chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Initial and follow up information has been received from a RN concerning a female pt (age not reported) who was vaccinated on an unspecified date (previously reported as approx Nov04) (route not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot648139/0009P). Subsequently, on 28Sep04 the pt developed an injection site reaction, including erythema, swelling, induration, local heat and pain. It was reported that the pt was treated with topical steroids and that she recovered from the injection site pain, redness and swelling on an unspecified date. Follow-up information has been received from the nurse indicating that "they never heard any information about this lot, and they were never advisied as to what they should do. A lot check has been requested. The records of testing prior to release of this lot have been checked by quality Assurance and foundt to be satisfactory. The lot complies with the standards of the center for Biologics Evaluation and Research and released. In addition, a review of the quality control Quarantine/Rejection system revealed that there were no open Quarantines registered against this lot/fill. It was also reorted that one additional patient experienced an adverse event following administration of PNEUMOVAX 23 (lot 645139/0005F)There was no product quality complaint involved. Additional information is not expected. It was also reported that one additional pt experienced an adverse events following administration of pneumococcal 23v polysaccharide vaccine (lot648139/0009P) (WAES0411USA02810).
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old white male with hypothyroidism (stable), elevated cholesterol (stable), cardiovascular disease (stable), hypertension, allergies to penicillin and clopidogrel bisulfate, and a history of mild cerebrovascular accident (found on MRI) and mild myocardial infarction who on 11/24/04 was vaccinated in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). Concomitant therapy included levothyroxine sodium 0.1ml daily for hypothyroidism, dipyridamole 25mg daily for hyperlipidemia, simvastatin 40mg daily for cardiovascular disease and baby aspirin 81 mg daily. On 11/26/04 the patient returned to the clinic with a cellulitis of left arm from fingertips to shoulder. The patient was treated with moxifloxacin hydrochloride 400mg daily, warm compresses, and elevation. The patient received pneumococcal 23v polysaccharide vaccine in October 1999, and stated that he did not recall a reaction at that time. The reporter indicated that on 11/24/04 the patient's wife also received pneumococcal 23v polysaccharide vaccine from the same vial, and had a mild local reaction (WAES0412USA00799). The reporter stated that other patients also received pneumococcal 23v polysaccharide vaccine from the same vial, and did not experience adverse symptoms. On 12/1/04 the patient returned to the office, and although his condition was improving, therapy with moxifloxacin hydrochloride was continued for an additional 10 days. Follow up information indicated that the patient returned to the office on 11/24/04 with left arm pain and swelling. He was diagnosed with cellulitis in the left arm characterized by redness, induration, warmth, and swelling from fingertips to shoulder. It was reported that the patient was treated with moxifloxacin hydrochloride 400mg daily for 7 days, with elevation, and warm compress twice daily. The patient returned to the office on 12/1/04 and the moxifloxacin hydrochloride was continued for 4 more days. The swelling and redness resolved with some mild tenderness in the left elbow. It was reported that the patient recovered. No product quality complaint was involved. The reporter considered cellulitis of left arm from fingertips to shoulder to be an other important medical event (OMIC). Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old white male with hypothyroidism (stable), elevated cholesterol (stable), cardiovascular disease (stable), hypertension, allergies to penicillin and clopidogrel bisulfate, and a history of mild cerebrovascular accident (found on MRI) and mild myocardial infarction who on 11/24/04 was vaccinated in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). Concomitant therapy included levothyroxine sodium 0.1ml daily for hypothyroidism, dipyridamole 25mg daily for hyperlipidemia, simvastatin 40mg daily for cardiovascular disease and baby aspirin 81 mg daily. On 11/26/04 the patient returned to the clinic with a cellulitis of left arm from fingertips to shoulder. The patient was treated with moxifloxacin hydrochloride 400mg daily, warm compresses, and elevation. The patient received pneumococcal 23v polysaccharide vaccine in October 1999, and stated that he did not recall a reaction at that time. The reporter indicated that on 11/24/04 the patient's wife also received pneumococcal 23v polysaccharide vaccine from the same vial, and had a mild local reaction (WAES0412USA00799). The reporter stated that other patients also received pneumococcal 23v polysaccharide vaccine from