chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning an approximately 70 year old male patient who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot # not reported). Subsequently the patient experienced a "severe" reaction where his whole arm was swollen. The reaction was treated with an unspecified steroid injection. Subsequently, the patient recovered from the adverse event (date unspecified). The patient had sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received regarding a case in litigation, concerning a female who on 10-MAY-2010 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 665250/1364Y, expiration date 06-MAY-2011). Subsequently, the patient experienced cellulitis. It was unspecified if the patient sought medical attention. At this time of reporting, the patient's outcome was unknown. No further information is available.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 47 year old female with sulfonamide and latex allergy and a history of rhinitis allergic, asthma and recurrent upper respiratory tract infections who on 06-APR-2010 was vaccinated intramuscularly the first 0.5ml dose of with PNEUMOVAX 23 (lot # 664653/1337Y). Concomitant therapy included EFFEXOR, AMBIEN, ATIVAN, ZYRTEC, SEASONIQUE, ADVAIR, VENTOLIN HFA, montelukast sodium (MSD) and DARVOCET-N. The nurse reported that on 06-APR-2010, the patient developed redness and tenderness at the injection site that extended down to her elbow after receiving PNEUMOVAX 23. That area of the patient's then became purple, swollen and painful but resolved within 6-7 days, on approximately 12-APR-2010. No laboratory tests were performed. The patient sought medical attention at an unrelated office visit. Follow-up information was received from the licensed visiting nurse who reported that the 47 year old patient (105 pounds and 64.8 inches), was vaccinated intramuscularly in the right deltoid with the first dose of PNEUMOVAX 23. The reporter stated that the evening of the injection, on 07-APR-2010 (previously reported as on 06-APR-2010), the patient had some redness and tender at injection site. The patient noted the redness was spreading from the injection site around her arm and down to elbow. The patient said that the redness turned to a purple color, was swollen and was painful to move. The reaction resolved after 6 to 7 days, on approximately 14-APR-2010. The patient did not require an emergency room/doctor visit. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received from a licensed visiting nurse who reported that on 06-APR-2010, the patient was vaccinated intramuscularly in the right deltoid with the first dose of PNEUMOVAX 23 at 14:56. This is one of several reports from the same source. Additional information is not expected.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old male with diabetes, hepatitis B, hepatitis C and dyslipidaemia and no drug reactions/allergies who on 13-JUL-2010 was vaccinated IM with the first dose of PNEUMOVAX 23 (lot # 663998/0623Y) into right deltoid. There was no concomitant therapy. On 13-JUL-2010 the patient experienced injection site pain and swelling beginning a half hour after vaccination. When the patient came to the office the next day (on 14-JUL-2010) he had moderate erythema and induration from below his shoulder to elbow on the injection arm. The patient also had a low grade fever. The patient was prescribed KEFLEX, VICODIN and MOTRIN. The outcome of the events was not reported. Follow up information has been received from the registered nurse concerning the 48 year old male patient with diabetes, hepatitis C, hyperlipidaemia and no illness at time of vaccination who on 13-JUL-2010 at 17:00 was vaccinated IM in the right deltoid with the first dose of PNEUMOVAX 23 (Lot number 663998/0623Y). Patient stated that approximately 30 minutes after injection he had onset of pain, increased pain and erythema occurred overnight and he was seen in the office on 14-JUL-2010. He was febrile at 100.8. There was no other lab test. Patient was put on KEFLEX and VICODIN. Patient was seen again on 15-JUL-2010 with decreased erythema and pain. Patient had no adverse events following prior vaccination. The patient did not keep the appointment on 19-JUL-2010. Follow up information has been received from the registered nurse indicated that the patient went to office visit on 16-JUL-2010 (previously reported as 15-JUL-2010) with decreased symptoms. The patient failed to appointment on 19-JUL-2010. On 19-JUL-2010 he was unable to reach by phone. Additional information is not expected.