chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Discomfort, Erythema, Injection site inflammation, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 74 year old female with allergies to acetaminophen (+) hydrocodone bitartrate (LORTAB) and acetaminophen (+) codeine phosphate (TYLENOL 3) who on 26-OCT-2005 was vaccinated intramuscular in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccines that day included the influenza vaccine (unspecified).  There was no illness at the time of vaccination.  On 26-OCT-2005 she had a severe local reaction on the right arm at or near the injection site of the pneumococcal 23v polysaccharide vaccine.  She had discomfort, bruising, inflammation and redness.  The outcome was unknown. Unspecified medial attention was sought.  No product quality complaint was involved.  Follow up information indicated that the patient returned to the office on 28-OCT-2005, she had felt arm discomfort on that day of injection.  Over the next 2 days, beginning on 28-OCT-2005, the patient had bruising and inflammation to the site and the surrounding area was red and hot with swelling.  No laboratory tests are performed and the patient recovered on 31-OCT-2005.  Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a health professional concerning a 74 year old female with allergies to acetaminophen (+) hydrocodone bitartrate (LORTAB) and acetaminophen (+) codeine phosphate (TYLENOL 3) who on 26-OCT-2005 was vaccinated intramuscular in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccines that day included the influenza vaccine (unspecified).  There was no illness at the time of vaccination.  On 26-OCT-2005 she had a severe local reaction on the right arm at or near the injection site of the pneumococcal 23v polysaccharide vaccine.  She had discomfort, bruising, inflammation and redness.  The outcome was unknown. Unspecified medial attention was sought.  No product quality complaint was involved.  Follow up information indicated that the patient returned to the office on 28-OCT-2005, she had felt arm discomfort on that day of injection.  Over the next 2 days, beginning on 28-OCT-2005, the patient had bruising and inflammation to the site and the surrounding area was red and hot with swelling.  No laboratory tests are performed and the patient recovered on 31-OCT-2005.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Follow up information has been received from a licensed practical nurse concerning a 74 year old male patient, with hypertension, hyperlipidemia, erectile dysfunction ("ED"), and unknown drug reactions/allergies who on 08-NOV-2005 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  It was also reported that the patient received a second dose of influenza virus vaccine (AVENTIS) intramuscularly in the right deltoid on the same day.  The patient stated "about 1 hour after she got home", on 08-NOV-2005, 'the area became red swollen, hot to touch".  There was no illness at the time of vaccination.  It was reported that the patient either presented to the office or called the office to report the adverse events.  The treatment was a warm compress and follow up call to the physician if needed.  Outcome was reported as unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old male with asthma who on 08-nov-2005 was vaccinated subcutaneous in right arm with a dose of pneumococcal 23v polysaccharide vaccine.  The patient was given a flu shot (unspecified) in the same arm as pneumococcal 23v polysaccharide vaccine.  On 08-nov-2005, 6 hours after the vaccination, the patient developed a cellulitis reaction, 103 F fever, erythema and pain.  The pain was reported as recovered.  There was no product quality complaint involved.  A lot check has been requested.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with the standard and revealed that there were no open quarantines registered against this lot/fill.  Additional informational has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site reaction, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient in approximately October 2005, was vaccinated intramuscularly with 0.5 ml of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccination at the same time included influenza virus vaccine (unspecified)(both vaccines were administered at separate sites and via separate syringes).  Subsequently the patient developed an injection site reaction.  The arm was red and swollen and was described as being "cellulitis like", however the patient was not diagnosed with cellulitis .  Unspecified ,medical attention was sought.  The patient was treated and the reaction "went down the next day".  Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who in approximately October 2005, was vaccinated intramuscularly with 0.5 ml of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccination at the same time included influenza virus vaccine (unspecified) (both vaccines were administered at separate sites and via separate syringes).  Subsequently the patient developed an injection site reaction.  No further details pertaining to the site reaction were available.  Unspecified medical attention was sought.  The patient subsequently recovered.  Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUX, PPV, TTOX
Symptoms: Pain
