chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old male with a history of high cholesterol who on 26-DEC-2006 was vaccinated with the first dose of Pneumovax 23 (lot #655152/0889F), 0.5 mL, IM in the left deltoid.  Concomitant therapy included niacin.  On 28-DEC-2006, the patient presented to the physician's office with cellulitis at the injection site which included redness and swelling after receiving Pneumovax 23 on 26-DEC-2006.  The patient was treated with antibiotics (cephalexin).  On an unspecified date, the patient recovered from the cellulitis at the injection site.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Rash
Clinical narrative: Information has been received from a consumer concerning her grandfather with no reported allergies and no pertinent medical history, who in November 2006, was vaccinated with one dose of Pneumovax 23.  It was reported the patient received the Pneumovax 23 by "oral" route.  It was reported that "soon after the vaccination" was given, the patient's arm swelled and he had a rash on most of the arm.  The reporter thought that the patient may have been diagnosed with pneumonia a few days ago.  The patient sought unspecified medical attention.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 12 month old male patient who on 28-DEC-2006 was vaccinated intramuscularly into the right thigh with a 0.5 mL dose of Pneumovax 23.  No problems have been reported.  In follow-up it was reported, that the patient should have been given the 4th series vaccine of PREVNAR but was mistakenly given Pneumovax 23.  The patient did not experience any adverse event and was doing fine to date.  The vaccines were stored next to each other in the refrigerator and the wrong vaccine was picked out.  The nurse practitioner stated that since this episode occurred the Pneumovax 23 and the PREVNAR have been moved/separated, so this mix up doesn't occur again.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 68 year old male with pulmonary problems (not specified) who on 20-DEC-2006 was vaccinated with Pneumovax 23 (Lot # 655499/0988F). It was reported that the patient presented back to the office on 21-DEC-2006 with fever and an injection site reaction which was sore, red, and swollen. At the time injection site reaction which was sore, red, and swollen. At the time of the report, the patient had recovered (date unknown). A lot checked of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with a history of lung problem unspecified who on 20-DEC-2006 was vaccinated with Pneumovax 23 (lot # 655499/0988F). There was no concomitant medication reported. On 21-DEC-2006, the patient presented back to the office with fever, and an injection site reaction which was sore, red, and swollen. On a unspecified date, the patient recovered from fever and the injection site reaction (sore, red, and swollen). The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 45 year old male with a history of lung disorder unspecified who on 20-DEC-2006 was vaccinated with Pneumovax 23 (lot # 655499/0988F).  No concomitant therapy was reported.  On 21-DEC-2006, the patient sought medical attention and presented back to the office with fever and an injection site reaction which was sore, red, and swollen.  On an unspecified date, the patient recovered from fever and injection site reaction (sore, red, and swollen).  No further information was available at the time of reporting.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a one year old male who on 17-NOV-2006 was vaccinated with Pneumovax 23 (0.5 ml) (lot # 651400/0618F), intramuscularly.  The patient was supposed to received PREVNAR.  The reporter stated that this was not a case of product confusion.  It was a mistake made due to the fact that they had just received a shipment of Pneumovax 23, which was on the shelf, and during the course of the busy day the patients were mistakenly given Prevnar.  Subsequently, the patient had not experienced any known symptoms.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Bone scan normal, Electromyogram normal, Erythema, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: Information has been received from a law office worker concerning an approximately 37 year old female with diabetes who on 19-NOV-2003 was vaccinated "in bottom part of deltoid muscle" with a second dose of Pneumovax 23 (lot 647634/0863N).  During the evening of 19-NOV-2003, the patient developed swelling and redness in her arm.  The patient reported that she had a "neuropathy disorder".  The patient also had pain and numbness in her shoulder after receiving Pneumovax 23.  The patient was treated with diphenhydramine HCl by her physician.  An electromyography and bone scan were within normal limits.  At the time of this report, the patient had not recovered.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complied with the standards of the agency and was released.  No further information is available.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Neuropathy, Oedema peripheral
Clinical narrative: Information has been received from a law office worker concerning an approximately 37 year old female with diabetes who on 19-NOV-2003 was vaccinated "in bottom part of deltoid muscle" with a second dose of Pneumovax 23 (lot 647634/0863N).  During the evening of 19-NOV-2003, the patient developed swelling and redness in her arm.  The patient reported that she had a "neuropathy disorder".  The patient also had pain and numbness in her shoulder after receiving Pneumovax 23.  The patient was treated with diphenhydramine HCl by her physician.  An electromyography and bone scan were within normal limits.  At the time of this report, the patient had not recovered.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complied with the standards of the agency and was released.  No further information is available.
