chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Cellulitis, Chills, Influenza like illness, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 yr old female pt with an allergy to PCN and codeine and a past medical history of carcinoma of the uterus, GERD, and lumbar spinal stenosis, who on 28Sep05 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). There were no other concomitant vaccination administered at the same time. On the day of vaccination with pneumococcal 23v polysaccharide vaccine, 28Sep05, the pt reported she began feeling poorly. She developed a sore arm, aches, and a temp as high as 105 deg F. On 01Oct05 she went to the ER with chills and shakes, and a feeling of weakness all over. She felt like she had the flu. She was treated with levofloxacin (Levaquin). The following laboratory studies were performed: urinalysis, chest x-ray, CBC and metabolic panel. Her diagnosis was cellulitis to her left upper arm and a localized reaction to pneumococcal 23v polysaccharide vaccine. She was discharged from the ER with levofloxacin for 10 days and medications for pain. Cold compresses were also recommended. The pt is recovering. The reporter considered the adverse events to be other important medical events (OMIC). Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Myalgia, Pyrexia, Tremor
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 yr old female pt with an allergy to PCN and codeine and a past medical history of carcinoma of the uterus, GERD, and lumbar spinal stenosis, who on 28Sep05 was vaccinated in the left arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). There were no other concomitant vaccination administered at the same time. On the day of vaccination with pneumococcal 23v polysaccharide vaccine, 28Sep05, the pt reported she began feeling poorly. She developed a sore arm, aches, and a temp as high as 105 deg F. On 01Oct05 she went to the ER with chills and shakes, and a feeling of weakness all over. She felt like she had the flu. She was treated with levofloxacin (Levaquin). The following laboratory studies were performed: urinalysis, chest x-ray, CBC and metabolic panel. Her diagnosis was cellulitis to her left upper arm and a localized reaction to pneumococcal 23v polysaccharide vaccine. She was discharged from the ER with levofloxacin for 10 days and medications for pain. Cold compresses were also recommended. The pt is recovering. The reporter considered the adverse events to be other important medical events (OMIC). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Information has been received from a RN pharmacist concerning a 53 yr old female with a sulfa allergy who on 04Oct05 was vaccinated IM in the deltoid with her second 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 650649/0790P, also reported as lot 650648/0967P). It was reported in follow up information that the pt developed soreness, redness and tenderness at the injection site and into her chest area on 04Oct05 at 8PM. She required medical intervention and was diagnosed with cellulitis and was hospitalized for treatment. Wound cultures were taken on 06Oct05 and were reported on 08Oct05 as no growth. At the time of this report the pt was recovered. No product quality complaint was involved. The pharmacist considered the pt's adverse experience to be an other important medical event (OMIC). Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Headache, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 47yr old female with sulfa allergy and diabetes who on 11Oct05 was vaccinated (left deltoid) with 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Within 24 hrs, on 12Oct05, the pt called the office and complained of pain at the injection site. On 13Oct05 the pt developed headache, hot, induration and swelling at injection site. The pt was treated with acetaminophen (Tylenol) and ibuprofen (unspecified). As of 14Oct05, the pt had not recovered. Pain, hot, induration and swelling at injection site and headache were considered to be disabling by the reporting physician. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a RN concerning a pt with a history of pulmonary disease who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 0650643/0790P). The registered nurse reported that the pt developed redness, swelling and heat in the injection site arm after vaccination, during the past 3 months. The pt received oral antibiotics. At the time of the report, it was unk if the pt recovered. The RN felt that redness, swelling and heat in the pt's injection site arm was considered to be disabling. It was also reported that two other pt's had similar experiences and were treated with oral antibiotics (WAES0606USA04360 and WAES0606USA04361). It was also reported that another pt had similar experiences and was treated with intravenous (IV) antibiotics (WAES0510USA08765). The RN reported that three pts recovered and one pt did not recover. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a health professional concerning an adult patient who, in the last month, in approximately October 2005, was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot # 649914/0578P). In approximately October 2005, in the last 30 days, the patient experienced cellulitis at the injection site and was treated in the hospital with IV antibiotics, recovered and was released. It was noted that the patient recovered within 3-7 days post vaccination. It was also noted that this was a revaccination and the patient had at least one and possibly as many as 6 prior vaccinations before this dose. No product quality complaint was involved. Cellulitis at injection site was considered to be an other important medical event (OMIC), immediately life-threatening, and disabling by the reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an adult pt who less than 2 days ago on approx 16Oct05 was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. (lot 649914/0578P). In Oct 2005 the pt experienced an injection site reaction including redness, swelling and local pain at the site. The pt was treated with diphenhydramine hcl (Benadryl). At the time of this report, the pt was still recovering. It was also noted that this was a revaccination and the pt had at least one and possibly as many as 6 prior vaccinations before this dose. No product quality complaint was involved. Injection site redness, injection site swelling and injection site pain were considered to be immediately life threatening, other important medical events (OMIC) and disabling by the reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning an adult pt who in the last 30 days, approx Oct 2005, was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649914/0578P). In approx Oct 2005, over the last 30 days, the pt experienced an injection site reaction including redness, swelling and pain and was treated with diphenhydramine hc1 (Benadryl). The pt recovered in 3-7 days. It was also noted that this was a revaccination and the pt had at least one and possibly as many as 6 prior vaccinations before this dose. No product quality complaint was involved. Injection site redness, swelling and pain were considered to be immediately life threatening, disabling and other important medical event by the reporter (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning one of four patients with a history of pulmonary disease who was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 0550549/0790P). The registered nurse reported that the patient developed redness, swelling and heat in the injection site arm after vaccination, during the past 3 months. The patient received intravenous antibiotics in an outpatient setting. At the time of the report, it was unknown if the patient recovered. The registered nurse felt that redness, swelling and heat in the patients injection site arm was considered to be disabling. It was also reported that three patients has similar experiences (WAES0510USA07487). The registered nurse reported that three patients recovered and one patient did not recover. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Malaise, Medication error
Clinical narrative: Information has been received from a pharmacist concerning an adult patient (age and gender not reported) with unknown medical history and unknown allergies, who in early Oct 2005, was vaccianted intramuscularly with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 644220/1119M) which had expired on 4/9/04. It was reported that the patient developed redness, swelling at the injection site and general malaise 24 hours post vaccination, was treated with cephalexin Keflex, and recovered fully in about one week. No product quality complaint was involved. The reporter considered the site reactions including redness at the injections site, swelling at the injection site and general malaise to be other important medical events (OMIC). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 54 year old female who on 10/24/05 at 4:30 pm was vaccinated with a first dose of Pneumococcal 23v polysaccharide vaccine (lot 647661/0055R), in the right deltoid. Subsequently, she called the physician complaining of pain at injection site. The patient was seen in the office on 10/26/05 for cellulitis to right shoulder, induration, erythema in linear area below injection site and running medially around anterior aspect of shoulder and into axilla. It was also reported that the patient had developed erythema around injection site and a red line to the axillary area. The patient was treated with azithromycin (Zithromax) for 5 days and warm compresses. The patient recovered. The reporter considered the patients adverse experience to be an other medical event (OMIC). It was also reported that two other patients had an adverse experience following vaccination with Pneumococcal 23v polysaccharide vaccine WAES0511USA00419 and WAES0511USA00420.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult (age and gender not reported) patient who in approximately Oct 2005 (over the last month), was vaccinated intramuscularly with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Subsequently, on an unspecified date, the patient developed an injection site reaction to include soreness, warmth, erythema and swelling. The patient was treated with antibiotics and on an unspecified date recovered fully. The patient experience was considered to be other important medical event by the reporter (OMIC). Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old male with unspecified medical history who on 11/4/2005 was vaccinated with Pneumococcal 23v polysaccharide vaccine (0.5 ml) (lot 650329/0747P), intramuscularly in the right arm. Concomitant therapy included unspecified medication. Subsequently the patient had a swollen, red, right arm, no fever. The patient was seen in the doctors office. The patient was diagnosed with cellulitis and was treated with oral antibiotics, The patient was considered to be doing well. The reporter considered the patients experience to be disabling. It was also reported that two other patients experienced cellulitis after being vaccinated with Pneumococcal 23v polysaccharide vaccine (WAES0511USA02279 and WAES0511USA02280). The reporting nurse requested a lot check. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a respiratory therapist concerning a female age not provided, who on 11/9/05 was vaccinated IM into the left arm with 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). The patient also received influenza virus vaccine unspecified on the opposite arm. On approximately 11/9/05, the patient developed hot, painful and swelling about size of half dollar at injection site. The physician ordered 50mg of diphenhydramine hydrochloride Benadryl PO and 30 mg prednisone for three days. The patient was reported as recovered. Hot, painful and swollen injection site was considered to be an other important medical event by the reporting respiratory therapist (OMIC). There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning an elderly female patient who is a diabetic and has a history of mastectomy who on approximately 20-OCT-2005 "three weeks ago" was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #649914/0578P). "Within 24 hours of dosing" the patient experienced cellulitis. It was noted that if she would have waited a few more days before contacting the physician's office, would have required hospitalization. It was noted that she was treated with compresses, antibiotics and acetaminophen (Tylenol). Subsequently, all of the patients recovered. No product quality complaint was involved. Cellulitis was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 54 year old female with unspecified medical history who on 11/7/05 was vaccinated with Pneumococcal 23v polysaccharide vaccine 0.5 ml (lot 650329/0747P) Concomitant therapy included unspecified medication. Subsequently, the patient developed a swollen, red arm. The patient was seen in the doctors office. The patient was diagnosed with cellulitis and was treated with oral antibiotics. The patient was reportedly doing well. The reporting nurse considered cellulitis to be disabling. It was also reported that two other patients experienced cellulitis after being vaccinated with Pneumococcal 23v polysaccharide vaccine WAES0511USA01525 and WAES0511USA02280. the reporting nurse requested a lot check. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female with unspecified medical history who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #650329/0747P) (0.5ml), intramuscularly. Concomitant therapy included unspecified medication. Subsequently, the patient experienced cellulitis. The patient was seen in the emergency room and was treated with antibiotics. The patient was reportedly "doing well". The reporting nurse considered cellulitis to be disabling. It was also reported that two other patients experienced cellulitis after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES#0511USA01525 & 0511USA02279). The reporting nurse requested a lot check. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a respiratory therapist concerning 49 year old black female educator (164 lb, 66") with no known drug allergies and sarcoidosis who on 07NOV-2005 was vaccinated intramuscularly with 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P).  The patient also received influenza virus vaccine (unspecified) on the opposite arm.  On 07-NOV-2005, the patient developed erythema, hot, itching and swelling about size of "half dollar" at injection site.  The physician ordered 50 mg by mouth of diphenhydramine hydrochloride (BENADRYL).  The patient was reported as recovered.  hot and swollen injection site was considered to be an other important medical event by the reporting respiratory therapist.  There was no product quality complaint involved.  Additional information is not expected. (considered an other medically important condition) (OMIC)
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypokinesia, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old female with asthma and type I diabetes mellitus who in 11/05 was vaccianted subcutaneously with 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). It was reported that the patient had been vaccinated with the first dose of Pneumococcal 23v polysaccharide vaccine. The registered nurse reported that the next day the patient developed a local reaction involving pain and difficulty moving her arm, which was diagnosed as cellulitis that required hospitalization and treatment with antibiotics. The patient sought medical attention. At the time of the report the patient was recovering. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female patient, with a history of vaccination (route unknown) by another facility with her first dose of Pneumococcal 23v polysaccharide vaccine (manufacturer unknown) >5 years ago and unknown drug reactions allergies, who on 11/17/05 was vaccinated intramuscularly in the left deltoid with a 0.5ml booster dose of Pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant therapy included metoprolol succinate (Toprol XL tablets), simvastatin Zocor, Lansoprazole Prevacid, aspirin, vitamins unspecified, Irbesartan Avapro, levothyroxine NA Synthroid and zolpidem tartrate Ambien. On 11/18/05 the patient developed a fever of 99 degree F, swelling, induration, and erythema at the injection site. The doctor diagnosed the problem as cellulitis and put her on cephalexin Keflex. He also told her to elevate the arm, ice it and take diphenhydramine hydrochloride Benadryl. On 11/21/2005 the patient called the office and indicated that she was nauseous from the cephalexin Keflex, the arm was improved, and therefore Keflex was stopped. The doctor would like an investigation into this lot number. The patients experiences