chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: It was reported that a 39 year old female patient received a Fluzone SV vaccination on 12/04/2000. Sometime after the vaccination the patient developed a local reaction, 4cm red, swollen tender area at the injection site which lasted for 3 days.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Dyspnoea, Malaise
Clinical narrative: It was reported that a 61 year old female patient received a Fluzone SV and a Pneumovax vaccination on 12/05/2000. Approximately 5 hours after vaccination, the patient developed general malaise, difficulty on expiration and stomach pain, which lasted approximately 40 hours and completely subsided.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Malaise, Myalgia, Pain
Clinical narrative: It was reported on 12/12/2000, the patient developed a fever of 101F, severe body aches and malaise for approximately 5 hours. Also developed redness and swelling at the site. The patient's muscles ached for about 12 hours. The patient was treated with Tylenol.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: It was reported on 12/12/2000, the patient developed a fever of 101F, severe body aches and malaise for approximately 5 hours. Also developed redness and swelling at the site. The patient's muscles ached for about 12 hours. The patient was treated with Tylenol.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Myalgia, Paraesthesia, Sleep disorder
Clinical narrative: Reportedly about 45 minutes after vaccination, the patient complained of severe pain in the left deltoid radiating to the hand and clavicle. The patient still experiences sporadic pain, especially at night when trying to sleep. The patient was seen in the ER on 10/18, treated and released. On 11/01/2001 seen by family physician who ordered physical therapy for 1 week - no relief. On 11/14/2001 the patient was referred to an orthopedic surgeon. The patient now an appt with a neurologist next week. From additional correspondence received on 02/22/2001, it was reported "neurologist appt cancelled initially due to decreased pain in arm. Approximately the second week of January 2001, numbness and tingling started from the shoulder to the fingertips with occasional pain. Rescheduled appts 02/28/2001. On 03/14/2001 the patient had her appt with the neurologist. The physician also states there is probably muscle reaction to the vaccine itself. The patient continues to have numbness and tingling in the left arm and hand occasionally with occasional pain in the deltoid, as of 03/21/2001.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Lacrimation increased, Pruritus
Clinical narrative: Reportedly, 15-20 minutes after the vaccination, the patient developed wheezing, itching all over and runny eyes. The patient was treated with Benadryl and Albuterol. The patient recovered from this experience.
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: Post vax, the patient reportedly developed Bells Palsy with left facial nerve paralysis. The patient was evaluated by a physician, underwent an MRI and a lumbar puncture. Steroid therapy was prescribed. The resolution is unknown.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspepsia
Clinical narrative: The patient reportedly developed heartburn immediately after the vaccination. The patient took Alka-Seltzer and the heartburn was resolved. From additional correspondence received 05/01/2001, it was reported there is no additional information available at this time. This case is closed.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: Reportedly at 6:20pm the patient complained of feeling of fullness in her chest. There was no wheezing. The patient was treated with Benadryl and given instructions to follow-up. There was no induration at the injection site. Reportedly the patient recovered from this experience.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: The evening of the injection, the injection area on the left upper arm was red, slightly raised and very sore. The erythema was approximately 3" long and 3/4" wide and felt hot to the touch. Stayed like this for 5 days. As of 01/09/2001, the area is no longer sore and the red strip is very slight but still visible on her arm. Additional correspondence received on 02/15/2001 reported that the patient recovered from this experience. It was requested on 02/12/2001 to send a copy of this report to MD. No further information was provided from correspondence returned on 03/08/2001.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Myalgia, Neuropathy peripheral, Pain, Rash erythematous
Clinical narrative: It was reported that the patient experienced a local reaction the next day after the vaccination with a slightly raised, red rash the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm, radiating from the vaccination site. The patient also had muscle soreness. The patient was treated with Benadryl and Excedrin, which alleviated her symptoms. From additional correspondence received on 04/20/2001, it was reported that the patient recovered from this experience. This case is closed.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: It was reported that the patient experienced a local reaction the next day after the vaccination with a slightly raised, red rash the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm, radiating from the vaccination site. The patient also had muscle soreness. The patient was treated with Benadryl and Excedrin, which alleviated her symptoms. From additional correspondence received on 04/20/2001, it was reported that the patient recovered from this experience. This case is closed.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Injection site rash
