chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a healthcare professional and a RN concerning a 46 year old white female receptionist with no known drug allergies who on 12/06/03, at 08:10, was vaccinated IM in the right deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). Concomitant therapy included "routine unnamed medications". There was no illness at the time of vaccination. The RN reported that on the evening of 12/09/03, the pt developed arm pain. On 12/10/03, the pt developed increased pain and redness in the left upper arm. The pt went to a healthcare facility and was subsequently hospitalized as a diagnosis of cellulitis was made. At that time, the pt was started on IV Unasyn. While hospitalized, a CBC and blood cultures were performed (results not available). The pt remained hospitalized for 3 days and was subsequently discharged from the hospital to home on Augmentin. At that time, the pt's cellulitis was considered to be resolved. It was noted that the pt's physician was concerned about this particular lot #. 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. The health care professional also reported that another pt developed swelling of the arm after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0312USA01690).  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulins increased
Clinical narrative: Information has been received from an adult female consumer with no pertinent medical history who was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 640981/1050L). Concomitant therapy included "Lexoxol", "Eskaligh" and estrogens, conjugated (Premarin). The reporter indicated that she developed benign biclonal gammopathy after vaccination. Diagnostic studies including "blood assays radio" were performed (results not provided).  It was noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. Unspecified medical attention was sought and prescription drug was not required. The event did abate and the pt was "recovering with sequelae." A product quality complaint was not involved. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a woman in a physician's office concerning a retired 83 year old white female with an allergy to codeine and tape who on 10/23/03 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647636/0944N). There was no illness at the time of vaccination. On 10/24/03 the pt developed right arm pain, swelling and tenderness and was unable to raise her arm. Unspecified medical attention was sought. The pt was treated with anti-inflammatories. No product quality complaint was involved. Subsequently the pt recovered. The reported expressed a concern with the lot.  It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647636/0944N) and developed adverse reactions (WAES # 0311USA00842, 0312USA00976, 0312USA00977). 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. No further information is expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Information has been received from a RN concerning a 60 year old female with no medical history and no allergies who, "in another state", on approximately 11/24/03 was vaccinated in the arm with a first dose of pneumococcal 23v polysaccharide vaccine. ON approximately 11/25/03, the day after her vaccination, the pt developed musculoskeletal pain in the arm. On 12/15/03 it was reported that the pain continues. Unspecified medical attention was  sought and the pt was treated with ibuprofen and heat. No diagnostic studies were performed. It was also reported that a prescription drug was required. It was also noted that "a few weeks before" the pt was vaccinated in the same arm with a dose of influenza virus vaccine (manufacturer unknown) and developed musculoskeletal pain in the arm but not as severe. No product quality complaint was involved. On 01/30/04 it was reported that there was no data on this pt and the reporter did not have the name of the person nor where the vaccination was given. She reported that she "was checking for someone that knew the person". The reporter noted that "as far as she knew, the problem did resolve on it's own." No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a doctor of pharmacy concerning a white male pt with no known allergies and no known medical history who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N). There was no illness at the time of vaccination. Subsequently, in November 2003, the pt developed local reactions including arm swelling and soreness, heat and redness.  The pt also developed an erythematous rash. Unspecified medical attention was sought. Subsequently, the pt recovered from the local reactions. A product quality complaint was not involved. The reporter requested a lot check. 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. The reporter also mentioned three other pt's who each had an experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot #647654/0865N)(WAES #0310USA03184).  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a women at a pharmacy concerning a white male with no known medical history or allergies who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. In 11/03, the pt experienced local reactions including arm swelling, heat, soreness and erythematous rash. Subsequently, the pt recovered.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Information has been received from a RN concerning a 74 year old female pt who on 12/15/03 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N). On approximately 12/15/03 the pt experienced redness, soreness and heat at the injection site and malaise. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that two other pt's (WAES # 0401USA00780 & 0401USA00781) had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a 67 year old male who on 11/18/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Shortly after receiving the vaccination, on approximately 11/18/03, the pt said that his arm swelled up from his shoulder down to his elbow. He also reported his arm was painful and he could not sleep on the swollen arm. The pt went to his physician who prescribed antibiotics to treat the swelling.  The pt said that he took the medicine for 2 days, his swelling went down and he is doing well.  The event abated and the pt recovered. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was "discontinued". A product quality complaint was not involved.  Information was received from a woman in a physician's office which indicated that she had no information and that the vaccination was not given at her office. Information was received from a RN which indicated that the pt experienced an adverse event (not further specified) from pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a LPN concerning a pt who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N). Other therapy administered on that same day included a dose of influenza virus vaccine (unspecified). The LPN reported that the pt developed cellulitis. The LPN reported "the don't know which vaccine caused it."  It was noted the pt required an oral antibiotic for treatment. It was noted the pt was not hospitalized. No other information was provided. There was no product quality complaint involved. The pt sought unspecified medical attention.  Upon internal review cellulitis was determined to be an other important medical event (OMIC). No additional information is expected. The reporter also indicated that another 3 pt's developed injection site reactions consisting of redness, swelling and itching; and another 2 pt's developed severe cellulitis-like reactions following vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647359/0740N).
