chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 70 year old female who on 12-JUN-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 659487/1960U). On 13-JUN-2008 the patient experienced an injection site reaction after vaccination. She experienced redness, swelling, and soreness at the site of injection. It was also noted that the swollen area was warm to touch. The patient sought medical attention at the practice. At the time of the report, the outcomes of the injection site redness, swelling and swollen area was warm to touch were unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 64 year old female who on 16-JUN-2008 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 659487/1960U). On 18-JUN-2008 the patient experienced an injection site reaction after vaccination. She experienced redness, swelling and soreness at the site of injection. It was also noted that the swollen area was warm to touch. The patient sought medical attention at the office. At the time of the report, the outcomes of the injection site redness, swelling and swollen area was warm to touch were unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a related who was vaccinated with a dose of PNEUMOVAX 23. Subsequently, the patient developed a rash post vaccination. At the time of the report, the patient was recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 69 year old female with a history of vaccination with BCG in the left arm (1938) and an allergy to penicillin who on 21-MAY-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 649694/0386P) IM in the right deltoid in the evening. On 21-MAY-2008 in the evening, the patient developed an injection site reaction. Her upper arm became red and itchy and she developed a fever. The patient also developed injection site edema. The patient recovered in 2-3 days after vaccination. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female with an allergy to lipstick, heart disease congenital, high blood pressure and a history of cholesterol levels raised and breast cancer, who on 19-JUN-2008 was vaccinated with 0.5 ml of PNEUMOVAX 23 (lot# 659150/1384U). It was unknown if this was the first or second dose. Concomitant therapy included LOTREL, TAXUS and ATENOL. On 20-JUN-2008 the patient experienced swelling at the injection site of her arm. Unspecified medical attention was sought during office visit. It was reported that the patient was treated with unspecified antibiotic. The patient's swelling at the injection site persisted. No additional information is available. No additional information is expected.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Asthenia, Axillary pain
Clinical narrative: Initial and follow-up information has been received from a physician, concerning his 61 year old, female retired wife with gastrooesophageal reflux disease, hiatal hernia, glycerin allergy, cholesterol high and osteoporosis who on 26-JUN-2008 (also reported as 24-JUN-2008) was vaccinated with the first dose of PNEUMOVAX 23 (lot # 659487/1960U), intramuscularly to the arm. Concomitant vaccinations on 26-JUN-2008 (also reported as 24-JUN-2008) included ZOSTAVAX (lot # reported as 566601). Other concomitant therapy included NEXIUM, ACTONEL, hormone replacement therapy (unspecified), ZETIA and FOSAMAX. Within 8-9 hours of receiving PNEUMOVAX 23 and ZOSTAVAX, the patient developed a high fever ranging from 101-102.2 with rigors, nausea, myalgia, arthralgia (especially back), and profound weakness. She developed an injection reaction in the left arm with pain, swelling, and a raised welt area of 6-7 cm surrounding the injection site. She also complained of left axilla pain. On 26-JUN-2008 the patient became dehydrated and was seen in the emergency room. Her temperature was 96.4, pulse rate was 108, respiratory rate was 16, oxygen saturation was 98% on room air, and blood pressure was 107/57. Laboratory work was obtained and a chest x-ray was performed. The patient had elevated lab studies: white blood cell count: 13.1 x 10^3/uL, c-reactive protein (CRP) was 20, her aspartate aminotransferase (AST) was reported as high at 70 U/L and her amino alanine transferase (ALT) was high at 63 U/L. General chemistry showed a low sodium of 133mmol/L, a low potassium of 3.3 mmol/L, and a high glucose of 224 mg/dl. Her chest x-ray showed no evidence of acute cardiopulmonary abnormality and her urinalysis was reported as normal, with trace occult blood. She was given intravenous (IV) fluids. Normal Saline .9% in the right hand. She refused ZOFRAN. It was also reported that she was treated with aspirin (manufacturer unknown) and phenergan as needed. The patient was discharged home, with a diagnosis of dehydration, myalgia and arthralgia. She was prescribed DARVOCET and a clear liquid diet. The patient was reported as recovered on 28-JUN-2008. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Blood glucose increased, Blood potassium decreased, Blood sodium decreased, C-reactive protein increased, Chest X-ray normal
