chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 61 year old female with meperidine allergy and drug allergy to epinephrine who on 11/6/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included Synthroid, Parnate, Xanax and Restoril. On approx. 11/7/01, the pt developed swelling of the arm, some erythema and soreness. It was noted that the symptoms were not localized to the injection site but wrapped around the arm up to the armpit. The pt's physician informed her that she had an infection and started her on therapy with Zithromax for treatment. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a 61 year old female with meperidine allergy and drug allergy to epinephrine who on 11/6/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy included Synthroid, Parnate, Xanax and Restoril. On approx. 11/7/01, the pt developed swelling of the arm, some erythema and soreness. It was noted that the symptoms were not localized to the injection site but wrapped around the arm up to the armpit. The pt's physician informed her that she had an infection and started her on therapy with Zithromax for treatment. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an RN concerning a 66 year old female pt who on 10/24/01 was vaccinated IM with the 2nd dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K) (P1: 1994). Concomitant therapy 1 week prior, on approx. 10/17/01, included a dose of influenza virus vaccine. On 10/25/01, the pt's left arm became red, swollen and sore from the injection site down. The pt was seen by a physician and dx'd with staph infection and started on antibiotics. No blood cultures were drawn at that time. The pt recovered from the staph infection. The RN reported that another female pt developed a sore arm when vaccinated with the same lot (WAES 01111484) (lot 636158/1456K). Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from an RN concerning a 26 year old female pt who on 11/1/01 was vaccinated IM, in the left deltoid, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 636158/1456K). Concomitant therapy that same day, included the 1st dose in the right deltoid of influenza virus vaccine (Fluzone) (lot U0682AA). On 11/2/01, the pt experienced a painful arm, developed a fever and her arm became swollen and red from the injection site to the elbow. The pt was seen by a physician on 11/5/01, dx'd with staph infection and started on antibiotics. Therapy with antibiotics was started on 11/6/01 and at the time of the report, it was unknown if the pt recovered. No culture was performed to confirm staph infection. The RN also reported that another female pt experienced pain and swelling when vaccinated with the same lot (WAES 01110739) (lot 636158/1456K). Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Asthma, Condition aggravated, Cough, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 13 month old black male, with asthma (diagnosed in September with bronch) and atopic eczema, who on 02/18/02 was vaccianted with the first dose of varicella virus vaccine live (lot 639889/0977L). Concomitant therapy, that same day, included the first dose of MMR II. Additional concomitant therapy included albuterol 250mg nebulizer "long-term." There was no illness at the time of vaccination. On 03/22/02 the pt began the prodromal phase of varicella, with a fever. During this phase, on 03/23/02 and 03/24/02, the pt's temp reached a high of 102 F. There were no other illness symptoms at that time. The prodrome was reported to have lasted three days. On 03/25/02, the pt developed 12 lesions, mostly vesicular, with scabs. It was noted that the lesions were not macular/papular, hemorrhagic, itchy, or in crops/waves. That day, he was seen in the physician's office. It was noted that the child was "not sick appearing." The rash was described as generalized on the face/head and trunk, lasting 7 days. The child also had a fever 103 f, that day, after the rash developed. He had continuous fever for two days. Once again, it was noted that the child was "not sick appearing." No prescriptions were given at that time and the lesions were not treated topically. He was diagnosed with varicella. The diagnosis was reported to be "certain" and a "reaction from VV." The "number of days sick" was reported as "2." There were no complications at the time of the office visit. However, the child experienced an exacerbation of asthma "the Friday after rash onset," on 03/29/02. The child was seen in the ER on 03/31/02, due to the asthma exacerbation. He presented with fever, rash "varicella three weeks after vaccine," cough and post-tussive emesis. That same day, he was hospitalized for one day. Admission diagnosis was status asthmatious with resolving VZV. Vital signs, upon admission, were as follows: pulse 174, respirations 58, and temperature 