chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old female who on 9/23/02 at 14:00 was vaccinated IM in the right arm with a dose of pneumococcal vaccine 23 polyvalent (642719/0376M). There was no illness at the time of vaccination. Concomitant medications included Levsin, Synthroid, Ativan and nortriptyline. On 9/25/02 the pt was seen in the doctor's office with erythema of the upper arm from the inner aspect to the outer aspect, 5x7cm around the vaccination site, which had started on 9/24/02 at 17:00. No treatment was ordered. It was also reported that another pt (WAES0209USA02591), vaccinated on the same date and from the same lot, developed similar symptoms. Additional info has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Congenital arterial malformation, Headache, Myalgia, Nausea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 40 year old female pt with chronic obstructive pulmonary disease who on 9/11/02 at 9:30am was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (642722/0165M). The nurse reported that, following the vaccination, the pt developed a swollen black and blue bagel-like area several inches below the site of the injection. The pt also experienced a headache, nausea, myalgia, and radiating pain up her arm and neck. Unspecified medical attention was sought, however, the pt did not require hospitalization. At the time of this report, the outcome of the events was unknown. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Conflicting follow-up info received from the licensed practical nurse revealed that the pt was vaccinated IM in the right deltoid with pneumococcal vaccine 23 polyvalent (641115/1159L). The nurse reported that on 9/12/02 at 8:30am the pt experienced injection site soreness, warmth, erythema, swelling, and induration, and nausea, arhtralgias, myalgias, headache, urticaria, and joint pain. No further details were provided, and at the time of this report, the outcome of the events was unknown. The LPN also reported that tow other patients experiences after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0210USA00559 and 0210USA00560). No further info is expected.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Oedema peripheral, Pain, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 40 year old female pt with chronic obstructive pulmonary disease who on 9/11/02 at 9:30am was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (642722/0165M). The nurse reported that, following the vaccination, the pt developed a swollen black and blue bagel-like area several inches below the site of the injection. The pt also experienced a headache, nausea, myalgia, and radiating pain up her arm and neck. Unspecified medical attention was sought, however, the pt did not require hospitalization. At the time of this report, the outcome of the events was unknown. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Conflicting follow-up info received from the licensed practical nurse revealed that the pt was vaccinated IM in the right deltoid with pneumococcal vaccine 23 polyvalent (641115/1159L). The nurse reported that on 9/12/02 at 8:30am the pt experienced injection site soreness, warmth, erythema, swelling, and induration, and nausea, arhtralgias, myalgias, headache, urticaria, and joint pain. No further details were provided, and at the time of this report, the outcome of the events was unknown. The LPN also reported that tow other patients experiences after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0210USA00559 and 0210USA00560). No further info is expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Balance disorder, Dizziness, Headache, Myalgia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old female pt with no past medical history who on 9/23/02 was vaccinated IM in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (642722/0165M). There was no illness at the time of vaccination. The nurse reported that following vaccination, the pt developed a swollen bagel-like area several inches below the site of injection. The pt also experienced a headache, nausea, myalgia, and radiating pain up the arm and neck. The pt also had severe vomiting for 6 hrs. Unspecified medical attention was sought, however, the pt did not require hospitalization. At the time of this report, the outcome of the events was unknown. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Conflicting follow up info was received from the licensed practical nurse who reported that on 9/23/02 the pt was vaccinated with pneumococcal vaccine 23 polyvalent. The nurse reported that on 9/23/02, the pt experienced radiating arm pain that went to the jaw and head. The pt also experienced headahce, dysequilibrium, dizziness, fever, weakness and vomiting for > 3 days which at the time of this report was still occurring. The LPN also reported two other patients experiences after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0210USA00259 and 0210USA00560). No further info is expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Neck pain, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old female pt with no past medical history who on 9/23/02 was vaccinated IM in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (642722/0165M). There was no illness at the time of vaccination. The nurse reported that following vaccination, the pt developed a swollen bagel-like area several inches below the site of injection. The pt also experienced a headache, nausea, myalgia, and radiating pain up the arm and neck. The pt also had severe vomiting for 6 hrs. Unspecified medical attention was sought, however, the pt did not require hospitalization. At the time of this report, the outcome of the events was unknown. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Conflicting follow up info was received from the licensed practical nurse who reported that on 9/23/02 the pt was vaccinated with pneumococcal vaccine 23 polyvalent. The nurse reported that on 9/23/02, the pt experienced radiating arm pain that went to the jaw and head. The pt also experienced headahce, dysequilibrium, dizziness, fever, weakness and vomiting for > 3 days which at the time of this report was still occurring. The LPN also reported two other patients experiences after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0210USA00259 and 0210USA00560). No further info is expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old female pt with no past medical history who on 9/23/02 was vaccinated IM in the left deltoid with the first dose of pneumococcal vaccine 23 polyvalent (642722/0165M). There was no illness at the time of vaccination. The nurse reported that following vaccination, the pt developed a swollen bagel-like area several inches below the site of injection. The pt also experienced a headache, nausea, myalgia, and radiating pain up the arm and neck. The pt also had severe vomiting for 6 hrs. Unspecified medical attention was sought, however, the pt did not require hospitalization. At the time of this report, the outcome of the events was unknown. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Conflicting follow up info was received from the licensed practical nurse who reported that on 9/23/02 the pt was vaccinated with pneumococcal vaccine 23 polyvalent. The nurse reported that on 9/23/02, the pt experienced radiating arm pain that went to the jaw and head. The pt also experienced headahce, dysequilibrium, dizziness, fever, weakness and vomiting for > 3 days which at the time of this report was still occurring. The LPN also reported two other patients experiences after being vaccinated with pneumococcal vaccine 23 polyvalent (WAES0210USA00259 and 0210USA00560). No further info is expected.
Age: 75.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Info has been received from a registered nurse concerning a 75 year old female pt with no known allergies, who on 10/11/2002 was vaccinated in the arm with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). The 1st dose of pneumococcal vaccine 23 polyvalent was administered in approx 1993. Concomitant vaccination with the 2nd dose included a dose of influenza virus vaccine in the other arm. On 10/12/2002 the pt developed a rash on her abdomen. By 10/13/2002 the rash was on her back from her neck to her buttocks, and on both of her arms down to her wrists. Medical attention was sought. On 10/13/2002 the pt was hospitalized, but no diagnosis was given. The pt was treated with antibiotics and was discharged from the hospital on 10/16/2002. The nurse reported that the pt was told, "never to have a flu shot again". Additional info has been requested.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Rash
Clinical narrative: Info has been received from a registered nurse concerning a 52 year old female employee with no known allergies and a past medical history of pneumonia, who on 10/14/2002 was vaccinated in the left arm with a 2nd dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). The 1st dose was administered in approx 1993. Concomitant vaccination with the 2nd dose included a dose of influenza virus vaccine in the right arm. By 10/16/2002 the pt had developed a rash and cellulitis on her left arm. The pt went to her doctor who prescribed antibiotics and cortisone cream, but she did not use the cream. Additional info has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 46 year old female who on 10/15/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent 0.5 ml SQ in right deltoid (lot #642722/0165M). Concomitant therapy included ethinyl estradiol - norethindrone acetate (Femhrt). On 10/16/2002, the pt developed an injection site reaction described as 2 small, red, raised areas and a larger area one inch below the injection site and an even larger red area approx 2.5 x 4cm on anterior aspect of upper arm, all areas were red and warm to touch. The pt also experienced warmth and pain in her right arm from her elbow to her shoulder. The nurse instructed the pt to apply ice and take diphenhydramine hydrochloride (BENADRYL) 25 mg orally. After 2 days the pt recovered from the injection site reaction. No further info is expected. Unspecified medical attention was sought.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a consumer from a medical office concerning a 69 year old female who on Oct 8, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #642749/011M). In Oct 2002, the patient developed injection site reaction that developed into cellulitis. The patient sought unspecified medical attention. The reporter provided information regarding three other patients (WAES0210USA01938,0210USA02078, and 0210USA02079). Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Info has been received from a pharmacist and a woman in a medical office concerning a 59 year old female who on 10/17/2002 at 10:00 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #642749/0111M). Concomitant therapy included influenza virus vaccine (FLUZONE) (lot #V0875AA). On 10/17/2002 at 16:00 the pt developed significant redness and swelling at the injection site (left shoulder/arm). It was noted that there was also "fever at the injection site". The health professional reported that an ER/doctor visit was required, and subsequently, the pt recovered from the experience. No additional info is expected.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Face oedema, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 10/11/02 was vaccinated in the left arm with a first dose of pneumococcal vaccine 23 polyvalent (641531/1352L). Concomitant therapy included a dose of the influenza virus vaccine. On approximately 10/12/02, within 24 hours of the vaccine administration, the pt developed an injection site reaction and her face swelled. The pt sought medical attention and was treated with meclizine and prednisone. Additional info has been requeste.