the same vial, and did not experience adverse symptoms. On 12/1/04 the patient returned to the office, and although his condition was improving, therapy with moxifloxacin hydrochloride was continued for an additional 10 days. Follow up information indicated that the patient returned to the office on 11/24/04 with left arm pain and swelling. He was diagnosed with cellulitis in the left arm characterized by redness, induration, warmth, and swelling from fingertips to shoulder. It was reported that the patient was treated with moxifloxacin hydrochloride 400mg daily for 7 days, with elevation, and warm compress twice daily. The patient returned to the office on 12/1/04 and the moxifloxacin hydrochloride was continued for 4 more days. The swelling and redness resolved with some mild tenderness in the left elbow. It was reported that the patient recovered. No product quality complaint was involved. The reporter considered cellulitis of left arm from fingertips to shoulder to be an other important medical event (OMIC). Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a healthcare worker concerning an adult female pt who in Nov 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Approx two days post vaccination, the pt developed a cellulitis type reaction at injection site, warmth, redness and painful. It was also reported that the pt sought unspecified medical attention. There was no product quality complaint involved. It was also reported that 3 other adult female pt's experienced the same adverse event following administration of pneumococcal 23v polysaccharide vaccine (lot 649914/0578P) (WAES 0501USA00531, 0501USA00532, and 0501USA00533). Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site reaction, Myalgia
Clinical narrative: Information has been received from a physician concerning an 81 yr old female who in 1994 and on 07Dec04 was vaccinated with a first and 0.5 milliliter second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot number 647681/0986N). On the day of immunization, the pt experienced a local injection site reaction of swelling and redness accompanied by body aches, chills and a fever. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. The physician requested an investigation into the lot number. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also experienced adverse events (WAES0412USA03121).
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an 81 yr old female who in 1994 and on 07Dec04 was vaccinated with a first and 0.5 milliliter second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot number 647681/0986N). On the day of immunization, the pt experienced a local injection site reaction of swelling and redness accompanied by body aches, chills and a fever. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. The physician requested an investigation into the lot number. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also experienced adverse events (WAES0412USA03121).
Age: 54.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a woman from a physician's office concerning a 54 yr old white female with a history of cellulitis who on the afternoon of 29Sep04 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647359/0740N). Concomitant vaccine therapy given IM in the left deltoid included a yearly dose of influenza virus vaccine (unspecified) (lot U1401BA). On the morning of 30Sep04 the pt developed a temp 101.5 and swelling and erythema over the shot site. Medical attention was sought and the pt's actual temp in the office was 99.9. It was reported that the pt received a 3 pak to prevent the reoccurrence of cellulitis. No diagnostic lab tests were performed. On 01Oct04 the pt recovered. No further information is expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a RN concerning a 50 yr old white female with a pseudoephedrine hydrochloride (Sudafed), telithromycin (Ketek), and ampicillin allergy, asthma, hypertension, PCE, allergic rhinitis, fibrocystic disease and a TB converter, who on 05Nov04 at approx 13:30 was vaccinated into the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot number 649111/0287P). There was no illness at the time of vaccination. On the evening of 05Nov05, the pt's left arm was red, swollen, uncomfortable, and started getting sore and was raised and progressively got worse. The pt was diagnosed with cellulitis. Unspecified medical attention was sought. Two weeks later, the pt recovered without serious complications. It was noted that there was no adverse events following prior vaccinations. No product quality complaint was involved. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 50 yr old white female with a pseudoephedrine hydrochloride (Sudafed), telithromycin (Ketek), and ampicillin allergy, asthma, hypertension, PCE, allergic rhinitis, fibrocystic disease and a TB converter, who on 05Nov04 at approx 13:30 was vaccinated into the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot number 649111/0287P). There was no illness at the time of vaccination. On the evening of 05Nov05, the pt's left arm was red, swollen, uncomfortable, and started getting sore and was raised and progressively got worse. The pt was diagnosed with cellulitis. Unspecified medical attention was sought. Two weeks later, the pt recovered without serious complications. It was noted that there was no adverse events following prior vaccinations. No product quality complaint was involved. Additional information is not expected.