chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction
Clinical narrative: Information has been received from a pharm. D. concerning a 62 year old male who was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (lot #: 662742/1117X). The patient developed an injection site reaction. The patient had severe erythema from his shoulder to elbow to his elbow. The patient was treated with ATARAX. The reporter did not know if the patient had received PNEUMOVAX in the past. The patient sought medical attention via office visit. Follow-up information has been received from the physician concerning this 62 year old male who on 10-MAR-2009, at 12:50 PM, was vaccinated IM with a dose of PNEUMOVAX (lot #: 662742/1117X). Subsequently, on the same day of vaccination (10-MAR-2009), the patient developed a severe erythema from his shoulder to his elbow. At the time of the report, the patient's status was unknown. This is one of several reports form the same source. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a Pharm. D. concerning a 60 year old female who on 04-MAR-2009 was vaccinated IM with a 0.5 ml PNEUMOVAX (lot # 662742/1117X). On 04-MAR-2009 the patient developed severe erythema of injection site. The erythema was from her deltoid to her elbow. The reporter did not know if the patient has received PNEUMOVAX in the past. She was unaware of any treatments given to the patient for her symptoms. The patient sought medical attention via office visit. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from an office manager concerning 8 patients who were vaccinated with PNEUMOVAX (lot # 662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patients sought medical attention in the office. In follow-up, the office manager indicated that 1 of the patients was a male who had a mild reaction to the PNEUMOVAX vaccination. The patient had redness around the injection site. This is one of several reports form the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received form an office manager concerning 8 patients who were vaccinated with PNEUMOVAX (lot # 662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patients sought medical attention in the office. In follow-up, the office manager indicated that one of the patients was a female who had a mild reaction to the PNEUMOVAX vaccination. The patient had redness around the injection site. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from an office manager concerning 8 patients who were vaccinated with PNEUMOVAX ( lot # 662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patients sought medical attention in the office. In follow-up, the office manager indicated that one of the patients was a female who had a mild reaction to the PNEUMOVAX vaccination. The patient had redness around the injection site. This is one of several reports form the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from an office manager concerning 8 patients who were vaccinated with PNEUMOVAX (662599/1076X). It was unspecified if this was the first or second dose for the patients. Subsequently the patients developed "very severe" injection site reactions. The patient sought medical attention in the office. In follow-up, the office manager indicated that one of the patients was a female who had a mild reaction to the PNEUMOVAX vaccination. The patient had redness around the injection site. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient, who on 11-MAR-2009 was vaccinated with the first dose of PNEUMOVAX (lot # 662785/1124X), intramuscularly. The nurse reported that on 13-MAR-2009, the patient developed cellulitis. She was treated with antibiotics and at the time of the report, the patient was recovering. The patient sought medical attention through an office visit. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient, who on 18-MAR-2009 was vaccinated with the first dose of PNEUMOVAX (Lot # 662785/1124X), intramuscularly. The nurse reported that on 20-MAR-2009, the patient developed cellulitis. The patient was treated with antibiotics and at the time of the report, the patient was recovering. The patient sought medical attention through an office visit. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Injected limb mobility decreased, Oedema peripheral