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Erythema, Hypotension, Injection site swelling, Leukocytosis
Clinical narrative: Information has been received from a physician concerning a 77 year old white retired male with a contrast dye allergy, high cholesterol and hypothyroidism who on 17DEC2003, was vaccinated IM in the left deltoid with the second dose of pneumococcal vaccine 23 polyvalent vaccine. No other vaccinations were administered on that same day. Concomitant therapy included Synthroid. There was no illness at the time of vaccination. The physician reported that on 18DEC2003, the pt developed leukocytosis (white blood cell count 12.3), extensive erythema and swelling of the injection site, a low grade fever of 99.4 F, hypotension as low as 72/47, felt dizzy and experienced lightheadedness. Unspecified medical attention was sought, but no treatment was required. Subsequently, the pt recovered from his events. The physician also reported that another pt developed erythema, redness and swelling of the injection after being vaccinated with pneumococcal vaccine 23v polysaccharide vaccine. Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 77 year old white retired male with a contrast dye allergy, high cholesterol and hypothyroidism who on 17DEC2003, was vaccinated IM in the left deltoid with the second dose of pneumococcal vaccine 23 polyvalent vaccine. No other vaccinations were administered on that same day. Concomitant therapy included Synthroid. There was no illness at the time of vaccination. The physician reported that on 18DEC2003, the pt developed leukocytosis (white blood cell count 12.3), extensive erythema and swelling of the injection site, a low grade fever of 99.4 F, hypotension as low as 72/47, felt dizzy and experienced lightheadedness. Unspecified medical attention was sought, but no treatment was required. Subsequently, the pt recovered from his events. The physician also reported that another pt developed erythema, redness and swelling of the injection after being vaccinated with pneumococcal vaccine 23v polysaccharide vaccine. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Information has been received from a woman in a physician's office concerning a 72 year old white female homemaker and pt with no pre-existing medical conditions and no illness at the time of vaccination, who on 23OCT2003 at 10:45 AM was vaccinated in the right deltoid with a second dose of pneumococcal vaccine 23v polysaccharide vaccine. On 25OCT2003 at 07:40 AM the pt developed a red, swollen right arm, which was hot to touch. The pt recovered. The reporter noted that the pt did not have adverse events following prior vaccinations. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Information has been received from an RN concerning a 68 year old white female with no past medical hx who on 17OCT2003 at 10:00 AM was vaccinated with a second dose of pneumococcal vaccine 23v polysaccharide vaccine, IM in the right deltoid. There was no concomitant medication or illness at the time of vaccination. On 18OCT2003 at 12:30 PM , the pt developed a "hot, swollen, red arm where dose of pneumococcal vaccine 23v polysaccharide vaccine  shot was given. It was also reported that the pt developed a painful arm. The pt recovered on 20OCT2003. There were no relevant diagnostic tests or laboratory data. It was also noted that the pt had received the first dose of pneumococcal 23v polysaccharide vaccine in 1998. It was also reported that four other pts had a similar reaction. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Information has been received from an RN concerning a 42 year old white male with no past medical hx who on 23OCT2003 at 10:00 AM was vaccinated with a second dose of pneumococcal vaccine 23v polysaccharide vaccine, IM in the right deltoid. There was no concomitant medication or illness at the time of vaccination. On 24OCT2003 at 7:00 AM , the pt developed a "red, warm, painful reaction to right shoulder to elbow."  The pt reportedly recovered.  It was noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine in 1998. It was also noted that the pt did not have any adverse events following previous vaccinations. There were no relevant diagnostic tests or lab data. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also reported that four other pt had a similar rxn. Additional info is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Information has been received from an RN concerning a 38 year old female with no past medical hx who on 31OCT2003 at 9:00 AM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine IM in the right deltoid. There was no illness at the time of vaccination. On 31OCT2003 at 3:00 PM the pt complained of "hot, red, swollen arm after pneumococcal 23v polysaccharide vaccine. The pt also reportedly had a painful arm. The pt was told to use Tylenol. The pt recovered 02NOV2003. There were no relevant diagnostic testes or lab data. It was noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine in 1998. It was also noted that the pt did not have any adverse events following previous vaccinations. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  It was also reported that four other pt had a similar rxn. Additional info is not expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a male physician who on 23DEC2003 was vaccinated intradermally with a dose of dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant therapy. The pharmacist reported that on 24DEC2003, the physician developed an 8 cm wheal at the injection site. The pharmacist also reported that the physician developed injection site redness and injection site pain that moved up his arm from the injection site. The physician was noted to be afebrile. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the outcomes were unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 53 year old female who in undergoing chemotherapy and has a hx of rxns to drugs who on 26DEC2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 27DEC2003 the pt developed an itchiness between her fingers on each hand and on each ankle. The pt took oral Benadryl and that helped the itching. As of the morning of 29DEC2003, the itching was still present. It was also noted that the adverse event abate. Unspecified medical attention was sought and treatment was required. A product quality complaint was not involved. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Rash erythematous
Clinical narrative: Information has been received from a woman in a physician's office concerning a 47 year old white female with asthma and no known allergies who on 10DEC2003 was vaccinated IM in the left deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. On the afternoon of 10DEC2003 the pt developed cellulitis of the arm that was red and bumpy. Unspecified medical attention was sought and no prescription drug was required. Subsequently, the pt recovered. It was also noted that on 12NOV2003, the pt was vaccinated IM in the left deltoid with a dose of influenza virus sAg 3v vaccine inactivated. No product quality complaint was involved. It was also reported that another pt was vaccinated with dose of pneumococcal 23v polysaccharide vaccine and developed cellulitis. No further info is expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old Caucasian male with no known allergies who on 27DEC2003 between 8:00-9:00 am was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included metoprolol succinate 25 mg QD. It was noted that on 13DEC2003, the pt was recovering from sinusitis. On 27DEC2003, (also reported as that evening or next day), the pt developed fever, chills and swelling of the right arm which was red and hot to touch. It was noted that although the temperature was not actually checked the pt's wife told the nurse "it probably went higher than 101." There were no diagnostic lab tests performed.  On 28DEC2003 , the next day the client slept most of the day and his arm continued red, swollen and warm. It was also noted that the pt felt okay and that he was almost back to normal. His arm continued to be a little red + swollen, however it was also noted that he had recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned that the pt's son was vaccinated with dose of pneumococcal 23v polysaccharide vaccine and experienced a similar reaction. Additional info has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from an RN concerning a female pt who on 21OCT2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Within 24 hours of vaccination, the pt developed an injection site reaction that was hot to touch. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that another female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed an injection site rxn. No further info is expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 72 year old white retired female with a codeine allergy, hypertension, high cholesterol and osteoporosis who on 17DEC2003, was vaccinated IM in the right deltoid with the second dose of pneumococcal 23v polysaccharide vaccine . No other vaccinations were administered on that same day. Concomitant therapy included alendronate Na, atenolol, Lozol, Lipitor and Valium. There was no illness at the time of vaccination. The physician reported that on 19DEC2003, the pt developed extensive erythema, redness and swelling of her injection site arm with induration. There were no blisters noted. Unspecified medical attention was sought, but no lab/diagnostic tests were performed and no treatment was required. Subsequently, the pt recovered from her events. The physician also reported that another pt developed erythema and swelling of the injection site, fever, hypotension, dizziness and lightheadedness after being vaccinated with pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a consumer and a physician concerning a pt with no allergies and no past medical hx who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed a local rxn and was swollen from the elbow to the shoulder. Unspecified medical attention was sought and prescription drug treatment was required. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was discontinued. A product quality complaint was not involved. The reporters also mentioned two other patients who experienced local reactions following vaccination with dose of pneumococcal 23v polysaccharide vaccine. The physician reported this was the first dose of pneumococcal 23v polysaccharide vaccine  for two of the pts and the third pt's vaccination hx was uncertain. Additional info has been requested.
