chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Rash, Swelling
Clinical narrative: intense pain starting in deltoid muscle migrating to elbow in the first hour. Unable to raise arm due to pain.  Rash progressing to solid redden area that was inflames and emense swelling in the next 24 hours.  Temperature of 99.7.  Swelling began to decrease after 48 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Erythema, swelling, and blisters of Right arm beginning on the day of administration. Treatment: Benadryl, Motrin, Bacitracin
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: This case was reported by a physician and described the occurrence of seizure disorder in a female subject of unspecified age who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced seizure disorder. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 47-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 4 August 2008 at 13:30 the subject received 2nd dose of ENGERIX B in the left arm. On 4 August 2008, at an unspecified time after vaccination with ENGERIX B, the subject experienced rash and fever. A systemic reaction. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL. At the time of reporting the events were unresolved.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Ejection fraction decreased, Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Vaccinia, Vomiting
Clinical narrative: Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Angiogram normal, Blood pressure, Body temperature increased, Cardiac enzymes increased, Chest pain
Clinical narrative: Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chills, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram ST segment elevation
Clinical narrative: Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Heart rate normal, Hypokinesia, Injection site erythema, Injection site pain
Clinical narrative: Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site swelling, Pain, Pericarditis, Pyrexia, Rash erythematous
Clinical narrative: Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Rash maculo-papular, Respiratory rate, Scan
Clinical narrative: Mild case of vaccinia, fatigue, malaise,  intermittent fever, occasional nausea and vomiting, chest pain, decreased ejection fraction 40%-45%.  9/16/08 Reviewed hospital medical records of 8/5-8/9/08. FINAL DX: smallpox immunization reaction; chest pain secondary to pericarditis/myocarditis after smallpox immunization Records reveal patient experienced substernal crushing heavy chest pain x 1 day started approx 10 days s/p vaccination with injection site pustules & swelling, fatigue, malaise, fever, nausea & vomiting.  ID & cardio consults done.  Progressed well w/NSAIDs & d/c to home.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash pustular
Clinical narrative: Patient received ZOSTAVAX 7-29-08.  Discovered small red pustules on left shoulder blade the next day - reported to pharmacy 8-4-08.  More red spots appeared 8-5-08.  Gave Benadryl and referred her to her family doctor.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event noted at this time after 27 year old female received HPV.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood glucose normal, Blood pressure, Haemoglobin normal, Hypotonia, Oxygen supplementation
Clinical narrative: After vaccines given (within minutes) patient slumped into chair slightly shaken of body, appeared pale in color, eyes staring upward vs. outward into space.  Patient placed on exam table, given O2 via face mask, BP 108/36, accucheck 87, Hbg 12, EMS called.  Patient was responsive within 5 minutes.  Before leaving awake, alert, no respiratory distress.  Refer to ER.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pallor, Staring, Tremor
Clinical narrative: After vaccines given (within minutes) patient slumped into chair slightly shaken of body, appeared pale in color, eyes staring upward vs. outward into space.  Patient placed on exam table, given O2 via face mask, BP 108/36, accucheck 87, Hbg 12, EMS called.  Patient was responsive within 5 minutes.  Before leaving awake, alert, no respiratory distress.  Refer to ER.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, MNQ
Symptoms: Back pain, Fall, Syncope
Clinical narrative: 15 minutes after immunization patient fainted in waiting room. She had been ambulating in exam room without difficulty and ambulated to waiting room by herself. Last meal greater than 12 hours prior to immunization. Complained of back pain as she fell back against the wall and slid to floor - Vitals checked.  Ice applied, juice grape and crackers given. Patient monitored x1 hr discharged to home with step mom.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Decreased appetite, Fatigue, Headache, Hypersomnia
Clinical narrative: Fatigue.  Slept for 3 hours.  Headache, decreased appetite starting 1 hour post injections.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Wrong technique in drug usage process
Clinical narrative: Patient was given improper reconstitution of Smallpox (Acam 2000), was diluted with 0.7 ml of sterile water.  Patient does not have adverse reaction at this time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Bronchospasm, Cough, Dyspnoea, Eye swelling, Hypersensitivity
Clinical narrative: Urticaria, bronchiospasm, swelling around eyes, cough, difficulty breathing, no severe distress.  Benadryl given, Albuterol breathing treatment administered.  Orapred given, observed for 1 hour.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria, bronchiospasm, swelling around eyes, cough, difficulty breathing, no severe distress.  Benadryl given, Albuterol breathing treatment administered.  Orapred given, observed for 1 hour.