Clinical narrative: Information has been received form an office worker concerning a 19 year old female with allergies to bees, FLEXERIL and CECLOR who on 25-MAR-2009 was vaccinated SQ into the right arm with a first 0.5 ml dose of PNEUMOVAX (lot # 661577/1161X). Concomitant therapy included albuterol inhaler. On 26-MAR-2009 the patient developed cellulitis after the vaccination. The patient experienced swelling, induration, immobility and redness of her right arm. She also had a fever. The patient sought medical attention at a physician's office. She was treated with antibiotics (unspecified). No lab tests were performed. As of 30-MAR-2009 the patient was recovering. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received form an office worker concerning a 19 year old female with allergies to bees, FLEXERIL and CECLOR who on 25-MAR-2009 was vaccinated SQ into the right arm with a first 0.5 ml dose of PNEUMOVAX (lot # 661577/1161X). Concomitant therapy included albuterol inhaler. On 26-MAR-2009 the patient developed cellulitis after the vaccination. The patient experienced swelling, induration, immobility and redness of her right arm. She also had a fever. The patient sought medical attention at a physician's office. She was treated with antibiotics (unspecified). No lab tests were performed. As of 30-MAR-2009 the patient was recovering. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old female with penicillin and KEFLEX allergy and no pertinent medical history who was vaccinated with a dose of PNEUMOVAX during the last pneumococcal season. Concomitant therapy included XANAX. The patient developed swelling at injection site. The patient recovered from swelling at injection site on an unspecified date. It was reported that the physician would not give the patient any other doses of PNEUMOVAX vaccine because of the adverse event. The patient consulted with pharmacist. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Flushing, Injection site pain, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a 48 year old female with common variable immunodeficiency and sulfonamide allergy and a history of pneumonitis referred to as "BOOP" who on 06-MAY-2008 was vaccinated with her first dose of PNEUMOVAX (lot number 658673/0990U) IM into her right deltoid. Concomitant therapy included albuterol inhaler. On 06-MAY-2008 2 hours after vaccination the patient developed malaise, scratchy throat and flushed cheeks. Later that night, the patient experienced soreness at the injection site, increased malaise, fever of 102.4F and chills. The patient was prescribed amoxicillin (+) AUGMENTIN, BENADRYL and TYLENOL. The patient was examined in the office on 08-MAY-2008 and the symptoms had improved. The patient had subsequently recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Throat irritation
Clinical narrative: Information has been received from a physician assistant concerning a 48 year old female with common variable immunodeficiency and sulfonamide allergy and a history of pneumonitis referred to as "BOOP" who on 06-MAY-2008 was vaccinated with her first dose of PNEUMOVAX (lot number 658673/0990U) IM into her right deltoid. Concomitant therapy included albuterol inhaler. On 06-MAY-2008 2 hours after vaccination the patient developed malaise, scratchy throat and flushed cheeks. Later that night, the patient experienced soreness at the injection site, increased malaise, fever of 102.4F and chills. The patient was prescribed amoxicillin (+) AUGMENTIN, BENADRYL and TYLENOL. The patient was examined in the office on 08-MAY-2008 and the symptoms had improved. The patient had subsequently recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician assistant concerning a 33 year old female with niacin allergy 01-Jan-2009 who on 04-FEB-2009 was vaccinated with her first dose of PNEUMOVAX (lot number 660685/0619X) 0.5ml IM into her left deltoid. On 08-FEB-2009, 4 days after administration of the first dose, the patient was diagnosed with pneumonia. The patient was evaluated at an urgent care facility, prescribed LEVOQUIN and was referred to an unspecified pulmonologist. On 30-MAR-2009 the patient was administered the second dose of PNEUMOVAX (lot number 660685/0619X) 0.25ml IM into her left deltoid. Concomitant therapy included VALTREX, propranolol HC1, YAZ, MSD and transfer factor. On 31-mar-2009 the patient developed swollen, red, hot reaction at the injection site of the left deltoid with golfball-sized area of induration. On 01-APR-2009 the patient was examined in the office and the symptoms were improving with use of BENADRYL and ice compresses. Follow up information was received from a physician. 4 days after injection on 04-FEB-2009 the patient developed pneumonia and was seen in urgent care. The patient was given LEVAQUIN with 10 days. She was not hospitalized. On 31-MAR-2009 the patient developed large local reaction at injection site. The physician indicated that the patient's experience required an emergency room/doctor visit. The patient recovered. There was no illness at time of vaccination. There was no relevant diagnostic tests and laboratory data. This is one of several reports received from the same source. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pneumonia
