chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from an office manager and the patient's mother concerning a 5 year old male, with no known allergies and no pertinent medical history, who on 30-OCT-2008 was vaccinated with PNEUMOVAX (lot # 659150/1384U) 0.5 ml intramuscularly in the left deltoid.  Concomitant medications include SINGULAIR.  On 31-OCT-2008 the patient developed a 2 x 3 cm raised area at injection site of the left deltoid.  The patient was seen in the office on 01-NOV-2008 and was prescribed OMNICEF.  The patient's mother reported that her son started "feeling bad" the day after he was given PNEUMOVAX.  The patient developed a fever and was lethargic.  He was "favoring his left arm" (the arm he was vaccinated in).  He went to the hospital on 01-NOV-2008 and was diagnosed with cellulitis but was not admitted.  He also developed a knot at the injection site.  The area of the knot and the cellulitis was about 2" x 4".  As of 20-NOV-2008, the cellulitis is gone, the knot is smaller and he was using his left arm.  The patient had seen the doctor a couple times about these events since he was given the injection.  This is one of several reports from the same source.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female patient with no pertinent medical history and no known allergies or drug reactions who on 23-October-2008 was vaccinated with the first dose of PNEUMOVAX (lot#655765/0061U) subcutaneous in her left arm. There was no concomitant medication. The pharmacist reported that on 23-Oct-2008 the patient's left arm at the injection site became red, swollen, hard, and hot after administration of the vaccine. The patient also experienced chills. The patient sought medical attention via telephone. This is one of two reports received from the same source.  Additional information has been received  on 19-Dec-2008 from a certified medical assistant at the physician's office. She stated that the patient has never contacted their office regarding her reaction to PNEUMOVAX  vaccine on 23-Oct-2008. The injection was administered pharmacy. The physician's office had nothing additional to add to the case since they did not administer or follow the patient for the adverse reaction. Additional information is is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 02-Oct-2008 was vaccinated with the second dose of PNEUMOVAX (lot# 655765/0061U) I.M. into right arm (first dose received "last year"). There was no concomitant medication. On 03-Oct-2008, the patient's right arm became swollen and painful after administration of the vaccine. She also developed a fever and was unable to move right arm. She missed a couple of days work because of symptoms. On 05-Oct-2008, the patient was recovered. This is one of two reports reported from the same source. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure normal, Chronic obstructive pulmonary disease, Heart rate normal, Hyperlipidaemia, Injection site induration
Clinical narrative: Information has been received from a physician concerning a female patient over 60 years of age who in October 2008 was vaccinated with PNEUMOVAX (lot# 662599/1076X), therapy date, route, site unknown). "In the last 10 days" approximately 19-Oct-2008, this patient developed severe local reactions in the injection arm. The patient experienced welts and swelling on the arm. A lot check is requested for PNEUMOVAX lot#662599/1076X. Unspecified medical attention was sought. The patient's outcome was unknown. Follow-up information has been received from the office and medical records concerning this 59 year old female retired financial administrative worker with fibromyalgia, migrating tendonitis, carpal tunnel syndrome (both hands), osteoarthritis, degenerative disc disease, Meniere's disease, balance disorder, deafness (both ears), psoriasis, LS+A sclerosis, Proteinuria, dyslipidemia, migraine, chronic obstructive pulmonary disease, diabetes mellitus non-insulin-dependent, smoker (half ppd) "Sulphur (swell up)". codeine (headache, vomiting). aspirin (stomach bleed and Motrin) (stomach bleed) allergies and a history of three cesarean section, colon surgery (2004). tonsillectomy and hospitalization during pregnancy for gallbladder who on 23-Oct-2008 was vaccinated in the right deltoid with a first dose of gallbladder who on 23-Oct-2008 was vaccinated in the right deltoid with a first dose of PNEUMOVAX (lot# 662599/1076X). Concomitant therapy included Lipitor, Zyrtec, Beconase aq, Ultracet, Symbicort, Fioricet, Darvocet-N, and Montelukast sodium (MSD). On 24-Oct-2008 the patient experienced swelling, induration and achiness in the area of the injection and required an emergency room, doctor's visit. It was noted that the patient's extremities had no tremors, varicose veins were absent, pulses 2+ bilateral, no clubbing, no cyanosis, no edema. The patient's right arm was indurated 5X8 cm, and was tender over the triceps area. The patient was reassured, and there was no evidence of cellulitis. Ice packs were recommended. The patient was instructed to continue her medications and have Zoster vaccine live (Merck) (MSD) x 1. At the time of the report the patient's status was unknown. Additional information about injection site urticaria was not reported. The patient's assessment: allergic reaction NOS (primary) hyperlipidemia, non-insulin-dependent diabetes mellitus and COPD. Additional information has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the evaluation and research and was released by the regulatory agency. This is one of several reports received from the same source.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Oedema peripheral, Respiratory rate decreased