Age: 1.1
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blister, Blood lead normal, Feeling abnormal, Full blood count normal, Otitis media
Clinical narrative: On 6th day after vaccine, child was "not himself" and had fever.  On 4th day, 4/15/08, T 101.9 with vesicles in various stages - some super infected and a left otitis media.
Age: 1.1
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Syphilis test negative
Clinical narrative: On 6th day after vaccine, child was "not himself" and had fever.  On 4th day, 4/15/08, T 101.9 with vesicles in various stages - some super infected and a left otitis media.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis left upper arm. 2nd to VARIVAX shot given at health center
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Induration, Pain, Skin warm
Clinical narrative: Area of induration, erythema, warmth and pain; was 11x13cm central cluster of blisters was 3x5cm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received a 3rd dose of VARIVAX today; wasn't realized that PROQUAD was given last year . No adverse event at this time.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: A warm circular tender area about 3in x 2in in dimension on right lateral side of thigh.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 102.2 - 103.5 -  no redness at site received HIB, PCV7, PEDIARIX 8-5-08 at Dr office vomiting yesterday and today
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Injection site pain, Myalgia, Nausea
Clinical narrative: Information has been received from a healthcare professional and a consumer concerning her husband who was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658075/0962U). After receiving the vaccine, the patient became nauseous, experienced a fever, muscle pain, joint pain and pain at injection site. The patient was hospitalized for 3 days and was put on IV antibiotics. At the time of this report, the patient felt "weak." It was also reported that the patient still had joint and muscle pain but the pain was lessened. No product quality complaint was involved. A lot check has been requested. 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 government and was released. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a healthcare professional and a consumer concerning her husband who was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658075/0962U). After receiving the vaccine, the patient became nauseous, experienced a fever, muscle pain, joint pain and pain at injection site. The patient was hospitalized for 3 days and was put on IV antibiotics. At the time of this report, the patient felt "weak." It was also reported that the patient still had joint and muscle pain but the pain was lessened. No product quality complaint was involved. A lot check has been requested. 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 government and was released. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 75 year old female with no pertinent medical history and no history of drug reactions/allergies who on 14-AUG-2007 was vaccinated with PNEUMOVAX 23 (lot # 655289/0958F) 0.5 ml IM in the left triceps. There was no concomitant medication. On 14-AUG-2007, the patient experienced an injection site reaction when the patient got home from the vaccination. At an office visit on 17-AUG-2007, the reaction was described as a red, tender, warm area with induration at the injection site that was 16 by 17 mm. The injection site reaction was characterized as possible cellulitis. On an unspecified date, a complete blood count was performed, no results reported. The patient was given a prescription for KEFLEX 500 mg three times a day for 7 days. The patient was contacted by the nurse by phone on 24-AUG-2007. The patient recovered on 27-AUG-2007. The registered nurse considered the events to be disabling. The nurse requested a lot check. 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 government and was released. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Incorrect route of drug administration, Injection site cellulitis, Underdose