Clinical narrative: It was reported that a 42 year old male received Fluzone SV '00-'01 USP from his Employee Health on 12/7/00. Within several days, he had arthritic-like pain in his shoulder and joint where vaccine was given. The was also a round, raised rash. The doctor put him on Prednisone 6 day pack. Now, 1 month later, there is a scaly, psoriasis-looking rash that is bumpy and scabbed over and 1/2" in diameter.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pityriasis rosea
Clinical narrative: A few days after the vaccination, the patient reportedly developed a local reaction at the injection site and then developed Pityriais-Rosea. No further information is anticipated. This case is closed.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain, Oedema
Clinical narrative: From an initial report received on 01/12/01, it was reported that a 41 year old female was given Fluzone SV '00 -'01 vaccine on 01/09/01. patient reportedly "developed edema and joint pain- elbow, wrists and ankles and fingers, also neck pain the evening after vaccination still persist". From additional correspondence received on 02/16/01, additional patient, vaccine, responsible physician and vaccine administrator information was provided.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site oedema, Injection site pain, Skin burning sensation
Clinical narrative: The patient reportedly experienced left arm pain, a burning sensation and swelling on 01/11/2001 after being seen by a private physician. The patient was treated with ibuprofen. From additional correspondence received on 02/27/2001, it was reported the patient is currently being treated for bursitis. The Dr advised these symptoms were not caused by the flu vaccine. No further information is anticipated. This case is closed.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Coordination abnormal, Oedema peripheral, Red blood cell sedimentation rate increased
Clinical narrative: Post vax, the patient reportedly experienced weakness in both feet and legs, uncoordinated, and swelling of both hands. The patient was evaluated by a neurologist. There was no confirmed diagnosis. The symptoms lasted 2 weeks and have resolved.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: From a report received on 01/04/01, it was reported that 10 minutes after pt received her vaccine, her entire arm became itchy with redness from itching at hand between thumb and forefinger. Treatment of Benadryl given with relief after 10-20 minutes.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: About 6 hours after pt received vaccine she developed tachycardia-120 bpm. The pt was seen in ER. Pt was back to normal in 2 or 3 days. From additional correspondence received on 02/27/01, additional pt, responsible Dr, vaccine administrator and laboratory data were provided. No further information is anticipated. This case is closed.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Nasal discomfort, Oesophageal spasm
Clinical narrative: It was reported that immediately after vaccination the pt could taste the vaccine, had esophageal spasms and a burning and nasal sensation, no respiratory distress or anaphylaxis. These symptoms lasted about 1/2 hour. Pt took Benadryl and was also seen in the emergency room. Further information is requested.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Alopecia
Clinical narrative: It was reported that 3- 4 days after receiving vaccine the pt's hair fell out. Pt had same experience with Hepatitis A & B vaccines, she lost 3/4 of her hair volume in 1998. Further information is requested.
Age: 42.0
Sex: F
Vaccine: FLU3, JEV, TYP
Symptoms: Cold sweat, Dizziness, Feeling hot, Flushing, Headache
Clinical narrative: Right after vaccinations the pt complained of feeling hot, clammy, and woozy and a light headache, skin color flushed. Pt was sidephhoretic. Pt had blood pressure taken several times until was normal. Pt stated that she felt hot and complained of tingling in both feet. Stated throat felt slightly tight when swallowing. No erythema on right or left arm. Pt stated she felt lightheaded. Pt given Epinephrine and Claritin with samples of Claritin to take home. At 1:25 pt still complained of tingling left arm and left leg but no signs or symptoms of distress. Was discharged per Dr.
Age: 42.0
Sex: F
Vaccine: FLU3, JEV, TYP
Symptoms: Paraesthesia, Throat tightness
Clinical narrative: Right after vaccinations the pt complained of feeling hot, clammy, and woozy and a light headache, skin color flushed. Pt was sidephhoretic. Pt had blood pressure taken several times until was normal. Pt stated that she felt hot and complained of tingling in both feet. Stated throat felt slightly tight when swallowing. No erythema on right or left arm. Pt stated she felt lightheaded. Pt given Epinephrine and Claritin with samples of Claritin to take home. At 1:25 pt still complained of tingling left arm and left leg but no signs or symptoms of distress. Was discharged per Dr.
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: Two days after vaccination pt presented with redness, swelling, warmth, and inflamed area. Seen by physician and diagnosed with cellulitis. Antibiotics were prescribed and pt is responding to treatment. Additional correspondence received on 04/06/2001, it was reported that the pt recovered from this experience.