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 60 yr old male who on 08Dec04 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647657/0947N). The pt reported that he had pneumococcal vaccine (unspecified) about ten years ago. On 09Dec04 the pt c/o swelling, redness, and pain at the injection site. The physician reported that the pt had a history of reacting to most vaccines or medicines he has tried. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a physician's assistant concerning a 64 yr old female who on 02Nov04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On 04Nov04 the pt was seen in the doctor's office and diagnosed with cellulitis at injection site and right deltoid. It was noted that the pt did not have a fever and she was treated with cephalexin (Keflex), warm compresses and ibuprofen (Advil). It was also reported that the pt recovered (date unk). There was no product quality complaint involved. It was also reported that one other pt experienced adverse effects following vaccination with pneumococcal 23v polysaccharide vaccine (lot 649988/0692P) (WAES0411USA03306). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning an adult female client with an unk previous vaccination history who was vaccinated (date not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently the client experienced a severe local site reaction and induration the size of a softball. It was reported that the client sought unspecified medical attention. No other information was available at the time of call. There was no product quality complaint involved. It was reported that two other adult females experienced local site reactions and induration after administration of pneumococcal 23v polysaccharide vaccine (lot unk) (WAES0502USA00004 and 0502USA00005). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 yr old female with an acetaminophen (Tylenol) allergy hives and latex allergy and a history of tachycardia, mastodynia and cholesterol, who on 09Dec04 was vaccinated into the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Concomitant therapy included clopidogrel bisulfate (Plavix), aspirin, pantoprazole sodium (protonix) and verapamil HC1 (Calan Sr). That same evening, the pt experienced redness and pain at the injection site of her right arm, and then pain down her arm. It was noted that the pt id not experience edema and was afebrile. On 13Dec04, it was reported that now the pt cannot lift or use her right arm. Treatment included warm compresses. It was also reported that the pt's past vaccination history was unk. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Initial and follow up information has been received from a RN concerning a 72 yr old female pt who on 07Dec04 was vaccinated in the arm (unspecified) with a dose of pneumococcal 23v polysaccharide vaccine (lot649732/0513P). It was reported that after vaccination, approx on 07Dec04, the pt subsequently developed bacterial cellulitis from pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). In follow up, the nurse reported that after the vaccination, the pt developed redness and swelling of the arm, and experienced extreme arm pain. The pt was diagnosed with bacterial cellulitis. The nurse reported that the pt's physician believed the reaction was from the vaccine. The pt was treated with an unnamed medication. In follow up, the nurse reported that the pt was treated with antibiotics (unspecified).  It was also reported that the pt received pneumococcal 23v polysaccharide vaccine five years ago. The physician expressed concern regarding the lot. The nurse reported that three other pt's experienced adverse events after administration of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) (WAES 0412USA01335 and 0412USA01726).  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Feeling hot, Hypokinesia, Injection site pain, Nausea
Clinical narrative: Information has been received from a health professional concerning an 87 yr old white male with a reported vitamin K allergy, history of coronary artery disease, four coronary artery bypass surgeries, type I diabetes mellitus, and an aneurysm who on the afternoon of 14Oct04 was vaccinated IM in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot 647636/0944N; also reported at 944N). Concomitant medication included warfarin sodium (Coumadin) (dose, duration, and indication not reported). Subsequently on 14Oct04, at 2000 hrs, the pt was seen in the ER at the hospital with left shoulder pain, nausea, chills, shaking and stated that "can't life my arm hurts so bad". The pt rated his pain a 10/10. It was reported that the pt's skin was pale, warm and dry, easy respiration. The pt was given diphenhydramine hydrochloride (Benadryl), 50mg PO to take at home and told to ice the shoulder. the following examination results were reported: 14Oct04: blood pressure measurement 148/88; vital sign measurement respiratory rate 18; total heartbeat count 76; temp measurement 96.2. It was also reported that on 18Oct04 the pt stated that his shoulder was still very sore. The pt was told to alternate ice 20 minutes and then next hour do heat for 20 minutes. It was also reported that at the time of vaccination the pt had actinic keratosis of the left cheek. The pt recovered on 19Oct04. No additional information is expected.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Pallor, Tremor
