chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Medication error
Clinical narrative: Information has been received from a physician concerning a pt who in Nov 05 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. In Nov 2005, the pt developed localized reaction in the vaccinated arm. The arm was red and swollen. The pt recovered. The pt has a previous dose of Pneumococcal 23v polysaccharide vaccine in 2004. There was no product quality complaint involved. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a 90 year old female who on approx 10/31/05 was vaccinated IM with 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). The pt was also vaccinated separately with influenza virus vaccine unspecified. Concomitant therapy included metoprolol succinate Toprol XL tablets, aspirin and prednisone. On 10/31/05, the pt developed cellulitis. The pt was treated with antibiotics. The pt was reported as not recovered. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a 64 year old retired female with hypertension, arthritis and mild scoliosis who on 10/31/05 at 1:45pm was vaccinated IM in left arm with a second dose (first dose was 20 years ago) of Pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant therapy included estrogens, conjugated (Premarin), ramipril (Altace), and acetaminophen + propoxyphene napsylate (Darvocet N). On 11/1/05 at 8:00 am, the pt developed severe swelling of left upper arm to approximately twice normal size, redness, no fever and itching. The pt visited the Dr's office. The events gradually resolved over the next 6 days. It was reported that the pt recovered on 11/7/05. No further information is available.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 62 yr old white female pt with right leg cellulitis who on 08Nov05 was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). Concomitant therapy included esomeprazole magnesium (Nexium), citalopram hydrobromide (Celexa), alprazolam, furosemide (Lasix), albuterol, and amoxicillin/clavulanate potassium (Augmentin). On 08Nov05 the pt developed 7 cm erythema, heat, and pain at injection site. The pt's outcome was unk. No further information is available.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 72 yr old retired male pt with an allergy to lidocaine who on 27Sep05 was vaccinated in the left upper arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot650454/0751P). On approx 27Sep05 the pt developed left upper extremity with cellulitic type reaction ie swelling. He was afebrile. The pt's outcome was unk. No further information is available.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased, Myalgia
Clinical narrative: Information has been received from a physician, via a company representative, concerning a 42 year old male, with type I diabetes mellitus, blood pressure and cholesterol, who on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown). Concomitant therapy included blood pressure (therapy unspecified) and cholesterol (therapy unspecified) medications, and insulin.  Subsequently, the day after the vaccinations and for the whole week, on an unspecified date, the patient experienced lost total control of his sugars and had to take twice the amount of insulin to maintain proper levels.  The physician noted that he is a reliable patient that maintains good control of his glucose levels normally.  The patient also suffered arm soreness the day after this vaccination.  Subsequently, 1 and a half weeks post vaccination the patient's glucose levels were back under control and the patient recovered from arm soreness.  No product quality complaint was involved.  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Pain, Vaccination complication
Clinical narrative: Information has been received from a nurse concerning a 63 year old Caucasian male with no medical history who on 14-NOV-2005 at 3:30 pm was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot#650330/0748P), in the left deltoid intramuscularly.  There were no illness at the time of vaccination.  On 15-NOV-2005 the patient developed severe left arm pain and difficulty lifting arm.  The patient came in on 15-NOV-2005 for follow up visit.  The patient's doctor diagnosed it as a localized reaction only.  Unspecified medical attention was sought.  The patient recovered.  There was no adverse following prior vaccination.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Oedema, Paraesthesia, Skin irritation
Clinical narrative: Information has been received from a 30 year old female with a penicillin allergy who on 15-NOV-2005 was vaccinated "subdermally" with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  Concomitant therapy included hormonal contraceptives (unspecified).  ON 15-NOV-2005 the patient administered the pneumococcal 23v polysaccharide vaccine in error.  She was "supposed to receive a TB test".  On 15-NOV-2005, a few after vaccination, she "developed a severe skin irritation, swelling, pain in wrist, tingling sensations in her fingers, skin redness and skin edema".  Unspecified medical attention was sought.  The patient's present status was reported as not recovered.  no product quality complaint was involved.  No further information is available.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a 30 year old female with a penicillin allergy who on 15-NOV-2005 was vaccinated "subdermally" with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  Concomitant therapy included hormonal contraceptives (unspecified).  ON 15-NOV-2005 the patient administered the pneumococcal 23v polysaccharide vaccine in error.  She was "supposed to receive a TB test".  