Age: 90.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Pruritus
Clinical narrative: Info has been received from a pharmacist concerning a 90 year old female who on 12/17/2001 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (lot #637093/0802L). Concomitant therapy included a dose of the influenza virus vaccine (manufacturer unknown). Subsequently, the pt developed itching and swelling at the injection site in the left arm. The pt sought medical attention and was treated with fexofenadine (ALLEGRA) and ice. Additional info has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 49-year-old white female patient with a history of asthma who on 10/24/2002 at 8:30 am was vaccinated SC in the right arm with a second dose of pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M).  The patient developed a cellulitis type reaction with redness, itching, and swelling in the injected arm.  The symptoms subsided in a few days.  No hospitalization was required.  Unspecified medical attention was sought.  Follow-up information from the registered nurse indicated that at 4:00 pm on 10/24/2002 the patient developed cellulitis of the right arm and was given dirithromycin (DYNABAC) (250mg).  The patient recovered on 10/27/2002.  The reporter also indicated that another female patient experienced the same event while on therapy with pneumococcal vaccine 23 polyvalent (Lot # 643251/0445M) (MSD) (WAES # 0301USA02039).  No further information is expected.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a RN concerning a 78 year old female pt with spinal stenosis, hypertension, myelodysplasia and a history of a cerebrovascular accident who on 10/24/02 at 14:30pm was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (641531/1352L or 643504/0735M). Concomitant vaccine therapy included a dose of influenza virus vaccine (Fluzone) in the left deltoid (U0872AG). Concomitant therapy included Vioxx 25mg daily, Norvasc 5mg dialy, diovan HCT, Detrol and iron pills. There was no illness at the time of vaccination. On 10/24/02 at 16:00 pm, the pt developed acute swelling, exquisite tenderness and moderate erythema of the right deltoid. Subsequently, the pt recovered. Unspecified medical attention was sought. Additional info has been requested.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Information has been received from a RN concerning a 78 year old female pt with diabetes mellitus who on 10/16/02 at 10am was vaccinated IM in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (641531/1352L or 643504/0735M). Concomitant vaccine therapy included a dose of influenza virus vaccine (Fluzone) given IM in the left deltoid (UC892AS). There was no illness at the time of vaccination. On 10/16/02 at 16:30pm the pt's husband called her physician's office and reported that at 14:00pm her right arm became swollen and quite painful. It was reported that it resolved in a few days with ice and ibuprofen. Subsequently, the pt recovered. Additional info has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure decreased, Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: Information has been received from an office worker and physician concerning a 52 year old white female with hypothyroidism who just finished treatment for ovarian cancer and has allergies to penicillin, cephalexin, tetracycline, clarithromycin, erythromycin, Dextran, Methogen and Telectin. During exercise the patient does not flush or get hives but feels very itchy, which her physician determined may be some sort of histamine release. On 10/29/02 the patient was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent IM in the right deltoid (640577/0995L). On the same day the patient was vaccinated with the influenza virus vaccine 0.5cc, IM, in the left deltoid (U0933AA). On 10/29/02 the patient developed erythema, redness, soreness, edema, and weakness in the injected arm. She further reported that the injected arm was painful to move for four days. The patient reported a fever of 100 degrees F. On 10/30/02 the patient was seen in the office. Her blood pressure was 106/68, pulse 64 and temperature 98.3. The upper aspect of the right arm had some swelling and erythema. No axillary nodes noted. The area was tender to touch, no bruising. It was painful for the patient to lift her arm. No high fever and no prior pneumonia vaccine was administered. The patient was treated with ice, ibuprofen 600mg three times a day and fexofenadine 60mg twice a day. By 11/6/02, or sooner, the patient recovered without incident. The physician felt the events were related to the pneumonia vaccine. No further information is expected.