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Two days after vaccination pt presented with redness, swelling, warmth, and inflamed area. Seen by physician and diagnosed with cellulitis. Antibiotics were prescribed and pt is responding to treatment. Additional correspondence received on 04/06/2001, it was reported that the pt recovered from this experience.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pruritus, Rash erythematous
Clinical narrative: From an initial report dated 04/20/01, it was reported a pt vaccinated on 01/04/2001 pt had a local reaction the next day. the pt developed a slightly raised, red, rash, the size of your hand. It was painful, itchy and she had some neuritis and numbness the length of her arm radiating from vaccination site. She also had muscle soreness. Spoke with her and she had just taken Benadryl and Excedrin on day 3. That did alleviate her symptoms. She is going to try to get the lot number from her vaccine. Pt called in 01/10/2001 with lot number.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Infection, Pain in extremity
Clinical narrative: It was reported that a 62 year old female pt received a Fluzone SV 00-01 vaccination in 11/00. Reported ten days after vaccination the pt developed painful spot on index toe on foot. After the first of the year (Jan 2001) the pt developed painful spots on right side of back-possible atypical shingles
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: After receiving vaccines, the pt developed numbness of the right deltoid, onset date not specified, which had progressively improved. From correspondence received on 06/29/01 it was stated shortly after vaccination pt's arm was like it was dead. To hold a cup of tea left hand had to pick right hand up-weak. Gradually gone, reported 100% return to normal on 06/12/01.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Dry mouth, Headache, Hyperhidrosis, Myalgia
Clinical narrative: It was reported that an 76 year old male pt received a Fluzone SV 00-01 vaccination in 11/2000. Reportly sometime after the vaccination (date not specified) the pt developed headaches, diaphoresis, abdominal pain, myalgia, and mouth. No further information was provided from mailed correspondence returned on 06/29/2001.
Age: 4.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Viral infection
Clinical narrative: Varicella zoster, developed approximately 11/01/2001
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, HEP, IPV, MMR
Symptoms: Petechiae
Clinical narrative: Petechiae on buccal mucosa, trunk and extremities. Pt was referred to ER for evaluation.
Age: 0.2
Sex: M
Vaccine: PNC, PNC
Symptoms: Antisocial behaviour, Listless, Oral intake reduced, Pyrexia, Staring
Clinical narrative: Increased sleep, listlessness, decreased eye contact "staring" away & past care givers. Decreased movement. Tone remained good. Perfusion good. Decreased appetite but sucks good when nursing.  Temp 101.3 R. No local signs 36-48 hr before resolution
Age: 0.2
Sex: M
Vaccine: PNC, PNC
Symptoms: Decreased appetite, Hypokinesia, Laboratory test abnormal, Listless, Pyrexia
Clinical narrative: Increased sleep, listlessness, decreased eye contact "staring" away & past care givers. Decreased movement. Tone remained good. Perfusion good. Decreased appetite but sucks good when nursing.  Temp 101.3 R. No local signs 36-48 hr before resolution
Age: 0.2
Sex: M
Vaccine: PNC, PNC
Symptoms: Somnolence, Staring
Clinical narrative: Increased sleep, listlessness, decreased eye contact "staring" away & past care givers. Decreased movement. Tone remained good. Perfusion good. Decreased appetite but sucks good when nursing.  Temp 101.3 R. No local signs 36-48 hr before resolution
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Aspiration, Choking, Cyanosis, Dyspnoea, Pallor
Clinical narrative: Choking spell (choking), aspiration spell (aspiration), not breathing well (dyspnoea, NOS), pale (pallor), perioral cyanosis (cyanosis NOS). F/U states: Country of origin; United States. A 3 month old female received her 2nd doses of Prevnar, Menomune, Havrix and Rabies vaccine (the given batch no. UA598AB is unknown for RabAvert) on 8/23/01. Approx. 5-6 hours, post vax, the infant experienced a "choking/aspiration spell". She also was "not breathing well" and turned pale with perioral cyanosis. EMS were called and the child was seen in an ER. The reporter noted that the infant recovered before reaching the ER. She was hospitalized where a result of a CBC, UA and "basic metabolic panel" were normal. Seriousness criteria: hospitalization, life-threatening. Causality: possible (for possible allergic reaction). No change is risk-benefit-ratio. No measures necessary. Addendum 11/15/01: According to information received, no rabies vaccine was administered to the child. The vaccines administered on 8/23/01 were Infanrix, Prevnar, Act-Hib and IPOL, rather than Havrix, Prevnar, Menomune and Rabies vaccine, as originally reported. Consequently, for RabAvert, this case is reclassified as non-company-drug. Causality unrelated (rabies was not administered.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Rash, Urticaria
