chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Immediate post-injection reaction, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who on 08-JAN-2009 was vaccinated with PNEUMOVAX (lot number 662663/0980X). The patient developed severe cellulitis reactions immediately after or by the evening of PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient sought medical attention at an emergency room. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. This is one of several reports received from the same source. Additional information has been received from the office manager who confirmed that several patients had injection site reactions. Additional information has been received from a licensed practical nurse (LPN) concerning a 68 year old male patient who on 12-JAN-2009 9:30 AM was vaccinated IM with the first dose of PNEUMOVAX vaccine (Lot number 662663/0980X). Subsequently, the patient developed weakness and pain in arm, redness, heat at site, edema, and fever. Subsequently, the patient was recovered from the adverse events in 5-7 days. It was not reported whether the patient sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Oedema, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a patient who on 08-JAN-2009 was vaccinated with PNEUMOVAX (lot number 662663/0980X). The patient developed severe cellulitis reactions immediately after or by the evening of PNEUMOVAX administration. The patient had symptoms, which included swelling, redness, pain and heat at the injection site. The patient sought medical attention at an emergency room. The patient was treated for cellulitis and was put either on an (unspecified) antibiotic and/or (unspecified) steroid. The outcome of the patient's adverse reaction was not reported. This is one of several reports received from the same source. Additional information has been received from the office manager who confirmed that several patients had injection site reactions. Additional information has been received from a licensed practical nurse (LPN) concerning a 68 year old male patient who on 12-JAN-2009 9:30 AM was vaccinated IM with the first dose of PNEUMOVAX vaccine (Lot number 662663/0980X). Subsequently, the patient developed weakness and pain in arm, redness, heat at site, edema, and fever. Subsequently, the patient was recovered from the adverse events in 5-7 days. It was not reported whether the patient sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a nurse concerning an 81 year old female who on an unknown date, was vaccinated with PNEUMOVAX (lot# not provided). Concomitant therapy included Influenza virus vaccine (unspecified). Subsequently the patient experienced a swollen red, feverish arm which was diagnosed as cellulitis. The patient was advised to use warm compresses, TYLENOL and BENADRYL. At the 2 week follow up, the symptoms had resolved. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Information  has been received from a nurse concerning a 53 year old female who on an unknown date, was vaccinated with PNEUMOVAX (lot # not provided). Subsequently the patient developed a red and feverish arm. the patient was advised to use warm compresses, TYLENOL and BENADRYL. Subsequently, the patient's symptoms had resolved. the patient sought unspecified medical attention. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a "over 65" year old female who in December 2008, was vaccinated with a dose of PNEUMOVAX (lot n, 659922/1667U) 0.5 ml. In December 2008, the patient experienced pain, swelling and warmth at the injection site. The patient sought medical attention. Subsequently, on an unknown date, the patient recovered. It was reported that the patient was fine at the time of reporting. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician and a nurse practitioner concerning an 80 year old female who on 12-JAN-2009 was vaccinated with a dose of PNEUMOVAX (Lot n. 661529/0868X). The patient reported that on 13-JAN-2008, her arm was swollen and red from the injection site down to her elbow after receiving PNEUMOVAX. The patient sought unspecified medical attention. The patient is being treated with antibiotics. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 79 year old female patient with asthma and allergic to morphine, penicillin and sulfonamide who on 14-JAN_2009 was vaccinated with a dose of PNEUMOVAX 23 (lot #662785/1124X) intramuscularly in the left arm. Concomitant therapy included vitamin D (unspecified), metformin, ADVAIR, AZMACORT, albuterol, SPIRIVA, COUMADIN, LASIX (furosemide)), potassium (unspecified), LIPITOR, VICODIN, captopril, carvedilol and meclizine. Subsequently the patient developed an injection site reaction. Her left arm became red, swollen and painful. Patient sought medical attention via office visit. No lab diagnostic studies were performed. Patient was given BENADRYL and the symptoms resolved. This is one of several reports received from the same source. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse and a medical assistant concerning a female patient who in December 2008, was vaccinated with a dose of PNEUMOVAX (Lot n. 659922/1667U) 0.5 ml.  In December 2008, the patient experienced pain, swelling and warmth at the injection site.  Follow up information received from the medical assistant reported that the patient was a 75 year old female.  The patient's pain, swelling and warmth at the injection site had resolved.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Erythema, Myalgia, Pain