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 48 year old male with diabetes, hepatitis B, hepatitis C and dyslipidaemia and no drug reactions/allergies who on 13-JUL-2010 was vaccinated IM with the first dose of PNEUMOVAX 23 (lot # 663998/0623Y) into right deltoid. There was no concomitant therapy. On 13-JUL-2010 the patient experienced injection site pain and swelling beginning a half hour after vaccination. When the patient came to the office the next day (on 14-JUL-2010) he had moderate erythema and induration from below his shoulder to elbow on the injection arm. The patient also had a low grade fever. The patient was prescribed KEFLEX, VICODIN and MOTRIN. The outcome of the events was not reported. Follow up information has been received from the registered nurse concerning the 48 year old male patient with diabetes, hepatitis C, hyperlipidaemia and no illness at time of vaccination who on 13-JUL-2010 at 17:00 was vaccinated IM in the right deltoid with the first dose of PNEUMOVAX 23 (Lot number 663998/0623Y). Patient stated that approximately 30 minutes after injection he had onset of pain, increased pain and erythema occurred overnight and he was seen in the office on 14-JUL-2010. He was febrile at 100.8. There was no other lab test. Patient was put on KEFLEX and VICODIN. Patient was seen again on 15-JUL-2010 with decreased erythema and pain. Patient had no adverse events following prior vaccination. The patient did not keep the appointment on 19-JUL-2010. Follow up information has been received from the registered nurse indicated that the patient went to office visit on 16-JUL-2010 (previously reported as 15-JUL-2010) with decreased symptoms. The patient failed to appointment on 19-JUL-2010. On 19-JUL-2010 he was unable to reach by phone. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning an 80 year old female patient with osteoporosis and high cholesterol who on 02-OCT-2001 was vaccinated with the first dose of PNEUMOVAX 23. On 19-JUL-2010, the patient was vaccinated in the left arm with the second dose of PNEUMOVAX 23 (lot# 664553/1242Y). On 20-JUL-2010, after vaccination with the second dose of PNEUMOVAX 23, the patient developed a reaction under her left arm in the medial aspect. The reaction was described as: red, swollen, warm to touch, firm and painful. The patient was seen in the office for medical attention. The patient was treated with antibiotics and MOTRIN. Subsequently, on an unspecified date the patient recovered. Follow up information has been received from a licensed practical nurse, concerning an 80 year old retired teacher, female patient with a penicillin allergy, and no illness at the time of vaccination who on 19-JUL-2010 at 13:00 hours was vaccinated intramuscularly in the left arm with the second dose of PNEUMOVAX 23 (lot# 664553/1242Y). The nurse reported that on 20-JUL-2010 the day after she received the second dose, the patient developed redness, swelling, warm to touch and pain along with back of the left arm. The patient required doctor visit. She was diagnosed with cellulitis. The patient was treated with antibiotics. On 24-JUL-2010 the patient had recovered from cellulitis. No further information is available.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning an 80 year old female patient with osteoporosis and high cholesterol who on 02-OCT-2001 was vaccinated with the first dose of PNEUMOVAX 23. On 19-JUL-2010, the patient was vaccinated in the left arm with the second dose of PNEUMOVAX 23 (lot# 664553/1242Y). On 20-JUL-2010, after vaccination with the second dose of PNEUMOVAX 23, the patient developed a reaction under her left arm in the medial aspect. The reaction was described as: red, swollen, warm to touch, firm and painful. The patient was seen in the office for medical attention. The patient was treated with antibiotics and MOTRIN. Subsequently, on an unspecified date the patient recovered. Follow up information has been received from a licensed practical nurse, concerning an 80 year old retired teacher, female patient with a penicillin allergy, and no illness at the time of vaccination who on 19-JUL-2010 at 13:00 hours was vaccinated intramuscularly in the left arm with the second dose of PNEUMOVAX 23 (lot# 664553/1242Y). The nurse reported that on 20-JUL-2010 the day after she received the second dose, the patient developed redness, swelling, warm to touch and pain along with back of the left arm. The patient required doctor visit. She was diagnosed with cellulitis. The patient was treated with antibiotics. On 24-JUL-2010 the patient had recovered from cellulitis. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site haematoma, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 79 year old female patient with hypothyroidism, osteoporosis, skin cancer and hernia who on 13-AUG-2002, was vaccinated with the first dose of PNEUMOVAX 23. On 02-AUG-2010, the patient was vaccinated in the left arm with the second dose of PNEUMOVAX 23 (Lot# 664553/1242Y) at 13:00 pm. On 03-AUG-2010, the patient developed a reaction under her left arm in the medial aspect after the vaccination with PNEUMOVAX 23. The reaction was described as red, swollen, warm to touch, firm, painful with a small amount of bruising at the injection site. On an unspecified date, the patient was diagnosed with cellulitis. The patient sought medical attention in the office. The patient was treated with antibiotics. At the time of the report, the patient was recovering. Follow-up has been received from licensed practical nurse concerning a 79 year old female patient with penicillin allergy who on 02-AUG-2010 at 13:00, was vaccinated IM in the left arm with the second dose of PNEUMOVAX 23 (Lot# 664553/1242Y). There was no illness at the time of vaccination. The licensed practical nurse stated that the patient called the next day "on 03-AUG-2010", and she had redness, swelling, warmth not to the injection site, but to the back side of her arm at 13:00 (previously reported as "it was red, swollen, warm to touch, firm, painful with a small amount of bruising at the injection site"). The patient made an appointment and the physician saw her. The patient was diagnosed with cellulitis and antibiotics were given. On 07-AUG-2010, the patient had recovered. No further information is available.