chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local reaction, Medication error
Clinical narrative: Information has been received from a licensed practical nurse concerning a female (age not reported) who on approximately 24-OCT-2006 was vaccinated with Pneumovax 23, 0.5 ml, IM.  This was the patient's second Pneumovax 23 injection because the first vaccination was stored improperly and given.  The physician's office contacted the patient to come in and gave the second Pneumovax 23 injection.  The date of administration of the improperly stored vaccination was reported as unknown.  On 30-OCT-2006 (yesterday), the patient was contacted and she was fine.  Follow-up information has been received from a licensed practical nurse who reported that the patient developed a local reaction of redness which resolved in two days.  Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old female with diabetes and chronic obstructive pulmonary disease with no drug allergies who on 29-OCT-2006 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included LIPITOR, NOVOLIN, AMBIEN, DUONEB, albuterol, REGLAN, potassium (unspecified), TOPROL XL TABLETS, furosemide, gabapentin, and PREVACID. On 31-OCT-2006 the patient experienced fever. At the time of the report, the patient was considered to be not recovered. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Angioedema, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from the husband of a female consumer (age not reported) who on 31-OCT-2006 was vaccinated with a dose of Pneumovax 23 and a dose of Zostavax (MSD) concomitantly in separate arms.  There has been no reaction at the Zostavax site (MSD).  On 01-NOV-2006, the husband of the patient reported that the Pneumovax 23 site became red, hot and swollen the morning after the injection.  Over the course of the day, the patient developed a warm "bump" that extended from shoulder to elbow, associated with shoulder and neck pain.  The patient's primary care physician evaluated the patient for a possible infection.  The physician thought that the reaction was a large hive and an antibiotic was prescribed.  The outcome of the event was not reported. No further information is available.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from the husband of a female consumer (age not reported) who on 31-OCT-2006 was vaccinated with a dose of Pneumovax 23 and a dose of Zostavax (MSD) concomitantly in separate arms.  There has been no reaction at the Zostavax site (MSD).  On 01-NOV-2006, the husband of the patient reported that the Pneumovax 23 site became red, hot and swollen the morning after the injection.  Over the course of the day, the patient developed a warm "bump" that extended from shoulder to elbow, associated with shoulder and neck pain.  The patient's primary care physician evaluated the patient for a possible infection.  The physician thought that the reaction was a large hive and an antibiotic was prescribed.  The outcome of the event was not reported. No further information is available.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a physician concerning a female in her 60's with pertinent medical history and drug reactions/allergies reported as unspecified who on 28-OCT-2006 was vaccinated with Pneumovax for the protection of chronic obstructive pulmonary disease (COPD). Concomitant medication was reported as unspecified. On 29-OCT-2006, the patient experienced pruritis. On an unspecified date, the patient sought medical attention. At the time of the report, the patient was recovering from the pruritis. Follow up information indicated that the patient had a sore and red arm that resolved without specific treatment. No further information was available. Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 77 year old male with pertinent medical history and drug reactions/allergies unspecified who on 30-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml subcutaneously.  Concomitant medication was unspecified.  On 31-OCT-2006, the patient developed redness, swelling and fever at the injection site that moved down to his forearm.  The patient medical attention.  No diagnostic studies were performed.  The event did not improve.  At the time of reporting, the patient had not recovered.  Additional information has been received from an other at the physician's office.  On an unspecified date, the patient recovered.  No additional information is expected.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 77 year old male with pertinent medical history and drug reactions/allergies unspecified who on 30-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml subcutaneously.  Concomitant medication was unspecified.  On 31-OCT-2006, the patient developed redness, swelling and fever at the injection site that moved down to his forearm.  The patient medical attention.  No diagnostic studies were performed.  The event did not improve.  At the time of reporting, the patient had not recovered.  Additional information has been received from an other at the physician's office.  On an unspecified date, the patient recovered.  No additional information is expected.