chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Demyelination, Hypoaesthesia, Lumbar puncture, Multiple sclerosis, Muscular weakness
Clinical narrative: Onset of what was later diagnosed as Multiple Sclerosis or another demylinating disorder. Began with numbness and muscle weakness on lower left side of body, including left buttock, leg, and foot. Onset was 06/26/2007. Rectum, tailbone area, and toes of right foot also went numb within 10 days after initial symptoms. Patient presented in mid-July with *no rectal tone* and was unable to defecate normally for nearly 2 weeks. Following an MRI of the brain (on 07/20/2007), which showed several lesions, was formally diagnosed with Multiple Sclerosis "or another demylinating disorder." 10/22/07-records received for DOS 7/16-7/22/07-DX:Multiple Sclerosis.On 6/27/07-suddenly awoke with insidious onset of left lower extremity numbness, symptoms distributed from hip to foot, felt lower extremity was heavy. Seen in ER no motor dysfunction seen in ER on 6/29/07-with weakness, referred to PCP-seen by PCP 7/3/07-decreased sensation on left buttock area, descreased sensation left side of genitals and rectum. 7/8/07-some dysfunction with defecation, unable to complete defaction. Sitting causes pain. MRI of spine no focal disk herniation or central canal stenosis. Neurology consults 7/19/07-left lower limb numbness for 1 month. Impression: first presentation of demyelination, syndrome is most keeping with Multiple Sclerosis.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Onset of what was later diagnosed as Multiple Sclerosis or another demylinating disorder. Began with numbness and muscle weakness on lower left side of body, including left buttock, leg, and foot. Onset was 06/26/2007. Rectum, tailbone area, and toes of right foot also went numb within 10 days after initial symptoms. Patient presented in mid-July with *no rectal tone* and was unable to defecate normally for nearly 2 weeks. Following an MRI of the brain (on 07/20/2007), which showed several lesions, was formally diagnosed with Multiple Sclerosis "or another demylinating disorder." 10/22/07-records received for DOS 7/16-7/22/07-DX:Multiple Sclerosis.On 6/27/07-suddenly awoke with insidious onset of left lower extremity numbness, symptoms distributed from hip to foot, felt lower extremity was heavy. Seen in ER no motor dysfunction seen in ER on 6/29/07-with weakness, referred to PCP-seen by PCP 7/3/07-decreased sensation on left buttock area, descreased sensation left side of genitals and rectum. 7/8/07-some dysfunction with defecation, unable to complete defaction. Sitting causes pain. MRI of spine no focal disk herniation or central canal stenosis. Neurology consults 7/19/07-left lower limb numbness for 1 month. Impression: first presentation of demyelination, syndrome is most keeping with Multiple Sclerosis.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Body temperature increased, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician and a registered nurse concerning a 18 week old male infant, with no medical history or no drug reactions/allergies, who on 09-MAY-2006 was vaccinated intramuscularly in the right leg with a second dose of Pneumovax (Lot # 650649/0790F). Concomitant therapy, received 09-MAY-2005 intramuscular included second dose of each: DTaP (AVENTIS C2254AA) in the left leg, ActHIB Aventis VE610AA) in the left leg, and IPOL AVENTIS Y0535 in the right leg. The nurse initially reported that this was a "prescription error". She explained that this was a new practice, and they had no Prevnar, but they did have Pneumovax 23, so Pneumovax 23 vaccine was ordered and that is what the baby received. She stated that normally they would wait for the Prevnar to come in. She further stated the physician called the child's parents and that no symptoms of any kind were noted. Follow up information from the physician indicated that the patient on 10-MAY-2006 developed a mild temperature to 100 degree. The patient subsequently recovered on 11-MAY-2006. It was reported that there was no illness at the time of vaccination and no diagnostic tests were performed. No product quality complaint was involved. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site cellulitis, Skin warm, Swelling