Age: 4.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Local reaction
Clinical narrative: Information has been received from a physician concerning a 4 year old female with a history of recurrent sinus infections who on 03-JAN-2007 was vaccinated with the first dose of Pneumovax 23, IM in the arm.  Concomitant medication was not reported.  On 03-JAN-2007, the physician reported that the patient developed a fairly severe local reaction after receiving Pneumovax 23.  The evening after the patient received the Pneumovax 23 the injection site became edematous and erythematous which involved her entire arm.  The patient sought unspecified medical attention.  This was the patient's first vaccination with Pneumovax 23 but the patient had received PREVNAR in the distant past with no problem.  The patient's severe local reaction and injection site edematous and erythematous persisted.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female who was "recently" vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (lot 651319/1007P).  The patient was concomitantly vaccinated with influenza virus vaccine (unspecified).  Subsequently the patient developed injection site pain, redness and swelling.  The patient sought medical attention and was treated with ADVIL.  Subsequently, the patient recovered.  Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a consumer concerning her 84 year old husband who on 30-NOV-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (lot 655291/0985F).  On 30-NOV-2006, the patient developed cellulitis.  The patient sought unspecified medical attention.  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site swelling, Malaise
Clinical narrative: Information has been received from a health professional ("medical assistant") concerning an approximately 51 year old male who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (Lot# 651437/0899F).  Concomitant vaccination included a dose of influenza virus vaccine (unspecified).  Subsequently the patient developed bad swelling of the right shoulder at the injection site.  The medical assistant noted the patient was "in bad condition."  The patient was seen in the emergency room but not admitted to the hospital. It was also reported that the patient recovered (date not reported).  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with arthritis and PEDIAZOLE allergy who on 05-JAN-2007 at 10:30 AM was vaccinated with Pneumovax 23 (0.5 ml), subcutaneously in the left arm.  Concomitant therapy "a few days" prior included REMICADE (IV), in the left hand.  On 05-JAN-2007 the patient presented to the office with local site reaction of cellulitis at the injection site of the left arm.  The patient was treated with comfort measures PRN.  There were no relevant diagnostic tests or laboratory data.  At the time of the report the patient was considered to be not recovered.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Medication error
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 73 year old female patient, whose reported weight was 135 pounds and whose reported height was 62 inches with hypertension who 7 years ago, approximately in the year 2000 was vaccinated intramuscularly in the left arm with Pneumovax 23 (reportedly with no reaction reported then).  On 03-JAN-2007 the patient was vaccinated intramuscularly with another dose of Pneumovax 23 (Lot # 651329/1047P).  On 03-JAN-2007, that evening, the patient reported an injection site reaction.  The physician reported the patient developed swelling and redness from the injection site, which was in her upper arm to her elbow.  On 04-JAN-2007, the patient went to the Emergency Room (ER) because the reaction worsened and was started on KEFLEX for possible cellulitis reaction.  The patient was not admitted.  The physician also reported that one week before the vaccine was administered, the product was left at room temperature for 48 hours.  At the time of the report, the patient had recovered, and also reported as "AE" not improved.  In follow-up it was reported by the physician that the patient had "probable cellulitis" from the site of vaccination (upper arm) just above the elbow, which began 24 hours after vaccination and resolved 3-4 days later.  The patient recovered on 08-JAN-2007.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from an office worker concerning a male who was vaccinated with a dose of Pneumovax 23.  Subsequently the patient developed swelling, redness, pain and was unable to lift his arm.  The patient was treated with unspecified antibiotics.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist via a physician concerning a patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, the patient developed an injection site reaction.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Hyperhidrosis, Injection site erythema, Injection site swelling, Insomnia