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure, Body temperature, Heart rate, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician via the Poison Control Center concerning a 37 year old female with no history of allergic reactions and who was afebrile who on 02-NOV-2006 was vaccinated with her first ever vaccination of Pneumovax 23, 0.5 ml, IM. Concomitant medication was not reported. On 02-NOV-2006, the patient experienced swollen and taught left arm, injection site soreness, injection site warmth, injection site erythema, injection site swelling and injection site induration. Measurements of both arms for comparison were taken and the right arm was 27 cm and the left arm was 29 cm. The patient's heart rate was 70, respiratory rate was 20 and blood pressure measurement was 102/62. The physician reported that the patient was discharged to home and told to use warm compresses and was prescribed treatment with MEDROL dose pack. The patient was instructed to follow-up in the morning with her primary care physician. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral, Respiratory rate
Clinical narrative: Information has been received from a physician via the Poison Control Center concerning a 37 year old female with no history of allergic reactions and who was afebrile who on 02-NOV-2006 was vaccinated with her first ever vaccination of Pneumovax 23, 0.5 ml, IM. Concomitant medication was not reported. On 02-NOV-2006, the patient experienced swollen and taught left arm, injection site soreness, injection site warmth, injection site erythema, injection site swelling and injection site induration. Measurements of both arms for comparison were taken and the right arm was 27 cm and the left arm was 29 cm. The patient's heart rate was 70, respiratory rate was 20 and blood pressure measurement was 102/62. The physician reported that the patient was discharged to home and told to use warm compresses and was prescribed treatment with MEDROL dose pack. The patient was instructed to follow-up in the morning with her primary care physician. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning an 81 year old female who on 31-OCT-2006 was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23.  The lot number was either 651373/0320F or 651318/1006P.  Concomitant therapy included hydrochlorothiazide (manufacturer unknown).  On 01-NOV-2006, "within the next 24 hours", the patient developed an area at the injection site that was red, swollen, painful and warm to touch.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning a 77 year old female who on 23-OCT-2006 was vaccinated intramuscurlary with a 0.5 mL dose of Pnemovax 23 (either Lot # 651373/0320F or Lot # 651318/1006F). Concomitant therapy included HYDRODIURIL, alendronate sodium (MSD), NORVAX, LIPITOR and SYNTHROID. On 24-OCT-2006 the patient developed an injection site reaction that included a 6" x 3" area that was red, swollen, painful and warm to touch. The patient sought unspecified medical attention. The patient was treated with unspecified antihistamines and unspecified antibiotics. Subsequently, the patient recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 63 year old female with sulfonamide allergy, allergy to aspirin and a history of right mastectomy who on 01-NOV-2006 was vaccinated IM with a 0.5 ml dose of Pneumovax 23 (lot #651325/1037P) concomitantly with a dose of influenza virus vaccine (unspecified).  It was reported that that physician had administered both vaccines in the left deltoid, 2 inches apart, because the right arm had poor circulation due to right mastectomy.  Other concomitant therapy included tamoxifen citrate.  On 01-NOV-2006, a few hours after vaccination, the patient experienced nausea and vomiting.  The patient was examined in the emergency room later that evening.  She was treated with unspecified IV fluids and anti-nausea medications and released.  On 02-NOV-2006, the patient recovered from nausea and vomiting.  Nausea and vomiting were considered to be other important medical events.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 62 year-old female home health aid who on 24-OCt-2006 at 8:30 am was vaccinated subcutaneously in the right upper arm with a first dose of Pneumovax 23 (Lot #651399/0486F) and a dose of influenza (unspecified) in the other arm. Subsequently the patient experienced redness, swelling and warm to touch at the injection site. The patient sought unspecified medical attention. The patient recovered approximately 24 hours later. The nurse stated that the patient's reaction was reported to her incorrectly. She stated that the injection site redness, swelling, and warmth were due to the influenza vaccine and not the Pneumovax 23 vaccine. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a male in his early 60's with pertinent medical history and drug reactions/allergies reported as unspecified who on an unspecified date was vaccinated with Pneumovax 23 (lot #651400/0618F).  Concomitant medication was reported as unspecified.  Subsequently on an unspecified date, the physician reported that the patient experienced "swelling in the entire arm" after Pneumovax 23 was given.  Subsequently on an unspecified date a couple of days later, the patient recovered from swelling in the entire arm.  Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 47 year old male with a history of hepatitis C and drug reactions/allergies reported as none who on 12-OCT-2006 was vaccinated with Pneumovax 23 (lot #653283/0001F).  Concomitant medication was reported as none.  On 12-OCT-2006, the patient experienced fever with a temperature of 101 degrees, 12 hours after immunization with Pneumovax.  