Clinical narrative: Initial and follow-up information has been received from a physician, concerning his 61 year old, female retired wife with gastrooesophageal reflux disease, hiatal hernia, glycerin allergy, cholesterol high and osteoporosis who on 26-JUN-2008 (also reported as 24-JUN-2008) was vaccinated with the first dose of PNEUMOVAX 23 (lot # 659487/1960U), intramuscularly to the arm. Concomitant vaccinations on 26-JUN-2008 (also reported as 24-JUN-2008) included ZOSTAVAX (lot # reported as 566601). Other concomitant therapy included NEXIUM, ACTONEL, hormone replacement therapy (unspecified), ZETIA and FOSAMAX. Within 8-9 hours of receiving PNEUMOVAX 23 and ZOSTAVAX, the patient developed a high fever ranging from 101-102.2 with rigors, nausea, myalgia, arthralgia (especially back), and profound weakness. She developed an injection reaction in the left arm with pain, swelling, and a raised welt area of 6-7 cm surrounding the injection site. She also complained of left axilla pain. On 26-JUN-2008 the patient became dehydrated and was seen in the emergency room. Her temperature was 96.4, pulse rate was 108, respiratory rate was 16, oxygen saturation was 98% on room air, and blood pressure was 107/57. Laboratory work was obtained and a chest x-ray was performed. The patient had elevated lab studies: white blood cell count: 13.1 x 10^3/uL, c-reactive protein (CRP) was 20, her aspartate aminotransferase (AST) was reported as high at 70 U/L and her amino alanine transferase (ALT) was high at 63 U/L. General chemistry showed a low sodium of 133mmol/L, a low potassium of 3.3 mmol/L, and a high glucose of 224 mg/dl. Her chest x-ray showed no evidence of acute cardiopulmonary abnormality and her urinalysis was reported as normal, with trace occult blood. She was given intravenous (IV) fluids. Normal Saline .9% in the right hand. She refused ZOFRAN. It was also reported that she was treated with aspirin (manufacturer unknown) and phenergan as needed. The patient was discharged home, with a diagnosis of dehydration, myalgia and arthralgia. She was prescribed DARVOCET and a clear liquid diet. The patient was reported as recovered on 28-JUN-2008. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Dehydration, Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a physician, concerning his 61 year old, female retired wife with gastrooesophageal reflux disease, hiatal hernia, glycerin allergy, cholesterol high and osteoporosis who on 26-JUN-2008 (also reported as 24-JUN-2008) was vaccinated with the first dose of PNEUMOVAX 23 (lot # 659487/1960U), intramuscularly to the arm. Concomitant vaccinations on 26-JUN-2008 (also reported as 24-JUN-2008) included ZOSTAVAX (lot # reported as 566601). Other concomitant therapy included NEXIUM, ACTONEL, hormone replacement therapy (unspecified), ZETIA and FOSAMAX. Within 8-9 hours of receiving PNEUMOVAX 23 and ZOSTAVAX, the patient developed a high fever ranging from 101-102.2 with rigors, nausea, myalgia, arthralgia (especially back), and profound weakness. She developed an injection reaction in the left arm with pain, swelling, and a raised welt area of 6-7 cm surrounding the injection site. She also complained of left axilla pain. On 26-JUN-2008 the patient became dehydrated and was seen in the emergency room. Her temperature was 96.4, pulse rate was 108, respiratory rate was 16, oxygen saturation was 98% on room air, and blood pressure was 107/57. Laboratory work was obtained and a chest x-ray was performed. The patient had elevated lab studies: white blood cell count: 13.1 x 10^3/uL, c-reactive protein (CRP) was 20, her aspartate aminotransferase (AST) was reported as high at 70 U/L and her amino alanine transferase (ALT) was high at 63 U/L. General chemistry showed a low sodium of 133mmol/L, a low potassium of 3.3 mmol/L, and a high glucose of 224 mg/dl. Her chest x-ray showed no evidence of acute cardiopulmonary abnormality and her urinalysis was reported as normal, with trace occult blood. She was given intravenous (IV) fluids. Normal Saline .9% in the right hand. She refused ZOFRAN. It was also reported that she was treated with aspirin (manufacturer unknown) and phenergan as needed. The patient was discharged home, with a diagnosis of dehydration, myalgia and arthralgia. She was prescribed DARVOCET and a clear liquid diet. The patient was reported as recovered on 28-JUN-2008. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site urticaria, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a physician, concerning his 61 year old, female retired wife with gastrooesophageal reflux disease, hiatal hernia, glycerin allergy, cholesterol high and osteoporosis who on 26-JUN-2008 (also reported as 24-JUN-2008) was vaccinated with the first dose of PNEUMOVAX 23 (lot # 659487/1960U), intramuscularly to the arm. Concomitant vaccinations on 26-JUN-2008 (also reported as 24-JUN-2008) included ZOSTAVAX (lot # reported as 566601). Other concomitant therapy included NEXIUM, ACTONEL, hormone replacement therapy (unspecified), ZETIA and FOSAMAX. Within 8-9 hours of receiving PNEUMOVAX 23 and ZOSTAVAX, the patient developed a high fever ranging from 101-102.2 with rigors, nausea, myalgia, arthralgia (especially back), and profound weakness. She developed an injection reaction in the left arm with pain, swelling, and a raised welt area of 6-7 cm surrounding the injection site. She also complained