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a 79 year old female patient with hypothyroidism, osteoporosis, skin cancer and hernia who on 13-AUG-2002, was vaccinated with the first dose of PNEUMOVAX 23. On 02-AUG-2010, the patient was vaccinated in the left arm with the second dose of PNEUMOVAX 23 (Lot# 664553/1242Y) at 13:00 pm. On 03-AUG-2010, the patient developed a reaction under her left arm in the medial aspect after the vaccination with PNEUMOVAX 23. The reaction was described as red, swollen, warm to touch, firm, painful with a small amount of bruising at the injection site. On an unspecified date, the patient was diagnosed with cellulitis. The patient sought medical attention in the office. The patient was treated with antibiotics. At the time of the report, the patient was recovering. Follow-up has been received from licensed practical nurse concerning a 79 year old female patient with penicillin allergy who on 02-AUG-2010 at 13:00, was vaccinated IM in the left arm with the second dose of PNEUMOVAX 23 (Lot# 664553/1242Y). There was no illness at the time of vaccination. The licensed practical nurse stated that the patient called the next day "on 03-AUG-2010", and she had redness, swelling, warmth not to the injection site, but to the back side of her arm at 13:00 (previously reported as "it was red, swollen, warm to touch, firm, painful with a small amount of bruising at the injection site"). The patient made an appointment and the physician saw her. The patient was diagnosed with cellulitis and antibiotics were given. On 07-AUG-2010, the patient had recovered. No further information is available.
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 14 week old male patient who on 09-AUG-2010, was vaccinated SQ with one dose of PNEUMOVAX 23 (Lot#: 665707/1407Y). No adverse effects were reported. Follow up information has been received from a registered nurse who reported that the patient was to received PREVNAR 13 and mistakenly received PNEUMOVAX 23 (Lot number 665707/1407Y). The nurse stated that the patient received PNEUMOVAX 23 (Lot number 665707/1407Y) due to a Medication Error and not Product Confusion. On 09-AUG-2010, the patient concomitantly received a dose of PEDIARIX, (Lot number AC21B177CA), ACTHIB (Lot number and the first dose of ROTATEQ (Lot number 664875/1442Y). Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Blood test, Cellulitis, Computerised tomogram normal, Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a 69 year old male with hypertension, hypercholesterolaemia and unspecified psychiatric disorder, and penicillin and contrast dye allergies who on 01-SEP-2010 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (Lot #: 665402/1339Y) into the left arm. Other suspect therapy included AFLURIA (manufacturer unspecified) given in the left arm on 01-SEP-2010. Concomitant therapies include unspecified medications for hypertension, hypercholesterolaemia and psychiatric disorder. On 02-SEP-2010 the patient developed cellulitis of the left arm at the injection site. The physician reported that cellulitis extended to the patient's elbow. The patient sought medical attention via phone call, and he was admitted to a hospital, and is being treated with intravenous antibiotics. The patient had taken unspecified blood tests (results unknown), and white blood cell count was 19,000. Blood cultures, unspecified CT scan and X-rays all revealed negative results. At the time of reporting, the patient was recovering. Cellulitis of the left arm at the injection site was considered to be disabling and an other important medical event by the reporter. Additional information has been requested. This is an amended report. The "vaccine purchased with" and "vaccinated at" fields have been updated to "unknown".
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased, X-ray normal
Clinical narrative: Information has been received from a physician concerning a 69 year old male with hypertension, hypercholesterolaemia and unspecified psychiatric disorder, and penicillin and contrast dye allergies who on 01-SEP-2010 was vaccinated IM with a 0.5ml dose of PNEUMOVAX 23 (Lot #: 665402/1339Y) into the left arm. Other suspect therapy included AFLURIA (manufacturer unspecified) given in the left arm on 01-SEP-2010. Concomitant therapies include unspecified medications for hypertension, hypercholesterolaemia and psychiatric disorder. On 02-SEP-2010 the patient developed cellulitis of the left arm at the injection site. The physician reported that cellulitis extended to the patient's elbow. The patient sought medical attention via phone call, and he was admitted to a hospital, and is being treated with intravenous antibiotics. The patient had taken unspecified blood tests (results unknown), and white blood cell count was 19,000. Blood cultures, unspecified CT scan and X-rays all revealed negative results. At the time of reporting, the patient was recovering. Cellulitis of the left arm at the injection site was considered to be disabling and an other important medical event by the reporter. Additional information has been requested. This is an amended report. The "vaccine purchased with" and "vaccinated at" fields have been updated to "unknown".