Clinical narrative: Information has been received from a medical assistant concerning an elderly female (age not reported) who on 18-DEC-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) 0.5 ml.  On approximately 18-DEC-2006, the patient experienced redness and swelling of the injection site, fever of 102-103 F, insomnia, and sweating.  The patient sought medical attention.  The patient was treated with BENADRYL.  The outcome of the events was not reported.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning an elderly female (age not reported) who on 18-DEC-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) 0.5 ml.  On approximately 18-DEC-2006, the patient experienced redness and swelling of the injection site, fever of 102-103 F, insomnia, and sweating.  The patient sought medical attention.  The patient was treated with BENADRYL.  The outcome of the events was not reported.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Insomnia, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning an elderly female (age not reported) who on 18-DEC-2006 was vaccinated with Pneumovax 23 (lot # 651404/0352F) 0.5 ml.  On approximately 18-DEC-2006, the patient experienced fever 102-103 F, insomnia, sweating, redness and swelling at the injection site.  The patient sought medical attention.  The patient was treated with BENADRYL.  The outcome of the events was not reported.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a healthcare worker (unspecified) concerning a patient (age and sex not reported) who in approximately December 2006 was vaccinated with Pneumovax 23 (lot # 655499/0988F).  In approximately December 2006, the patient experienced swelling and pain at the injection site and fever.  The outcome of the events was not reported.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F).  Concomitantly, the patient was vaccinated with influenza virus vaccine (unspecified).  On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient had fully recovered from the events (date unknown).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F).  It was reported that the patient had been vaccinated with yellow fever virus vaccine two weeks prior to the Pneumovax 23.  On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient had fully recovered from the events (date unknown).  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a patient who "two to three weeks ago" was vaccinated with Pneumovax 23 (lot # 650541/1004P).  Subsequently, the patient experienced redness and soreness around the injection site.  Subsequently, the patient recovered.  This report also involved two other patients, for a total of three, and it was reported that "two of the patients developed a fever."  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a patient with no past medical history who "one to two weeks ago" was vaccinated with Pneumovax 23 (lot # 650541/1004P).  Subsequently, the patient experienced redness and soreness around the injection site.  Subsequently, the patient recovered.  This report also involved two other patients, for a total of three, and it was reported that "two of the patients developed a fever."  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Headache, Pain
Clinical narrative: Information has been received from a registered nurse concerning a patient who "this week" was vaccinated with a second dose of Pneumovax 23 (lot # 655586/0881F).  Subsequently the patient experienced aching and headache.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old male who at 9:11 AM, on 08-NOV-2006, was vaccinated intramuscularly in the left deltoid with a first dose of Pneumovax 23 (Lot# 654981/0674F).  There was no illness at the time of vaccination.  On 09-NOV-2006 the patient developed redness and swelling with extension of redness into left upper arm, down to wrist, axilla area.  It was also reported that "the injection site was within normal limits although beyond it was red".  The patient was treated with antihistamines and antibiotics.  The patient was reported to be doing well on 13-NOV-2006 and would finish antibiotics on 15-NOV-2006.  The patient was considered recovered on 15-NOV-2006.  Additional information is not expected.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 53 year old male with immunosuppression, hepatitis C, cocaine abuse and no known drug allergies who on 09-JAN-2007 was vaccinated intramuscularly in the left deltoid with a 0.5 mL dose of Pneumovax 23 (Lot # 655499/0988F).  