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from an office worker and physician concerning a 52 year old white female with hypothyroidism who just finished treatment for ovarian cancer and has allergies to penicillin, cephalexin, tetracycline, clarithromycin, erythromycin, Dextran, Methogen and Telectin. During exercise the patient does not flush or get hives but feels very itchy, which her physician determined may be some sort of histamine release. On 10/29/02 the patient was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent IM in the right deltoid (640577/0995L). On the same day the patient was vaccinated with the influenza virus vaccine 0.5cc, IM, in the left deltoid (U0933AA). On 10/29/02 the patient developed erythema, redness, soreness, edema, and weakness in the injected arm. She further reported that the injected arm was painful to move for four days. The patient reported a fever of 100 degrees F. On 10/30/02 the patient was seen in the office. Her blood pressure was 106/68, pulse 64 and temperature 98.3. The upper aspect of the right arm had some swelling and erythema. No axillary nodes noted. The area was tender to touch, no bruising. It was painful for the patient to lift her arm. No high fever and no prior pneumonia vaccine was administered. The patient was treated with ice, ibuprofen 600mg three times a day and fexofenadine 60mg twice a day. By 11/6/02, or sooner, the patient recovered without incident. The physician felt the events were related to the pneumonia vaccine. No further information is expected.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female patient with no medical history and no allergies who on 10/26/02 at 10AM was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccine therapy included a dose of influenza virus vaccine (lot # E301126A) IM in the right deltoid. There was no illness at the time of vaccination. One hour after the patient received the injection her arm immediately developed some slight swelling. It continu8ed to swell and became hot and inflamed. The patient was diagnosed with cellulitis. On 1/27/03, it was reported that the patient was evaluated at a physician's office on 10/20/02 and treated with dicloxacillin for one week and had not called regarding this matter since that day. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Info has been received from a physician concerning a 75 year old (previously reported as 73 year old) female with no past medical history and no known allergies who in 1997 and on 10/14/2002 (previously reported as 10/15/2002) was vaccinated with the 1st and 2nd doses respectively of pneumococcal vaccine 23 polyvalent in the left deltoid (lot #640981/1050L). Concomitant therapy, that same day, included a dose of influenza virus vaccine (FLUVIRIN) given in the right deltoid (lot #E33362GA). Other concomitant therapy included warfarin sodium (COUMADIN), diltiazem hydrochloride (CARDIZEM CD), terazosin hydrochloride (HYTRIN), oxybutyninCl (DITOPAN), and atorvastatin calcium (LIPITOR). There was no illness at the time of vaccination. On 10/15/2002, the pt developed "severe swelling and soreness" which was "hot to touch" at the injection site. The left arm was red and warm with edema from the deltoid to the wrist. On 10/17/2002, the pt presented to her physician's office with "cellulitis". On 10/20/2002, the pt recovered. No further info is available.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Info has been received from a 50-year-old female with hypertension and a penicillin allergy who on 10/29/2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination the same day included a dose of influenza virus vaccine given in the left arm. Other concomitant therapy included hydrochlorothiazide (manufacturer unknown), atenolol and fosinopril sodium (MONOPRIL). On 10/29/2002 on the return home from her vaccination, the pt developed extreme swelling, fever and chills. Unspecified medical attention was sought. As of 11/06/2002, the pt had not recovered. On 11/11/2002 the pt reported that her right arm was getting better but still had some bruising. The swelling had gone down. The pt reported that she was having these reactions in the arm that was vaccinated with pneumococcal vaccine 23 polyvalent. Additional info has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 71 year old female patient who on Oct 10, 2002 at 15:30 was vaccinated IM in the upper right thigh with a first dose of pneumococcal vaccine 23 polyvalent (Lot# 640577/0995L). It was noted that the patient was on "other medications" but that she had "no other immunizations." On Oct 11, 2002 the patient was seen in the doctor's office because the site had become hot and swollen on Oct 10, 2003 in the PM. The oatient was treated with ice, applied topically. It was noted that the reporter had called to request replacement ofthe multiple dose vial ifthis vaccine because this patient and one other (WAES0210USA02758) had "developed local reactions to the injections from that vial"> The physician's office "has not heard from the patients since." The records oftesting prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with standards of the evaulation and research and was released. Follow up information indicated that the erythema developed within 24 hours of the vaccination and that the patient's symtoms resolved after 48 hours.  