103 deg F. It was noted that he was not admitted to an intensive care unit. No lab testing was performed, including varicella studies. The exacerbation of asthma was noted to be a pulmonary complication of varicella. He was treated with prednisone x 5 days, acetaminophen and an albuterol "machine." He did not received any antibacterial or antiviral agents during hospitalization. He was discharged on 04/01/02. Discharge diagnoses were bronchiolitis, varicella, and atopic eczema. The pt was reported to have recovered without known sequelae attributable to this episode. He did not miss any days of school. It was noted that the source and location of varicella exposure were unknown, but "shot February 2001: was noted. The child had no prior history of varicella and no chronic medical condition that depresses the immune system. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Bronchiolitis, Condition aggravated, Cough, Dermatitis atopic, Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning a 13 month old black male, with asthma (diagnosed in September with bronch) and atopic eczema, who on 02/18/02 was vaccianted with the first dose of varicella virus vaccine live (lot 639889/0977L). Concomitant therapy, that same day, included the first dose of MMR II. Additional concomitant therapy included albuterol 250mg nebulizer "long-term." There was no illness at the time of vaccination. On 03/22/02 the pt began the prodromal phase of varicella, with a fever. During this phase, on 03/23/02 and 03/24/02, the pt's temp reached a high of 102 F. There were no other illness symptoms at that time. The prodrome was reported to have lasted three days. On 03/25/02, the pt developed 12 lesions, mostly vesicular, with scabs. It was noted that the lesions were not macular/papular, hemorrhagic, itchy, or in crops/waves. That day, he was seen in the physician's office. It was noted that the child was "not sick appearing." The rash was described as generalized on the face/head and trunk, lasting 7 days. The child also had a fever 103 f, that day, after the rash developed. He had continuous fever for two days. Once again, it was noted that the child was "not sick appearing." No prescriptions were given at that time and the lesions were not treated topically. He was diagnosed with varicella. The diagnosis was reported to be "certain" and a "reaction from VV." The "number of days sick" was reported as "2." There were no complications at the time of the office visit. However, the child experienced an exacerbation of asthma "the Friday after rash onset," on 03/29/02. The child was seen in the ER on 03/31/02, due to the asthma exacerbation. He presented with fever, rash "varicella three weeks after vaccine," cough and post-tussive emesis. That same day, he was hospitalized for one day. Admission diagnosis was status asthmatious with resolving VZV. Vital signs, upon admission, were as follows: pulse 174, respirations 58, and temperature 103 deg F. It was noted that he was not admitted to an intensive care unit. No lab testing was performed, including varicella studies. The exacerbation of asthma was noted to be a pulmonary complication of varicella. He was treated with prednisone x 5 days, acetaminophen and an albuterol "machine." He did not received any antibacterial or antiviral agents during hospitalization. He was discharged on 04/01/02. Discharge diagnoses were bronchiolitis, varicella, and atopic eczema. The pt was reported to have recovered without known sequelae attributable to this episode. He did not miss any days of school. It was noted that the source and location of varicella exposure were unknown, but "shot February 2001: was noted. The child had no prior history of varicella and no chronic medical condition that depresses the immune system. Additional info has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Heart rate increased, Infection, Pyrexia, Respiratory rate increased, Vomiting
Clinical narrative: Information has been received from a physician concerning a 13 month old black male, with asthma (diagnosed in September with bronch) and atopic eczema, who on 02/18/02 was vaccianted with the first dose of varicella virus vaccine live (lot 639889/0977L). Concomitant therapy, that same day, included the first dose of MMR II. Additional concomitant therapy included albuterol 250mg nebulizer "long-term." There was no illness at the time of vaccination. On 03/22/02 the pt began the prodromal phase of varicella, with a fever. During this phase, on 03/23/02 and 03/24/02, the pt's temp reached a high of 102 F. There were no other illness symptoms at that time. The prodrome was reported to have lasted three days. On 03/25/02, the pt developed 12 lesions, mostly vesicular, with scabs. It was noted that the lesions were not macular/papular, hemorrhagic, itchy, or