chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an elderly male patient with a pertinent medical history ( no details provided) who on Jul 20 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 646322/0530N). Subsequently, the patient developed a red, swollen arm at injection site, Medical attention was sought. Ice and analgesic treatment was reported. The reporting physician requested a lot check. No product quality complaint. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was reported that two other patients had a similar reaction (WAES0407USA01800, WAES0407USA02326). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema, Pain, Pyrexia
Clinical narrative: Initial and follow up information has been received from a registered nurse and a 19 year old Hispanic female patient, with no known drug allergies and no past medical history reported, who on Jun 24 2004 at 8:23 pm was vaccinates intramuscularly into the left deltoid with the first dose of pneumococcal 23v polysaccharide vaccine (lot 645247/1171M). Concomitant therapy included drospirenone (+) ethinyl estradiol (Yasmin). There was no illness at time of vaccination. On Jun 26 2004 at 9:00 am, the patient developed redness, swelling, pain and a low grade temperature. The patient sought unspecified medical attention. At the time of this report, the patient was improving. Upon follow up it was reported that on Jun 26 2004, the patient presented to the emergency room with an abscess of the left upper arm. Subsequently, the patient recovered. No further information is available.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Oedema, Sensation of heaviness
Clinical narrative: Information has been received from a licensed practical nurse and a physician concerning a 66 year old white female with hypothyroidism and allergies to rofecoxib (WAES0503USA033462) and celecoxib (Celebrex) who at 10:30 on Jul 23 2004 was vaccinates intramuscularly in the upper left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant therapy included medroxyprogesterone acetate (Provera), estradiol (Estrace), and levothyroxine NA (Synthroid). The patient had no illness at the time of vaccination. Around dinner time on Jul 23 2004, the patient began to develop pain in the arm in a circumferential distribution around the injection site. The pain had progressed through the night with accompanying redness and swelling. The patient reported that the arm felt much heavier than the right. there was significant pain, and ice was applied. On Jul 24 2004, the patient presented to the emergency room in no distress with a temperature of 97.6F. She had an erythematous area in the left upper arm that was most prominent over the lateral deltoid and down toward the elbow though not all the way  to the joint. There was obvious swelling noted, and the skin was somewhat tense. The entire area of involvement with erythema was probably approximately 7 inches long by 3 to 4 inches wide, The assessment was localized reaction to pneumococcal 23v polysaccharide vaccine, left upper arm. the physician believed the patient was brewing a secondary cellulitis. the patients arm was elevated and ice packs were applied. The patient was treated with diphenhydramine HCL (Benadryl) 25 mg, acetaminophen hydrocodone bitartrate 5/500 (Lortab), and cephalexin (Keflex) 500  mg 4 times daily for 1 week. The patient recovered on Jul 26 2004. No additional information is expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tension
Clinical narrative: Information has been received from a licensed practical nurse and a physician concerning a 66 year old white female with hypothyroidism and allergies to rofecoxib (WAES0503USA033462) and celecoxib (Celebrex) who at 10:30 on Jul 23 2004 was vaccinates intramuscularly in the upper left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant therapy included medroxyprogesterone acetate (Provera), estradiol (Estrace), and levothyroxine NA (Synthroid). The patient had no illness at the time of vaccination. Around dinner time on Jul 23 2004, the patient began to develop pain in the arm in a circumferential distribution around the injection site. The pain had progressed through the night with accompanying redness and swelling. The patient reported that the arm felt much heavier than the right. there was significant pain, and ice was applied. On Jul 24 2004, the patient presented to the emergency room in no distress with a temperature of 97.6F. She had an erythematous area in the left upper arm that was most prominent over the lateral deltoid and down toward the elbow though not all the way  to the joint. There was obvious swelling noted, and the skin was somewhat tense. The entire area of involvement with erythema was probably approximately 7 inches long by 3 to 4 inches wide, The assessment was localized reaction to pneumococcal 23v polysaccharide vaccine, left upper arm. the physician believed the patient was brewing a secondary cellulitis. the patients arm was elevated and ice packs were applied. The patient was treated with diphenhydramine HCL (Benadryl) 25 mg, acetaminophen hydrocodone bitartrate 5/500 (Lortab), and cephalexin (Keflex) 500  mg 4 times daily for 1 week. The patient recovered on Jul 26 2004. No additional information is expected.