Age: 32.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Myalgia
Clinical narrative: Information has been received from a 32 year old female consumer with a history of tendonitis surgery, Caesarean section, tonsillectomy, laser-eye surgery, general allergies and drug allergies to PERCOCET, DARVOCET-N, AUGMENTIN, TIMENTIN and codeine (unspecified), who on 25-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663998/0623Y) (route no reported). Concomitant therapy included montelukast sodium (MSN) and XYZAL. The consumer reported that she experienced pain at the injection site, swelling, chills, vomiting and tiredness after being vaccinated with PNEUMOVAX 23. At the time of the report, the patient had no recovered. Laboratory test included yearly check-up (result  no provided). The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 32 year old female with drug allergies DARVOCET-N, AUGMENTIN, codeine and "Lafex" who on 25-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (IM) into her right arm. Secondary suspect therapy on 25-SEP-2010 included a dose of influenza (MSD) (SC) into her left arm. Concomitant therapy included montelukast sodium (MSD) 10 mg daily and omeprazole 20 mg daily. On 25-SEP-2010 (previously reported as 26-SEP-2010) the patient experienced dizziness, fatigue, fever and myalgia. On 01-OCT-2010, the patient recovered. No further information is available.
Age: 32.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Swelling, Vomiting
Clinical narrative: Information has been received from a 32 year old female consumer with a history of tendonitis surgery, Caesarean section, tonsillectomy, laser-eye surgery, general allergies and drug allergies to PERCOCET, DARVOCET-N, AUGMENTIN, TIMENTIN and codeine (unspecified), who on 25-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663998/0623Y) (route no reported). Concomitant therapy included montelukast sodium (MSN) and XYZAL. The consumer reported that she experienced pain at the injection site, swelling, chills, vomiting and tiredness after being vaccinated with PNEUMOVAX 23. At the time of the report, the patient had no recovered. Laboratory test included yearly check-up (result  no provided). The patient sought unspecified medical attention. Follow up information has been received from a physician concerning the 32 year old female with drug allergies DARVOCET-N, AUGMENTIN, codeine and "Lafex" who on 25-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23 (IM) into her right arm. Secondary suspect therapy on 25-SEP-2010 included a dose of influenza (MSD) (SC) into her left arm. Concomitant therapy included montelukast sodium (MSD) 10 mg daily and omeprazole 20 mg daily. On 25-SEP-2010 (previously reported as 26-SEP-2010) the patient experienced dizziness, fatigue, fever and myalgia. On 01-OCT-2010, the patient recovered. No further information is available.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unspecified date was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (Lot# not reported). Subsequently, in approximately April 2009 "a year and a half", the patient experienced cellulitis or injection site reaction. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Follow up information has been received from a registered nurse concerning the 68 year old male with high blood pressure, hyperlipidaemia and no known allergies who on 20-SEP-2010, at 18:00, was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (Lot# reported as "0739Z") into the left deltoid. The patient had Gram negative sepsis and adenocarcinoma of prostate at time of vaccination. It was reported that he complained of pain in left upper arm for some period of time. Last night he received PNEUMOVAX 23 vaccine same arm. On 20-SEP-2010, he complained of swelling, tenderness, warmth over the deltoid. The physician prescribed him amoxicillin/clavulanic acid 500mg bid for cellulitis. On 25-SEP-2010, the patient was stable and he was discharged. At the time of this report, the patient had recovered. The patient's condition was considered to be an other important medical event by the reporter. This is one of several reports received from the same source. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Injection site discolouration, Injection site haematoma, Skin discolouration
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 58 year old female patient who on 30-SEP-2010, was vaccinated with a dose of PNEUMOVAX 23 (Lot# 665904/0866Z). It was reported that on 30-SEP-2010, the patient experienced purple bruising at the injection site as well as the whole upper right arm. At the time of the report the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female patient with no known allergies who on 11-OCT-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot# 667912/0933Z) into the right arm, a dose of FLUVIRIN in her left arm. On 12-OCT-2010 the patient experienced soreness, red, swelling, severe muscle pain, and rash at injection site. She also had a fever. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Follow up information has been received from the pharmacist concerning the 70 year old female patient who on 11-OCT-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot# 667912/0933Z) into the right deltoid. There was no illness at time of vaccination. On 12-OCT-2010 the patient developed swelling and redness in right arm. She also ran a fever. At the time of this report, the patient had recovered from the events. Follow up information has been received from the pharmacist concerning the 70 year old female patient with drug hypersensitivity of DARVOCET-N, who on 11-OCT-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot# 667912/0933Z) into her right deltoid. Concomitant therapy included FLUVIRIN (lot# 11180811) into her left deltoid on the same day. On 13-OCT-2010, the patient had recovered from fever, red at injection site, swelling in right arm, and soreness in right arm. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Myalgia, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female patient with no known allergies who on 11-OCT-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot# 667912/0933Z) into the right arm, a dose of FLUVIRIN in her left arm. On 12-OCT-2010 the patient experienced soreness, red, swelling, severe muscle pain, and rash at injection site. She also had a fever. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Follow up information has been received from the pharmacist concerning the 70 year old female patient who on 11-OCT-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot# 667912/0933Z) into the right deltoid. There was no illness at time of vaccination. On 12-OCT-2010 the patient developed swelling and redness in right arm. She also ran a fever. At the time of this report, the patient had recovered from the events. Follow up information has been received from the pharmacist concerning the 70 year old female patient with drug hypersensitivity of DARVOCET-N, who on 11-OCT-2010 was vaccinated intramuscularly with the first 0.5ml dose of PNEUMOVAX 23 (lot# 667912/0933Z) into her right deltoid. Concomitant therapy included FLUVIRIN (lot# 11180811) into her left deltoid on the same day. On 13-OCT-2010, the patient had recovered from fever, red at injection site, swelling in right arm, and soreness in right arm. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site cellulitis, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old female patient with no known medical history and no known drug reactions/allergies who on 05-OCT-2010 was vaccinated IM in the right deltoid with PNEUMOVAX 23 (lot # 665708/0651Z). There was no concomitant medication. On 06-OCT-2010, the patient developed a fever and had severe swelling at the injection site. The patient made an emergency room visit on 09-OCT-2010 and was diagnosed with cellulitis at this region. She was prescribed KEFLEX 500mg twice a day 10 days on 11-OCT-2010. "The symptoms are resolving at this time." No diagnostic laboratory tests were performed. The nurse requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse concerning the 56 year old female patient with no medical history or illness at time of vaccination who on 05-OCT-2010 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 665708/0651Z) in the right arm. Concomitant therapies included: several doses of FLUZONE (lot number U3719AA) in the right arm and the first dose of ADACEL (lot number CB3516AA) in the left arm. On 06-OCT-2010 patient returned to office. What the patient requested were vaccines at once. Then the patient started with fever in 24 hours after injection. The patient was in the emergency room for cellulitis and treated with KEFLEX. Follow up information was received from the registered nurse reported that the patient completely resolved on an unspecified date. Additional information has been requested. This is one of several reports received from the same source.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Headache, Injection site erythema
Clinical narrative: Information has been received from a nurse practitioner concerning a 44 year old employee health male patient with asthma who on 13-OCT-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot # 667418/0978Z), 0.5 mL SC in the right upper arm. Concomitant therapy included albuterol. It was reported that on 13-OCT-2010 in the evening, the patient developed headache. The morning of 14-OCT-2010 he had generalized body aches, fatigue, and redness of his right arm. He continued to have symptoms as of the time of this  report, including an oral temperature of 102.1. He was given two TYLENOL and told to apply cool compresses to his arm to hydrate himself. His arm was hot and was an area of 5 inches x 4 and 1/2 inches. He had a follow up appointment on 16-OCT-2010. The patient sought medical attention at the office visit on 15-OCT-2010. Follow-up information has been received from a nurse practitioner who indicated that on 13-OCT-2010 the patient with no known drug allergies was vaccinated IM (previously reported as SC) with a 0.5 ml dose of PNEUMOVAX 23. Secondary suspect vaccination administered on the same day included a 0.5 mL IM dose of AFLURIA (lot # 11049121A). In the evening of 13-OCT-2010 the patient experienced headache (duration reported as 24 hours) and arm pain at the injection site (duration reported as 15d). On 14-OCT-2010 the patient experienced generalized body aches, fatigue and erythema and inflammation the injection site (duration reported as 15d). On 15-OCT-2010 the patient experienced chills, fever (102.1 oral, duration reported as 24 hours), increased erythema and inflammation extending to most of RUA (right upper arm). The patient was treated with TYELNOL and increased fluids. That same day the patient improved. On 16-OCT-2010 the patient's inflammation decreased. Erythema persisted to 28-OCT-2010. No prescription (Rx) required. on approximately 01-NOV-2010 the patient recovered. Additional information is not expected.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Injection site pain, Pain, Pyrexia, Skin warm