On 15-NOV-2005, a few after vaccination, she "developed a severe skin irritation, swelling, pain in wrist, tingling sensations in her fingers, skin redness and skin edema".  Unspecified medical attention was sought.  The patient's present status was reported as not recovered.  no product quality complaint was involved.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a  health professional concerning a female patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient experienced pain and swelling with erythema on the injection arm which listed for a couple of days.  Medical attention was not sought.  There was no product quality complaint involved.  The patient recovered.  No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated intramuscularly in the deltoid with a "standard" 0.5 ml dose of pneumococcal 23v polysaccharide vaccine 9lot 647661/0055R or 650083/0746P).  Subsequently patient the patient developed arm swelling.  Unspecified medical attention was sought.  The patient's outcome was unknown.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Injection site reaction, Pain, Swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#649914/0578P).  Subsequently, the patient developed a reaction at the injection site with redness with discoloration, swelling, hardness, and pain.  The patient's outcome was not reported.  No product quality was involved.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old white female (148 pounds) with a history of previous immunization with PNEUMOVAX 23 vaccine (1998) who on 26-OCT-2005 was vaccinated intramuscularly, into deltoid muscle, with a dose of PNEUMOVAX 23 vaccine (lot#647661/0055R).  On 27-OCT-2005 the patient developed redness at the injection site and experienced severe pain which lasted for 5 days.  On approximately 01-DEC-2005, the patient recovered.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Myalgia
Clinical narrative: Information has been received from a  registered nurse concerning a 69 year old white female (169 pounds 61") who on  28-OCT-2005, at 10:00 am was vaccinated intramuscularly, into deltoid muscle with a second dose os pneumococcal 23v polysaccharide vaccine (lot#647661/0055R).  On 28-OCT-2005 the patient's entire arm was sore and she had difficulty sleeping related to arm pain. It was noted that there was no redness or edema, only pain.  On 01-NOV-2005, the patient recovered.  Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 71 year old, white, male reported weight was 158 pounds (lb) and whose reported height was 5"9", who on 25-OCT-2005 at 10:30 am in the doctor's office was vaccinated intramuscularly in the right (Rt) deltoid muscle with PNEUMOVAX 23 vaccine (lot#647661/0055R).  It was reported that the patient had not received any prior doses of PNEUMOVAX 23 vaccine.  On 26-OCT-2005.  It was reported the patient experienced pain to arm, severe redness, edema to injection site for approximately 2 to 3 days post inoculation.  It was reported the patient recovered on 29-OCT-2005.  Additional information has been reported.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Pain, Shoulder pain
Clinical narrative: Information has been received a 61 year old female nurse with diabetes mellitus non insulin dependent who on an unknown date in approximately 1999 received her first dose of pneumococcal 23v polysaccharide vaccine and on 17-NOV-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (Lot#651322/1044P).  Concomitant therapy included metformin HCl (GLUCOPHAGE), hydrochlothiazide (+) telmisartan (MICARDIS HCT), estrogens, conjugated (PREMARIN) and atorvastatin calcium (LIPITOR).  On 17-NOV-2005 approximately 2-3 hours after receiving the vaccination the patient experienced sharp pain in shoulder and reported that she "could not move her arm".  She reported that on 18-NOV-2005 the pain and aching spread all over the body.  She reported that her arm became red and hot about two inches below the injection site.  She reported that the affected area was about 5 inches in length and wrapped around her arm.  The area was raised slightly with purple spots in it.  Unspecified medical attention was sought.  Subsequently, the patient reported that by 21-NOV-2005 there was little to no pain and the redness turned a brownish color.  She reported that she had recovered from the event.  Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Oedema peripheral, Swelling
Clinical narrative: Edema peripheral; injection site erythema; injections site discoloration; injection site warmth; local reaction; malaise; erythema Information has been received from a a medical assistant and a 58 year old female consumer with a history of "some times medications have the reverse of their intended effect" and allergies to penicillin and indomethacin sodium (Indocin) who on 18-NOV-2005 at approximately 12:00 PM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650648/0967P). There was no illness at the time of vaccination. Concomitant therapy included estrogens, conjugated (Premarin), vitamins (unspecified), metronidazole (Metrogel), alendronate sodium (Fosamax) and doxycycline. On 18-NOV-2005 by 5:00 PM on the same day the patient had a "huge red circle with white in the middle at injection site," The patient also noted that "her arm was very swollen". The patient took 800mg Ibuprofen and did not return to the physician until the next morning. On the morning of 19-NOV-2005 the patient was given cetirizine hydrochloride (Zyrtec) an unspecified injection and an unspecified antihistamine. The patient reported that after the treatment the swelling went down but the arm was "very red and still tender.: The patient noted that as of 21-NOV-2005 that her elbow was still a "little bit swollen: and her arm "still had tender areas." It was also reported that the patient had local reaction, redness, swelling, tenderness to touch and warmth at site with general malaise. Subsequently the patient recovered. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction. Information has been received from a registered nurse concerning a female patient (age not provided) who on unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot#650331/0749P). Five days after vaccination the patient developed injection site reaction. The patient was reported as recovered. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: Injection site swelling; injection site erythema; injection site warmth Information has been received from a registered nurse concerning a 78 year old male with no medical history who on 18-NOV-2005 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). There was no concomitant medication. Subsequently in November 2005, the patient experienced severely swollen, red and warm injection site. No diagnostic laboratory tests were performed. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: Injection site swelling; injection site erythema; injection site warmth Information has been received from a registered nurse concerning a 78 year old female who in 1998 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine. On 16-NOV-2005 the patient received an influenza virus vaccine (unspecified) in the right arm. On 18-NOV-2005 the patient received a booster dose of pneumococcal 23v polysaccharide vaccine (651329/1047P) 0.5 milliliters one time in the left deltoid IM. Concomitant therapy included alendronate sodium (MSD), ezetimibe (MSD), and simvastatin (MSD). On 19-NOV-2005 the patient went to the emergency room (ER) because the injection site on her left arm formed a 4x6 inch patch that was swollen, warm and erythematous. The patient did not have a fever. She was given diphenhydramine hydrochloride and acetaminophen (Tylenol) in the ER and was released. The patient recovered in November 2005. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Hypotension, Oedema peripheral, Swelling
Clinical narrative: Blood pressure decreased; erythema; feeling hot; injection site erythema; injection site swelling; edema peripheral Information has been received from a physician concerning an 81 year old female with hypertension who on 14-NOV-2005 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (650329/0747P). Concomitant therapy included "high blood pressure pills". The physician reported that on 15-NOV-2005 the patient developed a red swollen underside of the arm where the injection was given after receiving the pneumococcal 23v polysaccharide vaccine. The patient experienced a drop in blood pressure. Unspecified medical attention was sought. The patient had a history of hypertension and was removed from her blood pressure medication for 3 days because of the blood pressure drop. The decrease in blood pressure was resolved by 18-NOV-2005 and the patient's arm was continuing to improve.  In follow-up, the physician reported that the patient with hypertension and increased cholesterol was vaccinated with pneumococcal 23v polysaccharide vaccine (650329/0747P) intramuscularly in the left deltoid on 14-NOV-2005, the patient experienced left arm swelling, erythema and warmth. The patient's blood pressure decreased from usual hypertension range 160/90 to 100/60. The patient was treated with diphenhydramine hydrochloride (Benadryl). Her arm was elevated and her blood pressure medication was held. The patient's experience resolved without significant sequelae (also reported as resolved 29-NOV-2005). Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site urticaria, Rash erythematous, Skin burning sensation, Urticaria
Clinical narrative: Injection site urticaria; burning sensation; injection site urticaria; injection site reaction Initial and follow-up information has been received from a 61 year old female patient, with no known pertinent medial history or drug reactions/allergies reported who on 19-OCT-2005 was vaccinated intramuscularly with a dose of pneumococcal 23v polysaccharide vaccine (lot # unknown). Concomitant therapy included loratadine (Claritin) and diphenhydramine HCL (Benadryl). On approximately 21-OCT-2005 the patient experienced a reaction at the site of injection. The patient indicated that "it felt like it was burning and had bumps." On 02-DEC-2005 the patient reported that on 01-DEC-2005 she developed 9 new bumps on her arm near the site of injection. The patient's present status was reported as recovering. No product quality complaint was involved. No additional information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: Injection site pain; injection site erythema Information has been received from a registered nurse concerning a 67 year old female patient with a history of immunization in 2000 and unknown drug reactions/allergies reported who one 28-OCT-2005 was vaccinated intramuscularly in the left deltoid with a 0.5ml booster dose pneumococcal 23v polysaccharide vaccine (lot  #649914/0578P). Concomitant therapy included metoprolol succinate (Toprol XL tablets) raloxifen hydrochloride (Evista) and vitamins unspecified. It was reported that the patient received her first dose of pneumococcal 23v polysaccharide vaccine (route, dose and L# unknown) in 2000. Within 12 hours of vaccination, on 28-OCT-2005 the patient experienced her left arm became sore and red at the injection site. She did not have a fever. The pain was relieved with ice packs and acetaminophen (Tylenol). Subsequently, on