The patient also had redness and swelling to their right arm, at the injection site.  The patient sought unspecified medical attention, was hospitalized and treated with ZOSYN, LEVAQUIN and vancomycin.  On an unspecified date, a chest X-ray was performed which showed left lower lobe consolidation.  Subsequently on an unspecified date, the patient recovered from fever with a temperature of 101 degrees, redness and swelling to their right arm at the injection site.  Follow-up information has been received.  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.  No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a "older" female patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient developed a round band of inflammation below the injection site. The area was warm to the touch. The vaccination was administered at the pharmacy. The pharmacist indicated she had never seen anything like it before. The patient's outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Electrocardiogram, Erythema, Loss of consciousness, Oedema peripheral, Pain
Clinical narrative: Information has been received from a 66 year old female patient who on 17-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included a dose of influenza virus vaccine (unspecified) at the same time, in the opposite arm.  The same day, the patient "passed out twice", and developed redness, pain, and swelling in arm, and pain after receiving Pneumovax 23.  The patient went to the emergency room but was not admitted to the hospital.  She stated that although she received the flu vaccine the same day it was administered in the other arm and there was no reaction in that arm.  An EKG was performed (results not provided).  The patient indicated the events were improving but that she was not yet recovered.  The patient stated she had a reaction approximately 10 years ago (approximately 1996) but received both the influenza virus vaccine (unspecified) and the Pneumovax 23 in the same arm.  The reaction then was "pain and swelling but not as severe".  No further information is available.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: Information has been received from a 66 year old female patient who on 17-OCT-2006 was vaccinated with a dose of Pneumovax 23.  Concomitant therapy included a dose of influenza virus vaccine (unspecified) at the same time, in the opposite arm.  The same day, the patient "passed out twice", and developed redness, pain, and swelling in arm, and pain after receiving Pneumovax 23.  The patient went to the emergency room but was not admitted to the hospital.  She stated that although she received the flu vaccine the same day it was administered in the other arm and there was no reaction in that arm.  An EKG was performed (results not provided).  The patient indicated the events were improving but that she was not yet recovered.  The patient stated she had a reaction approximately 10 years ago (approximately 1996) but received both the influenza virus vaccine (unspecified) and the Pneumovax 23 in the same arm.  The reaction then was "pain and swelling but not as severe".  No further information is available.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Laboratory test, Malaise, Night sweats
Clinical narrative: Information has been received from a physician concerning a 16 year old female with an unknown medical history who on 01-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot #651319/1007P). On 03-NOV-2006 ("2 days later"), the patient was seen in the office because she was "sick", experienced night sweats and developed a "2 inch raised welt" at the injection site. The patient sought unspecified medical attention. Bloodwork was performed (results not provided). At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local reaction, Pruritus
Clinical narrative: Information has been received from a pharmacist (PharmD) concerning an approximately 51 year old female who on 23-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot # 651401/0619F).  Subsequently, the patient experienced itching and developed a local site reaction that was determined to be cellulitis.  The patient sought unspecified medical attention.  The patient was placed on unspecified antibiotics.  At the time of this report, the outcome was unknown.  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 complies with the standards of the agency and was released.  Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a 47 year old female, registered nurse with a history of chronic asthma who on 03-NOV-2006 was vaccinated with Pneumovax 23. At the time that the patient received the Pneumovax 23 she was taking BACTRIM for a pre-existent sinusitis. The patient received on the same date influenza virus vaccine (unspecified) at a different site. The patient reported that within 24 hours, she had developed an injection site reaction that included: redness, swelling, local heat, and a fever of 102 degrees Fahrenheit. The patient's injection site redness, swelling, local heat had since improved except the patient's fever. The patient sought unspecified medical attention. Additional information is not expected.