chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health care worker concerning a patient "over 55 or 60" years of age who "two weeks ago" was vaccinated with a dose of PNEUMOVAX (lot # 651399/0486F).  Subsequently, the patient experienced redness and swelling at the site of injection.  The patient was reportedly recovering.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Rash, Skin warm
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 61 year old female who on 06-OCT-2006 was vaccinated in the left deltoid with Pneumovax 23 (Lot# 655588/0883F). On 06-OCT-2006, the patient developed a rash and swelling to the left upper arm (previously reported to have a developed redness, swelling and warmth. The patient sought unspecified medical attention. The patient was treated with DECADRON 8 mg and an ice pack. At the time of this report, the patient had recovered from the events (date unknown). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Initial and follow up information has been received from a wholesaler's representative and a certified medical assistant concerning a 65 year old German female certified nursing assistant.  On 05-OCT-2006, at 10:00 AM, the patient was vaccinated intramuscularly in the deltoid with the second dose of PNEUMOVAX (Lot# 651404/0352F).  There were no illnesses noted at the time of vaccination.  On 06-OCT-2006, at 7:00 AM, the patient developed mottled erythema, tenderness and swelling distal to the injection site by a few centimeters and circumferential (previously reported as soreness, infection at the injection site, symptoms that consisted of severe subcutaneous edema which appeared down past the elbow near the forearm and edema accompanied by severe pain).  There was no reaction at the injection site.  At the time of this report, the patient had recovered from the events (date unknown).  No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with PNEUMOVAX.  On 31-AUG-2006 the patient experienced injection site pain and slight fever.  The reporter felt that the causal relationship between the patient's injection site pain and slight fever and therapy with PNEUMOVAX vaccine was unknown.  The reporter considered the patient's injection site pain and slight fever as non-serious.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Swelling
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 48 year old white female with diabetes mellitus II, hypertension and an allergy to morphine, who on 09-OCT-2006 was vaccinated intramuscularly in the left deltoid with a 0.5 mL first dose of PNEUMOVAX (Lot # 651401/0619F).  There was no concomitant medication.  On 09-OCT-2006 the patient experienced extreme injection site pain several hours after the vaccination.  She also developed mild swelling.  It was also reported that she could not even lift her arm.  The patient was prescribed acetaminophen (+) hydrocodone bitartrate (LORTAB) for pain.  Follow-up information from the nurse confirmed that the patient complained of extreme pain at the injection site less than or approximately 6 hours after immunization.  She also experienced decreased range of motion and stiffness in the muscles of her left arm.  The patient was reported as recovered on 12-OCT-2006.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Information has been received from a healthcare worker concerning a 64 year old menopausal female with hyperlipidemia, arthritis, hypertension, incontinence and diabetes who on 04-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of PNEUMOVAX (651400/0618F).  Concomitant therapy included ezetimibe (ZETIA), metformin HC1 (GLUCOPHAGE XR), fexofenadine hydrochloride (ALLEGRA), pravastatin Na (PRAVACHOL), diclofenac sodium (+) misoprostol (ARTHROTEC), tolterodine tartrate (DETROL LA), montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE), calcium (unspecified) (+) vitamin D (unspecified) and metoprolol succinate (TOPROL XL TABLETS).  On 04-OCT-2006 the patient had injection site soreness and pain.  The patient had redness at the injection site and redness also around the arm (redness was not completely around the arm).  On 08-OCT-2006 the patient also felt sick.  The patient sought unspecified medical attention.  At the time of the report, the patient was recovering.  Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Nasopharyngitis, Pain in extremity, Swelling