Age: 25.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Hypersensitivity, Injection site induration, Oedema, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an approximately 25 year old male scientist with no medical history and no allergies who on Jul 28 2004 was vaccinates in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). Concomitant vaccine therapy given in the right arm included a dose of hepatitis B vaccine, re comb (Energix-B). On the morning of Jul 29 2004 the patient developed a temperature of 101F, and his left arm was swollen and red the size of a baseball with induration the size of a golf ball. No adverse symptoms were noted in the right arm. the patient is taking acetaminophen (Tylenol) and ibuprofen (Advil). The patient called his doctor and was to be seen by him in Jul 30 2004. It was noted that the patient is working with vaccines and his company offered the vaccine to the employee, No product quality complaint was involved. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old male patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647660/0945N, Subsequently 4-5 hours post vaccination, the patient developed warmth, redness and swelling at injection site, the patient was treated with an unknown antibiotic. The patient was reportedly recovering. It was also reported that another patient had a similar reaction (WAES0408USA01563). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 58 year old white male who on Jul 08 2004 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 646322/0530N), in the left arm, Subsequently the patient developed a red, hot, swollen and tender upper arm. Subsequently, the patient recovered. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 27 month old daughter with no past medical history and no allergies who on Aug 06 2004 at 9:00 am was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 645646/0068N), in the leg. There was not concomitant medication. Subsequently, an hour and a half later, she developed a fever that lasted until Aug 09 2004. It was reported that the fever fluctuated between 102 and 104 degrees. The patient later developed muscle pains through body, especially in the leg where she received her injection. The fever broke the night of Aug 09 2004. The patient was also vomiting. On Aug 10 2004 it was reported that the paitent was back at 99%. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 9 yr old female who in May 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine. On 02Jun04 titers were taken and for 14 of the 23 valents the results were negative for seroconversion. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a 69 yr old white female who in Nov 1995 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647038/0926N), IM in the left deltoid. There was no illness at the time of vaccination. Subsequently on 05Aug04 the pt developed erythema, slight swelling, soreness from about 2 inches above injection site to just below elbow. Also reported as warmth, redness, swelling and pain down arm. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint involved. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a female pt (mother of a teenager) who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647038/0926N). Subsequently the pt developed swelling, pain and redness at injection site. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that others had a similar experience (WAES0408USA01759, 0408USA01760 and 0408USA01761). Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a 90 yr old female pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647660/0945N). Subsequently, 4-5 hrs post vaccination, the pt developed warmth, redness and swelling at injection site. The pt was treated with an unk antibiotic. The pt was reportedly recovering. It was also reported that another pt had a similar reaction (WAES0408USA00082). Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Irritability
Clinical narrative: Information has been received from a physician concerning a 11 wk old healthy male with no known allergies who on 16Aug04 was vaccinated IM in the left leg with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine instead of pneumovax 7 (Prevnar). There was no concomitant medication. There was no illness at the time of vaccination or adverse event following prior vaccination. On 16Aug04, in the PM, the pt developed an erythematous area at the site of injection on the leg, local swelling and irritability. It was noted that otherwise there was no adverse effect from this immunization. It was noted that for diagnostic lab data to see ER report (information not provided). Subsequently, the pt recovered on 19Aug04. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was requested.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 35 yr old white male with allergic rhinitis and chronic sinusitis who on 13Jul04, was vaccinated SC in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot647634/0863N). Concomitant therapy included an unspecified nasal spray. Within 24 hrs, the pt developed a fever which lasted for 3 days and swelling in his upper arms that lasted for 2 weeks. In follow up, the physician reported that on 13Jul04, at approx 23:00, the pt experienced soreness in the left arm, from the elbow to shoulder, and the left arm became swollen. The pt's arm was sore for 4 days. The physician was notified, and advised the pt to apply ice to the site and take NSAIDs as needed. Subsequently, on 17Jul04, the pt recovered. There was no product quality complaint involved. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Medication error
Clinical narrative: Information has been received from a Pharm D concerning a pt (age and gender not reported) who on 19Aug04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot not reported). The pharmacist reported that a nurse told him that the pt received the vaccine intradermally and the injection site was red and swollen. This was reported to be an other important medical event (OMIC). Unspecified medical attention was sought. Cool compresses were applied. The outcome was not reported. Additional information has been requested.
