chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.67
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: From initial information received on 8/2/04 from a health care professional regarding an adverse event occurring in the USA it was reported that a 20 month old male patient received an ACTHIB vaccination, lot number X0185 (US lot number UE100AA), administered IM in the right thigh, a DAPTACEL vaccination, lot number C1679AA, administered IM in the right thigh, an IPOL vaccination, lot number X0771-2, administered SC in the left thigh, and a PREVNAR vaccination, lot number 495703, administered IM in the left thigh on 7/28/04. After leaving the office on 7/28/04, the patient developed a high fever going to 105 degrees F. He was taken by ambulance to the hospital emergency room where he experienced four seizures. The patient was treated for febrile seizures and held for 24 hours. The patient recovered from this event.
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Pleural effusion, Pneumonia, Sepsis
Clinical narrative: Follow up information from the pediatrician provided race, dates of vaccine administration, dates of hospitalization, confirming diagnosis of pneumococcal pneumonia with pleural effusion, blood culture results, treatment regimen and recovery status. Information regarding Prevnar was received from a pediatrician regarding a 5 month old male patient who developed pneumococcal pneumonia with left pleural effusion. At 4 months of age, the infant received the second dose of vaccine on 11/13/03. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 11/13/03 and 9/12/03. Each regimen was 1 dose (IM). Concomitant medications were not reported. At 5 months of age, on 12/21/03, the infant was hospitalized. A blood culture performed the same day was positive for Streptococcus pneumoniae, serotype 19. The infant was diagnosed with pneumococcal pneumonia with left pleural effusion requiring thoracentesis. He was hospitalized for six days and treated with ceftriaxone therapy for 10 days. He fully recovered. No additional information was available at the time of this report.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Thrombocytopenic purpura
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 9 month old female patient who developed idiopathic thrombocytopenic purpura. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was one dose. Concomitant medications were not reported. On 7/10/02, a 9 month old female patient developed idiopathic thrombocytopenic purpura. The reporter considered this event to be immediately life threatening. The patient was hospitalized and treated with IV immunoglobulins. The reporter indicated that the patient has recovered. No additional information was available at the time of this report.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Demyelination, Encephalitis
Clinical narrative: Patient is currently home overseas. Mother reports via email that son became ill 6/28/04; rushed to hospital and diagnosed with demyelination encephalitis. Patient is still ill, but recovering.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives. Pt called us, and doctor, both counseled her to take Benadryl . Later, pt came in with rxn for prescriptions for Benadryl 50 mg and Prednisone 20 mg from ER at 11:00 on 10/01/2003
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Approximately 4pm 8/3, child received 3 vaccines MMR, DTaP, IPV. Mom called 9AM 8/4 left arm swollen, red. Came in for appointment 4pm 8/4 with cellulitis/ immunization rxn left arm.
Age: 78.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus
Clinical narrative: 5/28/04: Client received laceration on leg while shopping on 5/18/04. She saw physician 5/20/04 who recommended at TD booster. On 5/26/04 client developed itch on left arm and noticed erythema extending about 4" down from site she believes TD who given on left arm. Saw physicians 5/27/04 in relation to laceration and showed him the site on left arm. Dr. stated it
Age: 43.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Arthralgia
Clinical narrative: 7/7/04: pt experienced joint pain in left elbow, followed by joint pain in left hand. 7/8/04: pt experienced joint pain in right knee. Pt states he has taken Motrin for the pain.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Myalgia, Neck pain, Paraesthesia
Clinical narrative: Client states started having right arm muscle and neck muscle pain with numbness to right thumb and index finer around 6/28/04. Stated the soreness was getting worse so he went to a med center on 7/2/04 and was given a shot for pain and was told if it doesn't improve within a couple of days to follow up with his doctor. 7/6/04: saw his / doctor and was prescribed pain pills that client states just made him feel sick to his stomach so he stopped taking the medication. Client then went to chiropractor on 7/8 and 7/10/04. Client reported the above symptoms to health dept on 7/12/04 and states he currently has only a small amount of tingling to thumb/ index finger.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: REACTION UNEVAL
Age: 4.75
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at injection site.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: fever within 4-8 hours and seizure within 48 hours of vaccination with MMR #1, varicella #1, DTaP #4, Hib #4. Recovered from seizure. Neurologic function still intact but remains febrile at this time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Began to develop limp swelling and erythema of left upper arm around 24 hours after receiving DTaP #5 , IPV #4 in left upper arm. No fever. Positive for pruritus. No pain. Clinical exam consistent with description of limp swelling with 4th and 5th DTaPs
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Pt received DTaP 5/28/04 right thigh. 7/30/04: pt has red, swollen area around injection site and tender. Placed on Keflex 250 mg 1/2 tsp TID x 10 days. Cool compress to site.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: DTAP given 7/21/04: pt seen on 7/23/04 site of injection red, swollen. Pt given Keflex. Seen in office 7/26/04. Pt recovered .