Clinical narrative: Information has been received from a medical assistant concerning a 68 year old male patient with charcot's joint, bilaterally of the feet, peripheral neuropathy, osteomyelitis and seasonal allergies who on 09-OCT-2006 was vaccinated intramuscularly in the right arm with a 0.5 mL dose of Pneumovax 23 (Lot# 651400/0618F). Concomitant therapy included AMBIEN, omega-3 triglycerides, CENTRUM and garlic pills. On 09-OCT-2006 the patient experienced pain in the arm. Follow-up information from the reporter further indicated that on 09-OCT-2006 at approximately 6:40 PM, the patient experienced swelling and redness from the shoulder to below elbow, the area felt very hot and as swelling progressed, it settled in inner part of elbow. There was no illness at the time of vaccination. The reporter stated: "The patient also feels like he is coming down with a cold on the morning of 10/10/06." Follow-up from the reporter indicated that it took about two weeks (approximately 23-OCT-2006) before pain, soreness, and swelling resided. The patient was reported as recovered. The treatment was ice and ibuprofen. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 29 year old white male with type I diabetes mellitus for 22 years.  On 03-OCT-2006, at 4:15 PM, the patient was vaccinated intramuscularly in the right arm with the first 0.5 mL dose of PNEUMOVAX (lot #651320/1008P).  Concomitant therapy included a dose of influenza virus vaccine (unspecified).  On 03-OCT-2006, the patient developed extreme pain at injection site and muscle weakness in right arm at "h.s" (previously reported as could hardly move his arm).  It was very painful but there was no redness or swelling.  On 04-OCT-2006, at 4:00 AM, the patient went to the emergency room.  The patient was treated with acetaminophen (+) hydrocodone bitartrate (LORTAB) for pain and released.  No lab studies were performed.  On 06-OCT-2006, the patient had recovered from the events.  Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Information has been received from a health care professional concerning a 61 year old female physician with no medical history and no allergies or drug reactions who on 02-OCT-2006 was vaccinated intramuscularly in the left arm with a 0.5 ml dose of Pneumovax 23 (lot #651400/0618F). There was no illness at the time of vaccination. That same day at 1750 the patient experienced pain, redness and swelling at, and around the injection site, and felt sick and run down. The redness went around the entire left arm. The patient felt the worst on 03-OCT-2006. Unspecified medical attention was sought. No lab studies were performed. On 10-OCT-2006 the patient felt better but still had soreness at the injection site. On 06-NOV-2006 the patient overal felt better, but still had a little redness at the injection site. Subsequently the patient recovered. It was also noted that it had been 13 years since the patient's last vaccination with Pneumovax 23. No product quality complaint was involved. No further information is expected.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 54 year old female with high cholesterol and no allergies or drug reactions who on 09-OCT-2006 was vaccinated intramuscularly into the right arm with a 0.5 ml dose of Pneumovax 23 (lot #651400/0618F). Concomitant therapy included CENTRUM and AMBIEN CR. That same day the patient experienced pain that went to the shoulder and down the right arm like a dull ache and tenderness at the injection site. On 10-OCT-2006 the patient took two ADVIL, three times for the pain. It was noted that if the patient did not take the ADVIL, the pain would be worse. Unspecified medical attention was sought. No lab studies were performed. At the time of report the patient had not recovered. No product quality complaint was involved. It was also reported that the patient's "last vaccination" was 13 years ago. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old male with high blood pressure and no drug reactions or allergies who on 09-OCT-2006 was vaccinated intramuscularly in the deltoid with a 0.5 ml dose of Pneumovax 23 (lot#651406/0620F). Concomitant therapy included COREG. That night at 2100 the patient experienced severe pain in the arm that kept him up all night. Unspecified medical attention was sought. The patient's physician told him to take ALEVE. No labs studies were performed. At the time of report the patient was "still sore but better". It was noted that the patient had not been vaccinated with Pneumovax 23 in over five years. No product quality complaint was involved. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site infection, Oedema, Pain, Swelling
Clinical narrative: Initial and follow up information has been received from a wholesaler's representative, a certified medical assistant and a physician concerning a 77 year old retired male. On 26-SEP-2006, at 1:30 PM, the patient was vaccinated intramuscularly in the deltoid with the second dose of Pneumovax 23 (Lot# 651404/0352F). There were no illnesses noted at the time of vaccination. On 27-SEP-2006, at 7:30 AM, the patient developed mottled erythema, tenderness and swelling distal to the injection by a few centimeters and circumferential (previously reported as soreness, infection at the injection site, symptoms that consisted of severe subcutaneous edema which appeared down past the elbow near the forearm and edema was accompanied by severe pain. There was no reaction at the injection site. At the time of this report, the patient had recovered from the events (date unknown). No further information is available.