Clinical narrative: A 6 month old white female with atopic dermatitis and no known illness at the time of vaccination, was vaccinated with a second dose of hep B vaccine recombinant (yeast), IM in the right thigh, on 12-MAR-2001. Concomitant therapy, that day, included the third doses of ACT-HIB, Prevnar and Tripedia. There were no additional concomitant medications reported. The pt presented to the physicians office with a "few fine, minimally raised red patches 1-3mm in diameter" on her face and trunk. On 12-MAR-2001 the pt developed urticaria within 15 minutes of the immunization and was treated with Benadryl. The pt was sent to an allergy specialist for skin testing. The pt had tested positive for thimerosal allergy. Subsequent follow up indicated that the kin testing revealed an allergy to hep B vaccine recombinant (yeast) and Tripedia, but results were negative for allergy to Prevnar and ACT-HIB. On 12-MAR-2001, the pt recovered from her experience. Urticaria, testing positive for thimerosal and "allergy to DTaP and HBV" were determined to be other important medical events. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Injection site pain, Neck pain, Pain
Clinical narrative: Information has been received from an RN concerning a 65 year old female who was vaccinated at another physicians practice with the 1st dose of pneumococcal vaccine 23 polyvalent at the age of 52 and her 2nd dose at the age of 60. On 10/29/01, she was vaccinated with a 3rd dose of pneumococcal vaccine 23 polyvalent (lot 640744/0994L). On 10/29/01, about 4 hours, post vax, the pt came back to the office with pain in her arm, neck, back and under her breast. She had chills but no fever. She was also vomiting. The injection site was tender to touch. Subsequently, the pt was hospitalized. IV fluids and diphenhydramine hydrochloride (Benadryl) were started. She was also started on therapy with promethazine hydrochloride (Phenergan) for the vomiting. Additional information has been requested. F/U states: The pt was treated with Benadryl, IM, in the physician's office and was kept in the office for observation. The pt still complained of pain so she went to the hospital and was admitted to the telemetry unit where she was treated with IV fluids, diphenhydramine HCI q6 hours and meperidine hydrochloride (Demerol) for pain. She was also started on therapy with Phenergan for the vomiting. The pt was discharged from the hospital on 10/30/01. The discharge dx was intractable pain. The pt was seen in the physician's office on 11/12/01 and was currently receiving physical therapy for her pain. No further information is expected. The pt had no adverse reaction after receiving the 1st and 2nd doses.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Information has been received from an RN concerning a 65 year old female who was vaccinated at another physicians practice with the 1st dose of pneumococcal vaccine 23 polyvalent at the age of 52 and her 2nd dose at the age of 60. On 10/29/01, she was vaccinated with a 3rd dose of pneumococcal vaccine 23 polyvalent (lot 640744/0994L). On 10/29/01, about 4 hours, post vax, the pt came back to the office with pain in her arm, neck, back and under her breast. She had chills but no fever. She was also vomiting. The injection site was tender to touch. Subsequently, the pt was hospitalized. IV fluids and diphenhydramine hydrochloride (Benadryl) were started. She was also started on therapy with promethazine hydrochloride (Phenergan) for the vomiting. Additional information has been requested. F/U states: The pt was treated with Benadryl, IM, in the physician's office and was kept in the office for observation. The pt still complained of pain so she went to the hospital and was admitted to the telemetry unit where she was treated with IV fluids, diphenhydramine HCI q6 hours and meperidine hydrochloride (Demerol) for pain. She was also started on therapy with Phenergan for the vomiting. The pt was discharged from the hospital on 10/30/01. The discharge dx was intractable pain. The pt was seen in the physician's office on 11/12/01 and was currently receiving physical therapy for her pain. No further information is expected. The pt had no adverse reaction after receiving the 1st and 2nd doses.
Age: 32.0
Sex: F
Vaccine: MEA
Symptoms: Premature labour, Respiratory tract infection, Sinusitis
Clinical narrative: Information hasbeen received from a reistered nurse concerning a 32 yearold female with codeine allergy who on 10/18/2000 was vaccinated with a dose of the measles virus vaccine live (627545/0624K). On 1/5/01, pt was vaccinated with the measles virus vax. On 1/5/01, the pt stated she might be 6 weeks pregnant. Unspecified medical attention was sought. In follow-up, nurse reported that the pt's last menstrual period was 11/5/00. The pt's pregnancy was confirmed by US. The pt had two previous pregnancies and two previous live births without any birth defects. The pt did not have a history of miscarriage or stillbirth the patient was on vitamins (unspecified) during her pregnancy. On 2/15/01, pt had sinusitis and was placed on therapy with amoxicillin until 2/25/01. On 3/7/01, pt developed respiratory infection and was treated with azithromycin IV and Phenergan. On 7/8/01, pt went into preterm labor (37 week gestation). Pt was given terbutaline and nifedipine. On 8/15/01, pt delivered a normal 9 lb 5 oz male. The baby did not have any congenital anomalies. The infant did have reflux. Upon internal review, preterm labor was determined to be an other important medical event. No further info is available.