Clinical narrative: Information has been received from a health professional concerning an 87 yr old white male with a reported vitamin K allergy, history of coronary artery disease, four coronary artery bypass surgeries, type I diabetes mellitus, and an aneurysm who on the afternoon of 14Oct04 was vaccinated IM in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine (lot 647636/0944N; also reported at 944N). Concomitant medication included warfarin sodium (Coumadin) (dose, duration, and indication not reported). Subsequently on 14Oct04, at 2000 hrs, the pt was seen in the ER at the hospital with left shoulder pain, nausea, chills, shaking and stated that "can't life my arm hurts so bad". The pt rated his pain a 10/10. It was reported that the pt's skin was pale, warm and dry, easy respiration. The pt was given diphenhydramine hydrochloride (Benadryl), 50mg PO to take at home and told to ice the shoulder. the following examination results were reported: 14Oct04: blood pressure measurement 148/88; vital sign measurement respiratory rate 18; total heartbeat count 76; temp measurement 96.2. It was also reported that on 18Oct04 the pt stated that his shoulder was still very sore. The pt was told to alternate ice 20 minutes and then next hour do heat for 20 minutes. It was also reported that at the time of vaccination the pt had actinic keratosis of the left cheek. The pt recovered on 19Oct04. No additional information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Fatigue, Hypokinesia, Pain
Clinical narrative: Information has been received from a health professional concerning a 65 year old white female nurse with no known drug allergies and with a history of recent back surgery who on 11/02/2004 in the afternoon was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #647029/0514P).  At the time of vaccination, she complained of dyspnea and fatigue.  On 11/03/2004 in the morning, the patient stated that her arm was very sore, and she was unable to raise her arm above her head.  Her arm was red, swollen, and it hurt.  The patient stated that this lasted for 3 days.  The outcome was reported as recovered.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a health professional concerning a 65 year old white female nurse with no known drug allergies and with a history of recent back surgery who on 11/02/2004 in the afternoon was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #647029/0514P).  At the time of vaccination, she complained of dyspnea and fatigue.  On 11/03/2004 in the morning, the patient stated that her arm was very sore, and she was unable to raise her arm above her head.  Her arm was red, swollen, and it hurt.  The patient stated that this lasted for 3 days.  The outcome was reported as recovered.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a retired 82 year old white male with coronary artery disease, diabetes mellitus, arteriosclerotic heart disease, permanent pacemaker, aortic valve replacement and a history of coronary artery bypass who on the afternoon of 10/28/2004 was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0514P).  That same day the patient developed a sore, swollen arm that lasted for 3 days.  No further information is expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Shoulder pain
Clinical narrative: Information has been received from a health professional concerning a 77 year old white female with hyperlipideamia, morphine allergy, hypertension and asthma who on 10/14/2004 was vaccinated intramuscularly in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included HCTZ/triamterene (Maxzide) and an unspecified asthma inhaler.  During the evening of 10/14/2004, the patient presented to the emergency room complaining of left should pain.  It was noted that the left arm pain was a possible reaction to the vaccination received that day at the physician's office.  The patient stated, I can't lift my left arm, it feels like it is broken.  The patient's skin was pink, warm, and dry.  Her respirations were easy.  The patient was given diphenhydramine HCL 50 mg to take at home that night.  The patient was also to apply ice to her shoulder.  On 10/18/2004, the patient reported that her arm felt better.  Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Information has been received from a healthcare professional concerning an 80 year old retired white female with coronary artery disease, chronic congestive heart failure and no known allergies who on 09/07/2004 was vaccinated intramuscularly with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647636/0944N).  