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Initial and follow up information has been received from a wholesaler's representative, a certified medical assistant and a physician concerning a 77 year old retired male. On 26-SEP-2006, at 1:30 PM, the patient was vaccinated intramuscularly in the deltoid with the second dose of Pneumovax 23 (Lot# 651404/0352F). There were no illnesses noted at the time of vaccination. On 27-SEP-2006, at 7:30 AM, the patient developed mottled erythema, tenderness and swelling distal to the injection by a few centimeters and circumferential (previously reported as soreness, infection at the injection site, symptoms that consisted of severe subcutaneous edema which appeared down past the elbow near the forearm and edema was accompanied by severe pain. There was no reaction at the injection site. At the time of this report, the patient had recovered from the events (date unknown). No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning two "geriatric males" with "cardiac conditions" who on 10-OCT-2006 (also reported as 11-OCT-2006) were vaccinated with PNEUMOVAX (lot number 650541/1004P).  On 11-OCT-2006 the patients experienced local adverse reactions, including pain, redness, "fever" in the arm, tenderness and swelling near the injection site.  The patient's sought unspecified medical attention.  The patients' local adverse reaction, pain, redness, "fever" in the arm, tenderness and swelling near the injection site persisted.  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.  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.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning her husband. Additional information was received from a VAERS form via another company. A 54 year old male with sarcoidosis, migraine headaches, renal calculi, penicillin allergy and erythromycin allergy on 05-OCT-2006 was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 651332/1049F), subcutaneously (also reported as intramuscularly), in the right deltoid back of arm. Concomitant therapy that day included a dose of FLUZONE (lot # 112199AA); ("many" previous doses was reported), in the left deltoid. Other concomitant therapy included oxycodone, INDERAL and albuterol. The nurse stated that her husband received Pneumovax 23 in his right arm and the FLUZONE in his left arm. However, the chart documented Pneumovax 23 in the left arm and FLUZONE in the right arm. The nurse added that the vaccine administered in the right arm was placed "low on the back of the arm near the elbow." On 06-OCT-2006 the patient complained of pain, erythema, and edema at the site of the injection in the right arm and was examined by his physician that day. The physician diagnosed an allergic reaction and prescribed BENADRYL with ice compresses. On 10-OCT-2006 the edema of the right arm extended to the wrist. The patient was examinated by his physician on that day and was prescribed a MEDROL dose pack. The patient had elected not to take the MEDROL at that time. The physician had suggested an allergy consult to determine if the patient exhibited allergy to either vaccine. It was also reported that on 05-OCT-2006 the patient's right arm lower towards back began to hurt immediately. It became red, hot, swollen from upper arm then spread towards then to the wrist, then it began itching. At the time of the report it was still tender to the touch. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pruritus, Skin warm, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning her husband. Additional information was received from a VAERS form via another company. A 54 year old male with sarcoidosis, migraine headaches, renal calculi, penicillin allergy and erythromycin allergy on 05-OCT-2006 was vaccinated with a dose of Pneumovax 23 (0.5 ml) (lot # 651332/1049F), subcutaneously (also reported as intramuscularly), in the right deltoid back of arm. Concomitant therapy that day included a dose of FLUZONE (lot # 112199AA); ("many" previous doses was reported), in the left deltoid. Other concomitant therapy included oxycodone, INDERAL and albuterol. The nurse stated that her husband received Pneumovax 23 in his right arm and the FLUZONE in his left arm. However, the chart documented Pneumovax 23 in the left arm and FLUZONE in the right arm. The nurse added that the vaccine administered in the right arm was placed "low on the back of the arm near the elbow." On 06-OCT-2006 the patient complained of pain, erythema, and edema at the site of the injection in the right arm and was examined by his physician that day. The physician diagnosed an allergic reaction and prescribed BENADRYL with ice compresses. On 10-OCT-2006 the edema of the right arm extended to the wrist. The patient was examinated by his physician on that day and was prescribed a MEDROL dose pack. The patient had elected not to take the MEDROL at that time. The physician had suggested an allergy consult to determine if the patient exhibited allergy to either vaccine. It was also reported that on 05-OCT-2006 the patient's right arm lower towards back began to hurt immediately. It became red, hot, swollen from upper arm then spread towards then to the wrist, then it began itching. At the time of the report it was still tender to the touch. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a medical technician concerning a female who was vaccinated with PNEUMOVAX.  In September 2006 (reported as "a couple of weeks ago" on 11-OCT-2006), the patient experienced extreme stinging and pain down her arms and legs.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Pneumovax 23.  Subsequently, within 3-4 hours post-vaccination, the patient experienced pain in the injection arm, from the shoulder to the forearm, and chills.  The patient's outcome was unknown.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis, Pyrexia
Clinical narrative: Information has been received from a pharmacy student concerning a patient who was vaccinated with a dose of Pneumovax 23. Subsequently the patient experienced a fever and cellulitis at the injection site. It was reported that because of the patient's condition it was not sure if this AE could be related to the vaccine. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a female with no medical history and no allergies who on 03-OCT-2006 was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23 (lot #651357/0391F). There was no concomitant medication. Within hours of the vaccination, the patient experienced a localized reaction from the vaccination with redness, soreness and swelling at the injection site. She also developed a fever greater than 102 F and had nausea and vomiting for three days until she went to the emergency room and received IV BENADRYL and Prednisone. Nine days later, she still had soreness but her symptoms were resolving. It was also noted that she missed three days of work. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a female with no medical history and no allergies who on 03-OCT-2006 was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23 (lot #651357/0391F). There was no concomitant medication. Within hours of the vaccination, the patient experienced a localized reaction from the vaccination with redness, soreness and swelling at the injection site. She also developed a fever greater than 102 F and had nausea and vomiting for three days until she went to the emergency room and received IV BENADRYL and Prednisone. Nine days later, she still had soreness but her symptoms were resolving. It was also noted that she missed three days of work. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot #651401/0619F). Subsequently the patient experienced a local reaction including redness, soreness and swelling. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient "in her 40's, with diabetes, hypertension, reflux and an allergy to morphine who on 09-OCR-2006 was vaccinated intramuscularly with a dose of Pneumovax 23 (lot #651401/0619F). Concomitant therapy included DIOVAN, PREVACID, XANAX, BYETTA. Six hours after vaccination the patient experienced severe pain in the vaccinated arm, little redness, muscle stiffness and weakness in the arm, and limited range of motion in the arm. Unspecified medical attention was sought. No lab studies were performed. She was treated with LORTAB and naproxen. At the time of report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from an office staff member concerning a female adult patient who on 11-OCT-2006 was vaccinated with a first dose of Pneumovax 23 (0.5 ml) (lot # 651400/0618F), intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed edema, redness and warmth at the injection site. At the time of the report, the patient was considered to be recovering. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot # 65172/0741R). Subsequently the patient experienced redness, swelling and tenderness at the injection site. Unspecified medical attention was sought. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 48 year old male who on 12-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml, IM into left arm at 1215 hours. Concomitant therapy included LUNESTA. On 13-OCT-2006 at 1100 hours, the patient experienced his injection site was red, warm, and tender to the touch. the patient had no fever. The patient visited the physician's office with a complaint of a site reaction stating that it was very painful. The nurse informed the patient to take TYLENOL, CIPRO, BENADRYL during the day. The nurse requested a lot check. At the time of reporting, 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 met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information 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 degrees 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 was vaccinated with a fourth dose of Prevnar. At the time of the report, there were no adverse experiences reported. Follow-up reported that the patient had "done well." No pneumococcal infections have been noted. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female who on 04-OCT-2006 was vaccinated IM, into the left deltoid, with a second dose of Pneumovax 23 (lot#651357/0391F). On 05-OCT-2006 the patient developed pain and tenderness with swelling and redness at the left deltoid site. The patient reported that she could not perform activities of daily living for 1 day. Unspecified medical attention was sought. Subsequently, the patient recovered completely. Pain, swelling and redness at the left deltoid site were considered to be disabling events. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a female "less than 65 years" who on 10-OCT-2006 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included influenza virus vaccine (unspecified). On 12-OCT-2006 the patient experienced extreme pain, redness and swelling at the injection site, she was unable to use arm or hold pen, had a fever of 102 F, developed a rash on upper trunk and arms with some hives and nausea. On 13-OCT-2006 the patient experienced pain radiating down right leg following the sciatic nerve. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash, Sciatica
Clinical narrative: Information has been received from a nurse concerning a female "less than 65 years" who on 10-OCT-2006 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included influenza virus vaccine (unspecified). On 12-OCT-2006 the patient experienced extreme pain, redness and swelling at the injection site, she was unable to use arm or hold pen, had a fever of 102 F, developed a rash on upper trunk and arms with some hives and nausea. On 13-OCT-2006 the patient experienced pain radiating down right leg following the sciatic nerve. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse concerning a female "less than 65 years" who on 10-OCT-2006 was vaccinated with a first dose of Pneumovax 23. Concomitant therapy included influenza virus vaccine (unspecified). On 12-OCT-2006 the patient experienced extreme pain, redness and swelling at the injection site, she was unable to use arm or hold pen, had a fever of 102 F, developed a rash on upper trunk and arms with some hives and nausea. On 13-OCT-2006 the patient experienced pain radiating down right leg following the sciatic nerve. The patient was treated with TYLENOL. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female who on 12-OCT-2006, was vaccinated at her primary care physician's office with a second dose of Pneumovax 23 (Lot # 654981/0674F). The patient received the first dose of Pneumovax 23 in December 2001. Concomitant therapy included ACTOS, GLUCOCOPHAGE, GLUCOTROL, LEVOXYL, LEXAPRO, LASIX, ALLEGRA, NEXIUM. "A meter-dose inhaler" and Vitamin B-12. On 16-OCT-2006, the patient was at her endocrinologist's office and stated that she developed redness at injection site and a diffuse rash on arms and chest (upper). The patient was referred back to her primary care physician and was being treated with BENADRYL. No diagnostic studies were performed. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 53 year old female with HIV positive, and history of drug reaction/allergy to VIRAMUNE who on 12-OCT-2006 was vaccinated with Pneumovax 23 (lot # 651400/0618F) 0.5 ml, IM into left deltoid at 0930 hours. Concomitant therapy included LUNESTA, CELEBREX, IMODIUM, NORVIR, LEXIVA. On 12-OCT-2006, at 1119 hours, the patient called the physicians office with a complaint of a site reaction stating that it was very painful. The patient reported she had no fever. The patient reported that it go better on 12-OCT-2006 in the evening after taking TYLENOL during the day. On 13-OCt-2006, the patient recovered. The nurse 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 the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning an approximately 44 year old female with hypothyroidism, Addison's disease, and allergies to iodine, novocain, PABA and penicillin who in 1985 was vaccinated with a second dose of Pneumovax 23. Subsequently, in 1985, the patient developed cellulitis at the injection site. The patient was "probably taking" a steroid and thyroid medication at the time of the vaccine. The patient also received Pneumovax 23 in 1984 but did have any adverse experiences. Subsequently, the patient recovered from cellulitis at injection site. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a Doctor of Pharmacy (PHARMD) concerning a 77 year old female with an unspecified medical history who on 11-OCT-2006 was vaccinated with a dose of Pneumovax 23 (Lot 654593/0358F). On 12-OCT-2006, the day after the vaccination, the patient reported that her left arm was swollen from the elbow to the shoulder. The left arm was double the size of her right arm and was painful to touch. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a Doctor of Pharmacy (PharmD) concerning a 66 year old male who on 02-OCT-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot # 654593/0358F). On the same day of the vaccination (02-OCT-2006), the patient reported that 2/3 of his left arm was swollen and red. On 03-OCT-2006, by the next day, the patient's arm was swollen from the elbow to the shoulder. The patient sought unspecified medical attention. At the time of this report, the outcome was  unknown. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 47 year old male respiratory therapist with asthma, allergic rhinitis and allergies to AVELOX, SEPTRA, LEVAQUIN and a history of pneumonia multiple times, who on 09-OCT-2006 was vaccinated IM into the right deltoid with a first 0.5 ml dose of Pneumovax 23 (lot# 651401/0619F). Concomitant therapy included a dose of influenaz virus vaccine (unspecified) (batch# U2168A) into the left arm, ACCOLATE, ("UNIDUR"), INTAL, albuterol, PULMICORT, and calcium (unspecified). That night he had so much pain in his arm that he could not sleep on it. This was followed by a fever, intermittently to 38 degrees C, redness, and swelling. He began to feel a little bit better in the last 24 hours with no fever since 09-OCT-2006. On 13-OCT-2006, the patient woke up the erythema in the arm was descending down th biceps area toward the elbow. The patient was diagnosed with a severe systemic and local reaction. The patient was advised to continue to use an antihistamine and TYLENOL. The physician also gave the patient a prescription for KEFLEX 500 mg to use only if the patient developed shaking chills or a fever. If he did the patient would take one tablet 4 times day for 7 days and call the physician. At the time of this report, the patient had not recovered. No product quality complaint was involved. The nurse requested a lot check since she has never seen a reaction occur with the vaccine. 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 standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 46.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Sleep disorder, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 47 year old male respiratory therapist with asthma, allergic rhinitis and allergies to AVELOX, SEPTRA, LEVAQUIN and a history of pneumonia multiple times, who on 09-OCT-2006 was vaccinated IM into the right deltoid with a first 0.5 ml dose of Pneumovax 23 (lot# 651401/0619F). Concomitant therapy included a dose of influenaz virus vaccine (unspecified) (batch# U2168A) into the left arm, ACCOLATE, ("UNIDUR"), INTAL, albuterol, PULMICORT, and calcium (unspecified). That night he had so much pain in his arm that he could not sleep on it. This was followed by a fever, intermittently to 38 degrees C, redness, and swelling. He began to feel a little bit better in the last 24 hours with no fever since 09-OCT-2006. On 13-OCT-2006, the patient woke up the erythema in the arm was descending down th biceps area toward the elbow. The patient was diagnosed with a severe systemic and local reaction. The patient was advised to continue to use an antihistamine and TYLENOL. The physician also gave the patient a prescription for KEFLEX 500 mg to use only if the patient developed shaking chills or a fever. If he did the patient would take one tablet 4 times day for 7 days and call the physician. At the time of this report, the patient had not recovered. No product quality complaint was involved. The nurse requested a lot check since she has never seen a reaction occur with the vaccine. 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 standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a geriatric or patient less than 60 years of age who on 12-OCT-2006 was vaccinated IM with a dose of Pneumovax 23. On approximately 12-OCT-2006, the patient experienced intense pain and soreness in the arm. Unspecified medical attention was sought. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture negative, Chills, Influenza like illness, Injection site cellulitis, Injection site erythema
Clinical narrative: Information has been received from a healthcare worker who is a pharmacy buyer and a registered pharmacist concerning a 33 year old female with multiple sclerosis who on 26-FEB-2007 presented to the emergency room with increased weakness.  On 26-FEB-2007, prior to discharge, the patient was vaccinated with Pneumovax 23 (lot # 655668/1004F).  On 01-MAR-2007, the patient returned to the emergency room with increased weakness and reported that she had pain from the injection.  It was reported that there was no localized reaction, no swelling or erythema at the site.  At the time of this report, the outcome of th events was unknown.  Additional information has been requested.  This is one of several reports received from the same source. 02/18/2010 Laboratory finding revealed a red blood cell count of 4.03 x 1006, a hemoglobin of 12.6 g/dl, a hematocrit of 35.5 and a mean palatelet volum o f7.2 fl. The patient was admitted for antibiotics and pain control. An MRI of the left humerus revealed increased T2 signal along the fascial margin of the deltoid muscle belly, with mild increased T2 signal in the deltoid muscle, as well as increased signal within the overlying subcutaneous tissues. There as enhancemet in all of the areas of T2 signal abmormality. No fluid collection was identified. There was no abnormal marrow signal and no mass seen. The impression stated that the appearences could be related to localized cellulitis or inflammatoy response. No abscess was identified. A blood culture showed no growth in 5 days. The patient was hosptialized for 8 days. At the time of this report, the outcome of the events was unknown. No further information is expected. This is on of two reports received from the same source.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site nodule, Injection site pain, Nausea, Nuclear magnetic resonance imaging abnormal, Rash macular