Clinical narrative: Information has been received from a physician concerning a 79 year old male who on 20-MAY-2006 was vaccinated with a first dose of Pneumovax 23 (lot# 650302/1039F), subcutaneous in the upper posterior left arm. There was no concomitant medication. On 30-MAY-2006 the patient experienced swelling, redness, induration and cellulitis. The patient was treated with ice. It was reported that "patient's arm is slightly worse than yesterday." There were no relevant diagnostic tests or laboratory data. At the time of the report, the patient was considered to be not recovered. Follow up information has been received from the physician concerning the male patient with hypertension and high cholesterol who was vaccinated with his first dose of Pneumovax 23 on 30-MAY-2006, on 20-MAY-2006 as previously reported. The physician stated that on 01-JUN-2006, not 30-MAY-2006 as originally reported, the patient developed cellulitis-like reaction from the site of the injection distally 10 cm. Symptoms included redness, swelling, increased secondary warmth, induration, and mild tenderness. The patient's outcome was unknown. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Information has been received from a physician concerning a 79 year old male who on 20-MAY-2006 was vaccinated with a first dose of Pneumovax 23 (lot# 650302/1039F), subcutaneous in the upper posterior left arm. There was no concomitant medication. On 30-MAY-2006 the patient experienced swelling, redness, induration and cellulitis. The patient was treated with ice. It was reported that "patient's arm is slightly worse than yesterday." There were no relevant diagnostic tests or laboratory data. At the time of the report, the patient was considered to be not recovered. Follow up information has been received from the physician concerning the male patient with hypertension and high cholesterol who was vaccinated with his first dose of Pneumovax 23 on 30-MAY-2006, on 20-MAY-2006 as previously reported. The physician stated that on 01-JUN-2006, not 30-MAY-2006 as originally reported, the patient developed cellulitis-like reaction from the site of the injection distally 10 cm. Symptoms included redness, swelling, increased secondary warmth, induration, and mild tenderness. The patient's outcome was unknown. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 72 year old female with hypertension and increased cholesterol who on 30-MAY-2006 was vaccinated with a second dose of Pneumovax 23 (lot # 650302/1039F), subsequently in the upper posterior left arm. There was no concomitant medication. On 01-JUN-2006, "two days after vaccine" the patient developed a cellulitis-like reaction (also reported as cellulitis) posterior left upper arm from site of injection, distally 10 cm with redness, swelling, warmth, induration, mild tenderness. The patient was treated with ice. There were no relevant diagnostic or laboratory tests. The first vaccination of Pneumovax 23 was administered in October 1996. The patient was considered to be recovering. However, it was unknown if the patient recovered. It was noted that the patient had no adverse events following prior vaccinations. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 72 year old female with hypertension and increased cholesterol who on 30-MAY-2006 was vaccinated with a second dose of Pneumovax 23 (lot # 650302/1039F), subsequently in the upper posterior left arm. There was no concomitant medication. On 01-JUN-2006, "two days after vaccine" the patient developed a cellulitis-like reaction (also reported as cellulitis) posterior left upper arm from site of injection, distally 10 cm with redness, swelling, warmth, induration, mild tenderness. The patient was treated with ice. There were no relevant diagnostic or laboratory tests. The first vaccination of Pneumovax 23 was administered in October 1996. The patient was considered to be recovering. However, it was unknown if the patient recovered. It was noted that the patient had no adverse events following prior vaccinations. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a physician (pulmonologist) concerning a 68 year old male with chronic obstructive pulmonary disease who on an unspecified date was vaccinated with Pneumovax 23 (lot number unavailable). The physician did not know if this was the patient's first vaccination with Pneumovax 23. Subsequently, within 24 hours of vaccination, the patient developed severe swelling and
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse (hematology case manager) concerning a 14 year old male with sickle cell anaemia who on 01-JUN-2006 was vaccinated subcutaneously with a dose of Pneumovax 23. Subsequently, on 02-JUN-2006, the patient developed pain, redness and swelling from the shoulder to the elbow. The child was referred to a hospital emergency department. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Information has been received from a registered nurse (hematology case manager) concerning a 13 year old female with sickle cell anaemia who on 01-JUN-2006 was vaccinated with a dose of Pneumovax 23. On 02-JUN-2006 the patient developed pain, redness, and swelling from shoulder to wrist. The patient was referred to a hospital emergency department (ED). At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Pain, Physical examination abnormal