Concomitant therapy included interferon alfa, ribavirin, hydrocortisone, loratadine, WELLBUTRIN and BENADRYL.   One hour after vaccination, the patient reported that the injection site was painful.  On 10-JAN-2007, the patient reported the injection site as painful, red, swollen, and warm.  The patient was examined on 11-JAN-2007 and the injection site was still painful, red, swollen, and warm but much better than on 10-JAN-2007.  There was no infection noted at the injection site on 11-JAN-2007 but the patient was placed on KEFLEX prophylactically.  No laboratory diagnostic studies were performed.  On 11-JAN-2007, the patient was reported as recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.9
Sex: F
Vaccine: PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 month old female who on 11-JAN-2007 was vaccinated with a dose of Pneumovax 23 (lot 651321/1036P) instead of PREVNAR.  The certified medical assistant reported that the patient was due for a dose of PREVNAR, and the vial of Pneumovax 23 was pulled by mistake due to similarity of the vials.  The patient received unspecified medical attention, and it was confirmed that the patient was "fine".  The medical assistant stated that there was a plan in place to prevent a similar incident from happening again.  No additional information is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse and physician concerning a 69 year old female with vancomycin allergy, caecal cancer (Jan 1998), non-smoker, alcohol dependence syndrome and caffeine dependence and a history of rash, hysterectomy, mitral valve prolapse with severe mitral regurgitation, subacute bacterial endocarditis x2 (Dec 1998 and 1982) gastrooesophageal reflux disease, peptic ulcer disease, gastric ulcer, benign hepatic cyst, irritable bowel syndrome, diverticulosis, scarlet fever, sleep disorder, nocturnal leg muscle cramps, multiple blood transfusions, generalised anxiety disorder, panic disorder and uterine bleeding who on 18-DEC-2006 at 14:30 was vaccinated IM into the left deltoid with a second dose of Pneumovax 23 (lot# 651374/0485F).  On 18-DEC-2006 the patient went to the ER because her doctor's office was closed.  The patient experienced injection site rash, welt at injection site, erythema left upper arm, swelling upper arm, warm to the touch, allergic reaction, left deltoid pain, and was unable to move arm.  On 19-DEC-2006 the patient experienced motor vehicle accident and neck pain.  On 02-FEB-2007 the patient experienced osteoporosis.  Subsequently, the patient recovered.  On 19-DEC-2007 the patient was in a head on motor vehicle accident.  She complained of neck pain.  On 20-DEC-2006, she was seen in her physician's office for follow up to her reaction to Pneumovax 23.  On 02-FEB-2007, the patient was diagnosed with osteoporosis by a dexascan.  It was also noted that on 25-JAN-2001 the patient received a first dose of Pneumovax 23.  The patient's treatment plan was as followed: begin prednisone 40 mg po for five days, continue MACROBID 1 tablet BID for 5 days.  The patient was given samples to see if they would help her sleep, continue ECOTRIN 81 mg oral daily, IMMODIUM A-D as directed PRN, FLORA-Q 1 tablet oral daily, temazepam 15 mg oral at bedtime, AMBIEN CR 12.5 mg oral at bedtime PRN, LUNESTA 3 mg oral at bedtime PRN, MELATONIN 1 tablet oral at bedtime PRN, biotin 1 tablet oral TID, vitamin C 500 mg oral at night, glucosamine chondroitin 1 tablet oral BID, folic acid 800 mcg oral every day, TUMS 3 tablets oral at bedtime, vitamins (unspecified) 1 tablet oral at night, amoxicillin 3 grams prior to procedures for endocarditis prophylaxis.  The patient also had a tetanus shot less than five years ago.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Neck pain, Osteoporosis, Road traffic accident
Clinical narrative: Information has been received from a licensed practical nurse and physician concerning a 69 year old female with vancomycin allergy, caecal cancer (Jan 1998), non-smoker, alcohol dependence syndrome and caffeine dependence and a history of rash, hysterectomy, mitral valve prolapse with severe mitral regurgitation, subacute bacterial endocarditis x2 (Dec 1998 and 1982) gastrooesophageal reflux disease, peptic ulcer disease, gastric ulcer, benign hepatic cyst, irritable bowel syndrome, diverticulosis, scarlet fever, sleep disorder, nocturnal leg muscle cramps, multiple blood transfusions, generalised anxiety disorder, panic disorder and uterine bleeding who on 18-DEC-2006 at 14:30 was vaccinated IM into the left deltoid with a second dose of Pneumovax 23 (lot# 651374/0485F).  