an unknown date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Local reaction Information has been received from a registered nurse concerning a 44 year old female with hypothyroidism and type 2 diabetes mellitus and a history of obesity who in November 2005 was vaccinated subcutaneously with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot #649697/1038P). In November 2005, the patient developed a local reaction after receiving her first dose of pneumococcal 23v polysaccharide vaccine. The patient sought unspecified medical attention. At the time of the report the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Information has been received from a physician and a healthcare worker concerning a patient who was vaccinated subcutaneously with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient developed "swelling and heated skin in the area of the injection." It was reported that the patient sought unspecified medical attention and was not hospitalized. At the time of the report is was unknown if the patient recovered. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Influenza like illness, Oedema
Clinical narrative: Cellulitis Information has been received from a registered nurse concerning a 62 year old white male teacher with no know drug allergies, who on 14-NOV-2005 at 10:00 was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot #651318/1006P). On 14-NOV-2005, the patient experienced a swollen right arm and "flu symptoms." On 15-NOV-2005 the patient went to the emergency room. His arm was red and edematous from the deltoid to the forearm area was warm and painful to the touch. It was also noted that the patient was running a temperature. It was noted that the patient was diagnosed with cellulitis and received cefazolin sodium (Ancef), 1 gram IV. The redness of the arm remained unchanged and the patient had no other complaints. Laboratory diagnostic tests revealed a complete blood count was within normal limits, a potassium test was low at 2.9 and a glucose test was high at 134. The patient was released from the emergency room on oral antibiotics. The patient stated that he had potassium tablets at home that he was supposed to take daily. He will follow up with his own doctor. On 17-NOV-2005 the patient recovered from cellulitis. An investigation into this lot number was requested. No product quality complaint was involved. 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. In addition, a review of the Quality Control Quarantine/Rejeciton System revealed that there were no open Quarantines registered against this lot/fill. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Cellulitis Information has been received from a registered nurse concerning a 62 year old white male teacher with no know drug allergies, who on 14-NOV-2005 at 10:00 was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot #651318/1006P). On 14-NOV-2005, the patient experienced a swollen right arm and "flu symptoms." On 15-NOV-2005 the patient went to the emergency room. His arm was red and edematous from the deltoid to the forearm area was warm and painful to the touch. It was also noted that the patient was running a temperature. It was noted that the patient was diagnosed with cellulitis and received cefazolin sodium (Ancef), 1 gram IV. The redness of the arm remained unchanged and the patient had no other complaints. Laboratory diagnostic tests revealed a complete blood count was within normal limits, a potassium test was low at 2.9 and a glucose test was high at 134. The patient was released from the emergency room on oral antibiotics. The patient stated that he had potassium tablets at home that he was supposed to take daily. He will follow up with his own doctor. On 17-NOV-2005 the patient recovered from cellulitis. An investigation into this lot number was requested. No product quality complaint was involved. 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. In addition, a review of the Quality Control Quarantine/Rejeciton System revealed that there were no open Quarantines registered against this lot/fill. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 85-year-old female with Alzheimer's disease who on 01-NOV-2005 was vaccinated intramuscularly in the left deltoid with a 0.5 ml second dose of pneumococcal 23v polysaccharide vaccine (lot#651318/1006P).  Concomitant vaccination on 03-NOV-2005 in the right arm included a dose of influenza virus vaccine (unspecified).  It was noted that the patient received a first dose of pneumococcal 23v polysaccharide vaccine five years prior.  On an unspecified day in November 2000, the patient's left arm became swollen, painful, and red after vaccination.  Unspecified medical attention was sought and the problem resolved on its own in November 2005.  No diagnostic laboratory tests were performed.  The nurse requested an investigation into this lot number.  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 and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open registered against this lot/fill.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 60 year old female, with no medical history, who on 11-NOV-2005 was vaccinated with a 0.5 ml intramuscular dose in the right arm of pneumococcal 23v polysaccharide vaccine (Lot#650082/0691P).  Concomitant therapy on the same day included an intramuscular dose in the left arm of methotrexate.  It was reported that the patient was seen by a physician on 18-NOV-2005 complaining of a little swelling where she received her vaccine.  The patient was currently seen by a physician.  It was reported that the patient was recovering.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema, Pain