Age: 44.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Immune system disorder, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a healthcare worker and an LPN concerning a 44 year old Caucasian male pt who on 30DEC2003 was vaccinated in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine and immuno-supressive medications. On 31DEC2003, the pt called the medical office with complaints of tenderness and swelling at the injection site. An onset time of 13:33 on 31DEC2003 was noted. The pt's experience was also described as a "severe" local rxn that included swelling and soreness. There was no erythema, no fever or chills. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned two female pts who had similar local reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional info is not expected.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from an RN concerning an 18 year old Caucasian male pt with no known allergies who on 15DEC2003 at 4:30 PM was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. On 16DEC2003 in the am, post vaccination, the pt's arm was swollen, red and hurting. It was noted that the reaction was minimal.  There were no diagnostic laboratory tests performed. The outcome was recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned the patient's father who was vaccinated with dose of pneumococcal 23v polysaccharide vaccine and experienced a similar reaction. No further info is expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site reaction, Joint range of motion decreased, Pain
Clinical narrative: Information has been received from a health professional concerning a 63 year old white menopausal female with asthma, hypertension, allergy to naproxen, allergy to aspirin and allergy to most anti-inflammatories and a history of acute sinusitis, urinary incontinence, irritable bowel syndrome, osteoarthritis and allergic rhinitis who on 06JAN2004, at 9:30 , was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Vioxx, Nasacort, Clarinex, Detrol, Diovan HCT, Norvasc, Vitamin C and Vitamin E. On 07JAN2004 the pt was seen in the office with pain and redness of the arm. There was a large wheal around the injection site that went around the arm in a four inch band. It was described as red, warm and raised with no petechiae. It was painful to touch and with movement. She was afebrile. The pt was treated with Benadryl and Tequin for 7-10 days. No product quality complaint was involved. Follow up information from the health professional indicated that the pt came to the office with complaints of pain and redness in the right arm at the site of the dose of pneumococcal 23v polysaccharide vaccine given in the office. The pt was seen and was noted to have a large 3-4 inch band around the upper right arm that was red, raised and warm to touch. The pt complained of pain to touch and pain with movement. It was reported that a physician examined the patient. Treatment included Benadryl and Tequin. It was reported the pt recovered on approximately 13JAN2004. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 63 year old white menopausal female with asthma, hypertension, allergy to naproxen, allergy to aspirin and allergy to most anti-inflammatories and a history of acute sinusitis, urinary incontinence, irritable bowel syndrome, osteoarthritis and allergic rhinitis who on 06JAN2004, at 9:30 , was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Vioxx, Nasacort, Clarinex, Detrol, Diovan HCT, Norvasc, Vitamin C and Vitamin E. On 07JAN2004 the pt was seen in the office with pain and redness of the arm. There was a large wheal around the injection site that went around the arm in a four inch band. It was described as red, warm and raised with no petechiae. It was painful to touch and with movement. She was afebrile. The pt was treated with Benadryl and Tequin for 7-10 days. No product quality complaint was involved. Follow up information from the health professional indicated that the pt came to the office with complaints of pain and redness in the right arm at the site of the dose of pneumococcal 23v polysaccharide vaccine given in the office. The pt was seen and was noted to have a large 3-4 inch band around the upper right arm that was red, raised and warm to touch. The pt complained of pain to touch and pain with movement. It was reported that a physician examined the patient. Treatment included Benadryl and Tequin. It was reported the pt recovered on approximately 13JAN2004. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 58 year old Caucasian female pt with no pre-existing conditions who on 30OCT2003 at 15:15 was vaccinated with a 0.5 ml second dose IM in the right deltoid of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. The first dose was given in 1998. Subsequently the pt experienced hot, red, swollen and painful arms. Unspecified medical attention was sought. No lab diagnostics were done and no treatment was required No product attention was sought. No lab diagnostics were done and no treatment was required. No product quality complaint was involved. The reporter expressed a concern with the lot. Follow up information indicated that on 31OCT2003, the pt developed severe erythema of the deltoid from the shoulder to the elbow, with tenderness to palpation. It was noted that the pt recovered on 04NOV2003. The records of testing prior to release of this lot have been checked by AQ and found to be satisfactory. The lot complies with the standards of the center for biologics Evaluation and researched and was released. The other female pts had similar experience. The other male pt was vaccinated with dose of pneumococcal 23v polysaccharide vaccine and had the same reaction.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Malaise, Pruritus, Tenderness