Clinical narrative: Information has been received from a physician assistant concerning a 33 year old female with niacin allergy 01-Jan-2009 who on 04-FEB-2009 was vaccinated with her first dose of PNEUMOVAX (lot number 660685/0619X) 0.5ml IM into her left deltoid. On 08-FEB-2009, 4 days after administration of the first dose, the patient was diagnosed with pneumonia. The patient was evaluated at an urgent care facility, prescribed LEVOQUIN and was referred to an unspecified pulmonologist. On 30-MAR-2009 the patient was administered the second dose of PNEUMOVAX (lot number 660685/0619X) 0.25ml IM into her left deltoid. Concomitant therapy included VALTREX, propranolol HC1, YAZ, MSD and transfer factor. On 31-mar-2009 the patient developed swollen, red, hot reaction at the injection site of the left deltoid with golfball-sized area of induration. On 01-APR-2009 the patient was examined in the office and the symptoms were improving with use of BENADRYL and ice compresses. Follow up information was received from a physician. 4 days after injection on 04-FEB-2009 the patient developed pneumonia and was seen in urgent care. The patient was given LEVAQUIN with 10 days. She was not hospitalized. On 31-MAR-2009 the patient developed large local reaction at injection site. The physician indicated that the patient's experience required an emergency room/doctor visit. The patient recovered. There was no illness at time of vaccination. There was no relevant diagnostic tests and laboratory data. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEP, HIBV, IPV, PPV
Symptoms: Abasia, Injection site swelling, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 26 month old male patient, with no known drug reactions/allergies and no pertinent medical history, who on 02-APR-2009 was vaccinated with PNUEMOVAX (Lot #657525/0554U), intramusculary in the right thigh. Concomitant suspect therapy included PEDVAXHIB (manufacturer unknown) (right thigh) and hepatitis B virus (left thigh), given on 02-APR-2009. Other concomitant therapy included POLIOVIRUS vaccine (left thigh), given on 02-APR-2009.  The patient's parents called because the child had a fever and vomited. The right leg was swollen and the child could not walk. The patient was supposed to get PREVNAR but instead received PNEUMOVAX. The parents would be seen the physician. At the time of the report, the patient had not recovered. The parents would be seen the physician. Follow up information has been received from a physician concerning a 26 month old male with no pertinent medical history reported and no illness at the time of vaccination who on 02-APR-2009 at 2:30pm was vaccinated intramuscularly in the right thigh with a first dose of PNEUMOVAX (Lot # 657525/0554U). The physician reported that on 02-APR-2009 at 6:00pm the patient experienced thigh pain and fever. Subsequently, the patient recovered from these events on 03-APR-2009.  Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: HEP, HIBV, IPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 26 month old male patient, with no known drug reactions/allergies and no pertinent medical history, who on 02-APR-2009 was vaccinated with PNUEMOVAX (Lot #657525/0554U), intramusculary in the right thigh. Concomitant suspect therapy included PEDVAXHIB (manufacturer unknown) (right thigh) and hepatitis B virus (left thigh), given on 02-APR-2009. Other concomitant therapy included POLIOVIRUS vaccine (left thigh), given on 02-APR-2009.  The patient's parents called because the child had a fever and vomited. The right leg was swollen and the child could not walk. The patient was supposed to get PREVNAR but instead received PNEUMOVAX. The parents would be seen the physician. At the time of the report, the patient had not recovered. The parents would be seen the physician. Follow up information has been received from a physician concerning a 26 month old male with no pertinent medical history reported and no illness at the time of vaccination who on 02-APR-2009 at 2:30pm was vaccinated intramuscularly in the right thigh with a first dose of PNEUMOVAX (Lot # 657525/0554U). The physician reported that on 02-APR-2009 at 6:00pm the patient experienced thigh pain and fever. Subsequently, the patient recovered from these events on 03-APR-2009.  Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Chills, Dysgraphia, Headache, Injection site erythema