Clinical narrative: Information has been received from a Physician's Assistant (PA) concerning a female patient with a known phenol allergy who in November 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  In November 2005, the patient developed an injection site reaction because of the phenol allergy.  The phenol allergy was known before the injection was given.  Medical attention was sought.  The patient's outcome was unknown.  Follow up information has been received from the PA concerning the 85 year old white retired female with aortic aneurysm, hypertension, hyponatremia, osteoporosis, knee pain, pelvic pain, urinary tract infection (25-oct-2005), and allergies to sulfonamides, pseudoephedrine hydrochloride (SUDAFED), ampicillin, and rofecoxib (MSD), AND A HISTORY OF DYSURIA (12-SEP-2005), concussion with no loss of consciousness (10-MAR-2005), abrasion or friction burn of elbow without infection, and hematuria who in the morning of 01-NOV-2005 was vaccinated intramuscularly in right deltoid with her first dose of pneumococcal 23v polysaccharide vaccine (lot#650302/1039P).  Concomitant therapy included aspirin, sulfamethaxazole/trimethoprim (BACTRIM DS tablets), calcium (unspecified), alendronate sodium (+) cholecalciferol (MSD), ciprofloxacin hydrochloride (CIPRO), cephalexin (KEFLEX), metoprolol tartrate (LOPRESSOR), HCTZ/TRIAMTERENE (MAXZIDE), vitamins (unspecified), amlodipine besylate (NORVASC), levothyroxine Na (SYTHROID), acetaminophen/hydrocodone bitartrate (VICODIN tablets), vitamin D (unspecified), and vitamin E. It was reported that on the morning of 02-NOV-2005 the patient developed cellulitis with pain, redness, and edema.  She was placed on cephalexin (KEFLEX) 500 mg capsule, 1 capsule by mouth three times a day for seven days, and fexofenadine hydrochloride (ALLERGA) 180 mg tablet, 180 mg daily.  On recheck on 09-NOV-2005, the symptoms had resolved.  No further information is available.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a health professional concerning an 80 year old white female with penicillin allergy and no illness at the time of vaccination who at 2:00 pm on 22-AUG-2005 was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P).  On 22-AUG-2005, the patient called the office with complaint of a red arm, swollen, painful arm.  The patient was unable to use affected arm for 2 days due to the pain.  The patient was instructed to use cool compresses to the area and to follow up with office if not better or if symptoms changed.  On 24-AUG-2005, the patient recovered.  Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site reaction
Clinical narrative: Information has been received from an approx 60 to 65 yr old physician who on an unspecified date was vaccinated IM with a 0.5mL second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the physician developed a local reaction and flu like symptoms. The physician sought unspecified medical attention, and subsequently recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injection site pain, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 72 yr old white female, with allergy to amoxicillin (diarrhea) and a history of immunization in 1999, who on 30Aug05 was vaccinated at 11:00AM IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649912/0529P). On 30Aug05 4:00PM, the pt called the doctor's office and stated that she had welt at site, arm is painful from hand to shoulder, generalized weakness, and no nausea. Subsequently, on an unspecified date the pt recovered. It was reported that the pt had no known illnesses at the time of the vaccination. No further information is available.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a female in her twenties or thirties who on 14Nov05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On an unspecified date, the pt had a reaction at the injection site. The area was raised, red, and painful. Subsequently, on an unspecified date, the pt recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an adult pt, with unk medical history and unk drug reactions/allergies, who in early Nov 2005, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649694/0386P). In Nov 2005, the pt developed an injection site reaction to include redness, pain, local heat and swelling. The pt was treated with antibiotics and subsequently, fully recovered. No product quality complaint was involved. No additional information is expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 55 yr old male with diabetes and no known allergies who on approx 07Nov05 was vaccinated IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651328/1046P). Concomitant therapy included diabetic medication (therapy unspecified). Subsequently, the pt developed red, hot, painful and grapefruit size areas at the injection site. Medical attention was sought. The pt was treated with compresses. The pt was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning an adult female who on an unspecified date was vaccinated with the first 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On approx 14Nov05, week of 14Nov05, the pt developed injection site redness, swelling and fever. The pt sought unspecified medical attention. At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 78 yr old female who on 30Nov05 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 650648/0967P), IM in the deltoid. On 30Nov05 the pt had a local reaction described as redness, pain and swelling. At the time of the report, the pt was considered to be not recovered. Unspecified medical attention was sought. The reporter would like a lot investigation for lot 650648/0967P). 