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced swelling, pain at injection site and hot skin to touch.  The outcome of the events was not reported.  In follow up, the certified medical assistant reported that this patient had not developed hotness of swelling as originally reported.  The 44 year old female with diabetes mellitus, an allergy to codeine and hypercholesterolemia was vaccinated in the right arm on 07-NOV-2005 with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included influenza virus vaccine (unspecified), also given in the right arm the same day and tetanus toxoid, given in the left arm on the same day.  On 08-NOV-2005 the patient's right arm ached through to breast and chest.  There was no redness.  The patient's outcome was not reported.  No further information is available.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV, TTOX
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 65 year old patient who on 28-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included tetanus toxoid and influenza virus vaccine (unspecified).  Subsequently the patient experienced swelling, pain at injection site, hot skin to touch, red and warm to touch at injection site, and achiness all over.  The outcome of the events was not reported.  Follow up information has been received concerning the 65 year old male patient employed in a dental lab with coronary artery disease (CAD), diabetes mellitus, hypertension, and a history of myocardial infarction (2002) who on 28-OCT-2005 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine.  On the same day, the patient was also vaccinated in the right arm with influenza virus vaccine (unspecified), and in the left arm with tetanus toxoid.  Other concomitant therapy included pioglotazone hydrochloride (ACTOS). atorvastatin calcium (LIPITOR), aspirin, metoprolol, lisinopril, and glipizide.  On 29-OCT-2005 it was reported that the patient developed "red, hot and swollen at injection site".  The patient recovered.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 70 year old patient who on 28-OCT-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient experienced pain at injection site, hot skin to touch, swelling, achiness all over, and red and warm to touch at injection site.  The outcome of the events was not reported.  Follow up information has been received from a physician concerning the 70 year old female restaurant owner with hypertension, diabetes mellitus, hypothyroidism, anemia and allergies to clarithromycin (BIAXIN) and codeine who on 28-OCT-2005 was vaccinated in the right arm with her second dose (first dose in 2000) of pneumococcal 23v polysaccharide vaccine. lot number ( confirmed certified medical assistant stated when patient's chart was pulled the lot number was not the lot originally reported).  The patient was vaccinated with influenza virus vaccine in the left arm on the same day.  On 28-OCT-2005 the patient developed "right arm red, hot swollen, hard lump, feels flu like symptoms".  The patient required unspecified oral antibiotics and recovered on approximately 30-NOV-2005.  Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Hypersensitivity, Injection site inflammation, Pyrexia, Swelling
Clinical narrative: Information has been received from a 58 year old female with hypothyroidism an allergy to sulfa, who on 31-OCT-2005 was vaccinated subcutaneous in the right arm with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  Concomitant vaccine therapy administered on 31-OCT-2005 included a dose of influenza virus vaccine (unspecified) administered in the left arm.  Other concomitant medication included levothyroxine Na (SYNTHROID).  The patient reported that the next day, on 01-NOV-2005 she experienced a severe reaction and reported that her right upper arm swelled, was hot, red, filled with fluid, and was about 40 percent than normal.  She also experienced a fever and chills and reported that " I was in bed for a couple of days".  The adverse events improved and she recovered on 08-NOV-2005.  There was no product quality complaint reported.  The patient did not seek medical attention.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Information has been received from a license practical nurse concerning a 52 year old female daycare provider with sulfa allergy and no medical history, who on 09-NOV-2005, at 16:45, was vaccinated intramuscular into the right deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 09-NOV-2005, the patient was vaccinated intramuscular with a third dose of influenza virus split virion 3v vaccine inactivated (FLUZONE). Concomitant therapy included levothyroxine Na (LEVOXYL).  There was no illness at the time of vaccination.  On 11-NOV-2005 the patient developed cellulitis, fever and body aches.  The patient's arm was swollen and redeemed.  The patient was treated with cephalexin (KEFLEX) 500 mg four times a day for 10 days, gatifloxacia (TEQUIN) 400 mg every day for 5 days and ceftriaxone sodium sodium (ROCEPHIN) 500 mg every day for 3 days.  The patient was reported as recovered.  Follow up information from a health professional indicted that the patient was seen on 11-NOV-2005 by a physician and complained of a red, raised, swollen area at the injection site that spread to the axilla.  