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 male pt (co workers husband) who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647038/0926N). Subsequently the pt developed swelling, pain and redness at injection site. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that others had a similar experience (WAES0408USA01249, 0408USA01760 and 0408USA01761). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received on 13Aug04 from a RN concerning a pt who last week was vaccinated with pneumococcal 23v polysaccharide vaccine (lot647038/0926N). It was reported that the pt came back in this week because injection site was sore. The pt also developed swelling and redness at injection site. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that others had a similar experience (WAES0408USA01249, 0408USA01759 and 0408USA01761).  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647038/0926N). Subsequently the pt developed swelling, pain and redness at injection site. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that others had a similar experience (WAES0408USA01249, 0408USA01759 and 0408USA01760). Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Alopecia
Clinical narrative: Information has been received from a physician concerning a 41 yr old male HIV positive who on 07Aug04 was vaccinated with pneumococcal 23v polysaccharide vaccine. The pt was now reporting hair loss. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pneumonia, Viral infection
Clinical narrative: Information has been received from a doctor of pharmacy concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed pneumonia approx 48 hrs after receiving the vaccination. Unspecified medical attention was sought. At the time of this report, no additional information was provided. Additional information has been requested.
Age: 0.39
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Agitation, Somnolence
Clinical narrative: Information has been received from a health professional concerning a 20 week old white female who on 22Jun04 at 9:30AM was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 646712/1179N) (IM). Concomitant therapy that day and time included a second dose of diphtheria toxoid ((+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot U1301AA) (IM), a second dose of Hib conj vaccine (tet toxoid) (ACTHIB) (lot UE179AA) (IM) and a second dose of poliovirus vaccine inactivated (Vero) (Ipol) (lot W1440) (SC). On 22Jun04, at 11:30AM, the pt was reportedly crabby when she woke up from nap. The pt reportedly ate and went back to sleep. The pt recovered. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Malaise, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 10 yr old male who on 23Aug04 at 15:30 was vaccinated SC in the left arm with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P). There was no illness at the time of vaccination. On 26Aug04, 3 days post vaccination, the pt developed a fever, headache, nausea, neck pain, malaise, a sore arm and redness and pain at the injection site. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint was involved. Additional information has been requested. It was also reported that several other pt's at this office that received pneumococcal 23v polysaccharide vaccine have had AE's (WAES0409USA01310).
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Neck pain, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 10 yr old male who on 23Aug04 at 15:30 was vaccinated SC in the left arm with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot 647029/0460P). There was no illness at the time of vaccination. On 26Aug04, 3 days post vaccination, the pt developed a fever, headache, nausea, neck pain, malaise, a sore arm and redness and pain at the injection site. Unspecified medical attention was sought. Subsequently, the pt recovered. No product quality complaint was involved. Additional information has been requested. It was also reported that several other pt's at this office that received pneumococcal 23v polysaccharide vaccine have had AE's (WAES0409USA01310).