Clinical narrative: Information has been received from a healthcare worker who is a pharmacy buyer and a registered pharmacist concerning a 33 year old female with multiple sclerosis who on 26-FEB-2007 presented to the emergency room with increased weakness.  On 26-FEB-2007, prior to discharge, the patient was vaccinated with Pneumovax 23 (lot # 655668/1004F).  On 01-MAR-2007, the patient returned to the emergency room with increased weakness and reported that she had pain from the injection.  It was reported that there was no localized reaction, no swelling or erythema at the site.  At the time of this report, the outcome of th events was unknown.  Additional information has been requested.  This is one of several reports received from the same source. 02/18/2010 Laboratory finding revealed a red blood cell count of 4.03 x 1006, a hemoglobin of 12.6 g/dl, a hematocrit of 35.5 and a mean palatelet volum o f7.2 fl. The patient was admitted for antibiotics and pain control. An MRI of the left humerus revealed increased T2 signal along the fascial margin of the deltoid muscle belly, with mild increased T2 signal in the deltoid muscle, as well as increased signal within the overlying subcutaneous tissues. There as enhancemet in all of the areas of T2 signal abmormality. No fluid collection was identified. There was no abnormal marrow signal and no mass seen. The impression stated that the appearences could be related to localized cellulitis or inflammatoy response. No abscess was identified. A blood culture showed no growth in 5 days. The patient was hosptialized for 8 days. At the time of this report, the outcome of the events was unknown. No further information is expected. This is on of two reports received from the same source.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a healthcare worker who is a pharmacy buyer and a registered pharmacist concerning a 33 year old female with multiple sclerosis who on 26-FEB-2007 presented to the emergency room with increased weakness.  On 26-FEB-2007, prior to discharge, the patient was vaccinated with Pneumovax 23 (lot # 655668/1004F).  On 01-MAR-2007, the patient returned to the emergency room with increased weakness and reported that she had pain from the injection.  It was reported that there was no localized reaction, no swelling or erythema at the site.  At the time of this report, the outcome of th events was unknown.  Additional information has been requested.  This is one of several reports received from the same source. 02/18/2010 Laboratory finding revealed a red blood cell count of 4.03 x 1006, a hemoglobin of 12.6 g/dl, a hematocrit of 35.5 and a mean palatelet volum o f7.2 fl. The patient was admitted for antibiotics and pain control. An MRI of the left humerus revealed increased T2 signal along the fascial margin of the deltoid muscle belly, with mild increased T2 signal in the deltoid muscle, as well as increased signal within the overlying subcutaneous tissues. There as enhancemet in all of the areas of T2 signal abmormality. No fluid collection was identified. There was no abnormal marrow signal and no mass seen. The impression stated that the appearences could be related to localized cellulitis or inflammatoy response. No abscess was identified. A blood culture showed no growth in 5 days. The patient was hosptialized for 8 days. At the time of this report, the outcome of the events was unknown. No further information is expected. This is on of two reports received from the same source.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Blood culture negative, Condition aggravated, Granulocyte count increased, Haematocrit decreased