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a 31 year old male with a history of pneumonia and bacterial infection who on 02-NOV-2006 was vaccinated with Pneumovax 23 (Lot # 651401/0619F). On 04-NOV-2006 the patient experienced nausea, vomiting, swelling at injection site that went up his arm. The patient was seen in the Emergency Room (ER) and given antibiotics, but was not admitted. At the time of the report, it was not reported if the patient recovered. A lot check 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 of Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Nausea, Pruritus, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a female patient "around 61 years old" who on 02-NOV-2006 was vaccinated with a first dose of Pneumovax 23 (lot # 651401/0619F).  Subsequently, the patient developed nausea, vomiting, itching and swelling at the injection site.  The patient was treated with BENADRYL and "seem(ed) to be responding."  The pharmacist requested a lot check.  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 agency and was released.  Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a pediatric male patient who in approximately October 2006 ("about a month ago"), was vaccinated with a dose of Pneumovax 23.  Concomitant vaccine therapy included a dose of influenza virus vaccine (unspecified).  "Shortly after" receiving the vaccine, the patient developed a fever.  Unspecified medical attention was sought.  Subsequently, the nurse believed that the patient recovered with no problems.  No product quality complaint was involved.  Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an 84 year old female with no known drug allergies who on 01-NOV-2006 at 4:00 PM was vaccinated with a second dose of Pneumovax 23, in the left deltoid. There was no illness at the time of vaccination. The patient reported onset of pain two hours after injection. The patient had pain in the left shoulder, left tricep radiating into finger. The patient continued to worsen. The patient had office visit on 04-NOV-2006. There was no inflammation noted at the time of exam. The patient had stated that she had applied heat to injection site at onset of pain. The patient was given CELEBREX 400 mg PO daily, then 200 mg daily x 4 days. On 07-NOV-2006 the patient reported "greatly improved slight shoulder pain." The patient recovered. The patient received a first dose of Pneumovax 23 on 15-NOV-2001. Additional information is not expected.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Initial and follow-up information has been received from a health professional concerning a 59 year old male with no medical history or allergies who on 23-OCT-2006 at 14:15 was vaccinated subcutaneously with a 0.5 ml first dose of Pneumovax 23 (lot #651401/0619F).  There was no concomitant medication.  On 23-OCT-2006 (previously reported at 24-OCT-2006) the patient's vaccinated arm became painful, red, hot and swollen.  Unspecified medical attention was sought.  No labs were performed.  On approximately 30-OCT-2006 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician assistant concerning several patients (age and gender not reported) who on an unspecified date were vaccinated intramuscularly with the first dose of Pneumovax 23. Subsequently, the patients developed redness all over their arms at the injection site. The physician assistant demonstrated that the redness went "from the top of their shoulders, almost down to their elbows." The physician assistant had "recently seen patients with this same reaction for the first time and never before with Pneumovax 23." It was reported that the patients received the vaccine outside of the physician assistant's office, most likely in a clinic. The patients sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Accidental exposure, Dysgeusia
Clinical narrative: Information has been received from a pharmacist concerning a female (age not reported) nurse who was accidentally exposed to Pneumovax 23 about 0.25 ml orally. On 08-NOV-2006, while the nurse was administering Pneumovax 23 to a patient, she accidentally squirted the medication in her mouth (about 1/4 ml) and on her neck. The medication in her mouth (about 1/4 ml) and on her neck. The pharmacist reported that the nurse stated she had a bad taste in her mouth. The nurse brushed her teeth and used mouthwash. The nurse no longer has a bad taste in her mouth. The nurse had sought unspecified medical attention. There was no physician associated with this case as per the pharmacist. Subsequently, the patient recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 77 year old female with hypothyroidism, hypertension, no known drug allergies, and unknown if history of asthma who on 03-NOV-2006 was vaccinated with Pneumovax 23 (lot # 651404/0619F) 0.5 ml intramuscularly right deltoid. Concomitant therapy included policonsanol, SYNTHRODI, aspirin, albuterol and "propanolol". On 05-NOV-2006, 2 days post vaccination, the patient sought medical attention and went to the emergency room with cellulitis, was treated with oral antibiotics and released from the emergency room. She was not hospitalized. The cellulitis and redness was 1 to 2 inches under the right axilla, but not near the injection site. No laboratory diagnostic tests were performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female (weight 171#, height 62") with no known drug allergies who on 13-OCT-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM in the left deltoid.  Concomitant medication included influenza virus vaccine (CHIRON).  Previous vaccination with Pneumovax 23 in 2002 without problems.  