Clinical narrative: Information has been received from a physician concerning a female patient over 60 years of age who in October 2008 was vaccinated with PNEUMOVAX (lot# 662599/1076X), therapy date, route, site unknown). "In the last 10 days" approximately 19-Oct-2008, this patient developed severe local reactions in the injection arm. The patient experienced welts and swelling on the arm. A lot check is requested for PNEUMOVAX lot#662599/1076X. Unspecified medical attention was sought. The patient's outcome was unknown. Follow-up information has been received from the office and medical records concerning this 59 year old female retired financial administrative worker with fibromyalgia, migrating tendonitis, carpal tunnel syndrome (both hands), osteoarthritis, degenerative disc disease, Meniere's disease, balance disorder, deafness (both ears), psoriasis, LS+A sclerosis, Proteinuria, dyslipidemia, migraine, chronic obstructive pulmonary disease, diabetes mellitus non-insulin-dependent, smoker (half ppd) "Sulphur (swell up)". codeine (headache, vomiting). aspirin (stomach bleed and Motrin) (stomach bleed) allergies and a history of three cesarean section, colon surgery (2004). tonsillectomy and hospitalization during pregnancy for gallbladder who on 23-Oct-2008 was vaccinated in the right deltoid with a first dose of gallbladder who on 23-Oct-2008 was vaccinated in the right deltoid with a first dose of PNEUMOVAX (lot# 662599/1076X). Concomitant therapy included Lipitor, Zyrtec, Beconase aq, Ultracet, Symbicort, Fioricet, Darvocet-N, and Montelukast sodium (MSD). On 24-Oct-2008 the patient experienced swelling, induration and achiness in the area of the injection and required an emergency room, doctor's visit. It was noted that the patient's extremities had no tremors, varicose veins were absent, pulses 2+ bilateral, no clubbing, no cyanosis, no edema. The patient's right arm was indurated 5X8 cm, and was tender over the triceps area. The patient was reassured, and there was no evidence of cellulitis. Ice packs were recommended. The patient was instructed to continue her medications and have Zoster vaccine live (Merck) (MSD) x 1. At the time of the report the patient's status was unknown. Additional information about injection site urticaria was not reported. The patient's assessment: allergic reaction NOS (primary) hyperlipidemia, non-insulin-dependent diabetes mellitus and COPD. Additional information has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the evaluation and research and was released by the regulatory agency. This is one of several reports received from the same source.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness, Urticaria
Clinical narrative: Information has been received from a physician concerning a female patient over 60 years of age who in October 2008 was vaccinated with PNEUMOVAX (lot# 662599/1076X), therapy date, route, site unknown). "In the last 10 days" approximately 19-Oct-2008, this patient developed severe local reactions in the injection arm. The patient experienced welts and swelling on the arm. A lot check is requested for PNEUMOVAX lot#662599/1076X. Unspecified medical attention was sought. The patient's outcome was unknown. Follow-up information has been received from the office and medical records concerning this 59 year old female retired financial administrative worker with fibromyalgia, migrating tendonitis, carpal tunnel syndrome (both hands), osteoarthritis, degenerative disc disease, Meniere's disease, balance disorder, deafness (both ears), psoriasis, LS+A sclerosis, Proteinuria, dyslipidemia, migraine, chronic obstructive pulmonary disease, diabetes mellitus non-insulin-dependent, smoker (half ppd) "Sulphur (swell up)". codeine (headache, vomiting). aspirin (stomach bleed and Motrin) (stomach bleed) allergies and a history of three cesarean section, colon surgery (2004). tonsillectomy and hospitalization during pregnancy for gallbladder who on 23-Oct-2008 was vaccinated in the right deltoid with a first dose of gallbladder who on 23-Oct-2008 was vaccinated in the right deltoid with a first dose of PNEUMOVAX (lot# 662599/1076X). Concomitant therapy included Lipitor, Zyrtec, Beconase aq, Ultracet, Symbicort, Fioricet, Darvocet-N, and Montelukast sodium (MSD). On 