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site oedema, Injection site pain, Nausea
Clinical narrative: Information has been received from a certified medical concerning a 45 year old male who on 19Aug04 was vaccinated with pneumococcal  23v polysaccharide vaccine. It was reported that the pt believes he may received up to a 3ml dose of vaccine because he saw that the syringe was full. The pt shortly after vaccination developed swelling, redness, pain, dizziness and nausea. Unspecified medical attention was sought. It was noted that the pt's last (pneumococcal 23v polysaccharide vaccine) was last year. No product quality complaint involved. It was reported that the pt was recovering. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 36 yr old white female with hypersensitivity to meperidine hydrochloride (Demerol), asthma and Addison's disease who on 26Apr04 was vaccinated IM in the left deltoid with pneumococcal 23v polysaccharide vaccine (lot646494/1201N). Illnesses at the time of vaccination included sinusitis. On 27Apr04, in the PM, the pt developed redness and swelling at the injection site and a temp of 103 degrees. The swelling was the size of a half dollar. The pt was advised to take acetaminophen (Tylenol) or ibuprofen (Advil) every 4 to 6 hours and apply ice to the injection site. Subsequently, the pt recovered from the redness and swelling at the injection site and fever of 103 degrees two days later. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a male over 65 yrs of age who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Subsequently the pt developed redness and swelling near the injection site that extended to the shoulder to chest and just below the elbow. The physician also reported that the injection site was hot to touch. Unspecified medical attention was sought. No product quality complaint. It was noted that the pt had previously received a vaccination of pneumococcal 23v polysaccharide vaccine. It was also reported that two females had a similar reaction (WAES0409USA00780). Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a female pt who a few days ago in approx Sept 2004 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the injection site became very red, swollen and edematous. The affected area spread all the way down to her elbow. There were no hives or shortness of breath. The reporter did not know if the pt ever had a dose of pneumococcal 23v polysaccharide vaccine before. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Injection site oedema, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 49 yr old white male with type 1 diabetes mellitus and a penicillin allergy and no illness at the time of vaccination who at 3:00PM on 04Jun04 was vaccinated IM in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647797/0987N). Concomitant therapy included insulin lispro (Humalog). On 04Jun04, within 4 hrs of vaccination, the pt developed left arm swelling at injection site, fever, nausea and shortness of breath. On 06Jun04 the pt experienced ringing in ears, tingling and numbness on left side of face and headache. The pt was seen and treated with hydroxyzine HC1 (Atarax) 25mg and ibuprofen 800 mg (Motrin) 3 times daily. Additional information was received from the nurse practitioner who reported that the pt was contacted for follow up. The pt stated that the tingling sensation of his face and headache as well as the left arm swelling subsided after 3 days. The pt fully recovered on 09Jun04. No additional information is expected.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia, Pyrexia, Tinnitus
Clinical narrative: Information has been received from a nurse practitioner concerning a 49 yr old white male with type 1 diabetes mellitus and a penicillin allergy and no illness at the time of vaccination who at 3:00PM on 04Jun04 was vaccinated IM in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647797/0987N). Concomitant therapy included insulin lispro (Humalog). On 04Jun04, within 4 hrs of vaccination, the pt developed left arm swelling at injection site, fever, nausea and shortness of breath. On 06Jun04 the pt experienced ringing in ears, tingling and numbness on left side of face and headache. The pt was seen and treated with hydroxyzine HC1 (Atarax) 25mg and ibuprofen 800 mg (Motrin) 3 times daily. Additional information was received from the nurse practitioner who reported that the pt was contacted for follow up. The pt stated that the tingling sensation of his face and headache as well as the left arm swelling subsided after 3 days. The pt fully recovered on 09Jun04. No additional information is expected.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a RN concerning a 62 yr old white male referee with no known allergies, atrial fibrillation and hypertension who on 01Sep04 was vaccinated SC in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot647029/0460P). There were no adverse events following prior vaccinations. On 03Sep04 at 16:15 the pt developed cellulitis with redness, induration and edema from the shoulder to the armpit. Unspecified medical attention was sought. No diagnostic studies were performed. Subsequently the pt recovered. No product quality complaint was involved. The reporter felt that cellulitis was related to therapy with pneumococcal 23v polysaccharide vaccine. No further information is expected.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a consumer concerning her 5 yr old male son who in Jun 2002, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and it was vaccine and it was not effective per titer performed on her son. Unspecified medical attention was sought. It was noted that the pt had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: Information has been received from a pharmacist concerning a hospitalized 63 yr old female pt who on 10Sep04 was vaccinated with two doses pneumococcal 23v polysaccharide vaccine. The pharmacist reported that a nurse administered the two doses of pneumococcal 23v polysaccharide vaccine to the hospitalized pt by accident. There was no product quality complaint reported. No other information was available. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Decreased appetite, Feeling hot, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from a RN and follow up information from a nurse practitioner concerning a pt (age and gender not reported) who in 2004 (exact date not specified) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot647797/0987N). Subsequently, the pt experienced injection site reaction with raised hot area at site and fever. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). The nurse practitioner reported she had no further specific details for the case. She did however report that the pt's physician did not feel that these reactions were related to the pneumococcal 23v polysaccharide vaccine. The nurse also reported an approx 50 yr old female pt experienced injection site reaction, raised hot area on arm, temp, malaise, poor appetite and felt ill after vaccination with pneumococcal 23v polysaccharide vaccine (lot 647797/0987N) (WAES0409USA01176) and a male pt experienced injection site reaction with raised hot area at site and fever (WAES0409USA01642). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Diarrhoea, Feeling hot, Injection site swelling, Malaise
Clinical narrative: Information has been received from a RN and follow up information from a nurse practitioner concerning an approx 50 yr old female pt who in 2004 (exact date not specified) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot647797/0987N). Within 24 hrs of receiving the vaccination, the pt experienced injection site reaction with 4cm raised hot area on arm. The pt also developed temp of 103 F, malaise, poor appetite and the pt felt ill. Follow up information noted the pt also developed diarrhea. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). The nurse practitioner reported it took approx 1 week for the events to recover. The nurse practitioner felt that the events were related to the pneumococcal 23v polysaccharide vaccine. The nurse also reported a pt (age and gender not reported) experienced similar symptoms with raised hot area at site with fever (WAES0409USA01096) and a male pt who experienced similar symptoms (WAES0409USA01642). Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a RN and follow up information from a nurse practitioner concerning an approx 50 yr old female pt who in 2004 (exact date not specified) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot647797/0987N). Within 24 hrs of receiving the vaccination, the pt experienced injection site reaction with 4cm raised hot area on arm. The pt also developed temp of 103 F, malaise, poor appetite and the pt felt ill. Follow up information noted the pt also developed diarrhea. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). The nurse practitioner reported it took approx 1 week for the events to recover. The nurse practitioner felt that the events were related to the pneumococcal 23v polysaccharide vaccine. The nurse also reported a pt (age and gender not reported) experienced similar symptoms with raised hot area at site with fever (WAES0409USA01096) and a male pt who experienced similar symptoms (WAES0409USA01642). Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a 79 yr old female with diuresis, high blood pressure, thyroid disorder, chronic obstructive pulmonary disease, and allergy to codeine who in November 1996 and on 14Sep04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Concomitant therapy included an unspecified diuretic, unspecified high blood pressure medication, potassium, unspecified thyroid medication, unspecified inhaler for COPD and lansoprazole (Prevacid). On 16Sep04 the pt developed a red and swollen arm. The doctor ordered warm compresses. No product quality complaint involved. It was also reported that another pt had a similar reaction (WAES0409USA02643). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Feeling hot, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from a RN and follow up information from a nurse practitioner concerning a male pt who in 2004 (exact date not specified) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647797/0987N). Subsequently the pt experienced injection site reaction with raised hot area at site and fever. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). The nurse practitioner reported she was no other specific details for the case. She did however report that the pt's physician did not feel that these reactions were related to the pneumococcal 23v polysaccharide vaccine. The nurse also reported and approximately 50 year old female pt experienced injection site reaction, raised hot area on arm, temp, malaise, poor appetite and felt ill after vaccination with pneumococcal 23v polysaccharide vaccine (lot647797/0987N) (WAES0409USA01176) and another pt (age and gender not reported) experienced injection site reaction, raised hot area at site with fever (WAES0409USA01096). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a physician concerning an adult female patient who about two weeks ago on approximately Sep 06 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). In Sept 2004, the patient developed injection site reactions that included swelling and redness. Subsequently, the symptoms resolved within a week. Unspecified medical attention was sought. there was no product quality complaint involved. The reporter also mentioned another patient (Waes0409USA01764) who had developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female who on Sept 14 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 645852/0685N). Between Sept 15 2004 and Sept 17 2004 the patient developed pain, redness, and swelling at the injection site. She sought medical attention from her family doctor and was given a shot of cortisone. Subsequently, the patient recovered. No product quality complaint was involved. It was noted that the patient had received a dose of pneumococcal 23v polysaccharide vaccine 5 or 6 years prior to this vaccination. No further information is available.