Previous two vaccinations with influenza virus vaccine without problems.  Subsequently on 13-OCT-2006 at 03:45 pm, the patient returned to the physician's office with warmth, swelling, pain at injection and induration at injection (upper L arm).  Upon examination it was noted that the patient had left upper arm 2+ non pitting edema, mild warmth, erythema and tenderness.  The patient was treated with prednisone 10 mg tapered dose starting with 5Qday 4, 3, 2, 1 #15 and acetaminophen and VICODIN, PRN #15.  Subsequently a few days later, the patient recovered from warmth, swelling, pain, erythema and induration at injection (upper L arm).  Follow-up information has been received.  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: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female (weight 171#, height 62") with no known drug allergies who on 13-OCT-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM in the left deltoid.  Concomitant medication included influenza virus vaccine (CHIRON).  Previous vaccination with Pneumovax 23 in 2002 without problems.  Previous two vaccinations with influenza virus vaccine without problems.  Subsequently on 13-OCT-2006 at 03:45 pm, the patient returned to the physician's office with warmth, swelling, pain at injection and induration at injection (upper L arm).  Upon examination it was noted that the patient had left upper arm 2+ non pitting edema, mild warmth, erythema and tenderness.  The patient was treated with prednisone 10 mg tapered dose starting with 5Qday 4, 3, 2, 1 #15 and acetaminophen and VICODIN, PRN #15.  Subsequently a few days later, the patient recovered from warmth, swelling, pain, erythema and induration at injection (upper L arm).  Follow-up information has been received.  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: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old male (weight 158.5#, height 69") with no known drug allergies who on 11-DEC-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM i the right deltoid. Concomitant medication included CHIRO
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old male (weight 158.5#, height 69") with no known drug allergies who on 11-DEC-2006 was vaccinated with Pneumovax 23 (lot #651401/0619F), 0.5 ml, IM i the right deltoid. Concomitant medication included CHIRO
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Blood pressure, Body temperature decreased, Cellulitis, Erythema, Heart rate normal
Clinical narrative: Initial information has been received from a licensed practical nurse and a physician and follow up information was received from a registered nurse, concerning a 74 year old retired male with hypertension, coronary artery disease, hyperlipidema and chronic obstructive pulmonary disease who on 06-NOV-2006, was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (Lot# 651406/0620F).  Concomitant vaccination intramuscularly into the left deltoid a dose of influenza virus vaccine (unspecified) (Lot # 70618).  The licensed practical nurse reported that on 06-NOV-2006 the patient developed a local reaction after vaccination with Pneumovax 23.  His whole upper arm became red, warm and swollen to the elbow.  The physician diagnosed symptoms as cellulitis of right arm.  Unspecified antibiotics were prescribed.  It was also noted that his previous vaccination with Pneumovax 23 was given on 12-NOV-2001.  The registered nurse reported that the patient developed swelling and soreness at the injection site.  It was painful to move his right arm.  The area was red and warm to touch.  His body temperature was 97.2, blood pressure was 140/70, pulse 80 and respirations 20. After 2 days, symptoms began to improve.  By the third day (08-NOV-2006), the patient had recovered.  There was no product quality complaint involved.  There were no other adverse events noted by the patient.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Local reaction, Oedema peripheral
Clinical narrative: Initial information has been received from a licensed practical nurse and a physician and follow up information was received from a registered nurse, concerning a 74 year old retired male with hypertension, coronary artery disease, hyperlipidema and chronic obstructive pulmonary disease who on 06-NOV-2006, was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (Lot# 651406/0620F).  Concomitant vaccination intramuscularly into the left deltoid a dose of influenza virus vaccine (unspecified) (Lot # 70618).  The licensed practical nurse reported that on 06-NOV-2006 the patient developed a local reaction after vaccination with Pneumovax 23.  His whole upper arm became red, warm and swollen to the elbow.  The physician diagnosed symptoms as cellulitis of right arm.  Unspecified antibiotics were prescribed.  It was also noted that his previous vaccination with Pneumovax 23 was given on 12-NOV-2001.  The registered nurse reported that the patient developed swelling and soreness at the injection site.  It was painful to move his right arm.  The area was red and warm to touch.  His body temperature was 97.2, blood pressure was 140/70, pulse 80 and respirations 20. After 2 days, symptoms began to improve.  By the third day (08-NOV-2006), the patient had recovered.  There was no product quality complaint involved.  There were no other adverse events noted by the patient.  Additional information is not expected.
