assistant reported on 03-NOV-2008, the patient complained of cellulitis like injection site reaction with the vaccination.  The lot check has been requested by the medical assistant.  There were no lab diagnostics.  The patient sought medical attention.  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 agency and was released.  This is one of two reports received from the same source.  Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who is also her student with an allergy to eggs who was vaccinated with a dose of PNEUMOVAX vaccine. The pharmacist reported that the patient experienced and allergic reaction after PNEUMOVAX vaccine was given. The pharmacist stated she did not want to report this case because she was not certain the patient was certain it was an allergic reaction. It is unknown if the patient sought medical attention. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Oedema
Clinical narrative: Information has been received from a physician concerning a female who on 29-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot #660685/0619X). On approximately 29-OCT-2008 the patient developed edema and could not raised her arm. The patient's edema and could not raise her arm persisted. The physician stated he was given a "bad batch" of PNEUMOVAX vaccine. A lot check has been requested. This is one of several reports from the same physician. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot # 659148/1382U).  The medical assistant reported that the patient complained of cellulitis like injection site reaction with the vaccination.  The lot check has been requested by the medical assistant.  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 agency and was released.  This in one of two reports received from the same source.  Additional information is not expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female who on 30-OCT-2008 was vaccinated with PNEUMOVAX vaccine (lot #662599/1076X), 0.5ml, intramuscularly. Secondary suspect therapy included influenza virus vaccine (manufacturer unspecified) in the same arm on 30-OCT-2008. On 31-OCT-2008, 1 day after the vaccination, the patient experienced redness at the injection site, fever of 103f and chills. It was not known if this was the patient's first dose of PNEUMOVAX vaccine. The nurse was not aware if treatment was prescribed but stated the patient was recovering. The patient sought medical attention with a phone call to the office. This is one of 2 reports received from the same resource. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a physician concerning a female patient who no 03-NOV-2008 (1:30 PM) was vaccinated with the first dose of PNEUMOVAX (lot # 658673/0990U) in her right arm.  The physician reported that after receiving PNEUMOVAX, the patient developed redness, severe pain in her arm and cellulitis approximately 2 inches below the injection site.  The patient was given BENADRYL 25 mg four times a day, PREDNISONE 15 mg x 3 days, 10 mg x 4 days and 5 mg x 6 days and CEPHALEXEN 500 mg three times a day.  The patient sought medical attention at the doctor's office.  This is one of two reports received from the same source.  No additional information is expected.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 76 year old male with heart disease, elevated cholesterol, atrial fibrillation, enlarged prostate and allergy to epinephrine and a history of stroke who on 04-NOV-2008 was vaccinated with PNEUMOVAX vaccine, 0.5 mL, intramuscularly in arm. It was reported that on 04-NOV-2008, the patient developed local redness and swelling at injection site of PNEUMOVAX vaccine. This developed the evening of the injection. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist and a hospital employee who was the brother of a female patient who on an unknown date was vaccinated with PNEUMOVAX (site and route not reported) -  Subsequently the patient experienced severe reaction at injection site.  This is one of three reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Myalgia, Pain, Pain in extremity
Clinical narrative: Information has been received from a female with penicillin allergy, sulfonamide allergy and LEVAQUIN and certain drops allergy who in 2000 was vaccinated with PNEUMOVAX vaccine (manufacturer unknown) and did not have a reaction. The patient mentioned that she had a reaction to a pneumonia vaccine (unspecified which one). In 2005, at a different office she received the vaccine and experienced swollen gland, muscle pains and aches and painful welt on upper arm. The patient sought medical attention. At the time of the reporting, the patient had recovered. No further information is available.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a male who on 30-OCT-2008 was vaccinated with PNEUMOVAX (Lot #62599/1076X), 0.5ml, intramuscularly.  Secondary suspect therapy included influenza virus vaccine (manufacturer unspecified) in the same arm on 30-OCT-2008.  On 31-OCT-2008, 1 day after the vaccination, the patient experienced redness at the injection site,