of left axilla pain. On 26-JUN-2008 the patient became dehydrated and was seen in the emergency room. Her temperature was 96.4, pulse rate was 108, respiratory rate was 16, oxygen saturation was 98% on room air, and blood pressure was 107/57. Laboratory work was obtained and a chest x-ray was performed. The patient had elevated lab studies: white blood cell count: 13.1 x 10^3/uL, c-reactive protein (CRP) was 20, her aspartate aminotransferase (AST) was reported as high at 70 U/L and her amino alanine transferase (ALT) was high at 63 U/L. General chemistry showed a low sodium of 133mmol/L, a low potassium of 3.3 mmol/L, and a high glucose of 224 mg/dl. Her chest x-ray showed no evidence of acute cardiopulmonary abnormality and her urinalysis was reported as normal, with trace occult blood. She was given intravenous (IV) fluids. Normal Saline .9% in the right hand. She refused ZOFRAN. It was also reported that she was treated with aspirin (manufacturer unknown) and phenergan as needed. The patient was discharged home, with a diagnosis of dehydration, myalgia and arthralgia. She was prescribed DARVOCET and a clear liquid diet. The patient was reported as recovered on 28-JUN-2008. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Red blood cells urine positive, Urine analysis normal, Urticaria, White blood cell count increased
Clinical narrative: Initial and follow-up information has been received from a physician, concerning his 61 year old, female retired wife with gastrooesophageal reflux disease, hiatal hernia, glycerin allergy, cholesterol high and osteoporosis who on 26-JUN-2008 (also reported as 24-JUN-2008) was vaccinated with the first dose of PNEUMOVAX 23 (lot # 659487/1960U), intramuscularly to the arm. Concomitant vaccinations on 26-JUN-2008 (also reported as 24-JUN-2008) included ZOSTAVAX (lot # reported as 566601). Other concomitant therapy included NEXIUM, ACTONEL, hormone replacement therapy (unspecified), ZETIA and FOSAMAX. Within 8-9 hours of receiving PNEUMOVAX 23 and ZOSTAVAX, the patient developed a high fever ranging from 101-102.2 with rigors, nausea, myalgia, arthralgia (especially back), and profound weakness. She developed an injection reaction in the left arm with pain, swelling, and a raised welt area of 6-7 cm surrounding the injection site. She also complained of left axilla pain. On 26-JUN-2008 the patient became dehydrated and was seen in the emergency room. Her temperature was 96.4, pulse rate was 108, respiratory rate was 16, oxygen saturation was 98% on room air, and blood pressure was 107/57. Laboratory work was obtained and a chest x-ray was performed. The patient had elevated lab studies: white blood cell count: 13.1 x 10^3/uL, c-reactive protein (CRP) was 20, her aspartate aminotransferase (AST) was reported as high at 70 U/L and her amino alanine transferase (ALT) was high at 63 U/L. General chemistry showed a low sodium of 133mmol/L, a low potassium of 3.3 mmol/L, and a high glucose of 224 mg/dl. Her chest x-ray showed no evidence of acute cardiopulmonary abnormality and her urinalysis was reported as normal, with trace occult blood. She was given intravenous (IV) fluids. Normal Saline .9% in the right hand. She refused ZOFRAN. It was also reported that she was treated with aspirin (manufacturer unknown) and phenergan as needed. The patient was discharged home, with a diagnosis of dehydration, myalgia and arthralgia. She was prescribed DARVOCET and a clear liquid diet. The patient was reported as recovered on 28-JUN-2008. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Incorrect route of drug administration, Injection site erythema, Rash
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 71 year old white female with hypertension, dyslipidemia, senile dementia, depression and osteoporosis and no known allergies, who on 28-Nov-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot# not reported). Concomitant therapy included Simvastatin (MSD) Lexapro, Detrol LA, Alendronate, Lisinopril (manufacturer unknown) and Synthroid. On 26-June-2008 at 1:00pm (previously reported as 8:00am) the patient was vaccinated intradermally into her left forearm with a second dose of PNEUMOVAX 23 vaccine (lot# 659199/1541U). On 26-June-2008 at 9:00am, the patient also received a tuberculin purified protein derivative (PPD) intradermally in the right forearm. On 27-June-2008, the patient developed erythema at the injection site, about 6cm in diameter. At 12:30 pm (previously reported as 5:30pm) the patient developed a "red line" going upwards from the rash on left forearm about 11cm. The patient was examined by the physician. On 28-Jun-2008 (previously reported as 30-June-2008), the patient recovered from the 11 cm erythema on the left forearm. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old female who was vaccinated with PNEUMOVAX (date not reported). Concomitant therapy included PREVACID and ZIAC. On 27-JUN-2008, the patient was vaccinated with a second IM dose of PNEUMOVAX and experienced a large, red, swollen area at the site of injection that was about three inches in diameter. She also experienced muscle aches and a slight fever. On approximately 30-JUN-2008, about three days post vaccination the patient developed a cough. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Rash papular