On 18-DEC-2006 the patient went to the ER because her doctor's office was closed.  The patient experienced injection site rash, welt at injection site, erythema left upper arm, swelling upper arm, warm to the touch, allergic reaction, left deltoid pain, and was unable to move arm.  On 19-DEC-2006 the patient experienced motor vehicle accident and neck pain.  On 02-FEB-2007 the patient experienced osteoporosis.  Subsequently, the patient recovered.  On 19-DEC-2007 the patient was in a head on motor vehicle accident.  She complained of neck pain.  On 20-DEC-2006, she was seen in her physician's office for follow up to her reaction to Pneumovax 23.  On 02-FEB-2007, the patient was diagnosed with osteoporosis by a dexascan.  It was also noted that on 25-JAN-2001 the patient received a first dose of Pneumovax 23.  The patient's treatment plan was as followed: begin prednisone 40 mg po for five days, continue MACROBID 1 tablet BID for 5 days.  The patient was given samples to see if they would help her sleep, continue ECOTRIN 81 mg oral daily, IMMODIUM A-D as directed PRN, FLORA-Q 1 tablet oral daily, temazepam 15 mg oral at bedtime, AMBIEN CR 12.5 mg oral at bedtime PRN, LUNESTA 3 mg oral at bedtime PRN, MELATONIN 1 tablet oral at bedtime PRN, biotin 1 tablet oral TID, vitamin C 500 mg oral at night, glucosamine chondroitin 1 tablet oral BID, folic acid 800 mcg oral every day, TUMS 3 tablets oral at bedtime, vitamins (unspecified) 1 tablet oral at night, amoxicillin 3 grams prior to procedures for endocarditis prophylaxis.  The patient also had a tetanus shot less than five years ago.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse and physician concerning a 69 year old female with vancomycin allergy, caecal cancer (Jan 1998), non-smoker, alcohol dependence syndrome and caffeine dependence and a history of rash, hysterectomy, mitral valve prolapse with severe mitral regurgitation, subacute bacterial endocarditis x2 (Dec 1998 and 1982) gastrooesophageal reflux disease, peptic ulcer disease, gastric ulcer, benign hepatic cyst, irritable bowel syndrome, diverticulosis, scarlet fever, sleep disorder, nocturnal leg muscle cramps, multiple blood transfusions, generalised anxiety disorder, panic disorder and uterine bleeding who on 18-DEC-2006 at 14:30 was vaccinated IM into the left deltoid with a second dose of Pneumovax 23 (lot# 651374/0485F).  On 18-DEC-2006 the patient went to the ER because her doctor's office was closed.  The patient experienced injection site rash, welt at injection site, erythema left upper arm, swelling upper arm, warm to the touch, allergic reaction, left deltoid pain, and was unable to move arm.  On 19-DEC-2006 the patient experienced motor vehicle accident and neck pain.  On 02-FEB-2007 the patient experienced osteoporosis.  Subsequently, the patient recovered.  On 19-DEC-2007 the patient was in a head on motor vehicle accident.  She complained of neck pain.  On 20-DEC-2006, she was seen in her physician's office for follow up to her reaction to Pneumovax 23.  On 02-FEB-2007, the patient was diagnosed with osteoporosis by a dexascan.  It was also noted that on 25-JAN-2001 the patient received a first dose of Pneumovax 23.  The patient's treatment plan was as followed: begin prednisone 40 mg po for five days, continue MACROBID 1 tablet BID for 5 days.  The patient was given samples to see if they would help her sleep, continue ECOTRIN 81 mg oral daily, IMMODIUM A-D as directed PRN, FLORA-Q 1 tablet oral daily, temazepam 15 mg oral at bedtime, AMBIEN CR 12.5 mg oral at bedtime PRN, LUNESTA 3 mg oral at bedtime PRN, MELATONIN 1 tablet oral at bedtime PRN, biotin 1 tablet oral TID, vitamin C 500 mg oral at night, glucosamine chondroitin 1 tablet oral BID, folic acid 800 mcg oral every day, TUMS 3 tablets oral at bedtime, vitamins (unspecified) 1 tablet oral at night, amoxicillin 3 grams prior to procedures for endocarditis prophylaxis.  The patient also had a tetanus shot less than five years ago.  No product quality complaint was involved.  A lot check was requested.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Local reaction, Urticaria