Clinical narrative: Information has been received from an RN concerning a 79 year old female pt with unspecified cardiac problems who on 15DEC2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On approximately 15DEC2003 the pt experienced redness, soreness, heat and itching at the injection site and malaise. Unspecified medical attention was sought and the doctor recommended ice, Tylenol and Claritin for the itching. There was no product quality complaint involved. The reporter indicated that two other pt's had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Malaise, Tenderness
Clinical narrative: Information has been received from an RN concerning a 64 year old female who on 15DEC2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On approximately 15DEC2003 the pt experienced redness, soreness and heat at the injection site and malaise. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that two other pts had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from an infectious disease physician concerning an 11 year old male pt who on 08JAN2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently on 08JAN2004, the pt developed a local rxn below the injection site (pain and swelling) and a fever of 102 F. Unspecified medical attention was sought, but treatment was not required. As of 12JAN2004, the fever was gone and the pain and swelling were greatly reduced. A product quality complaint was not involved Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 81 year female pt with unspecified allergies who in November 2003, was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently in November 2003, the pt experienced injection site reaction which included injected site swelling, soreness and erythema. She was treated with Benadryl and cold compresses. As of 03DEC2003, the pt's adverse events abated. There was no product quality complaint involved. The reporter indicated that three other patients and had similar experiences following exposure to dose of pneumococcal 23v polysaccharide vaccine. Additional information has been been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional regarding a 70 year old male pt who in November 2003, was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently in November 2003, the pt experienced injection site reactions which included injection site swelling, soreness and erythema. He was treated with Benadryl and cold compresses. As of 03DEC2003, the pt's adverse events abated and it was reported that the pt was "recently seen at the office for an abnormal CT scan". There was no product quality complaint involved. The reporter indicated that three other pts had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Age: 79.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 79 year patient who in November 2003, was vaccinated with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently in November 2003, the pt experienced injection site reactions which included injection site swelling, soreness and erythema. The pt was treated with Benadryl and cold compresses. As of 03DEC2003, the pt's adverse events abated. There was no product quality complaint involved. The reporter indicated that three other patients and had similar experiences following exposure pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from an registered pharmacist concerning an adult female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed an injection site reaction. Unspecified medical attention was sought, but treatment was not requested. A product quality complaint was not involved. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional concerning an 85 year old female with no pertinent medical history who on 13JAN2004 was vaccinated wit a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. On 13JAN2004 the patient developed "swelling, itching and hot around injection site". The patient was told to put ice on the affected area. The outcome is unknown at this time. Unspecified medical attention was sought. There was no product quality complaint. No laboratory diagnostic studies were performed. The reporter also indicated that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Hypokinesia, Injection site induration, Pain
