chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Parvovirus B19 serology positive, Photophobia, Polymerase chain reaction, Protein total decreased
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Red cell distribution width increased, Rheumatoid factor negative, Serum ferritin increased, Ultrasound abdomen
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Urine colour abnormal, Urine human chorionic gonadotropin negative, Urine ketone body absent, Urine leukocyte esterase, Urine protein, quantitative
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count decreased, White blood cell count normal
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Local swelling, Neck pain
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 49 year old female who at 11:00 am on 21-OCT-2008 was vaccinated into the left deltoid with a dose of PNEUMOVAX (lot # 656223/1344U).  Concomitant therapy included FLUARIX (lot # UA367EA).  It was reported that on 22-OCT-2008 the patient called and stated that her left side of neck was swollen, her arm where she received PNEUMOVAX and FLUARIX was fine.  She was seen in agency at 1:30 pm on 22-OCT-2008, the left side of the neck was swollen, there was no redness or swelling at the injection site.  It was reported that her neck was sore.  The patient was told to visit a family doctor.  The patient called back on 23-OCT-2008 stated that the family doctor gave her a shot of cortisone and some "pain medicines".  The patient was treated with cold compresses for 20 min on neck, then off 10 min, and then back on neck 20 min.  The patient reported that her pain was less and the swelling is going away.  The patient was told by the physician at agency never to take another dose of PNEUMOVAX.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an 81 year old female patient who on 14-Oct-2008 was vaccinated with her second dose of PNEUMOVAX (lot number 656223/1344U) and FLUZONE (unspecified) into the left deltoid by intramuscular route. Concomitant therapy included influenza virus vaccine (unspecified). On 16-OCT-2008 the patient returned to clinic for swelling, redness and tenderness in left arm, from shoulder to elbow on front side only. The patient then told the nurse she had a reaction six years ago and had forgotten it was from a pneumonia shot. The patient was instructed to put on "moist compresses, (comma)", TYLENOL for pain and BENADRYL for allergic reaction. The patient was to call the clinic in the morning to relate her progress. It was reported that they were unable to reach the patient for 2 weeks. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from an office manager concerning a 66 year old female patient with sulfonamide allergy, and no pertinent medical history, who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 662785/1124X) intramuscularly in the left arm. Concomitant therapy included DIOVAN, LIPITOR, hydrochlorothiazide, cyclobenzaprine HCl (MSD), AMBIEN, MOBIC and pantoprazole. Subsequently the patient developed an injection site reaction. Her left arm became red, swollen and painful. Patient sought medical attention via an office visit. No lab diagnostic studies were performed. Patient was given BENADRYL and the symptoms resolved. This is one of several reports received from the same source. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: Information has been received from a 47 year old female consumer with celiac disease and no known allergies, who on 07-JAN-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 661040, 0397X) in the left arm. There was no concomitant medication. On 08-JAN-2009 at 03:30 am she woke up with a huge red lump that was hot on her left arm at the injection site. She also had fever, chills, headache, vomiting and nauseous, lost her appetite, and fatigue, was coughing and had phlegm. She also had a rash on her arm just below the injection site that covered her whole triceps and was the size of a dollar bill and a half. The consumer could not move her arm without pain, and has been icing her arm every day. The consumer talk to the physician and nurse. As of 12-JAN-2009 the consumer reported that her headache had gone away but she still can not move her arm and was still coughing up phlegm. The outcome of fever, chills, vomiting and nauseous, lost of appetite and fatigue were unknown. The patient did not go to work on 12-JAN-2009 because of the arm pain. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Information has been received from a 47 year old female consumer with celiac disease and no known allergies, who on 07-JAN-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 661040, 0397X) in the left arm. There was no concomitant medication. On 08-JAN-2009 at 03:30 am she woke up with a huge red lump that was hot on her left arm at the injection site. She also had fever, chills, headache, vomiting and nauseous, lost her appetite, and fatigue, was coughing and had phlegm. She also had a rash on her arm just below the injection site that covered her whole triceps and was the size of a dollar bill and a half. The consumer could not move her arm without pain, and has been icing her arm every day. The consumer talk to the physician and nurse. As of 12-JAN-2009 the consumer reported that her headache had gone away but she still can not move her arm and was still coughing up phlegm. The outcome of fever, chills, vomiting and nauseous, lost of appetite and fatigue were unknown. The patient did not go to work on 12-JAN-2009 because of the arm pain. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Increased upper airway secretion, Injected limb mobility decreased, Injection site mass, Injection site warmth, Nausea