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 35 year old female secretary with asthma exercise induced, Crohn's disease, terminal ileitis, transverse colitis in remission, gastrooesophageal reflux disease, gluten intolerance, lactose intolerance, diarrhea predominant irritable bowel syndrome, pernicious anaemia, vitamin B12 deficiency secondary to malabsorption syndrome, iron deficiency anaemia, migraine, costochondritis, cervical radiculopathy, plantar warts, dysmenorrhoea, penicillin allergy and drug hypersensitivity and a history of motor vehicle accident (01-FEB-2000), Pap smear (March 2006), oesophagogastroduodenoscopy with biopsy secondary to gastritis (19-OCT-2004), negative colonoscopy with biopsies (19-OCT-2004), arthroscopy and appendicectomy (1998) who on 10-JAN-2007 was vaccinated IM into the right deltoid with a first dose of Pneumovax 23 (Lot #651374/0485F).  Concomitant therapy included VENTOLIN HFA, clindamycin, cyanocobalamin, folic acid, iron (unspecified) (+) vitamins (unspecified), ORTHO TRI-CYCLEN and CECLOR.  Illness noted at office visit, same day as vaccination on 10-JAN-2007 included acute right otitis media and externa, refractory pharyngitis and reactive lymphadenitis.  Subsequently, on 10-JAN-2007, the patient developed a localized reaction of the right upper arm and injection site rash that was described as a red welt at the injection site that was warm to touch and painful.  No time line for the development of the rash was available.  The patient was told to take ADVIL with food, BENADRYL and ice the injection site.  The patient was not followed by the office but was considered recovered on an unspecified date.  No product quality complaint was involved.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released by the regulatory agency.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site warmth, Local reaction
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 70 year old female patient with an allergy to sulfonamide and estrogen who on 13-DEC-2006 was vaccinated with the first dose of Pneumovax 23 (lot# 651374/0485F).  On an unspecified day the patient developed a localized reaction in her right upper arm with erythema and swelling and injection site rash.  The rash was described as a red welt at the injection site which was warm to the touch and painful.  The patient did not seek medical advice at the time of the reaction.  Subsequently, on 16-JAN-2007 the patient was examined in the physician's office and had recovered from the event.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 70 year old female patient with an allergy to sulfonamide and estrogen who on 13-DEC-2006 was vaccinated with the first dose of Pneumovax 23 (lot# 651374/0485F).  On an unspecified day the patient developed a localized reaction in her right upper arm with erythema and swelling and injection site rash.  The rash was described as a red welt at the injection site which was warm to the touch and painful.  The patient did not seek medical advice at the time of the reaction.  Subsequently, on 16-JAN-2007 the patient was examined in the physician's office and had recovered from the event.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Feeling cold, Pain, Rash erythematous
Clinical narrative: Information has been received from a 79 year old female retired registered nurse with blood pressure high, muscle cramps, "four fractured lumbar spine disc under control", and allergies to penicillin, iodine, DEMEROL, codeine, quinine, BENADRYL and normal saline who on 18-OCT-2006 was vaccinated with Pneumovax 23 vaccine, intramuscularly. Concomitant therapy included Atenolol, trazodone HCl and TYLENOL. Subsequently, in the afternoon the patient experienced coldness and joints that ached. Four hours later the retired nurse experienced a temperature of 102 degrees F for 24 hours. The next morning the nurse broke out in a red, raised rash, that was stinging but not itchy. The retired nurse drank a lot of fluids to help with her reactions. The nurse recovered 4 to 5 days after she experienced these adverse reactions. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Muscle atrophy, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with asthma who in January 2007, was vaccinated with a 0.5 mL dose of Pneumovax 23.  The patient was concomitantly vaccinated with a dose of Vaqta (manufacturer unknown) in a different injection site.  On 16-JAN-2007, the patient developed a 2 cm circle of cellulitis around the injection site, muscle wasting, and a high fever.  On 17-JAN-2007, the cellulitis grew to a 9 cm circle, and the patient could not lift her arm.  The patient was treated with oral antibiotics since the patient was not septic as of the morning of 17-JAN-2007.  At the time of this report, the patient was still being treated and had not recovered.