No other information is expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Info has been received from a medical assistant concerning a 71-year-old female pt who on 10/10/2002 at 10:30 AM was vaccinated IM in the right deltoid with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot #640577/0995L). It was noted that the pt was on "other medications" but that she had "no other immunizations." On 10/10/2002 in the PM the pt was seen in the doctor's office because the site had become hot and swollen. It was noted that there was erythema at the site within 24 hours after injection. The pt was treated with ice, applied topically. It was noted that the reporter had called to request replacement of the multiple dose vial of this vaccine because this pt and one other (WAES #0210USA01416) had "developed local reactions to the injections from that vial." The physician's office "has not heard from the pts since." The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up info indicated that the pt's symptoms resolved after 48 hours. No further info is expected.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: information has been received from a health professional concerning a 44 year old female patient with a history of asthma and no illness at time of vaccination who on Nov 21, 2002 was vaccinated subcutaneously in the left arm with a first doe of pneumococcal vaccine 23 polyvalent (lot #643503/0541M). Concomitant therapy on Nov 21, 2002 included an intramuscular dose in the right arm influenza virus vaccine (Fluvirin) (lot # E8162GA) (it was noted that the patient had several previous doses). On Nov 22, 2002, the patient developed cellulitus in the left arm at the injection site for two days. The patient was treated with antibiotics and subsequently recovered. It was also reported that one male (WAES0212USA00380) and two other female patients (WAES0211USA02439) developed cellulitus at the injection site. The symptoms of two of the patients cleared up without event. Two patients were seen over the weekend within "a day or two of injections" and at the time of this report follow up had not occurred. No further information is expected.
Age: 13.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Pyrexia
Clinical narrative: Info has been received from a licensed practical nurse concerning a 13 year old pt who on 11/13/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot #643504/0735M). On 11/15/2002 the pt developed weakness and a fever of 102.5. Unspecified medical attention was sought. The pt's experience resolved in a few days. The reporter mentioned that a 2nd pt also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (MSD) (Lot #643504/0735M) (WAES #0301USA00179). Additional info has been requested. Follow up: The reporter mentioned that the pt's subling also had an experience following vaccination with pneumococcal vaccine 23 polyvalent (MSD) (Lot #643504/0735M) (WAES #0301USA00179). Additional info is not expected.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, TTOX
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a registered nurse concerning a 72 year old male on therapy with aspirin, a history of a pneumococcal vaccination (manufacturer unknown) (date unspecified) and "with no other past medical history" who on 10/08/2002 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0045M) and vaccinated, in the same arm, with concomitant suspect therapy tetanus toxoid. On 10/09/2002, 24 hours after administration, the pt developed redness and swelling in the arm that was injected. The pt was treated with a cold compress and diphenhydramine (BENADRYL), oral administration. The outcome of the pt's redness and swelling was unknown. The reporter expressed a concern regarding the lot number. Conflicting info has been received from a registered nurse. The registered nurse reported that on 10/08/2002 the pt was vaccinated IM in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent and vaccinated IM in the right deltoid with a dose of influenza virus vaccine (FLUZONE) (lot #U0913AA). The nurse also reported that on 10/08/2002, in the evening after the vaccination, the pt's arm that received the pneumococcal vaccine 23 polyvalent injection became red, swollen, painful and warm to touch. The area of inflammation extended from the deltoid to the wrist. The nurse recommended cold compresses, elevation and ibuprofen (ADVIL) to the pt, and subsequently, the symptoms lasted 3-4 days, then subsided. No additional info is expected. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported on 2 other patients that experienced a similar reaction (WAES #0210USA01284) and (WAES #0210USA01872).