Clinical narrative: Information has been received from a 47 year old female consumer with celiac disease and no known allergies, who on 07-JAN-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 661040, 0397X) in the left arm. There was no concomitant medication. On 08-JAN-2009 at 03:30 am she woke up with a huge red lump that was hot on her left arm at the injection site. She also had fever, chills, headache, vomiting and nauseous, lost her appetite, and fatigue, was coughing and had phlegm. She also had a rash on her arm just below the injection site that covered her whole triceps and was the size of a dollar bill and a half. The consumer could not move her arm without pain, and has been icing her arm every day. The consumer talk to the physician and nurse. As of 12-JAN-2009 the consumer reported that her headache had gone away but she still can not move her arm and was still coughing up phlegm. The outcome of fever, chills, vomiting and nauseous, lost of appetite and fatigue were unknown. The patient did not go to work on 12-JAN-2009 because of the arm pain. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Information has been received from a 47 year old female consumer with celiac disease and no known allergies, who on 07-JAN-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 661040, 0397X) in the left arm. There was no concomitant medication. On 08-JAN-2009 at 03:30 am she woke up with a huge red lump that was hot on her left arm at the injection site. She also had fever, chills, headache, vomiting and nauseous, lost her appetite, and fatigue, was coughing and had phlegm. She also had a rash on her arm just below the injection site that covered her whole triceps and was the size of a dollar bill and a half. The consumer could not move her arm without pain, and has been icing her arm every day. The consumer talk to the physician and nurse. As of 12-JAN-2009 the consumer reported that her headache had gone away but she still can not move her arm and was still coughing up phlegm. The outcome of fever, chills, vomiting and nauseous, lost of appetite and fatigue were unknown. The patient did not go to work on 12-JAN-2009 because of the arm pain. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Local reaction, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 09-JAN-2009 was vaccinated with PNEUMOVAX (lot number 658451/0963U):  route and site not reported).  On 10-JAN-2009 the patient developed redness, swelling and fever.  The patient was diagnosed with cellulitis and treated with ROCEPHIN.  The patient was recovering at the time of reporting. No further information is available.
Age: 19.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Swelling
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who on 09-JAN-2009 was vaccinated with PNEUMOVAX (lot number 658451/0963U):  route and site not reported).  On 10-JAN-2009 the patient developed redness, swelling and fever.  The patient was diagnosed with cellulitis and treated with ROCEPHIN.  The patient was recovering at the time of reporting. No further information is available.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Induration, Local reaction, Swelling
Clinical narrative: Information has been received from an office manager concerning a 68 year old female patient with no previous medical history reported, who on 08-DEC-2008 was vaccinated with a dose of PNEUMOVAX (Lot Number 662785/1124X) IM in the left arm.  Concomitant therapy included ACTONEL, iron (unspecified), WELLBUTRIN, NEXIUM, LEXAPRO, BONIVA and meclizine.  On approximately 08-DEC-2008, after received the dose of PNEUMOVAX, the patient developed injection site reaction.  The patient's left arm became red, swollen and painful.  The patient was given BENADRYL and the symptoms resolved.  The patient sought medical attention at office visit.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from an office manager concerning a 68 year old female patient with no previous medical history reported, who on 08-DEC-2008 was vaccinated with a dose of PNEUMOVAX (Lot Number 662785/1124X) IM in the left arm.  Concomitant therapy included ACTONEL, iron (unspecified), WELLBUTRIN, NEXIUM, LEXAPRO, BONIVA and meclizine.  On approximately 08-DEC-2008, after received the dose of PNEUMOVAX, the patient developed injection site reaction.  The patient's left arm became red, swollen and painful.  The patient was given BENADRYL and the symptoms resolved.  The patient sought medical attention at office visit.