It was noted that the patient said she had run a fever, but her temperature was normal in the physician's office.  The diagnosis was cellulitis and an abscess of the upper arm.  The patient was seen again on 12-NOV-2005 and received another injection of ceftriaxone sodium (ROCEPHIN), and the arm area looked improved.  The patient had not been seen since.  There was no product quality complaint involved.  Additional information is not expected.  This report is a consolidation of two reports concerning the same patient.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a license practical nurse concerning a 52 year old female daycare provider with sulfa allergy and no medical history, who on 09-NOV-2005, at 16:45, was vaccinated intramuscular into the right deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine.  On 09-NOV-2005, the patient was vaccinated intramuscular with a third dose of influenza virus split virion 3v vaccine inactivated (FLUZONE). Concomitant therapy included levothyroxine Na (LEVOXYL).  There was no illness at the time of vaccination.  On 11-NOV-2005 the patient developed cellulitis, fever and body aches.  The patient's arm was swollen and redeemed.  The patient was treated with cephalexin (KEFLEX) 500 mg four times a day for 10 days, gatifloxacia (TEQUIN) 400 mg every day for 5 days and ceftriaxone sodium sodium (ROCEPHIN) 500 mg every day for 3 days.  The patient was reported as recovered.  Follow up information from a health professional indicted that the patient was seen on 11-NOV-2005 by a physician and complained of a red, raised, swollen area at the injection site that spread to the axilla.  It was noted that the patient said she had run a fever, but her temperature was normal in the physician's office.  The diagnosis was cellulitis and an abscess of the upper arm.  The patient was seen again on 12-NOV-2005 and received another injection of ceftriaxone sodium (ROCEPHIN), and the arm area looked improved.  The patient had not been seen since.  There was no product quality complaint involved.  Additional information is not expected.  This report is a consolidation of two reports concerning the same patient.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Fatigue, Oedema peripheral, Pain, Swelling
Clinical narrative: Edema peripheral; fatigue; pain; erythema Information has been received from a physician and a registered nurse concerning a 73 year old retired white male with no allergies or medical history who on 31-OCT-2005 was vaccinated IM in the left deltoid with a second 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot #649914/0578F). Concomitant therapy included psyllium husk (Metamucil), aspirin daily, Vitamin B12 injection monthly, and a dose of influenza virus vaccine (unspecified) given in the right arm. There was no illness at the time of vaccination. A few hours post vaccination, the patient developed fatigue. At 2200 that night he developed an onset of redness and swelling in the left arm from his shoulder to his elbow and total body aches. Unspecified medical attention was sought. No lab studies were performed. Twelve hours later he felt completely fine. On 21-NOV-2005 he notified the office. It was also reported that in 1997 the patient had received a first dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. No further information is expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Swelling
Clinical narrative: Injection site pain; Swelling Initial and follow up information has been received from a licensed practical nurse concerning a 60 year old white female with arrhythmia. hormone replacement therapy, no known allergies an a prior immunization with pneumococcal 23v polysaccharide vaccine in 2000. On 26-OCT-2005, the patient was vaccinated intramuscularly into the left arm with pneumococcal 23v polysaccharide vaccine (Lot #651526/0604R). On that same day in the AM the patient was vaccinated intramuscularly into the right arm with the fourth dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (Lot #U1777AA). Concomitant therapy included verapamil, estrogens, conjugated (Premarin) and digoxin (Lanoxin). On 26-OCT-2005 in the PM the patient developed "extremely painful muscle at the injection site" and "some swelling x4days". On 30-OCT-2005 the patient recovered from the events. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain
Clinical narrative: Injection Site Pain Information has been received from a health professional concerning a 62 year old white retired female with hyperparathyroidism and no known allergies who on the morning of 27-OCT2005 was vaccinated IM into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #651523/0604R). Concomitant therapy given IM in the morning into right deltoid included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (influenza virus whole virion3v vaccine inactivated( (lot #U1777AA), calcium carbonate (+) cholecalciferol (Caltrate + D) and vitamins (unspecified) On 31-OCT-2005 the patient recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Swelling
Clinical narrative: Swelling Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified influenza virus vaccine given in the same arm. Subsequently, the patient developed swelling. Medical attention was sought. Subsequently, the patient recovered. No further information is available.