On 09/08/2004, the patient developed a red, swollen arm that hurt for 2 days.  It was reported that the patient recovered.  No additional information is expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 67 year old male with benign prostatic hyperplasia and black appearing stools who on 10/22/2004 in the afternoon was vaccinated intramuscularly in the left deltoid with a first dose of PNEUMOVAX 23 (lot # 647029/0514P).  On 10/23/2004 the patient indicated that the area was sore and tender to touch for one day after injection.  The outcome was reported as recovered.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Flushing, Pain, Pyrexia, Swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a retired white female with polymyalgia, hypertension and rheumatism who, during a routine physical exam, on 06/28/2004 at 0930, was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647271/1238N).  On the afternoon of 06/28/2004 the patient developed erythema, pain, and swelling of the left deltoid to the elbow, flushing, and a fever.  On 06/29/2004 the patient was afebrile.  No medical attention was sought.  No diagnostic lab tests were performed.  Approximately 3 to 5 days later the patient recovered.  It was also noted that the patient had had no adverse events following prior vaccinations.  No further information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old retired female patient (previously reported as 80 year old female non smoker, with emphysema (since Birth), COPD, hypercholesterolemia, dermatitis (2004), sleep apnoea (1980) and Bi pap, asthma (since birth), lipids high (2001), gastroesophageal reflux disease (2001), diverticulitis (2001), hypertension (2001), arthritis (2001), hypoglycemia (2001), astrocytoma and resection with left eye dominant (1947), strabismus secondary to astrocytoma (1947), unilateral carpal tunnel syndrome (1990), osteoporosis (1990), adenotonsillectomy (1944), cystocele and rectocele repair with hysterectomy (1997), right shoulder operation (1998), arthroscopy left knee (2001), foot operation (2000) and drug hypersensitivity and a history of stress test (2002) and allergies to dobutamine, Sumatriptan succinate (Imitrex), morphine, clarithromycin (Biaxin), ketorolac tromethamine (Toradol), Poly DM, and who is caffeine sensitive and had metal clips in her brain and there fore cannot have an MRI. On Dec 09 2004 the patient was vaccinated IM into the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P). It was reported that there was no illness at the time of vaccination. Several days later the patient developed redness and itching at the injection site. The patients symptoms are resolving, the patient sought unspecified medical attention. No further information was available. Follow up information has been received from a physician indication that the patient was seen in the emergency room on Dec 12 2004 for right upper arm swelling, redness and tenderness to the touch distal to the site of the shot which reportedly started on Dec 10 2004. Her blood pressure was 127/69, pulse 77 and temperature 97.7. Upon exam the patient was alert and in no distress. Her right upper arm had moderate erythema and no warmth. She ws diagnosed with cellulites of the right upper arm. She was discharged from the emergency room on cephalexin (Keflex and was told to follow up with her doctor in 2-3 days. Recovery status was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old retired female patient (previously reported as 80 year old female non smoker, with emphysema (since Birth), COPD, hypercholesterolemia, dermatitis (2004), sleep apnoea (1980) and Bi pap, asthma (since birth), lipids high (2001), gastroesophageal reflux disease (2001), diverticulitis (2001), hypertension (2001), arthritis (2001), hypoglycemia (2001), astrocytoma and resection with left eye dominant (1947), strabismus secondary to astrocytoma (1947), unilateral carpal tunnel syndrome (1990), osteoporosis (1990), adenotonsillectomy (1944), cystocele and rectocele repair with hysterectomy (1997), right shoulder operation (1998), arthroscopy left knee (2001), foot operation (2000) and drug hypersensitivity and a history of stress test (2002) and allergies to dobutamine, Sumatriptan succinate (Imitrex), morphine, clarithromycin (Biaxin), ketorolac tromethamine (Toradol), Poly DM, and who is caffeine sensitive and had metal clips in her brain and there fore cannot have an MRI. On Dec 09 2004 the patient was vaccinated IM into the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 650082/0691P). It was reported that there was no illness at the time of vaccination. Several days later the patient developed redness and itching at the injection site. The patients symptoms are resolving, the patient sought unspecified medical attention. No further information was available. Follow up information has been received from a physician indication that the patient was seen in the emergency room on Dec 12 2004 for right upper arm swelling, redness and tenderness to the touch distal to the site of the shot which reportedly started on Dec 10 2004. Her blood pressure was 127/69, pulse 77 and temperature 97.7. Upon exam the patient was alert and in no distress. Her right upper arm had moderate erythema and no warmth. She ws diagnosed with cellulites of the right upper arm. She was discharged from the emergency room on cephalexin (Keflex and was told to follow up with her doctor in 2-3 days. Recovery status was not reported. Additional information has been requested.