were considered to be other important medical event by the reporting physician (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition a review revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female patient, with a history of vaccination (route unknown) by another facility with her first dose of Pneumococcal 23v polysaccharide vaccine (manufacturer unknown) >5 years ago and unknown drug reactions allergies, who on 11/17/05 was vaccinated intramuscularly in the left deltoid with a 0.5ml booster dose of Pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant therapy included metoprolol succinate (Toprol XL tablets), simvastatin Zocor, Lansoprazole Prevacid, aspirin, vitamins unspecified, Irbesartan Avapro, levothyroxine NA Synthroid and zolpidem tartrate Ambien. On 11/18/05 the patient developed a fever of 99 degree F, swelling, induration, and erythema at the injection site. The doctor diagnosed the problem as cellulitis and put her on cephalexin Keflex. He also told her to elevate the arm, ice it and take diphenhydramine hydrochloride Benadryl. On 11/21/2005 the patient called the office and indicated that she was nauseous from the cephalexin Keflex, the arm was improved, and therefore Keflex was stopped. The doctor would like an investigation into this lot number. The patients experiences were considered to be other important medical event by the reporting physician (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition a review revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Convulsion, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physicians assistant concerning a 72 year old male with polycythaemia (stable in past 5 years), no allergies, and folliculitis of the face and neck. On 11/29/2005 the patient was hospitalized for a change in mental status and a seizure. It is part of the hospitals protocol to offer a patient the vaccine if they have not had one. The patient had never had one so that same day he was vaccinated intramuscularly with a first 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dose of influenza virus vaccine unspecified given approximately 11/15/05, phenytoin Dilantin, clopidogrel bisulfate Plavix, aspirin and doxycycline for folliculitis. On 11/30/05 the patient developed swelling and redness at the injection site. He was discharged from the hospital. On 12/1/05 he was seen in the ER with increasing symptoms. On 12/5/05 he was seen in the office with cellulitis of the right arm, distal to the injection site to the fingers. A CBC with differential and Protime time were pending. Therapy with aspirin and clopidogrel bisulfate Plavix were discontinued. A Doppler study of the right arm was negative for a deep vein thrombosis. On 12/8/05 the patient was scheduled to be seen by a neurologist for his seizure. The reporter felt that the cellulitis was disabling because he had still not recovered and was unable to use the arm due to the pain and swelling. He was scheduled to be seen in the office for a follow up visit. Cellulitis of right arm was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site inflammation, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 56 yr old female pt with allergies to codeine derivatives, penicillins and tetracyclines who on 04Nov05 (also reported as 05Dec05) was vaccinated IM in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot 650541/1004P) (also reported as 650542/1005P). Concomitant therapy included influenza virus vaccine (unspecified). There was no illness at the time of vaccination. The pt had a local reaction at the injection site on 08Nov05. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the pt called the office on 06Dec05 with pain, swelling and rash around injection site which began approx 15:00 on 05Dec05. The pt extended up toward her neck, left ribcage and left breast. On 06Dec05 she still had swelling, rash and pain around the injection site with limited mobility. On 06Dec05, the pt was advised to treat the symptoms with warm compresses and 400-600mg of ibuprofen to decrease inflammation and to help with pain. The pt was further advised to treat with diphenhydramine hydrochloride (Benadryl) (OTC), 25mg or loratadine (Claritin) 1-2 every 6-8 hrs and to call the office if symptoms persisted. At the time of this report, the pt had not called regarding above. The outcome of the events were unk. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning two patients who were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650454/0751P). Subsequently, the patients developed injection site swelling and fever. The patients are being treated with acetaminophen Tylenol and application of ice pack. No other information was available regarding the adverse event or the patients outcomes. There was no product quality complaint reported. The reporter considered the patients adverse experiences to be other important medical events (OMIC). No further information is available.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine.  Concomitant therapy that day included influenza virus vaccine (unspecified).  Subsequently the patient experienced cellulitis in the arm that the pneumococcal 23v polysaccharide vaccine was given.  Unspecified medical attention sought.