Age: 18.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site pain, Swelling
Clinical narrative: Injection site reaction; pain; erythema; skim warm; swelling. Information has been received from a licensed practical nurse concerning a 17 year old (also reported as 14 year old) white male with diabetes mellitus juvenile onset who on 07-NOV-2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine in the left deltoid (650649/0790P), intramuscularly in the left deltoid. Concomitant therapy that day included a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) (Batch #U1792AA) intramuscularly in the right deltoid. The patient experienced a local injection site reaction after receiving pneumococcal 23v polysaccharide vaccine, described as "swollen, red warmth and pain to left deltoid". The patient was told to use ice 2 to 3 times an hour and ibuprofen (Advil) and diphenhydramine hydrochloride (Benadryl). The patient recovered on 11-NOV-2005. There was no illness at the time of vaccination. The patient did not experience any adverse events following prior vaccinations. The records testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. Additional information not expected.
Age: 61.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site reaction, Myalgia
Clinical narrative: Injection site reaction; chills; myalgia Information has been received from a physician concerning a 61 year old male with diabetes who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy three days prior to the pneumococcal 23v polysaccharide vaccine included a dose of influenza virus vaccine (unspecified). Subsequently the patient experienced a severe injection site reaction with chills and myalgia. It was noted that the patient recovered on an unknown date. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Erythema; pain in extremity; edema; peripheral Information has been received from a health professional concerning a 61 year old white female with degenerative joint disease, hormone deficient, hyperparathyroidism, codeine and "sodium pent" allergy who on 25-OCT-2005 later in the PM was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #651523/0604R). Concomitant therapy included a IM dose in the left deltoid of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated) (Lot U1777AA). It was reported that the patient had "2+" doses of influenza virus split virion 3v vaccine inactivated (Fluzone) (influenza virus split virion 3v vaccine inactivated). On 25-OCT-2005 the patient complained of a red, painful and swollen arm after the immunization. It was reported that it lasted two days and the patient recovered.  Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pyrexia
Clinical narrative: Pyrexia; erythema Information has been received from a registered nurse concerning a 8 year old female with asthma who in late October 2005 was vaccinated SQ in right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot #not provided). The patient was given a flu shot (unspecified) in the same arm as pneumococcal 23v polysaccharide vaccine. Twelve hours post vaccination the patient developed a 103 F fever and erythema. The fever persisted for 12 hours. The patient was reported as recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Swelling
Clinical narrative: Pain in extremity; erythema; edema peripheral Information has been received from a licensed practical nurse concerning a 53 year old white female with a tetanus allergy and clindamycin allergy, who on 25-OCT-2005 was vaccinated IM into the right arm with a fifth dose of pneumococcal 23v polysaccharide vaccine (lot #651526/0604R). Concomitant therapy given IM into the left arm included a second dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (influenza virus whole virion 3v vaccine inactivated (lot #U1777AA) montelukast sodium (MSD) calcium (unspecified) (+) vitamins (unspecified) and temazepam (Restoril). There was no illness at the time of vaccination. On the evening of 25-OCT-2005 the patient's upper arm became extremely painful, red and swollen. The patient's arm remained painful and swollen for 4 to 5 days. Unspecified medical attention was sought. The patient was treated with ibuprofen and acetaminophen (Tylenol) for the discomfort. It was noted that the patient started to feed better after 7 days. On 01-NOV-2005 the patient recovered. An investigation into the lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been check by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 19.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain
Clinical narrative: Injection site pain; injection site erythema Information has been received from a registered nurse concerning an 18 year old male with asthma who on 01-DEC-2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #651318/1006P). Concomitant therapy given into the other arm included a dose of influenza virus vaccine (unspecified) (no reaction noted). On 01-DEC-2005 (previously report as 04-DEC-2005) the patient was seen in the doctor's office with an injection site reaction described as pain and redness. No diagnostic laboratory studies were performed. The patient was treated with cephalexin (Keflex). Four days later, the patient's symptoms completely resolved. No product quality complaint was involved. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 86 yr old female inpt with a diagnosis of cardiac arrhythmia who on 10Dec05 was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 651572/0741R) as a routine immunization during hospital stay. Concomitant therapy included warfarin sodium (Coumadin), atorvastatin calcium (Lipitor), isosorbide mononitrate (IMDUR), tolterodine tartrate (Detrol LA), diltiazem hydrochloride (Cardizem CD), and an unspecified influenza virus vaccine (given the same day, in the other arm). Later on 10Dec05, the pt developed a red raised area at the pneumococcal 23v polysaccharide vaccine injection site. The pt reported that the area was sore to the touch. On 12Dec05, the area of redness had increased to approx 4 by 6 inches in size. Tylenol was ordered for discomfort but had not been taken. Cold compresses had been used. At the time of the report, the pt had not recovered. Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a RN concerning an 58 yr old male with asthma who on 05Dec05 was vaccinated IM into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650330/0748P). Concomitant therapy given into the other arm included a dose of influenza virus vaccine (unspecified) (no reaction noted). That night, the pt experienced an injection site reaction described as pain with tenderness, swelling and redness. On 06Dec05, the pt was seen in the doctor's office. The pt was treated with cephalexin (Keflex). Two days later, the pt's symptoms completely resolved. No product quality complaint was involved. Additional information is not expected.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Malaise, Myalgia
Clinical narrative: Information has been received from a medical assistant via a company rep concerning a male physician who on approx 19Nov05 was vaccinated IM into the arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time in the same arm included a dose of influenza virus vaccine (unspecified). Subsequently, on approx 19Nov05, the pt was very ill for two days and experienced body aches, fever and severe site reaction involving a rash, soreness and swelling down his entire arm. Unspecified medical attention was sought. The physician was reported to have recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant via a company rep concerning a male physician who on approx 19Nov05 was vaccinated IM into the arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time in the same arm included a dose of influenza virus vaccine (unspecified). Subsequently, on approx 19Nov05, the pt was very ill for two days and experienced body aches, fever and severe site reaction involving a rash, soreness and swelling down his entire arm. Unspecified medical attention was sought. The physician was reported to have recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Information has been received from a RN concerning a 72 yr old male who on 23Nov05 was vaccinated IM in the arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot unspecified). Secondary suspect vaccinations included a dose of influenza virus vaccine (unspecified) given in the same arm as the pneumococcal 23v polysaccharide vaccine. On 23Nov05 the pt developed swelling and itching at the injection site. Unspecified medical attention was sought and the pt was given over the counter medications to calm his symptoms and he recovered (date unspecified). No product quality complaint was involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Lymphadenopathy, Pain, Tenderness
Clinical narrative: Information has been received from a physician concerning a 55 yr old white retired female with no allergies who in approx Oct 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot not reported). Concomitant suspect therapy included a dose of influenza virus vaccine (unspecified) administered at the same time into the same arm. On 26Oct05 the pt developed redness from the shoulder to elbow, swollen tender, axilla glands, and throbbing pain. It was reported that the pt stated that she received the pneumococcal 23v polysaccharide vaccine yearly for 10 yrs except last year. The pt outcome was not reported. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a 68 yr old white male with shellfish allergy who on 03Oct05 was vaccinated at 5:30PM IM into the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650331/0749P) and at the same time vaccinated IM into the right deltoid with a dose of influenza virus split virion 3v vaccine inactivated (Fluzone). Concomitant therapy included clopidogrel bisulfate (Plavix), ramipril (Altace) and rosuvastatin calcium (Crestor). There was no illness at the time of vaccination. At 7:00PM on 03Oct05 the pt complained of itching on the back of the neck and woke up at night with swollen, red left arm from the elbow to the shoulder. The pt was seen at the doctor's office and treated with ibuprofen, 800mg 3x/day and ice. At the time of the report the pt's present status was unk. No product quality complaint was involved. Pharmacists is requesting a lot check.  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information is not expected.