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a patient with no pertinent medical history and  allergy to hydromorphone who on 27-Feb-2009 was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 (lot number 662785/1124X) subcutaneously. Concomitant therapy included erythromycin (unspecified) and Lexapro. The physician reported that after receiving the vaccine on 27-Feb-2009 the patient experienced significant injection site reaction. The patient sought medical unspecified medical attention. Follow up information was received from a healthcare worker who requested a lot check for this vaccine, due to patients having adverse experiences. Follow up information was received from a healthcare worker who requested to receive follow up letters. Follow up information was received from a health care professional who mentioned that the patient had a lot of redness and a lot of swelling. The redness and swelling was the size of an apple. Follow up information was received from a registered nurse (R.N) who reported that a 66 year old female patient who had not known drug allergies was vaccinated with the first dose of PNEUMOVAX 23 (lot# 662785/1124X) subcutaneously into her right upper arm on 24-Feb-2009 (previously reported as 27-Feb-2009). There was no illness at the time of vaccination. On 24-Feb-2009, within 1-2 hours of vaccination, the patient experienced an injection site reaction was normal. Patient was seen by the physician. It was reported that the site was red, slightly swollen and warm. There were no laboratory diagnostics tests performed. The patient reported that this resolved over 24 hours. It was reported by the registered nurse that the patient recovered on 24-Feb-2009. Standard lot check investigations were performed on lot# 1124X. All in-process quality checks for the lot numbers in question were satisfactory. The lot met the requirements of the evaluation and research and were released. This is a consolidation of two reports concerning the same patient. This is one of several cases from the same source. No further information was available.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a patient who on 02-MAR-2009 was vaccinated with a dose of PNEUMOVAX (lot number not provided).  The physician reported that after receiving the vaccine on 02-MAR-2009 the patient experienced significant injection site reaction.  This is one of two reports from the same source.  Follow up information has been received from a storeroom supervisor from the physician's office concerning a patient who on 02-MAR-2009 was vaccinated with a dose of PNEUMOVAX (662785/1124X).  The storeroom supervisor wanted an investigation for the incidence of the reaction from this lot number.  A lot check has been requested.  Follow up information has been received from a physician and a registered nurse concerning a 57 year old female with cholesterol and asthma and no known drug allergies and no illness at the time of vaccination who on 03-MAR-2009 (previously reported as 02-MAR-2009) was vaccinated SC in the left upper arm at 03:30pm with first dose of PNEUMOVAX (lot number 662785/1124X).  Concomitant therapy included ADVAIR and METOPROLOL.  The physician reported that on 03-MAR-2009 (previously reported as 02-MAR-2009) within half hour after immunization the patient returned to his office to report that injection site was itchy.  She was seen by the physician.  The injection site was red, slightly swollen and warm.  Within 24 hours itching resolved, and within 48 hours the site returned to normal.  No lab studies were performed.  Follow up information has been received from a storeroom supervisor from the physician's office.  The reporter mentioned that the patient had a lot of redness and a lot of swelling.  The redness and swelling was the "sized of an apple".  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 a consolidation of two reports regarding the same patient.  Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a patient who on 02-MAR-2009 was vaccinated with a dose of PNEUMOVAX (lot number not provided).  The physician reported that after receiving the vaccine on 02-MAR-2009 the patient experienced significant injection site reaction.  This is one of two reports from the same source.  Follow up information has been received from a storeroom supervisor from the physician's office concerning a patient who on 02-MAR-2009 was vaccinated with a dose of PNEUMOVAX (662785/1124X).  The storeroom supervisor wanted an investigation for the incidence of the reaction from this lot number.  A lot check has been requested.  Follow up information has been received from a physician and a registered nurse concerning a 57 year old female with cholesterol and asthma and no known drug allergies and no illness at the time of vaccination who on 03-MAR-2009 (previously reported as 02-MAR-2009) was vaccinated SC in the left upper arm at 03:30pm with first dose of PNEUMOVAX (lot number 662785/1124X).  Concomitant therapy included ADVAIR and METOPROLOL.  The physician reported that on 03-MAR-2009 (previously reported as 02-MAR-2009) within half hour after immunization the patient returned to his office to report that injection site was itchy.  She was seen by the physician.  The injection site was red, slightly swollen and warm.  Within 24 hours itching resolved, and within 48 hours the site returned to normal.  No lab studies were performed.  Follow up information has been received from a storeroom supervisor from the physician's office.  The reporter mentioned that the patient had a lot of redness and a lot of swelling.  The redness and swelling was the "sized of an apple".  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 a consolidation of two reports regarding the same patient.  Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a healthcare worker concerning a 71 year old male patient with diabetes, hypertension and chronic obstructive pulmonary disease and no known drug allergies who in 2003 was vaccinated with the first 0.5 ml IM dose of PNEUMOVAX.  