Clinical narrative: Information has been received from a nurse practitioner concerning a 44 year old employee health male patient with asthma who on 13-OCT-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot # 667418/0978Z), 0.5 mL SC in the right upper arm. Concomitant therapy included albuterol. It was reported that on 13-OCT-2010 in the evening, the patient developed headache. The morning of 14-OCT-2010 he had generalized body aches, fatigue, and redness of his right arm. He continued to have symptoms as of the time of this  report, including an oral temperature of 102.1. He was given two TYLENOL and told to apply cool compresses to his arm to hydrate himself. His arm was hot and was an area of 5 inches x 4 and 1/2 inches. He had a follow up appointment on 16-OCT-2010. The patient sought medical attention at the office visit on 15-OCT-2010. Follow-up information has been received from a nurse practitioner who indicated that on 13-OCT-2010 the patient with no known drug allergies was vaccinated IM (previously reported as SC) with a 0.5 ml dose of PNEUMOVAX 23. Secondary suspect vaccination administered on the same day included a 0.5 mL IM dose of AFLURIA (lot # 11049121A). In the evening of 13-OCT-2010 the patient experienced headache (duration reported as 24 hours) and arm pain at the injection site (duration reported as 15d). On 14-OCT-2010 the patient experienced generalized body aches, fatigue and erythema and inflammation the injection site (duration reported as 15d). On 15-OCT-2010 the patient experienced chills, fever (102.1 oral, duration reported as 24 hours), increased erythema and inflammation extending to most of RUA (right upper arm). The patient was treated with TYELNOL and increased fluids. That same day the patient improved. On 16-OCT-2010 the patient's inflammation decreased. Erythema persisted to 28-OCT-2010. No prescription (Rx) required. on approximately 01-NOV-2010 the patient recovered. Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse reaction, Cellulitis, Injection site discomfort, Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a nurse practitioner concerning a 39 year old female patient with asthma, migraine, reflex sympathetic dystrophy, "at risk for septic infections", allergy to sulfa, PAXIL, PERCOCET, PAMELOR and PROZAC, who on 13-OCT-2010 was vaccinated SQ with a 0.5 ml dose of PNEUMOVAX 23 (Lot #667418/0978Z). Concomitant therapy included ADVAIR, FIOICET, TRILEPTAL, TREXIMET, OXYTROL, NEURONTIN and albuterol. On 13-OCT-2010 after receiving her first dose of PNEUMOVAX 23, the patient developed an adverse reaction. She was seen on 14-OCT-2010 for discomfort, erythema and inflammation at the injection site. She had no fever or other systemic symptoms. She was told to put ice on the area and elevate her arm. That evening she developed a fever of 101.5. The inflammation of her arm increased and she was evaluated at a local emergency room where she was diagnosed with cellulitis. She was treated with an antibiotic. The patient had stayed home from work on 15-OCT-2010. At the time of the report, the patient's cellulitis persisted. Follow up information received from the nurse practitioner indicated that the patient was a female, with stress incontinence and no acute illness, who on 13-OCT-2010 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 667418/0978Z), subcutaneously in her left upper arm. On the same date the patient was vaccinated with a third dose of influenza (lot # 11049121A), intramuscularly in her right upper arm. On 14-OCT-2010 the patient developed itching, redness at her left upper arm injection site. At 16:00 the patient developed swelling and erythema at her left upper arm injection site; it was hot to touch (oral temp was 98.7). The patient was instructed to had cold compress. At 21:00 the patient had increased swelling, erythema, temperature was 100.2; at 21:30 temperature was 101.5; the patient was treated at the emergency room with KEFLEX 500 mg QIDx10 D. The patient was diagnosed with cellulitis. The patient recovered from cellulitis on 18-OCT-2010. No further information is available.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 39 year old female patient with asthma, migraine, reflex sympathetic dystrophy, "at risk for septic infections", allergy to sulfa, PAXIL, PERCOCET, PAMELOR and PROZAC, who on 13-OCT-2010 was vaccinated SQ with a 0.5 ml dose of PNEUMOVAX 23 (Lot #667418/0978Z). Concomitant therapy included ADVAIR, FIOICET, TRILEPTAL, TREXIMET, OXYTROL, NEURONTIN and albuterol. On 13-OCT-2010 after receiving her first dose of PNEUMOVAX 23, the patient developed an adverse reaction. She was seen on 14-OCT-2010 for discomfort, erythema and inflammation at the injection site. She had no fever or other systemic symptoms. She was told to put ice on the area and elevate her arm. That evening she developed a fever of 101.5. The inflammation of her arm increased and she was evaluated at a local emergency room where she was diagnosed with cellulitis. She was treated