Age: 74.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Respiratory rate, Skin warm
Clinical narrative: Initial information has been received from a licensed practical nurse and a physician and follow up information was received from a registered nurse, concerning a 74 year old retired male with hypertension, coronary artery disease, hyperlipidema and chronic obstructive pulmonary disease who on 06-NOV-2006, was vaccinated intramuscularly in the right deltoid with a second dose of Pneumovax 23 (Lot# 651406/0620F).  Concomitant vaccination intramuscularly into the left deltoid a dose of influenza virus vaccine (unspecified) (Lot # 70618).  The licensed practical nurse reported that on 06-NOV-2006 the patient developed a local reaction after vaccination with Pneumovax 23.  His whole upper arm became red, warm and swollen to the elbow.  The physician diagnosed symptoms as cellulitis of right arm.  Unspecified antibiotics were prescribed.  It was also noted that his previous vaccination with Pneumovax 23 was given on 12-NOV-2001.  The registered nurse reported that the patient developed swelling and soreness at the injection site.  It was painful to move his right arm.  The area was red and warm to touch.  His body temperature was 97.2, blood pressure was 140/70, pulse 80 and respirations 20. After 2 days, symptoms began to improve.  By the third day (08-NOV-2006), the patient had recovered.  There was no product quality complaint involved.  There were no other adverse events noted by the patient.  Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site bruising, Pyrexia
Clinical narrative: Information has been received from agency (mfr. no 236874K06USA) from a 34 year old female consumer with multiple sclerosis who in October 2006, was vaccinated with Pneumovax 23. Concomitant suspect therapy included REBIF and influenza virus vaccine (unspecified). In October 2006, the patient experienced fever and bruising with injection site during administration of interferon beta-1a. Therapy with interferon beta-1a continued. The outcome of the fever and injection site bruising was not reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 65 year old female with allergies to penicillin and erythromycin who on 23-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #651404/0619F), in the left arm. There was no illness at the time of vaccination. On 24-OCT-2006 in the AM the patient's arm became red, hot and swollen (also reported as localized swelling and erythema). Subsequently, the patient recovered. No product quality complaint was involved. There were no relevant diagnostic tests or laboratory data. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 48 year old female with a recent diagnosis of diabetes who on 25-OCT-2006 was vaccinated subcutaneously in the left upper arm with a dose of Pneumovax 23 (lot #651401/0619F). On 26-OCT-2006 the patient's left upper arm developed an area of large erythematous induration and was tender and warm to touch, consistent with cellulitis and urticaria. On 27-OCT-2006, the patient was seen and treated with AUGMENTIN 875 mg twice a day for 10 days. No laboratory diagnostic studies were performed. On 01-NOV-2006, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 48 year old female with a recent diagnosis of diabetes who on 25-OCT-2006 was vaccinated subcutaneously in the left upper arm with a dose of Pneumovax 23 (lot #651401/0619F). On 26-OCT-2006 the patient's left upper arm developed an area of large erythematous induration and was tender and warm to touch, consistent with cellulitis and urticaria. On 27-OCT-2006, the patient was seen and treated with AUGMENTIN 875 mg twice a day for 10 days. No laboratory diagnostic studies were performed. On 01-NOV-2006, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female with high blood pressure and penicillin allergy who on 06-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot # 651406/0620F).  Concomitant therapy included NORVASC.  The patient reported a red, sore injection site arm later in the evening of 06-NOV-2006 and was told to ice the arm and take ZYRTEC.  The patient was examined in the office on 08-NOV-2006 and the injection site arm was swollen and bright red from the shoulder to the hand.  The patient was hospitalized on 08-NOV-2006 with cellulitis and was expected to be there for at least one week.  At the time of this report, the patient recovered from the cellulitis and was discharged from the hospital (date unknown).  Cellulitis was considered to be disabling, immediately life-threatening and an other important medical event by the reporter.  The reporter requested a lot check to be performed on Lot 651406/0620F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 71 year old female with hypertension and osteoporosis who on 27-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot 651320/1008P). The patient was concomitantly vaccinated in the other arm with a dose of varicella-zoster virus vaccine live (MSD) (lot 652936/0981F). On 27-OCT-2006, post vaccination, the patient's arm was red and swollen all the way down to the elbow. The patient received unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Induration, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Initial information has been received from the 51 year old male pharmacist patient via a company representative (brother of the patient) and follow-up information has been received from a licensed practical nurse.  The patient has no known drug allergies and a history of "several bouts of pneumonia over the last few years".  On approximately 1-NOV-2006, the patient was vaccinated with influenza virus vaccine (unspecified).  The next day (approximately 2-NOV-2006), the patient returned to the physician's office and was vaccinated with Pneumovax 23 (Lot # 651356/0089F).  Approximately two days later (approximately 4-NOV-2006), the patient developed a fever of 103 F, redness and warmth in the injection arm and the arm was "hard as a rock" and very painful.  The nurse reported that the patient went to the Emergency Department, "they didn't do anything" and the patient was sent home.  The patient returned to the physician's office the next day and was diagnosed with cellulitis.  