chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient in his 60's who a while ago was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed an injection site reaction with a complaint of pain at the site for several months. The condition then resolved. No further information was available concerning this patient. The reporter also mentioned a second patient who had an experienced post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The pt had a very red and painful arm for the entire day after the vaccine, that resolved in about a day as well. The pt was treated with ibuprofen (Advil) for pain relief and ice packs. It was noted the pt recovered. Unspecified medical attention was sought.  There was no product quality complaint involved. Followup information on 19Nov03 from the reporter indicated that two of the pt's may have had the vaccine a while ago and that she was not aware if any of the pts had any previous reactions to any other vaccines. The reporter expressed concern about the particular lot of the vaccine. It was noted that several pts developed severe local reactions from what appears to be the same lot and what appeared odd to the doctor was a man and his wife received pneumococcal. polysaccharide vaccine from two different lots and the male that had the different lot that the one mentioned had no adverse reaction but his wife complained of arm pain and tenderness. The records of testing prior to release of this lot have been check by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The reporter mentioned two other pts who developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Pain, Tenderness
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The pt complained of arm pain and tenderness. The pt was treated with ibuprofen (Advil) for pain relief and ice packs. It was noted that the pt recovered within a day or so. Unspecified medical attention was sought.  There was no product quality complaint involved. Followup information on 19Nov03 from the reporter indicated that two of the pt's may have had the vaccine a while ago and that she was not aware if any of the pts had any previous reactions to any other vaccines. The reporter expressed concern about the particular lot of the vaccine and mentioned that several pt's developed severe local reactions from what appears to be the same lot and what appeared odd to the doctor was a man and his wife received pneumococcal. polysaccharide vaccine from two different lots and the male that had the different lot that the one mentioned had no adverse reaction but his wife complained of arm pain and tenderness. The records of testing prior to release of this lot have been check by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  The reporter mentioned two other pts who developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine. No further information is expected.
Age: 11.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning an 11 yr old female with sickle cell disease who on in Sept 03 was vaccinated in the upper arm with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the child had received at least one dose in the past. Approximately 24 hrs after the vaccination, the pt developed a low grade fever and complains of neck pain. Apparently the pt was also down the shoulder and arm of the same side as the injection was administered. The physician was trying to rule out a reaction vs a sickle cell crisis. The outcome was unknown. Unspecified medical attention was sought, but no prescription drug treatment was required. No product quality complaint was involved. No other information or lot number available. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Information has been received from a physician concerning a 30 year old female who on 01Oct03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On the evening of 01Oct03 the pt developed erythema, swelling, and pain at the injection site. The pt was afebrile. The reporter indicated that the next day the pt was much improved. Unspecified medical attention was sought.  There was no product complaint involved. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: MMR
Symptoms: Oedema
Clinical narrative: Information has been received from a pharmacist concerning an approximately 68 year old male pt who on 04Oct2003 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine.  The pharmacist reported that three hours later the pt's arm was swollen from his upper arm to forearm. The pharmacist reported that he had referred the pt to a health care facility, but the pt declined. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Pain
Clinical narrative: Information has been received on 06Oct03 from a 64 year old female with a past medical history of several reactions to other medications who was vaccinated weeks ago with pneumococcal 23v polysaccharide vaccine, IM. There were no concomitant medications. Subsequently, the pt developed redness on her arm accompanied by pain. Additionally she reported feeling dizzy and lightheaded. The pt went to the ER but was not admitted. The pt reported as not recovered. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Insomnia, Oedema, Pain
