chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse and a health professional concerning a 70 yr old white retired male with a penicillin allergy, IV dye allergy, COPD, recurrent bronchitis, osteoporosis and a history of smoking (ceased in 1980's) who on 07Feb06 was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). Concomitant therapy included doxycycline. Since the pt was vaccinated he has been achy in his arm. He had developed some redness and swelling as well. He also developed a headache, was not sleeping well and had been feverish with no documented temps. The pt was diagnosed with cellulitis and was treated with cephalexin (Keflex) 500mg, four times daily for seven days. The pt was advised to rest that arm and keep it elevated as much as possible. It was noted that if the pt's conditions worsened he should follow up with his primary care physician and the pt will follow up in prompt care as needed. It was also noted on 09Feb06, the pt called and complained that his right arm was red and sore and the redness to the right arm was spreading downward. At the time of this report, the pt fully recovered. No product quality complaint was involved. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Fatigue, Feeling cold, Tenderness
Clinical narrative: Information has been received from a physician concerning his 79 yr old white wife with chronic obstructive pulmonary disease, asthma, osteoporosis and hypothyroidism who on 14Feb06 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, IM. Concomitant therapy included numerous medications. On 14Feb06 the pt experienced feeling of being cold and oral temp as low as 95.5F and local tenderness at injection site. The pt also experienced extreme fatigue which lasted about 2 weeks. The pt received a first dose of pneumococcal 23v polysaccharide vaccine 6 yrs ago. Unspecified medical attention was sought. Follow up reported that the pt experienced extreme fatigue for two weeks, then resolved (during Feb), asymptomatically. It was also reported that the pt experienced profound weakness, fatigue for 2 wks, resolved since. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a female physician via a company rep concerning the physician, about 35 yrs old, with asthma and unk drug reactions/allergies, who on 13Feb06 was vaccinated IM into the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). Concomitant therapy included montelukast sodium (Singulair). The physician reported that on 13Feb06 she experienced pain at the injection site, and developed swelling at the injection site and could not move her arm for 1 full day. Unspecified medical attention was sought. Subsequently, on an unk date she recovered. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Information has been received from a nurse, via a company rep, concerning a 10 yr old male with foetal alcohol syndrome, who in Dec 2005, was vaccinated IM in the thigh with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). In Dec 2005, the nurse reported after the vaccination the pt did not feel well, he developed a 104F fever and laid in bed for a few days. He did not have any injection site reactions. This was his first dose of pneumococcal 23v polysaccharide vaccine. No medical attention was sought. It was reported that his sister was vaccinated from the same vial and did not have any reaction. Subsequently, on an unspecified date the pt recovered. No product quality complaint was involved. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 62 yr old white female registered nurse with a codeine allergy, bronchitis, and no medical history, who on 17Feb06 was vaccinated IM into the left deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). There was no concomitant medication. On 17Feb06, the pt developed a fever of 103F. On 20Feb06, the pt developed swelling, redness and local heat at the injection site and a knot. Unspecified medical attention was sought. Subsequently, the pt recovered from swelling, redness and local heat at the injection site and a knot. The pt was recovering from a fever. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse via a company rep regarding the female nurse who on an unspecified date received the pneumococcal 23v polysaccharide vaccine (lot not provided). Subsequently, she experienced a 4 day localized erythema and painful swelling. The reporter felt that the nurse's experience was related to vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult (age and gender unk) pt who within the last six months, on an unk date, was vaccinated (route unk) with a 0.5ml dose pneumococcal 23v polysaccharide vaccine (lot650329/0747P). Subsequently, within the last six months on an unspecified date, the pt developed an injection site reaction which included pain, redness, swelling and local heat. Unspecified medical attention was sought. Subsequently, on an unspecified date the pt recovered. No product quality complaint was involved. A lot check has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult (age and gender unk) pt who within the last six months, on an unk date was vaccinated (route unk) with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650329/0747P). Subsequently, within the last six months on an unspecified date, the pt developed an injection site reaction which included pain, redness, swelling and local heat. Unspecified medical attention was sought. Subsequently, on an unspecified date the pt recovered. No product quality complaint was involved. A lot check has been requested. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Nausea, Vomiting