in crops/waves. That day, he was seen in the physician's office. It was noted that the child was "not sick appearing." The rash was described as generalized on the face/head and trunk, lasting 7 days. The child also had a fever 103 f, that day, after the rash developed. He had continuous fever for two days. Once again, it was noted that the child was "not sick appearing." No prescriptions were given at that time and the lesions were not treated topically. He was diagnosed with varicella. The diagnosis was reported to be "certain" and a "reaction from VV." The "number of days sick" was reported as "2." There were no complications at the time of the office visit. However, the child experienced an exacerbation of asthma "the Friday after rash onset," on 03/29/02. The child was seen in the ER on 03/31/02, due to the asthma exacerbation. He presented with fever, rash "varicella three weeks after vaccine," cough and post-tussive emesis. That same day, he was hospitalized for one day. Admission diagnosis was status asthmatious with resolving VZV. Vital signs, upon admission, were as follows: pulse 174, respirations 58, and temperature 103 deg F. It was noted that he was not admitted to an intensive care unit. No lab testing was performed, including varicella studies. The exacerbation of asthma was noted to be a pulmonary complication of varicella. He was treated with prednisone x 5 days, acetaminophen and an albuterol "machine." He did not received any antibacterial or antiviral agents during hospitalization. He was discharged on 04/01/02. Discharge diagnoses were bronchiolitis, varicella, and atopic eczema. The pt was reported to have recovered without known sequelae attributable to this episode. He did not miss any days of school. It was noted that the source and location of varicella exposure were unknown, but "shot February 2001: was noted. The child had no prior history of varicella and no chronic medical condition that depresses the immune system. Additional info has been requested.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Back pain, CSF test abnormal, Disturbance in attention, Dizziness, Dyskinesia
Clinical narrative: It was reported that on 4/10/00, the vaccinee received her 2nd SC injection of Lymerix. Reportedly, on 5/23/00, she began to experience "very bad" arthritic symptoms and lower back pain. She reported that by 7/00, she was so dizzy that she had a minor car accident and then "couldn't drive at all". Reportedly, she was being treated by a chiropractor and received massage therapy and acupuncture. She also reported that she experienced loss of concentration, ringing in her head, clicking in ears, neck pain, migraines and involuntary movements described as jerking. The onset of these events was not known. On 4/27/01, the pt received her 3rd SC injection of Lymerix. Reportedly, in 6/01, she underwent lumbar puncture. The CSF collected "showed 3 bands positive with slight inflammation". It was reported that she was treated for 1 month with ceftriaxone sodium (Rocephin). Reportedly, she waited a week but was still experiencing symptoms. She stated that her physician prescribed hydroxychloroquine phosphate (Plaquenil) and defixime (Suprax). She took Plaquenil and Suprax from 9/01 to 2/02. She stated that she "convalacood and symptoms got worse and worse". During the fall of 2001, she reportedly began to experience weakness in her legs. Reportedly, the pt underwent a 2nd lumbar puncture, which "showed the bands positive which reflected the same bands as in the vaccine". Reportedly, her doctor has prescribed more unspecified oral antibiotics. Although she initially stated that her experiences began in 3/00, she later stated that she has been "dealing with this for 12 years". The pt stated that "she is just trying to get the strength back in her legs and the mental concentration". The pt stated that she "is unsure if all this has some about due to the original illness, the vaccine therapy or if possibly she has been re-bitten". As of 7/16/02, the involuntary movements had reportedly resolved; the remainder of the events were reportedly ongoing. **Follow-up report on 9/25/02: On 9/19/02, the PT telephoned manufacturer to report her status. She stated that the car accident involved having "to come short on a mountain road to avoid hitting a deer. I didn't hit a car. It didn't involve another vehicle or hit a car or anything like that". She started, "I'm still positive or equivalent. I've had other tests. I've had two different labs. I continue to feel lousy. It's still bands 30 and 31. I go back to neurologist tomorrow with exactly the same symptoms... I'm basically disabled and... dysfunctional." The events described in this report are considered incapacitating because the pt reported that she can't drive.