On 04-MAR-2009 the patient received the second 0.5 ml dose of PNEUMOVAX IM into his right deltoid (lot # 661577/1161X).  Concomitant therapy included GLUCOPHAGE, ASPIRIN, LISINOPRIL (MSD), insulin and unspecified inhalers.  On 04-MAR-2009 the patient had injection site reaction after receiving the vaccine. He experienced redness, pain, swelling and warmth in his right arm at the injection site.  The patient was evaluated in the office and diagnosed with cellulitis.  The patient was treated with KEFLEX and BENADRYL.  The patient was seen in the office a second time, and at that time red streaks were noted on his right arm.  The dose of KEFLEX was increased.  No lab diagnostics studies were performed.  At the time of reporting, the outcome was unknown.  Follow up information was received from a physician concerning the 71 year old retired patient who on 04-MAR-2009 at 14:00 received the second 0.5 ml dose of PNEUMOVAX SC (previously reported as IM) into his right deltoid (lot # 661577/1161X).  On 04-MAR-2009 at 15:00 the patient experienced serious local reaction to immunization with circumferential erythema, induration, edema and tenderness arm at side of injection.  50 percent of arm was involved.  Treatment was given for secondary cellulitis.  On 13-MAR-2009 the patient recovered.  Injection site cellulitis was considered to be an other important medical event by the physician.  This is one of several reports from the same source.  Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a healthcare worker concerning a 71 year old male patient with diabetes, hypertension and chronic obstructive pulmonary disease and no known drug allergies who in 2003 was vaccinated with the first 0.5 ml IM dose of PNEUMOVAX.  On 04-MAR-2009 the patient received the second 0.5 ml dose of PNEUMOVAX IM into his right deltoid (lot # 661577/1161X).  Concomitant therapy included GLUCOPHAGE, ASPIRIN, LISINOPRIL (MSD), insulin and unspecified inhalers.  On 04-MAR-2009 the patient had injection site reaction after receiving the vaccine. He experienced redness, pain, swelling and warmth in his right arm at the injection site.  The patient was evaluated in the office and diagnosed with cellulitis.  The patient was treated with KEFLEX and BENADRYL.  The patient was seen in the office a second time, and at that time red streaks were noted on his right arm.  The dose of KEFLEX was increased.  No lab diagnostics studies were performed.  At the time of reporting, the outcome was unknown.  Follow up information was received from a physician concerning the 71 year old retired patient who on 04-MAR-2009 at 14:00 received the second 0.5 ml dose of PNEUMOVAX SC (previously reported as IM) into his right deltoid (lot # 661577/1161X).  On 04-MAR-2009 at 15:00 the patient experienced serious local reaction to immunization with circumferential erythema, induration, edema and tenderness arm at side of injection.  50 percent of arm was involved.  Treatment was given for secondary cellulitis.  On 13-MAR-2009 the patient recovered.  Injection site cellulitis was considered to be an other important medical event by the physician.  This is one of several reports from the same source.  Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker concerning a 71 year old male patient with diabetes, hypertension and chronic obstructive pulmonary disease and no known drug allergies who in 2003 was vaccinated with the first 0.5 ml IM dose of PNEUMOVAX.  On 04-MAR-2009 the patient received the second 0.5 ml dose of PNEUMOVAX IM into his right deltoid (lot # 661577/1161X).  Concomitant therapy included GLUCOPHAGE, ASPIRIN, LISINOPRIL (MSD), insulin and unspecified inhalers.  On 04-MAR-2009 the patient had injection site reaction after receiving the vaccine. He experienced redness, pain, swelling and warmth in his right arm at the injection site.  The patient was evaluated in the office and diagnosed with cellulitis.  The patient was treated with KEFLEX and BENADRYL.  The patient was seen in the office a second time, and at that time red streaks were noted on his right arm.  The dose of KEFLEX was increased.  No lab diagnostics studies were performed.  At the time of reporting, the outcome was unknown.  Follow up information was received from a physician concerning the 71 year old retired patient who on 04-MAR-2009 at 14:00 received the second 0.5 ml dose of PNEUMOVAX SC (previously reported as IM) into his right deltoid (lot # 661577/1161X).  On 04-MAR-2009 at 15:00 the patient experienced serious local reaction to immunization with circumferential erythema, induration, edema and tenderness arm at side of injection.  50 percent of arm was involved.  Treatment was given for secondary cellulitis.  On 13-MAR-2009 the patient recovered.  Injection site cellulitis was considered to be an other important medical event by the physician.  This is one of several reports from the same source.  Additional information is not expected.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hyperaesthesia, Pain, Periarthritis, Swelling