Clinical narrative: Initial and follow-up information has been received from an office manager concerning a 46 year old female with a history of breast cancer and an allergy to VICODIN, who on 20-SEP-2007 at 14:06 was vaccinated SC in the right arm with a 0.5 ml first dose of PNEUMOVAX 23 (lot #657525/0554U). Concomitant vaccinations included influenza virus vaccine (unspecified) (Lot# 79897) administered intramuscularly in the right deltoid. There were no illnesses at the time of the vaccination. On 21-SEP-2007 the patient developed cellulitis at the injection site. On 21-SEP-2007 the patient called and was seen in the physician's office. The patient was treated with KEFLEX. No laboratory diagnostics were performed. The patient recovered on an unspecified date. The office manager is requesting a lot check. A standard and enhanced 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 government and was released. The physician considered the cellulitis at the injection site to be an other important medical event. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a nurse and a healthcare worker, concerning a 62 year old male patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (lot # 654977/0888F), and developed cellulitis. The patient was hospitalized for treatment and evaluation (details not specified). At the time of this report, the outcome of the event was  unknown. This is one of several reports received from the same source (WAES #0709USA02720 and 0709USA03917)
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Pharyngolaryngeal pain, Swelling face
Clinical narrative: Information has been received from a pharmacist concerning a 35 year old male with sickle cell anaemia, TORADOL allergy and hospitalization for a sickle cell crisis who on 13-SEP-2007 was vaccinated with a dose of PNEUMOVAX 23 (lot #656222/0381U), 1 vial, IM prior to being discharged from the hospital. Concomitant medication was not reported. On 13-SEP-2007, shortly after receiving the PNEUMOVAX 23, the patient developed an anaphylactic reaction. He experienced facial swelling and throat discomfort. The patient was treated with SOLU-MEDROL, IV and an unspecified inhaler. The patient's hospitalization was prolonged as he was transferred to the Intensive Care Unit (ICU) for 48 hours. Unspecified medical attention was sought. The reporting pharmacist felt that anaphylactic reaction was related to therapy with PNEUMOVAX 23. At the time of reporting, the patient had improved 40%. Anaphylactic reaction was considered to be immediately life-threatening and 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 met the requirements of the government and was released. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Immediate post-injection reaction
Clinical narrative: Information has been received from a nurse concerning a 53 year old female who on 08-DEC-2000 was vaccinated with a 0.5 ml first dose of PNEUMOVAX 23. On 08-DEC-2000 the patient experienced anaphylactic reaction immediately after receiving PNEUMOVAX 23. She was admitted to the hospital and hospitalized for two days on 08-DEC-2000 and 09-DEC-2000. Subsequently, the patient recovered from the anaphylactic reaction. The reporting nurse considered anaphylactic reaction to be immediately life-threatening. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Information has been received from a 66 year old male pharmacist with arthritis and a narcotic hypersensitivity who on 23-JUL-2007 was vaccinated in the left deltoid with a dose of PNEUMOVAX.  The patient received an intraarticular injection of methylprednisolone in the right shoulder several hours prior to the administration of PNEUMOVAX.  Concomitant therapy included CELEBREX, vitamin E, and an unspecified multivitamin.  On 24-JUL-2007 the patient developed arthralgia, redness, warmth, and a firm nodule at the injection site.  The pharmacist stated, "I can hardly move around because of the joint pain".  The patient self-treated with KEFLEX 1000-1500 mg daily for 5 days.  On approximately 25-JUL-2007 the patient recovered from the injection site reaction, but the arthralgia persisted.  The patient had an appointment scheduled on 16-AUG-2007 with his physician to evaluate the arthralgia.  The pharmacist considered arthralgia to be a disabling event.  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased
Clinical narrative: Information has been received from a 66 year old male pharmacist with arthritis and a narcotic hypersensitivity who on 23-JUL-2007 was vaccinated in the left deltoid with a dose of PNEUMOVAX.  The patient received an intraarticular injection of methylprednisolone in the right shoulder several hours prior to the administration of PNEUMOVAX.  Concomitant therapy included CELEBREX, vitamin E, and an unspecified multivitamin.  On 24-JUL-2007 the patient developed arthralgia, redness, warmth, and a firm nodule at the injection site.  The pharmacist stated, "I can hardly move around because of the joint pain".  The patient self-treated with KEFLEX 1000-1500 mg daily for 5 days.  On approximately 25-JUL-2007 the patient recovered from the injection site reaction, but the arthralgia persisted.  The patient had an appointment scheduled on 16-AUG-2007 with his physician to evaluate the arthralgia.  The pharmacist considered arthralgia to be a disabling event.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Blood creatine phosphokinase normal, Blood culture negative, Cellulitis, Computerised tomogram abnormal, Erythema