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old male who was vaccinated with a dose of PNEUMOVAX 23 (lot 649692/0371P). Subsequently, the patient developed redness, warmth, soreness and swelling at the injection site. Unspecified medical attention was sought. The patient was treated with Augmentin and recovered. It was noted that the patient's physician thought it might be cellulitis. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a physician concerning an adult female patient who about two weeks ago on approximately Sept 06 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). In Sept 2004, the patient developed injection site reactions that included swelling and redness. Subsequently, the symptoms resolved within a week. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned another patient (WAES0409USA01690) who had developed a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647038/0926N). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Dyspepsia
Clinical narrative: information has been received from a consumer concerning her elderly mother with celiac disease who on Aug 27 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number not available). Subsequently, the patient has been experiencing more heart burn and stomach distress. The patient has seen her physician. the outcome was not reported. No further information is available.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient who is immunocompromised and who in approximately 2002 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). it was reported that the patient did not respond to an initial dose of pneumococcal 23v polysaccharide vaccine. No other information was provided. Unspecified medical attention was sought. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Feeling hot, Injection site hypersensitivity, Injection site reaction, Oedema
Clinical narrative: Information has been received from a physician concerning a male over the age of 65 who on Sept 20 2004 was vaccinates with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). On Sept 20 2004 the patient developed an injection site reaction. The reaction was described as a red swollen arm from elbow to shoulder and a hot feverish arm. The patient also experienced body aches and chills. The patients events persisted. No treatment was given for the reaction. It was reported that this was the patients second pneumococcal 23v polysaccharide vaccine. The patients first vaccination had been at least 5 years previously and there had Been no reaction to that vaccination. The physician reported that since this is the fifth reaction the practice has had in the past few months he would like an investigation into the lot 0371P. The physician also reported that another patient had the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 649692/0371P) (WAES0409USA02427). The physician also reported that 3 other patients had reactions after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 648139/0009F) (WAES0409USA00219, WAES0409USA00780). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a male over the age of 65 who on Sept 20 2004 was vaccinates with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). On Sept 20 2004 the patient developed an injection site reaction. The reaction was described as a red swollen arm from elbow to shoulder and a hot feverish arm. The patient also experienced body aches and chills. The patients events persisted. No treatment was given for the reaction. It was reported that this was the patients second pneumococcal 23v polysaccharide vaccine. The patients first vaccination had been at least 5 years previously and there had Been no reaction to that vaccination. The physician reported that since this is the fifth reaction the practice has had in the past few months he would like an investigation into the lot 0371P. The physician also reported that another patient had the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 649692/0371P) (WAES0409USA02427). The physician also reported that 3 other patients had reactions after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 648139/0009F) (WAES0409USA00219, WAES0409USA00780). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema, Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female over the age of 40 who on Sept 16 2004 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0486P). On Sept 17 2004 the patient called the office complaining of high fever and left arm red and swollen like a soft ball. The patient was treated with diphenhydramine HCL. AT the time of this report, there was no follow up with the patient and it was unknown if she recovered. The nurse requested that a lot check be performed on lot 649693/0486P. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory, The lot complies with the standards of the Center for Biologics Evaluation and research and was released. The nurse reported another patient who had similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 649693/0486P) (WAES0409USA02238). Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Oedema, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a male who on Sept 21 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #647271/1138N). on approximately Sept 22 2004 the patient developed redness from his shoulder to his wrist (site unspecified), and reported that the area was very painful and appeared to be swollen. the patients outcome was unknown. The LPN reported that the patient had received vaccinations with pneumococcal 23v polysaccharide vaccine in the past without incident. Additional information has been requested. The LPN also reported a male patient who developed similar events after vaccination with pneumococcal 23v polysaccharide vaccine (lot 647271/1138N) (WAES0410USA004371).