Clinical narrative: Initial and follow up information has been received from a physician concerning a 43 yr old black male with diabetes who on 09Dec05 at approx 2PM was vaccinated into site 6 with a dose of pneumococcal 23v polysaccharide vaccine (lot651329/1047P). On the evening of 09Dec05, the pt developed nausea and vomiting. On 12Dec05 the pt developed left arm swelling and erythema. On 13Dec05, the pt was seen by the physician and left arm redness was still present. On an unspecified date, the pt recovered. No further information is available.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning an 83 yr old female with cardiac failure congestive, angina pectoris, hypertension, gout, wheezing, osteoarthritis, hypercholesterolemia, gastroesophageal reflux disease, hearing loss, vision loss, penicillin allergy, sulfonamide allergy, seafood allergy, iodine allergy and allergies to epinephrine, allumiu; diphenhydramine HC1 (Benadryl), acetaminophen (Tylenol), cortisone, hydroxyzine HC1 (Atarax), prednisone and sedicane who on 21Feb05 was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). Concomitant therapy included albuterol, levothyroxine Na (Synthroid), olmesartan medoxomil (Benicar), metoprolol, folic acid, colchicine, aspirin, furosemide and calcitriol. Within 24 hrs of the injection, the pt developed hives at the injection site and up her neck and face. The pt called the office regarding her experience and received unspecified medical attention. At the time of this report, the pt's hives persisted. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site pain, Injection site swelling, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a RN concerning a 78 yr old female with a history of "same type of reaction after being vaccination with the flu vaccine" who on 23Feb06 was vaccinated IM into the right deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651524/0605R). The nurse reported that the next day, on 24Feb06, the pt presented to the office with right arm pain, right arm warmth and swelling at the injection site. The pt was treated with warm compress and oral diphenhydramine hydrochloride (Benadryl) as needed. It was also reported that the pt "has no allergy to eggs". The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a 78 yr old female with some food and environmental allergies and no medication allergies, who on 24Feb06 was vaccinated IM into the upper outer quadrant of right thigh with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). On 27Feb06 the pt presented to the office with right thigh pain, right thigh warmth and swelling at the injection site. The pt was treated with warm compress and oral diphenhydramine hydrochloride (Benadryl) as needed. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot#650453/0791P).  Subsequently the patient had a reaction to the pneumococcal 23v polysaccharide vaccine.  At the time of the report, it was unknown, if the patient recovered.  The registered nurse reported that another patient received pneumococcal 23v polysaccharide with the same (Lot#650453/0791P) and had a reaction.  A lot check of concern has been requested.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantines/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medial assistant concerning a 67 year old female, with unknown medical history and unknown drug reaction/allergies, who on 03-MAR-2006 was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#651330/1048P).  Later that same day, on 03-MAR-2006, the patient developed reddened area of 10 centimeters by 14.5 centimeters, swelling, and local heat at the injection site.  Unspecified medical attention was sought.  The patient's present statue was reported as recovering.  no product quality complaint was involved.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site inflammation, Swelling