Clinical narrative: Information has been received from a respiratory therapist and medical records concerning a 30 year old female with asthma, sinusitis, multiple environmental allergies, diabetes, thyroid goiter, obesity, restless less syndrome, and a history of partial thyroidectomy and cesarean section x2 with treatment of pre-eclampsia who on 06-AUG-2007 was vaccinated in the right deltoid with a first dose of PNEUMOVAX 23 (lot 655152/0889F). Concomitant therapy included ADVAIR, montelukast sodium, ZYRTEC, PRILOSEC, phentermine, WELLBUTRIN XL, MIRAPEX, and PROVENTIL. On approximately 08-AUG-2007, 2 to 3 days post vaccination (previously reported as 06-AUG-2007), the patient developed increased pain at the site of vaccination accompanied by erythema, swelling, increased tenderness. On 09-AUG-2007, the patient's right arm was swollen, red, and very warm to touch from shoulder to wrist. The patient was unable to bend the elbow secondary to edematous of length of arm. On 09-AUG-2007, the patient was hospitalized for further evaluation. Admission and discharge diagnosis was cellulitis. The patient was empirically started on therapy with vancomycin and ZOSYN. On 10-AUG-2007, x-ray of the right arm showed soft tissue swelling of the right humerus, but no fracture or osteomyelitis. CT of the arm showed increased density suggesting fluid or edema in the region of subcutaneous fat, posterior elbow. MRI of the humerus showed no localized fluid collections. There was subcutaneous edema of the right upper extremity, greatest in posterior elbow region, consistent with either cellulitis versus reaction to PNEUMOVAX 23. Infectious disease consultation thought it was likely right upper arm cellulitis associated with instrumentation from IM injection, less likely an allergic reaction since no pruritis or exacerbation of asthma. The patient had localized confluent erythema and warmth and tenderness also along the cellulitis infection. CPK was normal. Clindamycin was added to the patient's regimen. She continued to do well. She defervesced. Cultures were negative. She was transitioned to an oral regimen with continued improvement of her cellulitis and deemed stable for discharge home. On 12-AUG-2007, the patient was discharged to home on therapy with AUGMENTIN 875mg twice daily for 10 days and BACTRIM DS 1 tablet twice daily for 10 days. The patient was instructed to follow-up with primary care physician the following week. The respiratory therapist considered the patient's cellulitis to be disabling and an other important medical event. This is one of two reports from the same source. No additional information is expected.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a respiratory therapist and medical records concerning a 30 year old female with asthma, sinusitis, multiple environmental allergies, diabetes, thyroid goiter, obesity, restless less syndrome, and a history of partial thyroidectomy and cesarean section x2 with treatment of pre-eclampsia who on 06-AUG-2007 was vaccinated in the right deltoid with a first dose of PNEUMOVAX 23 (lot 655152/0889F). Concomitant therapy included ADVAIR, montelukast sodium, ZYRTEC, PRILOSEC, phentermine, WELLBUTRIN XL, MIRAPEX, and PROVENTIL. On approximately 08-AUG-2007, 2 to 3 days post vaccination (previously reported as 06-AUG-2007), the patient developed increased pain at the site of vaccination accompanied by erythema, swelling, increased tenderness. On 09-AUG-2007, the patient's right arm was swollen, red, and very warm to touch from shoulder to wrist. The patient was unable to bend the elbow secondary to edematous of length of arm. On 09-AUG-2007, the patient was hospitalized for further evaluation. Admission and discharge diagnosis was cellulitis. The patient was empirically started on therapy with vancomycin and ZOSYN. On 10-AUG-2007, x-ray of the right arm showed soft tissue swelling of the right humerus, but no fracture or osteomyelitis. CT of the arm showed increased density suggesting fluid or edema in the region of subcutaneous fat, posterior elbow. MRI of the humerus showed no localized fluid collections. There was subcutaneous edema of the right upper extremity, greatest in posterior elbow region, consistent with either cellulitis versus reaction to PNEUMOVAX 23. Infectious disease consultation thought it was likely right upper arm cellulitis associated with instrumentation from IM injection, less likely an allergic reaction since no pruritis or exacerbation of asthma. The patient had localized confluent erythema and warmth and tenderness also along the cellulitis infection. CPK was normal. Clindamycin was added to the patient's regimen. She continued to do well. She defervesced. Cultures were negative. She was transitioned to an oral regimen with continued improvement of her cellulitis and deemed stable for discharge home. On 12-AUG-2007, the patient was discharged to home on therapy with AUGMENTIN 875mg twice daily for 10 days and BACTRIM DS 1 tablet twice daily for 10 days. The patient was instructed to follow-up with primary care physician the following week. The respiratory therapist considered the patient's cellulitis to be disabling and an other important medical event. This is one of two reports from the same source. No additional information is expected.