24-Oct-2008 the patient experienced swelling, induration and achiness in the area of the injection and required an emergency room, doctor's visit. It was noted that the patient's extremities had no tremors, varicose veins were absent, pulses 2+ bilateral, no clubbing, no cyanosis, no edema. The patient's right arm was indurated 5X8 cm, and was tender over the triceps area. The patient was reassured, and there was no evidence of cellulitis. Ice packs were recommended. The patient was instructed to continue her medications and have Zoster vaccine live (Merck) (MSD) x 1. At the time of the report the patient's status was unknown. Additional information about injection site urticaria was not reported. The patient's assessment: allergic reaction NOS (primary) hyperlipidemia, non-insulin-dependent diabetes mellitus and COPD. Additional information has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the evaluation and research and was released by the regulatory agency. This is one of several reports received from the same source.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning an 84 year old female with leukemia (stable) at the time of vaccination, anaemia, osteoarthritis, cytopenia, venous insufficiency, allergy to amoxicillin and sulfonamide allergy who in 1997 was vaccinated with the first dose of PNEUMOVAX 23. In 2007, the patient was vaccinated with the first dose of FLUZONE. On 06-NOV-2008 at 9:15 AM, the patient was vaccinated SC (previously reported as IM) in the left deltoid with the second 0.5 ml dose of PNEUMOVAX 23 (lot # 661529/0868X). Concomitant therapy included the second dose of FLUZONE (lot # U2752AA) given in the right deltoid on the same day, prednisone, oxycodone, morphine, cyclobenzaprine HCl (MSD), MIRALAX, ACTONEL, methotrexate, levothyroxine Na, furosemide, PRILOSEC and folic acid. On 07-NOV-2008 at 10:00 AM, the patient experienced a fever with a temperature of 101.5 F, along with redness, swelling, warmth and pain on her arm at the injection site. The affected area on her arm was about 5 cm in circumference. The registered nurse reported in follow up that there was 4 cm x 4 cm red, hot, circular area to PNEUMOVAX 23 injection site. On an unspecified date, the patient recovered from the events. No lab tests were performed. The patient was seen in office and treated with an unspecified antibiotic. This is one of several reports received from the same source. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chills, Flushing, Injection site erythema, Injection site pain
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 63-year-old female patient with asthma, arthritis, and drug allergies were reported in follow-up), who on 03-NOV-2008 was vaccinated SC with a first dose of 0.5 ml PNEUMOVAX (lot # 661529/0868X) in the right arm, at 9:00 AM.  Concomitant vaccination included FLUZONE (lot # U2752AA) IM in the right deltoid (patient also had received FLUZONE last year).  Concomitant medications included FAMOTIDINE (MSD), amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL, IBUPROFEN, DETROL LA, AEROBID and ALBUTEROL inhaler as needed.  On 04-NOV-2008, at 4:15 PM, the patient experienced chills and a sensation of "burning up", along with redness, swelling, warmth and pain on her arm at the injection site.  The affected area on her arm was 4cm by 5cm.  It was also reported that on 05-NOV-2008, the patient reported chills, flushed face and a 4.5x5 cm red warm circular area to injection site.  She visited doctor's office and was treated with an unspecified antibiotic.  At the time of reporting, she had recovered from the events.  This is one of two reports received from the same source.  No further information is available.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 63-year-old female patient with asthma, arthritis, and drug allergies were reported in follow-up), who on 03-NOV-2008 was vaccinated SC with a first dose of 0.5 ml PNEUMOVAX (lot # 661529/0868X) in the right arm, at 9:00 AM.  Concomitant vaccination included FLUZONE (lot # U2752AA) IM in the right deltoid (patient also had received FLUZONE last year).  Concomitant medications included FAMOTIDINE (MSD), amitriptyline hydrochloride (manufacturer unknown), PLAQUENIL, IBUPROFEN, DETROL LA, AEROBID and ALBUTEROL inhaler as needed.  On 04-NOV-2008, at 4:15 PM, the patient experienced chills and a sensation of "burning up", along with redness, swelling, warmth and pain on her arm at the injection site.  The affected area on her arm was 4cm by 5cm.  It was also reported that on 05-NOV-2008, the patient reported chills, flushed face and a 4.5x5 cm red warm circular area to injection site.  She visited doctor's office and was treated with an unspecified antibiotic.  At the time of reporting, she had recovered from the events.  This is one of two reports received from the same source.  No further information is available.