with an antibiotic. The patient had stayed home from work on 15-OCT-2010. At the time of the report, the patient's cellulitis persisted. Follow up information received from the nurse practitioner indicated that the patient was a female, with stress incontinence and no acute illness, who on 13-OCT-2010 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 667418/0978Z), subcutaneously in her left upper arm. On the same date the patient was vaccinated with a third dose of influenza (lot # 11049121A), intramuscularly in her right upper arm. On 14-OCT-2010 the patient developed itching, redness at her left upper arm injection site. At 16:00 the patient developed swelling and erythema at her left upper arm injection site; it was hot to touch (oral temp was 98.7). The patient was instructed to had cold compress. At 21:00 the patient had increased swelling, erythema, temperature was 100.2; at 21:30 temperature was 101.5; the patient was treated at the emergency room with KEFLEX 500 mg QIDx10 D. The patient was diagnosed with cellulitis. The patient recovered from cellulitis on 18-OCT-2010. No further information is available.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female patient with no pertinent medical history and no drug reactions or allergies who on 22-SEP-2010 was vaccinated intramuscularly in the right arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665902/1426Y) (Expiration date: 02-JUL-2011). Concomitant therapy included JANUMET, magnesium (unspecified), COLACE, LIPITOR, PREVACID, LANTUS, lisinopril (manufacturer unknown), LEXAPRO and FLUZONE. The medical assistant reported that on 23-SEP-2010 the patient experienced fever, fatigue, upper arm from shoulder to elbow was swollen, hot and very painful. The medical assistant stated that the patient received FLUZONE in the same arm as PNEUMOVAX 23. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by an office visit on 24-SEP-2010. Patient's fever, fatigue, upper arm from shoulder to elbow was swollen, hot and very painful were considered to be disabling by the medical assistant because the patient could not move her arm. This is one of several reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female patient with no pertinent medical history and no drug reactions or allergies who on 22-SEP-2010 was vaccinated intramuscularly in the right arm with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 665902/1426Y) (Expiration date: 02-JUL-2011). Concomitant therapy included JANUMET, magnesium (unspecified), COLACE, LIPITOR, PREVACID, LANTUS, lisinopril (manufacturer unknown), LEXAPRO and FLUZONE. The medical assistant reported that on 23-SEP-2010 the patient experienced fever, fatigue, upper arm from shoulder to elbow was swollen, hot and very painful. The medical assistant stated that the patient received FLUZONE in the same arm as PNEUMOVAX 23. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by an office visit on 24-SEP-2010. Patient's fever, fatigue, upper arm from shoulder to elbow was swollen, hot and very painful were considered to be disabling by the medical assistant because the patient could not move her arm. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with no known medical history and no known drug reactions/allergies who on 28-SEP-2010 was vaccinated IM in the right deltoid with PNEUMOVAX 23 (lot # 665708/0651Z). There was no concomitant medication. On 29-SEP-2010 "the patient presented to the office with a fever and was diagnosed with cellulitis at the injection site. She was prescribed KEFLEX 500mg PO twice a day for 10 days. By the second day after treatment the cellulitis had all but resolved." The patient's outcome was also reported as "recovered, 2 days after treatment" on approximately 01-OCT-2010. No diagnostic laboratory tests were performed. The nurse requested a lot check. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from the registered nurse concerning the 61 year old patient with illness at time of vaccination of allergic rhinitis (AR) and no medical history who on 28-SEP-2010 was vaccinated in the right arm with the first dose of PNEUMOVAX 23 (lot # 665708/0651Z). Concomitant therapy included: several doses of FLUZONE (lot number U3053MA) in the left arm. On 29-SEP-2010 the patient developed cellulitis. She returned to office with cellulitis on 30-SEP-2010 and was treated with KEFLEX BID x 10 days. There was no lab diagnostic test performed. The patient recovered. Additional information is not expected. This is one of several reports from the same source.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Injection site pain, Injection site pruritus, Mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 53 year old female who on 13-OCT-2010 was vaccinated with PNEUMOVAX 23 (LOT number not provided). On 18-OCT-2010 the patient reported that "her arm was very sore and they could not move it and it was burning and itching", and "there was no redness involved". The patient sought unspecified medical attention. At the time of reporting, the outcome of the patient was not provided. Follow up information on 26-OCT-2010 reported that the patient with Type 2 diabetes mellitus and Hyperlipidaemia was vaccinated with a first dose of PNEUMOVAX 23 (LOT number 667418/0978Z) SC 18:12 on 13-OCT-2010. On 14-OCT-2010 the patient complained of left arm was extremely sensitive with burning and itching at injection site. It started about 24 hours after injection and the patient was advised ice and ADVIL prn. Follow up information from the nurse concerning that the patient was vaccinated with a first dose of PNEUMOVAX 23 (LOT number 667418/0978Z) SC 18:12 on 13-OCT-2010 on left arm. On 13-OCT-2010 the patient was vaccinated with a dose of FLUARIX (GlaxoSmithKline) (lot #AFLUA577CA) on the right deltoid IM. The patient called the office on 18-OCT-2010 to report her left arm was extremely sensitive, burning and itching at injection site, started about 24 hours post injection. The patient was recovered. Follow up information from the registered nurse reported that the patient was recovered from the AEs on 23-OCT-2010. No further information is available.