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Skin warm, X-ray abnormal
Clinical narrative: Information has been received from a respiratory therapist and medical records concerning a 30 year old female with asthma, sinusitis, multiple environmental allergies, diabetes, thyroid goiter, obesity, restless less syndrome, and a history of partial thyroidectomy and cesarean section x2 with treatment of pre-eclampsia who on 06-AUG-2007 was vaccinated in the right deltoid with a first dose of PNEUMOVAX 23 (lot 655152/0889F). Concomitant therapy included ADVAIR, montelukast sodium, ZYRTEC, PRILOSEC, phentermine, WELLBUTRIN XL, MIRAPEX, and PROVENTIL. On approximately 08-AUG-2007, 2 to 3 days post vaccination (previously reported as 06-AUG-2007), the patient developed increased pain at the site of vaccination accompanied by erythema, swelling, increased tenderness. On 09-AUG-2007, the patient's right arm was swollen, red, and very warm to touch from shoulder to wrist. The patient was unable to bend the elbow secondary to edematous of length of arm. On 09-AUG-2007, the patient was hospitalized for further evaluation. Admission and discharge diagnosis was cellulitis. The patient was empirically started on therapy with vancomycin and ZOSYN. On 10-AUG-2007, x-ray of the right arm showed soft tissue swelling of the right humerus, but no fracture or osteomyelitis. CT of the arm showed increased density suggesting fluid or edema in the region of subcutaneous fat, posterior elbow. MRI of the humerus showed no localized fluid collections. There was subcutaneous edema of the right upper extremity, greatest in posterior elbow region, consistent with either cellulitis versus reaction to PNEUMOVAX 23. Infectious disease consultation thought it was likely right upper arm cellulitis associated with instrumentation from IM injection, less likely an allergic reaction since no pruritis or exacerbation of asthma. The patient had localized confluent erythema and warmth and tenderness also along the cellulitis infection. CPK was normal. Clindamycin was added to the patient's regimen. She continued to do well. She defervesced. Cultures were negative. She was transitioned to an oral regimen with continued improvement of her cellulitis and deemed stable for discharge home. On 12-AUG-2007, the patient was discharged to home on therapy with AUGMENTIN 875mg twice daily for 10 days and BACTRIM DS 1 tablet twice daily for 10 days. The patient was instructed to follow-up with primary care physician the following week. The respiratory therapist considered the patient's cellulitis to be disabling and an other important medical event. This is one of two reports from the same source. No additional information is expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Incorrect dose administered, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 75 year old female with a penicillin allergy and an allergy to lima beans (sick to stomach) who on 27-JUN-2007 was vaccinated subcutaneously in the upper left arm with a 0.5 mL dose of PNEUMOVAX 23 (lot 656233/0200U). Concomitant therapy included calcium (unspecified), vitamin D (unspecified) and vitamins (unspecified). On 27-JUN-2007, in the evening, the patient developed pain in the left arm, little redness, and swelling. The patient went to the office on 29-JUN-2007 and was diagnosed with cellulitis. The patient was treated with levofloxacin. The patient subsequently went to the emergency room because her symptoms worsened. The patient was treated with clindamycin IV at the emergency room and was given oral clindamycin to be taken along with the levofloxacin. The patient was seen in the office on 03-JUL-2007 and was recovering. The patient's cellulitis was considered to be disabling because the patient couldn't lift her arm and was in alot of pain. No additional information is expected.