Sex: M
Vaccine: FLUN3, HEPAB, MMR, MNQ, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Movement disorder
Clinical narrative: Information has been received from a RN concerning a male pt (18 to 20 yrs of age) who on 25Jan06 was vaccinated SC in the left tricep with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included influenza virus 3v reassortant vaccine live intranasal (Flumist), hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix), meningococcal ACYW conj vaccine (dip toxoid) (Menactra), MMR vaccine, penicillin G benazathine (Bicillin) and tuberculin purified protein derivative. In less than 24 hrs, on approx 26Jan06 the pt experienced localized cellulitis like reactions, soreness from the tricep to axilla, redness, limited range of motion, hardness at injection site. The pt had a fever of 101. 6 deg F and had a CBC lab test performed. It was noted that in the past no reactions had been noted when the pt received the vaccine IM in the deltoid. Unspecified medical attention was sought. The outcome was reported as unk. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: FLUN3, HEPAB, MMR, MNQ, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a RN concerning a male pt (18 to 20 yrs of age) who on 25Jan06 was vaccinated SC in the left tricep with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included influenza virus 3v reassortant vaccine live intranasal (Flumist), hep A virus vaccine inactivated (+) hep B virus vaccine rHBsAg (yeast) (Twinrix), meningococcal ACYW conj vaccine (dip toxoid) (Menactra), MMR vaccine, penicillin G benazathine (Bicillin) and tuberculin purified protein derivative. In less than 24 hrs, on approx 26Jan06 the pt experienced localized cellulitis like reactions, soreness from the tricep to axilla, redness, limited range of motion, hardness at injection site. The pt had a fever of 101. 6 deg F and had a CBC lab test performed. It was noted that in the past no reactions had been noted when the pt received the vaccine IM in the deltoid. Unspecified medical attention was sought. The outcome was reported as unk. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a RN pharmacist concerning a pt who was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included influenza virus vaccine (unspecified). Subsequently the pt experienced cellulitis in the arm that the pneumococcal 23v polysaccharide vaccine was given. Unspecified medical attention was sought.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Medication error, Unintended pregnancy
Clinical narrative: Received Smallpox and Anthrax vaccinations on 6/9/06 following a negative urine pregnancy test. On 7/15/06 Serum Pregnancy test was done d/t last menstrual period on 5/17/06 and was positive. Pre-vaccination form was completed prior to vaccination and soldier did not indicate at that time any concerns regarding possibility of being pregnant.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 1.05
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: PRESENTED IN OFFICEWITH RASH ONSET @  48 hrs.ago.dx varicella
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injury, Malaise, Pain
Clinical narrative: Pt came to ED on 6/17/06 at approx 1400 for "well-healing" dog bite to right hand (palm). Pt had been bitten by a puppy two days prior to ED visit. In ED pt was given Tetanus and Diphtheria Toxoid 0.5ml IM to left deltoid and discharged. Pt was told to continue her Augmentin (already taking this med for sinus infection). Pt returned to ED two days later on 6/19/06 at 2000 for c/o "not feeling well", achey, and with redness and swelling of left deltoid at site of TD inj. Pt was examined and determined to have local reaction to TD immunization. Discharged home on naprosyn, chlorpheniramine, and ice packs. Told to continue Augmentin as she had been doing.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Condition aggravated, Dizziness, Feeling jittery, Flushing
Clinical narrative: I RECEIVED THE TDAP VACCINE AT 0800 AND ABOUT 0803 I STARTED TO FEEL VERY LIGHTHEADED, DIZZY, VERY FLUSHED, AND JITTERY.  I WENT TO THE ER AND MY BP WAS 200/110. THEY PUT ME ON O2, HEART MONITOR, AND AFTER ONE HOUR MY BP WAS STILL VERY HIGH.  THEY GAVE ME A CATAPRES TABLET.  ABOUT 30 MINUTES LATER MY BP WAS DOWN TO 157/86. HX HBP. TOOK 10MG VASOTEC AT 0400 BEFORE WORK.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Pharyngolaryngeal pain, Pruritus
Clinical narrative: Pt reports that 3 days after injection the site was itchy and she scratched it and a red patch developed.  Pt reports a concurrent sore throat.
Age: 57.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Red raised area (approx 3 1/2 ") around immunization site -  patient says its very "itchy".