Age: 11.0
Sex: M
Vaccine: DT, PPV
Symptoms: Cellulitis, Fasciitis, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Pt was referred from an allergy specialist for vax. Approximately 48 hours post vax, pt developed a severe injection site reaction. The area of induration was 10-15 cm in diameter. It was reported that an empiric anti-staph antibiotic was started with no improvement. He then started outpt therapy with Ancef. The area was reported to exhibit thickening and erythema. At the time of this report, the area was still indurated and peeling. The pt sought medical attention and was hospitalized for treatment of these events on an unspecified date. Follow-up info recvd from an MD indicated that the child was hospitalized for what "looked like a cellulitis." The child had been receiving IV antibiotics for 2 weeks at his home. The MD noted that because he was not the one who administered the vax, he was not sure if the vial was a multi-dose vial or not. Follow-up info recvd from MD indicated that the pt was seen in office on 10/30/01, 3 weeks since the vax and the onset of the cellulitis and fascitis syndrome. The pt had an 8 cm area of induration at the wides diameter of his arm. The MD was going to have the pt continue on the IV antibiotics at home and have another MRI done. Addtl info has been requested. Initial and follow up info has been recieved from a physician concerning an 11 year old male student with a history of periodic fevers who on 10/4/01 was vaccinated in the left upper arm with the first dose (635893/1197K) of pneumococcal vaccine 23 polyvalent upon referral from an allergy specialist for an immunology work-up. Concomitant therapy on 10/4/01 included a dose in the left thigh of diphtheria toxoid/tetanus toxoid. The child's skin eventually desquamated. The physician reported that the IV antibiotics were discontinued on 11/6/01 and that the pt recovered the same day. No further info is available.
Age: 11.0
Sex: M
Vaccine: DT, PPV
Symptoms: Red blood cell sedimentation rate increased, Skin exfoliation, Skin hypertrophy
Clinical narrative: Pt was referred from an allergy specialist for vax. Approximately 48 hours post vax, pt developed a severe injection site reaction. The area of induration was 10-15 cm in diameter. It was reported that an empiric anti-staph antibiotic was started with no improvement. He then started outpt therapy with Ancef. The area was reported to exhibit thickening and erythema. At the time of this report, the area was still indurated and peeling. The pt sought medical attention and was hospitalized for treatment of these events on an unspecified date. Follow-up info recvd from an MD indicated that the child was hospitalized for what "looked like a cellulitis." The child had been receiving IV antibiotics for 2 weeks at his home. The MD noted that because he was not the one who administered the vax, he was not sure if the vial was a multi-dose vial or not. Follow-up info recvd from MD indicated that the pt was seen in office on 10/30/01, 3 weeks since the vax and the onset of the cellulitis and fascitis syndrome. The pt had an 8 cm area of induration at the wides diameter of his arm. The MD was going to have the pt continue on the IV antibiotics at home and have another MRI done. Addtl info has been requested. Initial and follow up info has been recieved from a physician concerning an 11 year old male student with a history of periodic fevers who on 10/4/01 was vaccinated in the left upper arm with the first dose (635893/1197K) of pneumococcal vaccine 23 polyvalent upon referral from an allergy specialist for an immunology work-up. Concomitant therapy on 10/4/01 included a dose in the left thigh of diphtheria toxoid/tetanus toxoid. The child's skin eventually desquamated. The physician reported that the IV antibiotics were discontinued on 11/6/01 and that the pt recovered the same day. No further info is available.
Sex: F
Vaccine: PPV
Symptoms: Infection
Clinical narrative: Information has been received from a pharmacy sales representative concerning a female who on approx. 10/22/01 was vaccinated with pneumococcal vaccine 23 polyvalent. A few days later, in 10/01, the pt was hospitalized for a "infection". The same source also provided information regarding other persons' experiences with pneumococcal vaccine 23 polyvalent (WAES 01110031). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Hypokinesia, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a woman in a physician's office concerning a 58 year old Caicasian male pt with hyperlipidemia and coronary artery disease and no known allergies and a history of asbestos exposure who on 10/18/2001 was vaccinated in the right arm with a second dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccinations on 10/18/01 included a second dose in the right arm of Fluvirin. Other concomitant therapy included atenol, lisinopril, aspirin and hydrochlorothiazide. Subsequently, the patient developed erythema with 3+ edema. The affected area was from the injection site(deltoid)to his wrist, affecting his upper arm and forearm. It was reported that his arm was so bad that he couldn't touch his head. He was started on prednisone over the weekend (on approximately 10/20/20010. The condition was reported to not be resolving so that patient was started on amoxicillian trihydrate (+)Clavulanate potassium 875 mg twice daily for cellulitis. The reporter indicated that she thought the patient was improving because their office had not heard anything further from him. The reporter expressed a concern with the lot since 3 patients received the vaccine and "have had reaction". FOLLOW-UP information from a physician indicated that the patient developed swelling, erythema, pain of right arm from injection site to wrist, with a fever of 101. The patient was treated with antibiotics with resolutiuon of symptoms over approximately 10 days. No further information is availble.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Cough, Rash, Retching, Stomatitis