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 75 year old female with a penicillin allergy and an allergy to lima beans (sick to stomach) who on 27-JUN-2007 was vaccinated subcutaneously in the upper left arm with a 0.5 mL dose of PNEUMOVAX 23 (lot 656233/0200U). Concomitant therapy included calcium (unspecified), vitamin D (unspecified) and vitamins (unspecified). On 27-JUN-2007, in the evening, the patient developed pain in the left arm, little redness, and swelling. The patient went to the office on 29-JUN-2007 and was diagnosed with cellulitis. The patient was treated with levofloxacin. The patient subsequently went to the emergency room because her symptoms worsened. The patient was treated with clindamycin IV at the emergency room and was given oral clindamycin to be taken along with the levofloxacin. The patient was seen in the office on 03-JUL-2007 and was recovering. The patient's cellulitis was considered to be disabling because the patient couldn't lift her arm and was in alot of pain. No additional information is expected.
Sex: U
Vaccine: PPV
Symptoms: Chills, Headache, Injection site cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a physician, concerning who patients (gender and age not specified), who in June 2007 ("within the past week"), were vaccinated, with a dose, of PNEUMOVAX 23 (lot # not provided, though specified as different lots). After an unknown duration of time following the vaccination, the patients developed cellulitis. Follow up information from the physician indicated that there were 5 "serious injection site reaction with (PNEUMOVAX 23) since March." At the time of this report, the 3 patients included in this report had recovered with outpatient treatment (treatment not specified). The physician considered the injection site reactions to be serious, as other important medical events. Additional follow up information from the physician, identified a patient (gender and age not specified), who was vaccinated in the right tricep, on 15-MAR-2007, (a "low titer" was drawn on 08-FEb-2007) with a dose of PNEUMOVAX 23 (lot #655291/0985F). Five hours after the vaccination, the patient developed the start of an injection site reaction, also specified as cellulitis, that involved redness and swelling of the right tricep, chills and a headache. The reaction site was measured as 11 cm by 15 cm. Treatment included ALLEGRA, and the patient recovered (duration not specified). Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician, concerning who patients (gender and age not specified), who in June 2007 ("within the past week"), were vaccinated, with a dose, of PNEUMOVAX 23 (lot # not provided, though specified as different lots). After an unknown duration of time following the vaccination, the patients developed cellulitis. Follow up information from the physician indicated that there were 5 "serious injection site reaction with (PNEUMOVAX 23) since March." At the time of this report, the 3 patients included in this report had recovered with outpatient treatment (treatment not specified). The physician considered the injection site reactions to be serious, as other important medical events. Additional follow up information from the physician, identified a patient (gender and age not specified), who was vaccinated in the right tricep, on 15-MAR-2007, (a "low titer" was drawn on 08-FEb-2007) with a dose of PNEUMOVAX 23 (lot #655291/0985F). Five hours after the vaccination, the patient developed the start of an injection site reaction, also specified as cellulitis, that involved redness and swelling of the right tricep, chills and a headache. The reaction site was measured as 11 cm by 15 cm. Treatment included ALLEGRA, and the patient recovered (duration not specified). Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Initial and follow up information has been received from a physician and a healthcare professional, concerning an 18 year old male patient, with no pertinent medical history, who on 14-JUN-2007 was vaccinated subcutaneously in the upper right arm, with a dose, 0.5ml, of PNEUMOVAX (lot # 655501/1035F).  There was no concomitant medication.  On approximately 15-JUN-2007, at 12 hours after vaccination, he "gradually developed an injection site reaction," with cellulitis involving redness and warmth that spread over the next 2 days to include the upper right forearm with induration and a fever of 102.6 degrees.  Treatment included prednisone (manufacturer unspecified) and KEFLEX; the patient was referred to an infectious disease specialist (details not provided).  At the time of this report, the patient's symptoms had resolved.  The physician considered the injection site reaction to be serious as other important medical events.  Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician and a healthcare professional, concerning an 18 year old male patient, with no pertinent medical history, who on 14-JUN-2007 was vaccinated subcutaneously in the upper right arm, with a dose, 0.5ml, of PNEUMOVAX (lot # 655501/1035F).  