Clinical narrative: Information has been received from a healthcare worker who is a pharmacy buyer and a registered pharmacist concerning a 33 year old female with multiple sclerosis who on 26-FEB-2007 presented to the emergency room with increased weakness.  On 26-FEB-2007, prior to discharge, the patient was vaccinated with Pneumovax 23 (lot # 655668/1004F).  On 01-MAR-2007, the patient returned to the emergency room with increased weakness and reported that she had pain from the injection.  It was reported that there was no localized reaction, no swelling or erythema at the site.  At the time of this report, the outcome of th events was unknown.  Additional information has been requested.  This is one of several reports received from the same source. 02/18/2010 Laboratory finding revealed a red blood cell count of 4.03 x 1006, a hemoglobin of 12.6 g/dl, a hematocrit of 35.5 and a mean palatelet volum o f7.2 fl. The patient was admitted for antibiotics and pain control. An MRI of the left humerus revealed increased T2 signal along the fascial margin of the deltoid muscle belly, with mild increased T2 signal in the deltoid muscle, as well as increased signal within the overlying subcutaneous tissues. There as enhancemet in all of the areas of T2 signal abmormality. No fluid collection was identified. There was no abnormal marrow signal and no mass seen. The impression stated that the appearences could be related to localized cellulitis or inflammatoy response. No abscess was identified. A blood culture showed no growth in 5 days. The patient was hosptialized for 8 days. At the time of this report, the outcome of the events was unknown. No further information is expected. This is on of two reports received from the same source.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Haemoglobin decreased, Injection site pain, Lymphocyte count decreased, Mean platelet volume decreased, Monocyte count decreased
Clinical narrative: Information has been received from a healthcare worker who is a pharmacy buyer and a registered pharmacist concerning a 33 year old female with multiple sclerosis who on 26-FEB-2007 presented to the emergency room with increased weakness.  On 26-FEB-2007, prior to discharge, the patient was vaccinated with Pneumovax 23 (lot # 655668/1004F).  On 01-MAR-2007, the patient returned to the emergency room with increased weakness and reported that she had pain from the injection.  It was reported that there was no localized reaction, no swelling or erythema at the site.  At the time of this report, the outcome of th events was unknown.  Additional information has been requested.  This is one of several reports received from the same source. 02/18/2010 Laboratory finding revealed a red blood cell count of 4.03 x 1006, a hemoglobin of 12.6 g/dl, a hematocrit of 35.5 and a mean palatelet volum o f7.2 fl. The patient was admitted for antibiotics and pain control. An MRI of the left humerus revealed increased T2 signal along the fascial margin of the deltoid muscle belly, with mild increased T2 signal in the deltoid muscle, as well as increased signal within the overlying subcutaneous tissues. There as enhancemet in all of the areas of T2 signal abmormality. No fluid collection was identified. There was no abnormal marrow signal and no mass seen. The impression stated that the appearences could be related to localized cellulitis or inflammatoy response. No abscess was identified. A blood culture showed no growth in 5 days. The patient was hosptialized for 8 days. At the time of this report, the outcome of the events was unknown. No further information is expected. This is on of two reports received from the same source.
Age: 32.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Monocyte count increased, Red blood cell count increased, White blood cell count decreased, White blood cell count increased
Clinical narrative: Information has been received from a healthcare worker who is a pharmacy buyer and a registered pharmacist concerning a 33 year old female with multiple sclerosis who on 26-FEB-2007 presented to the emergency room with increased weakness.  On 26-FEB-2007, prior to discharge, the patient was vaccinated with Pneumovax 23 (lot # 655668/1004F).  On 01-MAR-2007, the patient returned to the emergency room with increased weakness and reported that she had pain from the injection.  It was reported that there was no localized reaction, no swelling or erythema at the site.  At the time of this report, the outcome of th events was unknown.  Additional information has been requested.  This is one of several reports received from the same source. 02/18/2010 Laboratory finding revealed a red blood cell count of 4.03 x 1006, a hemoglobin of 12.6 g/dl, a hematocrit of 35.5 and a mean palatelet volum o f7.2 fl. The patient was admitted for antibiotics and pain control. An MRI of the left humerus revealed increased T2 signal along the fascial margin of the deltoid muscle belly, with mild increased T2 signal in the deltoid muscle, as well as increased signal within the overlying subcutaneous tissues. There as enhancemet in all of the areas of T2 signal abmormality. No fluid collection was identified. There was no abnormal marrow signal and no mass seen. The impression stated that the appearences could be related to localized cellulitis or inflammatoy response. No abscess was identified. A blood culture showed no growth in 5 days. The patient was hosptialized for 8 days. At the time of this report, the outcome of the events was unknown. No further information is expected. This is on of two reports received from the same source.