Age: 37.0
Sex: F
Vaccine: LYME
Symptoms: Migraine, Muscular weakness, Neck pain, Tinnitus
Clinical narrative: It was reported that on 4/10/00, the vaccinee received her 2nd SC injection of Lymerix. Reportedly, on 5/23/00, she began to experience "very bad" arthritic symptoms and lower back pain. She reported that by 7/00, she was so dizzy that she had a minor car accident and then "couldn't drive at all". Reportedly, she was being treated by a chiropractor and received massage therapy and acupuncture. She also reported that she experienced loss of concentration, ringing in her head, clicking in ears, neck pain, migraines and involuntary movements described as jerking. The onset of these events was not known. On 4/27/01, the pt received her 3rd SC injection of Lymerix. Reportedly, in 6/01, she underwent lumbar puncture. The CSF collected "showed 3 bands positive with slight inflammation". It was reported that she was treated for 1 month with ceftriaxone sodium (Rocephin). Reportedly, she waited a week but was still experiencing symptoms. She stated that her physician prescribed hydroxychloroquine phosphate (Plaquenil) and defixime (Suprax). She took Plaquenil and Suprax from 9/01 to 2/02. She stated that she "convalacood and symptoms got worse and worse". During the fall of 2001, she reportedly began to experience weakness in her legs. Reportedly, the pt underwent a 2nd lumbar puncture, which "showed the bands positive which reflected the same bands as in the vaccine". Reportedly, her doctor has prescribed more unspecified oral antibiotics. Although she initially stated that her experiences began in 3/00, she later stated that she has been "dealing with this for 12 years". The pt stated that "she is just trying to get the strength back in her legs and the mental concentration". The pt stated that she "is unsure if all this has some about due to the original illness, the vaccine therapy or if possibly she has been re-bitten". As of 7/16/02, the involuntary movements had reportedly resolved; the remainder of the events were reportedly ongoing. **Follow-up report on 9/25/02: On 9/19/02, the PT telephoned manufacturer to report her status. She stated that the car accident involved having "to come short on a mountain road to avoid hitting a deer. I didn't hit a car. It didn't involve another vehicle or hit a car or anything like that". She started, "I'm still positive or equivalent. I've had other tests. I've had two different labs. I continue to feel lousy. It's still bands 30 and 31. I go back to neurologist tomorrow with exactly the same symptoms... I'm basically disabled and... dysfunctional." The events described in this report are considered incapacitating because the pt reported that she can't drive.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Myocardial infarction, Pneumonia
Clinical narrative: A pharmacist reported that an unidentified 80 year old male received Flu Shield (2000-2002 formula) vaccine in December 2001. Subsequent to immunization, the pt claims he developed heart attack, stroke and pneumonia (date not identified). The caller (pharmacist) refused to provide any additional info. This case was considered serious since heart attack and stroke were considered medically important (OMIC).
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Decreased appetite, Discomfort, Irritability, Lethargy
Clinical narrative: One hour after vaccine baby was crying and irritable. Seemed uncomfortable. Mother gave Tylenol throughout the day but did not seem to relieve symptoms. Temp 102 rectal reduced with Tylenol but came back in two hours. Baby continues crying into the night, did not nurse well, seemed lethargic. Child seen in ER at 1AM.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: One hour after vaccine baby was crying and irritable. Seemed uncomfortable. Mother gave Tylenol throughout the day but did not seem to relieve symptoms. Temp 102 rectal reduced with Tylenol but came back in two hours. Baby continues crying into the night, did not nurse well, seemed lethargic. Child seen in ER at 1AM.
Age: 0.75
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever (103 degrees) and irritability for 5 days. No specific treatment.
Age: 0.06
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Follow uP:  child had jerking movements, arched back, eyes rolled, no fever.  Hospitalized for observation only.  Had normal EEG-done since incident.  Follow UP:  child had jerking of body-arched back, eyes rolled, no fever.  Treated at medical center.
Age: 1.08
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Maculopapular erythematous rash on face, trunk and extremities.  Follow up:  child playing, no fever, not toxic.  Thoght to be from MMR.  Still resolving.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site hypersensitivity, Injection site reaction, Pruritus
Clinical narrative: Child complained of last night right arm feeling heavy and itching and no temp elevation noted. 7/31/02 1:30pm, Mother and child presented at health department. Site on upper right arm red, swollen, hard, hot to the touch and approximate size of an orange. No temp elevated or rash. Complained of itching at site only.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Sensation of heaviness, Swelling
Clinical narrative: Child complained of last night right arm feeling heavy and itching and no temp elevation noted. 7/31/02 1:30pm, Mother and child presented at health department. Site on upper right arm red, swollen, hard, hot to the touch and approximate size of an orange. No temp elevated or rash. Complained of itching at site only.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Extremely high fever and violent shaking and chills. Could not function.