Clinical narrative: Information has been received from an RN concerning three pts who in approximately January 2004, within the last three weeks and two of those within the last two days, who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The nurse did not provide specific pt details but reported that the pts developed local reactions that were very bothersome for them, including temporary loss of the full use of the arm, pain, erythema an hardness. Unspecified medical attention was sought and no treatment was required. No further details were provided. No product quality complaint was involved. It was noted that all the reactions came from the same lot number but upon inspection the vaccine "appears" to be fine. Information has been received from an RN concerning a 69 year old male with allergies to codeine, amoxicillin and Keflex who on 14JAN2004 was vaccinated IM in the left upper arm with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included ASA enteric coated 81 mg 1 PO daily, Lipitor, Wellbutrin 100 mg PO BID, Toprol XL 50 mg PO daily and Nitrolingual 0.4 mg/dose one under tongue as needed for chest pain. On 15JAN2004 the pt was seen in the physician's office for an allergic reaction to the vaccine. It was reported that the pt was "now" on Bactrim for a respiratory infection. The pt had developed increasing pain and redness at the left shoulder. There was no shortness of breath. The pt was in no acute distress. Her vital signs were: Temperature 99.0, BP 112/70, pulse 84, and respirations 18. The pt developed a local reaction that was very bothersome for her, including temporary loss of the full sue of the arm, pain, erythema and hardness. The pt had tenderness at the upper outer extremity especially over the deltoid region but also spreading circumferentially almost completely around the upper arm. There was no substantial tenderness and a mild amount of swelling associated with this. her lungs were clear. The pt was given an injection of 10 mg of Benadryl which produced no response, and 25 mg which also produced no response and the pt was not drowsy.  A prescription was given to the pt for prednisone 10 mg, two now, then one tonight, and then one BID starting on 16JAN2004. Side effects were discussed. Benadryl 50 mg which the pt could obtain in an over the counter form was noted. On 16JAN2004, the pt was to be seen for follow up to see how she was doing. Subsequently, the pt recovered. No product complaint was involved. It was also noted that 2 other pts wee vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed adverse reactions. It was noted that all the reactions came from the same lot number but upon inspection the vaccine "appears" to be fine. No further info is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from an RN concerning three pts who in approximately January 2004, within the last three weeks and two of those within the last two days, who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The nurse did not provide specific pt details but reported that the pts developed local reactions that were very bothersome for them, including temporary loss of the full use of the arm, pain, erythema an hardness. Unspecified medical attention was sought and no treatment was required. No further details were provided. No product quality complaint was involved. It was noted that all the reactions came from the same lot number but upon inspection the vaccine "appears" to be fine. Information has been received from an RN concerning a 69 year old male with allergies to codeine, amoxicillin and Keflex who on 14JAN2004 was vaccinated IM in the left upper arm with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included ASA enteric coated 81 mg 1 PO daily, Lipitor, Wellbutrin 100 mg PO BID, Toprol XL 50 mg PO daily and Nitrolingual 0.4 mg/dose one under tongue as needed for chest pain. On 15JAN2004 the pt was seen in the physician's office for an allergic reaction to the vaccine. It was reported that the pt was "now" on Bactrim for a respiratory infection. The pt had developed increasing pain and redness at the left shoulder. There was no shortness of breath. The pt was in no acute distress. Her vital signs were: Temperature 99.0, BP 112/70, pulse 84, and respirations 18. The pt developed a local reaction that was very bothersome for her, including temporary loss of the full sue of the arm, pain, erythema and hardness. The pt had tenderness at the upper outer extremity especially over the deltoid region but also spreading circumferentially almost completely around the upper arm. There was no substantial tenderness and a mild amount of swelling associated with this. her lungs were clear. The pt was given an injection of 10 mg of Benadryl which produced no response, and 25 mg which also produced no response and the pt was not drowsy.  A prescription was given to the pt for prednisone 10 mg, two now, then one tonight, and then one BID starting on 16JAN2004. Side effects were discussed. Benadryl 50 mg which the pt could obtain in an over the counter form was noted. On 16JAN2004, the pt was to be seen for follow up to see how she was doing. Subsequently, the pt recovered. No product complaint was involved. It was also noted that 2 other pts wee vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed adverse reactions. It was noted that all the reactions came from the same lot number but upon inspection the vaccine "appears" to be fine. No further info is expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 74 year old female with no pertinent medical history who on 13JAN2004 was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. On 13JAN2004 the pt developed "swelling, itching and hot around injection site". The pt was told to put ice on the affected area. The outcome is unknown at this time. Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. The reporter also indicated that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 65 year old female with no pertinent medical history who on 13JAN2004 was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. On 13JAN2004 the pt developed "swelling, itching and hot around injection site". The pt was told to put ice on the affected area. The outcome is unknown at this time. Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. The reporter also indicated that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional concerning an 67 year old female with no pertinent medical history who on 13JAN2004 was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. On 13JAN2004 the pt developed "swelling, itching and hot around injection site". The pt was told to put ice on the affected area. The outcome is unknown at this time. Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. The reporter also indicated that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site inflammation, Pain, Swelling