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 67 year old retired male with chronic obstructive pulmonary disease (based on long history of smoking), hypertension, coronary artery disease and hypoxia (at night with exertion), who on 01-JUN-2006 at 3:30 PM was vaccinated into the left upper deltoid with a second dose of Pneumovax 23 (lot# 651330/1048P). Concomitant therapy included atorvastatin calcium (LIPITOR), lisinopril, metoprolol succinate (TOPROL XL TABLETS), ibuprofen (MOTRIN), aspirin and tiotropium bromide (SPIRIVA). On 01-JUN-2006 (previously reported as evening of 02-JUN-2006) the patient developed pain, local swelling, induration, "doughy", warm and erythematous upper arm. He noted that the patient's lymph nodes were not swollen. The physician sent the patient to the emergency room for antibiotics. Follow-up information from the physician further indicated that the patient returned to his office on 02-JUN-2006 with left upper extremity cellulitis and swelling. He was admitted directly from the physician's office with significant swelling and some erythematous changes in the external and medial surfaces of the upper arm on the left. There was no fever, chills, rigors, nausea or vomiting. Upon examination, the physician reported that the patient was alert with breath sounds 12-14. There was some spongy feeling over the elbow, perhaps the bursal area. No adenopathy in the axilla and skin over the shoulder area, back and below the elbow appeared normal. His sensation was intact throughout and motor function was preserved. Passive flexion in the elbow and shoulder (left) movement was uncomfortable. The patient was diagnosed with a pneumococcal vaccination reaction. Arcus type. Upon admission, he was placed on vancomycin and imipenem. The physician discharged the patient home on 02-JUN-2006 with symptomatic management. The patient was considered recovered. The physician also noted that about a week after the event he met with the patient and the patient remember that he had a previous pneumococcal vaccination just 2 years prior. No further information is expected.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory rate, Skin warm, Swelling
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 67 year old retired male with chronic obstructive pulmonary disease (based on long history of smoking), hypertension, coronary artery disease and hypoxia (at night with exertion), who on 01-JUN-2006 at 3:30 PM was vaccinated into the left upper deltoid with a second dose of Pneumovax 23 (lot# 651330/1048P). Concomitant therapy included atorvastatin calcium (LIPITOR), lisinopril, metoprolol succinate (TOPROL XL TABLETS), ibuprofen (MOTRIN), aspirin and tiotropium bromide (SPIRIVA). On 01-JUN-2006 (previously reported as evening of 02-JUN-2006) the patient developed pain, local swelling, induration, "doughy", warm and erythematous upper arm. He noted that the patient's lymph nodes were not swollen. The physician sent the patient to the emergency room for antibiotics. Follow-up information from the physician further indicated that the patient returned to his office on 02-JUN-2006 with left upper extremity cellulitis and swelling. He was admitted directly from the physician's office with significant swelling and some erythematous changes in the external and medial surfaces of the upper arm on the left. There was no fever, chills, rigors, nausea or vomiting. Upon examination, the physician reported that the patient was alert with breath sounds 12-14. There was some spongy feeling over the elbow, perhaps the bursal area. No adenopathy in the axilla and skin over the shoulder area, back and below the elbow appeared normal. His sensation was intact throughout and motor function was preserved. Passive flexion in the elbow and shoulder (left) movement was uncomfortable. The patient was diagnosed with a pneumococcal vaccination reaction. Arcus type. Upon admission, he was placed on vancomycin and imipenem. The physician discharged the patient home on 02-JUN-2006 with symptomatic management. The patient was considered recovered. The physician also noted that about a week after the event he met with the patient and the patient remember that he had a previous pneumococcal vaccination just 2 years prior. No further information is expected.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 year old female, who works at a nursing home facility, who on 06-JUN-2006 was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # unknown), instead of a tuberculin purified protein derivative, and her arm is swollen. The nurse reported that the employee is scheduled to present to the clinic for a follow up. The patient's outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 39 year old female who on an unspecified date, "inadvertently received Pneumovax 23 vaccine intradermally instead of a Tuberculin Purified Protein Derivative injection". On 09-JUN-2006, the patient developed an erythematous area at the injection site which was several inches in diameter. The patient sought unspecified medical attention. The patient was treated with diphenhydramine hydrochloride (BENADRYL) and ibuprofen (MOTRIN). At the time of this report, the outcome of the event was unknown. The physician considered the event to be an other important medical event. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old female who on 08-JUN-2006 was vaccinated with a "single 0.5 ml dose" of Pneumovax 23. On approximately 08-JUN-2006 (also reported as "within 24 hours after receiving Pneumovax 23, the patient developed flu-like symptoms with aches and pains and had a fever. The patient sought unspecified medical attention. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: Information has been received from a pharmacist concerning a female patient 50-60 years old, with penicillin allergy, who in early June 2006 was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # unknown). One to two days after vaccination, the patient experienced systemic rash. She was treated as an outpatient with diphenhydramine hydrochloride (BENADRYL) and prednisone. At the time of the report the patient was currently in the emergency room. The patient's status was reported as not recovered. No product quality control was involved. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Pneumococcal infection
Clinical narrative: Information has been received from a lawyer concerning a male who was vaccinated with a dose of Pneumovax (manufacturer unknown) that had expired prior to administration. Subsequently, prior to 1999, the patient developed a pneumococcal infection. The patient sought unspecified medical attention. The outcome of the patient's pneumococcal infection was unknown. No further information is available.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Cough, Electrocardiogram normal, Injection site erythema, Pain in extremity
Clinical narrative: Information has been received from a physician's assistant concerning a 39 year old female with an allergy to ofloxacin (FLOXIN) who on 14-JUN-2006 received a 0.1 mL dose of Pneumovax 23 intradermally instead of tuberculin purified protein derivative skin testing in error. When the patient woke up the morning of 15-JUN-2006, the patient's arm was very sore. The patient had a 5 cm erythematous area at the injection site. She felt tightness on her chest and started coughing by lung time. The patient sought unspecified medical attention. An electrocardiogram was normal. The patient's inflammation resolved in 72 hours, and the patient subsequently recovered. No additional information is expected.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician's assistant concerning a 39 year old female with an allergy to ofloxacin (FLOXIN) who on 14-JUN-2006 received a 0.1 mL dose of Pneumovax 23 intradermally instead of tuberculin purified protein derivative skin testing in error. When the patient woke up the morning of 15-JUN-2006, the patient's arm was very sore. The patient had a 5 cm erythematous area at the injection site. She felt tightness on her chest and started coughing by lung time. The patient sought unspecified medical attention. An electrocardiogram was normal. The patient's inflammation resolved in 72 hours, and the patient subsequently recovered. No additional information is expected.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician's office via a wholesaler concerning a male over the age of 55 years who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 650302/1039F). Subsequently, the patient developed redness and swelling of the arm, warmth to the touch and arm pain lasting 3 days. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 78 year old female with drug hypersensitivity to aspirin who on 15-JUN-2006 was vaccinated intramuscularly in the deltoid with 0.5 ml of Pneumovax 23 (lot # 651321/1036P) (no previous history of any injection with Pneumovax 23. Concomitant therapy included desloratadine (CLARINEX), HCTZ/triamterene (DYAZIDE), alendronate sodium (MSD) and fluticasone propionate (FLONASE). It was reported that at the time of vaccination, the patient had "no problems". The medical assistant stated that the injection was one of the last two doses administered from this lot. Subsequently, on 15-JUN-2006 the patient experienced excruciating pain in the arm without redness or swelling and stated that she "could not lift her arm". Unspecified medical attention was sought. The patient was told to take anti-inflammatory medications to help resolve the symptoms. The patient was to be followed by his physician. At the time of this report, the patient had not recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Information has been received from a certified medical assistant concerning a 78 year old male with no pertinent medical history and no known allergies, who on 15-JUN-2006 was vaccinated intramuscular in the deltoid with 0.5 ml of Pneumovax 23 (lot # 651321/1036P). Concomitant therapy included lovastatin and phenytoin (DILANTIN). It was reported that at the time of vaccination, the patient had "no problems". The medical assistant stated that the injection was one of the last two doses administered from this lot. Subsequently, on 15-JUN-2006 the patient experienced excruciating pain in the arm without redness or swelling and stated that he "could not life his arm". Unspecified medical attention was sought. The patient was told to take anti-inflammatory medications to help resolve the symptoms. The patient was to be followed by his physician. The patient had a previous vaccination of Pneumovax 23 in 1998 but was not administered at the same practice, therefore little information pertaining to this vaccination was available. At the time of this report, the patient had not recovered. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Chest X-ray normal, Computerised tomogram abnormal, Injection site cellulitis