Age: 5.5
Sex: F
Vaccine: DTP, IPV, MMR
Symptoms: Epistaxis
Clinical narrative: Severe bleeding from nose.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Left thigh area 10cmx5cm erythema with itching. Tx: Benadryl 2 tsp every 6 hours and Elocon cream AAA.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Swelling
Clinical narrative: Left arm at deltoid area swollen and warm to the touch, the day after the vaccine this occurred. Ice and Tylenol to the patient per mom.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration
Clinical narrative: 8 1/2 x 6 1/2 induration.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Face oedema, Pruritus, Rash papular
Clinical narrative: Began as fine red papular rash on right upper arm spread over the next three days to both arms and both legs. Also had slight upper lip swelling on day four. had intense itching. Began Benadryl intermittently on day four, regularly on day five and six. Rash was gone by day seven except slightly on legs. No trouble swallowing or breathing. No hives.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Patient developed itchy rash on face about 2 hours after MMR vaccine. Subsequently became generalized without edema or respiratory symptoms. Patient was seen at local ER at 11:55 pm and improved after Benadryl and Decadron treatment.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Redness and swelling at right arm site (DTaP). Hives-generalized-Benadryl both developed within 24 hours of vaccine.
Age: 13.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Convulsion
Clinical narrative: 07/25/02 Grandmother called Health Dept and states "She had a seizure today at about 11am." 07/26/02 called pt's home to check on pt and grandmother reports that pt had a second seizure at 11pm last night.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis of right arm 20cm x 20cm treated with Keflex 750mg bid.
Age: 5.2
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Local redness, swelling, and tenderness.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Red swollen non-tender lump on right arm at site on DTaP, had fever x 2 days then afebrile.
Age: 1.2
Sex: M
Vaccine: DT
Symptoms: Erythema, Pyrexia, Rash papular
Clinical narrative: Approx 12 hours after DT, developed fever to 102 degrees F, N/V, red papular rash distant from injection site.
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local tenderness, redness, swelling at site of injection X 72 hours, then decrease , returned again X 24 +, resolved.
Age: 5.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 07/22/02 immunizations given: L arm DTaP, L arm MMR, R arm IPV. 07/24/02 visit to our office with redness and swelling to L arm. Visited urgent care at hospital later that evening. Advised to use Benadryl and Motrin q 4-6. Redness and sweling was 8cm x 13cm.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: On 07/24/02 L deltoid area started getting red and swollen. On 07/26/02 redness and swelling extends from L shoulder down arm to left wrist. Entire arm reddish-purple. Was seen by MD on 07/26/02. Tx with Decadron 2mg IM. Cont with Benadryl and cool compresses.
Age: 4.9
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 5x3cm erythema, 1cm induration on left thigh.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid with softball sized erythematous area warm to the touch. no skin breakdown present. cellulitis, No anaphylaxis.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Drug administration error, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a healthy 8 week old female with no known drug allergies and no past medical history who on 5/2/01 was vaccinated with the first dose of pneumococcal vaccine 23 polyvalent (lot 637263/1448K), IM in the right thigh, instead of Streptococcus pneumoniae vaccine (Prevnar). There were no concomitant medications. It was reported that there was a small area of erythema at the injection site. The pt sought unspecified medical attention. The mother of the pt reported the day after the injection that her child was "fine." Follow-up info reported that the physician stated that the error occurred as a result of "human error" on the part of the nurse. No further info is expected.
Age: 0.8
Sex: M
Vaccine: PPV
Symptoms: Drug administration error, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a 10 month old male with no known allergies and a history of prematurity (one month) who in approximately September 2000 at 2-3 months of age, was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent and was vaccinated with a second dose on 5/31/01 at age 10 months. Concomitant therapy included Motrin. On 5/31/01 the pt "was running a high fever" and was taken to the ER that night. While in the ER, the child received the second dose of pneumococcal vaccine 23 polyvalent. The outcome of the child's experience was not reported. No further details were provided. Additional info has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a 66 year old white female with an allergy to ampicillin, who on 06/11/01 was vaccinated with the second dose of pneumococcal vaccine 23 polyvalent (lot # 637261/1067K) in the left deltoid. Concomitant therapy included Timolol Maleate, levothyroxine na, famotidine, omeprazole and azithomycin. On 06/11/01, "later that day", the patient developed swelling of the left arm, particularly at the injection site, and  reported that the injection site became red and hot. She also developed a fever. She sought unspecified medical attention. FOLLOW- UP information, from the physician, indicated that the  patient had developed "intense pain and swelling at the pneumococcal vaccine 23 polyvalent site, left deltoid" on approximately 06/12/01 (also reported as 06/11/01) and was started on