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Information ahs been received from a registered nurse concerning a 75 year old male with no known drug allergies and no past medical history who on Oct 01, 2002 at 02:00pm was vaccinated IM in the right deltoid with a second dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M), and vaccinated IM in the left deltoid with a dose of influenza virus vaccine (Fluzone) (Lot #U0913AA). There was no illness at the time of vaccination. It was reported that the patient received a prior dose of pneumococal vaccine 23 polyvalent "a long time ago". On Oct 02, 2002, at 07:00pm, "24 hours after administration", the patient developed redness and swelling in the arm that was injected. The patient was treated with a cold compress and diphendramine HCL (Benadryl),oral administration. The outcome of the patient's redness and swelling was unknown. The reporter expressed a concern regarding the lot number. Conflicting information has been received from a registered nurse. The registered nurse reported that on Oct 01, 2002 at 07:00pm, "in the evening after the injection", the patient developed redness and swelling of his right arm, from the deltoid muscle down to his wrist, involving all but the inner aspect of his upper arm. The registered nurse also reported that there was fluid accumulation around the elbow, some tenderness of the elbow, and discomfort on moving. The patient was advised elevation, ice and ibuprofen (Advil). The patient's experience lasted 3-4 days, and subsequently , the patient recovered. It was reported to be unknown if laboratory diagnostics were performed. No additional information is expected. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the evaluation and research and was released.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Pain
Clinical narrative: Info has been received from a 73 year old female with no known allergies who on approx 10/28/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included isosorbide mononitrate (IMDUR) and diltiazem hydrochloride. Within a few minutes of being vaccinated on approx 10/28/2002, the pt experienced severe pain in her upper arm in an area about the size of her hand and stated that "sometimes the pain shoots through her chest." She further reported that the area was not swollen and there was no rash. The pt tried warm compresses and "pain medications" (therapy unspecified) however, as of 11/18/2002, she stated that "the pain (had) not subsided)." The pt sought unspecified medical attention. Additional info has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV, TTOX
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Info has been received from a registered nurse concerning a 71 year old female with a history of pneumonia and vaccination with a pneumococcal vaccine (manufacturer unknown) (date unspecified) who on 10/08/2002 was vaccinated IM in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and vaccinated, in the same arm, with a dose of concomitant suspect therapy tetanus toxoid. On 10/09/2002, 24 hours after administration, the pt developed redness and swelling in the arm that was injected. The pt was treated with a cold compress and diphenhydramine HCl (BENADRYL), oral administration. The outcome of the pt's redness and swelling was unknown. The reporter expressed a concern regarding the lot number. Conflicting info has been received from a registered nurse. The registered nurse reported that on 10/08/2002 the pt was vaccinated at 14:00 IM in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (lot #643251/0445M) and vaccinated IM in the right deltoid with a dose of influenza virus vaccine (FLUZONE) (lot #U0913AA). The nurse also reported that on 10/08/2002 at 19:00 in the evening after the vaccination, the pt's arm that received the pneumococcal vaccine 23 polyvalent became red, swollen, painful and warm to touch. The affected area extended from the deltoid muscle to the elbow. The pt was treated with cold compresses, and subsequently, the pt recovered. No additional info is expected. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The nurse also reported that 2 other patients experienced similar reactions (WAES #0210USA01873) and (0210USA01284).
Age: 10.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site mass, Rash, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year old male patient with ADHD and allergies to cefaclor (Ceclor), cefprozil (Cefzil),lorcarbef (Lorabid) and cefpodoxime proxetil (Vantin) who on Nov 13, 2002 at 10:15 was vaccinated intramuscularly in the right anterior thigh with a first dose of pnemococcal vaccine 23 polyvalent (lot#643504/0735M). Concomitant vaccination included an intramuscular seventh dose in the left anterior thigh of influenza virus vaccine (Fluzone) (lot #U0971AA). There was no illness at the time of vaccination. On Nov 15, 2002 in the am, the patient developed a "big red welt" also described as a "knot" at the injection site on the right anterior thigh. The patient also developed a rash on the left anterior thigh. the patient was afebrile. The patient was treated at home by the mother who is a medical doctor. On Nov 19, 2002, the patient recovered. The reporter mentioned that the patient's sibling also had a experience following vaccination with pneumococcal vaccine 23 polyvalent (lot #643504/0735M) (WAES0211USA02555). Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain, Rash
Clinical narrative: Information has been received from a woman in a physician's office concerning a 27 year old female patient who on Dec 03, 2002 at 2:00 pm was vaccinated by intramuscular injection in the left deltoid with a dose of pneumcoccal vaccine 23 polyvalent (lot #644107/0955M). Concomitant therapy given at same time included vaccination by an intramuscular injection in the right deltoid with a dose of influenza virus vaccine (Fluvirin) (lot # reported as E33902HA). The reporter indicated the patient called the clinic office at 14:30 on Dec 4, 2002 and reported her left arm was "red with rash", and she had pain in the vaccinated arm, which was described as "left arm hurt a lot." It was also indicated she had swelling in the vaccinated arm. it was noted the physician office told her to apply an ice pack and take acetaminophen (Tylenol). The reporter indicated the patient was instructed to return to the clinic if she was not better. It was reported that the patient recovered. the reporter has requested a lot check. The records of testing prior to release of this lot have been checked by compliance and found to be satisfactory. The lot complies with the standards of the center for evaluation and research and was released. The reporter mentioned another patient also had experience following vaccination with pneumococcal vaccine 23 polyvalent (WAES021201636).