Clinical narrative: Information has been received from a 59 year old female with asthma, high blood pressure, migraines, heart problem and penicillin, tetracycline, contrast x ray dye, "neuvain", morphine and spiriva allergies, who on 06-APR-2009 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included azithromycin prescription give to her the same day since her cat bit her, and many other medications which were unspecified. The consumer reported a couple hours after receiving PNEUMOVAX she experienced redness at the injection site that went into the soft tissues of her arm, chills that were so bad she went to bed with every warm thing she had plus a heating pad, had bone aches that hurt so bad she took pain pills, and she also had a headache. The consumer reported that she saw her physician on 08-APR-2009 and the physician stated that the patient experienced an allergic reaction to PNEUMOVAX, but since she took azithromycin later that night on 06-APR-2009, it helped her experience. Consumer reported that on 08-APR-2009 she still could not write,  but she was improved. No laboratories studies performed. The patient was recovering. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Incorrect route of drug administration, Skin burning sensation
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 40 year old (also reported as 44 year old) female with diabetes who on 11-APR-2009 (also reported as 13-APR-2009) was vaccinated with a dose of PNEUMOVAX 0.5 ml, IV instead of subcutaneous or intramuscular. Concomitant therapy included methylprednisolone, docusate Na, LOVENOX, FLONASE, MUCINEX, LEVEMIR, ATROVENT, CLARITIN, GLUCOPHAGE, PRILOSEC and BRETHINE. The patient was being treated for pneumonia. The physician reported that on the same day of vaccination, the patient was complaining of burning in the arm and numbness in her back. The patient was bradycardic and at the time of reporting was tachycardic. Unknown if any laboratory tests were performed. The patient was receiving ice packs at the IV site and was being monitored. As of 11-APR-2009, it was unknown if the patient was going to continue to receive PNUEMOVAX, as per pharmacist the patient was "doing ok". It was reported by pharmacist that the patient's heart rate initially went down, but at the time of reporting was "doing ok". No further information is available.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician and a health professional concerning a 71 year old male patient (weight 224 pounds, height 70 inches) with CODEINE allergy and diabetes who on 26-FEB-2009 at 09:30 am was vaccinated IM in his right deltoid with PNEUMOVAX.  At time of vaccination the patient had mild sinus congestion.  On 27-FEB-2009 the patient experienced cellulitis with fever, redness and swelling in upper arm of injection site.  The patient was examined in the emergency room but was not admitted.  On an unspecified date the patient recovered.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received form a medical assistant concerning a 67 year old female who on  03-APR-2009 was vaccinated with her second dose of PNEUMOVAX (lot number 662785/1124X), 0.5 ml IM.  (She had received her first dose in 2001).  On 03-APR-2009 after administration of her second dose of PNEUMOVAX the patient developed localized swelling at the site of injection, her upper arm became more swollen and red.  After a few days the upper arm improved but her lower arm started to swell.  She was examined in the emergency room at a hospital.  The patient was not admitted.  The patient was recovering.  Additional information was received from the medical assistant.  The patient was taking the following concomitant medication:  ACCUPRIL, hydrochlorothiazide (manufacturer unknown), GLUCOPHAGE, NAPROXEN and ESTRODERM patch.  Follow-up information was received from the medical assistant concerning the 67 year old female with CODEINE allergy, SULFA allergy, type 2 diabetes mellitus, hypertension and osteoarthritis who on 03-APR-2009 was vaccinated with her first (also reported by the medical assistant as her second) dose of PNEUMOVAX (lot number 662785/1124X) IM into her right arm.  On 03-APR-2009, at that PM the patient experienced swelling and redness near injection site.  The patient's swelling moved down to lower arm.  The patient was sent to emergency room.  It was unknown if there was illness at time of vaccination.  The patient's outcome was unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a case in litigation (WAES#0610USA13557) from a physician via medical records concerning a male who on unspecified date was vaccinated with PNEUMOVAX (lot number, route and site not reported). Subsequently the patient experienced allergy. It was unknown if the patient sought medical attention. The outcome was unknown. No further information is available.