Clinical narrative: Initials and follow up information has been received from a licensed practical nurse and a physician concerning a 78 year old male patient with hypertension and a history of prostate cancer, colon cancer, colectomy and bone spur who on 04-Dec-1998 was vaccinated with the first dose of PNEUMOVAX 23 (lot number not reported). On 13-March-2008, the patient was vaccinated intramuscularly in the deltoid with a second 0.5ml dose of PNEUMOVAX 23 (lot number 659486/1539U). Concomitant medications included Atenolol, Lisinopril, Casodex and Lupron. There was no illness at the time of vaccination. The physician reported that on 13-May-2008 the patient experienced a swollen red area over the site of injection and that the patient had not experienced any adverse events following prior vaccination. The nurse reported that on 19-May-2008, the patient experienced reddened arms with small clear dots after receiving the second vaccination. The patient's arm was examined during a scheduled office blood pressure check on 19-May-2008 and no treatment was rendered. The patient sought unspecified medical attention. No other symptoms reported. Subsequently, the patient recovered. No further information is expected.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Initial and follow up information has been received from a certified medical assistant concerning an 87 year old female with no medical history and no drug allergies, who was vaccinated subcutaneously into the left arm with a first dose of PNEUMOVAX (Lot # 659199/1541U). There was no concomitant medication. On 27-JUN-2008 the patient developed redness at the injection site down to here elbow. The injection site was sore and warm to touch. The patient sought unspecified medical attention. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: PPV, TTOX
Symptoms: Injection site pain
Clinical narrative: Initial and follow up information has been received from a physician and from a health professional and concerning a 35 year old male with no known drug allergies and no previous medical history who on 20-JUN-2008 at 12:00PM was vaccinated with a dose of PNEUMOVAX (lot# 659487/1960U) (route not reported) into the left deltoid at 12:00PM. The patient  had also been vaccinated with Tetanus vaccine in the other arm. There was no concomitant medication. The physician had indicated that the patient had experienced pain at the injection site from the PNEUMOVAX vaccine. The dose came from a single 5-dose vial. The pain had occurred a few hours after administration and resolved within 24-48 hours later. No further information is available. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning an adult female who a long time ago was vaccinated with PNEUMOVAX (lot # not reported) and had an allergic reaction. No additional information was provided. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 72 year old male with no known drug allergies and no previous medical history who was vaccinated with PNEUMOVAX (lot # 659487/1960U) (route and site not reported) between 24-Jun-2008 and 27-Jun-2008. There was no concomitant medication. The physician had indicated that the patient had experienced pain at the injection site from the PNEUMOVAX vaccine. The dose came from a single 5-dose vial. The pain had occurred a few hours after administration and resolved within 24-48 hours later. No further information is available. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Initial and follow up information has been received from a physician concerning a 65 year old female patient who on 26-JUN-2008 at 10:00 AM was vaccinated into the right deltoid with PNEUMOVAX (lot# 659487/1960U). It was unknown if there was any concomitant medication. The physician reported that the patient experienced pain at the injection site from the PNEUMOVAX vaccine. The dose came from a single 5-dose vial. The pain occurred a few hours after administration and resolved within 24-48 hours later. It was unknown if medical attention was sought. No further information is available. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 68 year old female who on unspecified date was vaccinated into shoulder of the arm (unspecified which arm) with PNEUMOVAX (lot # and dose # were unspecified). It was reported that on unspecified date the patient developed injection site reaction of redness, swelling and low grade fever. Unspecified medical attention was sought by visiting office. At the time of this report the patient had not recovered. No other information available. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: PPV