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Sleep disorder
Clinical narrative: 1 month post vaccination patient still has a knot at the injection site which she reported as getting larger, and she is unable to sleep on the affected side (left).  She is currently out of town, so she was instructed to follow up with a local provider to assess the situation.  She has had a knot since the vaccine was administered.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Insomnia, Musculoskeletal stiffness, Pain, Screaming
Clinical narrative: Four hours post DTaP vaccination cried more intensely than I had ever heard him cry before.  As he was screaming his body was tense and his arms were raised and stiff.  I tried to nurse but he would not feed.  His temp was normal.  He looked distant and it seemed that he was in intense pain.  His chin was shaking and his arms appeared to jerk simultaneously a few times, similar to Moro reflex.  He screamed for less than 1/2 hour during which time we gave him Infant Tylenol.  He soon calmed down and fell in and out of a restless sleep for a couple hours after which he was back to himself.  His reaction was very acute, but intense.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Tremor
Clinical narrative: Four hours post DTaP vaccination cried more intensely than I had ever heard him cry before.  As he was screaming his body was tense and his arms were raised and stiff.  I tried to nurse but he would not feed.  His temp was normal.  He looked distant and it seemed that he was in intense pain.  His chin was shaking and his arms appeared to jerk simultaneously a few times, similar to Moro reflex.  He screamed for less than 1/2 hour during which time we gave him Infant Tylenol.  He soon calmed down and fell in and out of a restless sleep for a couple hours after which he was back to himself.  His reaction was very acute, but intense.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Convulsion, Pyrexia, Rash macular
Clinical narrative: Fever (39.7 rectal) and tonic clonic seizure 7/19/06, 8 days after vaccines given. Seen in ER, normal exam. Still fever at recheck 7/21/06, faint macular rash on trunk. Had 1 other febrile seizure 6/26/06.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Malaise
Clinical narrative: Evening after vaciination experienced fever/chills/malaise/fatigue/arthralgia/neck pain/back pain.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain, Pyrexia
Clinical narrative: Evening after vaciination experienced fever/chills/malaise/fatigue/arthralgia/neck pain/back pain.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Laboratory test abnormal
Clinical narrative: 20 yo male c/o anterior chest pain and mild shortness of breath which started 4 days after receiving smallpox vaccination (13Jul06).  His symptoms were initially some fever (subjective), chills and malaise.  However these sx resolved and the chest discomfort continue to increase in intensity and not related to position.  Pain describe as "needles" over on his heart.  PE: normal, EKG was showing abnormal ST segments throughout most leads.  Admitted to telemetry at hospital.   Chest discomfort diminished at the time of discharge. DX: myopericarditis.  DX: Acute Pericarditis
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Malaise, Pericarditis, Pyrexia
Clinical narrative: 20 yo male c/o anterior chest pain and mild shortness of breath which started 4 days after receiving smallpox vaccination (13Jul06).  His symptoms were initially some fever (subjective), chills and malaise.  However these sx resolved and the chest discomfort continue to increase in intensity and not related to position.  Pain describe as "needles" over on his heart.  PE: normal, EKG was showing abnormal ST segments throughout most leads.  Admitted to telemetry at hospital.   Chest discomfort diminished at the time of discharge. DX: myopericarditis.  DX: Acute Pericarditis
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Erythema, Rash
Clinical narrative: Rash presented 7/16/06 in am fine red rash.
Age: 1.07
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Chicken Pox
Age: 11.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: 8-9 cm diameter read in to right deltoid Pt on Cefzil 250/5 100cc m Tsp BID, red, swollen at site.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash vesicular, Somnolence
Clinical narrative: Pt developed increased sleeping and temperature to 104.3 R. Pt was irritable. Decreased PO intake. All within 8 hours after immunization. Upon exam vesicular lesions noted in post pharyngeal probable coxsackie A-16 virus. Pt to take Tylenol/Motrin. Fluids, rest.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Viral infection
Clinical narrative: Pt developed increased sleeping and temperature to 104.3 R. Pt was irritable. Decreased PO intake. All within 8 hours after immunization. Upon exam vesicular lesions noted in post pharyngeal probable coxsackie A-16 virus. Pt to take Tylenol/Motrin. Fluids, rest.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Screaming
Clinical narrative: Inconsolable crying for two hours
Age: 1.26
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Pyrexia, Rash papular, White blood cell disorder
Clinical narrative: Diffuse papular rash head to lower legs, fever>101.