Age: 85.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot number 662785/1124X, route and site not reported). It was not known if this was the first dose of PNEUMOVAX for the patient. After vaccination the patient developed erythema, swelling and warmth at the site of injection adn going down the arm and fever. The outcome was unknown. Additional information was received from the medical assistant. The 85 year old male with type 2 diabetes mellitus, hypertension and hyperlipidaemia who on 13-APR-2009 was vaccinated with the second dose of PNEUMOVAX (lot number 662785/1124X) IM into his right arm. On 13-APR-2009 the patient experienced swelling and redness at the site of injection. The injection site was warm to touch. The patient has fever. The patient required doctor visit. the patient was treated with KEFLEX, 500mg three times a day for 7 to 10 days. The patient recovered. It was unknown if there was illness at the time of vaccination. This is one of several reports from the same source. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Abdominal pain, Burning sensation, Change of bowel habit, Constipation
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot number 662785/1124X, route and site not reported). It was not known if this was the first dose of PNEUMOVAX for the patient. After vaccination the patient developed erythema, swelling and warmth at the site of injection and going down the arm and fever. The patient also developed abdominal cramps, nausea, pain and cold feet, and change in bowel movements (cycles of 2 large bowel movements, cramps, and constipation). The outcome was unknown. Additional information was received from the medical assistant. The patient was taking the following concomitant medications: SYNTHROID, aspirin and ASTELIN. The patient went to the emergency room but not admitted to the hospital. Follow-up information has been received from the medical assistant concerning an 80 year old female with CIPRO allergy (nausea, vomiting), chronic obstructive pulmonary disease, hypothyroidism and hypertension who on 02-APR-2009 was vaccinated with PNEUMOVAX (lot number 662785/1124X, route and site not reported) IM on 02-APR-2009 the patient experienced redness and swelling at the site of injection. The patient had fever, erratic heart rate, nausea, cold feet, burning back and burning stomach. The patient was sent to a emergency room. It was unknown if there was illness at th etime of vaccination. The patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Heart rate irregular, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot number 662785/1124X, route and site not reported). It was not known if this was the first dose of PNEUMOVAX for the patient. After vaccination the patient developed erythema, swelling and warmth at the site of injection and going down the arm and fever. The patient also developed abdominal cramps, nausea, pain and cold feet, and change in bowel movements (cycles of 2 large bowel movements, cramps, and constipation). The outcome was unknown. Additional information was received from the medical assistant. The patient was taking the following concomitant medications: SYNTHROID, aspirin and ASTELIN. The patient went to the emergency room but not admitted to the hospital. Follow-up information has been received from the medical assistant concerning an 80 year old female with CIPRO allergy (nausea, vomiting), chronic obstructive pulmonary disease, hypothyroidism and hypertension who on 02-APR-2009 was vaccinated with PNEUMOVAX (lot number 662785/1124X, route and site not reported) IM on 02-APR-2009 the patient experienced redness and swelling at the site of injection. The patient had fever, erratic heart rate, nausea, cold feet, burning back and burning stomach. The patient was sent to a emergency room. It was unknown if there was illness at th etime of vaccination. The patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral, Pain, Peripheral coldness, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot number 662785/1124X, route and site not reported). It was not known if this was the first dose of PNEUMOVAX for the patient. After vaccination the patient developed erythema, swelling and warmth at the site of injection and going down the arm and fever. The patient also developed abdominal cramps, nausea, pain and cold feet, and change in bowel movements (cycles of 2 large bowel movements, cramps, and constipation). The outcome was unknown. Additional information was received from the medical assistant. The patient was taking the following concomitant medications: SYNTHROID, aspirin and ASTELIN. The patient went to the emergency room but not admitted to the hospital. Follow-up information has been received from the medical assistant concerning an 80 year old female with CIPRO allergy (nausea, vomiting), chronic obstructive pulmonary disease, hypothyroidism and hypertension who on 02-APR-2009 was vaccinated with PNEUMOVAX (lot number 662785/1124X, route and site not reported) IM on 02-APR-2009 the patient experienced redness and swelling at the site of injection. The patient had fever, erratic heart rate, nausea, cold feet, burning back and burning stomach. The patient was sent to a emergency room. It was unknown if there was illness at th etime of vaccination. The patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot number 662785/1124X, route and site not reported). It was not known if this was the first dose of PNEUMOVAX for the patient. After vaccination the patient developed erythema, swelling and