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Hypokinesia, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 78 year old retired female with allergies to sulfonamides, codeine, BIAXIN, and CEFTIN, who on 11-OCT-2005 at 12:00 was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (lot # 650452/0753F). There were no illnesses at the time of vaccination. The patient stated that her arm started to feel uncomfortable before she left the physician's office that day. On 11-OCT-2005 the patient complained of irritation of the right arm with increased pain, redness and swelling which started in the area of injection. Her arm became very sore and she had difficulty raising her arm over her head. The patient tried to manage with ice and BENADRYL at home. The next day, the area was very swollen down passed the elbows and was reddened and tender. On 13-OCT-2005 the patient returned to the physician's office with severe upper arm pain and tenderness. She was diagnosed with an allergic reaction to Pneumovax 23. The patient was treated with a ROCEPHIN injection, ALLEGRA, ice and BENADRYL. The patient's symptoms lasted approximately 5 to 7 days. It was also noted that the patient had no problems with her first dose of Pneumovax 23. No further information is expected.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Tenderness
Clinical narrative: Information has been received from a licensed practical nurse concerning a 78 year old retired female with allergies to sulfonamides, codeine, BIAXIN, and CEFTIN, who on 11-OCT-2005 at 12:00 was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (lot # 650452/0753F). There were no illnesses at the time of vaccination. The patient stated that her arm started to feel uncomfortable before she left the physician's office that day. On 11-OCT-2005 the patient complained of irritation of the right arm with increased pain, redness and swelling which started in the area of injection. Her arm became very sore and she had difficulty raising her arm over her head. The patient tried to manage with ice and BENADRYL at home. The next day, the area was very swollen down passed the elbows and was reddened and tender. On 13-OCT-2005 the patient returned to the physician's office with severe upper arm pain and tenderness. She was diagnosed with an allergic reaction to Pneumovax 23. The patient was treated with a ROCEPHIN injection, ALLEGRA, ice and BENADRYL. The patient's symptoms lasted approximately 5 to 7 days. It was also noted that the patient had no problems with her first dose of Pneumovax 23. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a nurse concerning a patient over the age of 60 years who on 06-NOV-2006, in the am, was vaccinated intramuscularly with Pneumovax 23.  Subsequently on an unspecified date, the patient developed gland swelling under the injected arm.  Unspecified medical attention was sought.  Subsequently, the patient recovered from the swollen glands.  Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician via a pharmacist and a health professional at a physician's office concerning a 78 year old male with diabetes, hypertension and high cholesterol who on an unspecified date was vaccinated intramuscularly with Pneumovax 23 (lot # 654977/0888F).  Subsequently the patient developed cellulitis at the injection site.  Unspecified medical attention was sought.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Feeling abnormal, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an approximately 40 year old female physician colleague with psoriasis and no known allergies who on 17-JAN-2007 was vaccinated with Pneumovax 23 in the lateral aspect of the right thigh.  Subsequently the patient experienced feels bad, developed chills, and is swollen and tender at the injection site.  The patient sought unspecified medical attention.  Treatment included comfort measures.  The adverse events persisted.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Erythema, Feeling of body temperature change, Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 69 year old retired female with drug allergy to cortisone, osteoarthritis, osteoporosis, fatigue and constipation who on 16-JAN-2007 was vaccinated with a first dose of Pneumovax 23 (lot number 651320/1008), 0.5 ml intramuscularly in the left deltoid at 9:05 AM.  Concomitant therapy included NAPROSYN, ACTONEL, CITRICAL PLUS WITH MAGNESIUM, CENTRUM SILVER, lisinopril (MSD), docusate Ca, omega-3 marine triglycerides and vitamin E.  On 16-JAN-2007, in the evening, the patient developed pain, redness, felt feverish, and had muscle aches.  On 18-JAN-2007, the patient presented to the physician's office complaining that she felt like she had a fever and her left arm was swollen just below the injection site.  The swollen area of the arm was 23 by 15 centimeters.  There was no fever, temperature was 98.0.  The injection site was clear from erythema.  A confluent papular area started 2.5 to 3 cm below the site and there was an area 23 by 15 centimeters of demarcated erythema.  No laboratory diagnostic studies were performed.  The patient was treated with an ice pack and also continued taking NAPROSYN at home.  The outcome of the events was not reported.  No additional information is expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Pain, Rash papular