There was no concomitant medication.  On approximately 15-JUN-2007, at 12 hours after vaccination, he "gradually developed an injection site reaction," with cellulitis involving redness and warmth that spread over the next 2 days to include the upper right forearm with induration and a fever of 102.6 degrees.  Treatment included prednisone (manufacturer unspecified) and KEFLEX; the patient was referred to an infectious disease specialist (details not provided).  At the time of this report, the patient's symptoms had resolved.  The physician considered the injection site reaction to be serious as other important medical events.  Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning his wife, a 36 year old female with celiac disease and no known allergies, who on 01-JUN-2007 was vaccinated with a dose of PNEUMOVAX 23. There was no concomitant medication. On 02-JUN-2007, the pharmacist's wife started to experience soreness at the injection site (unspecified arm). On 03-JUN-2007, she developed a headache, fever, chills, body aches, nausea, and redness with pain and swelling at the injection site. The redness at the injection site spread around the arm, and became a patch measuring 3 x 6 inches, and included a more localized injection site reaction described as a pink, warm, triangular patch. The pharmacist noted the swelling and pain had decreased, but reported that his wife "can't do much but lay on the couch." At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. The pharmacist considered one or more of the events to be significantly disabling/incapacitating. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning his wife, a 36 year old female with celiac disease and no known allergies, who on 01-JUN-2007 was vaccinated with a dose of PNEUMOVAX 23. There was no concomitant medication. On 02-JUN-2007, the pharmacist's wife started to experience soreness at the injection site (unspecified arm). On 03-JUN-2007, she developed a headache, fever, chills, body aches, nausea, and redness with pain and swelling at the injection site. The redness at the injection site spread around the arm, and became a patch measuring 3 x 6 inches, and included a more localized injection site reaction described as a pink, warm, triangular patch. The pharmacist noted the swelling and pain had decreased, but reported that his wife "can't do much but lay on the couch." At the time of this report, the patient had not recovered from the events. The patient sought unspecified medical attention. The pharmacist considered one or more of the events to be significantly disabling/incapacitating. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Local reaction
Clinical narrative: Information has been received from a certified medical assistant concerning two patient who were vaccinated with PNEUMOVAX 23. Subsequently the patients experienced cellulitis-like reactions. The patients were treated with an antibiotic. At the time of the report it was unknown if the patients recovered. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. In follow-up it was reported by the physician that a patient with no pre-existing allergies, birth defects, or medical conditions was vaccinated intramuscularly in the a.m., on approximately 26-JAN-2007, with PNEUMOVAX 23, (Lot # 651406/0620F). It was reported that the patient had a localized cellulitic-like reaction. The patient had a clinical exam only. It was reported that the patient recovered. The reporter stated that there were three other patients that had localised cellulitic-like reactions after receiving the PNEUMOVAX 23, (WAES # 0711USA03296, # 0711USA03297, 0711USA03298). Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 10 month (original report was at 4 month) old female child who on 04-MAY-2007 was vaccinated with a dose of PNEUMOVAX 23. In follow up it was reported that on 08-MAY-2007 she was vaccinated with concomitant therapy which included diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (lot # AC14B044AA), poliovirus vaccine (lot # Z0547) and Hib conj vaccine (unspecified carrier) (lot # UE958AA). In follow up it was reported that the patient experienced slight redness and swelling which resolved couple days later. No further problems. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old female with hypertension who in 31-MAY-2007 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 655499/0988F).  There was no concomitant medication.  Subsequently the patient experienced "50 cent piece size" injection site reaction, the area was warm and sore.  The patient has not been seen by the physician but the registered nurse anticipated treatment of an unknown type.  At the time of the report, the patient had not recovered.  Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Local reaction