Symptoms: Medication error, No adverse event, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a healthy female infant who on 17-JUL-2008 was inadvertently vaccinated with PNEUMOVAX(lot number: 657626/1084U) (route not known) instead of PEDIARIX(lot number: AC21B138BA). The nurse reported that the boxes were right next to each other in the refrigerator. Both boxes are pink and white and both vials have maroon caps on them. Product confusion occurred. In follow up it was reported that patient recovered and had no treatments. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Antinuclear antibody increased, Erythema, Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a 60 year old female consumer with hurting joints, non-specific connective tissue disorder and THIMEROSAL allergy who about 5-10 years ago was vaccinated with either a dose of PNEUMOVAX.  There was no concomitant medication.  The day after vaccination, the vaccinated arm swelled up to the size of a grapefruit or larger.  The area was red and hot.  The patient became very ill and had a temperature of 104 F.  The symptoms resolved in a couple of days.  The patient tested high on anti-nuclear antibodies.  No medical attention was sought.  Additional information has been requested.  This is an amended report.  The adverse event term of "very ill" which maps to "malaise" has been added.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a 60 year old female consumer with hurting joints, non-specific connective tissue disorder and THIMEROSAL allergy who about 5-10 years ago was vaccinated with either a dose of PNEUMOVAX.  There was no concomitant medication.  The day after vaccination, the vaccinated arm swelled up to the size of a grapefruit or larger.  The area was red and hot.  The patient became very ill and had a temperature of 104 F.  The symptoms resolved in a couple of days.  The patient tested high on anti-nuclear antibodies.  No medical attention was sought.  Additional information has been requested.  This is an amended report.  The adverse event term of "very ill" which maps to "malaise" has been added.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Myalgia, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 69 year old female with no drug reactions or allergies and depression, asthma and a history of breast cancer who on 09-JUL-2008 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX (Lot #661039/0248X). Concomitant therapy included PROZAC and albuterol. Within a few hours of vaccination, the patient developed a local reaction. Symptoms included redness, pain and swelling. Within 24 of vaccination, the patient developed systemic reactions including fever and myalgia. The patient was told to use ice and TYLENOL. The patient does not recall receiving PNEUMOVAX prior to this. Unknown medical attention was sought. Patient outcome was recovered on an unspecified date. The report is related to WAES # 0807USA04073 from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 69 year old female with no drug reactions or allergies and depression, asthma and a history of breast cancer who on 09-JUL-2008 was vaccinated IM with the first 0.5 ml dose of PNEUMOVAX (Lot #661039/0248X). Concomitant therapy included PROZAC and albuterol. Within a few hours of vaccination, the patient developed a local reaction. Symptoms included redness, pain and swelling. Within 24 of vaccination, the patient developed systemic reactions including fever and myalgia. The patient was told to use ice and TYLENOL. The patient does not recall receiving PNEUMOVAX prior to this. Unknown medical attention was sought. Patient outcome was recovered on an unspecified date. The report is related to WAES # 0807USA04073 from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Initial and follow-up formation has been received from a physician concerning a 35 year old female patient with allergies (unspecified), but no known drug reactions/allergies, who on 18-JUL-2008 was vaccinated with a 0.5 mL first dose of PNEUMOVAX (lot # not provided).  Concomitant therapy included montelukast sodium (MSD), ALLEGRA-D, NASONEX.  Subsequently the patient developed an injection site reaction following vaccination described as a "welt the size of a softball that was really hot."  The patient also developed a fever of 104.0 degrees "for the past 36 hours."  The physician prescribed a topical steroid and BENADRYL.  The physician also reported that "the patient had a similar reaction to the TB test."  At the time of reporting, the patient was recovering.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Information has been received from a physician concerning a 66 year old male patient with no known drug allergies who on 14-JUL-2008 was vaccinated IM in the deltoid with a second dose of 0.5 mL PNEUMOVAX (lot # 661039/0248X) and developed localized and systemic reactions. Concomitant therapy included atenolol, fexofenadine hydrochloride, piroxicam, triamterene/hydrochlorothiazide, aspirin and FLONASE. The local reaction included redness, swelling and pain and occurred within a few hours of vaccination. The systemic reactions were within 24 hours and included fever and myalgia. The patient was told to use ice and TYLENOL. The patient was seen last week for his symptoms and was told to call the office if he did not get better. The physician had not heard from the patient since. At the patient's appointment on 14-Jul-2008, the patient could not remember whether or not he had received a dose of PNEUMOVAX (lot # not provided) previously but is was later found out after vaccination that he had received one dose approximately 2 years ago. The patient's outcome was not known. This is one of two reports from the same source (WAES# 0807USA04021). Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 66 year old male patient with no known drug allergies who on 14-JUL-2008 was vaccinated IM in the deltoid with a second dose of 0.5 mL PNEUMOVAX (lot # 661039/0248X) and developed localized and systemic reactions. Concomitant therapy included atenolol, fexofenadine hydrochloride, piroxicam, triamterene/hydrochlorothiazide, aspirin and FLONASE. The local reaction included redness, swelling and pain and occurred within a few hours of vaccination. The systemic reactions were within 24 hours and included fever and myalgia. The patient was told to use ice and TYLENOL. The patient was seen last week for his symptoms and was told to call the office if he did not get better. The physician had not heard from the patient since. At the patient's appointment on 14-Jul-2008, the patient could not remember whether or not he had received a dose of PNEUMOVAX (lot # not provided) previously but is was later found out after vaccination that he had received one dose approximately 2 years ago. The patient's outcome was not known. This is one of two reports from the same source (WAES# 0807USA04021). Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a female consumer (age unknown) who on an unspecified date was vaccinated (route unknown) with a dose of PNEUMOVAX (manufacturer unknown, lot # unknown) and a dose of influenza virus vaccine (unspecified, manufacturer unknown).  Subsequently, after receiving the vaccinations, on an unknown date, the patient experienced injection site reactions.  It is unknown if the patient sought medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Initial and follow up information has been received from a physician and a certified medical assistant concerning a 65 year old female patient who on 05-MAY-2008 at 10:30, was vaccinated intramuscularly into the left arm (previously reported as the right upper arm) with a dose of PNEUMOVAX (Lot# 657526/0555U).  There were no concomitant medications.  On 07-MAY-2008 the patient developed cellulitis.  The cellulitis became worse and the patient required an emergency room visit, with no hospital confinement.  The patient was also seen by a dermatologist and treated with antibiotics.  The patient is now fully recovered.  The physician reported that the cellulitis was a result of the patient's skin structure, and not associated with the vaccine.  No product quality complaint was involved.  The reporter considered cellulitis to be an other important medical event.  Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 94 year old female who on 16-JUL-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 658673/0990U). On 16-JUL-2008 the patient experienced injection-site soreness and swelling and was hospitalized. On an unspecified date, the patient recovered from injection-site soreness and swelling. No product quality complaint was involved. The physician requested that a lot check should be performed. Injection-site soreness and swelling were considered to be disabling. 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.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 55 year old male who on 16-JUL-2008 was vaccinated with PNEUMOVAX (lot # 658673/090U). On 16-JUL-2008 the patient experienced injection site soreness and injection site erythema. Subsequently, the patient recovered from injection site soreness and injection site erythema. The patient sought medical attention and contacted 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 for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported), with concomitant medications, pertinent medical history and drug reactions/allergies unspecified, who on 22-JUL-2008 was vaccinated with a dose of PNEUMOVAX (lot # 659149/1383U), 0.5 ml, intramuscularly (IM). Subsequently, on an unspecified date, the patient experienced soreness, redness and heat at the injection site. The patient sought unspecified medical treatment from the physician and was reported to be recovering. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 27-Jul-2008 was vaccinated with PNEUMOVAX 23 (lot# 662042/0622X) (route, site of administration not reported). The patient experienced injection site reaction after receiving the vaccine on the same day. The injection site became red and swollen. The patient sought unspecified  medical attention. The patient was recovering. This is one of several reports 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 evaluation and research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 27-JUL-2008 was vaccinated with PNEUMOVAX (Lot # 662042/0622X) (route, site of administration not reported).  The patient experienced injection site reaction after receiving the vaccine on the same day.  The injection site became red and swollen.  The patient sought unspecified medical attention. The patient was recovering.  This is one of several reports 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: M
Vaccine: PPV