diphenhydramine HCL (Benadryl), loratidine (Claritin), and ice. The physician reported  that the patient recovered from the pain and swelling on 06/16/01. However, the consumer stated in her original report, on 06/19/01, that her arm is much better now, except it is still slightly swollen. It was also reported that on 11/15/96, the patient had previously received one dose of pneumococcal vaccine 23 polyvalent. No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Irritability, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 2.5 month old female with no post medical history and no known drug allergies who on 07/03/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy on 07/03/01 included poliovirus vaccine, Hib conjugate vaccine (Acthib hemophilus B conjugate vaccine) and diptheria toxoid/pertussis vaccine/teta. There were no concomitant medications or current illness. On approximately 07/05/01, the infant experienced a slight temperature elevation and was "cranky". Unspecified medical attention was sought. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 65 year old Caucasian female family member with no known drug allergies and a past medical history of thyroid cancer (2000) who on 07/11/01 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent, in the left upper arm. Concomitant medications included levothyroxine sodium (Synthroid) and hormone replacement therapy. On 07/12/01, within 72 hours of vaccination, the patient developed redness, swelling (induration) and warmth from the injection site to the elbow. It was also reported that the patient developed a fever which lasted for one day. The attending physician advised elevation and cool compresses to the affected area. It was reported that the patient recovered. No further information is expected.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 36 year old female who on07/13/01 was vaccinated with pneumococcal vaccine 23 polyvalent. On 07/13/01, in the evening, the patient experienced body aches, fatigue and a fever of 103.5. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a female patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The patient stated that she had an allergy to  the pneumococcal vaccine. The patient also reported an experience with alendronate sodium (WAES01072401). Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Pneumonia
Clinical narrative: Information has been received from a health professional concerning a 6 year old male who is severely mentally retarded from a beta streptococcus infection at birth. In March, 1999, the patient developed streptococcal pneumonia A meningitis and was successfully treated for this condition. In May, 1999, the patient again presented to the ER and was dx with a strep pneumococcal sepsis. The patient was again successfully treated for this and recovered. The registered nurse reported  that in July, 1999, the patient was vaccinated with pneumococcal vaccine 23 polyvalent, intramuscular injection. On 04/20/01, the patient once again showed a pneumonia A sepsis. The registered nurse  indicated that the patient was dx after having positive blood cultures. The patient was subsequently vaccinated with Streptococcus pneumoniae vaccine. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a 51 year old female with a "sinus history" who on approximately 07/03/01 was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the patient began to experience fatigue and malaise. Unspecified medical attention was sought. Additional information has been sought.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Cough, Dyspnoea, Hypoaesthesia, Hypotrichosis
Clinical narrative: Information has been received from a female with a history of laceration and a September, 1997 diphtheria toxoid allergy resulting in muscle pain (myalgia) and inability to move her neck (neck disorder). In October, 1997, she was vaccinated with a dose of pneumococcal vaccine 23 polyvalent Concomitant therapy that same day included a dose of influenza virus vaccine. It was reported that "ever since she received these three vaccines" the patient has experienced a variety of health problems, including shortness of breath, flu-like symptoms, coughing w/out mucous, muscle spasms throughout her body, some swelling in her feet blurred vision, hair loss, enlarged lymph nodes, lots of chest pain, numbness in extremities and tingling in her extremities. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Lymphadenopathy, Muscle spasms, Oedema peripheral, Paraesthesia
Clinical narrative: Information has been received from a female with a history of laceration and a September, 1997 diphtheria toxoid allergy resulting in muscle pain (myalgia) and inability to move her neck (neck disorder). In October, 1997, she was vaccinated with a dose of pneumococcal vaccine 23 polyvalent Concomitant therapy that same day included a dose of influenza virus vaccine. It was reported that "ever since she received these three vaccines" the patient has experienced a variety of health problems, including shortness of breath, flu-like symptoms, coughing w/out mucous, muscle spasms throughout her body, some swelling in her feet blurred vision, hair loss, enlarged lymph nodes, lots of chest pain, numbness in extremities and tingling in her extremities. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vision blurred