Age: 36.0
Sex: U
Vaccine: MMR
Symptoms: Chills, Pyrexia
Clinical narrative: 1.5hr-2hr after MMR given. Client complained of chills with fever ranging from 101-104 degrees. Fever of 101 on 7/28 when called. Did not see MD.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Pain, Rash papular, Skin discolouration
Clinical narrative: The pt got Tetanus toxoid on 7/1/04 and the same day, she claimed that she had some tiny papular lesion in both sides of the hands, basically on both thumbs going to the metacarpal area to the wrist bilaterally. It became darkish. At the beginning, she had some pain in the right elbow and the next day she had the pain on the let side of the shoulder secondary to the shot. Since then the spots have been spreading and becoming quite dark. No associated itchiness, burning sensation, numbness. No systemic symptoms as fever, headache, body ache, muscle ache, back pain, neck pain, rashes, nausea, vomiting, diarrhea, weight loss, night sweats.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: DTAP to RAT given became red, swollen, hard and warm to touch. Redness 14x15cm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Swollen, redness  leg left. No fever
Age: 2.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Asthenia, Balance disorder, Eye movement disorder, Hypokinesia
Clinical narrative: 10 minutes after receiving vaccines appeared weak, unbalanced, responding slowly to verbal command, eyes rolling
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema
Clinical narrative: local erythema and edema: left thigh
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Nasal congestion, Tinnitus
Clinical narrative: Pain in all joint : stronger in both. Knees right ankle. Elbows. Congestion with head with ringing in right ear.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Received immunizaton left deltoid: 7/30/04. Site warm, edematous. LUE circ 29cm. RUE circ 26 cm
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: 08/03/04 Pt was given Dapt right arm, 8/04/04, pt had swelling, redness, warm to touch. Pt was instructed to take Benadryl. 25mg every 6hours as need. Motrin for pain 150mg every 8 hours.
Age: 68.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Pt sons called reported that his mother had bad reactions from TD vaccine given 07/12/04 on left deltoid muscles. Pt left arm with redness, swelling and very hot to touch with moderate pain. Pt son states also mom took Tylenol for pain on left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eye oedema
Clinical narrative: Mother called 7/30/04 state client received 4yr shots 7/29/04 c/o rash later afternoon 7/29/04. Eye edema 7/30/04. Advised to see Dr ASAP for evaluation of child for reaction to immunization or illness. Attempted to contact mother later in the day 7/30/04. All telephone numbers were invalid. Telephoned Dr office no clients seen in the office, staff in training.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Erythema, Hypoxia, Respiratory rate decreased, Urticaria
Clinical narrative: pt began developing diffuse redness and cough approximately 10-15 min post immunization. Within 30 min, pt had bright red urticarial rash from face to hind thigh. Lungs plus wheeze with decreased breath sounds after 2 albuterol nebs, O2 at 6 liters and 2 Epi Renal, within one hour, rash and wheezing resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Wheezing
Clinical narrative: pt began developing diffuse redness and cough approximately 10-15 min post immunization. Within 30 min, pt had bright red urticarial rash from face to hind thigh. Lungs plus wheeze with decreased breath sounds after 2 albuterol nebs, O2 at 6 liters and 2 Epi Renal, within one hour, rash and wheezing resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP
Symptoms: Oedema
Clinical narrative: After 24 hours developed severe swelling of right arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP
Symptoms: Swelling
Clinical narrative: After 24 hours developed severe swelling of right arm.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Started yesterday afternoon with fever and notice a few slightly raised spots on trunk. Today has raised spots on face, chest, arm, a few on back. >than 50 spots.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Oedema
Clinical narrative: 8/5/04 Pt came into clinic left arm swollen and warm (.8cmx6cm). Advised parent to give Tylenol, Benadryl topical cream and cool compress. Also advised to return to clinic if pt worsens.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 37 year old white female with no allergies or medical conditions who on 2/18/04 was vaccinated SQ in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647797/0987N). There was no illness at the time of vaccination. Subsequently the patient experienced arm sensitivity, swelling of the arm and a large red area about 5cm. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that the patient's large red area about 5cm, arm sensitivity and swelling started on 2/20/04. There were no labs or diagnostic tests done and there were no serious effects. The patient recovered. Another patient had the same experience after vaccination with pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 49 year old female with an allergy to sulfa drugs who on 1/9/04 at 10:30 AM was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 646322/0530N). There was no illness at the time of vaccination. On 1/12/04 in the PM, the patient developed a cellulitis at the injection site. Erythema and induration at the site were noted. The patient had a fever of 102 degrees F for 1 day. Diphenhydramine hydrochloride was given and the erythema was gone after one day. The induration remained and the patient was prescribed amoxicillin (+) clavulanate potassium 875mg BID for 10 days. The outcome was reported as recovered on 1/28/04. There were no diagnostic tests or laboratory data. There were no adverse events following prior vaccinations for the patient or her siblings. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that one other patient developed a cellulitis. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647178/1200N). Subsequently, the patient developed fever, edema, and erythema at the injection site. Unspecified medical attention was sought. No further information was available. A product quality complaint was not involved. The reporter also mentioned a second patient who had an experience post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 647178/1200N). The reporter stated that 26 vials of pneumococcal 23v polysaccharide vaccine remained at their facility and they would like replacement vials. The records of testing prior to 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.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Information has been received from a LPN concerning a male pt in his 30's with no past medical history and no allergies who on 23Feb2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine, instead of a PPD intradermally. There was no concomitant medication. On 24Feb04 the pt was seen in the doctor's office with redness, swelling, and pain of left forearm inner aspect. The pt was treated with cephalexin for one week. There was no quality of product complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacy risk manager concerning a 60 year old female who on 15Nov03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt developed cellulitis at the injection site. The pt was hospitalized to received inpatient treatment with antibiotics. There was no product quality complaint involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 29 year old female who on 16Feb04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the pt experienced arm sensitivity, swelling of the arm and a large red area about 5cm. Unspecified medical attention was sought. No product quality complaint was involved. Another pt had the same experience after the vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Cough, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a physician concerning a 48 year old white female teacher with no allergies and a history of a splenectomy 25 years ago for Hodgkin's Disease who on 30Dec03, was vaccinated in the left deltoid at another practice with a dose of pneumococcal 23v polysaccharide vaccine. Within a minute of the vaccination the pt developed nausea, lightheaded, sweating/diaphoresis, chest tightness and coughing. There was no loss of consciousness.  Unspecified medical attention was sought. The symptoms subsided within 2 minutes without intervention and there was no reoccurrence. The physician thought this was a vagal reaction.  No product quality complaint was involved. Another pt had the same experience after the vaccination with pneumococcal 23v polysaccharide vaccine. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from an office manager concerning a pt with no medical history and no allergies who on 03Mar04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. Subsequently the pt developed swelling, redness and hot to touch at the injection site. No medical attention was sought and no diagnostic studies were performed. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed swelling, redness and hot to touch at the injection site. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest pain, Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a 67 year old Caucasian female with morphine and codeine allergies who on 06Jan04 in the AM was vaccinated IM in the left deltoid with a second booster dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. The next day the injection site was swollen to twice the normal size, had redness at the site and was hot to touch. She contacted her physician's office. She also had great pain which the physician prescribed ibuprofen and acetaminophen prn. These medications did not reduce her pain. It took about 7 days for the swelling to be reduced. Subsequently, the following events occurred which the pt believes was caused by the pneumococcal 23v polysaccharide vaccine: She had chest and back pain. She visited the ER at the hospital and was discharged from the ER the next day. A myocardial infarction was ruled out. No diagnostic studies were performed. the pt noted that 5 years ago, in 1999, she has tolerated an initial dose of pneumococcal 23v polysaccharide vaccine very well. No product quality complaint was involved. Follow up information received from the pt's physician reported that on 06Jan04  the pt had pain swelling left arm. There were no relevant diagnostic tests performed. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a 67 year old Caucasian female with morphine and codeine allergies who on 06Jan04 in the AM was vaccinated IM in the left deltoid with a second booster dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. The next day the injection site was swollen to twice the normal size, had redness at the site and was hot to touch. She contacted her physician's office. She also had great pain which the physician prescribed ibuprofen and acetaminophen prn. These medications did not reduce her pain. It took about 7 days for the swelling to be reduced. Subsequently, the following events occurred which the pt believes was caused by the pneumococcal 23v polysaccharide vaccine: She had chest and back pain. She visited the ER at the hospital and was discharged from the ER the next day. A myocardial infarction was ruled out. No diagnostic studies were performed. the pt noted that 5 years ago, in 1999, she has tolerated an initial dose of pneumococcal 23v polysaccharide vaccine very well. No product quality complaint was involved. Follow up information received from the pt's physician reported that on 06Jan04  the pt had pain swelling left arm. There were no relevant diagnostic tests performed. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site pain, Oedema
Clinical narrative: Information has been received from a registered nurse concerning an over 60 year old male who on approximately 15Mar04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On approximately 15Mar04, several hours after vaccination, the pt developed injection site pain, redness, warmth and swelling. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. A pt from the same source had a similar experience.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site reaction, Oedema
Clinical narrative: Information has been received from a physician concerning a 79 year old female pt with a history of pulmonary problems who on 21Mar04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The physician reports that now, at the time of this report (23Mar2004), the pt has a 4 inch x 8 inch area of erythema, swelling and possibly cellulitis at the injection site. It was noted the pt was prescribed, cephalexin as a treatment. It was unknown as to whether any laboratory or diagnostic studies were performed. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema, Pruritus, Pyrexia
Clinical narrative: Information has been received from a certified medical assistant concerning a 71 year old male with gout, hypertension, hypercholesteremia, and diverticulitis who on 23Mar04 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included bisoprolol fumarate/HCTZ (Ziac) 5 mg once daily, allopurinol, 300mg once daily, meloxicam (Mobic) 15mg once daily, sildenafil citrate (Viagra) 100mg prn, hydrochlorothiazide (+) Valsartan (Diovan HCT 160) 12.5 mg once daily atorvastatin calcium (Lipitor) 10mg once daily and colchicine 0.6 once daily. On 24Mar04 the pt developed a fever. On 25Mar04 the pt came in to the office with a red, itchy area on the upper trunk, right arm and right  side, and swelling. His temperature was 98.9 the client was treated with a steroid injection. It was reported that the pt had not recovered. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed a local site reaction. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site mass, Oedema
Clinical narrative: Information has been received from a RN concerning a 63 year old white male dialysis pt who on 19Mar04 at 10:15AM was vaccinated IM in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. On 20Mar04 at 6:00AM within 24 hours of vaccination the pt developed right arm cellulitis, erythema, and edema surrounding the right elbow extremity both proximally and distally. The area was very warm with 1+ pitting edema medially. Unspecified medical attention was sought. The problem resolved after two to three days. No diagnostic laboratory tests were performed. A product quality complaint was not involved. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a certified medical assistant concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed a local site reaction. No further information is available. Additional information has been requested.  It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed a red itchy area and swelling.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Information has been received from a PA concerning a 40 year old female who on 03/26/04 at 15:30 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). Subsequently the pt developed a large local reaction. The reporter indicated that the reaction was not serious and that she did not know the recovery status.  Follow up information indicated that on 03/27/04, approximately 18 hours after vaccination, the pt complained of a large local reaction 3x2 inches with erythema and wheal. It continued for the next several days. The outcome was reported as recovered on 04/01/04.  The reporter also indicated that another pt developed an adverse experience after vaccination with pneumococcal 23v polysaccharide vaccine (WAES # 0402USA01911).  No further information is expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Bronchitis acute, Cough, Dyspnoea, Haemoptysis