Clinical narrative: Information has been received from a 64 year old male patient with allergic to PENICILLIN who on 24-SEP-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (lot # "89124").  Concomitant therapy included PANTOPRAZOLE.  On 25-SEP-2008 the patient experienced sore arm.  Later he was diagnosed with adhesive capsulitis.  No lab diagnostic studies were performed.  At the time of reporting, the patient was not recovered.  The patient sought unspecified medical attention.  Follow up information was received from the patient who reported that the lot # was 662020/0614X.  It was reported that the patient had swelling also and was in a physical therapy for adhesive capsulitis.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: Information has been received from a 64 year old male patient with allergic to PENICILLIN who on 24-SEP-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (lot # "89124").  Concomitant therapy included PANTOPRAZOLE.  On 25-SEP-2008 the patient experienced sore arm.  Later he was diagnosed with adhesive capsulitis.  No lab diagnostic studies were performed.  At the time of reporting, the patient was not recovered.  The patient sought unspecified medical attention.  Follow up information was received from the patient who reported that the lot # was 662020/0614X.  It was reported that the patient had swelling also and was in a physical therapy for adhesive capsulitis.  Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anxiety, Chest X-ray normal, Incorrect route of drug administration, Respiratory disorder
Clinical narrative: Information has been received from a pharmacist concerning a 33 year old female with asthma, sleep apnea who was in hospital for shortness of breath and was administered PNEUMOVAX, 0.5ml, intravenously on 11-APR-2009.  The patient developed back spasms and numbness in her arms and back immediately.  She also had bradycardia which developed into tachycardia.  She had been given SOLU-MEDROL to treat her shortness of breath right before she was given PNEUMOVAX.  The pharmacist was not sure whether or not this adverse event prolonged the patient's hospitalization.  The patient sought medical attention and recovered.  Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Bradycardia, Hypoaesthesia, Incorrect route of drug administration, Muscle spasms, Tachycardia
Clinical narrative: Information has been received from a pharmacist concerning a 33 year old female with asthma, sleep apnea who was in hospital for shortness of breath and was administered PNEUMOVAX, 0.5ml, intravenously on 11-APR-2009.  The patient developed back spasms and numbness in her arms and back immediately.  She also had bradycardia which developed into tachycardia.  She had been given SOLU-MEDROL to treat her shortness of breath right before she was given PNEUMOVAX.  The pharmacist was not sure whether or not this adverse event prolonged the patient's hospitalization.  The patient sought medical attention and recovered.  Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA, PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from an office manager concerning a 6 year old male patient with no known allergies and no pertinent medical history.  Who on 31-OCT-2008 was vaccinated with 0.5 ml of a dose of PNEUMOVAX in the right deltoid (I.M.) (Lot# 662042/0622X).  There was no concomitant medication.  On 31-OCT-2008 the patient developed hard, swollen, and tender to touch area at the injection site of the right deltoid.  Subsequently, the patient was seen in the office on 03-NOV-2008 and was prescribed AUGMENTIN.  The patient had recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA, PPV, PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 6 year old male patient with no known allergies and no pertinent medical history.  Who on 31-OCT-2008 was vaccinated with 0.5 ml of a dose of PNEUMOVAX in the right deltoid (I.M.) (Lot# 662042/0622X).  There was no concomitant medication.  On 31-OCT-2008 the patient developed hard, swollen, and tender to touch area at the injection site of the right deltoid.  Subsequently, the patient was seen in the office on 03-NOV-2008 and was prescribed AUGMENTIN.  The patient had recovered.  This is one of several reports from the same source.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PPV, RV5
Symptoms: Cyanosis, Oxygen saturation, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning an 8 week old patient who on 20-MAR-2009 was vaccinated with PNEUMOVAX vaccine instead of PREVNAR by mistake due to an office error. On 20-MAR-2009 the patient experienced "blue in the face" after the vaccine was given. The physician stated that upon examination the infant was fine and the pulse oximeter was normal. On 20-MAR-2009 the patient recovered. The patient sought medical attention via speaking to physician. Follow up information was received from the office manager concerning the 8 week old female patient who on 20-MAR-2009 was vaccinated with PNEUMOVAX vaccine (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. On 20-MAR-2009 the patient also received PENTACEL, RECOMBIVAX HB (manufacturer unknown), and ROTATEQ (MSD). Follow up information was received from the office manager which reported that on 20-MAR-2009 the patient was vaccinated IM with the first dose of PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. On 20-MAR-2009 the patient also received the first IM dose of PENTACEL (lot # C3274AA), the first IM dose of RECOMBIVAX HB vaccine (MSD) (lot# 662390/1039X), and the first PO dose of ROTATEQ vaccine (MSD) (lot # 660377/0274X).There was no illness at the time of vaccination. On 20-MAR-2009, after leaving office the patient "turned blue" when she was strapped in the car seat. It lasted a few seconds, and the patient pinked up on her own. The patient's parents brought her right back in office. Pulse oximeter was 97-98%. No abnormality was detected. On 20-MAR-2009 the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PPV, RV5