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. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. It was also reported that another pt had a similar reaction (WAES0512USA00209). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 65 yr old male with diabetes, heart disease and reaction to tuberculin test who on 29Nov05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot650648/0957P), IM in the deltoid. On 30Nov05 the pt experienced a severe local reaction with redness, severe pain and massive swelling from the elbow to shoulder in arm where pneumococcal 23v polysaccharide vaccine was given. At the time of the report, the pt was considered to be not recovered. Unspecified medical attention was sought. The reporter would like a lot investigation for lot 650648/0967P. 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. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. It was also reported that another pt had a similar reaction (WAES0512USA00204). Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Sleep disorder, Swelling
Clinical narrative: Information has been received from a healthcare professional concerning a 78-year-old retires white female patient with no known drug allergies, who on 07-NOV-2005 at 14:00 was vaccinated in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot#650648-0967P).  She was not ill at the time of vaccination.  The patient called the physician's office the day after vaccination, on 08-NOV-2005 and reported that on 07-NOV-2005 at approximately 15:00 her left arm was red, swollen and very painful from the elbow to the shoulder.  She reported that she was up all night with pain and reported that it hurts to move the affected arm.  The patient was instructed to come to the office for evaluation and she was instructed to use ice or cold compresses to the affected arm.  Her temperature was 98.6.  It was noted that she recovered on 09-NOV-2005.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse a female patient who on approximately 01-NOV-2005 (three weeks ago) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced an injection site reaction.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 01-DEC-2004 was vaccinated with a dose if pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient experienced an injection site reaction. The patient's outcome was unknown.  Additional has been requested.
Sex: U
Vaccine: PPV
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Information has been received from a health professional concerning a physician who on approximately 03-NOV-2005 'within the last two weeks" was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#649914/0578P). Within the last two weeks, the physician developed nausea, vomiting and diarrhea.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Injection site erythema, Injection site reaction, Pain, Pruritus
Clinical narrative: Initial and follow up information has been received from a licensed visiting nurse concerning a 78 year old retired white female with a general symptom, "Wygesic".  On 26-SEP-2005, at 10:30 am, the patient was vaccinated intramuscularly into the right deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (Lot#649979/0531P).  On 26-SEP-2005, the patient developed injection site reaction.  The patient was treated with a topical cream. On 26-SEP-2005, at 7:00 pm, the patient developed itching, redness at injection site. swelling and pain.  On 27-SEP-2005, in the am, the patient reported "difficult to use arm", increased heart rate and increased blood pressure.  The patient sought unspecified medical attention.  On 28-SEP-2005, the patient recovered from the events.  No further information is available.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tachycardia
Clinical narrative: Initial and follow up information has been received from a licensed visiting nurse concerning a 78 year old retired white female with a general symptom, "Wygesic".  On 26-SEP-2005, at 10:30 am, the patient was vaccinated intramuscularly into the right deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (Lot#649979/0531P).  On 26-SEP-2005, the patient developed injection site reaction.  The patient was treated with a topical cream. On 26-SEP-2005, at 7:00 pm, the patient developed itching, redness at injection site. swelling and pain.  On 27-SEP-2005, in the am, the patient reported "difficult to use arm", increased heart rate and increased blood pressure.  The patient sought unspecified medical attention.  On 28-SEP-2005, the patient recovered from the events.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a female patient greater than 65 years of age who was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine.  It was reported that no other vaccinations were given with the pneumococcal 23v polysaccharide vaccine.  The patient was reported as generally healthy with "no major health problems".  Subsequently, the patient developed injection site cellulitis which lasted at the most for 3 days.  The patient recovered from the injection site cellulitis.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a female patient greater than 65 years of age who was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine.  It was reported that no other vaccinations were given with the pneumococcal 23v polysaccharide vaccine.  It was reported as generally healthy with "no major health problems".  Subsequently, the patient experienced injection site cellulitis which lasted at the most for 3 days.  The patient recovered from the injection site cellulitis.