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Diarrhoea, Hypokinesia, Malaise, Pain, Peripheral coldness
Clinical narrative: Info has been received from a licensed visiting nurse concerning a 44-year-old male pt with diabetes and hypercholesterolemia and an allergy to amoxicillin (manufacturer unknown) who on 12/11/2002 at 4:00 PM was vaccinated IM in the left deltoid with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643783/0709M). Concomitant medication included glyburide (+) metformin hydrochloride (GLUCOVANCE) (500 mg tab-2 po q AM and 1 q PM), ramipril (ALTACE) (2.5 mg cap-1po qd) and atorvastatin calcium (LIPITOR) (10mg tab-1 po HS). There was no illness at the time of vaccination. On 12/12/2002 at 12:00 PM the pt presented to the doctor's office with complaints of ankle pain, rib pain, deep neuralgia pain, unusually cold hands and loose stools. It was reported that the office had to put on the pt's shirt because he was unable. The report indicated that the doctor plans to treat the pt with ibuprofen and may do bloodwork.  Follow up info was received from a licensed visiting nurse indicated that the pt woke up at midnight on 12/12/2002 with left arm pain. He could not move his arm, elbow or shoulder due to the pain. He then developed malaise, pain down the arm, and diarrhea x1 stool. His left deltoid became warm to touch and the pt complained of coldness in his left hand and pain in his lateral ankle joint and rib. On 12/13/2002, it was noted that the pt was doing better and had less pain, but his hands were still cold. The overall report from the pt indicated that he was doing better. The reporter indicated that the pt recovered "a few days later". Relevant laboratory data included a high white blood cell count at 15.5, red blood cell count at 5.87, CK was normal, and they will repeat a CBC in a few weeks. No further info is expected.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Medication error
Clinical narrative: Information has been received from a RN concerning a male who on 10/29/02 at 9:40am was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (644103/0710M) instead of receiving a tuberculin purified protein derivative skin test. There was no illness at the time of vaccination. On 10/29/02 at 16:30pm the pt developed an area of redness measuring 2 inches by 1.5 inches at the site. It was reported that the pt had no fever and no treatment was required. Subsequently, the pt recovered. Additional info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a registered nurse concerning a female registered nurse with no medical history and no allergies who on Oct 29, 2002 at 09:30am was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (lot#644103/0710M) instead of receiving a tuberculin purified protein derivative skin test. There were no concomitant medications. There was no illness at time of vaccination and there was no adverse events following priori vaccinations. On Oct 29, 2002 at 16:00pm the patient reportedly had an inflammatory reaction describes as an area of soreness and redness measuring 2 x 2, with a nine inch red line up the arm towards the axilla. There was no fever present. The patinet was treated with celecoxib (Celebrex) by her own physician. Subsequently, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Medication error
Clinical narrative: Information has been received from a RN concerning a female with no medical history and no allergies who on 10/29/02 at 9:30am was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (644103/0710M) instead of receiving a tuberculin purified protein derivative skin test. There was no concomitant medication. There was no illness at the time of vaccination and there were no adverse events following prior vaccinations. On 10/29/02 at 16:00pm the pt developed redness at the site measuring 2 inches x 1 3/4 inches and 1 inch going up the arm. The pt was sent to her medical doctor and was started on Zithromax 500mg stat and then one daily for four days. Subsequently, the pt recovered. Additional info is not expected.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Medication error
Clinical narrative: Information has been received from a RN concerning a female who on 10/29/02 at 9:30am was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (644103/0710M) instead of receiving a tuberculin purified protein derivative skin test. There was no illness at the time of vaccination and there were no adverse events following prior vaccinations. On 10/30/02 the pt developed redness measuring 2.5 inches by 1.5 inches. There was no fever present. It was reported that on 11/4/02 the pt recovered. Additional info is not expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Medication error