Symptoms: Cyanosis, Oxygen saturation normal, Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning an 8 week old patient who on 20-MAR-2009 was vaccinated with PNEUMOVAX vaccine instead of PREVNAR by mistake due to an office error. On 20-MAR-2009 the patient experienced "blue in the face" after the vaccine was given. The physician stated that upon examination the infant was fine and the pulse oximeter was normal. On 20-MAR-2009 the patient recovered. The patient sought medical attention via speaking to physician. Follow up information was received from the office manager concerning the 8 week old female patient who on 20-MAR-2009 was vaccinated with PNEUMOVAX vaccine (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. On 20-MAR-2009 the patient also received PENTACEL, RECOMBIVAX HB (manufacturer unknown), and ROTATEQ (MSD). Follow up information was received from the office manager which reported that on 20-MAR-2009 the patient was vaccinated IM with the first dose of PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. On 20-MAR-2009 the patient also received the first IM dose of PENTACEL (lot # C3274AA), the first IM dose of RECOMBIVAX HB vaccine (MSD) (lot# 662390/1039X), and the first PO dose of ROTATEQ vaccine (MSD) (lot # 660377/0274X).There was no illness at the time of vaccination. On 20-MAR-2009, after leaving office the patient "turned blue" when she was strapped in the car seat. It lasted a few seconds, and the patient pinked up on her own. The patient's parents brought her right back in office. Pulse oximeter was 97-98%. No abnormality was detected. On 20-MAR-2009 the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Influenza like illness, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with tenaus and dipt, sulfa and codeine allergy who on 05-MAY-2009 was vaccinated with the first dose of PNEUMOVAX vaccine (lot # 662599/1076X) at a pharmacy. On 05-MAY-2009 after receiving PNEUMOVAX vaccine, the patient developed redness and swelling at injection site. The patient was in the office for routine blood work scheduled prior to receiving PNEUMOVAX vaccine on 08-MAY-2009. The patient had the physician look at her left arm injection reaction while in the office. No treatment from the physician. At the time of this report, the patient was not recovered from redness and swelling at injection site. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood test, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with tenaus and dipt, sulfa and codeine allergy who on 05-MAY-2009 was vaccinated with the first dose of PNEUMOVAX vaccine (lot # 662599/1076X) at a pharmacy. On 05-MAY-2009 after receiving PNEUMOVAX vaccine, the patient developed redness and swelling at injection site. The patient was in the office for routine blood work scheduled prior to receiving PNEUMOVAX vaccine on 08-MAY-2009. The patient had the physician look at her left arm injection reaction while in the office. No treatment from the physician. At the time of this report, the patient was not recovered from redness and swelling at injection site. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with tenaus and dipt, sulfa and codeine allergy who on 05-MAY-2009 was vaccinated with the first dose of PNEUMOVAX vaccine (lot # 662599/1076X) at a pharmacy. On 05-MAY-2009 after receiving PNEUMOVAX vaccine, the patient developed redness and swelling at injection site. The patient was in the office for routine blood work scheduled prior to receiving PNEUMOVAX vaccine on 08-MAY-2009. The patient had the physician look at her left arm injection reaction while in the office. No treatment from the physician. At the time of this report, the patient was not recovered from redness and swelling at injection site. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Influenza like illness, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a female who on 07-MAY-2009 was vaccinated with a dose of PNEUMOVAX (Lot# 662599/1076X). On 08-MAY-2009, the patient's arm became red and swollen from the injection site to her elbow. The patient was not recovered. Laboratory tests were not performed. The patient sought unspecified medical attention by an office visit. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood test, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a female who on 07-MAY-2009 was vaccinated with a dose of PNEUMOVAX (Lot# 662599/1076X). On 08-MAY-2009, the patient's arm became red and swollen from the injection site to her elbow. The patient was not recovered. Laboratory tests were not performed. The patient sought unspecified medical attention by an office visit. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a female who on 07-MAY-2009 was vaccinated with a dose of PNEUMOVAX (Lot# 662599/1076X). On 08-MAY-2009, the patient's arm became red and swollen from the injection site to her elbow. The patient was not recovered. Laboratory tests were not performed. The patient sought unspecified medical attention by an office visit. Additional information has been requested.