Clinical narrative: Information has been received concerning a 69 year old female patient, who weights 210 pounds and is 64 1/4 inches tall, and has no pertinent medical history or known drug allergies, who on 18-NOV-2008 was vaccinated with a dose of PNEUMOVAX (lot# 658673/0990U) subcutaneously and with a dose of FLUZONE (influenza virus split virion 3v vaccine inactivated) lot # U2771AA) intramuscularly.  On 18-NOV-2008 the patient experienced pain, erythema 5 to 7 cm redness, joint aches and muscle aches.  Patient was seen in the office twice.  No laboratory diagnostic studies performed.  Patient was treated with Ranitidine and Allegra 60 mg for 2 weeks.  At the time of this report patient had recovered.  No further information is available.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Body temperature increased, Cough, Heart rate normal, Oedema peripheral
Clinical narrative: Information has been received by a drug wholesaler representative concerning a patient who on 20-JAN-2009 was vaccinated with a dose of PNEUMOVAX (lot no. 659922/1667U). On an unknown date, the patient experienced several swelling in the arm and he could barely moved the swollen arm. The patient was hospitalized. Follow up information was received from the physician assistant who reported that the patient who had Hypertension and no known drug allergies. On 21-JAN-2009 the patient went to the doctor complaining of left arm and fingers swollen after vaccination subcutaneously with the second 0.5 mL dose of PNEUMOVAX vaccine in the left triceps area at 8:50 AM. The patient also had left elbow pain and had mild point of tenderness to injection area. There was no warmth or erythema. The patient had pain in a scale of 6/10 and the patient stated it was worst. There were no signs of infection. Physician assistant reported that the patient had used codeine (unspecified) for pain which helped. The patient also complaint of dry cough for 1 day. The patient denied nausea, vomiting and diarrhea, shortness of breath or chest pain. At the physical exam the patient was normal, blood pressure measurement: 130/70, heart rate 76 and temperature 98.2. The patient was advised to use warm comprises to area and do range of motion exercise. The patient was prescribed VICODIN tablets, 500 mg each 6 to 8 hours for pain. The patient was scheduled for a follow up one week after and he did not show up. No further information is available. This is one of several reports from the same source.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received by a drug wholesaler representative concerning a patient who on 20-JAN-2009 was vaccinated with a dose of PNEUMOVAX (lot no. 659922/1667U). On an unknown date, the patient experienced several swelling in the arm and he could barely moved the swollen arm. The patient was hospitalized. Follow up information was received from the physician assistant who reported that the patient who had Hypertension and no known drug allergies. On 21-JAN-2009 the patient went to the doctor complaining of left arm and fingers swollen after vaccination subcutaneously with the second 0.5 mL dose of PNEUMOVAX vaccine in the left triceps area at 8:50 AM. The patient also had left elbow pain and had mild point of tenderness to injection area. There was no warmth or erythema. The patient had pain in a scale of 6/10 and the patient stated it was worst. There were no signs of infection. Physician assistant reported that the patient had used codeine (unspecified) for pain which helped. The patient also complaint of dry cough for 1 day. The patient denied nausea, vomiting and diarrhea, shortness of breath or chest pain. At the physical exam the patient was normal, blood pressure measurement: 130/70, heart rate 76 and temperature 98.2. The patient was advised to use warm comprises to area and do range of motion exercise. The patient was prescribed VICODIN tablets, 500 mg each 6 to 8 hours for pain. The patient was scheduled for a follow up one week after and he did not show up. No further information is available. This is one of several reports from the same source.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Contusion, Erythema, Fatigue, Oedema peripheral