Clinical narrative: Information has been received from a RN concerning a 87 year old female pt with no allergies and a history of high blood pressure who on 06Oct03 was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination on 06Oct03 included a IM dose in the right deltoid of influenza virus sAg 3v vaccine inactivated (FLUVIRIN). The pt did not recall if she had received vaccinations in the past. Concomitant therapy included amlodipine besylate (+) benazepril hydrochloride (Lotrel) and potassium supplementation. On 06OCt03 at approximately 20:00 (also reported as 16:00), a few hours post vaccination, the pt's left arm became sore. Later that night, the arm was warm to touch and swollen from just above the left antecubital space to about 6 inches below the shoulder. The pt had difficulty sleeping due to discomfort because the arm was achy. On 07Oct03, generalized warmth, redness and edema continued. On 07Oct03, the pt was seen in the medical office. The pt had edema of the left antecubital area to five inches below the shoulder with warmth and redness but there was no lumps on palpation, no knots or bruises. The pt was able to use her left hand and no numbness or tingling was noted. The pt stated that she felt better than the day before. Treatment was not required. On 08Oct03, the pt reported that she had taken acetaminophen (Tylenol) last pm and her arm was less swollen and less painful. Subsequently, the pt recovered. A product quality complaint was not involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23v polyvalent. Within 24 hours of vaccination, the pt developed urticaria. The pt was seen over a thee week pd. None of the reactions were severe but appeared to be a type three allergic reaction. Unspecified medical attention was sought and no treatment was required. There was no product quality complaint involved. It was noted that the pt recovered. The physician also mentioned other patients who had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Additional information is expected.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from MA and Physician concerning a retired 68 year old white female pt with a history of high blood pressure, degenerative joint disease, complaint of "having stomach trouble", and allergies to PCN and erythromycin who on 10/01/03 at 11:20am was vaccinated IM in the left deltoid muscle with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). The pt was also taking other medications. On 10/02/03 pt came in to the physician's office because her left arm was "red and heat swelling", (also reported by MA as the pt developed swelling, redness and pain at the injection site). The pt was told to take Benadryl and use a cold pack (also reported by MA as treated with antibiotics). Lab tests were not performed. A product quality complaint was not involved. The physician reported that the pt recovered on 10/05/03.  The reporter also mentioned two other pt's who had similar experiences post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N)(WAES # 0310USA01464 & 0310USA01465).  Two of the three pt's felt tired. It was noted that the lot number was the same for all 3 pt's.  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 additional information is expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a 79 year old white female with a medical history of an allergy to PCN, benign thyroid neoplasm, atrial fibrillation, hypertension NOS and chronic obstructive airway disease (also reported as illnesses at the time of vaccination) who on 10/01/03 in the PM was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot # 643784/0676M).  Concomitant therapy included Procardia, Lanoxin, Coumadin, Advair and albuterol (therapy unspecified). The pt was seen in the office on 10/03/03 in the AM with left arm red at injection site, swollen at injection, and painful. She was treated with Xenalog ointment and Zyrtec. It was unknown if the condition had resolved. Medical attention was sought. There was no product quality complaint involved.  Follow up information indicated that the pt recovered from the redness and swelling at the injection site on 10/07/03.  The reporter also mentioned other pt's who received pneumococcal 23v polysaccharide vaccine every 5 years for 3 to 4 doses (WAES # 0310USA01515).  No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a LPN concerning a male pt who was vaccinated with an IM dose of pneumococcal 23v polysaccharide vaccine 0.5mL/once. Subsequently, the pt had a localized reaction and developed redness, swelling and pain at the injection site. There were no diagnostic lab tests performed. There was no medical treatment required. It was noted that the nurse was not sure if this was the first or second dose of the vaccine.  Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the office indicated the reporter requested a "cease follow up". No further information is requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from MA concerning a 40 year old female pt who on 10/08/03 was vaccinated IM in the deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). The pt was also taking other medications. Approximately 5 hours post vaccination, the pt developed swelling, redness and pain at the injection site.  The pt was treated with antibiotics and Benadryl. Lab tests were not performed. A product quality complaint was not involved. The reporter also mentioned two other pt's who had similar experiences post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N)(WAES # 0310USA01317 & 0310USA01465).  Two of the three  pt's also felt tired.  It was noted that the lot number was the same for all 3 pt's.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 64 year old male patient who on 08OCT2003 was vaccinated IM in the deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. The pt was also taking other medications. Approximately five hours post vaccination, the pt developed swelling, redness and pain at the injection site. The pt was treated with abx and Benadryl. laboratory tests were not performed. A product quality complaint was not involved. Follow up information was received form the physician concerning a retired 63 year old white male pt with hypertension, polycystic kidney and a drug allergy to alloparinol who on 06OCT2003 at 11:30 was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. An adverse event onset time of 9:22 on 07OCT2003 was noted. The pt called and stated his arm was sore and hurting where the vaccine was given. The pt had an oral temperature of 99.8 it he am. The pt was not able to sleep the previous night. Per the physician, the pt was to take Tylenol and Benadryl 25mg three times a day and use a cold compact The pt was instructed to come in if it got worse. On 10OCT2003, the pt recovered. The medical assistant also mentioned two other patient who had similar experiences post vaccination with pneumococcal 23v polysaccharide vaccine. Two of the three pt also felt tired. It was noted that the lot number was the same for all three patients. 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 research and was released. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective, Infection, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with hypertension, reactive airway disease and hypercholesterolemia who on 01OCT2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included albuterol sulfate + Combivent, fish oil, fluticasone propionate + Advair, rofecoxib, hydrochlorothiazide, Losartan potassium and Prevacid. No hx of any rxn to any other vaccination. It was noted that the pt had sinus drainage at the time of vaccination. It was also noted that the vaccination was given to the pt at her cardiologist office. On 02OCT2003 (previously reported as 06OCT2003), the pt was seen in the office with an "injection site huge, size of fist, red, warm", a fever of 103F and was diagnosed with pneumonia. It was also noted that the pt was not hospitalized and was treated with Benadryl, 1 dose "thus far" of Rochepin IM, Augmentin, Tylenol and Ibuprofen. Medical attention was sought. There was no product quality complaint involved. It was noted that the pt recovered form the injection site reaction and the pneumonia. The reporter also mentioned two other pts who were vaccinated with pneumococcal 23v polysaccharide vaccine and experienced similar reactions. No further information is expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pneumonia, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with hypertension, reactive airway disease and hypercholesterolemia who on 01OCT2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included albuterol sulfate + Combivent, fish oil, fluticasone propionate + Advair, rofecoxib, hydrochlorothiazide, Losartan potassium and Prevacid. No hx of any rxn to any other vaccination. It was noted that the pt had sinus drainage at the time of vaccination. It was also noted that the vaccination was given to the pt at her cardiologist office. On 02OCT2003 (previously reported as 06OCT2003), the pt was seen in the office with an "injection site huge, size of fist, red, warm", a fever of 103F and was diagnosed with pneumonia. It was also noted that the pt was not hospitalized and was treated with Benadryl, 1 dose "thus far" of Rochepin IM, Augmentin, Tylenol and Ibuprofen. Medical attention was sought. There was no product quality complaint involved. It was noted that the pt recovered form the injection site reaction and the pneumonia. The reporter also mentioned two other pts who were vaccinated with pneumococcal 23v polysaccharide vaccine and experienced similar reactions. No further information is expected.