Clinical narrative: Information has been received from a health care worker concerning a 40 year old female healthcare consultant with penicillin allergy who on 08-MAY-2007 was vaccinated IM with a dose of PNEUMOVAX 23 lot # 655766/0038U. The reporter reported that patient had very large local reaction and possible cellulitis. She was treated with 1 gram ROCEPHIN and 500 mg CEFTIN twice daily x 7days. She was also advised to keep arm elevated and apply ice. The patient recovered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist, concerning a patient (age and gender not specified), who was vaccinated on an unspecified date ("in the past"), with a dose of PNEMOVAX 23, and subsequently had an allergic reaction (symptoms and details unspecified) to the vaccine.  At the time of this report, it was unknown if the patient had recovered from the event.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Overdose
Clinical narrative: Initial and follow up information has been received from a pharmacist, concerning a 65 year old male patient, with benign prostatic hypertrophy and a seizure disorder, who on 08-JUN-2007, at approximately 8:25am, received two doses, of PNEUMOVAX 23; he was vaccinated IM in the left deltoid with one 0.5ml dose and also IM in the right deltoid with one 0.5ml dose of PNEUMOVAX 23 (Lot #655291/0985F) (previously reported as lot #655289/0958F).  Concomitant therapy included FLOMAX, phenytoin and finasteride (manufacturer not specified).  The pharmacist confirmed that there were no adverse events noted, and the patient was considered "recovered" on the same day, 08-JUN-2007.  The patient sought unspecified medical attention.  No additional information is expected.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning an over 60 year old female who in June 2002 was vaccinated with a dose of PNEUMOVAX five years ago.  Subsequently the patient developed a severe reaction with a rash.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 64 year old female with hypertension who on 31-MAY-2007 was vaccinated IM in the left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (lot # 655289/0958F).  Concomitant therapy included ATENOLOL MF, glucosamine, calcium (unspecified) and vitamins (unspecified).  On 10-JUN-2007 the patient developed redness, itching, warmth, soreness and a raised 1 1/2 by 1 1/4 inch around the injections site of the left deltoid muscle.  The physician prescribed cold compress, TYLENOL and BENADRYL.  On 01-JUN-2007 symptoms were improving.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male (age unknown), who in approximately November 2006, was vaccinated with a dose of PNEUMOVAX.  After receiving the vaccination the patient's arm was extremely painful and swelled at injection site more then usual and the redness went all the way down his arm.  At the time of the report, the patient had recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an office manager concerning a 71 year old female with thyroid disorder who was a vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of the PNEUMOVAX 23 (lot # 655152/0889F). Concomitant therapy included aspirin and SYNTHROID. Post vaccination, the patient experienced pain at the injection site, arm swelling and she was hot to touch. The patient sought unspecified medical attention. The office staff is requesting a lot check. A standard lot check investigator 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. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from an office manager concerning a female who was vaccinated with a dose of PNEUMOVAX (lot # 655152/0889F).  Subsequently, the patient experienced pain at the injection site, swelling and her arm was hot to touch.  The patient sought unspecified medical attention.  The office staff is requesting a lot check.  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 research center and was released.  This is one of two reports from the same source.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Accidental overdose, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse, concerning a patient (gender and age unspecified) who on 19-JUN-2007, was vaccinated with two doses of PNEUMOVAX 23.  The nurse stated that the patient "has no symptoms."  Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 6 month old patient who on 12-JUN-2007 was inadvertently vaccinated with PNEUMOVAX instead of PREVNAR.  No adverse reactions were reported at the time of the report and the patient was "safe."  The reporter stated that the medical assistant made an error and "chose the wrong vial from the refrigerator and didn't know there was a difference."  Additional information has been requested.