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus
Clinical narrative: Information has been received from a nurse concerning a 53 year old female who on 13-OCT-2010 was vaccinated with PNEUMOVAX 23 (LOT number not provided). On 18-OCT-2010 the patient reported that "her arm was very sore and they could not move it and it was burning and itching", and "there was no redness involved". The patient sought unspecified medical attention. At the time of reporting, the outcome of the patient was not provided. Follow up information on 26-OCT-2010 reported that the patient with Type 2 diabetes mellitus and Hyperlipidaemia was vaccinated with a first dose of PNEUMOVAX 23 (LOT number 667418/0978Z) SC 18:12 on 13-OCT-2010. On 14-OCT-2010 the patient complained of left arm was extremely sensitive with burning and itching at injection site. It started about 24 hours after injection and the patient was advised ice and ADVIL prn. Follow up information from the nurse concerning that the patient was vaccinated with a first dose of PNEUMOVAX 23 (LOT number 667418/0978Z) SC 18:12 on 13-OCT-2010 on left arm. On 13-OCT-2010 the patient was vaccinated with a dose of FLUARIX (GlaxoSmithKline) (lot #AFLUA577CA) on the right deltoid IM. The patient called the office on 18-OCT-2010 to report her left arm was extremely sensitive, burning and itching at injection site, started about 24 hours post injection. The patient was recovered. Follow up information from the registered nurse reported that the patient was recovered from the AEs on 23-OCT-2010. No further information is available.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received regarding a 55 year old male who was vaccinated with a dose of PNEUMOVAX 23 "PRF 25 Y" on 17-OCT-2010. On 17-OCT-2010, the patient experienced inflammation and swelling at the injection site after being administered PNEUMOVAX 23. The patient sought unspecified medical attention. The patient was given an unspecified antibiotic for treatment and then given a single prescription for treatment. The adverse event improved, "on therapy." Additional information has been received regarding a 55 year old male who received a dose of PNEUMOVAX 23, 0.5 ml, injection into his left deltoid on 17-OCT-2010. Over the next 72 hours, the site became hot to the touch, swollen, and the patient soon after developed a fever. A few days after the injection, and after the symptoms did not subside, the patient sought medical care with his primary care physician, who prescribed an antibiotic and advised the patient to come back if the "site and symptoms increased, which it did." The following day, the patient saw his physician who then prescribed a "staged" Rx to which the adverse reaction "was effected and symptoms were gone approximately 4 days later and no further treatment has been, or will be sought." Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a 50 year old female patient with hypertension and no illness at time of vaccination who on 28-SEP-2010 at 7:45 was vaccinated subcutaneously into her left arm with her first dose of PNEUMOVAX 23 (lot number 666558/0449Z). The nurse stated that on 29-SEP-2010 the patient's call her to report that on 28-SEP-2010 she was fine until 16:00 when her left arm and neck started to hurt. The patient took some TYLENOL and went to bed. The patient woke up in middle of night with left arm still hurting and felt weak, almost passed out. She had to lay on kitchen floor. Next day, she went to work but had to go home due to weakness and feeling faint. The patient did not seek medical attention. No laboratory diagnostics studies were performed. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Movement disorder, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning an 80 year old male who on 13-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23. On 14-OCT-2010, the patient called to report that his left arm was sore and could not lift it at all. The physician told him to ice his arm. Follow up information has been received from the reporting Registered Nurse (R.N.) concerning an 80 year old male with no illness at time of vaccination who on 13-OCT-2010 AM was vaccinated subcutaneously with the second dose of PNEUMOVAX 23 (Lot#667418/0978Z) in his left arm. On 14-OCT-2010, the patient called to report that his left arm was extremely sore, very difficult to move arm; tender to touch at site of injection, slight redness, patient denied swelling. There was no lab diagnostic performed. At the time of the report, the patient had recovered from his adverse events. No further information is available.