The patient was treated with a topical steroid cream for the arm swelling.  Subsequently, the patient is totally recovered from cellulitis.  The nurse reported that the physician felt that the cellulitis was definitely caused by the PNEUMOVAX 23 and noted that the patient will not receive this vaccine again in the future.  Cellulitis was considered another important medical event by the reporting pharmacist and the licensed practical nurse.  The cellulitis was considered disabling by the pharmacist, but considered not disabling by the licensed practical nurse.  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Initial information has been received from the 51 year old male pharmacist patient via a company representative (brother of the patient) and follow-up information has been received from a licensed practical nurse.  The patient has no known drug allergies and a history of "several bouts of pneumonia over the last few years".  On approximately 1-NOV-2006, the patient was vaccinated with influenza virus vaccine (unspecified).  The next day (approximately 2-NOV-2006), the patient returned to the physician's office and was vaccinated with Pneumovax 23 (Lot # 651356/0089F).  Approximately two days later (approximately 4-NOV-2006), the patient developed a fever of 103 F, redness and warmth in the injection arm and the arm was "hard as a rock" and very painful.  The nurse reported that the patient went to the Emergency Department, "they didn't do anything" and the patient was sent home.  The patient returned to the physician's office the next day and was diagnosed with cellulitis.  The patient was treated with a topical steroid cream for the arm swelling.  Subsequently, the patient is totally recovered from cellulitis.  The nurse reported that the physician felt that the cellulitis was definitely caused by the PNEUMOVAX 23 and noted that the patient will not receive this vaccine again in the future.  Cellulitis was considered another important medical event by the reporting pharmacist and the licensed practical nurse.  The cellulitis was considered disabling by the pharmacist, but considered not disabling by the licensed practical nurse.  Additional information has been requested.
Sex: U
Vaccine: PNC, PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose Prevnar. The physician stated that there was an error on the part of the office. Specifically, 70 doses of Pneumovax 23 were ordered instead of Prevnar because both products were next to each other on the order form. It was reported that 40 doses were administered with the belief that they were Prevnar. It was reported that there was no confusion in regards to product packaging. The physician stated that the problem had been corrected at the office and did not foresee any future problems. On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of Prevnar. There were no adverse experiences reported. Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted. Additional information is not expected.
Sex: U
Vaccine: PNC, PPV
Symptoms: Medication error, No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose of PREVNAR.  The physician stated that there was  an error on the part of the office.  Specifically, 70 doses of Pneumovax 23 (MSD) were ordered instead of PREVNAR because both products were next to each other on the order form.  It was reported that 40 doses were administered with the belief that they were PREVNAR.  It was reported that there was no confusion in regards to product packaging.  The physician stated that the problem had been corrected at the office and did not foresee any future problems.  On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of PREVNAR.  There were no adverse experiences reported.  Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted.  Additional information is not expected.
Sex: U
Vaccine: PNC, PPV
Symptoms: Drug ineffective, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose of Prevnar. The physician stated that there was an error on the part of the office. Specifically, 70 doses of Pneumovax 23 were ordered instead of Prevnar because both products were next to each other on the order form. It was reported that 40 doses were administered with the belief that they were Prevnar. It was reported that there was no confusion in regards to product packaging. The physician stated that the problem had been corrected at the office and did not foresee any future problems. On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of Prevnar. There were adverse experienced reported. Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted. Additional information is not expected.
Sex: U
Vaccine: PNC, PPV
Symptoms: Medication error, No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose of PREVNAR.  The physician stated that there was an error on the part of the office.  Specifically, 70 doses of Pneumovax 23 (MSD) were ordered instead of PREVNAR because both products were next to each other on the order form.  It was reported that 40 doses were administered with the belief that they were PREVNAR.  It was reported that there was no confusion in regards to product packaging.  The physician stated that the problem had been corrected at the office and did not foresee any future problems.  On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of PREVNAR.  There were no adverse experiences reported.  Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted.  Additional information is not expected.
Sex: U
Vaccine: PNC, PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose Prevnar. The physician stated that there was an error on the part of the office. Specifically, 70 doses of Pneumovax 23 were ordered instead of Prevnar because both products were next to each other on the order form. It was reported that 40 doses were administered with the belief that they were Prevnar. It was reported that there was no confusion in regards to product packaging. The physician stated that the problem had been corrected at the office and did not foresee any future problems. On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of Prevnar. There were no adverse experiences reported. Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted.erse experiences reported. Additional information is not expected.