Clinical narrative: Information has been received from a RN concerning a 52 year old female mental health social worker who on 10/29/02 at 9:30am was vaccinated intradermally in the left forearm with a second dose of pneumococcal vaccine 23 polyvalent (644103/0710M), instead of receiving a tuberculin purified protein derivative skin test. There were no adverse events following prior vaccinations. There was no illness at the time of this vaccination. On 10/30/02 at 8am, the pt developed an area of redness measuring 3 inches by 4 inches on her forearm. It was reported that no treatment was required. Subsequently, on 11/4/02, the pt recovered. Additional info is not expected.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Medication error
Clinical narrative: Information has been received from a RN concerning a 32 year old female mental health worker who on 10/29/02 at 9:30am was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (644103/0710M) instead of receiving a tuberculin purified protein derivative skin test. There were no adverse events following prior vaccinations. There was no illness at the time of this vaccination. On 10/30/02 at 8am, the pt developed an area of redness measuring 1 inch by 1 inch at the site. It was reported that the pt had no fever and that no treatment was required. Subsequently, on 11/8/02, the pt recovered. Additional info is not expected.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site pain, Medication error
Clinical narrative: Information has been received from a RN concerning a 29 year old female with a history of pleurisy who on 10/29/02 at 9:30am was vaccinated intradermally in the left forearm with a first dose of pneumococcal vaccine 23 polyvalent (644103/0710M) instead of receiving a tuberculin purified protein derivative skin test. There was no concomitant medications. There was no illness at the time of vaccination. On 10/29/02 at 15:30pm the pt complained of pain and soreness at the site. It was reported that the pt was seen that afternoon and given a 4mg dose pack  of prednisone. On the night of 10/29/02, the pt complained of chest pain and was advised by the reporter to see her primary care physician or go to the local ER if the symptoms continued. It was reported that the pt did not follow up with her physician until 10/31/02. The treating physician did not indicate any treatment for the chest pain, just a note reporting that she had been seen. The pt returned to work on 11/4/02. Subsequently, the pt recovered. Additional info is not expected.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Arthralgia, Chills, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Info has been received from a registered nurse concerning a 68 year old female pt who was vaccinated with the "first documented" dose of pneumococcal vaccine 23 polyvalent (lot #641329/1264L). Subsequently, 6 hours after administration, the pt developed chills, sweating, low grade fever, arm pain, swelling and redness. The swelling reportedly "remitted 3 days later," but still had joint pain. The pt sought unspecified medical attention. It was also reported that 2 other pts (WAES #0210USA02453 and 0211USA01412) experienced symptoms after vaccination with pneumococcal vaccine 23 polyvalent. Additional info has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site swelling, Nausea, Pyrexia
Clinical narrative: Info has been received from a registered nurse concerning a 68 year old female pt who was vaccinated with the "first documented" dose of pneumococcal vaccine 23 polyvalent (lot #641329/1264L). Subsequently, 6 hours after administration, the pt developed chills, sweating, low grade fever, arm pain, swelling and redness. The swelling reportedly "remitted 3 days later," but still had joint pain. The pt sought unspecified medical attention. It was also reported that 2 other pts (WAES #0210USA02453 and 0211USA01412) experienced symptoms after vaccination with pneumococcal vaccine 23 polyvalent. Additional info has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Info has been received from a registered nurse concerning a 68 year old female pt who was vaccinated with the "first documented" dose of pneumococcal vaccine 23 polyvalent (lot #641329/1264L). Subsequently, 6 hours after administration, the pt developed chills, sweating, low grade fever, arm pain, swelling and redness. The swelling reportedly "remitted 3 days later," but still had joint pain. The pt sought unspecified medical attention. It was also reported that 2 other pts (WAES #0210USA02453 and 0211USA01412) experienced symptoms after vaccination with pneumococcal vaccine 23 polyvalent. Additional info has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: Info has been received from a registered nurse concerning a 68 year old female pt who was vaccinated with the "first documented" dose of pneumococcal vaccine 23 polyvalent (lot #641329/1264L). Subsequently, 6 hours after administration, the pt developed chills, sweating, low grade fever, arm pain, swelling and redness. The swelling reportedly "remitted 3 days later," but still had joint pain. The pt sought unspecified medical attention. It was also reported that 2 other pts (WAES #0210USA02453 and 0211USA01412) experienced symptoms after vaccination with pneumococcal vaccine 23 polyvalent. Additional info has been requested.