Clinical narrative: Information has been received from a physician concerning a 64 year old female with hypertension, hyperlipidemia, and hypothyroidism and with no known drug allergies who on 03/04/04 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N).  Concomitant therapy included amlodipine besylate (Norvasc)(2.5mg qd), simvastatin (20mg qd) and levothyroxine NA (Synthroid)(0.05mg qd). The pt presented to the physician on 03/04/04 with complaints of recurrent warts on her nose, and wanted the dermatologist to remove. At this visit, the pt was vaccinated. On approximately 03/07/04, "one or two days following vaccination" (also reported as "about 3 to 4 days after vaccine"), the pt began to experience cold symptoms. The symptoms worsened and the pt returned to the clinic on 03/18/04. At that time, the pt stated that a day or two after receiving pneumococcal 23v polysaccharide vaccine, she started with cold symptoms, coughing, wheezing, mild shortness of breath ("improved now"), mild increased temperature, but no real fever/chills. The pt's lungs had scattered rhonchi with an occasional inspiratory wheeze. She was noted to have good air movement but sounded very congested. The pt was prescribed Zithromax, an albuterol inhaler (2 puffs every 4 hours as needed), codeine phosphate (+) guaifenesin and loratadine (Claritin)(10mg qd). The pt was diagnosed with acute bronchitis. The pt returned to the clinic on 03/29/04 with a productive cough with yellow, blood-tinged mucus and a low grade fever. Her lungs were clear to auscultation. She was treated with Tequin. The pt was diagnosed with sinusitis. Unspecified medical attention was sought. There was no product quality complaint. There were no adverse events following prior vaccinations. Lab data is listed below.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Sinusitis, Wheezing
Clinical narrative: Information has been received from a physician concerning a 64 year old female with hypertension, hyperlipidemia, and hypothyroidism and with no known drug allergies who on 03/04/04 was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N).  Concomitant therapy included amlodipine besylate (Norvasc)(2.5mg qd), simvastatin (20mg qd) and levothyroxine NA (Synthroid)(0.05mg qd). The pt presented to the physician on 03/04/04 with complaints of recurrent warts on her nose, and wanted the dermatologist to remove. At this visit, the pt was vaccinated. On approximately 03/07/04, "one or two days following vaccination" (also reported as "about 3 to 4 days after vaccine"), the pt began to experience cold symptoms. The symptoms worsened and the pt returned to the clinic on 03/18/04. At that time, the pt stated that a day or two after receiving pneumococcal 23v polysaccharide vaccine, she started with cold symptoms, coughing, wheezing, mild shortness of breath ("improved now"), mild increased temperature, but no real fever/chills. The pt's lungs had scattered rhonchi with an occasional inspiratory wheeze. She was noted to have good air movement but sounded very congested. The pt was prescribed Zithromax, an albuterol inhaler (2 puffs every 4 hours as needed), codeine phosphate (+) guaifenesin and loratadine (Claritin)(10mg qd). The pt was diagnosed with acute bronchitis. The pt returned to the clinic on 03/29/04 with a productive cough with yellow, blood-tinged mucus and a low grade fever. Her lungs were clear to auscultation. She was treated with Tequin. The pt was diagnosed with sinusitis. Unspecified medical attention was sought. There was no product quality complaint. There were no adverse events following prior vaccinations. Lab data is listed below.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site inflammation
Clinical narrative: Information has been received from a nurse concerning a female pt over 70 years old who in approximately the end of March or the beginning of April 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The nurse indicated that a physician had reported that the pt experienced inflammation (area unknown) and was admitted to the hospital. At the hospital, it was determined that the pt had cellulitis. At the time of the report, the pt was still in the hospital and had not recovered. It was noted that therapy with pneumococcal 23v polysaccharide vaccine was "discontinued". It was also noted that the vaccine was not linked directly to the outcome of cellulitis but "it occurred about the same time". A product quality complaint was not involved. Additional information has been requested. The reporter also indicated that the physician had seen "two or three other cases" with similar experiences after therapy with pneumococcal 23v polysaccharide vaccine (WAES # 0404USA00807).