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Anger, Injection site hypersensitivity, Oedema, Pain, Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female in her 40s who on Sept 21 2004 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0486P). The nurse reported that 5 hours post vaccination the patient developed a high fever and angry, red, painful, swollen left arm. the patient was treated with diphenhydramine HCL. On follow up, the patient still had the red. sore arm. The patient stated that the arm felt heavy, almost like after a diphtheria or tetanus shot. The nurse requested that a lot check be performed on lot 649693/0486P. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse reported another patient who had similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 649693/0486P) (WAES0409USA02062). Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Sensation of heaviness
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female in her 40s who on Sept 21 2004 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 649693/0486P). The nurse reported that 5 hours post vaccination the patient developed a high fever and angry, red, painful, swollen left arm. the patient was treated with diphenhydramine HCL. On follow up, the patient still had the red. sore arm. The patient stated that the arm felt heavy, almost like after a diphtheria or tetanus shot. The nurse requested that a lot check be performed on lot 649693/0486P. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse reported another patient who had similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 649693/0486P) (WAES0409USA02062). Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Angioneurotic oedema, Condition aggravated, Injection site oedema, Urticaria
Clinical narrative: Information has been received from a 34 year old female with insulin dependent diabetes mellitus since 11 months old, hypertension, hypercholesterolaemia and no drug reaction or allergies who on 02-AUG-2004 at 13:15 PM was vaccinated in the left arm with a 0.5 ml dose of Pneumovax 23 (lot number 647029/0460P). Concomitant therapy included Humulin, Synthroid, Effexor, Lipitor and lisinopril. At the time of vaccination, she was on an insulin pump and was in good control. The pt reported that within days of the vaccination (reported as 05-AUG-2004 and 14-AUG-2004), she had swelling of the site on the arm. then hives all over her body. She returned to her doctor who sent her to an allergist. She was placed on therapy with several medications to control the hives including Allegra and Remeron. She was not getting any better. She subsequently developed angioedema in her eyes, lips, hand and feet. She reported that her "blood sugar control had been completely destroyed". She stated that she had missed a great of work due to this problem. She was in good control of her diabetes which she no longer had. She worked everyday, which she no longer could do. She indicated that the medications to keep her hives under control were so terrible on her blood sugars that she was not sure how much longer she would be able to take them. It was noted that there was no acute illness at the time of vaccination. At the time of this report, the pt had not recovered. Follow-up information reported that the pt's urticaria have become chronic. She is seen by local allergist/dermatologist at a hospital clinic. Urticaria is considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site oedema, Pain
Clinical narrative: Information has been received from a health care worker concerning a 46 year old white female laboratory supervisor with no relevant medical history or illness at the time of vaccination who on Sept 21 2004 was vaccinated intramuscularly in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647028/0564N). On Sept 22 2004, the patient developed swelling at the injection site, and her arm was red. The patients arm hurt for 5-6 days. The patient subsequently recovered in 10 days. No additional information is expected.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 55 year old white female laboratory director with no relevant medical history or illness at the time of vaccination who on Sept 21 2004 was vaccinated intramuscularly in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 647028/0564N). It was reported that the patient received a first dose of pneumococcal 23v polysaccharide vaccine on Mar 02 2004. On Sept 21 2004, the patient developed swelling, redness, and pain at the injection site. the patient had swelling from clavicle and shoulder blade to elbow. She could not move her arm. She was seen by a physician on Sept 22 2004, and was treated with unspecified steroids and and allergy type medicine. The patient gradually got better and could use her arm normally by Sept 25 2004. The patient recovered on Sept 25 2004. No additional information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling hot, Injection site hypersensitivity, Injection site reaction, Oedema
Clinical narrative: Information has been received from a physician concerning a female over the age of 65 who on Sept 20 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P). ON Sept 20 2004 the patient developed in injection site reaction. The reaction was described as red swollen arm from elbow to shoulder and a hot feverish arm. The patient also experienced body aches and chills. The patients events persisted. No treatment was given for the reaction. It was reported that this was the patients second pneumococcal 23v polysaccharide vaccine. The patients first vaccination has been at least 5 years previously and there had been no reaction to that vaccination. The physician reported that since this is the fifth reaction the practice has had in the past few months he would like an investigation in the the lot 0371P. The physician also reported that another patient had the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot 649692/0371P) (WAES0409USA01988). The physician also reported that 3 other patients had reactions after vaccination with pneumococcal 23v polysaccharide vaccine (lot 648139/0009P) (WAES0409USA00219, WAES0409USA00780). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. the lot complies with the standards of the Center for Biologics Evaluation and Research was released. Additional information is not expected.