Age: 1.78
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever to 103.9 within 4 hrs of injection
Age: 40.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Medication error, Neuritis, Visual disturbance
Clinical narrative: 39 yo pt who developed visual disturbances within a week of receiving Hep A and Tdap vaccinations. Eval by neuro and ophthal. Post vaccine neuritis, final diagnosis.
Age: 1.01
Sex: F
Vaccine: HEPA
Symptoms: Periorbital oedema, Urticaria
Clinical narrative: Child received vaccine 7/19/06. By 7/20/06 noc had noticed hives on trunk and B periorbital edema. The hives worsened by 7/21/06, date seen in office. Benadryl and oral steroids prescribed.
Age: 1.03
Sex: M
Vaccine: HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Irritability, Rash, Rash pruritic
Clinical narrative: Skin rash developed 9 days after MMR dose 1 was administered. Afebrile. Has been fussy, seems itchy. Treated w/ Benadryl
Sex: F
Vaccine: MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Right arm very sore and both shoulders became very stiff with headache, low grade fever. Pt seen by Dr.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Varicella vaccine site turned red and swollen approx 10 mins after injection with 27x35 mm induration, warm to touch.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: c/o myalgia in ER, temp 100.3 arm soreness at injection site. ER doctor's discharge dx tetanus reaction. Attempted to call pt x2 no answer.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Swelling left thigh 3/4cm no Rx needed. No erythema, no tenderness, resolved without rx.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Swelling and redness of left upper arm from above shoulder to elbow. 7/14/06 seen by family MD, Treated with Benadryl and Tylenol and ice. 7/17/06 completely recovered.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Mother states fever 103 yesterday 6/29/06. Mother instructed to call Pediatrician for F/U. no redness, swelling at injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site reaction
Clinical narrative: 2" swelling at DTaP shot site.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, VARCEL
Symptoms: Eye disorder, Hypersensitivity, Pruritus, Rash
Clinical narrative: 2am the night the shots given broke out in rash on trunk and arms, itching, eyes burning. Saw Dr told allergic reaction to one of the 3 shots given told to use Benadryl caps 3x day.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Left shoulder deltoid area swelling and some redness, mild tenderness.
Age: 0.87
Sex: F
Vaccine: HIBV, PPV
Symptoms: Cough, Medication error, Pharyngitis, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an 11 month old Asian female with no medical history or allergies who on 11May05, at 10:30AM, was accidentally vaccinated in the left thigh with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650644/0887P). Concomitant vaccine that day, at 10:30AM, included a second dose in the right thigh of Hib conj vaccine (tet toxoid) (Acthib) (lot UE392AA). There was no illness at the time of vaccination. The child has manifested no additional symptoms. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the next day after vaccination, on 12May05, the pt developed a fever of 105F for one night. On 13May05 the fever was gone, but she developed a slight rash and started cold symptoms with sneezing, coughing, runny nose and sore throat. After one week the symptoms were gone. There were no lab tests done. The pt recovered before 24May05. Additional information is not expected.
Age: 0.87
Sex: F
Vaccine: HIBV, PPV
Symptoms: Rash, Rhinitis, Rhinorrhoea, Sneezing
Clinical narrative: Information has been received from a health professional concerning an 11 month old Asian female with no medical history or allergies who on 11May05, at 10:30AM, was accidentally vaccinated in the left thigh with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650644/0887P). Concomitant vaccine that day, at 10:30AM, included a second dose in the right thigh of Hib conj vaccine (tet toxoid) (Acthib) (lot UE392AA). There was no illness at the time of vaccination. The child has manifested no additional symptoms. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the next day after vaccination, on 12May05, the pt developed a fever of 105F for one night. On 13May05 the fever was gone, but she developed a slight rash and started cold symptoms with sneezing, coughing, runny nose and sore throat. After one week the symptoms were gone. There were no lab tests done. The pt recovered before 24May05. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an adult pt who in approx Feb 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). In approx Feb 2005, the pt experienced injection site reactions described as swelling, soreness, warmth, erythema and induration. Unspecified medical attention was sought. It was noted that the pt was treated with levofloxacin (Levaquin). Subsequently, the pt recovered. A lot check will be performed. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.