Age: 44.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Tremor
Clinical narrative: Initial and follow up information has been received from a physician via a wholesaler concerning a 44 year old patient (previously reported as 4 patients) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P).  Subsequently the patient developed the shakes and swelling around the injection site.  The patient did not undergo a work up or hospitalization.  No other information was available.  In follow up information it was reported that 4 other patients developed the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine.  Additional information has been requested.
Age: 39.0
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling, Tremor
Clinical narrative: Initial and follow up information has been received from a physician via a wholesaler concerning a 39 year old patient who was vaccinated with a  dose of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).  Subsequently the patient developed the shakes and swelling around the injection site.  The patient did not undergo a work up or hospitalization.  No other information was available.  In follow up information it was reported that 4 other patients developed the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).  Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Tremor
Clinical narrative: Initial and follow up information has been received from a physician via a wholesaler concerning a 73 yr old pt (previously reported as 4 pt's) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). Subsequently the pt developed the shakes and swelling around the injection site. The pt did not undergo a work up or hospitalization. No other information was available. In follow up information it was reported that 4 other pt's developed the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot649111/0287P) (WAES 0411USA02514, 0412USA01843, 0412USA01844, 0412USA01846). Additional information has been requested.
Age: 85.0
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Tremor
Clinical narrative: Initial and follow up information has been received from a physician via a wholesaler concerning an 85 yr old pt (previously reported as 4 pt's) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649111/0287P). Subsequently the pt developed the shakes and swelling around the injection site. The pt did not undergo a work up or hospitalization. No other information was available. In follow up information it was reported that 4 other pt's developed the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot 649111/0287P) (WAES 0411USA02514, 0412USA01843, 0412USA01845, 0412USA01844). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Information has been received from a 67 yr old female receptionist with acid reflux, sulfa allergy and a history of a splenectomy who in 2000 and on 24Nov04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot 649912/0529P). There was no illness at the time of vaccination. Concomitant therapy included levothyroxine Na (Synthroid), ethinyl estradiol (+) levonorgestrel (Preven), estrogens, conjugated (Premarin) and pantoprazole sodium (Protonix). That same day, the pt developed swelling, erythema and tenderness at the site of vaccination. On 26Nov04, the pt was evaluated by her doctor and was treated with ice, naproxen sodium (Naprelen), and acetaminophen (Tylenol) prn. On 02Dec04, a follow up call was made and revealed that the pt was doing much better and had recovered. No product quality complaint was involved. Further information is not expected.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Hypersensitivity, Malaise, Nausea, Pyrexia
Clinical narrative: Information has been received from a 50 yr old male pt with penicillin allergy and allergies to some antibiotics and no relevant medical history who at the end of Oct 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). Concomitant suspect therapy administered on the same day included an unspecified tuberculosis test (manf unk). Additional concomitant suspect therapy included "meklazine" (meclizine) (dates, dose and indication not reported). The consumer reported that he began to feel feverish, nauseated, drained of energy and weird on the inside right after pneumococcal 23v polysaccharide vaccine was administered. The consumer also stated that he believes that he may be having an allergic reaction with the polysaccharide content. No outcome was reported. There was no product quality complaint involved. Additional information is not expected.