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a RN concerning a over 60 year old female who on approximately 03/15/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N).  On approximately 03/15/04, several hours after vaccination, the pt developed injection site pain, redness, warmth and swelling.  Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. A pt from the same source had a similar experience WAES# 0403USA01639.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a RN concerning an adult female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). Subsequently, the pt developed an injection site reaction that included pain, swelling, redness and warmth. Unspecified medical attention was sought. The pt was treated with prednisone. The pt has reported improvements in her symptoms. A product quality complaint was not involved. The reporter also mentioned another female pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N) (WAES#0404USA01267).  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a RN concerning an adult female pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). Subsequently, the pt developed an injection site reaction that included pain, swelling, redness and warmth. Unspecified medical attention was sought. The pt was treated with OTC ibuprofen (Advil) and cold compresses applied to the site. The pt has reported improvements in her symptoms. A product quality complaint was not involved. The reporter also mentioned another female pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N)(WAES#0404USA01121).  Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 50 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647635/0864N). Subsequently, the pt experienced cellulitis. It was reported that she was not hospitalized, but she did seek medical attention and was treated with an antibiotic. The pt has recovered. No additional information was provided. No product quality complaint was involved.  Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a RN concerning an approximately 45 year old female nurse who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 04/13/04 the pt developed splotches on her arm at and around the site of injection. Unspecified medical attention was sought and no treatment was required. It was reported that the pt had not yet recovered. No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a CMA concerning 2 females who were vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N). Each female was vaccinated on a different date. However, one day post vaccination, the females had red, hot to touch, swollen left arms from the deltoid to the elbow. No other information was available. The outcome is unknown.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned one other female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N) and developed an adverse event (WAES # 0404USA02195).  The reporter expressed a concern regarding the lot #, requesting a lot check. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a MA concerning an 81 year old male with no medical history who on 04/19/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). There was no concomitant therapy. The medical assistant reported that in April 2004, the pt developed redness and swelling at the injection site. Unspecified medical attention was sought and on 04/21/04, the pt was given a triamcinolone acetonide (Kenalog) injection as treatment. No lab/diagnostic tests were performed. At the time of this report, the outcome was unknown. The MA also reported that another pt developed redness and swelling at the injection site after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0405USA00169).  Additional information has been requested. Follow-up information inndicated that the patient was doing fine. He was treated with an antibiotic and no further work-up was necessary. He recovered after the treatment. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from a CMA concerning a female pt who was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N). One day post vaccination, the pt had a red, hot to touch, swollen left arm from the deltoid to the elbow, and she developed cellulitis.  The pt was treated with antibiotics and recovered.  Unspecified medical attention was sought. There was no product quality complaint. No other information was available. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned one other female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N) and developed an adverse event (WAES # 0404USA02020).  The reporter expressed a concern regarding the lot #, requesting a lot check. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature normal, Chronic sinusitis, Cough, Nausea, Productive cough
Clinical narrative: Information has been received from a 74 year old female pt with "allergies" and who is currently on estrogens, conjugated (Premarin), who on 04/07/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included estrogens, conjugated (Premarin). The pt reported that 11 days after the vaccination (04/18/04), she experienced fever 99-100 (for the past 4 days), severe rash, nausea, vomiting, inundated clear mucous and coughing continuously. She reported that the physician gave her the vaccination "to build up her immunities". No further information was given. There was no treatment required and no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.  Additional information received from the physician's office, on form completed 7/29/05. The physician had said the patient did not have an allergic reaction to the pneumococcal 23v polysaccharide vaccine. The physican saw the patient for chronic sinusitis. The patient saw another physician and reported that they thought it was "maybe a reaction".
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Information has been received from a 74 year old female pt with "allergies" and who is currently on estrogens, conjugated (Premarin), who on 04/07/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included estrogens, conjugated (Premarin). The pt reported that 11 days after the vaccination (04/18/04), she experienced fever 99-100 (for the past 4 days), severe rash, nausea, vomiting, inundated clear mucous and coughing continuously. She reported that the physician gave her the vaccination "to build up her immunities". No further information was given. There was no treatment required and no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.  Additional information received from the physician's office, on form completed 7/29/05. The physician had said the patient did not have an allergic reaction to the pneumococcal 23v polysaccharide vaccine. The physican saw the patient for chronic sinusitis. The patient saw another physician and reported that they thought it was "maybe a reaction".