Clinical narrative: Information has been received from a medical assistant concerning a 75 year old female with allergic reaction to penicillin and LEVAQUIN and aspirin and naproxen hypersensitivity who on 09-JAN-2009 was vaccinated with a dose of PNEUMOVAX (lot no. 662599/1076X) 0.5 ml, IM into the right arm.  Concomitant therapy included chondroitin sulfate sodium (+) glucosamine sulfate, ramipril, lovastatin, vitamins (unspecified) and calcium (unspecified).  On 09-JAN-2009 the patient experienced erythema, swelling and soreness in right arm.  The patient also experienced fatigue and weakness.  On an unknown date, the patient recovered.  Follow up information was received from a health professional which reported that the patient experienced erythema, swelling, soreness, bruising in right arm, fatigue and weakness on 10-JAN-2009 at 9:00 am.  On 15-JAN-2009 the patient recovered from the events.  The patient weight was 164 pounds and height 63 inches.  The patient had no illness at the time of vaccination.  Additional information is not expected.  This is one of several reports from the same source.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 75 year old female with allergic reaction to penicillin and LEVAQUIN and aspirin and naproxen hypersensitivity who on 09-JAN-2009 was vaccinated with a dose of PNEUMOVAX (lot no. 662599/1076X) 0.5 ml, IM into the right arm.  Concomitant therapy included chondroitin sulfate sodium (+) glucosamine sulfate, ramipril, lovastatin, vitamins (unspecified) and calcium (unspecified).  On 09-JAN-2009 the patient experienced erythema, swelling and soreness in right arm.  The patient also experienced fatigue and weakness.  On an unknown date, the patient recovered.  Follow up information was received from a health professional which reported that the patient experienced erythema, swelling, soreness, bruising in right arm, fatigue and weakness on 10-JAN-2009 at 9:00 am.  On 15-JAN-2009 the patient recovered from the events.  The patient weight was 164 pounds and height 63 inches.  The patient had no illness at the time of vaccination.  Additional information is not expected.  This is one of several reports from the same source.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Injected limb mobility decreased, Injection site induration, Insomnia
Clinical narrative: Information has been received from a medical assistant concerning a 32 year old female patient with no pertinent medical history, who on 20-JAN-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 663012/1163X) intramuscularly in her right arm.  Concomitant therapy included ALBUTEROL, ZOLOFT, PULMICORT and hormonal contraceptives (unspecified).  It was reported that the patient experienced pain, tenderness, and swelling in her right arm after administration of her first dose of PNEUMOVAX.  It was reported that she was not able to sleep or pick up her kids because of pain.  The patient sought medical attention with an office visit.  At the time of the report, the patient had not recovered.  Follow-up information has been received from the physician's office (reporter source not identified) that at 2:30 PM on 20-JAN-2009 the patient with no known drug allergies and no illness at the time of vaccination was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 663012/1163X) intramuscularly in her right arm.  At 9:00 AM on 21-JAN-2009 the patient experienced skin irritation, fatigue, swelling, redness and hard at the injection site.  The patient also experienced pain and the patient could lift arm to carry child.  The patient could not sleep.  The patient recovered from the adverse events on 24-JAN-2009.  The reporter assessed the events as non serious.  This is one of several cases from the same source.  No further information is available.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain, Skin irritation, Tenderness
Clinical narrative: Information has been received from a medical assistant concerning a 32 year old female patient with no pertinent medical history, who on 20-JAN-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 663012/1163X) intramuscularly in her right arm.  Concomitant therapy included ALBUTEROL, ZOLOFT, PULMICORT and hormonal contraceptives (unspecified).  It was reported that the patient experienced pain, tenderness, and swelling in her right arm after administration of her first dose of PNEUMOVAX.  It was reported that she was not able to sleep or pick up her kids because of pain.  The patient sought medical attention with an office visit.  At the time of the report, the patient had not recovered.  Follow-up information has been received from the physician's office (reporter source not identified) that at 2:30 PM on 20-JAN-2009 the patient with no known drug allergies and no illness at the time of vaccination was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 663012/1163X) intramuscularly in her right arm.  At 9:00 AM on 21-JAN-2009 the patient experienced skin irritation, fatigue, swelling, redness and hard at the injection site.  The patient also experienced pain and the patient could lift arm to carry child.  The patient could not sleep.  The patient recovered from the adverse events on 24-JAN-2009.  The reporter assessed the events as non serious.  This is one of several cases from the same source.  No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia, Tenderness