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a female patient greater than 65 years of age who was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine.  It was reported that no other vaccinations were given with the pneumococcal 23v polysaccharide vaccine.  The patient was reported as generally healthy with "no major health problems".  Subsequently, the patient experienced injection site cellulitis which lasted at the most for 3 days.  The patient recovered from the injection site cellulitis.  No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a  patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient developed cellulitis.  Unspecified medical attention was sought.  After several days, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 64 year old male with a bupropion hydrochloride (WELLBUTRIN) allergy, who on 06-DEC-2005 was vaccinated subcutaneously into the left arm with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot#649697/1038P).  Within hours, the patient experienced an injection site reaction to include pain, redness, swelling and local heat all the way to the elbow.  It was noted that to was hard for the patient to move his arm due to the pain.  The pain was treated with amoxicillin (+0 clavulanate potassium (AUGMENTIN), twice a day for 7 days.  There were no laboratory diagnostic studies performed.  Within one week, the patient recovered.  Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a physician and a medical assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient developed erythema, swelling, and pain of the upper forearm.  Unspecified medical attention was sought.  Subsequently the patient recovered.  No product quality was involved.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 75 year old male with hypertension, hypothyroidism, high cholesterol, no known allergies and a history of atrial fibrillation, who on 30-NOV-2005 was vaccinated intramuscularly into the right arm with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#651329/1047P).  The patient's list of concomitant medications was not available.  On 02-DEC-2005 the patient experienced rash at the injection site and on the legs and trunk.  The doctor prescribed him with methylprednisone (MEDROL) Dosepak, cetirizine hydrochloride 9ZYRTEC) 10 mg daily,a nd famotidine (MSD) 20 MG twice a day.  It was noted that the patient has not been back to the office for follow up yet.  No diagnostic laboratory studies were performed.  It was noted that the patient was improving but the outcome was unknown.  It was also noted that the patient received his first dose of pneumococcal 23v polysaccharide vaccine in 1998.  No product quality complaint was involved.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a male in his mid 60's who on approximately 10-NOV-2005 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot651329/1047P).  Subsequently, the patient developed fever, and erythema and edema at injection site.  Subsequently, the patient recovered.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female in her mid 60's who on approximately 10-NOV-2005 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Subsequently, the patient experienced fever, erythema and edema at injection site.  Subsequently, the patient recovered.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female in mid 60's who on approximately 10-NOV-2005 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P).  Subsequently, the patient experienced fever, and erythema and edema at injection site.  Subsequently, the patient recovered.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from health professional concerning a female in her mid 60's who on approximately 10-NOV-2005 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P).  Subsequently, the patient experienced fever, and erythema and edema at injection site.  Subsequently, the patient recovered.  No further information is available.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pruritus, Rash
Clinical narrative: Information has been received from a female nurse who on 09-NOV-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650083/0746P).  The patient reported that on 09-NOV-2005 approximately four hours post injection she experienced injection site pain, itching, local swelling, and the site feeling "firm and felt thick".  She reported that on a later unspecified date she developed a rash and open sores at the injection site.  At the time of this report the patient was recovering from the event.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a female (age not reported) who on 12/8/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). That same day the pt experienced a sore arm. At the time of this report it was unknown if the pt had recovered from the sore arm. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a NP concerning a 35 year old female who one week ago (on approx 12/5/05) was vaccinated IM with 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine. On approx 12/5/05 the pt experienced severe cellulitis. The NP reported that the pt is presently recovering. No product quality complaint was involved. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 40 year old female with multiple sclerosis who on 12/5/05 at 11:45am was vaccinated, IM into the left deltoid with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 650649/0790P). Concomitant therapy included interferon beta la Avonex. On 12/5/05 at 6:00pm, the pt developed a sore swollen left arm and a fever body temp of 100. The pt was treated with acetaminophen and codeine phosphate Tylenol with codeine 3. At the time of the report, the pts outcome was unknown. No further information is available.