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 69 year old retired female with drug allergy to cortisone, osteoarthritis, osteoporosis, fatigue and constipation who on 16-JAN-2007 was vaccinated with a first dose of Pneumovax 23 (lot number 651320/1008), 0.5 ml intramuscularly in the left deltoid at 9:05 AM.  Concomitant therapy included NAPROSYN, ACTONEL, CITRICAL PLUS WITH MAGNESIUM, CENTRUM SILVER, lisinopril (MSD), docusate Ca, omega-3 marine triglycerides and vitamin E.  On 16-JAN-2007, in the evening, the patient developed pain, redness, felt feverish, and had muscle aches.  On 18-JAN-2007, the patient presented to the physician's office complaining that she felt like she had a fever and her left arm was swollen just below the injection site.  The swollen area of the arm was 23 by 15 centimeters.  There was no fever, temperature was 98.0.  The injection site was clear from erythema.  A confluent papular area started 2.5 to 3 cm below the site and there was an area 23 by 15 centimeters of demarcated erythema.  No laboratory diagnostic studies were performed.  The patient was treated with an ice pack and also continued taking NAPROSYN at home.  The outcome of the events was not reported.  No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning an adult patient who was vaccinated IM with a 0.5 mL dose of Pneumovax 23 (lot #655288/1174F).  Subsequently, within 24 hours, the patient developed swelling, redness and pain at the injection site.  The patient sought unspecified medical attention.  On an unspecified date, the patient recovered.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Information has been received from a physician concerning a 24 year old female with asthma who on 17-JAN-2007, at 14:00, was vaccinated with a first dose of Pneumovax 23 (lot #654977/0888F) concomitantly with a dose of influenza virus vaccine (unspecified).  Other concomitant therapy included FLOVENT, albuterol and hormonal contraceptives (unspecified).  On 18-JAN-2007, at 15:00, the patient developed a fever as high as 103 and shaking chills despite therapy with TYLENOL.  The patient also experienced nausea, headaches, and pain and mild swelling at the injection site.  The patient sought medical attention and was treated with ADVIL, TYLENOL and supportive measures.  There were no laboratory or diagnostic tests performed.  On 19-JAN-2007, the patient recovered.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Information has been received from a physician concerning a 24 year old female with asthma who on 17-JAN-2007, at 14:00, was vaccinated with a first dose of Pneumovax 23 (lot #654977/0888F) concomitantly with a dose of influenza virus vaccine (unspecified).  Other concomitant therapy included FLOVENT, albuterol and hormonal contraceptives (unspecified).  On 18-JAN-2007, at 15:00, the patient developed a fever as high as 103 and shaking chills despite therapy with TYLENOL.  The patient also experienced nausea, headaches, and pain and mild swelling at the injection site.  The patient sought medical attention and was treated with ADVIL, TYLENOL and supportive measures.  There were no laboratory or diagnostic tests performed.  On 19-JAN-2007, the patient recovered.  Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Chills, Dizziness, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 26 year old female with no illness at the time of being vaccinated, asthma, and no history of drug reactions/allergies who on 17-JAN-2007 was vaccinated with first dose of Pneumovax 23 (lot # 654977/0888F) in the deltoid at 8:30 AM.  Concomitant therapy included influenza virus vaccine (unspecified) was also given on 17-JAN-2007.  Other concomitant therapy included birth control, ADVAIR, albuterol, and ZYRTEC.  On 18-JAN-2007, at 8 AM, the patient experienced fever, nausea, chills, dizziness, swelling, redness, and soreness at the injection site.  The patient sought medical attention.  The injection site had a softball size swelling with tenderness.  Treatment was supportive.  No diagnostic studies were performed.  At the time of reporting, the patient was recovering.  Additional information was received from the physician.  The patient was treated with non-steroidal anti-inflammatory drugs (NSAIDS), rest, and fluids.  On 20-JAN-2007, the patient recovered. No additional information is expected.