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 69 year old male with drug allergies of novocaine who on 05-Nov-2009 was vaccinated with PNEUMOVAX (lot# 662661/0978X) . Concomitant therapy included flu vaccine (manufacturer unspecified) in the opposite arm. Subsequently, the patient had a red area on his arm and was unable to lift his arm. The patient came to office today and the red area started below injection site and was to the elbow. The patient did not have a fever, but the arms was bright red and warm to touch. The patient stated that he had a reaction to vaccine in the past but could not remember what vaccine it was. The patient was vaccinated with PNEUMOVAX vaccine in past in November of 1997, and he did not have a reaction at that time. The patient's  adverse events persisted. It was reported the patient sought unspecified medical attention. The patient subsequently experienced drug reaction/allergies to Amitriptyline HCl.(MSD) (WAES#0911USA02063). Additional information was received from the patient's physician who reported that the patient with drug allergies of Novocaine and pre-existing condition of hemochromatosis on 05-Nov-2008 was vaccinated SQ with PNEUMOVAX vaccine in the right arm (lot# 662661/0978X). On 06-Nov-2008, the patient experienced red, sore, swollen arm. The patient's adverse events were recovered. No further information is available.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a doctor of pharmacy concerning an 81 year old male patient with no known drug reactions/allergies and who was admitted for intractable headache prior to vaccination, who on 15-NOV-2008 was vaccinated with PNEUMOVAX (Lot # 662263/0743X). Concomitant therapy included prednisone, hydromorphone, fentanyl, PROTONIX, SYNTHROID, warfarin, ZOFRAN, TYLENOL and phenytoin. The doctor of pharmacy reported that on 15-NOV-2008 the patient experienced large amount of swelling and redness at site of injection lasting several hours after administration of PNEUMOVAX. The patient sought medical attention via telephone. At the time of report the patient had recovered. This is one of two reports received from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 45 year old female with erythromycin reactions and NSAIDs, a history of hospital for gastrointestinal bleed prior to administration of PNEUMOVAX, who on 13-NOV-2008 was vaccinated with PNEUMOVAX (lot # 662263/0743X), 0.5 ml via intramuscular in left arm. Concomitant therapy included FLEXERIL, VICODIN, LIPITOR, PLAVIX, aspirin. On 13-NOV-2008 the patient experienced swelling and redness at the site of injection in left arm for several hours after administration of PNEUMOVAX. The influenza virus vaccine (unspecified) was administered in her right arm the same day as PNEUMOVAX. No additional information was provided. The patient sought medical attention via telephone. No lab diagnostics studies performed. On 14-NOV-2008 the patient was recovered from swelling and redness at the site of injection in left arm. This is one os several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 65 year old female patient with fluid retention, drug reaction to codeine and tamoxifen citrate, allergy to molds, trees and grass, and sarcoidosis and medical history of breast cancer 12 years ago who 04-NOV-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (Lot # was not available) 0.5cc, intramuscularly on left leg. Concomitant therapy included influenza virus vaccine (unspecified), VALTREX, acyclovir, hydrochlorothiazide (manufacturer unknown), ASTELIN, allergy serum, calcium (unspecified), vitamins (unspecified), guaifenesin, ibuprofen and omega-3 marine triglycerides. On 05-NOV-2008 the patient experienced low grade fever lasted for 2 days and she started to develop cellulitis across the top of her left thigh, 3 inches wide by 7 inches long that later went down on the side of the thigh. Patient noted that her left thigh was inflamed, red, hot and sore. Patient reported that cellulitis stayed for 7 days. There were no laboratory diagnostic studies performed. At the time of the report on 20-NOV-2008, the patient was "recovering". The patient sought medical attention with her physician. Additional information has been received from a physician who reported that the patient had facial pain secondary to dental disease, penicillin allergy, sulfonamide allergy and latex allergy. Other concomitant therapy included folic acid, lysine and biotin. On 04-NOV-2008 the patient developed redness and edema of left thigh ( at site of PNEUMOVAX injection). The patient was seen in the office in November 2008 and physician prescribed antibiotics for possible cellulitis, but the patient never took, antibiotics because erythema and edema started to improve. At the time on the report the patient was recovered. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 65 year old female patient with fluid retention, drug reaction to codeine and tamoxifen citrate, allergy to molds, trees and grass, and sarcoidosis and medical history of breast cancer 12 years ago who 04-NOV-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX (Lot # was not available) 0.5cc, intramuscularly on left leg. Concomitant therapy included influenza virus vaccine (unspecified), VALTREX, acyclovir, hydrochlorothiazide (manufacturer unknown), ASTELIN, allergy serum, calcium (unspecified), vitamins (unspecified), guaifenesin, ibuprofen and omega-3 marine triglycerides. On 05-NOV-2008 the patient experienced low grade fever lasted for 2 days and she started to develop cellulitis across the top of her left thigh, 3 inches wide by 7 inches long that later went down on the side of the thigh. Patient noted that her left thigh was inflamed, red, hot and sore. Patient reported that cellulitis stayed for 7 days. There were no laboratory diagnostic studies performed. At the time of the report on 20-NOV-2008, the patient was "recovering". The patient sought medical attention with her physician. Additional information has been received from a physician who reported that the patient had facial pain secondary to dental disease, penicillin allergy, sulfonamide allergy and latex allergy. Other concomitant therapy included folic acid, lysine and biotin. On 04-NOV-2008 the patient developed redness and edema of left thigh ( at site of PNEUMOVAX injection). The patient was seen in the office in November 2008 and physician prescribed antibiotics for possible cellulitis, but the patient never took, antibiotics because erythema and edema started to improve. At the time on the report the patient was recovered. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 35 year old female patient who on 18-NOV-2008 was vaccinated with PNEUMOVAX (Lot # 661528/0867X).  On approximately 21-NOV-2008 the patient experienced that her "entire arm is a welt now".  The Doctor of Pharmacy reported the area is from her upper arm down her elbow.  At the time of the report on 21-NOV-2008, the patient was "not recovered".  The patient sought medical attention with the Doctor of Pharmacy.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old female patient who on 10-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot#657526/0555U) 0.5ml intramuscularly. Concomitant therapy included FLUVIRIN given on 10-NOV-2008. On 12-NOV-2008 the patient developed redness and cellulitis at the injection site and also had, vomiting and fever. The patient sought medical attention and was treated with KEFLEX. At the time of the report the patient was recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Headache, Injection site cellulitis, Sinus headache
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female patient who on 31-OCT-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot# 659199/1541U) 0.5ml intramuscularly. On 01-NOV-2008 the patient developed cellulitis at the injection site, headache, cough and sinus pressure. Patient sought medical attention and was treated with KEFLEX. At the time of reporting the patient had recovered. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 50 year old female patient with shellfish allergy and who on 02-DEC-2008 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot # 662100/0742X). Concomitant therapy included influenza virus vaccine (unspecified). The pharmacist reported that the patient's arm swelled up after receiving the vaccine. The injection site had a big red area. The patient sought unspecified medical attention by calling the pharmacist. At the time of report the patient was not recovered. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Information has been received from a registered nurse at the County Health Department, concerning a 54 year old female patient who on 13-NOV-2008 was vaccinated with a dose of PNEUMOVAX (Lot #661577/1161X) . Concomitant therapy included influenza virus vaccine (unspecified) at a separate injection site. Within four hours of receiving the PNEUMOVAX, the patient experienced redness and swelling below the injection site, hives at the injections site and on the top of her feet, and a fever. The patient treated herself with BENADRYL after speaking to the reporter. Patient was recovered by the next morning. Follow up information received from a registered nurse on 26-JAN-2009. It was reported that the patient on 13-NOV-2008 was vaccinated intramuscularly with a first dose of PNEUMOVAX (Lot #661577/1161X) into the left deltoid at 15:30. Concomitant therapy included FLUZONE intramuscularly into the left deltoid. The patient did not have pertinent medical history, no drug reactions/allergies. On 13-NOV-2008 at 18:30, the patient experienced left arm swollen, hives, itching, warm to touch, pain and tenderness all at injection site. The patient took per oral BENADRYL. On 14-NOV-2008, the patient recovered. The patient did not see a physician but reported the symptoms to the office on 17-NOV-2008. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a registered nurse at the County Health Department, concerning a 54 year old female patient who on 13-NOV-2008 was vaccinated with a dose of PNEUMOVAX (Lot #661577/1161X) . Concomitant therapy included influenza virus vaccine (unspecified) at a separate injection site. Within four hours of receiving the PNEUMOVAX, the patient experienced redness and swelling below the injection site, hives at the injections site and on the top of her feet, and a fever. The patient treated herself with BENADRYL after speaking to the reporter. Patient was recovered by the next morning. Follow up information received from a registered nurse on 26-JAN-2009. It was reported that the patient on 13-NOV-2008 was vaccinated intramuscularly with a first dose of PNEUMOVAX (Lot #661577/1161X) into the left deltoid at 15:30. Concomitant therapy included FLUZONE intramuscularly into the left deltoid. The patient did not have pertinent medical history, no drug reactions/allergies. On 13-NOV-2008 at 18:30, the patient experienced left arm swollen, hives, itching, warm to touch, pain and tenderness all at injection site. The patient took per oral BENADRYL. On 14-NOV-2008, the patient recovered. The patient did not see a physician but reported the symptoms to the office on 17-NOV-2008. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Alanine aminotransferase increased, Alanine aminotransferase normal, Anion gap decreased, Arthralgia, Aspartate aminotransferase increased
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Aspartate aminotransferase normal, Blood calcium decreased, Borrelia burgdorferi serology negative, CSF cell count normal, CSF culture negative
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: CSF protein normal, Computerised tomogram abnormal, Computerised tomogram head, Dizziness, Epstein-Barr virus antibody positive
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Gram stain, Haematocrit decreased, Haematocrit normal, Haematology test abnormal, Headache
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Hepatic function abnormal, Hepatitis A antibody negative, Hepatitis B antibody negative, Hepatitis B core antigen, Hepatitis C antibody negative
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test, Leukopenia, Myalgia, Nuclear magnetic resonance imaging brain, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a "40" year old female who on 08-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot # not provided). The patient experienced "aches and pains and felt like they were going to pass out" within 24 hours of receiving the PNEUMOVAX 23 vaccine. The physician reported that the patient went to the Emergency Room and at the Emergency Room the patient had a CDC test which revealed a leukopenia and LFT which revealed abnormal results. The patient was referred back to physician for follow up. Additional information has been received from the physician concerning a 44 year old female with a history of gastric bypass in 2005 and no illness at time of vaccination who on 08-DEC-2008 at 10:44 am was vaccinated with her second dose of IM PNEUMOVAX 23 (Lot  660717/0224X) in the left deltoid. On 09-DEC-2008, the patient experienced fever and myalgia along with "pressure" in head. The patient was given "AMOX", with no help. The fever resolved, but myalgia/headache worsened. The patient had swelling of the hands and feet and arthralgia and photophobia. The patient went to the emergency room. Lab results from 15-DEC-2008: WBC count-2.07 K/uL (3.9-9.5), anion gap-5 (6-18), hematocrit (HCT)-37.2% (38.0-49.0), alanine aminotransferase (ALT)-446 U/L (24-65), aspartate aminotransferase (AST)-454 U/L (0-40), calcium-8.7 mg/dL (8.9-10.3), total protein-5.9 gm/dL (6.1-7.9), urine acetone-+1 negative, and urine protein (quantitative)-+1 negative. Lab results from 16-DEC-2008: Lyme IgG WB-negative, Lyme IgM WB-negative, parvovirus B19 IgG-4.7 H positive, EBV nuclear antigen, Ab, IgG-378 AU/mL positive, EBV Ab VCA IgG-3190 H AU/mL positive, ferritin assay-791.50 H ng/mL (6.00-115.0), hepatitis A IgM antibody-negative, hepatitis B core Ab-negative, hepatitis B surface antigen-negative, and hepatitis C antibody-negative. Lab results from 18-DEC-2008: rheumatoid arthritis factor-21.8 IU/mL (0.0-20.0), CSF red blood cell-22 /cumm (0), CSF red blood cell-12 /cumm (0), WBC-4.76 K/uL (3.9-9.5), CSF culture-no growth, gram stain CSF-no organisms seen, HCT-35.5% (38.0-49.0), ALT-393 U/L (24-65), AST-193 U/L (0-40), total protein-6.9 g/dL (6.1-7.9), HCG-negative, urine color-brown, urine leukocyte esterase-trace negative, Lyme disease PCR CSF/synovial-not detected, and CT of the brain without contrast-questional focus of white matter hypoattenuation in subcortical posterior right frontal lobe. No definite abnormality, specifically, there is no hemorrhage or mass effect. Lab results from 08-JAN-2009: RDW-14.9 H % (11.2-13.2), WBC-5.9 10 (3.1-9.2), HCT-38.1% (34.5-47.8), ALT-27 IU/L (10-40), and AST-16 IU/L (3-42). On an unknown date, the patient was reported to have had an abdominal ultrasound of the RUQ (results not reported) and MRI of brain (results not reported). No further information is expected.