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with exercise induced asthma and allergies to penicillin and sulfonamide who on 11/16/05 at 2:30pm was vaccinated IM, into the left deltoid, with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). Concomitant therapy included influenza vaccine (lot U1827AA) given IM into the right deltoid. On 11/16/05, shortly after the vaccination, the patient developed redness, warmth, swelling and pain at left deltoid injection site. The patient visited the ER due to the pain but no treatment was required. Follow up reported that the patient sought medical attention via a doctors visit and the patient was treated with unspecified antihistamine and antibiotic. The patient recovered within 2 weeks. The reporting registered nurse considered redness, swelling, warmth and pain at injection site to be other important medical events (OMIC). Additional information is not available.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Initial and follow up information has been received from a office manager of a physician's office concerning a male pt, who was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine and subsequently experienced cellulitis in his arm after receiving the vaccination. The office manager reported the pt had been in the ER for another reason; however, he received the dose of pneumococcal 23v polysaccharide vaccine, due to the state law that requires hospitals to offer it before a pt leaves the hospital. The pt was treated in the ER and the reporter noted that the pt's stay was prolonged. Hospitalized was noted. No further information was available regarding the adverse event or the pt's outcome. There was no product quality complaint reported. The reporter felt that cellulitis was an other important medical event (OMIC). Other business partner numbers included E200505558. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old African American female with allergy to penicillin and sulfa who on 10/31/05 was vaccinated a first dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot # 651318/1006P), IM in the left arm. There was no illness at the time of vaccination. On 11/2/05, the patient presented to the office with injection site pain, swelling, and tenderness of the left arm. It was also reported that two days post immunization the patient developed pain, redness, swelling in left arm. The patient complained of fever and dizziness. The patient was rechecked on 11/3/05 patient continued to complain of tenderness to site. The patient's temperature was 100 F. The left arm increasingly remained edematous with 2" circular area of erythema. The patient was treated with analgesic and has since recovered. The reporter requested a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open quarantines registered against th is lot/fill. Injection site pain, swelling, and tenderness of the left arm was considered to be disabling and an other important medical event by the reporter (OMIC). No further information is available. Other business partner numbers include E200505556.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old African American female with allergy to penicillin and sulfa who on 10/31/05 was vaccinated a first dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot # 651318/1006P), IM in the left arm. There was no illness at the time of vaccination. On 11/2/05, the patient presented to the office with injection site pain, swelling, and tenderness of the left arm. It was also reported that two days post immunization the patient developed pain, redness, swelling in left arm. The patient complained of fever and dizziness. The patient was rechecked on 11/3/05 patient continued to complain of tenderness to site. The patient's temperature was 100 F. The left arm increasingly remained edematous with 2" circular area of erythema. The patient was treated with analgesic and has since recovered. The reporter requested a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open quarantines registered against th is lot/fill. Injection site pain, swelling, and tenderness of the left arm was considered to be disabling and an other important medical event by the reporter (OMIC). No further information is available. Other business partner numbers include E200505556.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a female pt who was vaccinated with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649695/0512P) and within 72 hrs she developed cellulitis at the injection site. The pt sought medical attention and was treated with antibiotics. The pt recovered. There was no product quality complaint reported. The reporter considered cellulitis at injection site to be an other important medical event (OMIC) and disabling. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a health professional concerning a 52 year old immunocompromised female with rheumatoid arthritis who on 12/08/05 was vaccinated SC in the right arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Concomitant therapy the same day included influenza virus vaccine (unspecified) and tuberculin given in the left arm. On 12/10/05 the patient presented with cellulitis of her right arm. She was treated with antibiotics and has recovered. There was no product quality complaint involved. Cellulitis of right arm was considered to be an other important medical event (OMIC) and disabling. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who was vaccianted with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P) and within 72 hours she developed cellulitis at the injection site. The patient sought medical attention and was treated with antibiotics. The patient recovered. There was no product quality complaint reported. The reporter considered cellulitis at injection site to be an other important medical event (OMIC) and disabling. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female with hypertension, diverticulitis, osteoporosis, arthritis, and a sulfa allergy who at 1:15pm on 1/4/06 was vaccianted intramuscularly in the left arm with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Concomitant therapy included alprazolam Xanax, amlodipine besylate Norvasc, Telmisartan Micardis, ranitidine HCL Zantac, risedronate sodium Actonel, vitamins and acetaminophen Tylenol. Approximately 15 to 20 minutes after injection, the arm became tingling and itchy. Within a hour of vaccination, the patient developed swelling, hardness, redness and itching to her upper left arm. On 1/5/06 the patient went to the ER with worsening symptoms. There she was diagnosed with cellulitis and was treated with levofloxacin Levaquin. the patient was evaluated in the physicians office on 1/9/06. At that time, her left inner upper arm was red, warm, swollen and hard down to her fingers. Doppler studies completed on 1/9/06 were negative. Impression, No evidence of acute deep venous obstruction of the left upper extremity. The physician discontinued levofloxacin and started the patient on Cephalexin Keflex 500mg twice daily. The nurse reported that the patient was seen in follow up on 1/11/06. The patient still had a small red bump at the injection site, but was considered recovered from the event. Additional information received via medical records indicated that the diagnosis at the ER included hypersensitivity reaction of the left arm. The patients cellulitis was considered an other medical event (OMIC). No additional information is expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female with hypertension, diverticulitis, osteoporosis, arthritis, and a sulfa allergy who at 1:15pm on 1/4/06 was vaccianted intramuscularly in the left arm with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649914/0578P). Concomitant therapy included alprazolam Xanax, amlodipine besylate Norvasc, Telmisartan Micardis, ranitidine HCL Zantac, risedronate sodium Actonel, vitamins and acetaminophen Tylenol. Approximately 15 to 20 minutes after injection, the arm became tingling and itchy. Within a hour of vaccination, the patient developed swelling, hardness, redness and itching to her upper left arm. On 1/5/06 the patient went to the ER with worsening symptoms. There she was diagnosed with cellulitis and was treated with levofloxacin Levaquin. the patient was evaluated in the physicians office on 1/9/06. At that time, her left inner upper arm was red, warm, swollen and hard down to her fingers. Doppler studies completed on 1/9/06 were negative. Impression, No evidence of acute deep venous obstruction of the left upper extremity. The physician discontinued levofloxacin and started the patient on Cephalexin Keflex 500mg twice daily. The nurse reported that the patient was seen in follow up on 1/11/06. The patient still had a small red bump at the injection site, but was considered recovered from the event. Additional information received via medical records indicated that the diagnosis at the ER included hypersensitivity reaction of the left arm. The patients cellulitis was considered an other medical event (OMIC). No additional information is expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old male, with ampicillin allergy, sulfamethoxazole allergy, and simvastatin (manufacturer unknown) allergy, who on 1/13/06 was vaccinated intramuscularly in the left deltoid with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). ON 1/15/06 the patient was presented to the ER and diagnosed with cellulitis. The patient was treated with clindamycin manufacturer unknown and released. The patients present status was reported as unknown. The pharmacists is requesting a lot check. The patients experience was considered to be an other important medical event by the reporter (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old male who on 1/13/06 was vaccinated intramuscularly in the left deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). On 1/15/06 the patient was presented to the ER and diagnosed with cellulitis. The patient was treated with Ibuprofen Motrin and released. The patients present status was reported as unknown. The pharmacist is requesting a lot check. The patient's experience was considered to be an important medical event by the reporter (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a  healthcare worker/office manager concerning a 74 year old female, with unknown medical history and unknown drug reaction/allergies, who on 1/24/06 was vaccinated intramuscularly with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651330/1048P). About 4 hours post vaccination, on 1/24/06, the patient developed swelling and redness near the injection site. She was treated at a local ER with some form of steroids and released. The patients present status was reported as recovering. The was product quality complaint involved. The patients experiences were considered to be other important medical events (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient with a history of pulmonary disease who was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 0650649/0790P). The registered nurse reported that the patient developed redness, swelling and heat in the injection site arm after vaccination, during the past 3 months. The patient received oral antibiotics. At the time of the report, it was unknown if the patient recovered. The registered nurse felt that redness, swelling and heat in the patients injection site arm was considered to be disabling. It was also reported that two other patients had similar experienced and were treated with oral antibiotics WAES0606USA04360 and WAES0510USA07487. It was also reported that another patient had similar experiences and was treated with intravenous IV antibiotics WAES0510USA08765). The registered nurse reported that three patients recovered and one patient did not recover. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient with a history of pulmonary disease who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 0650649/0790P). The registered nurse reported that the patient developed redness, swelling and heat in the injection site arm after vaccination, during the past 3 months. The patient received oral antibiotics. At the time of the report, it was unknown of the patient recovered. The registered nurse felt that redness, swelling and heat in the patient's injection site arm was considered to be disabling. It was also reported that two other patient's had similar experiences and were treated with oral antibiotics (WAES0510USA07487 and WAES0606USA04361). It was also reported that another patient had similar experiences and was treated with IV antibiotics (WAES0510USA08765). The registered nurse reported that three patient recovered and one patient did not recover. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Medication error
Clinical narrative: Information has been received from a pharmacist concerning an adult patient (age and gender not reported) with unknown medical history and unknown allergies, who in early October 2005, was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot # 644220/1119M) which had expired on 4/9/04. It was reported that the patient developed redness, swelling at the injection site and general malaise 24 hours post vaccination, was treated with cephalexin, and recovered fully in about one week. No product quality complaint was involved. The reporter considered the site reactions including redness at the injection site, swelling at the injection site and general malaise to be other important medical events (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult (age and gender not reported) pt who in approximately Oct 2005 (over the last month), was vaccinated IM with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Subsequently, on an unspecified date, the pt developed an injection site reaction to include soreness, warmth, erythema and swelling. The patient was treated with antibiotics and an on unspecified date recovered fully. The patient experienced was considered to be other important medical event by the reporter (OMIC). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult (age and gender not reported) patient who in approximately in October 2005 ("over the last month"), was vaccinated intramuscularly with a 0.5 mL dose pneumococcal 23 v polysaccharide vaccine (Lot # 649695/0512P). Subsequently, on an unspecified date, the patient developed an injection site reaction to include soreness, warmth, erythema and swelling. the patient was treated with antibiotics and on an unspecified date recovered fully. The patient experience was considered to be an other important medical events (OMIC) by the reporter. additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with an allergy to the flu vaccine who on 24May06 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 653284/0002P). That same day, post immunization, the pt experienced an anaphylactic reaction and was hospitalized. She was treated with epinephrine and diphenhydramine (Benadryl). Subsequently, the pt recovered. Anaphylactic reaction was considered to be an other important medical event (OMIC) and immediately life threatening. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Blood urine, Cellulitis, Feeling hot, Hypokalaemia
Clinical narrative: Initial information (via a company rep) and follow up information has been received from a physician, concerning a 45 yr old white female, with no known medical history and no known drug reactions/allergies reported, who on 05May06 was vaccinated SC in the right arm with a first dose of pneumococcal 23v polysaccharide vaccine (650644/0004F). Concomitant therapy included vancomycin. It was previously reported that on 05May06 after receiving the immunization the pt developed cellulitis. It was reported that the pt experienced redness, swelling and pain to her arm. Follow up information from the physician indicated that on 06May06 the pt contacted the doctor about fever and red painful arm at the injection site. The doctor notified infusion center and they met with the pt. The pt was given vancomycin, IV. The pt was seen in the doctor's office and reported that the right arm upper area was red and hot to touch. The area was approx 20cm x 10 cm and marked. The pt returned on 07May06 for more vancomycin and it was noted that the pt had slightly decreased red area. The doctor saw the pt again on 08May06. On 08May06 the pt had a complete blood count, urinalysis, and chemistry performed. The results are as follows: Complete Blood count (WBC 10.9 K/mm3 high, SEGS 83.2% high, Lymphocytes 9.5% low); Hematology (ESR 45 mm/hr high); Urinalysis (occult blood 10/microL high; RBC 10-20/HPF abnormal, other findings few budding yeast); chemistry (potassium 3.4 mEq/L low). All other results were within normal expected range. The pt received daptomycin 4mg/kg IV. On 09May06 the pt was seen and it was noted that the arm greatly improved. It was reported that the pt had a fever of unk origin at the time of vaccination. The pt recovered on an unspecified date. No product quality complaint was involved. The pt's experiences were considered to be an other important medical event (OMIC). Additional information is not expected.