warmth at the site of injection and going down the arm and fever. The patient also developed abdominal cramps, nausea, pain and cold feet, and change in bowel movements (cycles of 2 large bowel movements, cramps, and constipation). The outcome was unknown. Additional information was received from the medical assistant. The patient was taking the following concomitant medications: SYNTHROID, aspirin and ASTELIN. The patient went to the emergency room but not admitted to the hospital. Follow-up information has been received from the medical assistant concerning an 80 year old female with CIPRO allergy (nausea, vomiting), chronic obstructive pulmonary disease, hypothyroidism and hypertension who on 02-APR-2009 was vaccinated with PNEUMOVAX (lot number 662785/1124X, route and site not reported) IM on 02-APR-2009 the patient experienced redness and swelling at the site of injection. The patient had fever, erratic heart rate, nausea, cold feet, burning back and burning stomach. The patient was sent to a emergency room. It was unknown if there was illness at th etime of vaccination. The patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female who on 15-APR-2009 was vaccinated with a single dose of PNEUMOVAX (lot number, route and site not reported). On 15-APR-2009 after receiving the vaccine, the patient's arm became very swollen and she could not lift her arm. It was unspecified if the patient sought medical attention. Her outcome was unknown. Follow-up information was received from the registered nurse. The nurse reported that on 14-APR-2009 the patient was vaccinated with the second dose of PNEUMOVAX (lot number 661527/0112Y) SQ into her left arm. On 14-APR-2009, 12 hours past injection the patient's injection site ("fatty part" of her left arm) got swollen, red, pain and difficulty lifting her arm and the symptoms continued into the next day. The patient also felt nauseated during this time. There was no illness at time of vaccination. There were no known drug allergies. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female who on 15-APR-2009 was vaccinated with a single dose of PNEUMOVAX (lot number, route and site not reported). On 15-APR-2009 after receiving the vaccine, the patient's arm became very swollen and she could not lift her arm. It was unspecified if the patient sought medical attention. Her outcome was unknown. Follow-up information was received from the registered nurse. The nurse reported that on 14-APR-2009 the patient was vaccinated with the second dose of PNEUMOVAX (lot number 661527/0112Y) SQ into her left arm. On 14-APR-2009, 12 hours past injection the patient's injection site ("fatty part" of her left arm) got swollen, red, pain and difficulty lifting her arm and the symptoms continued into the next day. The patient also felt nauseated during this time. There was no illness at time of vaccination. There were no known drug allergies. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient who was vaccinated with a dose of PNEUMOVAX. The patient experienced cellulitis after being given the vaccine. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a Medical Assistant (M.A.) concerning a 17 year old male patient with migraine and sinus infection who on 16-APR-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 661527/0112Y) subcutaneously into his arm. Concomitant therapy included WELLBUTRIN, ALLEGRA-D, ASTELIN, LEXAPRO, PROTONIX and ZOFRAN. It was reported that the patient woke up the next morning (17-APR-2009) with high fever and his arm which received the vaccination was swollen and had a rash. The patient went to the emergency room and was treated with intravenous antibodies and then released. It was reported that the patient was recovering at the time of the report. It was reported that the physician would like a lot check for PNEUMOVAX 23 (Lot # 661527/0112Y). 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. No further information is available.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin G, Blood test, Chills, Cough, Incorrect dose administered
Clinical narrative: Information has been received from a physician assistant concerning a 64 year old female with low immunoglobulin, diabetes, hypercholesterolaemia, niacin allergy and a history of recurrent infections who on 06-AUG-2008 was vaccinated with a 0.5 mL first dose of PNEUMOVAX (lot # 658673/0990U), intramuscularly into the right deltoid. Concomitant therapy included HUMALOG, GLUMETZA, glimepiride and CRESTOR . On the same date, 3 hours after administration of PNEUMOVAX, the patient experienced pain at the injection site, fever, chills and cough. The patient recovered by using TYLENOL and treating her arm with ice. On 07-NOV-2008 the patient received a 0.3 mL second dose, and on 21-NOV-2008 a 0.2 mL third dose of PNUEMOVAX. The reporter stated that "medicare guidelines require that patients receive two doses of PNEUMOVAX in order for the office to receive payment", according to the reporter this was why the patient was given subsequent doses. It was also reported that the physician thought that it would be better to split the subsequent dose instead of giving a full 0.5 mL dose to decrease chances of having another adverse event. The patient did not experience any symptoms with the 0.3 mL or the 0.2 mL doses.  The patient had an IGG and an autoimmune bloodwork. The patient sought medical attention through a phone call.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia, Underdose