Clinical narrative: Initial and follow up information has been received from a respiratory therapist and a physician concerning a 54 year old white male utility compliance supervisor, non-smoker with unspecified allergies, snoring, and a history of appendicitis, tonsillectomy, recurrent bronchitis symptoms, haemolytic anemia, kidney stones (required hospitalization), gallbladder resection, status post splenectomy (1996), asbestos (1990-1992), hiatal hernia, hiatal hernia repair x2 and hand surgery. Illness at the time of vaccination included staphylococcal pneumonia. Family history included colon and bone cancer. On 06-JUN-2006 at 15:00, the patient was vaccinated IM into the right deltoid with a first 0.5 ml dose of Pneumovax 23 (lot # 649697/1038P). Concomitant therapy included meprednisone, fluticasone propionate (+) salmeterol xinafoate (ADVAIR), "gamifloxacin", montelukast sodium (MSD), acetaminophen (TYLENOL), amoxicillin (+) clavulanate potassium (AUGMENTIN), trazodone Hcl, guaifenesin (MUCINEX) and hydrocodone polistirex (+) phenyltoloxamine polistirex (TUSSIONEX). On 07-JUN-2006, the patient developed cellulitis of the right deltoid. The patient's right upper arm was hot to the touch, with a hard area 25 centimeters in diameter. On 07-JUN-2006, a chest CT scan revealed lungs within normal limits and a small hiatal hernia and some calcifications were seen involving the tail of the pancreas. On 08-JUN-2006 the patient was seen by his physician for a follow up visit. His arm was described as a large 8.5 cm indurated, hot, and tender with a painful shoulder that showed streaks which had become progressively worse. The patient was treated with ciprofloxacin hydrochloride (CIPRO), amoxicillin (+) clavulanate potassium (AUGMENTIN), sulfamethoxazole (+) trimethoprim (BACTRIM), methylprednisolone (MEDROL), rifampin and clarithromycin (BIAXIN). On 10-JUN-2006, the physician noted that the patient was symptom free and his events resolved (patient stated symptoms resolved after 2 days). No product quality complaint was involved. Cellulitis was considered to be an other important medical event. Additional information is not expected.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative concerning an 89 year old male patient with a history of sepsis who "2 months ago" on approximately 21-APR-2006 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included warfarin sodium (COUMADIN), digoxin, omeprazole (PRILOSEC) and "KESLEX." On approximately 21-APR-2006 the patient experienced "swollen arm where the injection site was." Subsequently the patient recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female in her sixties who on 22-JUN-2006 was vaccinated intramuscularly with a 0.5 mL second dose of Pneumovax 23. Within 4 hours of vaccination, the patient returned to the clinic. The patient's arm was painful, pink colored, swollen, warm to touch with a round circumscribed area 7-8 cm of deltoid. The patient was treated with an unspecified oral steroid. At the time of this report, the patient had not recovered. The PharmD. indicated that she had reported all of the information that she had concerning the patient's experience. No additional information is expected.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a medical assistant concerning an over 60 year old male with "pulmonary issues" who in June 2006, was vaccinated with a dose of Pneumovax 23 (lot #651320/1008P). Subsequently, in June 2006, the patient experienced cellulitis. Unspecified medical attention was sought. No lab studies were performed. At the time of report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an 86 year old male with no medical history or allergies who on 17-APR-2006 at 1315 was vaccinated subsequently with a first dose of Pneumovax 23 (lot #651332/1049P). There was no illness at the time of vaccination. On 18-APR-2006 at 1500 the injection site was red, warm to the touch and swollen. It was noted
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Lymphocyte count decreased, Neutrophil count increased