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Information has been received from medical records regarding a case in ligation with rofecoxib (WAES# 0590USA03739) concerning a male patient (age unknown), who on 26-NOV-2002 was vaccinated in the left upper outer arm with a dose of PNEUMOVAX. The next day, on 27-NOV-2002, the patient developed pain and mild swelling in the left elbow, especially medial aspect as well as the medial proximal forearm. The patient was having trouble getting his rings on and off. Within the next twenty-four hours the patient had improved. It was reported that the patient had no previous vaccinations with PNEUMOVAX. The patient was seen by the physician and appeared to be pleasant and well. Examination of the left upper extremity revealed no tenderness, warmth, or erythema at the injection site in the left deltoid region. There was some tenderness involving the medial aspect of the elbow and proximal forearm medially. There was no joint swelling, no warmth, or erythema, and no swelling of he hand. The distal neurovascular function was intact. The patient was advised to try ibuprofen or ALEVE as needed, ice, and to follow-up with the physician as needed. No further information is available.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 84 year old mother who received PNEUMOVAX (lot # not reported) while she was in the hospital, and developed redness, pain and swelling of her arm at the injection site.  The patient sought medical attention.  No other information was available.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse practitioner concerning a patient who about a month ago, July 2008, was inadvertently vaccinated with PNEUMOVAX 23 (lot# not reported) for 2nd dose in place of in place of PREVNAR. The nurse practitioner reported that the confusion was due to a miscommunication between the nurse and herself. She confirmed with the nurse that the patient should receive PREVNAR, when she actually meant PNEUMOVAX vaccine. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) with drug reactions/allergy to RELAFEN and SOMA who on 15-OCT-1997 was vaccinated with the first dose of PNEUMOVAX 23 (lot not reported). The patient did not have any adverse symptoms after first vaccination. Concomitant therapy included alendronate sodium (MSD), PRAVACHOL and PREMARIN. On 01-DEC-2004, the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot not reported). Within 48 hours of the second vaccination, the patient developed a swollen arm. The patient was examined on 03-DEC-2004 and treated with KEFLEX for cellulitis. The patient recovered on an unspecified date. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a retired male patient with no known allergies and status post hip replacement who on 10-AUG-2008 was vaccinated via intradermal route into left forearm with 0.5 mL dose of PNEUMOVAX 23 (lot not reported). The reporter reported that the patient's arm turned red, swollen and it was sore. The condition resolved after three days and patient recovered. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 57 year old female with unknown allergies who on 07-AUG-2008 was vaccinated with PNEUMOVAX (lot # 655501/1035F). On 12-AUG 2008, the patient returned to the physician's office with injection site redness which was sized at half of her upper arm, injection site swelling and warm to touch. The patient also had a fever. The medical assistant reported that MEDROL DOSEPAK and antibiotic (unspecified) was ordered for the patient. The patient was also sent for chest x-ray, results were not back as yet. At the time of reporting, the patient had not recovered from injection site redness, injection site swelling and warm to touch and fever. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Laboratory test abnormal
Clinical narrative: Information has been received from a physician's assistant concerning a 62 year old female with a history of immunodeficiency who in approximately April 2008, was vaccinated with a 0.5 mL dose of PNEUMOVAX 23. Subsequently, the patient had titers drawn that showed 4 of 7 titers to be low. The patient sought medical attention. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 76 year old male patient with no known drug allergies, hypertension and a history of prostate cancer who on 29-JUL-2008 was vaccinated IM into the arm with a dose of PNEUMOVAX lot # 659149/1383U. Concomitant therapy included atenolol and CASODEX. The medical assistant reported that on 30-JUL-2008, the patient developed cellulitis of the arm after receiving the PNEUMOVAX. On 30-JUL-2008 the patient was evaluated by a physician (oncologist) and was admitted to the hospital for approximately 1 1/2 weeks. He was treated with unspecified antibiotics and the symptoms resolved on an unspecified day. No other symptoms or treatment reported. No other information was available. This is one of two reports from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a female in her 50's with diabetes who "one year ago", was vaccinated with her first dose of PNEUMOVAX (Lot #, site and route not reported).  One day after receiving the vaccine, the patient experienced hives, fever and a rash.  The patient sought unspecified medical attention.  On an unspecified date, the patient recovered from hives, fever and rash.  No additional information was provided.