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 16-JAN-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 662599/1076X) intramuscularly in her right arm.  Concomitant therapy included montelukast sodium, CRESTOR, CELEBREX, PROZAC, calcium (unspecified), vitamin D (unspecified) and iron (unspecified).  It was reported that on 16-JAN-2009 the patient experienced erythema, pain, tenderness, and swelling in her right arm and (from her elbow to upper arm) after administration of the first dose of PNEUMOVAX vaccine.  It was reported that the patient also experienced a "low grade" fever.  The patient had been recovering at the time of the report.  The patient sought medical attention with an office visit.  Follow-up information has been received from a health professional concerning a 65 year old female with no illness at time of vaccination and codeine allergy who on 16-JAN-2009, at 9:00, was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 662599/1076X) intramuscularly in her right deltoid.  On 18-JAN-2009, at 9:00, the patient developed redness, pain and swelling.  Subsequently, the patient recovered from redness, pain and swelling.  This is one of several cases from the same source.  No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a male patient who was vaccinated with PNEUMOVAX 23 (Lot # 661529/0868X). The medical assistant reported that the patient developed a large, red, swollen reaction at the injection site after receiving the vaccine. The area was so large it hung over the elbow. The date of administration and the date of onset of the symptoms are not available. It is not known if this was the patient's first dose of the vaccine. The physician examined the patient and prescribed prednisone. At the time of the report, the patient had not recovered. The patient sought medical attention at the physician's office. This is one of several reports from the same source. Follow-up information was received on 09-FEB-2009 from the health care worker confirmed that there was one patient that had injection site reaction. She could not provide patient identifiers. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a patient who in January 2009, was vaccinated with a dose of PNEUMOVAX (659922/1667U). In January 2009 the patient went to ER for possible cellulitis in the injection site arm but was not admitted. As of 23-JAN-2009 the outcome of the patient was unknown. This is one of 2 reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness
Clinical narrative: Information has been received from an immunization coordinator concerning a female patient with rheumatoid arthritis who on 23-JAN-2009 was vaccinated with PNEUMOVAX.  Concomitant medication included "medication for rheumatoid arthritis".  Within 24 hours of vaccination, the patient developed some flu-like symptoms that lasted over the weekend after receiving the PNEUMOVAX vaccine.  At the time of reporting the immunization coordinator stated that the patient was feeling better as of that morning.  Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received concerning a 58 year old male patient with mixed hyperlipidaemia, diabetes mellitus, gout and hypertension who on 12-JAN-2009 at 8:50 a.m., was vaccinated with a first dose of PNEUMOVAX 23, intramuscularly in the left arm, lot 3 663012/1163X. On 12-JAN-2009 at 11:00 a.m. the patient experienced soreness, redness and swelling from left shoulder to elbow for 2 days. Patient recovered on 14-JAN-2009. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a medical assistant concerning three patient who in January 2009, were vaccinated with a dose of PNEUMOVAX (Lot # 659922/1667U). In January 2009 the patients developed swelling, redness, warm to touch, and soreness in the injection arm. As of 23-JAN-2009 the outcome of the patients were unknown. Attempts are being made to obtain additional information to distinguish the individual patient's. This is one report of 2 from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Body height below normal, Chills, Injection site reaction, Mobility decreased, Muscle mass
Clinical narrative: Information has been received from a consumer concerning herself (a 72 year old female) with fibromyalgia, short gut syndrome, history of diarrhea, rotator cuff surgery and shingles as well as allergies to penicillin, sulfa, neomycin, codeine, (PERCODAN) and (CIPRO) who on 26-JAN-2009 was vaccinated intramuscularly in her left deltoid with the first dose of PNEUMOVAX vaccine. Since receiving the vaccine (on 26-JAN-2009) the patient had experienced an injection site reaction including muscle pain, decreased mobility, chills and fever of 100F. She had taken TYLENOL and hydrocodone to relieve the pain. She stated she had a small stature and small muscle mass. At the time of reporting the patient was not recovered. The patient called to the physician's office for medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a consumer concerning herself (a 72 year old female) with fibromyalgia, short gut syndrome, history of diarrhea, rotator cuff surgery and shingles as well as allergies to penicillin, sulfa, neomycin, codeine, (PERCODAN) and (CIPRO) who on 26-JAN-2009 was vaccinated intramuscularly in her left deltoid with the first dose of PNEUMOVAX vaccine. Since receiving the vaccine (on 26-JAN-2009) the patient had experienced an injection site reaction including muscle pain, decreased mobility, chills and fever of 100F. She had taken TYLENOL and hydrocodone to relieve the pain. She stated she had a small stature and small muscle mass. At the time of reporting the patient was not recovered. The patient called to the physician's office for medical attention. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 50 year old female with PENICILLIN allergy and "a lot of medications" allergies and a history of "PEG tube" and gastrointestinal problems who on 19-NOV-2008 was vaccinated intramuscularly with first 0.5 mL dose of PNEUMOVAX (LOT # 661529/0868X).  On 21-NOV-2008 the patient experienced swelling, warmth and redness at the site of injection about 8cm by 17cm. The patient was treated with TYLENOL, BENADRYL and cold compresses. Complete cell count and "CHEM14" were performed and no results were provided. Subsequently, the patient recovered from the events. The patient sought medical attention in the office. This is one of several reports received from the same source. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 85 year old female with heart and lung problems, arthritis, penicillin allergy, sulfa allergy and codeine allergy who on 07-OCT-2008 was vaccinated intramuscularly with the first 0.5 mL dose of PNEUMOVAX (LOT# 660717/0224X). On 10-OCT-2008 the patient experienced swelling, pain and redness at the site of injection. The patient was treated with cold compresses. Subsequently, the patient recovered from the events. The patient sought medical attention in the office. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 78 year old female with type 2 diabetes, chronic obstructive pulmonary disease and hypertension and no known drug allergies who on 10-NOV-2008 was vaccinated intramuscularly with the first 0.5 mL dose of PNEUMOVAX (LOT# 661529/0868X).  There was no concomitant medication.  On 18-NOV-2008 the patient experienced swelling and itching at the site of injection.  The patient was treated with TYLENOL, BENADRYL and cold compresses.  Subsequently, the patient recovered from the events.  The patient sought medical attention in the office.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 83 year old male with chronic obstructive pulmonary disease heart problems and no known drug allergies who on 28-JUL-2008 was vaccinated intramuscularly with the first 0.5 mL dose of PNEUMOVAX (LOT# 659487/1960U). Concomitant therapy included "pulmonary medication". On 29-JUL-2008 the patient experienced warmth, swelling and redness at the site of injection from shoulder to elbow of same arm after administration of his first dose of PNEUMOVAX vaccine. The patient was treated with MSD, TYLENOL, BENADRYL and KEFLEX. Subsequently, the patient recovered from the events. The patient sought medical attention in the office. This is one of several reports received from the same source. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Nasopharyngitis
Clinical narrative: Information has been received from a consumer concerning his 84 year old sister who was vaccinated with her first dose of PNEUMOVAX vaccine when she was 82 year old. Recently the patient was vaccinated with her second dose of PNEUMOVAX vaccine. After receiving the second dose the patient developed cold symptoms with swollen lymph nodes on her neck. The outcome of the patient's cold symptoms with swollen lymph nodes on her neck was not reported. No further information is available.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning an 84 year old male patient with iodine and NEOSPORIN allergy, osteoporosis and osteoarthritis who on 26-JAN-2009 was vaccinated with his second dose of PNEUMOVAX 23 (lot # 663012/1163X) IM. On 28-JAN-2009 the patient developed erythema and slight tenderness at the injection site. The patient was instructed to apply heat to the area. The patient had visited office for medical attention. At the time of reporting, the patient's erythema and slight tenderness at the injection site persisted. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Injection site irritation
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient with allergic reaction to AUGMENTIN and clindamycin and osteoarthritis who on 27-JAN-2009 was vaccinated with PNEUMOVAX (lot # 663012/1163X) IM. It is unknown if this is the patient's first dose of PNEUMOVAX. The patient developed a localized reaction at the site of injection. The area is large, irritated and red. The patient had visited office for medical attention. The patient's localized reaction at the injection site persisted. Follow-up information has been received from healthcare professional that the patient went to the office on 29-JAN-2009 with cellulitis-like reaction involving erythema, warmth and induration. The affected area was 4 x 6 cm on her right arm with smaller satellite lesions of erythema and induration. The healthcare professional confirmed that this had been the patient's first dose of PNEUMOVAX. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This is the second of four patients from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Skin warm, Vaccination complication