Clinical narrative: Information has been received from a registered nurse concerning an 89 year old retired female who on 05-MAY-2006, at 12:00 p.m., was vaccinated with a first dose of Pneumovax 23 (lot # 651332/1049P). Subsequently the patient experienced cellulitis type reaction with redness, swelling and warmth from the elbow to shoulder. Body temperature measurement by mouth was 101. Laboratory data revealed a slightly elevated neutrophil count and decreased lymphocytes. The patient was treated with lactobacillus, 1 capsule twice daily for 17 days and amoxicillin (+) clavulanate potassium (AUGMENTIN), 500 mg twice daily for 10 days. On 09-MAY-2006, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician via a company representative concerning a patient who "10 years ago" in approximately 1996 was vaccinated with a dose of Pneumovax 23. Subsequently the patient experienced swollen arm where the injection site was. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Information has been received from a physician's assistant concerning a female (age not reported) who on 14-JUN-2006 received a 0.1 mL dose of Pneumovax 23 intradermally instead of tuberculin purified protein derivative skin testing in error. Subsequently, the patient developed redness in her arm with a 7.5 cm erythematous area at the injection site. The patient sought unspecified medical attention. No other symptoms were reported. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician's office via a wholesaler concerning a female over the age of 55 years who on an unspecified date was vaccinated with a dose of Pneumovax 23 (lot 650302/1039P). Subsequently, the patient developed redness and swelling of the arm, warmth to the touch and arm pain lasting 3 days. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Arthralgia, Body temperature increased, Injection site erythema, Injection site pain, Lymphocyte count normal
Clinical narrative: Initial and follow up information has been received from a physician concerning a 54 year old female nurse (198 pounds) with hypertension and hypercholesteorlaemia and a history of mastectomy and breast cancer who on 27-JUN-2006 (previously reported as 28-JUN-2006) was vaccinated IM into the left deltoid with a first dose of Pneumovax 23 (lot # 651373/0320F). Secondary concomitant therapy included a second dose of tetanus toxoid (lot # u1584ea) (previously reported as diphtheria toxoid/tetanus toxoid) IM into the left deltoid. On 27-JUN-2006, within several hours the patient experienced fever 102.7 F, severe myalgias, nausea, general malaise, joint pain and injection site reaction with redness and tenderness. She was treated with acetaminophen (TYLENOL) prn, ice pack, and Phenergan prn. The patient required a doctor visit and improved within 3 to 4 days. Laboratory findings included a WBC 12,800, 77 segs, 14 lymphs band 9 bands. She recovered on 30-JUN-2006 from fever, malaise, myalgias and nausea. Fever 102.7 F, myalgia, joint pain and injection site reaction were considered to be disabling according to the reporter. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Malaise, Myalgia, Nausea, Neutrophil count increased, Neutrophil percentage increased
Clinical narrative: Initial and follow up information has been received from a physician concerning a 54 year old female nurse (198 pounds) with hypertension and hypercholesteorlaemia and a history of mastectomy and breast cancer who on 27-JUN-2006 (previously reported as 28-JUN-2006) was vaccinated IM into the left deltoid with a first dose of Pneumovax 23 (lot # 651373/0320F). Secondary concomitant therapy included a second dose of tetanus toxoid (lot # u1584ea) (previously reported as diphtheria toxoid/tetanus toxoid) IM into the left deltoid. On 27-JUN-2006, within several hours the patient experienced fever 102.7 F, severe myalgias, nausea, general malaise, joint pain and injection site reaction with redness and tenderness. She was treated with acetaminophen (TYLENOL) prn, ice pack, and Phenergan prn. The patient required a doctor visit and improved within 3 to 4 days. Laboratory findings included a WBC 12,800, 77 segs, 14 lymphs band 9 bands. She recovered on 30-JUN-2006 from fever, malaise, myalgias and nausea. Fever 102.7 F, myalgia, joint pain and injection site reaction were considered to be disabling according to the reporter. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Initial and follow up information has been received from a physician concerning a 54 year old female nurse (198 pounds) with hypertension and hypercholesteorlaemia and a history of mastectomy and breast cancer who on 27-JUN-2006 (previously reported as 28-JUN-2006) was vaccinated IM into the left deltoid with a first dose of Pneumovax 23 (lot # 651373/0320F). Secondary concomitant therapy included a second dose of tetanus toxoid (lot # u1584ea) (previously reported as diphtheria toxoid/tetanus toxoid) IM into the left deltoid. On 27-JUN-2006, within several hours the patient experienced fever 102.7 F, severe myalgias, nausea, general malaise, joint pain and injection site reaction with redness and tenderness. She was treated with acetaminophen (TYLENOL) prn, ice pack, and Phenergan prn. The patient required a doctor visit and improved within 3 to 4 days. Laboratory findings included a WBC 12,800, 77 segs, 14 lymphs band 9 bands. She recovered on 30-JUN-2006 from fever, malaise, myalgias and nausea. Fever 102.7 F, myalgia, joint pain and injection site reaction were considered to be disabling according to the reporter. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 67 year old female with breast cancer, and drug allergies to sulfonamides, povidone-iodine (BETADINE), "griseofulvin", "primidone", acetaminophen (+) hydrocodone bitartrate (VICODIN), ranitidine hydrochloride (ZANTAC), and "nabumetone" and a history of dystonia which causes tremors, who on 30-JUN-2006 was vaccinated into the right arm with a dose of Pneumovax 23. Concomitant therapy included phenobarbital, lovastatin, acetazolamide and estradiol. On 30-JUN-2006, the patient experienced itching and swelling in her right arm in the area she was given the vaccine. Gradually, the itching and swelling became more severe until her entire right upper arm was swollen. Unspecified medical attention was sought. No diagnostic laboratory studies were given. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site haematoma
Clinical narrative: Information has been received from a doctor of pharmacy student concerning an inpatient (age and gender unknown) who on the "past week or two", on approximately 14-JUN-2006, was vaccinated intramuscular with a 0.5 mL dose of Pneumovax 23 (Lot # unknown) while in the hospital. The student reports a hospital patient was on eptifibatide (INTEGRILIN) drip and heparin for myocardial infarction. Prior to this admission the patient was on warfarin sodium (COUMADIN). While in the hospital the patient received Pneumovax 23. A hematoma developed at the vaccine injection site within a few hours. The patient remains in the hospital. No product quality complaint was involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site cellulitis
Clinical narrative: Information has been received from a medical assistant concerning a 68 year old female with an allergy to penicillin and codeine and no significant medical history who on 23-FEB-2006 at 0900 was vaccinated in the left deltoid with a second dose of Pneumovax 23 (lot # 651322/1044P). There was no illness at the time of vaccination. The patient was being seen for a routine check-up. On 27-FEB-2006 the patient developed cellulitis with injection site redness and swelling down the arm to the mid-deltoid. She had a fever of 100.5, chills, erythema and pain. The patient was prescribed levofloxacin (LEVAQUIN) 500 mg daily x 10 days and ice packs to the area prn. On 01-MAR-2006 the patient recovered. On 25-JUL-2006 the patient called the office and reported that the area of injection was still sore to the touch. The reporter felt that cellulitis was considered to be an other important medical event. No further information is expected.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of Pneumovax 23. Other concomitant therapy included a dose of influenza virus vaccine (unspecified), an illegible therapy and budesonide (NASOCORT). On 17-FEB-2006, the patient experienced an injection site rash. Within 2 to 3 weeks (also reported as "a few days"), the patient recovered. The physician also reported on the patient's experienced with montelukast sodium (WAES # 0607USA00837). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician assistant concerning a patient (age and gender not reported) who on an unknown date, was vaccinated intramuscular with a 0.mL of Pneumovax 23 (Lot# 651321/1036P). Subsequently, within 48 hours of vaccination, the patient developed swelling, redness, warmth and severe soreness around the injection site. The reporter indicated that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient had recovered. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, Pain in extremity
Clinical narrative: Initial and follow up information has been received from a registered nurse and doctor's office concerning a 55 year old white male patient, with hypertension (HTN) and coronary artery disease (CAD) and no know drug allergies, who on 11-JUL-2006 at 14:30 pm was vaccinated (route unknown) in the deltoid with a first dose of Pneumovax 23 (Lot # 650329/0747P) which expired on 19-APR-2006. The nurse originally reported that the patient did not have any adverse symptoms and unspecified medical attention was sought. Follow up information from the physician's office indicated that "the patient did not have any reaction to the injectable except a sore left arm" (onset date unknown). It was reported that "after checking supplies-realized patient was injected with an expired [pneumococcal 23v polysaccharide vaccine] inj." It was reported that the "patient was not ill, came in for medication refill only." No product quality complaint was involved. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician assistant concerning a male patient (age not reported) who on 10-JUL-2006 was vaccinated intramuscularly with a 0.5mL dose of Pneumovax 23 (Lot # 651321/1036P). Subsequently, within 48 hours of vaccination (approximately 12-JUL-2006) the patient developed swelling, redness, warmth and severe soreness around the injection site. Additional information from the physician assistant also indicated that this patient had developed a fever of 102F on the evening of 13-JUL-2006 (outcome of fever not reported). She also noted that the patient was doing much better. He was still recovering and had only slight edema. The reporter indicata3ed that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient was recovering. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a male patient (age not reported) who on 10-JUL-2006 was vaccinated intramuscularly with a 0.5mL dose of Pneumovax 23 (Lot # 651321/1036P). Subsequently, within 48 hours of vaccination (approximately 12-JUL-2006) the patient developed swelling, redness, warmth and severe soreness around the injection site. Additional information from the physician assistant also indicated that this patient had developed a fever of 102F on the evening of 13-JUL-2006 (outcome of fever not reported). She also noted that the patient was doing much better. He was still recovering and had only slight edema. The reporter indicata3ed that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient was recovering. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician assistant concerning a patient (age and gender not reported) who on an unknown date was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot# 651321/1036P). Subsequently, within 48 hours of vaccination, the patient developed swelling, redness, warmth and severe soreness around the injection site. The patient had also developed a fever of 101F. The reporter indicated that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient had recovered. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics and Research and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a patient (age and gender not reported) who on an unknown date was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot# 651321/1036P). Subsequently, within 48 hours of vaccination, the patient developed swelling, redness, warmth and severe soreness around the injection site. The patient had also developed a fever of 101F. The reporter indicated that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient had recovered. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics and Research and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician assistant concerning a female patient (age not reported) who on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23 (Lot # 651321/1036P). Subsequently, within 48 hours of vaccination, the patient developed swelling, redness, warmth and severe soreness around the injection site. The reporter indicated that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient had recovered. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question ahs been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral
Clinical narrative: Information has been received from an office manager concerning a male patient who was vaccinated with a dose of Pneumovax 23 (lot #651321/1036P). Subsequently, on 13-JUL-2006, the patient experienced red, swollen arm with numbness in palm of hand. The patient saw a physician. The physician sent him to the emergency room but he was not seen right away so he returned back to the physician's office. The physician requested a lot check. Unspecified medical attention was sought. The physician 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 Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a Certified Medical Assistant and a Nurse Practitioner concerning a 19 year old male student with asthma, seasonal allergies, iodine allergy and a history of repeated pneumonias and supraventricular tachycardia (SVT) s/p ablation and no illness at the time of vaccination who on 10-JUL-2006 was vaccinated intramuscularly in the deltoid with a 0.5mL first dose of Pneumovax 23 (lot 651172/1210R). On 13-JUL-2006, the patient developed a severe cellulitis at the injection site with a 10 inch diameter, high fever, and chills. The patient went to the local emergency room and was hospitalized. The patient was transferred to another hospital and received unspecified IV antibiotics and steroids. At the time of this report, the outcome of the patient's condition was unknown. Injection site cellulitis was considered to be immediately life-threatening by the Certified Medical Assistant. Follow-up information received from the Nurse Practitioner did not indicate that the patient's cellulitis was considered life threatening. The release of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional information is expected.