Clinical narrative: Approximately 10 min post vax, pt developed cough, gagging sensation, funny feeling in mouth, perioral swelling. Pt was given epi 1:1000 0.2ml SQ and diphenhydramine 12.5mg po. Symptoms improved, but then pt developed urticaria 50 min later. She recvd 2nd epi 0.2ml SQ and was transported to the hospital.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: Approximately 10 min post vax, pt developed cough, gagging sensation, funny feeling in mouth, perioral swelling. Pt was given epi 1:1000 0.2ml SQ and diphenhydramine 12.5mg po. Symptoms improved, but then pt developed urticaria 50 min later. She recvd 2nd epi 0.2ml SQ and was transported to the hospital.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Pt experienced an anaphylactic reaction within 15 minutes of receiving vax. Pt required medical intervention, intubation and hospitalization in ICU.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Autism, Cellulitis, Conjunctivitis, Cough
Clinical narrative: 12/03/1997 fever 3 days, eyes puffy, fussy, mild cough, runny nose, puss very early peril orb cellulitis, augment in. 12/10/1997 5 days diaper rash, red scrotum and pus, s dellitis lesions, candid diaper rash, nystatin cream. 12/12/1999, Hypotonia throughout extremities and trunk, 7/01/1999, Speech, hearing, intuening, poor eye contact concerns. 98/11/1999, Autism, significant delay in speech.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Face oedema, Hypotonia, Pyrexia, Rash, Rhinitis
Clinical narrative: 12/03/1997 fever 3 days, eyes puffy, fussy, mild cough, runny nose, puss very early peril orb cellulitis, augment in. 12/10/1997 5 days diaper rash, red scrotum and pus, s dellitis lesions, candid diaper rash, nystatin cream. 12/12/1999, Hypotonia throughout extremities and trunk, 7/01/1999, Speech, hearing, intuening, poor eye contact concerns. 98/11/1999, Autism, significant delay in speech.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Autism, Bone development abnormal, Hypotonia, Increased appetite, Muscular weakness
Clinical narrative: 8/13/97, pt's legs and feet gave way. He was bow-legged in lower legs and his feet turned in. Pt noted to have poor eye contact at 18 mos of age at which time milk addiction also started. 02/12/1999 pt had hypotonia throughout extremities and trunk. 7/1/99 pt was intoeing and had poor eye contact. 8/11/99 pt diagnosed as having autism with significant delay in speech.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Speech disorder, Staring
Clinical narrative: 8/13/97, pt's legs and feet gave way. He was bow-legged in lower legs and his feet turned in. Pt noted to have poor eye contact at 18 mos of age at which time milk addiction also started. 02/12/1999 pt had hypotonia throughout extremities and trunk. 7/1/99 pt was intoeing and had poor eye contact. 8/11/99 pt diagnosed as having autism with significant delay in speech.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Autism, Bone disorder, Decreased appetite, Hearing impaired, Hypotonia
Clinical narrative: 4/29/97-Rash all over body, cranky, decreased appetite and 3 days of fever. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. Pt had yellow eye discharge at 6 months of age with his 3rd polio (+) DTP (+) Hib.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Irritability, Muscle disorder, Pyrexia, Rash, Speech disorder
Clinical narrative: 4/29/97-Rash all over body, cranky, decreased appetite and 3 days of fever. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. Pt had yellow eye discharge at 6 months of age with his 3rd polio (+) DTP (+) Hib.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Staring
Clinical narrative: 4/29/97-Rash all over body, cranky, decreased appetite and 3 days of fever. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. Pt had yellow eye discharge at 6 months of age with his 3rd polio (+) DTP (+) Hib.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Bone disorder, Cough, Eye discharge, Hearing impaired, Hypotonia
Clinical narrative: 2/14/97-Eye discharge (yellow), fever for 2 days and a cough. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Muscle disorder, Pyrexia, Speech disorder, Staring
Clinical narrative: 2/14/97-Eye discharge (yellow), fever for 2 days and a cough. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Autism, Bone disorder, Ecchymosis, Hearing impaired, Hypotonia
Clinical narrative: 12/20/96-Discoloration around eyes and bluish mark on bridge of nose. 2/12/99-hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. At 2 months of age, pt had right eye discharge, post vax of 1st , Polio (+) DTP (+) Hib.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Muscle disorder, Skin discolouration, Speech disorder, Staring
Clinical narrative: 12/20/96-Discoloration around eyes and bluish mark on bridge of nose. 2/12/99-hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech. At 2 months of age, pt had right eye discharge, post vax of 1st , Polio (+) DTP (+) Hib.