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient with allergic reaction to AUGMENTIN and clindamycin and osteoarthritis who on 27-JAN-2009 was vaccinated with PNEUMOVAX (lot # 663012/1163X) IM. It is unknown if this is the patient's first dose of PNEUMOVAX. The patient developed a localized reaction at the site of injection. The area is large, irritated and red. The patient had visited office for medical attention. The patient's localized reaction at the injection site persisted. Follow-up information has been received from healthcare professional that the patient went to the office on 29-JAN-2009 with cellulitis-like reaction involving erythema, warmth and induration. The affected area was 4 x 6 cm on her right arm with smaller satellite lesions of erythema and induration. The healthcare professional confirmed that this had been the patient's first dose of PNEUMOVAX. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. This is the second of four patients from the same source. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PNC
Symptoms: Body temperature increased, Feeling hot, Injection site warmth, Oedema peripheral, Pain
Clinical narrative: Information has been received from an office manager concerning a 32 year old male who on 04-EC-2008 was vaccinated with a dose of PNEUMOVAX (lot #: 660685/0619X). On approximately 04-DEC-2008, within 2 days of giving the vaccine, the patient had fever and a "swollen, red and hot arm". The patient recovered on an unspecified date. The patient contacted office for medical attention. Follow-up information was received from a health professional concerning a 32 year old white male who in 04-DEC-2008 morning was vaccinated SC with the first dose of PNEUMOVAX (lot #: 660685/0619X) into the left arm. In the morning of 05-DEC-2008 the patient developed fever 102.9, swollen arm, body body arch and warm at the site of injection. The patient sought medical attention by doctor visit. This is one of several reports received from the same source. No further information is expected.
Age: 32.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 32 year old male who on 04-EC-2008 was vaccinated with a dose of PNEUMOVAX (lot #: 660685/0619X). On approximately 04-DEC-2008, within 2 days of giving the vaccine, the patient had fever and a "swollen, red and hot arm". The patient recovered on an unspecified date. The patient contacted office for medical attention. Follow-up information was received from a health professional concerning a 32 year old white male who in 04-DEC-2008 morning was vaccinated SC with the first dose of PNEUMOVAX (lot #: 660685/0619X) into the left arm. In the morning of 05-DEC-2008 the patient developed fever 102.9, swollen arm, body body arch and warm at the site of injection. The patient sought medical attention by doctor visit. This is one of several reports received from the same source. No further information is expected.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pruritus
Clinical narrative: Information has been received from a health professional concerning an 81 year old female with rheumatoid arthritis, allergic reaction to vancomycin, streptomycin, penicillin, codeine and tuberculin test reaction in the past but no diagnosis of tuberculosis who on 19-JAN-2009 was vaccinated I.M. with a 0.5ml dose of PNEUMOVAX vaccine (lot #: 663012/1163X) in the right arm. It was reported that the patient concomitant took "buckets full of med", but the caller would not specific medications. The patient was given PNEUMOVAX vaccine on in the past on 30-NOV-2001. On 21-JAN-2009, the patient came back to the office because of an injection site reaction. The exam revealed erythema of her right lateral arm without warmth. The patient had no fever. The physician determined that it was an allergic-type reaction with pruritus. The patient was prescribed clindamycin and was told to ice the area. The patient recovered on 29-JAN-2009. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a medical technologist concerning a 43 year old female with a sulfonamide allergy and a history of arthralgias, alcoholism, liver failure and drug reaction to ARTHROTEC who on 22-DEC-2008 was vaccinated with her first dose of PNEUMOVAX (lot number 663012/1163X) Im into her left arm. Concomitant therapy included VICODIN and vitamin supplements. On 23-DEC-2008 the patient was seen by the physician because she had swelling, induration, warmth and erythema at the injection site. The are was 15 x 10 cm. the patient also had satellite areas of induration and erythema. The patient had no fever. The patient was prescribed clindamycin and told to ice the are. On 24-DEC-2008 the patient was doing better. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements if the Center and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a medical technologist concerning a 43 year old female with a sulfonamide allergy and a history of arthralgias, alcoholism, liver failure and drug reaction to ARTHROTEC who on 22-DEC-2008 was vaccinated with her first dose of PNEUMOVAX (lot number 663012/1163X) Im into her left arm. Concomitant therapy included VICODIN and vitamin supplements. On 23-DEC-2008 the patient was seen by the physician because she had swelling, induration, warmth and erythema at the injection site. The are was 15 x 10 cm. the patient also had satellite areas of induration and erythema. The patient had no fever. The patient was prescribed clindamycin and told to ice the are. On 24-DEC-2008 the patient was doing better. A standard lot check was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements if the Center and was released. This is one of several reports received from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Hypoaesthesia, Injection site erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a office manager and a physician assistant concerning a 36 year old female who on 21-JAN-2009 was vaccinated with PNEUMOVAX 23 (lot number 660685/0619X, route and site not reported). Subsequently the patient developed fever, redness in the arm where the vaccine was given. The physician assistant stated that the patient's "entire arm was swollen". Additional information was received via a telephone call from a physician with no new information about this patient. Follow up information was received from a physician. The physician reported that the patient was vaccinated with her first dose of PNEUMOVAX 23 IM into her left deltoid. On 21-JAN-2009 the patient developed cough, soreness and numbness in whole arm and swelling. The patient required doctor visit. There was no illness at time of vaccination. Outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a office manager and a physician assistant concerning a 36 year old female who on 21-JAN-2009 was vaccinated with PNEUMOVAX 23 (lot number 660685/0619X, route and site not reported). Subsequently the patient developed fever, redness in the arm where the vaccine was given. The physician assistant stated that the patient's "entire arm was swollen". Additional information was received via a telephone call from a physician with no new information about this patient. Follow up information was received from a physician. The physician reported that the patient was vaccinated with her first dose of PNEUMOVAX 23 IM into her left deltoid. On 21-JAN-2009 the patient developed cough, soreness and numbness in whole arm and swelling. The patient required doctor visit. There was no illness at time of vaccination. Outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an office manager concerning a 32 year old male who on 01-DEC-2008 was vaccinated with PNEUMOVAX 23 (lot number 660685/0619X, route and site not reported). After the vaccine was given, the patient developed swollen, red and warm arm. The patient subsequently recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Chills, Erythema, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 65 year old female who on 19-NOV-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 659149/1383U). Subsequently the patient experienced fever chills, painful red arm. The patient called office for medical attention. Subsequently, the patient recovered on an unknown date. Follow-up information was received from the healthcare worker concerning the 65 year old female. It was reported that the patient, with no relevant medical history, who on 19-NOV-2008 was vaccinated IM into the right deltoid with a first dose of PNEUMOVAX 23 (lot # 659149/1383U). There was no illness at time of vaccination. On 20-NOV-2008 the patient experienced "right deltoid 3x2 inch redness, fever, 100-103.2 F and equilibrium bad". The patient visited a physician for medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Laboratory test
Clinical narrative: Information has been received from a 65 year old female with SULFONAMIDE allergy who on 26-JAN-2009 was vaccinated with a 0.5 ml dose of PNEUMOVAX in the arm. No lot number was provided. Concomitant vaccine included ZOSTAVAX (Merck) (MSD) on 26-JAN-2009. Other concomitant therapy included estrogens (unspecified) and vitamins (unspecified). On 26-JAN-2009 the patient experienced pain at the injection site. The patient sought medical attention. "Routine labs" were performed. Subsequently, the patient recovered from injection site pain 2 day after administration, on 28-JAN-2009. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a female inpatient at his hospital who was given a dose of PNEUMOVAX 23 intravenously over the weekend and developed an injection site reaction. The patient was already an in-patient at the hospital when she was given the dose. The reaction did not prolonged her hospital stay and the patient had already been discharged. It was not known if the patient had received PNEUMOVAX 23 previously. The pharmacist did not have any details because he heard the information second-hand. The patient sought medical attention. No further information is available.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Infection, Injection site necrosis, Injection site scab