Clinical narrative: Initial and follow up information has been received from a licensed visiting nurse concerning an 80 year old, white, retired female whose reported weight was 140 pounds with allergy to penicillin, clarithromycin (BIAXIN) and rofecoxib (MSD) with osteoarthritis, osteoporosis, hypertension, hyperthyroidism, high cholesterol and hyperglycemia, who on 22-SEP-2005 was vaccinated in the left arm, intramuscularly (previously reported subcutaneously) with her third dose of pneumococcal 23v polysaccharide vaccine (Lot#649977/0706P).  It was reported that the patient had no illness at the time of vaccination.  It was reported the vaccination was routine due to the patient's age.  On 23-SEP-2005, it was reported the patient presented with a red, swollen arm (deltoid region), the area the size of an orange or grapefruit and previously reported that, the patient developed a local reaction arm became very red and inflamed, area was about 4 inches by 5 one half inches.  The patient was treated with heat and ibuprofen (ADVIL), the patient sought unspecified medical attention.  It was reported that the patient was previously vaccinated with pneumococcal 23v polysaccharide vaccine in 1984 and 1997.  At the time of the report, the patient had recovered.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 73 year old white female with Penicillin allergy and sulfonamide allergy and a history of high cholesterol who on 08-SEP-2005 was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (Lot number 649977/0706P) (first dose received October 1997).  Concomitant therapy included pravastatin Na (PRAVACHOL) and lisinopril (ZESTRIL).  In September 2005, "within a couple of days of vaccination", the patient experienced local swelling and redness (severe) from her shoulder to elbow.  Unspecified medical attention was sought.  Subsequently, on an unspecified date, the patient recovered from the local swelling and redness (treatment unknown).  No further information is expected.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Information has been received from a physician, via a company representative, and follow up information has been received from a licensed practical nurse concerning a 74 year old white female, with unknown drug reaction/allergies, who on 28-FEB-2006 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot#649697/1038P).  It was reported that the patient was vaccinated in approximately 1998 with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included therapies (list not given).  On 28-FEB-2006, at 8:00 pm, the patient developed redness, warm skin, pain, and swelling from shoulder to elbow in injected arm, and also pain.  Ice was applied and ibuprofen (ADVIL) was taken.  Subsequently, approximately 36 hours post vaccination, the patients symptoms resolved.  There was no illness at the time of vaccination.  No product quality complaint was involved.  Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a 38 year old female, with pulmonary hypertension secondary to ASD, Atherosclerotic heart disease, and unknown drug reaction/allergies, who on 2/28/06 was vaccianted route unknown with a second dose of Pneumococcal 23v polysaccharide vaccine lot unknown. Concomitant therapy included epoprostenol sodium Flolan. The nurse reported that on 10/14/04 the pt was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine. The nurse reported that the pt developed a severe topical reaction after the second vaccination with Pneumococcal 23v polysaccharide vaccine. The follow up information received from the nurse confirmed that on the morning of 3/2/06 the pts arm became very red, painful and swollen. Subsequently on an unspecified date, the pt recovered. The nurse noted that the pt had other health issues and may have been immunocompromised at that time. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Myalgia, Pyrexia, Skin discolouration
Clinical narrative: Information has been received from a 65 year old female with several drug reaction/allergies and unknown pertinent medical history, who on 3/7/06 was vaccinated SC with a dose of Pneumococcal 23v polysaccharide vaccine (lot 651859/0877R). Concomitant therapy included levothyroxine Synthroid. On 3/7/06, two hours after shot, the pt developed muscle pain, joint pain, slight fever and a white strip going down her arm from the injection site. the pts muscle pain and joint pt and slight fever and a white strip going down her arm from the injection site persisted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed cellulitis. The pts outcome was unknown. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 37 year old female with no drug allergies who on 3/10/06 was vaccinated IM with a 0.5ml, first dose of Pneumococcal 23v polysaccharide vaccine (651320/1009P). Concomitant therapy included bupropion HCL Wellbutrin, fluticasone propionate + salmeterol xinafoate Advair and albuterol sulfate Proventil. On 3/10/06 the pt arm became swollen, red and warm to touch. The pt also experienced flu like symptoms and vomiting. The pt sought unspecified medical attention. At the time of the report, the pt was recovering. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 79 year old female, with allergic reaction to antibiotics and codeine, who on 3/13/06 was vaccinated IM in the left arm with a second dose of 0.5ml of Pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). Concomitant therapy included estradiol (Climara), patch. On 3/13/06 the pts left arm became swollen, red, warm to touch. She also developed flu like symptoms and felt nauseous. The pts present status was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Diabetes mellitus, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 71 year old male with non insulin dependent diabetes and elevated cholesterol who on 3/13/06 was vaccinated IM, into the left arm, with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). Concomitant therapy included Lovastatin. On 3/13/06, 7 hours after the vaccination, the pt developed severe nausea, vomiting, chills and redness, swelling and warmth at the injection site. Unspecified medical attention was sought. At the time of the report, the pt was recovering. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 71 year old male with non insulin dependent diabetes and elevated cholesterol who on 3/13/06 was vaccinated IM, into the left arm, with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). Concomitant therapy included Lovastatin. On 3/13/06, 7 hours after the vaccination, the pt developed severe nausea, vomiting, chills and redness, swelling and warmth at the injection site. Unspecified medical attention was sought. At the time of the report, the pt was recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning an adult pt who in approx Feb 2006 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). Subsequently the pt developed an injection site reaction to included redness, swelling and pain at the injection site. Unspecified medical attention was sought. At the time of the report the pt was recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a pt who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). Subsequently, the pt experienced pain and swelling in the injection site arm. The pts outcome was unknown. The nurse requested a lot check be performed on this lot since she was concerned about using it again.  The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards of and was released. In addition a review of the Quality control quarantine rejection system revealed that there were no open quarantines registered against this lot/fill.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site reaction, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old female nurse with asthma and multiple environmental allergies including yeast, mold grass, trees, and weeds who on 3/17/06 was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 651147/1117R). Concomitant therapy included unspecified allergy injection on 3/17/06. Later that day on 3/17/06, the pt developed cellulitis. The cellulitis affected just the upper arm where the injection was given with fever, chills and aches. The pt was treated with unspecified antibiotics. The pt subsequently recovered after finishing antibiotic treatment. The pt also developed injection site cellulitis and pain post vaccination with hepatitis B vaccine WAES0605USA01650. No additional information is expected.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Initial and follow up information has been received from a physician and a registered nurse concerning a 75 year old female who on 10/12/05 was vaccinated IM in the left arm with a dose of Pneumococcal 23v polysaccharide vaccine. On 10/13/2005 the pt developed arm swelling around the injection site. The nurse indicated in follow up that the pts daughter reported her mother developed a red and swollen left upper arm from her shoulder to elbow and that it was painful. The pt was treated with Tylenol and cold compresses. Subsequently, the pt recovered on approx 10/20/05. It was also reported that the pt may have been one previous vaccination with Pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Oedema
Clinical narrative: Information has been received from a physician assistant, via a company representative, concerning a female age unknown, with asthma, who in 1985 was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown). Concomitant therapies included unspecified medications therapy unspecified, for asthma. About 20 years ago, in 1985, the pt developed swelling from elbow to neck after being vaccinated. Symptoms were treated with cold compresses. After a week symptoms resolved. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning his mother, a 65 year old female, with rheumatoid arthritis, hypothyroidism and hypertension and the thyroid removed in the past, who in early Feb 2006, was vaccinated IM with the first dose 0.5 Pneumococcal 23v polysaccharide vaccine (lot unknown). Concomitant therapy included etobolac Lodine, Quinapril HCL Accupril and levothyroxine NA Synthroid. Within a day of vaccination, the pt developed a large, hard, painful, softball sized area of erythema with itching. The doctor was notified and unspecified medical attention was sought. The pt was treated with warm compresses and ibuprofen ore acetaminophen. At the time of the report the area was the size of a ping pong ball. The pt presented status was reported as improving but not resolved. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated last week with Pneumococcal 23v polysaccharide vaccine (lot 650457/0973P). Subsequently, the pt developed arm redness. Unspecified medical attention was sought. No further information is available.