Clinical narrative: Information has been received from a physician assistant concerning a 64 year old female with low immunoglobulin, diabetes, hypercholesterolaemia, niacin allergy and a history of recurrent infections who on 06-AUG-2008 was vaccinated with a 0.5 mL first dose of PNEUMOVAX (lot # 658673/0990U), intramuscularly into the right deltoid. Concomitant therapy included HUMALOG, GLUMETZA, glimepiride and CRESTOR . On the same date, 3 hours after administration of PNEUMOVAX, the patient experienced pain at the injection site, fever, chills and cough. The patient recovered by using TYLENOL and treating her arm with ice. On 07-NOV-2008 the patient received a 0.3 mL second dose, and on 21-NOV-2008 a 0.2 mL third dose of PNUEMOVAX. The reporter stated that "medicare guidelines require that patients receive two doses of PNEUMOVAX in order for the office to receive payment", according to the reporter this was why the patient was given subsequent doses. It was also reported that the physician thought that it would be better to split the subsequent dose instead of giving a full 0.5 mL dose to decrease chances of having another adverse event. The patient did not experience any symptoms with the 0.3 mL or the 0.2 mL doses.  The patient had an IGG and an autoimmune bloodwork. The patient sought medical attention through a phone call.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling abnormal, Joint swelling, Oedema peripheral
Clinical narrative: Information has been received from a consumer concerning his 73 year old wife with no previous medical history reported who on 26-DEC-2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included antimicrobial (unspecified). The patient was admitted to the hospital because of pneumonia on 25-DEC-2008. A day later she received the dose of PNEUMOVAX. On 27-DEC-2008, when she was discharged, she felt "spaced out" and experienced fatigue. Two weeks after the discharge, approximately on 10-JAN-2009, the patient experienced swelling on her shoulder, hand and knees. The patient's "spaced out", fatigue and swelling on her shoulder, hand and knees persisted.  The patient sought unspecified medical attention. Follow-up information was received from the consumer who reported that his wife would have another appointment with the orthopedic surgeon who had been treating her for her ongoing swelling of knees and hands. The patient had taken CELEBREX and a steroid dosepack of 21 tablets (name and manufacturer unspecified). The consumer reported that the treatment provided temporary relief but the symptoms kept returning. The consumer described the knee swelling as a "type of paralysis" of the leg. Orthopedic surgeon diagnosed it as arthritis. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a healthcare worker concerning an approximately 56 year old male with no pertinent medical history who in early April of 2009, was vaccinated with PNEUMOVAX (lot # 661529/0868X) (dose and route unspecified). The patient experienced persistent pain at the injection site for two weeks after the vaccination, and he went to the office to seek some medical attention. At the time of reporting the patient was not recovered from the event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX (lot # not reported). The patient developed cellulitis 1 day after administration of PNEUMOVAX vaccine. The patient was examined in the emergency room but was not admitted. The patient is recovering. This is one of several reports received from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse who in approximately 2008, about one year ago, was vaccinated with the second dose of PNEUMOVAX. The patient experienced severe cellulitis like reaction after receiving the second dose of PNEUMOVAX. Subsequently, the patient recovered from severe cellulitis like reaction. The patient sought unspecified medical attention. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: PPV
Symptoms: Muscular weakness, Neuropathy peripheral, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a 27 year old male patient with diabetes who on 22-APR-2009 was vaccinated with a dose of PNEUMOVAX (lot # not reported) 0.5ml. Concomitant therapy included medication for his diabetes. On 22-APR-2009 the patient experienced tingling in his right arm and weakness and c7 neuropathy. At the time on the reporting patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 65 year old female who on 20-APR-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX. On 24-APR-2009 the patient the patient came into the office because she had redness and swelling in the injection site which site was of a silver dollar. The nurse reported that the physician believed that the experience could be cellulitis. The nurse reported that the patient was doing better. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a 65 year old female consumer with ALLEGRA, household cleaning products, kiwi, nuts, and preservatives in eyes drops allergies, who on 24-APR-2009 was vaccinated with a dose of PNEUMOVAX. Patient did not know if this was her first or second vaccination with PNEUMOVAX. On 24-APR-2009 the patient experienced soreness and swelling at the injection site, the consumer reported that the reaction has moved across her arm and under her arm. She also had injection site hives and heat. The symptoms have responded to BENADRYL and ice. The patient was recovering. The patient sought medical attention through a phone call. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 65 year old female consumer with ALLEGRA, household cleaning products, kiwi, nuts, and preservatives in eyes drops allergies, who on 24-APR-2009 was vaccinated with a dose of PNEUMOVAX. Patient did not know if this was her first or second vaccination with PNEUMOVAX. On 24-APR-2009 the patient experienced soreness and swelling at the injection site, the consumer reported that the reaction has moved across her arm and under her arm. She also had injection site hives and heat. The symptoms have responded to BENADRYL and ice. The patient was recovering. The patient sought medical attention through a phone call. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and the office manager concerning 19 patients who were vaccinated with PNEUMOVAX instead of (PREVNAR) by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the office manager concerning a 12 month old female who on 23-JAN-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of (PREVNAR) by mistake due to an office error. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Feeling cold, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a medical care administrator concerning her 60 year old mother (physician), with a rheumatoid arthritis with sulfa allergy who on 26-APR-2009 was vaccinated with PNEUMOVAX (dose, route not reported, lot number: 659148/1382U, expiration date: 12-JUN-2009) on the arm. Concomitant therapy included ZOSTAVAX on 25-APR-2009, (dose, route not reported, lot number: 663178/1414X, expiration date: 28-APR-2010) on the other arm, for the treatment of prophylaxis. Other concomitant therapy was stopped "several weeks prior to vaccination" (date unspecified): SYNTHROID and ENBREL. The patient started to feel "crummy and really wretched yesterday" (on 26-APR-2009 and 27-APR-2009). She had redness swelling and erythema at the injection site on the arm that was vaccinated with PNEUMOVAX (unspecified side) also she felt cold, had fevers between 101F to 103F.  On 28-APR-2009, the patient had fever 102.7F and she was taking TYLENOL for the fever. The patient's outcome was not recovered and she sought medical attention, her husband was the physician. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Oedema peripheral
Clinical narrative: Information has been received from a 47 year old male consumer with allergy to water pills who in May 2008, was vaccinated in the left arm with first dose of PNEUMOVAX (dose, route and lot number not reported).  There was no concomitant medication.  The consumer reported that he was hospitalized prior to receive the vaccine due to a coma from "pneumonia in the pancreas" and seizures.  Before he was discharged from the hospital he was given a dose of PNEUMOVAX.  He believed that it was a "bad shot" because it was "milky white".  He had an immediate reaction with arm numbness beginning one to two minutes after vaccination.  He said his whole arm swelled for four months.  The consumer reported that "he now has numbness from his arm to his ribcage".  The patient's numbness from his arm to ribcage persisted.  The patient was seen by two neurologists.  Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who on 24-APR-2009 was vaccinated with a dose of PNEUMOVAX (lot number not provided). On 25-APR-2009 the patient experienced fever of 101 Fahrenheit. The patient's arm swelled up. The outcome was unknown. Follow up information was received from the physician by phone indicated that out of 12 patients who received PNEUMOVAX from the same lot, 3 of the patients experienced adverse events. Follow up information was received from a physician via telephone on 06-MAY-2009. It was reported that the 80 year old female patient was vaccinated with a dose of PNEUMOVAX (lot# 662744/1085X) on 25-Apr-2009. Concomitant therapy included BENADRYL and TYLENOL. It was reported that the patient called the physician's office the next day (26-APR-2009) with a fever (102F) and swelling of the arm. On an unspecified date the patient recovered. This is one of several reports from the same source. No further information is available.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Underdose, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 29 year old female patient with no pertinent medical history an no known drug allergies/drug reactions who on 28-APR-2009 was vaccinated with a 0.09 ml dose of PNEUMOVAX (Lot # 661527/0112Y) intradermally. Concomitant therapy included oral hormonal contraceptives (unspecified). It was also reported that the patient received her TB test on 28-APR-2008. It was reported that there was a pink line at the injection site. It was reported that the patient was not supposed to received PNEUMOVAX; it was given due to human error, not product confusion. The patient sought medical attention with an office visit. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from an immunization coordinator concerning a 72 year old female with depression who in 2001 was vaccinated with the first dose of PNEUMOVAX vaccine (route and site not reported). On 30-APR-2008, the patient was vaccinated with the second dose of PNEUMOVAX (lot # 657143/0380U, route and site not reported). The patient was on "a lot of concomitant medications, some for depression "but medication were unspecified. On 01-MAY-2008 the patient developed injection site reaction. The patient's arm swelled about 1 and 1/2 times its normal size. The patient visited the physician's office and was told to use compresses and to take BENADRYL. On an unknown date, the patient recovered from the vents. The events were considered to be non serious per the reporting immunization coordinator. Additional information has been requested.