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 43 year old white female with an allergy to PCN and no pertinent medical hx who on 13OCT2003 at 2:00pm was vaccinated IM in the upper right arm with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. There was no illness at the time of vaccination. The reporter indicated that the pt developed a localized injection site reaction to the vaccination. The pt experienced redness and inflammation at the injection site. Unspecified medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. Follow up information was received form the woman in the doctor's office which indicated that on 13OCT2003 at 4:00pm, the pt's RA developed terrible pain, swelling and redness. A doctor visit was required and the pt subsequently recovered from the right arm pain, swelling and redness.  The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  No further information is expected. The reporter also indicated that one pt experienced a swollen tongue after therapy with pneumococcal 23v polysaccharide vaccine and that two pts experienced redness and inflammation at the injection site after therapy with pneumococcal 23v polysaccharide vaccine.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site abscess, Injection site induration, Pyrexia
Clinical narrative: Information has been received from a family nurse practitioner concerning a 56 year old female with no allergies and with a history of pneumonia "earlier in the he year" who on 24OCT2003 at 10:30 Am was vaccinated IM in the right deltoid with a first 0.5 dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. On 29OCT2003 the pt developed a cellulitis noted to be an abscess at the injection site.  On 29OCT2003, the pt had  a fever of 102 degrees Fahrenheit for one day. On 31OCT2003, the pt was note to have erythema and induration of the upper arm with tenderness and a firmness of tissue. The pt was prescribed Augmentin 875 mg PO BID for 10 days. Unspecified medical attention was ought. There was no product quality complaint involved. There was no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the pt or her siblings The reporter also indicated that one other pt was developed a cellulitis. This is a consolidation of two reports concerning the same pt. No further information is expected.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a family nurse practitioner concerning a 56 year old female with no allergies and with a history of pneumonia "earlier in the he year" who on 24OCT2003 at 10:30 Am was vaccinated IM in the right deltoid with a first 0.5 dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. On 29OCT2003 the pt developed a cellulitis noted to be an abscess at the injection site.  On 29OCT2003, the pt had  a fever of 102 degrees Fahrenheit for one day. On 31OCT2003, the pt was note to have erythema and induration of the upper arm with tenderness and a firmness of tissue. The pt was prescribed Augmentin 875 mg PO BID for 10 days. Unspecified medical attention was ought. There was no product quality complaint involved. There was no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the pt or her siblings The reporter also indicated that one other pt was developed a cellulitis. This is a consolidation of two reports concerning the same pt. No further information is expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from an RN concerning a 67 year old female pt who on 21JAN2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No to her vaccinations were administered at the same time. On 22JAN2004, the pt developed cellulitis at the injection site. Medical attention was sought. The pt was prescribed Cefzil and warm packs. A product quality complaint was not involved. Cellulitis at the injection site was considered to be an other important medical event. The reporter also mentioned three other pts who developed injection site reactions post vaccination with pneumococcal 23v polysaccharide vaccine. Additional info has been requested.(OMIC)
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Swelling, Tenderness
Clinical narrative: Information has been received from an RN concerning an approximately 70 yea old male pt who on 16DEC2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently in approximately December 2003, the pt developed right arm swelling, tenderness and cellulitis. Medical attention was sought. the pt was treated with an abx. A product quality complaint was not involved. Right arm cellulitis was considered to be an other important medical event. The reporter also mentioned a female pt who experience an adverse event post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.