Age: 70.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning an approximately 70 year old male (reported as 70+) who was vaccinated with dose of pneumococcal 23v polysaccharide vaccine during a flu vaccination at his pharmacy. "It is thought that this dose was a revaccination". Concomitant therapy that day included as dose of influenza virus vaccine. The reporter indicated that the pt developed severe swelling and tenderness at the injection site. No other information or lot number was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from an RN concerning a 48 year old male with hypertension and gout who on 25AUG2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. There was no hx of any previous rxn to any other vaccination."  Concomitant medication "at the time of vaccination" included Allopurinol and hypertensive medications. On 25AUG2003, patient developed a "local injection site reaction large, fist size within 20 minutes of vaccination" also reported as "immediately developed an injection site reaction"). It was noted that the pt was not hospitalized, was treated with Benadryl and ice was applied. It was noted that he was observed for a half hour before being sent home. The reporter expressed concern about the particular lot of vaccine mentioned that the "second and third pt received lot #0873M". Medical attention was sought. There was no product quality complaint involved. It was noted that the pt recovered completely. The records of testing prior to release of this lot have been checked by AQ and found to be satisfactory. The reporter also mentioned two other pts who were vaccinated with pneumococcal 23v polysaccharide vaccine and experienced similar reactions. No further information is expected
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Skin discolouration, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a female patient "in her 70s" with a chronic renal insufficiency, hypertension, type II diabetes mellitus, hyperkalemia, and "ASVD" who on 05SEP2003 was vaccinated "from a multi-dose vial" with a second dose of pneumococcal 23v polysaccharide vaccine . A prior vaccination in 1998 with pneumococcal 23v polysaccharide vaccine was "without any type of reaction". Concomitant medication included Pletal, Plavix, Lasix, Zoloft, Glucatrol, Toprol XL, omeprazole, and aspirin. On 05SEP2003, "later that afternoon", the pt developed "swelling from site to elbow", which now appears as a green bruised area. It as noted that the pt was not hospitalized, was not seen in the office but was seen each day by home health (treatment not specified). The reporter expressed concern about the particular lot of vaccine and mentioned that the "second and third pt received lot 0873M". Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that the pt had recovered. 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 of the Center for Biologics Evaluation and research and was released. The reporter also mentioned two other pts who were vaccinated with pneumococcal 23v polysaccharide vaccine and experienced similar reactions. Additional information is expected.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a retired 70 year old white male pt with hypertension, diabetes and arthritis and has an allergy to penicillin, who on 08OCT2003 at 10:30 AM was vaccinated in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included Glucophage, Accupril, Flomax. The physician reported that he believes this was the pt's first dose of pneumococcal 23v polysaccharide vaccine. The physician reported that on 09OCT2003 at 10:00 AM the pt developed redness, a rash, and swelling of the left arm where the vaccine was administered. Also the left arm was reported to be painful and tender where the vaccine was administered. The pt was given a prescription for Benadryl 25mg, one tablet PO ever 12 hours as needed for treatment of the left arm. It was noted that the pt's condition had improved. The physician reported the pt's outcome as unknown. Medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a pt who  was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine intradermally and developed a "nasty site reaction". Unspecified medial attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. The physician reported that, three days after being vaccinated, the pt's arm became swollen, red, warm to the touch and tender. Unspecified medical attention was sought, but no prescription drug treatment was required and laboratory/diagnostic tests were performed. Subsequently, the pt's event abated. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Dyspnoea, Hypersensitivity, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 57 year old female who on 13OCT2003 was vaccinated in the RA with a second dose of pneumococcal 23v polysaccharide vaccine. The first dose was 5 to 6 years ago. On 13OCT2003 the pt experienced horrible pain and swelling at the injection site RA. On 14OCT2003 the pt was in the office with chills, but no fever. She had taken ibuprofen earlier in the day. She also had myalgias, arthralgias, (joints hurting) shortness of breath and overall not feeling well. It was reported that the physician was concerned that this may be a serum sickness/ allergic response. An unknown treatment was reported for the event and the pt had not recovered. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Myalgia, Serum sickness