Age: 0.2
Sex: M
Vaccine: DTPHIB, OPV
Symptoms: Autism, Bone disorder, Dermatitis atopic, Eye discharge, Hearing impaired
Clinical narrative: 9/28/96-Right eye discharge, possible LDS (mild) and URI. 11/18/96-Mild atopic dermatitis. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/1/99-Autism and significant delay in speech.
Age: 0.2
Sex: M
Vaccine: DTPHIB, OPV
Symptoms: Hypotonia, Muscle disorder, Speech disorder, Staring, Upper respiratory tract infection
Clinical narrative: 9/28/96-Right eye discharge, possible LDS (mild) and URI. 11/18/96-Mild atopic dermatitis. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/1/99-Autism and significant delay in speech.
Sex: M
Vaccine: HEP
Symptoms: Autism, Bone disorder, Hearing impaired, Hypotonia, Muscle disorder
Clinical narrative: 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech.
Sex: M
Vaccine: HEP
Symptoms: Speech disorder, Staring
Clinical narrative: 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adrenal insufficiency, Pyrexia
Clinical narrative: Febrile illness with adrenal insufficiency in pt with Addison's disease.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt noted some itching at site of injection about an hour after receiving vaccine. Itched until about 8:00 pm 10/03/2001. Pt called back to state (10/04/2001, 4:00 pm) that the arm was red, hard, swollen, tender, and warm. No elevation of temperature noted. Much improved by 3 days.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus
Clinical narrative: Pt noted some itching at site of injection about an hour after receiving vaccine. Itched until about 8:00 pm 10/03/2001. Pt called back to state (10/04/2001, 4:00 pm) that the arm was red, hard, swollen, tender, and warm. No elevation of temperature noted. Much improved by 3 days.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient complained of flu like symptoms; body aches and chilly feeling. The patient developed redness at the injection site in an 3 cm area. The redness, swelling and pain increased on 10/30/2001 with swelling to the elbow.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: The patient complained of flu like symptoms; body aches and chilly feeling. The patient developed redness at the injection site in an 3 cm area. The redness, swelling and pain increased on 10/30/2001 with swelling to the elbow.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Post vax, the patient complained her index finger and thumb on her left hand went completely numb, preceded by tingling.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: The patient complained of redness, swelling, itching and warmth to the injection site.
Age: 70.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient's spouse reports the patient had a local reaction to the left arm with redness and swelling at the injection site.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The patient complained of soreness and redness at the injection site the day after the vaccination. The area around the injection site was approximately 6" long and 4" wide and was raised and red. The patient was treated with Benadryl and Tylenol.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Vertigo, Vomiting
Clinical narrative: Approximately seven hours post vaccine the patient had a sudden onset of vertigo, near syncope and several episodes of vomiting. 911 was called by the family. The patient's vital signs were checked, but the patient declined treatment or transport to the hospital.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The patient developed hives over her entire body starting from her feet and spreading upwards around 5:30 pm, 11/03/2001.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient experienced soreness overnight and swelling to the elbow. The patient was seen in the office and her left arm was swollen the elbow and warm to the touch.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Hyperhidrosis, Nausea, Throat tightness
Clinical narrative: Within 10 minutes post vax, the patient experienced heart arrhythmia, her airway was tight, she was nauseous and sweating. Patient was treated with Epipen and taken to ER. Doctors determined her reaction was due to lactose intolerance.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: Post vax the patient reported itching and redness of the left deltoid.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The patient reported redness and pain at the injection site in an area 4" in diameter. The patient complained of pain from the elbow to the shoulder. Symptoms subsided in 5 days.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: The patient developed cellulitis one day post vax.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Arthralgia, Chills, Cough, Glossodynia
Clinical narrative: On 10/19/2001 the patient developed flu like symptoms which gradually worsened. The patient complained of chills, hot and cold, cough, red and sore upper palate and throat, sore tongue, sore joints and loss of appetite. The patient was treated with Xylocaine gel, Swish and Swallow, and Tylenol.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pharyngolaryngeal pain, Stomatitis
Clinical narrative: On 10/19/2001 the patient developed flu like symptoms which gradually worsened. The patient complained of chills, hot and cold, cough, red and sore upper palate and throat, sore tongue, sore joints and loss of appetite. The patient was treated with Xylocaine gel, Swish and Swallow, and Tylenol.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Fatigue, Flushing, Malaise, Muscle spasms
Clinical narrative: Post vax, the patient complained of a sick feeling, very tired, loss of appetite, leg cramps and facial flush. These symptoms lasted 7 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Angioneurotic oedema, Pruritus, Swelling, Urticaria
Clinical narrative: Post vax, the patient developed abdominal hives, palmar itching, swelling and angioedema of her lip.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness, Tremor
Clinical narrative: Ten minutes post vax the patient complained of feeling shakey and his throat feels tight. The patient was treated with Benadryl.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Post vax the patient developed a blister on her left arm and her left arm was swollen. There was no evidence of cellulitis.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Post vax the patient developed swelling and reddening of the right deltoid. The patient was treated with cold compresses.