Clinical narrative: Information has been received from a semi-retired physician concerning his 67 year old wife with asthma and CODEINE allergy and a history of atopic dermatitis eczema as a child who "5 years ago", in February 2004, was vaccinated with the first dose of PNEUMOVAX (lot# not reported).  There was no reaction after the first dose.  On 13-JAN-2009 the patient received the second dose of PNEUMOVAX (lot# not reported).  Concomitant therapy included ADVAIR, ALBUTEROL, ATROVENT, CELEBREX, PREMARIN, OMEPRAZOLE (MSD) and ACTONEL.  Within 3 to 4 days of the vaccination, on approximately 16-JAN-2009, the patient had a large wheal about 15-20mm across that was indurated, erythematous then evolved into a small nodule indurated area and now (03-FEB-2009) measured 10mm across.  The patient has been applying topical BENADRYL and taking systemic BENADRYL and RANITIDINE.  The patient saw a nurse practitioner who put the wife on CEPHALEXIN because the nurse practitioner thought the area looked infected.  There was a central necrotic area at the injection site that was crusted over with peripheral ring erythema that went that went out 15mm.  There was still a nodule and indurated in the center and getting better but not totally healed.  This area was pruritic and still was pruritic but less.  The patient sought medical attention in office visit.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: No reaction on previous exposure to drug, Nodule, Pruritus, Scab, Urticaria
Clinical narrative: Information has been received from a semi-retired physician concerning his 67 year old wife with asthma and CODEINE allergy and a history of atopic dermatitis eczema as a child who "5 years ago", in February 2004, was vaccinated with the first dose of PNEUMOVAX (lot# not reported).  There was no reaction after the first dose.  On 13-JAN-2009 the patient received the second dose of PNEUMOVAX (lot# not reported).  Concomitant therapy included ADVAIR, ALBUTEROL, ATROVENT, CELEBREX, PREMARIN, OMEPRAZOLE (MSD) and ACTONEL.  Within 3 to 4 days of the vaccination, on approximately 16-JAN-2009, the patient had a large wheal about 15-20mm across that was indurated, erythematous then evolved into a small nodule indurated area and now (03-FEB-2009) measured 10mm across.  The patient has been applying topical BENADRYL and taking systemic BENADRYL and RANITIDINE.  The patient saw a nurse practitioner who put the wife on CEPHALEXIN because the nurse practitioner thought the area looked infected.  There was a central necrotic area at the injection site that was crusted over with peripheral ring erythema that went that went out 15mm.  There was still a nodule and indurated in the center and getting better but not totally healed.  This area was pruritic and still was pruritic but less.  The patient sought medical attention in office visit.  Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # 657526/0555U). Subsequently, the patient experienced "huge induration on his deltoid and also erythema". The patient sought unspecified medical attention. On an unspecified date, the patient recovered. Follow up information has been received from a physician on 07-APR-2009. It was reported that the 26 year old male patient with pneumonia at the time of vaccination, who on 15-DEC-2008 was vaccinated in the right deltoid with one dose of PNEUMOVAX 23 (Lot # 657526/0555U) at 4:00 p.m. On 16-DEC-2008, in the afternoon, the patient experienced significant deltoid swelling, pain, redness and induration. Local reaction at site of injection was more than normally seen with immunization. There was no other rash, no airway obstruction. Subsequently, the patient recovered. This is one of two cases from the same source. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified date was vaccinated with a dose of PNEUMOVAX. Subsequently, the patient experienced "induration on his deltoid and erythema". It is unknown if the patient sought medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from a physician on 07-APR-2009. It was reported that the 50 year old male patient with bronchitis at the time of vaccination, who on 18-DEC-2008 was vaccinated in the left deltoid with one dose of PNEUMOVAX (Lot # 657526/055U) at 2:00 pm. On the same day, in the evening, the patient felt sick and had fever, Thursday night and Friday. The patient had chills and spot where shot was given was red, hard swollen. The patient started feeling better on 20-DEC-2008 and improved from there on. The patient had a greater than palm sized area of swelling. redness, pain and induration. This reaction was much more than physician usually see with immunization. There was no airway obstruction, no other rash/skin changes. This is one of two case from the same source. Additional information is not expected.