Age: 76.0
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 76 yr old retired white female with carotid narrowing and no known drug allergies, who on 11Nov04 at 1:30PM, was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. On 12Nov04 at 10:00AM, the pt developed swelling, redness and pain at site.  The nurse reported that the pt was treated with diphenhydramine hydrochloride (Benadryl) and warm soaks and that the pt recovered on an unspecified date. It was also reported that the pt had chronic obstructive pulmonary disease, bronchitis at the time of vaccination. No additional information is expected.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a LPN concerning a 42 yr old disabled white female with a erythromycin allergy, who on 08Nov04 was vaccinated IM in the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot649988/0692). On 09Nov04 the pt developed localized swelling, warmth, and erythema, approx 3 inch diameter. The nurse reported that the pt had a viral upper respiratory infection at the time of vaccination. It was also reported that the pt was treated with diphenhydramine hydrochloride (Benadryl), 25-50mg PO every 8 hrs and cefditoren pivoxil (Spectracef), 200mg PO, twice a day for 5 days. The pt recovered on 12Nov04. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Initial and follow up information has been received from a physician concerning a pt (age and gender not reported) who was vaccinated (date not reported) with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). Subsequently the pt developed cellulitis at the injection site that was self limited and resolved in 5-7 days. It was also reported that the pt sought unspecified medical attention. There was no product quality complaint involved. Additional information is not expected.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a 40 yr old male with drug hypersensitivity who on 19Oct04 was vaccinated IM in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included fenofibrate (Tricor), warfarin sodium (Coumadin) and glyburide (+) metformin hydrochloride (Glucovance). On 19Oct04 the pt developed severe swelling and redness in his arm and left hand. The pt was seen at his doctor's office but no treatment was provided. Subsequently, the pt recovered from the severe swelling and redness in his arm and left hand. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 78 yr old retired white female with allergies to aspirin, codeine, raloxinfene hydrochloride (Evista), and cilostazol (Pletal) who on 01Sep04 at 11:40AM was vaccinated IM in the left arm with the second dose of pneumococcal 23v polysaccharide vaccine (lot 647359/0740N) (previous vaccination with pneumococcal 23v polysaccharide vaccine was in Oct92). The pt had no illness at the time of vaccination. Concomitant therapy included risedronate sodium (Actonel), diltiazem hydrochloride (Cardizem CD), famotidine, aspirin and tolterodine tartrate) (Detrol LA). On 01Sep04 at 3:00PM the pt experienced throbbing sensation/pain, swelling, redness and fever in the arm. Unspecified medical treatment was sought. The pt subsequently recovered from the throbbing sensation/pain, swelling, redness and fever in the arm (recovery date unk). Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received concerning a 73 yr old female nurse with sulfa allergy who on 03Nov04 was vaccinated IM into the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). On 03Nov04 the pt experienced swelling, redness and pain at left deltoid injection site. The pt was putting ice on the deltoid. Subsequently, the pt recovered. Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 74 yr old male oncology pt with no known drug allergies, who on 20Dec04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On 22Dec04 the pt experienced pain, redness and swelling from the injection site to the elbow. The pt was treated with antibiotics. The pt's outcome was unk. Unspecified medical attention was sought. No product quality complaint was involved. The nurse would like a lot check for Lot 0692P. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot649988/0692P) and experienced adverse events (WAES0501USA0060 and 0501USA00661). The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Contusion, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 70-80 year old female who on approx 20Dec04 last week was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included warfarin sodium (Coumadin). On approx 21Dec04, the day after vaccination, the pt experienced redness from her elbow to her shoulder. On approx 22Dec04 two days after vaccination, the pt had a little bruising on her arm. Unspecified medical attention was sought. She was treated with cephalexin (Keflex). The pt's outcome was unk. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and had adverse events (WAES0412USA01731 and 0501USA01732). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Contusion, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 70-80 year old female who on approx 20Dec04 last week was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included warfarin sodium (Coumadin). On approx 21Dec04, the day after vaccination, the pt experienced redness from her elbow to her shoulder. On approx 22Dec04 two days after vaccination, the pt had a little bruising on her arm. Unspecified medical attention was sought. She was treated with cephalexin (Keflex). The pt's outcome was unk. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and had adverse events (WAES0412USA01731 and 0501USA01732). Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Contusion, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 72 year old white retired female with an allergy to sulfa. On Dec 20 2004 the patient was vaccinated in her right deltoid with pneumococcal 23v polysaccharide vaccine (lot 649988/0692). On an unspecified date the patient developed right whole upper arm shoulder to elbow redness and right whole upper arm shoulder to elbow bruising. At the time of vaccination the patient had left zygoma swelling and her left eye teared alot. it was reported the patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Contusion, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 72 year old white retired female with an allergy to sulfa. On Dec 20 2004 the patient was vaccinated in her right deltoid with pneumococcal 23v polysaccharide vaccine (lot 649988/0692). On an unspecified date the patient developed right whole upper arm shoulder to elbow redness and right whole upper arm shoulder to elbow bruising. At the time of vaccination the patient had left zygoma swelling and her left eye teared alot. it was reported the patient sought unspecified medical attention. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Information has been received from a health professional concerning a female pt with no medical history or allergies, who was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). There was no concomitant medication. Subsequently, the pt experienced pain and tenderness, and developed red streaks around her arm near the injection site. Within three to four days, the symptoms abated and the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected. It was also reported that two additional pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (WAES0501USA00539, 0502USA00116) and experienced adverse events.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, FLUX, PPV
Symptoms: Medication error, Pyrexia
Clinical narrative: Information has been received from a physician regarding his 7 month old healthy daughter who on 26Dec04 he inadvertently vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot unk). Concomitant therapy on 26Dec04 included a dose of influenza virus vaccine (unspecified) and a dose of diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (Pediarix). The report indicated that medical attention was sought. On 26Dec04 the pt experienced a mild fever. It was reported that the physician transported the pneumococcal 23v polysaccharide vaccine overseas (country unk). At the time of the report the outcome is unk. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Information has been received from a RN concerning an 80 yr old male who on 21Dec04 at 11:55 was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). That evening, the pt developed a 3x5 inch welt. On 22Dec04, the welt increased to 6x10 inches down over his elbow, and was scarlet colored. It was also reported that there was swelling and the area was hot and very sore to the touch. On 23Dec04, the pt had an office visit with his provider and immunization information was requested. On 27Dec04, the swelling and redness decreased, the area was slightly warmer, and pruritus was noted. Unspecified medical attention was sought. It was reported that the pt fully recovered without complications. No product quality complaint was involved. Further information is not expected.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a RN concerning an 80 yr old male who on 21Dec04 at 11:55 was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). That evening, the pt developed a 3x5 inch welt. On 22Dec04, the welt increased to 6x10 inches down over his elbow, and was scarlet colored. It was also reported that there was swelling and the area was hot and very sore to the touch. On 23Dec04, the pt had an office visit with his provider and immunization information was requested. On 27Dec04, the swelling and redness decreased, the area was slightly warmer, and pruritus was noted. Unspecified medical attention was sought. It was reported that the pt fully recovered without complications. No product quality complaint was involved. Further information is not expected.