Age: 52.0
Sex: F
Vaccine: HEPA, IPV, PPV, TYP
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physicians assistant concerning a 52 year old female with no medical history and no allergies who on 3/23/06 was vaccianted with a dose of Pneumococcal 23v polysaccharide vaccine 0.5ml (lot 651524/0605R), IM. Concomitant therapy included poliovirus vaccine, hepatitis A vaccine inactive Havrix and typhoid vaccine unspecified. On 3/24/06 the pt experienced redness at the injection site and swelling at the injection site. The pt was seen in the ER of 3/25/06. The pt was treated with antibiotics for possible cellulitis VS immunologic reaction. The pt was to have a follow appointment with an infectious disease specialist. It was reported to be unclear if this was her first vaccination with Pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a female who on an unspecified date was vaccinated with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine. Approx 2 to 3 months ago in approx Nov 2005, the pt developed hives at the injection site of Pneumococcal 23v polysaccharide vaccine. The pt was treated with diphenhydramine HCL, and the pt recovered in a week. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 66 year old female with history of arthritis, hypertension, and uterine fibroids who on 3/23/06 was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine 0.5ml lot 650644/0004F, IM. Within a few hours, the pt experienced swelling and bumps at the injection site. The pt experienced a swollen deltoid to the elbow, redness and heat to touch. It was also sore. CBC was done, no results reported. The pt was prescribed cephalexin Keflex and something for the itching. At the time of the report the pts status was unknown.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Information has been received from a health professional concerning a 66 year old female with history of arthritis, hypertension, and uterine fibroids who on 3/23/06 was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine 0.5ml lot 650644/0004F, IM. Within a few hours, the pt experienced swelling and bumps at the injection site. The pt experienced a swollen deltoid to the elbow, redness and heat to touch. It was also sore. CBC was done, no results reported. The pt was prescribed cephalexin Keflex and something for the itching. At the time of the report the pts status was unknown.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner in her 30's with no medical history who in Dec 2001 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Subsequently, in first 24 hours, at 3:00pm she experienced severe arm pain, low grade fever 99.0 and pain in right arm for three days. The pt made a full recovery. It was also reported that the pt was previously vaccinated with Pneumococcal 23v polysaccharide vaccine on an unspecified date. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a healthcare worker and a licensed practical nurse, concerning a 51 year old female who on 3/23/06 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650644/0004F). The healthcare worker reported that within a few hours, on 3/23/06, the pt developed swelling and bumps at the injections site. The nurse also reported that the pt developed a swollen deltoid to the elbow, redness, heat to touch. It was also reported that the pt experienced sore and had malaise. Unspecified medical attention was sought. No treatment prescribed. It was noted that the pt was not hospitalized and the experienced were not life threatening. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a healthcare worker and a licensed practical nurse, concerning a 51 year old female who on 3/23/06 was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650644/0004F). The healthcare worker reported that within a few hours, on 3/23/06, the pt developed swelling and bumps at the injections site. The nurse also reported that the pt developed a swollen deltoid to the elbow, redness, heat to touch. It was also reported that the pt experienced sore and had malaise. Unspecified medical attention was sought. No treatment prescribed. It was noted that the pt was not hospitalized and the experienced were not life threatening. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site warmth, Nausea, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 67 year old female who on 3/25/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included colesvelam hydrochloride Welchol and ezetimibe Zetia. Later that day on 3/25/06 the pt experienced high fever, nausea, and arm was hot and swollen. The pt was advised to use compresses. The pt was to be seen at the office sometime 3/29/06 or 3/30/2006. There were no relevant laboratory or diagnostic tests. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Information has been received from a physician, via a company representative, and a nurse concerning an 80 year old female, with unknown medical history and unknown drug reactions/allergies, who on 11/15/05 was vaccinated route unknown with a dose of Pneumococcal 23v polysaccharide vaccine (651523/0604R). The next day on 11/16/05, the pt developed swelling, redness, and tenderness to her right upper arm. The nurse confirmed that the pt developed cellulitis. The pt was treated with three doses of cephalexin Keflex and subsequently recovered on an unspecified date. No product quality complaint was involved. The nurse could not provide additional details, However she reported that the office would keep track of additional reactions involving Pneumococcal 23v polysaccharide vaccine. The doctor retrained staff on how to store and administer the vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated "last week" with pneumococcal 23v polysaccharide vaccine (lot650457/0973P). Subsequently, the pt developed "what appeared to be cellulitis". Unspecified medical attention was sought. No further information is available.