Clinical narrative: Information has been received from a female with a history of laceration and a September, 1997 diphtheria toxoid allergy resulting in muscle pain (myalgia) and inability to move her neck (neck disorder). In October, 1997, she was vaccinated with a dose of pneumococcal vaccine 23 polyvalent Concomitant therapy that same day included a dose of influenza virus vaccine. It was reported that "ever since she received these three vaccines" the patient has experienced a variety of health problems, including shortness of breath, flu-like symptoms, coughing w/out mucous, muscle spasms throughout her body, some swelling in her feet blurred vision, hair loss, enlarged lymph nodes, lots of chest pain, numbness in extremities and tingling in her extremities. The patient sought medical attention. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old Caucasian male patient with no known medical history or allergies who on 08/08/01 at 15:30 was vaccinated in the upper left arm with a dose of pneumococcal vaccine 23 polyvalent  (lot number 637262/1068K). Concomitant therapy on 09/09/01 included tuberculin purified protein derivative (PPD Tine Test). There was no illness at the time of vaccination. Subsequently, on 08/10/01, the patient experienced an injection site reaction that was red, painful, warm to the touch, about 3.5 in X 6.5 in in size and a fever of 103 degree F to almost 104 deg. F that continued through 08/12/01.  The patient sought unspecified medical attention and the doctor recommend treatment with diphenhydramine HCL (Benadryl) cream, ice and children ibuprofen (Motrin).  FOLLOW UP information from the physician indicated that on 08/11/01, the patient presented to the office and he was a"sick trooper today and he definitely looks it and acts it". This is a reaction to the vaccine he received which happens to be pneumococcal vaccine 23 polyvalent". He was pale faced and very unhappy. Everything hurts him, especially his right arm where the vaccine was given. His chest was normal, lungs clear, HR 80 NSR and his abdomen was normal. He had a rather large erythematous, painful, warm to the hot swelling and induration measuring  4.5 inches in length and 3.5  inches  wide red-hot induration. His neuro exam was intact. The physician reported that this was " the first severe reaction to pneumococcal vaccine 23 polyvalent in many cases of having had the shot". The physician planned to keep in touch with the family. FOLLOW UP information from the physician indicated that the patient had totally recovered. It was reported that the patient's school required him to receive pneumococcal vaccine 23 polyvalent. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Pain
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient experienced a sore arm. It was unknown if the patient sought medical attention. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a patient (demographics unknown) who, on a unspecified date, was vaccinated with one dose of pneumococcal vaccine 23 polyvalent (lot # 637263/1448K). It was reported that, on an unspecified date, the patient developed red streaking from the injection site, down the arm, but did not require hospitalization. Unspecified medical attention was sought. The reporter had no further information at the time of report. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Drug administration error, Injection site induration, Oedema, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who in approximately August 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot number unknown). There were no concomitant vaccinations, but it was unknown if there were concomitant drug therapies. Subsequently, the patient presented to the physician's office twice with severe arm pain in the entire arm, "pitting edema" from her biceps to her elbow and injection site induration 3-6 inches wide. It was reported that the swelling spread into the underlying tissue 3 inches in all directions from the injection site. It was noted that the patient was afebrile. The patient was treated with cold packs and acetaminiphen (TYLENOL). It was reported that the patient recovered from her experience. Follow up information indicated that the reporter felt that the patient's severe arm pain in the entire arm, "pitting edema" from her biceps to her elbow, injection site induration 3-6 inches wide and injection site swelling were not related to therapy with pneumococcal vaccine 23 polyvalent, but rather due to improper technique administering the shot. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Drug administration error, Injection site induration, Injection site oedema, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning 7 female patients who in approximately August 2001 were vaccinated with doses of pneumococcal vaccine 23 polyvalent (lot # unknown). There were no concomitant vaccinations, but it was unknown if there were concomitant drug therapies. Subsequently, the patients presented to the physician's office with severe arm pain in the entire arm, injection site edema 3-6 inches wide and injection site induration 3-6 inches wide. IT was reported that the swelling spread into the underlying tissue 3 inches in all directions from the injection site. It was noted that the patients were afebrile. The patients were treated with cold packs and acetaminophen (TYLENOL). It was reported that the patients recovered. Follow up information indicated that the reporter felt that the patients' severe arm pain in the entire arm, injection site induration 3-6 inches wide and injection site swelling/edema 3-6 inches wide were not related to the therapy with pneumococcal vaccine 23 polyvalent, but rather due to improper technique administering the shot. No further information is available.