Clinical narrative: Information has been received from a physician concerning a 57 year old female who on 13OCT2003 was vaccinated in the RA with a second dose of pneumococcal 23v polysaccharide vaccine. The first dose was 5 to 6 years ago. On 13OCT2003 the pt experienced horrible pain and swelling at the injection site RA. On 14OCT2003 the pt was in the office with chills, but no fever. She had taken ibuprofen earlier in the day. She also had myalgias, arthralgias, (joints hurting) shortness of breath and overall not feeling well. It was reported that the physician was concerned that this may be a serum sickness/ allergic response. An unknown treatment was reported for the event and the pt had not recovered. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Information has been received from a 49 year old female registered nurse with lupus, degenerative joint disease, gastroesophageal reflux disease and thalassemia who on 11MAR2003 at 1:00 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM in the left deltoid. There was no illness at the time of vaccination. On 11MAR2003 at 9:00 PM the patient developed acute swelling (to left upper arm: triple in size), severe pain, tenderness, unable to move/ rotate at shoulder, increased warmth and redness at the injection site. It was reported that "her arm became so swollen that she had trouble wearing her lab jacket. The arm looked so bad that she thought at first that she had cellulitis." It was reported that "narcotic pain medication was required" and Advil for swelling. Her signs and symptoms reportedly lasted 3-4 days and the pt recovered. It was noted that the pt had an adverse event following a prior unspecified vaccination at 49 years of age. There were no relevant diagnostic laboratory tests performed. There was no product quality complaint involved. No further information is expected.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a 49 year old female registered nurse with lupus, degenerative joint disease, gastroesophageal reflux disease and thalassemia who on 11MAR2003 at 1:00 PM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM in the left deltoid. There was no illness at the time of vaccination. On 11MAR2003 at 9:00 PM the patient developed acute swelling (to left upper arm: triple in size), severe pain, tenderness, unable to move/ rotate at shoulder, increased warmth and redness at the injection site. It was reported that "her arm became so swollen that she had trouble wearing her lab jacket. The arm looked so bad that she thought at first that she had cellulitis." It was reported that "narcotic pain medication was required" and Advil for swelling. Her signs and symptoms reportedly lasted 3-4 days and the pt recovered. It was noted that the pt had an adverse event following a prior unspecified vaccination at 49 years of age. There were no relevant diagnostic laboratory tests performed. There was no product quality complaint involved. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a female pt who on approximately 25SEP2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed an intense rash and hives at the injection site. Unspecified medical attention was sought and the pt was treated with Benadryl and the hives went away. The pharmacist did not know what dose number this was for the vaccine and could not provide any follow up information because he did not have access to pt information. No product quality complaint was involved. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a licensed Practical nurse concerning a white 85 year old female pt with no report pre-existing medical conditions, who on 16OCT2003 at 15:30 PM was vaccinated IM in the deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. The licensed practical nurse reported that the pt received 2 vaccines within 2 months of each other (also reported as may have received 2 doses of pneumococcal 23v polysaccharide vaccine within the last three months). It was noted that on 16OCT2003, the pt experienced a mild local reaction for 24 hours. The licensed practical nurse reported the pt recovered on 17OCT2003. It was noted that the pt did not have an illness at the time of vaccination. There were no laboratory or diagnostic tests performed and there was no product quality complaint reported. No treatment was required. No other information was available. Unspecified medical attention was sought. No further information is expected.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning an 83 year old female pt who on 14OCT2003 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine. The pt presented to the doctor's office on 16OCT2003, with a red, swollen and tender left arm. The pt's treatment was ice and elevate when needed. The nurse practitioner indicated that the pt called back to the office on 17OCT2003, to say she is a little better. No product quality complaint was involved. Additional information has been requested. It was also reported form the same source that another pt had a similar experience.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information ahs been received form an RN concerning a 65 year old female pt who on 30SEP2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 13OCT2003, the pt developed a rash on her neck and arms. Unspecified medial attention was sought, but the pt was not hospitalized. The pt treated her rash with calamine lotion. A product quality complaint was not involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received form a nurse practitioner concerning a retired 68 year old white female with no medial history and no allergies who on 06OCT2003 was vaccinated IM with a second (previously reported as a first) dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 06OCT2003, within hours of the vaccination, the pt developed a serious local rxn with injection site redness, swelling and pain. The pt developed cellulitis of her arm from her elbow to her shoulder and was seen for follow up twice. She was treated with NSAID's and local ice. Subsequently, the pt recovered. The duration was reported as 6 hours to 4 days. No product quality complaint was involved. It was also reported that three other female patient's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed injection site redness, swelling and pain.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a pt who, "within the past week", on approximately 9OCT2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. "The following day", on approximately 10OCT2003 the pt experienced cellulitis at the injection site and a fever. No further information was available. Unspecified medical attention was sought. 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 to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released. This is one of 3 pts reported by the same reporter. The two other pts experienced injection site cellulitis after vaccination with the same lot. One of the three pts was treated with an unknown abx. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Tongue oedema