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old female with hypertension and sulfonamide allergy who on 22-JUL-2008 was vaccinated intramuscularly in the arm with a dose of PNEUMOVAX 23 (Lot # 659149/1383U; dose # unspecified). Concomitant therapy included hydrochlorothiazide (unspecified). On 23-JUL-2008 the patient experienced a swollen, reddened arm. The patient sought unspecified medical attention in the office. The patient applied ice and then heat to arm and took TYLENOL for discomfort. On 30-JUL-2008, also reported as "within a week's time (exact date unspecified)", the patient recovered from the swollen, reddened arm and discomfort. No other symptoms and no other treatment were reported. No additional information was provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Abasia, Dysuria, Gait disturbance, Guillain-Barre syndrome, Impaired work ability
Clinical narrative: Initial and follow up information has been received from a 60 year old male physician concerning himself, who in September 2002 and 16-SEP-2003 at 09:00 was vaccinated intramuscularly with the first and second doses of PNEUMOVAX (second dose lot # 644218/1027M). On 16-SEP-2003 the patient experienced an inappropriate schedule of the vaccine. On approximately 16-SEP-2003 the patient experienced Guillain barre syndrome. He complained of dragging his feet and became unable to walk. He could urinate at first but had difficulty 12 hours later. He then had paralysis up to the bottom of his ribs. Then function began to return over the next four weeks, moving down to his feet. There were no relevant diagnostic tests performed. He only missed 2 days of work but had trouble walking x 1 month, then he was "ok". Subsequently, (reported as 15-OCT-2008) the patient recovered from Guillain-Barre syndrome. No product quality complaint was involved. The reporting physician considered Guillain-Barre syndrome to be disabling. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Paralysis
Clinical narrative: Initial and follow up information has been received from a 60 year old male physician concerning himself, who in September 2002 and 16-SEP-2003 at 09:00 was vaccinated intramuscularly with the first and second doses of PNEUMOVAX (second dose lot # 644218/1027M). On 16-SEP-2003 the patient experienced an inappropriate schedule of the vaccine. On approximately 16-SEP-2003 the patient experienced Guillain barre syndrome. He complained of dragging his feet and became unable to walk. He could urinate at first but had difficulty 12 hours later. He then had paralysis up to the bottom of his ribs. Then function began to return over the next four weeks, moving down to his feet. There were no relevant diagnostic tests performed. He only missed 2 days of work but had trouble walking x 1 month, then he was "ok". Subsequently, (reported as 15-OCT-2008) the patient recovered from Guillain-Barre syndrome. No product quality complaint was involved. The reporting physician considered Guillain-Barre syndrome to be disabling. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PPV
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Irritability, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old male who on 18-AUG-2008 was vaccinated with a dose of PNEUMOVAX 23 vaccine. Concomitant therapy included DTaP (+) tetanus toxoid and poliovirus vaccine. The nurse reported that the 6 month old child may have received PNEUMOVAX 23 vaccine. The office was not sure that the child received PNEUMOVAX 23 vaccine. The child developed fever up to 104 degrees Fahrenheit and vomiting with increased irritability within 7 hours of vaccination on 18-AUG-2008. The patient sought medical attention by telephone, but no treatment information was provided. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 65 year old female (weight 150#, height 63") with drug allergies to MIACALCIN, NAPROSYN and ZITHROMAX who on 15-AUG-2008 at 11:00 am was vaccinated with the first dose of PNEUMOVAX, IM in the right deltoid. Concomitant medications were not reported. There were no illness reported at the time of vaccination. On 15-AUG-2008 at 08:00 pm, the patient developed severe headache, swelling and redness at injection site, throbbing, fever and chills. On 16-AUG-2008, the patient sought unspecified medical attention and was treated with dexamethasone, TORADOL, ROCEPHIN, and vitamin B-12. Subsequently on 18-AUG-2008, the patient recovered from severe headache, swelling at injection site, redness at injection site, throbbing, fever and chills. The causality of the events were not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Pain in extremity
Clinical narrative: Information has been received from an approximately 61 year old female consumer with no allergies/drug reactions and no pertinent medical history who reported that "about 5 years ago" (approximately 2003) she was vaccinated with PNEUMOVAX 23 vaccine (lot # not reported). There was no concomitant medication. "Soon after getting shot" she experienced a raised red welt at injection site to another and down to elbow which went away in a couple of weeks. She also reported having pain in her arm which lasted about one year. Unspecified medical attention was sought. Additional information is not expected.