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 73 yr old white female with allergies to ibuprofen (Motrin), celecoxib (Celebrex), levofloxacin (Levaquin), and diflunisal (Dolobid) who in the morning on 30Jan06 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 651320/1008P). At 9:20AM on 31Jan06 the pt experienced sore arm and hard to move arm. Treatment of ice and acetaminophen (Tylenol) was prescribed. There was no illness at the time of vaccination. Outcome not reported. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician via a company rep, and a nurse concerning a female pt in her early 50's, with unk medical history and unk drug reactions/allergies, who on approx 15Nov05 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (651523/0604R). On approx 16Nov05 (in the same week) the pt developed cellulitis involving the whole arm. There was no medication given. The pt was instructed to apply hot or warm compresses. Outcome unk. The nurse could not provide additional details. However, she reported that the office would keep track of additional reactions involving pneumococcal 23v polysaccharide vaccine. The doctor also re-trained staff on how to store and administer the vaccine. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician, via a company rep, and a nurse concerning a male pt in his 40's to 50's, with unk medical history and unk drug reactions/allergies, who on approx 15Nov05 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (651523/0604R). On approx 16Nov05 (in the same week), the pt developed cellulitis. Information on the outcome was not known. The nurse could not provide additional details. However, she reported that the office would keep track of additional reactions involving pneumococcal 23v polysaccharide vaccine. The doctor also re-trained staff on how to store and administer the vaccine. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Blister, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 63 yr old female who on 13Feb06 was vaccinated pneumococcal 23v polysaccharide vaccine (lot650330/0748P). Concomitant therapy that day included Hib conj vaccine (manf unk). Subsequently, the pt experienced myalgia and pain, swelling and tenderness at the pneumococcal 23v polysaccharide vaccine site of injection. The upper arm became swollen, red, purplish. There were also clear vesicles. The joint area became swollen. After the pt developed the symptoms she called the physician. The pt was not seen by the physician. The symptoms were considered to be nonserious. The pt was prescribed prednisone and was told to use cold compress. A low grade fever was also reported. The pt recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Skin discolouration, Tenderness
Clinical narrative: Information has been received from a physician concerning a 63 yr old female who on 13Feb06 was vaccinated pneumococcal 23v polysaccharide vaccine (lot650330/0748P). Concomitant therapy that day included Hib conj vaccine (manf unk). Subsequently, the pt experienced myalgia and pain, swelling and tenderness at the pneumococcal 23v polysaccharide vaccine site of injection. The upper arm became swollen, red, purplish. There were also clear vesicles. The joint area became swollen. After the pt developed the symptoms she called the physician. The pt was not seen by the physician. The symptoms were considered to be nonserious. The pt was prescribed prednisone and was told to use cold compress. A low grade fever was also reported. The pt recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult pt with diabetes who in approx Feb 2006 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot650302/1039P). Subsequently, the pt developed an injection site reaction to include redness, swelling and pain at the injection site. Unspecified medical attention was sought. At the time of the report, the pt was recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a RN concerning an adult pt who in approx Feb 2006 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650302/1039P). Subsequently the pt developed an injection site reactino to include redness, swelling and pain at the injection site. Unspecified medical attention was sought. At the time of the report, the pt was recovering. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a female (age/unk), with unk medical history and unk drug reactions/allergies, who on 04Apr06 date was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot 651320/1006P). Subsequently, in Apr 2006, the pt experienced pain at the injection site, fever, chills and fatigue, after receiving the vaccination. The pt's status was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a female (age unk), with unk medical history and unk drug reactions/allergies, who on an unspecified date was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot651321/1036P). Subsequently, on an unspecified date, the pt experienced pain at the injection site, fever, chills and fatigue, after receiving the vaccination. The pt's status was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning a female (age unk) with unk medical history and unk drug reactions/allergies, who on an unspecified date was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot 651321/1036P). Subsequently, on an unspecified date the pt experienced pain at the injection site, fever, chills and fatigue, after receiving the vaccination. The pt's status was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 63 yr old female, with unk medical history, who on 13Apr06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot651328/1046P). There was no concomitant medication. On 13Apr06 the pt developed erythema, pain and heat in a 2 3" area around the injection site. The pt was treated with hot compresses. No product quality complaint was involved. The reporting physician requested a lot check. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Neuralgia
Clinical narrative: Information has been received from a physician concerning a 52 yr old white male, physician's assistant, with a penicillin allergy (blisters) and a drug hypersensitivity (muscle aches, liver) who on 27Feb06 was vaccinated SC in the left arm with second dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). On 28Feb06 the pt developed marked swelling and erythema of the left upper arm, and subsequently neuralgia type pain. The pt is being treated for the next 4 months with lyrra 75g in the am and 50g in the pm. It was reported that the pt was pain free while being treated with lyrra. Subsequently, on an unspecified date the pt recovered. It was reported that the pt had no adverse events following prior vaccination. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant and a nurse via a company rep, concerning an 82 yr old female with hypothyroidism, gastroesophageal reflux disease, hyperglycaemia, osteoporosis, irritable bowel syndrome and glaucoma and a history of hypertension and skin lesion who on 18Apr06 was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot651321/1036P). Concomitant therapy included levothyroxine Na (synthroid), therapy unspecified (Timidol), ascorbic acid, calcium carbonate (Os Cal), glucosamine, acetaminophen (Tylenol), vitamin E and therapy unspecified (Maxaid Hydrid Cholithiax). On 18Apr06 the pt called the doctor's serve stating the she had redness and swelling at the injection site of left deltoid. The doctor office called the pt yesterday (19Apr06) and the pt was improving, but had not yet recovered. Treatment ice pack for comfort measures. The nurse mentioned that the pt had a local reaction and developed swelling down to her elbow. The pt's present status was reported as improving. No product quality control was involved. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 50 yr old male, with diabetes mellitus, who on 18Apr06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). On 18Apr06 the pt developed severe swelling of his injection site arm. It was reported that pt was not hospitalized, but he was seen in the ER and released. No product quality complaint was involved. Outcome was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a female pt who in April 2006, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. In April 2006, the pt experienced hives. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a female who a week ago was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot 651332/1049P), SC. Subsequently, the pt experienced warm, red, swollen local reaction. The pt's primary physician was contacted and suggested application of ice and to continue monitoring the pt. The pt was also given diphenhydramine (Benadryl). It took approx four days for the symptoms to resolve. The pt recovered. There were no relevant diagnostic or lab tests performed. The nurse requested a lot check. The records of testing prior to release of this lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a RN concerning a male who a week ago was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot651332/1049P), SC. Subsequently, the pt experienced warm, red, swollen local reaction. The pt's primary physician was contacted and suggested application of ice and to continue monitoring the pt. It took approx four days for the symptoms to resolve. The pt recovered. There were no relevant diagnostic or laboratory tests performed. The nurse requested a lot check. The records of testing prior to release of this lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency.  Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician, via company rep, concerning a 77 yr old male, with hypertension, who on an unspecified date was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). On an unspecified date the pt developed swelling and redness from the upper arm to the forearm after receiving the vaccination. The pt was treated with levofloxacin (Levaquin) and recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician, via a company rep, concerning a 72 yr old male, with hypertension and unk drug reactions/allergies, who on an unspecified date was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). On an unspecified date the pt developed swelling and redness from his upper arm to forearm after receiving the vaccination. The pt was treated with cefprozil (Cefzil) and on an unspecified date recovered. No product quality complaint was involved. Additional information has been requested.