Clinical narrative: Information has been received from a woman in a doctor's office concerning a female pt with no documented allergies or pertinent medical hx who on 17OCT2003 was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. The reporter indicated that the pt developed a localized rxn to the vaccination. The pt experienced redness and inflammation at the injection site. The pt also developed a swollen tongue. The pt was treated in the office with oxygen and monitoring. the pt recovered within 30 minutes and was then sent home. The pt has been fine since then. It was noted within 30 minutes and was then sent home. The pt has been fine since then. It was noted that prescription drug was not required. A product quality complaint was not involved. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released. The reporter also indicated that three other pts experienced redness and inflammation at the injection site after therapy with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a PA concerning a female who on 20OCT2003 was vaccinated IM in the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine. The PA reported that on 20OCT2003, the pt's left deltoid became swollen, red and very painful after being vaccinated. Unspecified medical attention was sought, but no lab/diagnostic tests were performed no prescription drugs were required to treat the pt's events. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on 21OCT2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. concomitant therapy included hydrocortisone, Buspar, Paxil and Stratera. Subsequently, the pt developed redness and soreness at the vaccination site. Unspecified medical attention was sought. It was reported that the pt was recovering with sequelae. There was no product quality complaint involved. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Insomnia, Oedema
Clinical narrative: Information has been received from a nurse concerning an 82 year old male pt who on 21Oct03 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. The nurse reported that the pt received a larger than 0.5ml dose of pneumococcal 23v polysaccharide vaccine. The exact amount is not known. The pt also developed an injection site reaction. The injection site became red, his arm swelled up, and he had difficulty sleeping. It was noted that his current state of health was unknown. Unspecified medical attention was sought. This report did not involved a product quality complaint. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 73 year old female who on 10/22/03 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # 647654/0865N). P1: just one year ago (Physician reported that he does not know why patient got second dose so close to the first"). Subsequently the patient developed significant local and systemic (fever and joint pain) reactions. The physician indicated that the patient was not hospitalized, but she was treated with ceftriaxone sodium. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information from the physician indicated that he was only covering the office for 48 hours and he believes both were significant local reactions which did not require further treatment. Upon internal review, the significant local and systemic (fever and joint pain) reactions were considered to be other important medical events (OMIC). The reporter also indicated that one other patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647654/0865N) and developed a similar reaction. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site warmth, Rash
Clinical narrative: Information has been received from an RN concerning 53 year old female who on 21OCT2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Within 24 hours of vaccination, the pt developed an injection site rxn that was hot to touch. On 23OCT2003, she developed a rash that extended from the shoulder to the injection site. Unspecified medical attention was sought A complete blood work up was done. It was reported that after two days the pt recovered. There was no product quality complaint involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No further information is expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 63 year old female pt with drug hypersensitivity to Bactrim, codeine, lisinopril, comeprazole, Zantac, ragweed allergy, mold allergy and rhinitis allergic who on 07OCT2003 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Concomitant medication included estradiol. Metro cream and famotidine. On 08OCT2003 the pt experienced injection site hives and hives up arm and onto shoulder; total of 13-15 cm. It was noted that there was no relevant diagnostic tests or laboratory data. It was also noted that the pt recovered. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site pain, Tenderness
Clinical narrative: Information has been received from an RN concerning an 30 year old female employee who on 23OCT2003 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. On 23OCT2003, 4 hours after vaccination, the pt called and asked if soreness, pain and a knot at site of injection was normal. The lot number was not known. Unspecified medical attention was sought, but no treatment was required for the event. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a male pt with arthritis who on approximately 23OCT2003 was vaccinated IM with a 0.5ml second dose of pneumococcal 23v polysaccharide vaccine. On 23OCT2003 the pt developed a swollen and sore are and a fever >102F. No diagnostic lab tests were performed. Unspecified medical attention was sought and no prescription drug was required. It was also reported that in 1998, 5 years ago the pt had received a first dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning an adult male pt, over the age of 65, who was vaccinated with pneumococcal 23v polysaccharide vaccine, "every year for unknown interval of time." The pt sought unspecified medical attention. There was no product complaint involved. Follow up information reported that the pt had injection site soreness. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning an adult female who on 10/22/03 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (lot # 647654/0865N). P1: six years ago. Subsequently the patient developed significant local and systemic (fever and joint pain) reactions. The physician indicated that the patient was not hospitalized, but she was treated with ceftriaxone sodium. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information from the physician indicated that he was only covering the office for 48 hours and he believes both were significant local reactions which did not require further treatment. Upon internal review, the significant local and systemic (fever and joint pains) reactions were considered to be other important medical events (OMIC). The reporter also indicated that one other patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647654/0865N) and developed a similar reaction. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a physician and  a registered nurse concerning a 61 year old retired Japanese female with a hx of bacterial endocarditis of the mitral valve who on 28OCT2003 at 0915 was vaccinated SC in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. The pt was S/P a mitral valve replacement at the time of vaccination. On 28OCT2003 at 1200, the pt developed "redness and swelling on the spot" where the vaccine was given and that the injection site felt hard and slightly sore. Unspecified medical attention was sought and it was noted that a prescription drug was required and the arm was packed with ice. On 29OCT2003 the pt recovered. There was no product quality complaint involved. The reporter also mentioned that two other pts experienced a similar rxn. No further information is expected.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient between the age of 68 and 78 years old who on 10/17/03 at a flu clinic was revaccinated in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N). Concomitant vaccine therapy included a normal adult dose of influenza virus vaccine. Subsequently, within hours of the vaccination, the patient developed redness, swelling and pain at the injection site in the arm where the pneumococcal 23v polysaccharide vaccine had been given. The patient was treated in the emergency room with IV ceftriaxone sodium. The patient was later seen by her own physician and has since recovered. It was also reported that the patient thought that it had been more than 5 years since she was vaccinated, however, it was reported that in November 2002 she had been vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. Upon internal review, redness, swelling, and pain at the injection site were determined to be other important medical events (OMIC). It was also reported that three other female patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646159/0287N) and also developed redness, swelling and pain at the injection site. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an LPN concerning a 73 year old female with no allergies or medical hx who at 3:00 PM on 27OCT2003 was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. In 1997, the pt received a first dose of dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt reported that she noticed soreness and pain around the injection site at 9:00pm on 27OCT2003. The next morning, the area was red, swollen and hot to the touch. The pt went back to the clinic where the reporter measured the area to be about six inches by six inches. The pt was instructed to apply ice packs and keep the arm elevated. It was also noted that no treatment was required. At the time of the report, the pt was noted to be "recovering with sequelae." A product quality complaint was not involved. Follow up information was received from a family nurse practitioner which indicated that the pt returned to the office on 28OCT2003 with a six inch area of edema which was red and hot to the touch at and below the injection site. The pt subsequently recovered. No further information is expected.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from an LPN concerning a 73 year old female with no allergies or medical hx who at 3:00 PM on 27OCT2003 was vaccinated IM in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. In 1997, the pt received a first dose of dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt reported that she noticed soreness and pain around the injection site at 9:00pm on 27OCT2003. The next morning, the area was red, swollen and hot to the touch. The pt went back to the clinic where the reporter measured the area to be about six inches by six inches. The pt was instructed to apply ice packs and keep the arm elevated. It was also noted that no treatment was required. At the time of the report, the pt was noted to be "recovering with sequelae." A product quality complaint was not involved. Follow up information was received from a family nurse practitioner which indicated that the pt returned to the office on 28OCT2003 with a six inch area of edema which was red and hot to the touch at and below the injection site. The pt subsequently recovered. No further information is expected.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a male pt over the age of 60 who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The medical assistant reported that the pt developed a "sever local reaction" within hours of receiving the pneumococcal 23v polysaccharide vaccine; and described the reaction as localized, not systemic, red, swollen and warm to touch. The pt had to be treated with Keflex. It was reported that the pt recovered within a couple of days. The assistant also stated, that this reaction has occurred over the past year intermittently, but no lot numbers could be obtained for the other rxns. Unspecified medical attention was sought. Additional information has been requested.