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647660/0945N). Subsequently the pt developed redness, swelling and pain at and around the injection site. The pt was seen at their local ER and was released. Unspecified medical attention was sought. There was no product quality complaint involved.  The reported indicated that several pt's (WAES # 0403USA00248) had similar experiences following exposure to pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning a pt with no medical history and no allergies who on 03/02/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N). There was no concomitant medication. Subsequently, the pt developed swelling, redness and hot to touch at the injection site. No medical attention was sought and no diagnostic studies were performed. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N) and developed swelling, redness and hot to touch at the injection site (WAES # 0403USA00640 & 0404USA02544).  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Information has been received from an office manager concerning a pt with no medical history and no allergies who on 03/02/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N). There was no concomitant medication. Subsequently, the pt developed swelling, redness and hot to touch at the injection site. No medical attention was sought and no diagnostic studies were performed. No product quality complaint was involved. It was also reported that two other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647272/0664N) and developed swelling, redness and hot to touch at the injection site (WAES # 0403USA00640 & 0404USA02543).  Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a MA concerning an 66 year old male with no medical history who on 04/20/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647271/1138N). There was no concomitant therapy. The medical assistant reported that in April 2004, the pt developed redness and swelling at the injection site. Unspecified medical attention was sought and on 04/22/04, the pt was given a triamcinolone acetonide (Kenalog) injection as treatment. No lab/diagnostic tests were performed. At the time of this report, the outcome was unknown. The MA also reported that another pt developed redness and swelling at the injection site after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0404USA02084).  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an approximately 30 year old male who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647038/0926N). Within 48 hours of vaccination, the pt experienced a site reaction from the should to the elbow including "swollen, red, hot, and tender to touch."  It was reported that the pt was treated with antibiotics for the condition. This was one out of two pt's reported. It was reported that "one of the pt's developed a fever". The other pt (WAES # 0405USA01694) had a similar reaction after vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647038/0926N). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a 70 year old female who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The RN reported that, immediately after being vaccinated, the pt developed erythema and swelling at the injection site. The pt was subsequently sent home with ice as treatment. The following day, the pt returned to the physician's office and a diagnosis of cellulitis was made. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Hot flush, Injection site erythema, Pain
Clinical narrative: Information has been received from a 36 year old female medical technologist with no past medical history who on 04/30/04 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Advair. Subsequently, "over the week" the pt developed fever, chills, injection site erythema (6x6 inch in size) and continuous hot flashes with body aches and headaches. The pt contacted her allergist who recommended Motrin and ice. The pt did not believe that she ever had pneumococcal 23v polysaccharide vaccine before. It was reported that as of 0/06/04 the pt was doing "slightly better". No product quality complaint involved. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a 36 year old female medical technologist with no past medical history who on 04/30/04 was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy included Advair. Subsequently, "over the week" the pt developed fever, chills, injection site erythema (6x6 inch in size) and continuous hot flashes with body aches and headaches. The pt contacted her allergist who recommended Motrin and ice. The pt did not believe that she ever had pneumococcal 23v polysaccharide vaccine before. It was reported that as of 0/06/04 the pt was doing "slightly better". No product quality complaint involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a MA concerning a 57 year old white female with asthma (asthma attack approximately 03/09/04) who on 04/20/04 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 64777/0987N).  Suspect vaccination on the same day at approximately 1630 included a fourth or fifth dose in the Left deltoid (previously reported as right deltoid) of tetanus toxoid (Lot # U1024AA). There was no illness at the time of vaccination. It was noted that the pt had no incident with the "3-4" previous doses of tetanus toxoid. The pt was given the pneumococcal 23v polysaccharide vaccine and tetanus toxoid vaccine into the right deltoid within one inch apart per the pt. On  04/20/04, she began having pain in the right deltoid later that evening, at 24:00, with fevers and redness to deltoid. On 04/23/04, the pt was seen for cellulitis of the right deltoid. There were no diagnostic laboratory tests performed. The patient recovered on 30-Apr-2004. Cellulitis was determined to be an other important medical event (OMIC). Additional information has been requested. No further information is expected.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 38 year old healthy diabetic female with allergies who on 02/26/04 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647657/0947N). It was reported that there was no injection site reaction at the time of vaccination. On 03/29/04 and 04/27/04 the pt had titers done that showed a minimal response to the vaccine. Unspecified medical attention was sought, but no treatment was required.  No product quality complaint was involved. Additional information has been requested.