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a licensed practical nurse concerning a male who, "a couple of weeks ago," on approximately 08/23/2001, was vaccinated with one dose (lot # 637095/0946K) of pneumococcal vaccine 23 polyvalent. Subsequently "within a day or two post-vaccination," on approximately 08/24/2001, the patient developed cellulitis. The patient sought unspecified medical attention. It was also reported that another patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent, from the same lot (lot #637095/0946K), and also developed cellulitis (WAES01090919). The reporter expressed a concern with the lot. The records of testing prior to release of this lot (637095/0946K) have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a pharmacist concerning a patient (demographics unspecified) who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently the patient had an allergic reaction. The pharmacist had no further details on the allergic reaction. The patient sought unspecified medical attention. Additional information has been received.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received on 09/14/2001 from a medical assistant concerning a patient with no known allergies who "a few weeks ago" was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the arm. Subsequently, the patient developed a hot, swollen arm, same arm as the injection site. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site oedema, Injection site reaction
Clinical narrative: Information has been received from a medical assistant concerning a male patient with no known allergies who "this week (approximately 9/10/01) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent in the arm. Subsequently, the patient developed a hot, swollen arm in the same arm as the injection site. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a female patient who on 11/20/00 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient experienced swelling and pain where she was vaccinated. On 9/20/01, the patient reported that she was still experiencing pain and swelling where she was given pneumococcal vaccine 23 polyvalent. She also reported that she had recently been told that she had arthritis in that shoulder. Unspecified medical attention was sought. Follow up information from the registered nurse reported the office records indicate that patient received a dose of the flu vaccine in the left arm, but the patient reports that she received pneumococcal vaccine 23 polyvalent. The RN reported that the influenza vaccine could have been responsible for the reaction. No further information is available.
Age: 1.5
Sex: M
Vaccine: DTP, HIBV, PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Information has been received from a woman in a doctor's office and a physician concerning an 18 month 18 month old caucasian male patient with no past medical history and no known allergies who on 20 SEP 2001 was vaccinated IM in the left thigh with the first dose (lot number 635892/1197K) of pneumococcal vaccine 23 polyvalent. Concomitant therapy on 20 SEP 2001 included the fourth dose (lot number 57043 reported, invalid for the product) in the left thigh of hib conjugate vaccine and the fourth dose (lot number A992A2) IM in the right thigh of diphtheria toxoid/pertussis vaccine/tetanus toxoid. There were no illnesses at the time of vaccination. On 21 SEP 2001, the patient developed a swollen right thigh (also reported as a swollen left thigh), which was characterized by erythema, warmth and pain. Subsequently, on 22 SEP 2002, the patient related to the therapy with pneumococcal vaccine 23 polyvalent, but was a reaction to the diphtheria toxoid/pertussis vaccine/tetanus toxoid. No further information is available.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Rash
Clinical narrative: Information has been received form a consumer with high blood pressure, blood protein-MGUS, and a mold allergy with post nasal drip and a past medical history of hysterectomy who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Concomitant therapy included levothyroxine sodium (SYNTHROID). The patient had an allergic reaction, a red rash, after receiving the vaccine. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Myalgia
Clinical narrative: Information has been received on 26 SEP 2001 from a consumer concerning his wife who on 9 JUL 2001 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The patient had an unusual soreness within the first week. The patient also felt feverish but her temperature was a degree or 2 low. On 26 SEP 2001 it was reported that the patient was still experiencing the problems. The patient sought unspecified medical attention. The reporter was also vaccinated and had similar symptoms (WAES01093033). Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Information has been received on 26 SEP 2001 from an approximately 56 year old male who in the early 1990s and more recently was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown). The patient reported that after the first dose he had an unusual soreness about 2-3 weeks afterward for about 3-4 months. After his booster dose he had the same reaction. The patient sought unspecified medical attention. It was reported that the patient recovered. It was also noted that the patient's wife had similar symptoms after being vaccinated (WAES01093033). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Information has been received from an RN concerning her 70 year old mother who in 2/95, was vaccinated with pneumococcal vaccine 23 polyvalent. The pt, subsequently, developed swelling at and around the injection site, fever and general malaise. The pt had sought medical attention for her experience. All symptoms had since resolved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Lung infiltration
Clinical narrative: Information has been received from a pharmacist concerning an elderly pt who in approx. 10/01, was vaccinated with pneumococcal vaccine 23 polyvalent. The pharmacist reported that a few days after vaccination, a CXR showed infiltrate. The pt had sought medical attention for his  experience. Additional information has been requested.