Age: 36.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Headache, Nausea, Swelling
Clinical narrative: Post vax the patient complained of swelling arms, nausea, and headaches.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Injection site induration, Injection site warmth, Myalgia
Clinical narrative: Post vax the patient experienced vesicular eruptions, erythema, warmth and induration  at the injection site, a mild headache, myalgia and a low grade fever.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Post vax the patient experienced vesicular eruptions, erythema, warmth and induration  at the injection site, a mild headache, myalgia and a low grade fever.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Swelling
Clinical narrative: Post vax the patient developed a swollen arm, painful to touch. The patient was treated with Tylenol and recovered.
Age: 47.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Contusion, Injection site inflammation, Joint range of motion decreased, Pain
Clinical narrative: Post vax the patient developed a very inflamed area 7-8 cm /809 cm in diameter, bruised in the middle. The right arm was very sore and could not be picked up without using the left arm. The patient was treated with Benadryl and ice packs.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site swelling, Nausea
Clinical narrative: The patient felt sick for a few minutes post vax. The next day the patient had swelling that lasted a few days, the size of a baseball. The patient's arm is now bruised, but clearing.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The patient's arm was red, warm and ached after vaccination.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling developed 36 hours post vaccine with the left arm measuring 4 cm larger than the right. Probable cellulitis.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient complained of soreness, redness, and warmth around the vaccination site the day after injection. The affected area was 2" wide x 4" long and was slightly raised. After 3 days the area was still slightly sore, but the redness was gone.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Pruritus, Urticaria
Clinical narrative: Post vax the injection site was red, hot and itchy. The patient had hives on her chest and abdomen. The patient was treated with Medrol Dispenspack and Zyrtec.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: The patient developed redness and itching at the injection site in an area 50mm long x 10mm wide. The patient was treated with cold packs and Claritin.
Age: 7.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Approximately 4-5 diameter hot erythematous reaction on left deltoid-Benadryl 2 tsps every 4-6 hrs for reaction prescribed.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt developed a large red, warm, area surrounding vaccine site w/advancing erythematous boarder.
Age: 1.7
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site mass, Lymphadenopathy
Clinical narrative: Mom reported that child developed enlarged lymph nodes in the right femoral area, a knot at the site of injection the size of a golf ball, and redness the size of a quarter after being immunized on 9/6/01. she stated the same reaction occurred after the first Prevnar on 7/5/01 Lymph nodes still enlarged off and on.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Pain
Clinical narrative: 8/2/01 leg sore, Tylenol given. Won't take bottle. Isn't drinking. Referred to Md. 8-3-01 child ok. Seen Md -ok. As of 10-05-01 child ok.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Mom reported infant received Prevnar vaccine on 10/17/01. On 10/21/01 she noticed her infant had a mild case of hives on extremities and trunk and face. Approximately 15 hives all total. took infant to PMP on 10/22/01, no treatment indicated. Hives no longer in visible on 10/24/01. No further complications noted.
Age: 0.3
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Choking, Rash maculo-papular, Rhinorrhoea
Clinical narrative: On 8-28/01, at night time she acted like she was choking with her secretions. Her skin got splotchy. Acted as if she couldn't breath. Mucous from the mouth lasted 1 hour.
Age: 0.7
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PNC
Symptoms: Wrong drug administered
Clinical narrative: 8 month old was in exam room with older sibling who was scheduled to get shots also. Pt inadvertly given MMR. (see back)
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site swelling
Clinical narrative: Golf ball size swelling at shot sight of vaccines-right leg.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC
Symptoms: Erythema, Injection site oedema
Clinical narrative: Generalized erythema, edema of left upper arm from slhoulder to elbow which is painless and has full range of motion.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Vomiting
Clinical narrative: Vomiting after each feeding for one week. Diet gradually advanced from clear liquids to bland solids. Vomiting resolved.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash erythematous
Clinical narrative: On 10-17-01 grandmother reports fever of 103.6 then rash developed - red, raised. Rash worsened over time  and when in heat. Took to ER for evaluation, unsure if vaccine RX or 3 day measles. Rash and fever still present.